- where the controlled product is a pure substance, the chemical identity of the controlled product and, where the controlled product is not a pure substance, the chemical identity of any ingredient thereof that is a controlled product and the concentration of that ingredient,
- where the controlled product contains an ingredient that is included in the Ingredient Disclosure List and the ingredient is in a concentration that is equal to or greater than the concentration specified in the Ingredient Disclosure List for that ingredient, the chemical identity and concentration of that ingredient,
- the chemical identity of any ingredient thereof that the supplier has reasonable grounds to believe may be harmful to any person and the concentration of that ingredient,
- the chemical identity of any ingredient thereof the toxicological properties of which are not known to the supplier and the concentration of that ingredient, and
- such other information with respect to the controlled product as may be prescribed; and
14. Subject to the Hazardous Materials Information Review Act, no supplier shall import a controlled product intended for use in a work place in Canada unless
- the supplier obtains or prepares, on the importation of the controlled product, a material safety data sheet with respect to the controlled product that discloses the information referred to in subparagraphs 13(a)(i) to (v) and keeps the material safety data sheet available for such purposes as may be prescribed; and
- the controlled product or container in which the controlled product is packaged has applied to it a label that discloses prescribed information and has displayed on it all applicable prescribed hazard symbols.
Interpretation / Discussion of Sections 13 and 14
Controlled Product: Whether a product, material or substance is or is not a controlled product is determined by assessing the product against the criteria specified in Part IV of the Controlled Products Regulations (CPR). Part IV of the CPR describes products, materials or substances that are included in the classes set out in Schedule II of the HPA. If a product, material or substance meets any of the criteria in Part IV, it is a controlled product within the terms of the HPA and, subject to exemptions, cannot be sold in or imported into Canada unless the supplier meets the requirements for MSDSs, labels and information disclosure.
Intended Use (of the Controlled Product): "Intended for use in a work place" refers to the intention of the supplier. A supplier who sells a controlled product to a retail outlet for use by consumers is not subject to the WHMIS supplier MSDS and label requirements of Part II of the HPA even if an employer, in turn, buys the product from the retail outlet for use in the employer's work place. If, however, a controlled product is sold to a work place for the purpose of being packaged or repackaged for subsequent sale including sale to consumers, this operation does constitute intended use. Use includes any situation where a worker may potentially be exposed to a substance in a work place and includes a repackaging operation, .
Employer obligations: WHMIS employer requirements place a general duty on the employer to train "a worker who works with a controlled product or in proximity to a controlled product." The general policy document of the WHMIS employer requirements makes a distinction between storage, handling, use and disposal. This policy document states the following:
- a worker who works with a controlled product is any worker who stores, handles, uses or disposes of a controlled product, or who supervises another worker performing these activities;
- "in proximity" is the area in which worker health and safety could be at risk during:
- storage, handling use or disposal of the product;
- maintenance operations; or
- emergencies, such as an accidental leak or spill.
Charging Fees for Provision of MSDSs: As Section 13 of the HPA requires that a supplier provide a MSDS as a condition of sale of a controlled product, the supplier cannot charge a separate fee, above or beyond the price of the product itself, in connection with the provision of the MSDS. The withholding of a MSDS by a supplier because of non-payment of a MSDS fee by the purchaser of the controlled product would constitute a serious violation of the HPA. A request for payment for MSDSs in respect of non controlled products, or requests from individuals wishing to acquire a supplier's MSDS who have not purchased the supplier's product, is outside of the scope of the HPA.
Internet, use of to transmit MSDSs in repsect of sale: As section 13 of the HPA requires a positive action by the transmitter to convey the transmitted document to the recipient, making a MSDS available on the Internet without ensuring that the purchaser is able to access this information does not absolve a supplier of the legal requirement to transmit a MSDS as a condition of sale.
The use of the Internet to transmit an MSDS would be acceptable if the supplier is able to demonstrate the following:
- the purchaser has downloaded the complete and correct MSDS, i.e., one that contains all of the required information;
- the downloading is done "at the time of the sale of the controlled product" as required under section 24 of the CPR; and
- the downloaded file is readable
Satisfaction, on the part of the supplier, may be provided through written confirmation, provided to the supplier from the purchaser, specifying that the above conditions have been met.
A more passive approach to the section 13 obligation, ie., where the supplier would simply post an MSDS on its Web site, would need to be reflected in the legislation.
With the consent of both parties, transmission of a MSDS by e-mail by a supplier to a customer via the Internet is an acceptable means of transmitting a MSDS.
The United States Occupational Safety and Health Administration has also communicated the conditions for the acceptability of the use of the Internet to provide MSDSs:
- OSHA Standards Interpretation and Compliance Letters; "Manufacturers' use of the Internet for distribution of MSDSs to downstream users"; February 20, 1997 letter from Stephen Mallinger, Acting Director Office of Health Compliance Assistance to Kevin Johnson, CIH, CSP Corporate EH&S Manager, Chiron Diagnostics Corporation; http://www.osha.gov/pls/oshaweb/owadisp.show_document?
p_table=INTERPRETATIONS&p_id=22353&p_text_version=FALSE - OSHA Standards Interpretation and Compliance Letters; " Internet use for posting MSDSs"; June 16, 1997 letter from Greg Watchman Acting Assistant Secretary to Honorable Jay W. Johnson U.S. House of Representative; http://www.osha.gov/pls/oshaweb/owadisp.show_document?
p_table=INTERPRETATIONS&p_id=22427&p_text_version=FALSE
Internet, use of to "obtain" or "prepare" a MSDS in respect of importation: Section 14 of the HPA places a legal requirement on the Canadian importer of a controlled product to obtain or prepare a MSDS as a condition of importation. Regulatory agencies have agreed to accept the use of the Internet to fulfill the requirement to "obtain" a MSDS on the condition that the Canadian importer is able to generate and provide a hard copy of the MSDS disclosing the prescribed information to an inspector if requested to do so.
Legibility of MSDSs: As required by paragraph 13 (a), the supplier must "transmit a MSDS. ". The term "transmit" is defined in section 11 of the HPA and includes transmittal by electronic and optical means. Sometimes, as a result of electronic or optical transmittal, the quality of the print may vary. In contrast to the explicit requirement that labels be "easily legible" (see section 21 of the CPR), there is no analogous requirement regarding the legibility of MSDSs. MSDSs which are not legible, however, are not considered to be in compliance with the HPA requirement to transmit a MSDS.
Transmission of MSDSs: The term "transmit" is defined in section 11 of the HPA (English version only). The MSDS must accompany, or be provided before, the sale of the controlled product. As provided for by section 6 of the CPR, a supplier need not send a MSDS in respect of subsequent sales of the same product if the MSDS provided with the original sale is not more than three years old. Refer to Section 29 of the CPR for requirements regarding updating MSDSs.
Gasoline and Propane, Sale of ~: Retail sales of gasoline or propane from a service station are exempted from WHMIS requirements as the sale of the product is intended for consumer use. Consideration will be given to amending the CPR to exclude the requirements for an MSDS on non-retail sales of gasoline, propane, etc., into a vehicle storage tank directly connected to an internal combustion engine or gas turbine engine. Until such time, it is the administrative policy to treat such non-retail sales as exempt. However, where fuel is being sold and delivered to a workplace (e.g., schools, businesses, industrial plants etc.), the WHMIS obligations arise because the product is being sold for use in a workplace. Since the product is transported in bulk, the MSDS and label information may be transmitted to the purchaser on or before the delivery of the product (such as at the time the contract is established); .
"Unknown" Ingredients: When the chemical identity of an ingredient of a controlled product is unknown" but the precursor constituents of the ingredient are known, a question arises as to what should be disclosed on the MSDS. In this case, the MSDS for a controlled product that contains an unknown "reaction product" for which the chemical identity is required to be disclosed should indicate:
- the best available chemical characterization of the reaction product, and only if that does not adequately describe the nature of the product;
- the chemical identity of precursor constituents that react to produce the product .
There are situations in which two or more known chemicals ("precursor constituents") react to produce an unknown ingredient ("reaction product"). The chemical identity of this "reaction product" will be required to be disclosed on the MSDS of a controlled product if it meets any of the three categories of ingredients required to be disclosed under paragraphs 13(a)(i), (iii) or (iv) of the HPA; .
Testing: A supplier is not required to undertake "state-of-the art" testing to determine ingredients. Testing, however, would normally be necessary to determine ingredients where they are unknown, . If foreign suppliers of ingredients refuse to give ingredient disclosure information, a number of products will be excluded from use by Canadian industries. A controlled product cannot be sold or imported into Canada unless the ingredient disclosure requirements of the HPA are met. The importer retains the legal responsibility for ingredient disclosure or lack thereof in respect of the importation of a controlled product; ; i.e., it is incumbent on the Canadian supplier / Canadian importer to undertake whatever testing is necessary to meet the ingredient disclosure requirements of the HPA.
Biohazardous Infectious Materials - chemical identity of ~: In the case of a biologically infectious material (Division 3 of Class D - Poisonous and Infectious Materials), "chemical identity" refers to the infectious organism itself and not its chemical makeup;a .
Section 13:
Section 13 of the HPA sets out the ingredients which, subject to trade secret provisions and specified conditions such as the cut-offs established in section 4 of the CPR, must be disclosed on the MSDS. It is not appropriate to use qualifiers such as "may contain" in relation to MSDS ingredient disclosure. Subparagraphs 13(a)(i) to (iv) describe the four categories of ingredients of a controlled product whose chemical identity and concentration must be disclosed on an MSDS. (Where ingredients present below their cut-off may have an additive or synergistic effect, suppliers are encouraged to disclose the identity and concentration of those ingredients):
Subparagraph 13(a)(i):
Where the controlled product is a pure substance, disclosure of the concentration of the pure substance is not required.
The chemical identity and concentration of an ingredient of a controlled product found in a concentration equal to or greater than the concentration specified in the Ingredient Disclosure List (IDL) must be disclosed on the MSDS. The IDL does not play a part in determining whether a product is a controlled product under the HPA.
Ingredients included on the IDL are one of the four categories of ingredients whose identity and concentration must be disclosed on the MSDS if present in a controlled product. An ingredient may be listed on the IDL and yet may not fall within any of the prescribed hazard criteria of the PR. Also, the IDL is not a complete listing of ingredients that fall within the prescribed hazard criteria of the CPR. Therefore, the IDL cannot be used as a basis to determine whether a product is a controlled product. The IDL can be used to determine whether an ingredient contained in a controlled product must be disclosed on the MSDS. Where an ingredient does not appear on the IDL, disclosure of the chemical identity of that ingredient may still be required by subparagraphs 13(a)(i), (iii) or (iv).
Where the concentration cut off for an ingredient in a mixture established under paragraph 4(a) of the CPR is lower than the cut off established in the IDL, the lower cut off takes precedence, (Refer to the interpretation of section 17 of the HPA for additional information on the IDL).
This paragraph requires the disclosure of ingredients that ". may be harmful to any person. ". This is meant to include all ingredients that the supplier has reasonable grounds to believe may have an adverse effect on workers. As a working definition, adverse effect may be taken to mean:
- injury to humans which is primarily caused by occupational exposure and which results in any reversible or irreversible material impairment to health or irreversible diminished functional capacity, or
- injury to mammals when validly tested in accordance with established scientific principles which results in any reversible or irreversible material impairment to health or irreversible diminished functional capacity.
This includes ingredients which, in a published article referred to in public scientific sources, indicate an adverse effect on man or mammals as well as through in vitro tests. Therefore, any ingredients in a controlled product which meet this criterion must be disclosed on the MSDS.
Subparagraph 13(a)(iv) is meant to refer to ingredients for which the supplier has no information about any of its toxicological properties. It was agreed that "the result of any one short-term bioassay or a repetition of that bioassay (e.g. a single Ames Test, positive or negative) shall not be considered in deciding whether anything is known about the toxicological properties of the material". Footnote 1
Section 12 of the CPR prescribes the additional information that must be disclosed on a MSDS. Refer to all of Part I, sections 4 to 13, of the CPR for complete information on the material safety data sheet.
Section 19 of the CPR prescribes the information that must be disclosed on the label of a controlled product or container in which the controlled product is packaged. Paragraph 19(1)(d) prescribes the hazard symbols that must be displayed on the label. Section 22 of the CPR provides information on the reproduction of the hazard symbols which are depicted in Schedule II of the CPR. Refer to all of Part II, sections 14 to 22, of the CPR for complete labelling requirements.
Section 2 of the HPA defines the term "import" as to "import into Canada". Based on the definitions provided in general dictionaries, importing into Canada means bringing goods from anywhere outside of Canada into Canada. In 1983, J. Dickson of the Supreme Court of Canada, in the matter of Bell vs. the Queen, (1983) 8 CCC (#d) 97, speaking for the majority, stated that "to actually commit" importing, an accused must bring in, or cause to be brought in, to Canada, goods from a foreign country. As such, any person who brings in, or causes to be brought in, to Canada, goods from a foreign country, can be considered an importer. Consequently, retailers and distributors can be said to be importers within the meaning of the HPA.
Moreover, when a sales representative takes an order and arranges the delivery of products from a foreign country or a customs bonded warehouse to a client in Canada, he/she is causing goods from a foreign country to be brought into Canada. Therefore, according to the Supreme Court of Canada's definition of importing, sales representatives "import" within the meaning of the HPA, even if the products imported never come into their possession.
According to paragraph 17(1)(b) of the Customs Bonded Warehouses Regulations:
"17(1) Goods shall not be manipulated, altered or combined with other goods while in a bonded warehouse except for the purpose of or in the course of.
(b) complying with any applicable law of Canada or of a province."
Consequently, the HPA does apply to products contained in warehouses located in Canada even in cases where the operator of the warehouse is not Canadian.
HPA Sections 15 - Regulations
Regulations
15. (1) Subject to section 19, the Governor in Council may make regulations
- specifying, for each class listed in Schedule II, products, materials and substances to be included in that class;
- establishing, for any class listed in Schedule II, divisions or subdivisions of that class and specifying, for each controlled product included in that class, the division or subdivision into which it falls;
- prescribing information to be disclosed on a material safety data sheet or label; [1999, c. 31, s. 129]
- prescribing the form and manner in which information shall be disclosed on a label and the manner in which a label shall be applied to a controlled product or container in which a controlled product is packaged;
- prescribing hazard symbols and the manner in which hazard symbols shall be displayed on a controlled product or container in which a controlled product is packaged;
- exempting from the application of this Part and the regulations or any provision thereof, on such terms and conditions as may be specified in the regulations, the sale or importation of controlled products in such quantities or concentrations, in such circumstances, at such places, premises or facilities, for such purposes or in such containers as are specified in the regulation;
- prescribing the manner of determining any quantities or concentrations of controlled products exempted pursuant to any regulation made under paragraph (f);
- prescribing circumstances in which for the purposes of paragraphs 13(a) and 14(a), a material safety data sheet may disclose, in lieu of the concentration of an ingredient of a controlled product, a range of concentration within which the concentration falls and prescribing the range of concentration that shall be disclosed on the material safety data sheet in such circumstances;
- defining the expressions "bulk shipment", "hazardous waste" and "work place" for the purposes of this Part;
- requiring any supplier who sells or imports a controlled product intended for use in a work place in Canada to provide, as soon as is practicable in the circumstances, any information referred to in paragraph 13(a) that is in the possession of the supplier to any physician or other medical professional specified in the regulations who requests that information for the purpose of making a medical diagnosis of, or rendering medical treatment to, a person in an emergency;
- requiring any physician or medical professional to whom information is provided by a supplier pursuant to any regulation made under paragraph (j) to keep confidential any information specified by the supplier as being confidential except for the purpose for which it is provided;
- subject to the Hazardous Material Information Review Act, requiring any supplier who sells or imports a controlled product intended for use in a work place in Canada to identify, as soon as is practicable in the circumstances, on request of any person within a class of persons specified in the regulations, the source of information for any toxicological data used in the preparation of any material safety data sheet that has been transmitted by the supplier to any person pursuant to paragraph 13(a) or has been obtained or prepared by the supplier pursuant to paragraph 14(a);
- prescribing any other matter or thing that by this Part is to be or may be prescribed; and
- generally for carrying out the purposes and provisions of this Part.
(2) For greater certainty, a regulation made pursuant to paragraph (1)(a) may describe a product, material or substance specified thereby to be included in a class listed in Schedule II by reference to any properties or characteristics of the product, material or substance or by reference to any other criteria and any product, material or substance that has those properties or characteristics or meets those criteria shall, for the purposes of this Act, be deemed to have been included in that class by the egulation.
(3) A regulation made pursuant to subsection (1) incorporating a law, standard or specification by reference may incorporate that law, standard or specification as amended from time to time.
Interpretation / Discussion Of Section 15
This section constitutes the legislative authority under which the Controlled Products Regulations have been established.
HPA Section 16 - Disclosure of Generic Chemical Identity
16. Where, pursuant to the Hazardous Materials Information Review Act, a supplier is exempt from disclosing on a material safety data sheet or label the chemical identity of a controlled product or the chemical identity of any ingredient of a controlled product, the supplier shall disclose on the material safety data sheet or label the generic chemical identity of the controlled product or ingredient with as much precision as is consistent with the exemption.
Interpretation / Discussion of Section 16
Precision of Generic Chemical Identity: If a supplier has applied for or has been granted an exemption from disclosing the chemical identity of a controlled product or the chemical identity of any ingredient of a controlled product, the supplier is still required to disclose the generic chemical identity as precisely as reasonably possible while still protecting the trade secret.
If, for example, there was a double bond somewhere in a molecule, the chemical identity of a very complex high molecular weight organic molecule could be described as a "substituted ethylene". In such a case, however, "substituted ethylene" would not be considered to meet the intent of the original consensus on this issue. This is reflected in the WHMIS Steering Committee Report which refers to "a generic name as precise as reasonably possible. ". WHMIS stakeholders reaffirmed that the quoted phrase be used as a guideline for use by the Hazardous Materials Information Review Commission (HMIRC) and inspectors in the interpretation of both section 16 of the HPA and subparagraph 16(b)(ii) of the CPR; .
An information bulletin, originally published as issue No. 4, October, 1992, issued by the Hazardous Materials Information Review Commission, provides guidance on the use of generic chemical identities; http://www.hmirc-ccrmd.gc.ca/
Generic chemical identity used to describe more than one ingredient: Where a supplier is exempt from disclosing more than one ingredient identity in the same controlled product and more than one of those ingredients can be described by the same generic chemical identity, the supplier may replace those ingredient identities on an MSDS by a single pluralized generic chemical identity. The single generic chemical identity must be capable of describing each of the ingredients it replaces with as "much precision as is consistent with the exemption" under the Hazardous Materials Information Review Act (HMIRA). Where, for example, a supplier is exempt under the HMIRA from disclosing the identity of heptane, octane and nonane in a controlled product, the supplier may disclose, in place of three generic chemical identities, the identifier "saturated aliphatic hydrocarbons" to meet the requirement of this section of the HPA, .
Interim Orders
16.1 (1) The Minister may make an interim order that contains any provision that may be contained in a regulation made under this Part if the Minister believes that immediate action is required to deal with a significant risk, direct or indirect, to health or safety.
(2) The Minister may make an interim order in which any power referred to in sections 17 and 18 is deemed to be exercised, if the Minister believes that immediate action is required to deal with a significant risk, direct or indirect, to health or safety.
(3) An interim order has effect from the time that it is made but ceases to have effect on the earliest of
(a) 14 days after it is made, unless it is approved by the Governor in Council,
(b) the day on which it is repealed,
(c) in the case of an interim order made under subsection (1), the day on which a regulation made under this Part that has the same effect as the interim order comes into force and, in the case of an interim order made under subsection (2), the day on which an order made by the Governor in Council under this Part that has the same effect as the interim order comes into force, and
(d) one year after the interim order is made or any shorter period that may be specified in the interim order.
(4) No person shall be convicted of an offence consisting of a contravention of an interim order that, at the time of the alleged contravention, had not been published in the Canada Gazette unless it is proved that, at the time of the alleged contravention, the person had been notified of the interim order or reasonable steps had been taken to bring the purport of the interim order to the notice of those persons likely to be affected by it.
(5) An interim order
(a) is exempt from the application of sections 3, 5 and 11 of the Statutory Instruments Act; and
(b) shall be published in the Canada Gazette within 23 days after it is made.
(6) For the purpose of any provision of this Part other than this section and section 19, any reference to regulations made under this Act is deemed to include interim orders, and any reference to a regulation made under a specified provision of this Act is deemed to include a reference to the portion of an interim order containing any provision that may be contained in a regulation made under the specified provision.
(7) A copy of each interim order must be tabled in each House of Parliament within 15 days after it is made.
(8) In order to comply with subsection (7), the interim order may be sent to the Clerk of the House if the House is not sitting.
[2004, c. 15, s. 68.]
Discussion of Section 16.1
The Public Safety Act, 2002 (PSA), received Royal Assent on May 6, 2004. The PSA amends several existing statutes to provide a power permitting the responsible Minister to make an interim order if the Minister believes that immediate action is required to deal with a significant risk, direct or indirect, to human life, health, safety, security, or the environment, and where existing regulation-making authority is available. These interim order provisions can also be found in section 5.1 of Part I of the HPA.
An interim order covers matters for which regulations would normally be made except that the immediacy of the threat requires an immediate response.
What is an Interim Order? An interim order is a regulation that is issued by the Minister in the case of a situation that presents a significant risk, direct or indirect, to human health, public safety, security, or the environment.
Under what conditions can an Interim Order be used? An interim order is to be used when there is an immediate threat or imminent risk of a significant proportion to human health, public safety, security, or the environment, which requires immediate action, with no time to resolve the issue through the standard regulatory process, and/or where the current regulatory authorities are insufficient, or where those regulatory processes or standards are an impediment to carrying out an immediate response to an emergency situation. An interim order can be used if all the following questions can be answered in the affirmative:
- Can the outcome only be achieved through ensuring compliance with new regulatory requirements or by removing unnecessary existing statutory or regulatory impediments?
- Can the change to the rules be performed under the existing regulation-making authorities available in a statute containing an interim order provision?
- Would the federal regulatory process not be timely enough, even when expedited, to mitigate the risk within an acceptable period?
Provisions to ensure control over the actions of Ministers: Several provisions ensure a significant degree of control over the actions of Ministers in an emergency situation and include the following:
- the period within which the Minister is required to obtain approval from the Governor-in-Council is 14 days after the interim order is made;
- a copy of the interim order must be tabled in each house of Parliament within 15 days from the time it is issued, notwithstanding whether Parliament is in session;
- the Governor-in-Council approved interim order will be valid only for a period of up to one year;
- the interim order will be published in the Canada Gazette within 23 days from the time it is made;
- no person can be convicted of contravening the interim order, unless at the time of the contravention the interim order had been published in the Canada Gazette, the person had been notified, or reasonable steps had been taken to inform the person;
- the interim order can be repealed at any time; and
- interim orders are referred to the Standing Joint Committee on the Scrutiny of Regulations.
HPA Section 17 - Ingredient Disclosure List
Ingredient Disclosure List
17.(1) Subject to section 19, the Governor in Council may, by order,
- establish a list, to be known as the Ingredient Disclosure List, of products materials and substances, any of which may be an ingredient of a controlled product; and
- specify, for the purposes of paragraphs 13(a) and 14(a), a concentration for each product, material or substance included on the list.
(2) Subject to section 19, the Governor in Council may, by order, amend the Ingredient Disclosure List
- by adding thereto any product, material or substance:
- by specifying, for the purposes of paragraphs 13(a) and 14(a), a concentration for each product, material or substance added thereto pursuant to paragraph (a); and
- by substituting a concentration for a concentration specified for any product material or substance included thereon.
(3) Subject to section 19, the Governor in Council may, by order, amend the Ingredient Disclosure List by deleting therefrom any product, material or substance, and the concentration specified for that product, material or substance, if the Governor in Council is satisfied that the inclusion of the product, material or substance on the Ingredient Disclosure List is no longer necessary.
(4) The Governor in Council shall, in making any order pursuant to subsection (1),(2) or (3), be guided by the health and safety criteria for ingredient disclosure established by the Minister after consultation by the Minister with the government of each province and with such organizations representative of workers, organization representative of employers and organizations representative of suppliers as the Minister deems appropriate.
Interpretation / Discussion of Section 17
The Ingredient Disclosure List (IDL) was published in the Canada Gazette, Part II, SOR\88-64 on January 20, 1988. As of September, 2000, the IDL has not been amended and as of that date, no amendments had been projected.
The IDL is a list of chemicals identified in alphabetical order by their common name. The corresponding Chemical Abstracts Service (CAS) registry number is provided where available. Each chemical has a corresponding concentration "cut-off" of either 0.1% or 1.0% (weight/weight). Ingredients included in the IDL are one of the four categories of ingredients whose identity and concentration must be disclosed on an MSDS if found in a controlled product above the concentration cut-off; (see subparagraph 13(a)(ii) of the HPA).
The criteria used to determine whether to include an ingredient in the IDL were broader than the criteria used for defining what is a WHMIS controlled product. Substances that are not considered hazardous enough to be controlled products in themselves but are considered health hazards have been included in the IDL in addition to substances that do meet the criteria in the Controlled Products Regulations (CPR). Therefore, although a chemical included in the IDL which is not itself a controlled product is not subject to the HPA label nor MSDS requirements, when included in a controlled product above its cut-off concentration, its identity and concentration must be disclosed on the MSDS.
In addition to the potential to cause adverse health effects, the extent to which the ingredients were or are being put to commercial use was also a determining factor affecting inclusion in the IDL. The IDL, however, is far from exhaustive in listing ingredients that meet the criteria in the CPR.
HPA Section 18 - Amendments to Schedule II
Amendments to Schedule II
18.(1) Subject to section 19, the Governor in Council may, by order, amend Schedule II.
(2) The Minister shall cause a copy of each order made pursuant to subsection (1) to be laid before each House of Parliament on any of the first fifteen days on which that House is sitting after the day the order is made.
(3) If both Houses of Parliament resolve that an order or any part of an order made pursuant to subsection (1) should be revoked, the order or that part thereof is thereupon revoked.
Interpretation / Discussion of Section 18
Please refer to the information provided under sections 5 and 6 of the HPA regarding the Governor in Council and the regulatory process.
HPA Section 19 - Consultation
Consultation
19. A regulation under subsection 15(1) or an order under section 17 or 18 may be made by the Governor in Council only on the recommendation of the Minister made after consultation by the Minister with the government of each province and with such organizations representative of workers, organizations representative of employers and organizations representative of suppliers as the Minister deems appropriate.
INTERPRETATION / DISCUSSION of SECTION 19
The Minister of Health Canada respects the legislative requirement to consult with affected parties through the WHMIS Current Issues Committee (CIC). The following are the terms of reference for the CIC:
- The Current Issues Committee will serve as the forum for consultation on matters concerning the interpretation or modification of the Workplace Hazardous Materials Information System (WHMIS).
- The Current Issues Committee has no formal powers; its role is to make recommendations to departments and agencies responsible for WHMIS legislation including recommendations for modifications to WHMIS or changes in its scope.
- Membership of the Committee will be limited to persons sponsored by one of the member groups, i.e., employers, suppliers, labour and the WHMIS regulatory agencies and will consist of the Chairperson and representatives from:
- organized labour;
- employers;
- suppliers;
- provincial and territorial Occupational Safety and Health agencies;
- the Hazardous Materials Information Review Commission;
- Human Resources and Skills Development Canada, Labour Program; and
- Health Canada (WHMIS Division).
HPA Section 20 - Disclosure
Disclosure
20.(1) Where the Minister has reason to believe that a product, material or substance is a product, material or substance that may be included in a class listed in Schedule II by a regulation made pursuant to paragraph 15(1)(a), the Minister may, by registered mail, send a written notice to any person who is engaged in the business of manufacturing, processing, importing, packaging or selling the product, material or substance requesting the disclosure of information relating to the formula, composition, chemical ingredients or hazardous properties of the product, material or substance and such other information as the Minister deems necessary for the purpose of determining whether the product, material or substance is or may be a danger to the health or safety of any person who may handle it in a work place or be exposed to it in a work place.
(2) Every person to whom a notice referred to in subsection (1) is sent shall disclose to the Minister, in the manner and within the period specified by the Minister in the notice, any information described in subsection (1) that is requested in the notice and is in the possession of the person.
(3) Subject to subsection (4), information received by the Minister from a person pursuant to subsection (1) is privileged and notwithstanding the Access to Information Act or any other Act or law, shall not be disclosed to any other person except as may be necessary for the administration or enforcement of this section or for the purposes of section 15.
(4) The Minister shall not, when consulting with the government of a province or an organization of workers, organization of employers or organization of suppliers pursuant to section 19, for the purposes of section 15, disclose the name of any person from whom the Minister has received information pursuant to subsection (1) or any of such information that is specified, in writing, by the person as being confidential.
INTERPRETATION / DISCUSSION of SECTION 20
Information under this section will be requested solely for the purpose of determining whether Schedule II needs to be amended. Information will not be requested to enforce existing Regulations.
The requirement to provide information includes only that information which is in the possession of the person to whom the request is sent.
The use or disclosure of any information received pursuant to this section, except for the purpose of administering or enforcing this section or for the purpose of making regulations, is an offence under section 28 of the HPA and punishable by fine or imprisonment.
The Access to Information Act came into force on July 1, 1983. It provides a right of access by the public to information in records under the control of a government institution.
However, under paragraph 20(1)(b) of the Access to Information Act, records are exempt from scrutiny where they contain financial, commercial, scientific or technical information that is confidential information supplied by a third party and is treated consistently in a confidential manner by the third party.
This exemption is intended to protect information of a confidential nature provided by a business or other commercial interest to the government, regardless whether the information was provided pursuant to a statutory obligation or on a voluntary basis.
HPA Section 21 - Inspectors and Analysts
Inspectors and Analysts
21.(1) The Minister may designate as an inspector or analyst for the purposes of this Act any person who, in the Minister's opinion, is qualified to be so designated.
(2) The Minister shall furnish every inspector with a certificate of designation and, on entering any place pursuant to subsection 22(1), an inspector shall, if so required, produce the certificate to the person in charge thereof.
Interpretation / Discussion of Section 21
The Minister's authority to designate inspectors and analysts has been delegated to the Department.
Section 21 authorizes the Minister to designate inspectors and analysts for the purpose of enforcing the Act. Inspectors are provided with a certificate of designation and, if asked to do so, the inspector must show this certificate when seeking entry under the authority of subsection 22(1).
Under Memoranda of Understanding between the Minister and the provincial, territorial and federal, (Labour Program at Human Resources Development Canada), Ministers administering occupational safety and health legislation, responsibility for the inspection program for the WHMIS requirements set out in Part II of the HPA has been delegated to these jurisdictions. However, Health Canada remains ultimately responsible for the administration of the HPA and regulations established under this Act.
Please refer to the discussion under section 30 which deals with the use of a certificate of an analyst in court.
HPA Sections 22, 23 and 24 - Search, Seizure and Forfeiture
Search, Seizure and Forfeiture
22.(1) An inspector may at any reasonable time enter any place where the inspector believes on reasonable grounds any hazardous product is manufactured, prepared, preserved, processed, packaged, sold or stored for sale, processing or packaging and
(a) examine any product, material or substance that the inspector believes on reasonable grounds is a hazardous product and take samples thereof, and examine any other thing that the inspector believes on reasonable grounds is used or is capable of being used for the manufacture, preparation, preservation, processing, packaging, sale or storage of a hazardous product;
(b) open and examine any receptacle or package that the inspector believes on reasonable grounds contains any hazardous product;
(c) examine any books, records or other documents that the inspector believes on reasonable grounds contain any information relevant to the enforcement of this Act and make copies thereof or of any portion thereof;
(d) where the inspector believes on reasonable grounds that any computer system on the premises contains data relevant to the enforcement of this Act or that such data is available to the computer system, use the computer system or cause it to be used to search any data contained in or available to the computer system, reproduce any record or cause it to be reproduced from the data in the form of a printout or other intelligible output and seize the printout or other output for examination or copying; and
(e) seize any product, material or substance, or any labelling advertising, material or other thing, by means of or in relation to which the inspector believes on reasonable grounds any provision of this Act or of any regulation made under this Act has been contravened or has not been complied with.
(2) The owner or person in charge of a place entered by an inspector pursuant to subsection (1) and every person found therein shall give the inspector such assistance and furnish the inspector with such information as the inspector may, for thepurpose of exercising the powers referred to in paragraphs (1)(a) to (e), reasonably require them to give or furnish.
(3) All information that, pursuant to the Hazardous Materials Information Review Act, a supplier is exempt from disclosing under paragraph 13(a) or (b) or 14(a) or (b) and that is obtained by aninspector who is admitted to any place pursuant to the powers conferred on an inspector by subsection (1) is privileged and, notwithstanding the Access to Information Act or any other Act or law, shall not be disclosed to any other person except for the purposes of the administration and enforcement of this Act.
3.(1) No person shall obstruct, or knowingly make any false or misleading statement either orally or in writing to, an inspector while the inspector is engaged in carrying out any duties or functions under this Act or any regulation made under this Act.
(2) Except with the authority of an inspector, no person shall remove, alter or interfere in any way with any thing seized under this Act by an inspector.
24. Any thing seized under this Act may at the option of an inspector be kept or stored in the building or place where it was seized or be removed to any other proper place by or at the direction of an inspector.
Interpretation / Discussion of Sections 22, 23 and 24
Sections 22 to 24 give inspectors the powers necessary to enable them to carry out their duties under the Hazardous Products Act HPA.
Section 22 describes the entry and the search and seizure powers of an inspector. It is important to remember that, legally, entry is a separate act from search and seizure. Accordingly, the criteria which justify entry are different from the criteria which justify seizure.
Legal entry can be made where the inspector reasonably believes that any of the processes described in the opening words of subsection 22(1) are occurring or where the product is being stored for sale, processing or packaging. Mere importation of a hazardous product is not sufficient. The hazardous product could simply be in transit.
Legal search and seizure requires a belief on reasonable grounds that a violation of the HPA or the regulations made under that Act has occurred. This belief is in addition to a reasonable belief that the elements that support legal entry exist.
For example, the advertisement of a hazardous product may provide grounds for legal entry into the place the product is being stored for sale but, without more, the advertising of a hazardous product will not provide grounds for a search and seizure since there is no evidence on which to reasonably believe that the Act or the regulations have been violated.
Subsection 22(1) sets out powers, not duties. For example, the words "may . enter" do not imply an obligation to enter, but give the inspector the power to enter where the criteria for legal entry are met.
"Any reasonable time" means reasonable in the circumstances. It is generally interpreted to mean the normal business hours of the firm involved. This interpretation may be broadened under some circumstances - for example, if there is reason to believe that there is imminent danger of a hazardous product reaching the public.
"Any place" is generally interpreted as a place of business, including a warehouse, although it can also include a home. Entering a home is not advisable unless the home is being used as a place of business or unless there is a sufficient compelling reason. Subsection 22(1) permits entry into a vehicle in which goods are being transported where the vehicle is a place where hazardous products are undergoing any of the processes in the opening words of subsection 22(1) or are being stored for sale, processing or packaging.
"Reasonable grounds" means reasonable in the circumstances but does not require "certainty". Knowledge of test reports, or other information indicating that a product is a WHMIS controlled product, would constitute "reasonable grounds". Such knowledge does not have to be first hand knowledge, but can be based on information from a reliable person.
A "hazardous product" means a prohibited product (a product listed in Part I of Schedule I), a restricted product (a product listed in Part II of Schedule I) or a controlled product (a product that is included by the Controlled Products Regulations in any of the classes listed in Schedule II to the act). Where the product is listed as a general product category (e.g., matches) it carries with it a broader power of entry than where the product is specifically described in the item (e.g., textile fibre products having certain burning characteristics).
"Is manufactured, etc." is written in the present tense, but is not interpreted so literally as to mean that the action must be occurring just as the inspector is seeking entry. However, if the suspected manufacture, etc., occurred several years ago and is not still occurring, the inspector's right of entry would have to be based on a belief that hazardous products were being prepared, preserved, packaged, or stored for sale, etc..
"Preserved" could include products being preserved for private use and not for sale, and would, therefore, support the power to enter the premises but not to seize the product.
"Stored for sale" includes stored for distribution. The words "for sale" apply only to the word "stored" and not to the preceding words. Goods stored in a warehouse are usually goods stored for sale. Also see the definition of "sell" in section 2 of the Act.
"Examine" means to gather evidence, but does not mean to damage or destroy a product by such examination. Damage to packaging may be unavoidable but, if destructive examination of the product is required, it is Departmental policy to take samples for such examination.
"Take samples" is interpreted as the power to take sufficient samples for test purposes.
If the inspector wants to take samples to determine whether the WHMIS MSDS or labelling requirements have been met, the inspector can seize samples under the seizure power set out in paragraph 22(1)(e).
The examination of "books, records or other documents" must be relevant to enforcement of the HPA. An i nspector does not have the power to examine or copy documents which are clearly not relevant, such as documents relating to price, cost, or financial matters only. Invoices, shipping documents and information regarding product contents may be examined and copied. It appears that documents can be removed from the premises for copying, but it is preferable to obtain the trader's consent.
"Copies" can be made by hand if necessary or by photocopier. If a photocopier is available, and the inspector is unreasonably denied use of it, the refusal to give the inspector access to the photocopier could be construed as a violation of subsection
23(1). Any copies or extracts should be signed by the inspector and, preferably, by the owner or manager of the firm for identification and future use as evidence. Photography is also an acceptable method of obtaining copies.
"Seize" means to bring under the control but not the ownership of the inspector. Seizure is intended to procure the evidence for use in a prosecution or in order to determine whether to prosecute. Seizure for the purpose of removing hazardous products from the market is considered to be consistent with the intent of the Act.
The criteria which authorize seizure are more restricted than those authorizing entry, examination, etc. To justify seizure, the inspector must believe that a violation "has" occurred.
Paragraph 22(1)(e),authorizes seizure relating to violations of any provisions of the HPA or of the regulations; i.e., this authorization is not limited to violations of section 4, 13 or 14 of the HPA.
The "owner or person in charge" and the staff on the premises that has been entered under the power set out in subsection 22(1) must assist the inspector. Assistance includes help in moving boxes or other large items, and can involve minor expenses for the firm.
Specific reference to the "owner or person in charge" in addition to the reference to "every person found therein" means that the owner or manager, even if absent from the premises, is obliged to assist the inspector, and can be required to make a reasonable effort to come to the premises to provide that assistance. The amount of time which the owner or the staff would be "reasonably" required to devote to assisting the inspector will vary with each case.
The information that an owner or manager may be required to furnish can include the formulations of products if known. In the case of prohibited and restricted hazardous products it is not reasonable to require the owner or manager to obtain formulation information where it is not already known. A supplier would be expected to know the ingredients of its WHMIS controlled products.
Inspectors can only require the owner or manager to furnish information about a "hazardous product" as defined in section 2 of the Act or that is relevant to the enforcement of the Act. Information relating
to all other products, (e.g. products of concern in regulatory development projects) can be requested by the inspector but the owner or manager cannot be compelled under subsection 22(2) to provide the requested information.
All assistance and information demanded by the inspector must be relevant to carrying out the powers set out in paragraphs 22(1)(a) to (e).
Obstruction of an inspector includes refusal to allow entry to premises where such entry is authorized under subsection 22(1) and any other Act which prevents the inspector from carrying out his or her duties.
Under subsection 23(1) it is also an offence to make false or misleading statements "knowingly"; i.e., intentionally.
Under subsection 23(2) it is an offence to remove, alter or interfere with a seized product without the authorization of an inspector. This subsection is intended to prevent tampering with seized products that are left in the care and control of the supplier.
Also under subsection 23(2), the inspector can authorize removal of the seized products to another location for storage or for re-working, re-labelling or recalling a product. Where a product is moved to another location the cost of transportation and insurance is borne by the firm or firms involved and the owner or manager may be requested to sign a form to this effect. Authorization for removal can also be given in cases where the firm involved wishes to have the products transferred to some other location for storage. Again, the firm bears the expenses.
Section 24 permits an inspector to leave the seized products where he or she has seized them or, where the inspector considers it appropriate to remove, or arrange removal of, the seized products to a different location. The probability that seized products may be tampered with would be a consideration in exercising this power. Where the probability of tampering is high, it is usual for the enforcing jurisdiction to bear the risks and costs of removal and storage.
A "proper place" includes warehouse space appropriate to the type of product, the premises of a manufacturer or distributor serving as a central location for storage of recalled goods, or the office of the inspector. Although removal to a private home is not necessarily advisable, there may be circumstances in which a private home could be considered a proper place for the storage of seized goods.
Release from Seizure by the Inspector: The Act does not expressly provide for releasing goods from seizure where the seized goods are no longer considered hazardous. This is because once a seized product is no longer hazardous (i.e. no longer in violation), there is no longer any authority to continue the seizure. In practice, where, within two months after the date of seizure, seized products are altered with the inspector's permission to bring them into compliance with the Act or regulations or for some other reason are no longer considered hazardous, the inspector can release the goods from seizure. Where products have been seized for longer than two months, the Minister must authorize the release of the goods. This is because two months after the date of the seizure care and control over the seized goods passes to the Minister under subsection 25(5) of the Act. Thereafter only the Minister has the authority to dispose of the seized goods.
Alternatives to Seizure: The inspector is not legally obliged to seize a hazardous product, and, in practice, seizure is used only as a final recourse. The less expensive and disruptive options of corrective action by the dealer to rework a product or voluntarily recall and destroy a hazardous product are often accomplished by agreement.
Since the export of hazardous products is not prohibited by the Act, the export or re-export of non-complying products is sometimes an appropriate solution. Refer to the discussion under section 25 and 26, i.e. "Restoration", for the policy on the export of seized goods.
HPA Sections 25 and 26 - Restoration
25.(1) Where any product, material, substance or other thing has been seized under this Act, any person may, within two months after the date of the seizure on prior notice having been given in accordance with subsection (2) to the Minister by registered mail addressed to the Minister at Ottawa, apply to a provincial court judge within whose territorial jurisdiction the seizure was made for an order of restoration under subsection (3).
(2) The notice referred to in subsection (1) shall be mailed at least fifteen clear days prior to the day on which the application is to be made to the provincial court judge and shall specify
(a) the provincial court judge to whom the application is to be made;
(b) the place where and the time when the application is to be heard;
(c) the product, material, substance or other thing in respect of which the applicant is to be made; and
(d) the evidence on which the applicant intends to rely to establish that the applicant is entitled to possession of the thing in respect of which the application is to be made.
(3) Subject to section 26, where, on the hearing of an application made under subsection (1), the provincial court judge is satisfied
(a) that the applicant is entitled to possession of the product, material, substance or other thing seized, and
(b) that the thing seized is not and will not be required as evidence in any proceedings in respect of an offence under section 28, the judge shall order that the thing seized be restored forthwith to the applicant.
(4) Subject to section 26, where, on the hearing of an application made under subsection (1), the provincial court judge is satisfied that the applicant is entitled to possession of the thing seized but is not satisfied as to the matters mentioned in paragraph (3)(b), the judge shall order that the thing seized be restored to the applicant
(a) on the expiration of four months after the date of the seizure if no proceedings in respect of an offence under section 28 have been commenced before that time; or
(b) on the final conclusion of any such proceedings in any other case.
(5) Where no application has been made under subsection (1) for the restoration of any product, material, substance or other thing seized under this Act within two months after the date of the seizure, or an application therefor has been made but on the hearing thereof no order of restoration is made, the thing so seized shall be delivered to the Minister who may make such disposition thereof as the Minister thinks fit.
26.(1) Where a person has been convicted of an offence under section 28, any hazardous product seized under this Act by means of or in respect of which the offence was committed is forfeited to Her Majesty and shall be disposed of as the Minister directs.
(2) Where an inspector has seized a hazardous product under this Act and the owner thereof or the person in whose possession the product was at the time of seizure consents in writing to its destruction, the hazardous product is thereupon forfeited to Her Majesty and shall be destroyed or otherwise disposed of as the Minister directs.
Interpretation / Discussion of Sections 25 and 26
Subsection 25(1) and 25(2):
The owner of seized products may make an application to a judge for restoration of the products within two months of the date of seizure. "Two months" means two calendar months, for example, from June 7 to August 8. Under section 28 of the Interpretation Act, the actual date of seizure is not counted, but all of the last day of the two month period is included. For example, if a product was seized at 9:00 a.m. on June 7, the two month period would expire at 12:00 midnight on August 8. If the last day of the two month period was a holiday, the time period would then expire at midnight on the next day that was not a holiday. If the month in which the time period expires does not have a calender day corresponding to the specified expiry date, for example, February 31, then the time period expires at the end of the last day of that month, for example, midnight February (28 or 29, in a leap year).
The Minister must be notified of the restoration application at least fifteen days in advance. This notification must contain the information specified in subsection 25(2). "Fifteen clear days" does not include the first and last day of the fifteen day period. For example, if the application for restoration is to be made on July 31, the notice to the Minister must be mailed on July 15 or earlier.
Subsection 25(3) and 25(4):
At a restoration application, the judge does not rule on whether or not the product is hazardous, but only on who is entitled to possession of, or who owns, the seized products and whether or not the products are or will be required as evidence in court proceedings. This may have the effect of forcing the initiation of a prosecution to prevent restoration of seized goods.
Subsection 25(5):
After 2 months from the date of seizure, if no application for restoration has been made, or if such an application has been denied, the seized products must be delivered to the Minister for disposition. After the two month period, the things seized cannot be altered, removed, restored, exported, etc. without the Minister's authority.
"Delivered" means physically transporting the goods to the Minister or to a delegated person. In practice, physical delivery does not occur. The important aspect of subsection 25(5) is the delegation to the Minister of the authority to dispose of seized goods owned by another person. The goods are not forfeited, and do not become the property of the Crown under subsection 25(5). In practice, this authority is not always exercised immediately on the expiration of the 2 month period. For example, if seized goods are in the process of being altered by a dealer acting in good faith with the inspector's authority, it is likely that the alterations will be allowed to continue. When the products have been brought into compliance, the Minister will exercise his authority and restore the products to their owner as a "fit" disposition. Other circumstances, such as pending prosecution, or attempts to arrange export, can also result in a delay in the Minister exercising his authority of disposition.
In cases where no attempt to alter the seized products is being made or no other circumstances warrant delay, the Minister can exercise his authority at anytime after 2 months from the date of seizure. When the Minister orders the removal and destruction of a product, it is usual for the enforcing jurisdiction to bear the costs of such removal and destruction. If, however, the disposition involves restoration of the seized goods to their owner, or their export, the owner must bear all costs.
The practice of allowing a delay in the exercise of the authority given to the Minister in subsection 25(5) is neither expressly allowed by the Act nor is it prohibited. Such delays are consistent with both the intent and the reasonable administration of the Act.
Subsection 26(1):
After a conviction, the hazardous products are forfeited to and become the property of the Crown. They are then disposed of as the Minister directs, with the costs of removal and disposal paid by the enforcing jurisdiction.
Subsection 26(2):
The owner may consent to the destruction of the seized products. The products are then forfeited to the Crown for disposal under the direction of the Minister. The consent to destruction must be in writing and must be given by the legal owner of the goods or by the person in whose possession they were at the time of seizure.
Since forfeiture means that the right of property in the goods has been transferred to the Crown, the cost of removal and destruction becomes the responsibility of the enforcing jurisdiction. Even when products have not been seized, the owner may wish to forfeit the products to the Crown for disposal or destruction. As subsection 26(2) does not apply to products which have not been seized, written consent to the disposal is not required by law. However, consent in writing to the forfeiture and disposal or destruction of the products must always be obtained by the inspector to avoid any lawsuits for unauthorized disposal. Costs of removal and disposal are the responsibility of the enforcing jurisdiction.
Export of Seized Goods: The Act does not prohibit the export or re-export of hazardous products or seized goods, and there are some cases in which export or re-export may be a suitable method of disposition. Within 2 months after the date of seizure, the inspector may authorize the export of seized products under subsection 23(2). After the two months after the date of seizure, the Minister must approve any export of the seized products as a suitable method of disposition. In both cases, the goods are not released from seizure and thus remain under the control of the inspector or the Minister until they have left the country.
The appropriate authority in the receiving country must be advised of the nature of the hazard involved and of the fact that the product is not acceptable for sale in Canada. That authority must indicate by a notice of agreement that the products involved are acceptable for sale in the receiving country, before the export of the seized products is permitted. This authority is not required where the product is being returned to the country where it was manufactured. Policies regarding export of non-complying products that have not been seized are set out in the discussion under sections 22, 23 and 24 Search, Seizure and Forfeiture.
HPA Section 27 - Regulations
Regulations
27. The Governor in Council may make regulations
(a) respecting the powers and duties of inspectors and analysts and the taking of samples and the seizure, detention, forfeiture and disposition of products, materials, substances and other things; and
(b) generally for carrying out the purposes and provisions of this Part.
Interpretation / Discussion of Section 27
To date, no formal regulations have been established under the authority of this section of the Act.
HPA Section 28 - Offence, Punishment and Procedure
Offence, Punishment and Procedure
28. (1) Every person who contravenes or fails to comply with any provision of this Act or of any regulation made under this Act is guilty of an offence and is liable
(a) on summary conviction, to a fine not exceeding one hundred thousand dollars or to imprisonment for a term not exceeding six months or to both; or
(b) on proceedings by way of indictment, to a fine not exceeding one million dollars or to imprisonment for a term not exceeding two years or to both.
(2) Where a corporation commits an offence under subsection (1), any officer, director or agent of the corporation who directed, authorized, assented to, acquiesced in or participated in the commission of the offence is a party to and guilty of the offence and is liable on conviction to the punishment provided for the offence, whether or not the corporation has been prosecuted or convicted.
(3) Proceedings by way of summary conviction is respect of an offence under paragraph (1)(a) may be instituted at any time within but not later than twelve months after the time when the subject matter of the proceedings arose.
Interpretation / Discussion of Section 28
Section 28 outlines the scope of the penalties for a violation of any provision of the HPA or the regulations made under that Act.
Offenses punishable under section 28 include, in addition to the offenses set out in section 4, 13, and 14, obstruction of an inspector or knowingly making a false or misleading statement to an inspector as per subsection 23(1); removing altering or interfering with seized goods as per subsection 23(2); disclosure of privileged information, subsection 10(3); and refusal to supply information as required by section 30 of the Controlled Products Regulations.
The penalties stated in subsection 28(1) are the maximum penalties. The actual penalty is determined by the courts.
The term "person" means any legal entity. It includes individuals and corporations. Normally a business or corporation will be charged with an offence in the name of the business or corporation. The President or principal shareholder would not be charged unless he or she were directly involved in the alleged offence.
Summary Proceedings and Indictment:
Subsection 28(1) sets out two procedural options for prosecuting offenders. The choice is made by the Crown prosecutor when the alleged offender is charged and the choice normally depends upon the gravity of the offence and whether it is a repeat offence.
A summary proceeding is one in which a minor crime or misdemeanour is dealt with by a judge relatively quickly and without a jury. The magistrate has the authority to deal summarily ("at once", "without ceremony") with these charges, for which the maximum penalty is a $100,000 fine and/or six months imprisonment. The Act permits laying summary conviction charges at any time within twelve months after the time when the subject matter of the prosecution arose. If, for some reason, the prosecution cannot be initiated within the twelve month period, the charge must be laid by indictment. There is no time limit on proceedings by way of indictment.
The "time when the subject matter of the prosecution arose" refers to the time that the violation occurred; that is, took place. The enforcing jurisdiction may not become aware of the non-complying nature of the sale, etc., until a later date; for example, after a laboratory analysis of a sample of the product. Under section 28 of the Interpretation Act, if the offence occurred on June 1, 1996 the twelve month period would expire at midnight on June 2, 1997. If June 2, 1997 were a holiday, then the time period would expire at midnight of the next day that is not a holiday. If the month in which the twelve month period expires does not have a calendar day corresponding to the specified expiry date (e.g., September 31), then the time period expires at midnight of the last day of that month (e.g., midnight September 30).
An indictable offence is more serious than a summary offence and carries with it more severe maximum penalties. A person convicted of an indictable offence under the Act can be imprisoned for up to two years in addition to or instead of a fine in an amount determined at the discretion of the court but not to exceed one million dollars. Where the offender is a corporation, there is no individual to be imprisoned so the corporation can only be fined.
An accused charged with an indictable offence under the HPA has the right to choose to be tried before a provincial court judge, a justice of the superior court, or, unless the accused is a corporation, a judge and jury. If the accused does not elect to be tried by a provincial court judge, a preliminary hearing is held before a provincial court judge to determine whether there is a prima facie case against the accused; that is, whether the prosecution has sufficient evidence which, if believed, would establish that the offence had been committed. If the provincial court judge decides that the evidence is sufficient, he or she will commit the accused for trial. If the evidence is not considered sufficient, the case will be dismissed.
An example of where a violation might appropriately be prosecuted as an indictable offence is where the accused had been previously convicted of the same offence or where there are numerous apparent violations. In addition, where an accused has failed to cooperate with an investigation, a prosecutor may decide to proceed by way of indictment.
Most cases brought to prosecution under the HPA should be treated as summary offenses in view of the less lengthy and less complicated procedure involved.
HPA Section 29 - Exception, etc., Need Not be Mentioned and Burden of Proof
29. (1) No exception, exemption, excuse or qualification prescribed by law is required to be set out or negatived, as the case may be, in an information or indictment for an offence under section 28 of this Act or under section 463, 464 or 465 of the Criminal Code in respect of an offence under section 28.
(2) In any prosecution for an offence mentioned in subsection (1), the burden of proving that an exception, exemption, excuse or qualification prescribed by law operates in favour of the accused is on the accused and the prosecutor is not required except by way of rebuttal, to prove that the exception, exemption, excuse or qualification does not operate in favour of the accused, whether or not it is set out in the information or indictment.
Interpretation / Discussion of Section 29
The "information" or "indictment" referred to in subsection 29(1) is the court form containing the wording of the actual charge being laid against the accused. In the wording of the information, 29(1) indicates that it is sufficient to state that the importation, advertisement or sale of a prohibited product, or a restricted product that does not accord with the applicable Regulations under the HPA, or the importation or sale of a WHMIS controlled product which does not comply with the Controlled Products Regulations, has occurred. Elaboration by the Crown of the possible exceptions, exemptions, etc. is not required. For example, a charge involving a restricted product need only set out the fact of the sale of the item. The charge need not make reference to a regulation that would have permitted the sale of the item had the requirements of that regulation been met. In actual practice, however, the information will likely state that the conditions of a regulation that would have permitted a legal sale of the product were not met by the accused.
Subsection 29(2) clearly states that the accused has the onus of proving that an exception, exemption, etc. operates in the accused's favour. This means that once the Crown prosecutor has proved that the accused sold, for example, a controlled product that could only be sold as authorized by a regulation, the accused has the onus of proving the defence that an exception or exemption in the regulation applies to the accused and, hence, that the sale of the product in question was legal. The Crown is not required to prove a negative; that is, that the exceptions or exemptions do not operate in favour of the accused.
Again, in practice, the Crown prosecutor would anticipate the defence set out in Section 29. As part of his or her case, the Crown prosecutor would present evidence (e.g., laboratory test results) that the product in question did not fall within any exception or exemption set out in a regulation. By proving that the product was non-complying, the Crown prosecutor prevents the accused from raising a defence of exception or exemption.
The regulations made under the authority of the HPA are not the only exceptions that an accused can raise. Some items in Schedule I to the HPA include express exceptions: See Part I, items 7, 16, 17(2) and 26 and Part II, items 13(k), 27, 29 and 30. In these cases also, the Crown should provide evidence that the product does not fall within any of the exceptions listed in the item.
The regulations specify that every product must comply. Consequently, if ten articles are seized, all ten must pass the tests for compliance. If any fail to pass those tests, then an offence has occurred and a prosecution can be commenced. If the prosecution fails and the accused is acquitted, it is not possible to lay a second charge in respect of these same ten seized articles. However, an inspector can return to the accused's establishment and seize more of the same articles (same lot, etc.) and have them tested again. Should any of this second sample fail the tests, then a second prosecution can be commenced. This latter situation is not "double jeopardy"; that is, prosecuting twice for the same offence. The second testing failure is a second offence involving a separate and different set of facts. It is, as a result, a completely new offence.
HPA Section 30 - Certificate of Analyst
30. (1) Subject to this section, a certificate of an analyst stating that the analyst has analyzed or examined a product, material or substance and stating the result of the analysis or examination is admissible in evidence in any prosecution for an offence mentioned in subsection 29(1) and in the absence of any evidence to the contrary is proof of the statements contained in the certificate without proof of the signature or the official character of the person appearing to have signed the certificate.
(2) The party against whom a certificate of an analyst is produced pursuant to subsection (1) may, with leave of the court, require the attendance of the analyst for the purposes of cross-examination.
(3) No certificate shall be received in evidence pursuant to subsection (1) unless the party intending to produce it has, before the trial, given to the party against whom it is intended to be produced reasonable notice of that intention together with a copy of the certificate.
Interpretation / Discussion of Section 30
An analyst's certificate that verifies that a product does not comply with the Hazardous Products Act or its regulations is, by itself, evidence that is sufficient to prove an offence. Unless counsel for the accused, with the court's permission, requires that the analyst appear in court for a cross-examination of the certificate, the analyst does not need to testify. In practice, the Department is usually prepared for the analyst, or some other qualified expert, to testify in person.
However, before an analyst's certificate can be used as evidence, the Crown must notify the accused of the Crown's intent to submit an analyst's certificate into evidence and must give the accused a copy of the certificate. The copy is given to the accused to permit his or her counsel to examine the certificate and to prepare a defence, if one is available.
"Reasonable notice" means that the notice of intention to use the certificate must be given within a reasonable length of time in advance of the trial date. The length of time that is considered "reasonable" is a question of fact and will vary with the circumstances of each case. While in some cases a two days notice period has been found to be "reasonable", it is preferable to give at least two weeks notice.
HPA Section 31 - Trial of Offence
31. A complaint or information in respect of an offence under section 28 may be heard, tried or determined by a provincial court judge or a justice if the accused is resident or carrying on business within the territorial jurisdiction of the provincial court judge or justice, although the matter of the complaint or information did not arise in that territorial jurisdiction.
Interpretation / Discussion of Section 31
This section permits a choice of the place in which the charges will be laid and the trial will occur: the place the offence occurred or the place in which the accused resides; i.e., it provides for court proceedings to occur near the residence or place of business of the accused, rather than where the alleged offence occurred.
HPA Schedule II - Classes of WHMIS Controlled Products
SCHEDULE II (Section 2)
Class A -- Compressed Gas
Class B -- Flammable and Combustible Material
Class C -- Oxidizing Material
Class D -- Poisonous and Infectious Material
Class E -- Corrosive Material
Class F -- Dangerously Reactive Material
R.S., 1985, c. 24 (3rd Supp.), s. 2.
Interpretation / Discussion of Schedule II
A product, material or substance which falls within any of the hazard criteria set out in sections 33 to 65 of the CPR is a "controlled product" and, unless exempted under section 12 of the HPA, is subject to the supplier MSDS and label requirements of the HPA if the controlled product is sold or imported for use in a Canadian workplace.
It is the responsibility of the party marketing the product in Canada or the Canadian importer to assess the product against the classification criteria of the CPR.
CPR Section 1 - Short Title
The WHMIS logo depicted in the cover page was developed to be a readily recognizable graphic identification of this national, partnership program. The outer border of the logo forms a triangle which represents the tripartite partnership of WHMIS; i.e., governments, industry and labour. Within the triangle there are three distinct symbols. On the lower, left hand side is depicted part of a maple leaf which represents the government of Canada, and the provincial and territorial governments. To the right of the maple leaf, in the middle, is a solid obelisk which represents industry. To the right of the obelisk on the lower, right hand side is a stylized, stick man which represents Canadian workers and organized labour.
Regulations Respecting Controlled Products
Short Title Summary of Amendments
The following are the amendments to the Controlled Products Regulations (CPR) as summarized in the "Consolidated Index of Statutory Instruments, January 1, 1955 to September 30, 2001", Canada Gazette, Part II, September 30, 2001:
Controlled Products Regulations - Summary of Amendments
CPR Section Registration CPR Section Registration s. 2, "mixture" SOR/97-543; s.13(E) s. 27 SOR/88-555; s.5
SOR/97-543; s.18s. 5.1 added, SOR/89-150; s.1 s. 32, "IARC" SOR/97-543; s.19(E) s. 8.1 added, SOR/88-555; s.1
repealed, SOR/97-543; s.14s. 32, "respiratory tract sensitization" SOR/2001-254; s.9 s. 8.2 added, SOR/88-555; s.1 s. 32, "skin sensitization" SOR/2001-254; s.9 s. 9 SOR/2001-254; s.1(F) s. 33 SOR/97-543; s.20E s. 10.1 added. SOR/2001-254; s.2 s. 34 SOR/97-543; s.21 s. 11 SOR/2001-254; s.3 s. 39 SOR/97-543; s.22(F) s. 12 SOR/97-543; s.15
SOR/2001-254; s.4s. 57 SOR/97-543; s.23(F) s. 14 SOR/88-555; s.2
SOR/2001-254; s.5s. 60 SOR/97-543; s.24(F) s. 15.1 added, SOR/88-555; s.3
repealed, SOR/97-543; s.16s. 62 SOR/97-543; s.25 s. 17.1 added, SOR/2001-254; s.6 Sch. I SOR/97-543; s.26(F) and 27(E) s. 19 SOR/2001-254; s.7 Sch. I.1 added, SOR/2001-254; s.10 s. 20 SOR/88-555; s.4 Sch. IV SOR/97-543; s.28 s. 25 SOR/97-543; s.17 Sch. V SOR/97-543; s.29 and 30(F) s. 26 SOR/2001-254; s.8 1. These Regulations may be cited as the Controlled Products Regulations.
Interpretation / Discussion Of Section 1
The Controlled Products Regulations (CPR) have been established under the authority of section 15 of the (Hazardous Products Act) HPA. The purpose of these regulations is threefold: to prescribe the form and content of information to be disclosed on material safety data sheet s (MSDSs) and labels of controlled products; to prescribe the conditions for exemption from the requirements of sections 13 and 14 of the HPA (i.e., the requirements for MSDSs, labels and information disclosure); and third, the regulations to provide the criteria which define the products that fall into the WHMIS classes and divisions of controlled products.
The CPR are organized into four parts:
Part I deals with exemptions in relation to MSDSs followed by MSDS form and content specifications (sections 4 to 13);
Part II deals with exemptions in relation to labels followed by label form and content specifications (sections 14 to 22);
Part III deals with general exemptions and specifications for both MSDS and labels (sections 23 to 31); and
Part IV lists the scientific criteria which define controlled products (sections 34 to 66).
Definitions for terms used throughout the CPR are found in section 2. Definitions related to classification under WHMIS and, hence, used only in Part IV of the CPR, are found in section 32.
CPR Section 2 - Interpretation
2. (1)In these Regulations,
"Act" means the Hazardous Products Act; (Loi)
"CAS registry number" means the identification number assigned to a chemical substance by the Chemical Abstracts Service Division of the American Chemical Society; (numéro d'enregistrement CAS)
"complex mixture" means a mixture that is a combination of many chemicals, has a commonly known generic name and is
- naturally occurring,
- a fraction of a naturally-occurring mixture that results from a separation process, or
- a modification of a naturally-occurring mixture or a modification of a fraction of a naturally-occurring mixture that results from a chemical modification process; (mélange complexe)
"hazard information" means information on the proper and safe storage, handling and use of a controlled product and includes information relating to its toxicological properties; (renseignements sur les dangers)
"LC50" means the concentration of a substance in air that, when administered by means of inhalation over a specified length of time in an animal assay, is expected to cause the death of 50 per cent of a defined animal population; (CL50)
"LD50" means the single dose of a substance that, when administered by a defined route in an animal assay, is expected to cause the death of 50 per cent of a defined animal population; (DL50)
"laboratory sample" means, in respect of a controlled product, a sample of the controlled product that is intended solely to be tested in a laboratory but does not include a controlled product that is to be used
- by the laboratory for testing other products, materials or substances, or
- for educational or demonstration purposes; (échantillon pour laboratoire)
"mixture" means a combination of two or more products, materials or substances that do not undergo a chemical change as a result of interaction between them; (mélange) [SOR/97-543; s.13]
"nurse" means a registered nurse registered or licensed under the laws of a province; (infirmier ou infirmière)
"product identification number" means the number and letters, if any, specified in column II of an item of List II in Schedule II to the Transportation of Dangerous Goods Regulations that correspond to the product specified in column I of an item of that List; (numéro d'identification du produit)
"product identifier" means, in respect of a controlled product, the brand name, code name or code number specified by a supplier or the chemical name, common name, generic name or trade name; (identificateur du produit)
"research and development" means systematic investigation or search carried out in a field of science or technology by means of experiment or analysis, other than investigation or search in respect of market research, sales promotion, quality control or routine testing of controlled products, and includes
- applied research, namely, work undertaken for the advancement of scientific knowledge with a specific practical application in view, and
- development, namely, use of the results of applied research for the purpose of creating new, or improving existing, processes or controlled products; (recherche et développement)
"risk phrase" means, in respect of a controlled product or a class, division or subdivision of controlled products, a statement identifying a hazard that may arise from the nature of the controlled product or the class, division or subdivision of controlled products; (mention de risque)
"supplier identifier" means, in respect of a controlled product, the name of the supplier of the controlled product. (identificateur du fournisseur)
(2) For the purposes of Part II of the Act,
"bulk shipment" means a shipment of a controlled product that is contained, without intermediate containment or intermediate packaging, in
- a vessel with a water capacity of more than 454 litres,
- a freight container, a road vehicle, a railway vehicle, a portable tank, a freight container carried on a road vehicle, railway vehicle, ship or aircraft, or a portable tank carried on a road vehicle, railway vehicle, ship or aircraft,
- the hold of a ship, or
- a pipeline; (expédition en vrac)
"hazardous waste" means a controlled product that is intended for disposal or is sold for recycling or recovery; (résidu dangereux)
"work place" means a place where a person works for remuneration. (lieu de travail)
Interpretation / Discussion Of Section 2
bulk shipment: Ingots of controlled products shipped without wrapping (of any sort) are eligible for the label exemptions detailed in section 15 of the CPR. This policy was agreed upon to avoid having to provide a separate supplier label for each individual ingot of the same controlled product; .
product identification number: The "product identification number" must be disclosed, if available, for the product as a whole and not for individual ingredients of the controlled product. ( Note: PINs have been replaced by "UN Number" in the Clear Language version of the Transportation of Dangerous Goods Regulations and it is anticipated that the definition for "product identification number" in the CPR will be replaced with "UN number" has the meaning assigned to that term by the Transportation of Dangerous Goods Regulations. (numéro UN)".
risk phrase: For information regarding the "qualifying" of risk phrases, refer to the interpretation of section 25 of the CPR.
work place: Farms are considered to fall within the definition of "work place". Therefore, suppliers of controlled products to farms, (which are otherwise not exempt from WHMIS supplier requirements by virtue of section 12 of the HPA), must comply with the WHMIS requirements of the HPA; .
CPR Section 3 - Concentration Expressed as a Percentage
Concentration Expressed as a Percentage
3. Where in these Regulations, other than in sections 11 and 36, the concentration of an ingredient is expressed as a percentage, the percentage shall be taken as an expression of the ratio of the weight of the ingredient to the weight of the controlled product.
Interpretation / Discussion of Section 3
This section of the CPR establishes that, with the noted exceptions, concentrations expressed throughout the CPR are ratios of weight to weight only, i.e., not weight to volume, volume to volume, etc .
CPR Section 4 - Concentration Cut-off
PART I - MATERIAL SAFETY DATA SHEET
Exemptions - Concentration Cut-off
4. The sale or importation of a controlled product, other than a complex mixture or a component of a controlled product that is a complex mixture, is exempt from the application of paragraph 13(a) or 14(a) of the Act in respect of the requirement to disclose on a material safety data sheet the chemical identity and the concentration of
- an ingredient that is found in the controlled product in a concentration of less than 0.1 per cent and is a teratogen or an embryotoxin referred to in section 53, a carcinogen referred to in section 54, a reproductive toxin referred to in section 55, a respiratory tract sensitizer referred to in section 56 or a mutagen referred to in section 57; or
- an ingredient that is an ingredient other than an ingredient referred to in paragraph (a) and that is found in the controlled product in a concentration of less than one per cent, unless the ingredient is included in the Ingredient Disclosure List and the concentration specified for the ingredient in the List is 0.1 per cent.
Interpretation / Discussion of Section 4
This section establishes the cut-off concentrations for ingredients below which an ingredient does not have to be disclosed on an MSDS. (Where ingredients present below their cut-off may have an additive or synergistic effect, suppliers are encouraged to disclose the identity and concentration of those ingredients)
Ingredients that are teratogens, embryotoxins, carcinogens, reproductive toxins, respiratory tract sensitizers or mutagens as defined by the hazard criteria do not have to be disclosed if they are present below 0.1% (weight/weight). Any other ingredient referred to in subparagraphs 13(a)(i) to (iv) of the Hazardous Products Act (HPA) need not be disclosed if its concentration is less than 1% (weight/weight), unless it is on the Ingredient Disclosure List (IDL) and the concentration specified on the IDL for that ingredient is 0.1% (weight/weight).
It should be noted that, by virtue of section 3 of these Regulations, the cut-off concentrations set out in this section are expressed on a weight/weight basis. (By virtue of subsection 11(1), the concentration of an ingredient can be expressed on the MSDS as weight/volume or volume/volume.)
Complex mixtures: The cut-off exemptions from the requirements of paragraphs 13(a) and 14(a) of the HPA established by this section of the CPR do not apply to a controlled product that is a complex mixture nor to a component of a controlled product that is a complex mixture. (For requirements related to ingredient disclosure of complex mixtures, refer to section 5 of the CPR).
Conflicting cut-off concentrations: Where the concentration cut-off established under paragraph 4(a) of the CPR for an ingredient within a mixture is lower than the cut-off established in the IDL, the lower cut-off takes precedence; .
CPR Section 5 - Complex Mixtures
Complex Mixtures
5.(1)The sale or importation of a controlled product that is a complex mixture is exempt from the application of paragraph 13(a) or 14(a) of the Act in respect of the requirement to disclose on a material safety data sheet the chemical identity and concentration of the ingredients of the complex mixture if the generic name of the complex mixture is disclosed on the material safety data sheet.
(2)The sale or importation of a controlled product that contains a component that is a complex mixture is exempt from the application of paragraph 13(a) or 14(a) of the Act in respect of the requirement to disclose on a material safety data sheet the chemical identity and concentration of the ingredients of the component if
- the component is found in the controlled product in a concentration of less than 0.1 per cent and is a teratogen or an embryotoxin referred to in section 53, a carcinogen referred to in section 54, a reproductive toxin referred to in section 55, a respiratory tract sensitizer referred to in section 56 or a mutagen referred to in section 57;
- the component is a component other than a component referred to in paragraph (a) and is found in the controlled product in a concentration of less than one per cent, unless the component is included in the Ingredient Disclosure List and the concentration specified for that component in the List is 0.1 per cent; or
- the commonly known generic name and concentration of the component in the controlled product is disclosed on the material safety data sheet.
Interpretation / Discussion of Section 5
In this section, cut-off concentrations are established for ingredients that are complex mixtures. The term "complex mixture" is defined in section 2 of the CPR. Turpentine, petroleum distillates and atmospheric air are examples of complex mixtures. A complex mixture can be comprised of a multitude of ingredients whose concentrations may vary from batch to batch. A synthetic mixture of gases which approximates the composition of atmospheric air does not fit the definition of a complex mixture because it is not naturally occurring. Therefore, for such a mixture, the MSDS must disclose the ingredients in accordance with Section 13(a) of the HPA.
Requirement to Disclose the Identity of a Complex Mixture: The intent of the CPR is that, subject to cut-offs, etc., the MSDS discloses the identity of all complex mixtures contained in the controlled product.
When WHMIS was being developed, WHMIS participants raised the issue of the common use of complex mixtures in "pure" form and as components of various products. Although these complex mixtures made up a significant portion (if not all) of a product, often many ingredients of the complex mixture would be present below cut-off concentrations in the final product.
As the composition of complex mixtures often varies, if normal ingredient disclosure requirements applied, extensive testing would have to be undertaken on the part of the supplier. Also, if normal ingredient disclosure requirements applied to complex mixtures, in many cases only a minor portion of the overall complex mixture would have to be disclosed. Had the cut-offs established in section 4 of the CPR applied to a product which contained, for example, 30% turpentine and the most abundant single ingredient in the turpentine was n-heptane at 3% (i.e., 0.9% of the total product consisted of n-heptane), a supplier would not be required to disclose any ingredient information in respect of a substance which constitutes 30% of the product. Furthermore, it was recognized that in a significant number of cases, toxicological studies as well as physical tests were conducted and results were only available for the complex mixture--not its individual ingredients.
As a compromise, it was agreed that the generic name of a complex mixture could be disclosed in place of the ingredients of the complex mixture but that the concentration cut-offs established in section 4 would not apply to complex mixtures or a component that was a complex mixture.
A complex mixture will likely contain numerous ingredients. The supplier has the option of:
- disclosing the name and concentration of the complex mixture; or
- disclosing the names and concentrations of all the ingredients of the complex mixture, even if the concentrations of each ingredient is below the applicable cut-off for single ingredients specified in section 4, i.e. below 0.1% or 1%, whichever is applicable.
Since the concentration cut-offs established in section 4 do not apply to "a complex mixture or a component of a controlled product that is a complex mixture", if the supplier does not take advantage of the exemption in subsection 5(2), the supplier cannot apply the cut-off established in section 4 in relation to the ingredients of the complex mixture. Although hypothetically possible, in practical terms, it is impossible to disclose all ingredients if there is no cut-off limit. Therefore, as the second choice is neither a pragmatic nor a realistic "option", the MSDS must disclose the identity of all complex mixtures in the controlled product.
Requirement to Associate Individual Ingredients with a Complex Mixture: Suppliers wishing to use a single MSDS in the marketing of their products in Canada and the United States (U.S.) may have to disclose certain chemicals comprising a complex mixture in order to respect individual U.S. state laws. If individual ingredients of a complex mixture are disclosed, the MSDS should clearly identify which of the disclosed ingredients are components of the complex mixture (or specify which ingredients are components of which complex mixture if there is more than one complex mixture in the controlled product). As stated above, the MSDS must still disclose the identity of all complex mixtures contained in the controlled product.
Subsection 5(1) and Paragraph 5(2)(c):
In the case of a controlled product comprised of 100% of a complex mixture (e.g. pure turpentine), the commonly known generic name for the complex mixture may be disclosed on the MSDS in lieu of the names of the individual ingredients of the complex mixture. When a complex mixture is a component of a controlled product (e.g. a controlled product that is a solution containing 5% turpentine), the generic name of the complex mixture and its concentration can also be disclosed in lieu of the chemical identity and concentration of the ingredients of the complex mixture.
Complex mixtures that are teratogens, embryotoxins, carcinogens, reproductive toxins, respiratory tract sensitizers or mutagens and found in a concentration of less than 0.1% (weight/weight) do not have to be disclosed on the MSDS. Any other complex mixture included in the hazard criteria does not need to be disclosed if its concentration is less than 1% (weight/weight) unless the complex mixture is on the IDL and the concentration specified on the IDL for that complex mixture is 0.1% (weight/weight).
CPR Section 5.1 - Flavours and Fragrances
Flavours and Fragrances
5.1(1)For the purposes of this section.
"flavour" means a product, material or substance that is used solely to impart a taste to another product, material or substance; (saveur)
"fragrance" means a product, material or substance that is used solely to impart a smell to another product, material or substance. (parfum)
(2)The sale or importation of a controlled product that is a flavour or fragrance is exempt, for as long as paragraph 12(b) of the Act is in force, from the application of paragraph 13(a) or 14(a) of the Act in respect of the requirement to disclose on a material safety data sheet the chemical identity and concentration of the ingredients of the controlled product if
- the generic chemical identities of the ingredients of the controlled product and the concentrations thereof are disclosed on the material safety data sheet;
- the supplier of the controlled product maintains a record of the chemical identities and concentrations of the ingredients of the controlled product at a place in Canada where an inspector may enter at any reasonable time for the purposes of the administration and enforcement of Parts II and III of the Act; and
- for the purposes of section 30, the supplier of the controlled product discloses on the material safety data sheet an emergency telephone number by means of which access to the information set out in the record referred to in paragraph (b) may be obtained at any time.
(3)The sale or importation of a controlled product that contains a component that is a flavour or fragrance is exempt, for as long as paragraph 12(b) of the Act is in force, from the application of paragraph 13(a) or 14(a) of the Act in respect of the requirement to disclose on a material safety data sheet the chemical identity and concentration of the ingredients of the component if
- the generic chemical identities of the ingredients of the component and the concentrations thereof are disclosed on the material safety data sheet;
- the supplier of the controlled product or of the component maintains a record of the chemical identities and concentrations of the ingredients of the component at a place in Canada where an inspector may enter at any reasonable time for the purposes of the administration and enforcement of Parts II and III of the Act; and
- the supplier of the controlled product or of the component discloses on the material safety data sheet, in parentheses after the information referred to in paragraph (a), the following information, namely,
- the product identifier of the component,
- for the purposes of section 30, an emergency telephone number by means of which access to the information set out in the record referred to in paragraph (b) may be obtained at any time, and
- a statement to the effect that in a medical emergency, a physician or nurse may obtain the chemical identity and concentration of any ingredient of the component set out in the record maintained pursuant to paragraph (b) by calling the emergency telephone number disclosed under subparagraph (ii) and specifying the product identifier of the component.
(4)Where an inspector obtains information from a record referred to in paragraph (2)(b) or (3)(b), the inspector shall keep the information confidential except for the purposes of the administration and enforcement of Parts II and III of the Act.
Interpretation / Discussion of Section 5.1
The addition of this section (through Amendment No. 2 to the CPR) established an exemption from the disclosure of the chemical identity and concentration of the ingredients of a controlled product, or component of a controlled product, if that product or component is a flavour or a fragrance. The other ingredients (ie. those that do not constitute a flavour or fragrance) must still be disclosed subject only to exemption under the Hazardous Materials Information Review Act (HMIRA) as specified in the CPR. Initially, it was agreed that the exemption relating to flavours and fragrances will only exist for as long as paragraph 12(b) of the HPA is in force (see below--"Continuation of Exemption. ").
The exemption is subject to the condition that the generic chemical identities of the ingredients be disclosed on the MSDS. (The Hazardous Materials Information Review Commission has issued an information bulletin which provides guidance on the use of generic chemical identities.)
The supplier must also maintain a record of the chemical identities and concentrations of the ingredients of the controlled product or component of the controlled product. This information must be provided to a designated inspector upon request so that compliance with the provisions of the regulations can be verified.
Paragraph 5.1(2)(a):
The concentration of the ingredients that correspond to the generic identities should represent the sum of the concentrations of all the ingredients with the same generic chemical identity.
Paragraphs 5.1(2)(b) and 5.1(3)(b):
When a foreign manufacturer exports flavours or fragrances to a Canadian supplier which is not part of the same company, the manufacturer may want only to entrust the required information to a third party. This amendment was drafted with this situation in mind. The requirement "at a place in Canada", stated in paragraphs 5.1(2)(b) and 5.1(3)(b), is satisfied if the required information is deposited with a third party (such as a legal firm, commercial subsidiary, etc.) anywhere in Canada, and the Canadian supplier is given the address of the third party so that it can be reached at any reasonable time by an inspector.
Continuation of Exemption for Flavours and Fragrances: The tripartite sectoral committee which reviewed the exemptions established by paragraph 12(b) of the HPA recommended that "the special provisions in respect to disclosure of chemical identities of flavours and fragrances, as described in Sections 5.1 of the CPR, be maintained subject to the following modifications:
- the current reference to "for as long as paragraph 12(b) of the Act is in force" in subsections 5.1(2) and (3) be removed;
- the "generic chemical identities" of the ingredients be listed in place of the actual chemical identities with greater consistency and precision;
- clarify that the CAS number, LC50 and LD50, would not be required to be disclosed on the MSDS since the CAS number would, and LD50 could, help reveal trade secret formulations;
- modify section 31 of the CPR so that a supplier would be required to provide the source of information for toxicological data used in the preparation of a MSDS only to an inspector on request (and not to users or purchasers) for the purpose of administering and enforcing Parts II and III of the HPA; and
- carcinogens as defined by the CPR be disclosed by their chemical identities."
CPR Section 6 - Controlled Products With Same Product Identifier
Controlled Products With Same Product Identifier
6. The sale or importation of a controlled product is exempt from the application of paragraph 13(a) or 14(a) of the Act in respect of the requirement to transmit, obtain or prepare a material safety data sheet for the controlled product if
- the controlled product is part of a shipment of controlled products that have the same product identifier and a material safety data sheet is transmitted with the shipment or is obtained or prepared for one of the controlled products; or
- the supplier has transmitted to the person to whom the controlled product is sold or the supplier who imports the controlled product has in his possession a material safety data sheet for a controlled product that has the same product identifier and the material safety data sheet
- discloses information that is current at the time of the sale or importation, and
- was prepared and dated not more than three years before the date of the sale or importation.
Interpretation / Discussion of Section 6
Section 6 of the CPR provides a MSDS exemption in respect of controlled products having "the same product identifier".
Kits, MSDSs for - a single MSDS will be acceptable for a kit subject to the following conditions:
- the MSDS must disclose the product identifier of every individually packaged controlled product within the kit;
- the MSDS must clearly disclose which ingredients (subject to disclosure under section 13 of the HPA) are contained in which individually packaged controlled product within the kit;
- the MSDS must disclose all information required by the CPR for every individually packaged controlled product within the kit and clearly indicate to which individually packaged controlled product the information pertains; and
- when new hazards can result from the intermixing of the contents of the individually packaged products in the kit, this information should be disclosed on the MSDS .
if a supplier decides to provide an MSDS for each individually packaged controlled product in the kit, information on new hazards that can result from the intermixing of the contents of the individually packaged products in the kit should be disclosed on each relevant MSDS.
Paragraph 6(a):
For a shipment of identical controlled products, by virtue of paragraph 6(a), the supplier is permitted to transmit (in the case of sale) or obtain or prepare (in the case of importation) a single MSDS for the whole shipment.
Paragraph 6(b):
If an "adequate" MSDS for a controlled product has already been sent to a customer prior to the date of sale, a supplier is not required to furnish MSDSs with subsequent shipments of the same product to that customer.
In addition, where the importer already has an adequate MSDS, an additional MSDS does not have to be obtained or prepared for subsequent importations of the same product by that importer.
An "adequate" MSDS, in this context, means a MSDS which bears information that is current when the product is sold or imported and was prepared and dated no more than 3 years (3 X 365 days) prior to the date on which the product is being sold or imported.
CPR Section 7 - Generic Material Safety Data Sheet
Generic Material Safety Data Sheet
7. (1) The sale or importation of a controlled product whose chemical composition is similar to the chemical composition of other controlled products in its group is exempt from the application of paragraph 13(a) or 14(a) of the Act in respect of the requirement to transmit, obtain or prepare a material safety data sheet for the controlled product if a generic material safety data sheet for the group of controlled products is transmitted, obtained or prepared.
(2) The generic material safety data sheet referred to in subsection (1) shall disclose
- where the range of concentration of an ingredient of the controlled product is different from the range of concentration of the ingredient in the other controlled products in the group, beside the name of the controlled product and the ingredient, the range of concentration of the ingredient in the controlled product, in accordance with section 11; and
- where the hazard information in respect of the controlled product is different from the hazard information in respect of the other controlled products in the group, beside the name of the controlled product, the hazard information for the controlled product.
Interpretation / Discussion of Section 7
A generic MSDS may be used for a group of controlled products with similar chemical composition. However, if the concentration range for an ingredient of a particular controlled product in the group is different from the range declared for the rest of the group, this must be indicated on the MSDS beside the name of that product and beside that ingredient. The permissible concentration ranges are set out in section 11. If the hazard information for a particular controlled product in the group differs from that of the other products in the group, the hazard information relevant to that product must be disclosed on the MSDS beside the name of the product.
An example where a supplier might choose to use a generic MSDS is if the supplier is supplying a series of coloured paints where the only difference from product to product is the pigment used. In such a case, the supplier would be required to list all of the products to which the MSDS applies under the product identifier. If, for example, the yellow-coloured paint is more toxic because of the pigment used, a note on the generic MSDS would be required disclosing the additional toxicological hazards associated with the yellow paint.
Where a supplier sells a line of similar (base) products to distributors or users who blend the bases in various proportions to obtain the final usable product (e.g., automotive paints), a supplier's generic MSDS is acceptable for such a line of products.
The supplier's generic MSDS and the blender's generic MSDS must disclose, under the appropriate heading, all special hazard information related to particular ingredients. For example, special first aid measures concerning a particular ingredient must be disclosed under the "First Aid Measures" section of the MSDS.
An acceptable alternative to providing a MSDS for every blend which discloses the concentration of the ingredients for the blends is to provide the supplier's generic MSDS which discloses the concentrations of hazardous ingredients in the bases; either the blender's generic MSDS or the label must disclose the concentrations of the bases in the final product.
A series of MSDSs could also be prepared for a group of products within a line which have the same base ingredients but which vary with respect to the concentrations of other ingredients, . The intent of WHMIS is to provide complete hazard information to workers. Therefore, the words "may contain" and other phrases which leave some ambiguity as to the composition and, consequently, the health hazard of the product in question, are discouraged.
Crude petroleum oil: In the case of crude petroleum oil, which falls within the definition of a complex mixture, because the hazardous nature of crude oil is such that it varies within a wide range from field to field, and even within the same field, a generic MSDS is acceptable only if it addresses all of the potential hazards of the group of controlled products to which it applies.
For example, crude oil that contains H2 S falls within the D1A classification criteria. However, when the supplier knows that the crude oil does not contain H2 S, the supplier must remove the hazard information and classification associated with H2 S. The dividing line between sweet and sour crude is not a definite one. Even sweet crude may contain sufficient H2 S, either in solution or in the headspace of a storage or transport container which may be harmful to workers upon unprotected exposure. Crude oil that is spiked with butane, subject to the appropriate concentration cut-off, must be identified and its hazard indicated.
It is understood that workers handling crude oil should have received a considerable amount of training (as is required by provincial OSH regulations) specific to the work site. The generic MSDS for crude oil will act as an additional source of hazard information warning of the potential hazards; .
CPR Section 8 - Employer Exemptions
Employer Exemptions
8. The sale of a controlled product to an employer is exempt from the application of paragraph 13(a) of the Act in respect of the requirement to disclose information that could be the subject of a claim for exemption under subsection 11(2) of the Hazardous Materials Information Review Act if
- the employer has filed a claim for exemption or is exempt from disclosing that information in respect of the controlled product under
- the Hazardous Materials Information Review Act, or
- the laws of a province; and
- the information referred to in section 26 or 27, or
- where the information referred to in section 26 or 27 is not available, an emergency telephone number of the employer that will enable a physician or nurse to obtain any informa-tion referred to in paragraph 13(a) of the Act that is in the possession of the employer for the purpose of making a medical diagnosis of, or rendering medical treatment to, a person in an emergency.
Interpretation / Discussion of Section 8
This exemption does not apply to importation.
An employer who purchases a controlled product may consider the following categories of information to be confidential business information (CBI):
- the chemical identity or concentration of any ingredient of a controlled product;
- the name of any toxicological study that identifies any ingredient of a controlled product;
- the chemical name, common name, generic name, trade name or brand name of a controlled product; or
- information that could be used to identify a supplier of a controlled product
An employer, either directly or indirectly, may be required to disclose this information pursuant to the provisions of the Canada Labour Code.
Under provincial law, an employer may file a claim for exemption from disclosing the CBI on MSDSs in the employer's workplace. Depending on the province, the employer may file a claim for an exemption under the Hazardous Materials Information Review Act or under laws particular to that province. An employer who has received an exemption may wish to ensure that the same information does not appear on a supplier MSDS arriving at the employer's facility. This section enables the supplier to accommodate the employer's exemption by allowing the supplier to sell the product to the employer who has the exemption without disclosing the employer's CBI on the MSDS.
If the supplier chooses to accommodate his/her purchaser (i.e., the employer), the following conditions must be met:
If the employer's exemption is allowed under the Hazardous Materials Information Review Act, the supplier must replace the exempt information with the registry number and status of claim information (see section 26 or 27).
If the employer's exemption is allowed under provincial law directly by the province (such as is the case in Nova Scotia) and section 26 or 27 information is not available, the supplier must replace the exempt information with an emergency telephone number provided by the employer on the MSDS.
CPR Section 8.1 - Secondary Supplier Exemptions [Repealed, SOR/97-543, s. 14]
Interpretation / Discussion of Section 8.1
Note : This section has been repealed.
Section 8.1 had been added through the first amendment to the CPR, (SOR/DORS/88-555) to prevent a disruption in the availability of the affected products and relieved the commercial impact that would have otherwise fallen on secondary suppliers when WHMIS came into effect on October 31, 1988.
The addition of sections 8.1 (and 15.1) established a temporary exemption until March 15, 1989, for secondary suppliers from transmitting, obtaining or preparing a MSDS and applying a label, respectively, to a controlled product that is a mixture. This exemption was subject to the condition that, as of July 31, 1988, the secondary supplier or manufacturer of the mixture had not received a MSDS from the primary supplier in respect of a controlled product of the primary supplier which was an ingredient in the mixture of the secondary supplier.
CPR Section 8.2 - Secondary Supplier Exemptions
Secondary Supplier Exemptions
8.2 The sale of a controlled product by a supplier, in this section referred to as the secondary supplier, is exempt from the application of paragraph 13(a) of the Act in respect of the requirement to disclose on a material safety data sheet the chemical identity or concentration of an ingredient of the controlled product if
- the ingredient is sold either directly or indirectly by another supplier, in this section referred toas the primary supplier, who has filed a claim for exemption or is exempted from disclosing thechemical identity or concentration of the ingredient under the Hazardous Materials Information Review Act;
- the chemical identity or concentration of the ingredient is
- unknown to the secondary supplier, or
- known to the secondary supplier and the secondary supplier has obtained the information inconfidence, express or implied, and is obligated by contract or trust, express or implied, or otherwise by law or equity to maintain the confidentiality of the information;
- the information referred to in section 26 or 27 in respect of
- where the secondary supplier has filed a claim for exemption or is exempted from disclosing information that could be used to identify the primary supplier, that claim or exemption, or
- in any other case, the primary supplier's claim or exemption with the words "other supplier" in parentheses after that information,
Interpretation / Discussion of Section 8.2
Section 8.2 provides an exemption for secondary manufacturers (i.e., 2° suppliers) from disclosure requirements for ingredients purchased from a primary (1° ) supplier if the 1° supplier has filed a claim for exemption or is exempt from disclosing that information under the Hazardous Materials Information Review Act (HMIRA).
Section 8.2 was added to the CPR through Amendment No. 1. This section removes the burden from 2° suppliers of determining the chemical identity or concentration of these ingredients by eliminating the cost that would otherwise be incurred by these suppliers should they be required to determine the chemical identity or concentration of ingredients withheld from them by their suppliers through exemption under the HMIRA.
The term "indirectly", as used in paragraph 8.2(a), is meant to include those situations where there may be more than one supplier incorporating a 1° supplier's ingredient which is the subject of a claim for exemption (CFE) under the HMIRA. Therefore, even if a manufacturing process included 3° and 4° manufacturers, for the purposes of section 8.2, all parties incorporating the 1° supplier's trade secret ingredient into their own product are considered to be 2° suppliers and thereby exempt from disclosure of the applicable information.
The addition of this section also eliminated the economic burden which industry would have otherwise incurred had every firm involved in the manufacturing of the end product been required to file a CFE accompanied by the associated fee for an ingredient which was already the subject of a CFE filed by their 1° supplier.
CPR Section 9 - Laboratory Sample
Laboratory Sample
9. (1) Where a supplier has not obtained or prepared a material safety data sheet in respect of a controlled product, the sale or importation of a laboratory sample of the controlled product is exempt from the application of paragraph 13(a) or 14(a) of the Act in respect of the requirement to transmit, obtain or prepare a material safety data sheet if the laboratory sample is packaged in a container that
- contains a quantity of less than 10 kilograms of the controlled product; and
- has a label applied to it in accordance with section 16.
(2) The sale or importation of a laboratory sample of a controlled product is exempt from the application of paragraph 13(a) or 14(a) of the Act in respect of the requirement to disclose the chemical identity of an ingredient of the controlled product on a material safety data sheet if
- the laboratory sample is intended solely to be tested for research and development purposes; and
- the generic chemical identity of the ingredient is disclosed on the material safety data sheet.
Interpretation / Discussion of Section 9
Subsection 9(1) provides an exemption from the requirement to provide, prepare or obtain an MSDS for laboratory samples under the specified conditions. Subsection 9(2) provides an exemption from normal ingredient disclosure requirements on MSDSs of laboratory samples used for research and development if the condition in paragraph 9(2)(b) is met.
"Laboratory sample" and "research and development" are terms which are defined in subsection 2(1) of the CPR. Lab samples must be products "intended solely to be tested in a laboratory." A laboratory includes non-traditional laboratory settings such as facilities designed to conduct testing:
- in the field (i.e., with or without a temporary enclosure such as a tent);
- adjacent to production lines after sampling from the line; or
- in steam/heating plants after sampling from valves, etc.
Therefore, the exemptions described in section 9 would apply in such cases;.
MSDSs for infectious agents: Health has prepared MSDSs for several common potentially infectious agents. The MSDS are organized to contain health hazard information such as infectious dose, viability (including decontamination), medical information, aboratory hazard, recommended precautions, handling information and spill procedures. The intent of these documents is to provide a safety resource for laboratory personnel working with these infectious substances. Because these workers are usually working in a scientific setting and are potentially exposed to much higher concentrations of these human pathogens than the general public, the terminology in these MSDS is technical and detailed, containing information that is relevant specifically to the laboratory setting. These MSDSs can be accessed from the "Publications" page of the WHMIS web site.
MSDSs for diagnostic specimens: The HPA applies to the sale and importation of a controlled product. Internal distribution of a substance, such as from one hospital to another, both of which operate under the auspices of a given Ministry of Health, is outside of the scope of the HPA/CPR. As for other employer generated substances which are not sold in Canada, enquiries relating to an employer's obligations regarding MSDS and other information requirements for diagnostic specimens should be directed to the occupational safety and health agency having jurisdiction.
Paragraph 9(2)(b):
The chemical identity of a complex organic molecule with a high molecular weight could be described as a "substituted ethylene" if its molecular structure contained a double bond. In this case, however, "substituted ethylene" would not be considered to meet the intent of this paragraph. During the development of WHMIS, it was agreed that the phrase "a generic name as precise as reasonably possible. " be used as a guideline when a supplier is required to disclose a generic name as opposed to the specific chemical identity, (ref.: Report of the (WHMIS) Steering Committee, April 1985). WHMIS stakeholders had agreed that the quoted phrase be used as a guideline for use by the Hazardous Materials Information Review Commission as well as by inspectors in the interpretation of both section 16 of the HPA and subparagraph 16(b)(ii) of the CPR. This phrase can also be used as a guideline in the application of paragraph 9(2)(b); .
CPR Section 10 - Laboratory Supply House
Laboratory Supply House
10. The sale or importation of a controlled product is exempt from the application of paragraph 13(a) or 14(a) of the Act in respect of the requirement to transmit, obtain or prepare a material safety data sheet if
- the controlled product
- originates from a laboratory supply house,
- is intended for use in a laboratory, and
- is packaged in a container in a quantity of less than 10 kilograms; and
Interpretation / Discussion of Section 10
A supplier of a controlled product that meets the conditions in paragraph 10(a) will not have to transmit, obtain or prepare an MSDS if all of the information required to be disclosed on an MSDS is disclosed on the label of the product.
A laboratory is intended to include non-traditional laboratory settings such as testing:
- in the field (i.e. with or without a temporary enclosure, such as a tent);
- adjacent to production lines after sampling from the lines;
- in steam/heating plants after sampling from a valve, etc.
Therefore, laboratory supply house chemicals intended for use in such settings are eligible for the exemption provided by this section of the CPR; .
CPR Section 10.1 - [Exemptions, MSDS]; Radioactive nuclides and non-radioactive carrier material, mixtures of
[Mixtures of Radioactive Nuclides and Non-Radioactive Carrier Materials]
10.1 The sale or importation of a controlled product that is a mixture of one or more radioactive nuclides and one or more non-radioactive carrier materials is exempt from the application of paragraph 13(a) or 14(a) of the Act if
- the carrier material
- is present in an amount that is
- in the case of a liquid or gaseous carrier material, no more that 1.0 ml in volume, or
- in the case of a solid carrier material, no more than 1.0 g in weight, and
- a carcinogen under Subdivision A of Division 2 of Class D referred to in section 54,
- a toxic or reactive material under Division 1 of Class 6 and Packing Group I of the Transportation of Dangerous Goods Regulations, or
- an infectious material under Division 3 of Class D of these Regulations or Division 2 of Class 6 of the Transportation of Dangerous Goods Regulations and can be handled in accordance with the physical containment requirement set out in Schedule I.1 to these Regulations;
Interpretation / Discussion of Section 10.1
The Nuclear Safety and Control Act (NSC Act), S.C. 1997, c.9, which came into force on May 31, 2000, and replaced the Atomic Energy Control Act, redefines "nuclear substance", (formally defined as "prescribed substance"), to include only the radioactive components of radioactive nuclide mixtures. As a result, non radioactive controlled product carrier materials in radioactive nuclide mixtures are now subject to the WHMIS requirements of the HPA even though the exclusion for nuclear substances pursuant to paragraph 12(d) of the HPA remains.
Paragraph 10.1(a)
Paragraph 10.1(a) provides an MSDS exemption for very small quantities of liquid, solid or gaseous controlled product carrier materials (except where the carrier material is a carcinogen, very toxic or reactive or is a biohazardous infectious material included in Risk Group 2, 3 or 4). This exemption takes into account that in chemical and clinical laboratory environments:
- radioactive mixtures usually involve very minimal quantities of carrier materials;
- laboratory workers who handle radioactive nuclides receive specific training to avoid any exposure; and
- existing levels of regulatory health and safety control in relation to the radioactive component affords a considerable safety margin to the handling of the carrier component.
With respect to infectious materials, clause 10.1(a)(ii)(C) limits the small quantity exemption to infectious materials included in Risk Group 1. Schedule I.1 is an extract from the Health Canada Laboratory Biosafety Guidelines, 1996, 2 nd edition, Subchapter 5.1: Containment Level 1 for Risk Group 1 microorganisms (or low individual or community risk agents)
Paragraph 10.1(b):
This paragraph provides an exemption for carrier materials used in diagnostic or therapeutic procedures which are approved by Health Canada. The carrier material, which may serve as a vehicle for injected or ingested radio nuclides or radio-labelled compounds, is usually innocuous.
Paragraph 10.1(c):
Paragraph 10.1(c) provides an MSDS exemption for radioactive nuclide/carrier materials which are highly radioactive. As these materials are handled by remote control in entirely closed, shielded "hot cells", personal contact is not possible and any exposure is avoided.
Note: The Transport Packaging of Radioactive Materials Regulations, referred to in paragraph 10.1(c), has been renamed the Packaging and Transport of Nuclear Substances Regulations. These regulations are established under the Nuclear Safety and Control Act. They do not include the table of A1 and A2 values that were included in Part I of Schedule I to the previous regulations. Instead, they refer to the Regulations for the Safe Transport of Radioactive Material of the International Atomic Energy Agency (IAEA) which includes this table. (Paragraph 1(2)(d) of the Packaging and Transport of Nuclear Substances Regulations replaces the values for molybdenum 99.) The Canadian Nuclear Safety Commission distributes reprints of the IAEA Regulations.
CPR Section 11 - [Exemptions, MSDS]; Concentration of Ingredients, Range of
Range of Concentration of Ingredients
11. (1) For the purposes of this section, where the concentration of an ingredient of a controlled product or a complex mixture that is a component of a controlled product is expressed as a percentage, the percentage shall be an expression of the ratio of
(a) the weight of the ingredient or the complex mixture to the weight of the controlled product;
(b) the volume of the ingredient or the complex mixture to the volume of the controlled product; or
(c) the weight of the ingredient or the complex mixture to the volume of the controlled product.(2) Where the concentration of an ingredient of a controlled product or a complex mixture that is a component of a controlled product is required to be disclosed on a material safety data sheet and the ingredient or complex mixture is not always present in the same concentration in the controlled product, the material safety data sheet may disclose, in lieu of the actual concentration of the ingredient or complex mixture, that the ingredient or complex mixture falls within one of the ranges of concentration set out in subsection (3), where the actual concentration of the ingredient or complex mixture falls within that range.
(3) For the purposes of subsection (2), the ranges of concentration are the following:
(a) from 0.1 to 1 per cent;
(b) from 0.5 to 1.5 per cent;
(c) from 1 to 5 per cent;
(d) from 3 to 7 per cent;
(e) from 5 to 10 per cent;
(f) from 7 to 13 per cent;
(g) from 10 to 30 per cent;
(h) from 15 to 40 per cent;
(i) from 30 to 60 per cent;
(j) from 40 to 70 per cent; and
(k) from 60 to 100 per cent.(4) If the concentration of an ingredient in a controlled product is not always the same, a material safety data sheet may disclose, in lieu of the actual concentration of an ingredient of a controlled product or of a complex mixture that is a component of a controlled product, a range of concentration other than a range set out in subsection (3) if the disclosed range of concentration falls entirely within a range of concentration set out in subsection (3); [SOR/2001-254; s. 3]
(5) Where the concentration of an ingredient of a controlled product or a complex mixture that is a component of a controlled product disclosed on a material safety data sheet is expressed as a percentage or in a range of concentration set out in subsection (3) or (4), the material safety data sheet shall also disclose which of the ratios set out in subsection (1) is being expressed.
Interpretation / Discussion of Section 11
Subsection 11(1):
Subsection 11(1) requires that the percent concentration of components within a mixture be expressed in one of three ways only: weight/weight, volume/volume or weight/volume. Mole percent was not referenced in this section because it had never been proposed. Mole percent is viewed as an acceptable method of expressing concentration and it has been proposed that this section be modified when the CPR is next amended, .
Subsection 11(2):
Subsection 11(2) allows the disclosure of a range of concentration in lieu of the actual concentration of the ingredient for the purposes of disclosure on the MSDS where the ingredient is not always present in the same concentration in the controlled product.
Subsection 11(3):
The use of "may contain" with respect to ingredient disclosure is not acceptable. The disclosure of ranges other than ranges specified in CPR 11(3) in respect of ingredients that are not subject to disclosure is outside of the scope of the HPA; e.g., (i) ingredients that do not fall within the criteria set out in paragraph 13(a) of the HPA or (ii) ingredient(s) that would be subject to disclosure but are present below the cut-off(s) established in section 4 of the CPR, .
Where the concentration of ingredients in a series of controlled products covered by the same MSDS varies from batch to batch by more than any one of the ranges specified in subsection 11(3) of the CPR because of changes in raw materials or the location of withdrawal of the product from a process stream, and the hazard information for that series of products is otherwise the same, as an administrative policy, it was agreed that the supplier may disclose more than one range on the MSDS provided the reason for such disclosure is also disclosed on the MSDS, . To prevent abuse of this administrative allowance, this policy does not enable a supplier to combine the specified ranges into a single expanded range exceeding any of the ranges specified in paragraphs 11(3)(a) through (k). For example, the MSDS could disclose that a product contains "5 to 10, 10 to 30 or 30 to 60% of ingredient X"; the supplier may not combine these three ranges and disclose that the product contains "5 to 50% of ingredient X".
Subsection 11(4):
By virtue of this subsection, the disclosure of a concentration range that falls within a range specified in paragraphs 11(3)(a) through (k) may be disclosed on the MSDS.
Subsection 11(5):
The MSDS must specify the type of ratio being disclosed in respect of the concentration; a suitable abbreviation is acceptable, i.e., w/w, v/v, w/v.
Compressed Gas Mixtures - information disclosure:
To address the nature of specific types of compressed gas mixtures, the following policies, , were adopted in relation to each of the mixtures listed:- "Inert Gas Mixture" be used as the product identifier,
- the label bear all required hazard information,
- the actual concentrations of the inert gas ingredients be disclosed on the label on a voluntary basis, and
- a single MSDS be used for this group of products which lists all possible ingredients. The hazard information would be the same for all products in the group; .
- the products be identified on the label as a "Carbon Dioxide/Inert Gas Mixture",
- the label bear all required hazard information,
- the actual concentration of carbon dioxide be disclosed on the label and, on a voluntary basis, the actual concentration of inert gas(es) be disclosed on the label, and
- the MSDS list carbon dioxide and all inert gases as possible constituents. The hazard information would be the same in all cases;
For mixtures of oxygen and one or more inert gases it is acceptable that:
(a) Mixtures containing less than 21% oxygen and varying proportions of one or more of the inert gases
- bear a label identifying the product as a gas mixture containing less than 21% oxygen, as well as required hazard information and actual concentration of oxygen. The actual concentration(s) of the inert gas(es) should be disclosed on a voluntary basis. Footnote 2
- the MSDS would list oxygen and all the inert gases as possible constituents. The hazard information would be the same in all cases.
-
bear a label identifying the product as a mixture of more than 21% oxygen, as well as required hazard information and actual concentration of oxygen. The actual concentration(s) of the inert gas(es) should be disclosed on a voluntary basis.
For flammable gas/inert gas mixtures, which do not contain toxic or corrosive ingredients, it is acceptable that:
(a) Where a single flammable gas is found in a concentration less than the LFL (lower flammable limit) for that gas in air,
-
the product bear a label identifying the product as a non-flammable gas mixture as well as disclosing the required hazard information and actual concentration of the flammable gas. The concentration(s) of the inert gas(es) should be disclosed on a voluntary basis.
-
would bear a label identifying it as a flammable gas mixture, as well as required hazard information and actual concentration(s) of the flammable gas(es). The concentration(s) of the inert gas(es) should be disclosed on a voluntary basis.
CPR Section 12 - Information to be Disclosed on a Material Safety Data Sheet
Information to be Disclosed on a Material Safety Data Sheet
12. (1) For the purposes of subparagraph 13(a)(v) and paragraph 14(a) of the Act, a material safety data sheet shall disclose the nine categories of information set out in column I of an item of Schedule I and each category shall be identified by a heading that is the same as or similar to the suggested heading set out for that category in column II of that item.
(2) Subject to subsections (3) to (10), for the purposes of subparagraph 13(a)(v) and paragraph 14(a) of the Act, the material safety data sheet of a controlled product shall disclose, under an appropriate heading set out in column II of an item of Schedule I or a similar heading, the information set out in each applicable subitem of column III of that item, including the unit of measure, where applicable, if the information is available to the supplier. [SOR/2001-254; s. 4]
(3) The material safety data sheet of a controlled product shall disclose the information set out in column III of subitems 1(1) and 2(1) and (2) of Schedule I under the appropriate heading set out in column II of items 1 and 2 of that Schedule or the similar heading referred to in subsection (1). [SOR/97-543; s. 15]
(4) Information disclosed under one heading of a material safety data sheet is not required to be repeated under any other heading.
(5) Where any information required to be disclosed by subsection (2) is the subject of a claim for exemption or of an exemption under the Hazardous Materials Information Review Act, the information shall be replaced by the information required to be disclosed by section 26 or 27.
(6) Where there is no information disclosed in respect of a category set out in column I of an item of Schedule I, the material safety data sheet shall disclose, under the heading for that category in English, the words "not available" or "not applicable", as the case may be, and the material safety data sheet shall disclose, under the heading for that category in French, the words " pas disponible " or " sans objet ", as the case may be.
(7) Where a controlled product is sold to a distributor for the purpose of sale or resale, the distributor is not required, on the material safety data sheet, to disclose the supplier identifier of the distributor and particulars of the distributor, if the supplier identifier and particulars of the manufacturer or importer are disclosed on the material safety data sheet in accordance with subsection (2).
(8) Where a controlled product is packaged for a distributor by a manufacturer, the manufacturer is not required, on the material safety data sheet, to disclose the name of the manufacturer and particulars of the manufacturer, if the supplier identifier and particulars of the distributor are disclosed on the material safety data sheet in accordance with subsection (2).
(9) Where a supplier imports a controlled product for his own use, the supplier is not required, on the material safety data sheet, to disclose the name of the manufacturer and particulars of the manufacturer.
(10) Where the LD50 or LC50 of a controlled product that is a mixture is determined by testing the mixture, the supplier shall disclose, on the material safety data sheet for the controlled product, that LD50 or LC50 in place of the LD50 or LC50 of the ingredients of the mixture.
(11) In addition to the information required to be disclosed by subsection (2), a material safety data sheet shall disclose all additional hazard information that is available to the supplier with respect to the controlled product or, if appropriate, a product, material or substance that has similar properties, including any evidence based on established scientific principles. [SOR/2010-38; s.1]
Discussion of Section 12
The general format and content of material safety data sheets (MSDSs) is prescribed in this section. For information regarding specific MSDS items and subitems, refer to Schedule I to the CPR.
Classification: disclosure of the "WHMIS" classification is not required on the MSDS. However, if it is company policy to voluntarily disclose this information, then all classifications must be disclosed. If it is company policy to disclose Class B and Class D Divisions and, in the case of Class D, the Subdivisions, then all Divisions and Subdivisions must be disclosed. (Please also refer to the discussion of section 43 of the CPR for information relating to "Redundancy of multiple classifications within WHMIS Class D".)
Format - Use of sixteen ILO heading MSDSs, etc.: As an administrative policy, MSDSs for WHMIS controlled products which use the ILO, ISO or EC, ANSI or GHS 16 heading format are accepted as meeting compliance requirements of CPR Section 12, provided that all 16 headings are disclosed (in the sequence recommended by these other standards) and that the required content specified under Schedule I, Column III of the CPR is addressed. Under the ILO heading "Regulatory Information", the following statement should appear: "This product has been classified in accordance with the hazard criteria of the Controlled Products Regulations and the MSDS contains all the information required by the Controlled Products Regulations." All headings and subheadings which appear on the MSDS must be addressed by disclosing the relevant information or by declaring that the information is not available or not applicable, as appropriate; .
Language requirements: Refer to subsections 24(1) and 24(2) of the CPR.
Revisions to MSDSs: Refer to section 29 of the CPR.
Untested mixtures: For information regarding the disclosure of toxicological and other information for untested mixtures, refer to the discussion under the appropriate category in Schedule I to the CPR in this manual.
Subsection 12(1):
The MSDS must disclose the nine headings shown in column II of Schedule I of the CPR. Although the headings need not be identical to the wording used here they must clearly describe the category of information listed in column I of Schedule I.
These headings may be combined to form one heading provided that the information contained under the combined heading includes subheadings which are similar to the heading specified in column II of Schedule I; . A combined heading such as "Preparation and Product Information" should not be used since preparation information relates to the preparation of the MSDS and not the product. The nine required headings may be given different prominence on the MSDS (i.e., some may appear as subheadings under another heading; for example, "Fire and Explosion Hazard" may appear as a subheading under the heading "Physical Data"); . Additional headings to describe categories of information other than the nine listed categories may appear on an MSDS.
Subsection 12(2):
This subsection states the conditions under which information in column III of Schedule I must be disclosed and where on the MSDS that information must be disclosed.
With the exception of subitems 1(1), 2(1) and (2), all subitems in column III of Schedule I must be disclosed on the MSDS if that information is both "applicable" (to the controlled product) and "available" to the supplier. "Applicable" information is any information that could help the purchaser and users to properly and safely handle, store and use the product; . "Available" means that the supplier has the information or could readily obtain the information. Testing the product to determine information in column III is not necessary; however, much of the information may be "available" because the product may have been tested to determine if it meets the criteria.
It is recommended that if suppliers use standard MSDS forms, they should indicate "not available" or "not applicable" under any subcategory of information for which there is a specific box on the MSDS where no information is disclosed. A short form for these statements is allowed as long as it distinguishes between the two. For example, "n.a." makes no distinction and is unacceptable while "n.av." and "n.ap." are acceptable. In French, the short forms n.d. (non disponible) and s.o. (sans objet) would be acceptable. (The abbreviated form should be explained on the MSDS); .
The CPR will be amended to more explicitly state that all subheadings which appear on an MSDS be addressed by disclosing the relevant information or by declaring that the information is not available or not applicable, as appropriate, i.e., no subheadings which are on the supplier's MSDS can be left blank. However, the requirement for a subitem to actually appear would be unchanged from the present; i.e. information corresponding to a subitem is, with specific exceptions, only required if it is available and applicable; .
"Disclosure. under an appropriate heading" means, with the exception of subitems 1(1), 2(1) and (2), all applicable and available subitems in column III must be disclosed under the heading chosen by the supplier for the category of information that the item is found under in Schedule I or under a heading for another category found in Schedule I. For example, LD50 or LC50 values for an ingredient or a mixture could be disclosed under the heading chosen for category 1 (Hazardous Ingredients) or category 7 (Toxicological Properties). However, placing subitem 5(1) (conditions of flammability) under the heading for category 7 would not be appropriate.
Subsection 12(3):
The information required to be disclosed by subitems 1(1), 2(1) and (2) of Schedule I must always be disclosed and must always be disclosed on the MSDS under the heading (or a similar heading) chosen for category 1 and 2 information, i.e., the information in respect of these subitems is always considered to be available and applicable. If a supplier chooses to disclose this information under other headings on the MSDS, in contrast to the information required under other Schedule I subitems, it must still be disclosed under the appropriate (or similar) heading set out in items 1 and 2 of column II of Schedule I.
Subsection 12(4):
Subsection 12(2) requires "applicable" and "available" information in column III of Schedule I to be disclosed under "an appropriate heading set out in column II". In some cases, a supplier may believe that it is more appropriate to disclose column III information under a column II heading other than under which that column III subitem appears. This subsection clarifies that where a supplier has already disclosed information on the MSDS, that information need not be reiterated elsewhere on the MSDS.
Subsection 12(5):
Ingredient identity or concentration, subitem 1(1) of column III of Schedule I, will be exempted from the disclosure requirements of subsection 12(3) only if the supplier has filed a claim or is granted an exemption under the Hazardous Materials Information Review Act. However, the exempted information must be replaced under the heading chosen for category 1 (Hazardous Ingredients) with the registry number of the claim and the other status of claim information required under sections 26 or 27 of the CPR
Subsection 12(6):
Where a supplier has no information that is applicable and available under one of the nine required headings, the supplier must state the reason why there is no information supplied, i.e., the MSDS must disclose "not available" or "not applicable".
Where no information is disclosed in respect of a subheading which appears on the MSDS, a user of the product will not know if information is missing or if it is "not available" or "not applicable". The CPR will be amended to more explicitly state that all subheadings which appear on an MSDS be addressed by disclosing the relevant information or by declaring that the information is not available or not applicable, as appropriate.
Disclosing "no" or "no evidence" in respect of a Column III subitem conveys that a test has been conducted and that the result was negative. It is considered inappropriate to disclose "no" or "no evidence" if the decision was based on the unavailability of information rather than professional judgement. In such circumstances, therefore, "not available" should be disclosed.
Subsections 12(7) and (8):
There are two situations where a supplier of a controlled product may disclose a name other than his/her own as the "supplier identifier" on the MSDS.
Under subsection 12(7), any distributor of the product, whether the distributor is selling the product to another distributor or to an industrial consumer, may use the manufacturer's or importer's name as the "supplier identifier".
Under subsection 12(8), where the supplier is a manufacturer who is custom packaging the controlled product for a distributor, the distributor's name may be used as the "supplier identifier".
Subsection 12(9):
This subsection applies to importation only. An employer who is required to disclose "information that could be used to identify a supplier of a controlled product" either directly or indirectly, pursuant to the provisions of the Canada Labour Code, may file a claim for exemption under subsection 11(2) of the Hazardous Materials Information Review Act if the employer considers such information to be confidential business information.
Subsection 12(10):
When the LD50 or LC50 of a mixture is unknown, LD50 or LC50 values for the ingredients are useful in providing some indication of the toxicity of the mixture. However, if the LD50 or LC50 of the mixture is known, disclosure of the LD50 s or LC50 s for the ingredients is unnecessary.
If the LD50 (or LC50 ) of a mixture is unknown but the LD50 (or LC50 ) of all the ingredients present in a concentration equal to or greater than 1% are known, then the mixture is considered to be a tested mixture with an LD50 (or LC50 ) derived from the formula in subsection 45(1) of the CPR. For such a mixture, the MSDS may disclose the LD50 (or LC50 ) derived from the formula in place of the LD50 (or LC50 ) of the ingredients; .
Subsection 12(11):
This subsection was included in the Regulations to ensure that information relating to hazards posed by a controlled product that may not be encompassed by the subitems set out under column III of Schedule I will be disclosed on the MSDS. The term "hazard information" is defined in section 2 of the CPR.
To meet the requirement to disclose "all additional hazard information that is available to the supplier with respect to the controlled product or, if appropriate, a product, material or substance that has similar properties, including any evidence based on established scientific principles", it may not be adequate for a supplier to rely on his/her own knowledge of the product. Suppliers should review relevant information available from, for example:
- the Canadian Centre for Occupational Health and Safety;
- publications of the regulatory agency with jurisdiction at the workplace;
- publications made available by industry or trade associations of which the employer is a member, and by labour organization(s) which represent workers at the workplace;
- published technical literature; ; etc.
Subsection 12(11) requires minimal disclosure of the toxicological properties and the proper and safe storage, handling and use of the controlled product, not of individual ingredients. The particulars of disclosure would depend upon the notoriety of the properties; that is, what the supplier actually knows or what a reasonable supplier acting with reasonable diligence would know.
Subsection 12(11) had required a supplier to disclose on the MSDS "any other hazard information with respect to the controlled product of which the supplier is aware or ought reasonably be aware" . The SJCSR concluded that the HPA does not provide the authority for the CPR to state "aware or ought reasonably to be aware" . To address this, subsection 12(11) was amended through SOR/2010-38, effective February 23, 2010. As indicated in the Regulatory Impact Analysis Statement that accompanied this and related amendments:
- ". They [the amendments] will not change the scope of the HPA/CPR nor what is encompassed by the term 'controlled product'. They do not provide extra powers to the Government nor do they increase the burden for the regulated community."
As these amendments were projected to have no socio-economic impact, they were exempted from pre-publication in Part I of the Canada Gazette.
CPR Section 13 - Information to be Disclosed on Material Safety Data Sheet[conflicting toxicological information]
13. (1) Where information respecting the toxicological properties of a controlled product disclosed on a material safety data sheet may be interpreted in such a way as to qualify or contradict other toxicological information disclosed on the material safety data sheet, the material safety data sheet shall include sufficient information concerning the toxicological studies so as not to mislead a person as to the nature or extent of the hazard posed by the controlled product.
(2) For the purposes of determining whether information may mislead a person as to the nature or extent of a hazard, the general impression that the information conveys shall be taken into account.
Interpretation / Discussion of Section 13
Also see discussion under section 25 of the CPR.
Subsection 13(1):
Results derived from toxicity testing of a product can be inconclusive or conflicting. However, it is important that when such information is disclosed on the MSDS, it be done in a way that does not imply that there are no hazards posed by the product (assuming that the product meets the criteria). This can be done by including enough information about the conflicting study so that a proper judgement about the validity of the study can be made.
Subsection 13(2):
This subsection places the onus on suppliers to communicate the hazards associated with a controlled product in a clear, unambiguous manner that does not contradict other information disclosed on the MSDS.
For example, many individuals believe that an exposure limit, in the absence of a qualification to the contrary, is the time weighted average (TWA) exposure limit. It is misleading to disclose a short term exposure limit (STEL) or a ceiling (C) value without qualifying it as such. Therefore, it is considered unacceptable to disclose an exposure limit without specifying which type, ie., without distinguishing between TWA vs STEL vs C.
CPR Section 14 - [Label exemptions], Inner Containers
Part II LABLES - Exemptions Inner Containers
14. (1) For the purposes of this section, "outer container" means the most outward container of a controlled product that is visible under normal conditions of storage and handling, but does not include the most outward container if it is the only container of the controlled product (contenant extérieur). [SOR/88-555; s. 2]
(2) The sale or importation of a controlled product is exempt from the application of paragraph 13(b) or 14(b) of the Act in respect of the requirement to apply a label to a container that is:
- the inner container of the controlled product, if
- the outer container is not labelled in accordance with paragraph (d),
- the person to whom the controlled product is sold undertakes in writing to apply a label in accordance with paragraph 13(b) or 14(b) of the Act to the inner container; and
- in the case of a controlled product that is a mixture of one or more radioactive nuclides and one or more non-radioactive carrier materials, the mixture is packaged in more than one container and the outer container is labelled as required by these Regulations; [SOR/2001-254; s. 4]
Interpretation / Discussion of Section 14
Under the Act, all containers of a controlled product must be labelled. In many cases, a single product may be packaged in more than one container. For example, a powdered chemical may be packaged in a plastic bag within a small box and, during shipping and storage, many small boxes may be contained within a larger box. This section lists special circumstances under which some of these containers may be exempted from WHMIS labelling requirements.
Kits, labelling of : When there are multiple different controlled products within a single container, such as a kit, each inner container must have the appropriate WHMIS supplier label applied to it. It is recognized that the labelling requirements for the outer container containing different controlled products is a problem which may be addressed by an amendment when the CPR are reviewed in the future. In the interim, the labelling of such outer containers will be left to the discretion of suppliers; .
Subsection 14(1) :
The phrase "but does not include the most outward container if it is the only container of the controlled product" was added to this subsection through Amendment No. 1 to the CPR.
An "outer container" is defined as the container normally visible when a controlled product is handled during transport or stored prior to use. By implication, all containers within this "outer container" are "inner containers". The exemptions from labelling requirements of outer containers provided under the conditions specified in subsection 14(2) do not apply in those circumstances where the outer container is the only container of the controlled product.
Subsection 14(2) :
There are four situations where containers of controlled products will not require WHMIS supplier labels.
Under paragraph 14(2)(a), the supplier or importer will not have to label inner containers according to the WHMIS label requirements if the following two conditions are met. First, the outer container of the product must have a WHMIS label on it and, second, the supplier must have in his/her possession a letter written by the purchaser which states that the purchaser will apply a WHMIS supplier label to the inner containers. Reference is made to paragraph 14(2)(d) in subparagraph 14(2)(a)(i) in order to prohibit a supplier from utilizing the outer container exemption in (d). This is to ensure that there is at least one WHMIS label on the controlled product. A purchaser is in no way obligated by this section to enter into such a contractual arrangement with his/her supplier.
Subparagraph 14(2)(a)(iii) provides an exemption from the WHMIS labelling requirement on the primary container where a mixture of radioactive nuclides and non-radioactive carrier materials is packaged in more than one container. Only the outermost container needs WHMIS labelling since workers will normally handle only that outer package. If in using or handling the material, the outer container is removed, then WHMIS-equivalent regulations under the Nuclear Safety and Control Act require the licensee to re-label the newly exposed container. Hence, the mixture will always bear a visible label
on its outer container.Paragraph 14(2)(b) states that a package liner does not require a supplier label. A package liner is, for example, the plastic bag used to contain a powder within a box. As such a product would normally be kept in the box during storage and use, labelling the package liner would be unnecessary. If, however, the product is intended to be stored and used from the plastic bag alone, it would not be considered to be a package liner and would require WHMIS labelling.
Paragraphs 14(2)(c) and (d) both deal with specific circumstances whereby an outer container is exempted from WHMIS labelling. Under paragraph (c), an outer container that does not obstruct the visibility of a WHMIS label on an inner container will not require a label. For example, if several boxes of a controlled product were shrink wrapped with clear plastic to a pallet, the shrink wrapping (outer container) would not require a WHMIS label if WHMIS labels could be seen on the boxes through the plastic.
As provided for by paragraph 14(2)(d), if an outer container has a label in accordance with Transportation of Dangerous Goods Regulations (a TDG label), the outer container will not require a WHMIS label; inner containers, however, must have WHMIS labels. If a product does not have any inner containers (e.g., a drum of solvent), then this exemption is not applicable, i.e., a WHMIS supplier label must be applied to the container. The fact that a product falls within the concept of of a "limited quantity" under section 1.17 or other special provisions set out in the TDGR would not preclude the exemption afforded by paragraph 14(2)(d) of the CPR. However, given the minimal TDG labelling required for a "limited quantity", suppliers may wish to apply a WHMIS supplier label on the outer container for such products. Not all controlled products will require TDG labelling since the criteria for controlled products are broader than the criteria for products covered by TDG Regulations.
CPR Section 15 - Bulk Shipments
Bulk Shipments
15. (1) The sale or importation of a bulk shipment of a controlled product is exempt from the application of paragraph 13(b) or 14(b) of the Act if
- a label, material safety data sheet or statement in writing disclosing the information required to be disclosed by section 19 in respect of the controlled product is transmitted to the person to whom the controlled product is sold on or before the date on which the person receives the bulk
shipment; or - the supplier has transmitted to the person to whom the controlled product is sold or the supplier who imports the controlled product has in his possession a label, material safety data sheet or statement in writing that
- is for a controlled product that has the same product identifier, and
- discloses the information that is required to be disclosed by section 19 in respect of the controlled product and is current at the time of the sale or importation.
(2) For the purposes of subsection (1), where the information is transmitted on a material safety data sheet or a statement in writing, hazard symbols required to be disclosed by paragraph 19(1)(d) in respect of the controlled product may be replaced by reference to the class and, in the case of a controlled product included in Class D - Poisonous and Infectious Materials, the division into which
the controlled product falls.Interpretation / Discussion of Section 15
Subsection 15(1) :
The term "bulk shipment" is defined in subsection 2(2) of the CPR. Typically, a product shipped in bulk is transported to a work site and, upon arrival, transferred into a storage container. In such situations, labelling of the container in which the product is transported would not provide WHMIS label information to workers at the worksite. During transit, hazard warnings will be covered by the Transportation of Dangerous Goods Regulations. The employer at the work site, however, will need the supplier label information in order to properly label his/her on-site storage containers. Section 15 offers an exemption from WHMIS labelling requirements on containers of bulk shipments on the conditi on that the supplier WHMIS label information is sent to the purchaser.
Label information is specified in section 19 of the CPR and includes the product identifier, supplier identifier, hazard symbols, risk phrases, precautionary measures and, where appropriate, first aid measures. Several of these items are not normally required on MSDSs.
The label information can be sent to the purchaser in three forms. It can be sent on a WHMIS label, as additional information on a material safety data sheet or in a written statement..
Concerns have been expressed that the information which would normally appear on a supplier label is not immediately distinguishable and sometimes difficult to extract from the MSDS when the label information is transmitted within the body of the MSDS. Typically, a product shipped in bulk is transported to a worksite and, upon arrival, transferred into a storage container. During transit, hazard warnings will be covered by the Transportation of Dangerous Goods Regulations. The employer at the worksite, however, will need the supplier label information in order to properly label his/her on-site storage containers. Section 15 offers an exemption from WHMIS labelling requirements on containers of bulk shipments on the condition that the supplier WHMIS label information is sent to the purchaser.
- As one of the three key communication elements of the WHMIS program, the supplier label provides, in addition to other information, the risk phrases applicable to the controlled product.
To facilitate the application of the appropriate label to the controlled product, should a supplier/importer of bulk shipments choose to provide supplier label information on the MSDS as opposed to providing a separate label (or by disclosing the label information on a separate sheet), the label information should be set apart and readily discernible from the other information disclosed on the MSDS; .
Paragraph 15(1)(a) is intended to deal with the first-time sale of a bulk shipment to a purchaser. The bulk shipment is exempted from WHMIS labelling requirements if all of the label information is sent to the purchaser on or before receipt of the product by the purchaser.
Paragraph 15(1)(b) is intended to cover subsequent sales of the same product sent in bulk shipments to a purchaser. Subsequent bulk shipments of the product are exempted from the WHMIS labelling requirements if the purchaser or importer is already in possession of all of the label information and if
that information is still valid at the time of sale or importation.Ingots of controlled products shipped without wrapping of any sort are eligible for the label exemptions detailed in section 15 of the CPR. This policy was agreed upon to avoid having to provide a separate supplier label for each individual ingot of the same controlled product; .
Subsection 15(2) :
Subsection 15(2) deals with the cases where the label information is transmitted on an MSDS or in a written statement. In such cases, transmission of the hazard symbols is not required. Provision of information advising of the classes and, in the case of class D, the division that the product falls into, will enable the employer to respect OSH worksite labelling and training obligations.
CPR Section 15.1 - Secondary Supplier Exemptions [Repealed, SOR /97-543]
Interpretation / Discussion of Section 15.1
Note: This section has been repealed.
Section 15.1 had been added through the first amendment to the CPR, (SOR/DORS/88-555) to prevent a disruption in the availability of the affected products and relieved the commercial impact that would have otherwise fallen on secondary suppliers when WHMIS came into effect on October 31, 1988.
The addition of sections 15.1 (and 8.1) established a temporary exemption until March 15, 1989, for secondary suppliers from applying a label and transmitting, obtaining or preparing a MSDS, respectively, to a controlled product that is a mixture. This exemption was subject to the condition that, as of July 31, 1988, the secondary supplier or manufacturer of the mixture had not received a MSDS from the primary supplier in respect of a controlled product of the primary supplier which was an ingredient in the mixture of the secondary supplier.
CPR Section 16 - Laboratory Samples
Laboratory Samples
16. Where a supplier has not obtained or prepared a material safety data sheet in respect of a controlled product, the sale or importation of a laboratory sample of the controlled product is exempt from the application of paragraph 13(b) or 14(b) of the Act if the laboratory sample is packaged in a container that
- contains a quantity of less than 10 kilograms of the controlled product; and
- has a label applied to it that discloses, in respect of the controlled product, the following information:
- lthe product identifier,
- the chemical identity or generic chemical identity of any ingredient of the controlled product referred to in any of subparagraphs 13(a)(i) to (iv) of the Act, if known by the supplier,
- the supplier identifier,
- the statement "Hazardous Laboratory Sample. For hazard information or in an emergency, call (number disclosed under subparagraph (v))/Échantillon pour laboratoire de produit dangereux. Pour obtenir des renseignements sur les dangers ou en cas d'urgence, composer (le numéro divulgué en vertu du sous-alinéa (v))", and
- an emergency telephone number of the supplier that will enable
- a user of the controlled product to obtain hazard information in respect of the controlled product, and
- a physician or nurse to obtain any information in respect of the controlled product that is referred to in paragraph 13(a) of the Act and is in the possession of the supplier for the purpose of making a medical diagnosis of, or rendering treatment to, a person in an emergency.
Interpretation / Discussion of Section 16
There may be cases where the information required on WHMIS labels is not available. The exemption in this section allows these samples to be distributed with WHMIS labels that disclose less information than is normally required.
The term "distribute", which is used in the definition of "sell" (see section 2 of the HPA), does not include internal distribution within an organization but does include transfer between independent organizations or companies. Where a laboratory sample is distributed within an organization, OSH requirements must be adhered to. Where independent organizations are involved, the laboratory sample, if it is a controlled product, must meet the requirements of Section 16 of the CPR. Samples which are shipped to an outside laboratory for testing have to be labelled in accordance with Section 16 of the CPR as this is considered distribution; .
For a supplier to take advantage of this exemption, the sample must meet three criteria. First, the product must meet the definition of a laboratory sample in subsection 2(1) of the CPR; second, the sample must be less than ten kilograms; and, third, the product must not have previously had an MSDS prepared for it.
Samples that meet these three criteria must have on their labels the information prescribed in subparagraphs 16(b)(i), (iii), (iv), (v) and, if available to the supplier, the information prescribed in subparagraph 16(b)(ii).
Samples of a product that are being distributed for marketing purposes do not qualify for this exemption.
Many laboratory samples will not have to meet labelling requirements because they will either not meet the criteria set out in Section 33 of the CPR or they fall within the exemptions set out in Section 4 of the CPR:
as many products are routinely sampled and analyzed, the supplier can rely on previous test results on similar samples as per Section 33(1) of the CPR;
section 33(2) of the CPR for determining Class D products makes reference to "information of which the supplier is aware or ought reasonably to be aware";
air samples taken by OSH inspectors will normally be exempt on the basis of the concentration cut-off stated in Section 4 of the CPR; .
Therefore, although not specifically required by the regulations, suppliers intending to use this exemption should state on the labels and MSDSs words such as "Research and development sample. For laboratory use only. Échantillon pour recherche et développement. Pour utilisation dans un laboratoire seulement."; . Refer also to the discussion under section 9.
Labelling of infectious agents: Health Canada has prepared MSDSs for several common potentially infectious agents which can provide a source of information for labelling. These MSDSs can be accessed from the "Publications" page of the WHMIS web site.
Labelling of diagnostic specimens: The HPA applies to the sale and importation of a controlled product. Internal distribution of a substance, such as from one hospital to another, both of which operate under the auspices of a given Ministry of Health, is outside of the scope of the HPA/CPR. As for other employer generated substances which are not sold in Canada, enquiries relating to an employer's obligations regarding labelling and other information requirements for diagnostic specimens should be directed to the occupational safety and health agency having jurisdiction.
Subparagraph 16(b)(ii):
The chemical identity of a very complex high molecular weight organic molecule could be described as a "substituted ethylene" if there was a double bond somewhere in the molecule. In such a case, however, "substituted ethylene" would not be considered to meet the intent that "a generic name as precise as reasonably possible. " be disclosed. The quoted sentence is from the Report of the (WHMIS) Steering Committee and reflects the original consensus on this issue. WHMIS stakeholders subsequently agreed that the above-quoted phrase be used as a guideline by the Hazardous Materials Information Review Commission as well as inspectors in the interpretation of both section 16 of the HPA and subparagraph 16(b)(ii) of the CPR; .
CPR Section 17 - Laboratory Supply House
Laboratory Supply House
17. The sale or importation of a controlled product is exempt from the application of paragraph 13(b) or 14(b) of the Act if
- the controlled product
- originates from a laboratory supply house,
- is intended for use in a laboratory, and
- is packaged in a container in a quantity of less than 10 kilograms; and
- the product identifier,
- where a material safety data sheet is available, a statement to that effect,
- risk phrases that are appropriate to the controlled product or to the classes, divisions or subdivisions into which the controlled product falls,
- precautionary measures to be followed when handling, using or being exposed to the controlled product, and
- where appropriate, first aid measures to be taken in case of exposure to the controlled product.
Interpretation / Discussion of Section 17
Persons working in laboratories are typically better informed about the hazards posed by products in their workplace than persons working outside of the laboratory setting. This section allows for reduced information requirements on labels of products destined for use in laboratories.
Suppliers of controlled products that meet the origin, destination and size requirements stated in paragraph 17(a) may utilize this exemption.
The labels on these products do not require the depiction of hazard symbols nor disclosure of a supplier identifier. Through the addition of subsection 20(2), (Amendment No. 1 to the CPR), the label information prescribed in this section for products meeting the stated criteria need not be within the WHMIS "hash" border depicted in Schedule III to the CPR. The labels will not require a statement making reference to the availability of the MSDS only if all of the MSDS information is disclosed on the label (i.e., if the supplier has utilized the exemption in section 10 of the CPR). Therefore, subparagraph 17(b)(ii) should not be taken to imply that an MSDS is not required for these controlled products.
"Intended for used in a laboratory" includes non-traditional lab settings such as field testing (with or without a temporary enclosure), production line sampling and testing and steam/heat plant sampling and testing;
CPR Section 17.1 - [Exemptions, label], Radioactive nuclide and non-radioactive carrier material, mixtures of
[Mixtures of Radioactive Nuclides and Non-Radioactive Carrier Materials]
17.1 The sale or importation of a controlled product that is a mixture of one or more radioactive nuclides and one or more non-radioactive carrier materials is exempt from the application of paragraph 13(b) or 14(b) of the Act if
- the carrier material
- is present in an amount that is
- in the case of a liquid or gaseous carrier material, no more that 1.0 ml in volume, or
- in the case of a solid carrier material, no more than 1.0 g in weight, and
- a carcinogen under Subdivision A of Division 2 of Class D referred to in section 54,
- a toxic or reactive material under Division 1 of Class 6 and Packing Group I of the Transportation of Dangerous Goods Regulations, or
- an infectious material under Division 3 of Class D of these Regulations or Division 2 of Class 6 of the Transportation of Dangerous Goods Regulations and can be handled in accordance with the physical containment requirement set out in Schedule I.1 to these
Regulations;
Interpretation / Discussion of Section 17.1
The Nuclear Safety and Control Act (NSC Act), S.C. 1997, c.9, which came into force on May 31, 2000, and replaced the Atomic Energy Control Act , redefines "nuclear substance" (formally defined as "prescribed substance") to include only the radioactive components of radioactive nuclide mixtures. As a result, non radioactive controlled product carrier materials in radioactive nuclide mixtures are now subject to the WHMIS requirements of the HPA even though the exclusion for nuclear substances pursuant to paragraph 12(d) of the HPA remains.
Paragraph 17.1(a)
Paragraph 17.1(a) provides a label exemption for small quantities of liquid, solid or gaseous controlled product carrier materials (except where the carrier material is a carcinogen, very toxic or reactive or is a biohazardous infectious material included in Risk Group 2, 3 or 4). This exemption takes into account that in chemical and clinical laboratory environments:
- radioactive mixtures usually involve very minimal quantities of carrier materials;
- laboratory workers who handle radioactive nuclides receive specific training to avoid any exposure; and
- existing levels of regulatory health and safety control in relation to the radioactive component affords a considerable safety margin to the handling of the carrier component.
With respect to infectious materials, clause 10.1(a)(ii)(C) limits the small quantity exemption to infectious materials included in Risk Group 1. Schedule I.1 is an extract from the Health Canada Laboratory Biosafety Guidelines, 1996, 2 nd edition, Subchapter 5.1: Containment Level 1 for Risk Group 1 microorganisms (or low individual or community risk agents)
Paragraph 17.1(b):
This paragraph provides an exemption for carrier materials used in diagnostic or therapeutic procedures which are approved by Health Canada. The carrier material, which may serve as a vehicle for injected or ingested radio nuclides or radio-labelled compounds is usually innocuous.
Paragraph 17.1(c):
Paragraph 17.1(c) provides a label exemption for radioactive nuclide/carrier materials which are highly radioactive. As these materials are handled by remote control in entirely closed, shielded "hot cells", personal contact is not possible and any exposure is avoided.
Note: The Transport Packaging of Radioactive Materials Regulations, referred to in paragraph 17.1(c), has been renamed the Packaging and Transport of Nuclear Substances Regulations. These regulations are established under the Nuclear Safety and Control Act. They do not include the table of A1 and A2 values that were included in Part I of Schedule I to the previous regulations. Instead, they refer to the Regulations for the Safe Transport of Radioactive Material of the International Atomic Energy Agency (IAEA) which includes this table. (Paragraph 1(2)(d) of the Packaging and Transport of Nuclear Substances Regulations replaces the values for molybdenum 99.) The Canadian Nuclear Safety Commission distributes reprints of the IAEA
Regulations.CPR Section 18 - Labels of Bulk Shipments
Labels of Bulk Shipments
18. For the purposes of subsection 11(2) of the Act, a label of a bulk shipment is included with or accompanies the bulk shipment when it is included with the shipping documents that accompany the bulk shipment.
Interpretation / Discussion of Section 18
Paragraphs 13(b) and 14(b) of the Hazardous Products Act (HPA) state that a controlled product or a container of a controlled product must have a WHMIS label applied to it as a condition of sale or importation. For the reasons listed in the interpretation of section 15 of the CPR, applying a label to the container of a bulk shipment is unnecessary.
Subsection 11(2) of the HPA states that, in the case of bulk shipments, applied means "is included with or caused to accompany the bulk shipment in the manner prescribed". This section prescribes that manner. This section, in conjunction with section 15, provide a range of labelling options for suppliers of controlled products shipped in bulk.
CPR Section 19 - Information to be Disclosed on Labels
Information to be Disclosed on Labels
19. (1) The label applied to a controlled product or the container in which a controlled product is packaged shall disclose, in respect of the controlled product, the following information:
- the product identifier;
- subject to subsections (3) and (4), the supplier identifier;
- a statement to the effect that a material safety data sheet is available;
- subject to subsection (5), hazard symbols set out in column II of Schedule II that correspond with the classes in which the controlled product is included and the divisions into which the controlled product falls as set out in column I of that Schedule; and
- where the container has a capacity of more than 100 millilitres, the following information:
- risk phrases that are appropriate to the controlled product or to the classes, divisions or subdivisions into which the controlled product falls,
- precautionary measures to be followed when handling, using or being exposed to the controlled product, and
- where appropriate, first aid measures to be taken in case of exposure to the controlled product.
(2) Paragraphs (1)(a) and (b) do not apply in respect of the sale of a controlled product to an employer who has filed a claim for exemption or is exempt under the Hazardous Materials Information Review Act or under the laws of a province from disclosing
- the chemical name, common name, generic name, trade name or brand name of a controlled product, if the label discloses the code name or code number specified by the supplier; or
- any information that could be used to identify the supplier of the controlled product, if that information is replaced by
- the information referred to in section 26 or 27, or
- where the information referred to in section 26 or 27 is not available, the information required to be disclosed under the laws of the province.
(3) Where a controlled product is sold to a distributor for the purpose of sale or resale, the distributor is not required, in the information disclosed on the label under paragraph (1)(b), to disclose the supplier identifier of the distributor if the supplier identifier of the manufacturer or importer is disclosed on the label.
(4) Where a controlled product is packaged for a distributor by a manufacturer, the manufacturer is not required, in the information disclosed on the label under paragraph (1)(b), to disclose the supplier identifier of the manufacturer if the supplier identifier of the distributor is disclosed on the label.
(5) Where a controlled product falls into Divisions 1 and 2 of Class D - Poisonous and Infectious Material, paragraph (1)(d) does not apply in respect of the requirement to disclose on the label applied to the controlled product or the container in which the controlled product is packaged the hazard symbol set out in column II of Schedule II that corresponds to Division 2 of Class D - Poisonous and Infectious Material as set out in column I of that Schedule.
(6) Paragraphs (1)(b) and (e) do not apply to the sale or importation of a controlled products that is a mixture of one or more radioactive nuclides and one or more non-radioactive carrier materials.
[SOR/2001-254; s. 7]DISCUSSION of SECTION 19
This section of the CPR specifies the information that must be disclosed on a WHMIS supplier label. For information relating to language requirements of this disclosure, please see subsection 24(3) of the CPR.
Only the information specified in this section should be placed within the WHMIS border within the WHMIS "hash" border depicted in Schedule III to these Regulations. Refer to subsection 20(1) and 21(1) of the CPR for additional information on this issue.
Classification: Disclosure of the "WHMIS" classification is not required on the label. However, if it is company policy to voluntarily disclose this information, then all classifications must be disclosed. If it is company policy to disclose Class B and Class D Divisions and, in the case of Class D, the Subdivisions, then all Divisions and Subdivisions must be disclosed. (Please also refer to the discussion of section 43 of the CPR in the Reference Manual for information relating to "Redundancy of multiple classifications within WHMIS Class D".)
Subsection 19(1):
This subsection lists all information that is normally required on a WHMIS label. Small size containers that have a volume of 100 millilitres or less require the information specified in paragraphs
; containers with a volume of more than 100 millilitres require the information specified in paragraphs
. The 100 millilitre size refers to the volume of the container and not the volume of the product.Paragraphs 19(1)(a) and 19(1)(b):
"Product identifier" and "supplier identifier" are terms which are defined in section 2 of the . As required by section 28 of the , the product identifier disclosed on the label must be identical to that disclosed on the MSDS. Thedoes not contain an analogous requirement for the supplier identifier. The definition of "supplier identifier" does not include "the city where the principal place of business is located". Therefore, in contrast to the MSDS requirements, only the name and not the address of the supplier need appear on the label of the controlled product;
Paragraph 19(1)(d):
Hazard symbols are depicted in Schedule II of the. If a product meets the criteria for more than one Class or Division, all of the applicable symbols, with the exception stated in subsection 19(5), must be displayed on the WHMIS label.
Hazard symbols should be large enough to provide a clear warning to workers. In contrast to the Consumer Chemicals and Containers Regulations, 2001 (CCCR-2001), the size of the hazard symbols has not been prescribed in the CPR. Suppliers, however, may wish to use the CCCR-2001 as a guideline for symbol size. (The CCCR apply to chemical products sold to consumers. These products are included as items 1 and 2 of Part II of Schedule I to the HPA).
The CCCR-2001 requirement for minimum symbol size is based on the "main display panel". In the CCCR-2001, the requirement for minimum symbol size is based on the "the main display panel". The CCCR-2001 require that the hazard symbol must be at least such a size that it covers 3% of the "main display panel", but must be no smaller than 6 mm (¼ inch) in diameter. In the case of large containers, the symbol need not exceed 50 mm (2 inches). The "the main display panel" is the area of the largest side of a box or, for a cylinder, it is either the area of the top or 40% of the side surface area, whichever is larger.
Paragraph 19(1)(e):
Specifically worded risk phrases, precautionary measures and first aid statements have not been prescribed by the
. The term"risk phrases" is defined in section 2 of the. Examples of acceptable risk phrases and precautionary measures in English and French are found in Council Directives of the European Economic Community posted on the "LABEL" page of the national WHMIS Web site.
For information regarding the "qualifying" of risk phrases, refer to the interpretation of section 25 of the CPR.
First aid measures should be limited to immediate measures to be taken by the victim or coworkers that are specific to the product and not measures to be taken by a medical professional. The first aid measures are not meant to include, for example, the treatment to be taken if a person receives burns in a fire resulting from a flammable controlled product. First aid measures must provide information necessary for the immediate on-site treatment of a person who has experienced adverse acute effects resulting from an accident with or overexposure to the controlled product. If applicable, the first aid measures disclosed must be specific to the route of entry, i.e., inhalation versus skin or eye contact, etc.. The label must disclose first aid measures if they are applicable to the product. If the product's toxicity is negligible, first aid measures would not be applicable.
Subsection 19(2):
An employer, who is a purchaser of a controlled product, may consider the product identifier or the name of his/her supplier as confidenti al business information because it might allow a competitor to determine the ingredients used to create his/her product. Under WHMIS, the employer may file a claim for exemption from having that information revealed on labels in his/her workplace. Depending on the province, the employer will claim an exemption under the
Hazardous Materials Information Review Act) or under laws particular to that province. If an employer is exempt under the HMIRA or laws particular to a province, allowance is made in this subsection for the supplier to accommodate the employer's exemption. If the employer's exemption is allowed under
, the supplier may replace the exempt information with the information contained in section 26 or 27, such as the registry number. If the employer's exemption is allowed under laws particular to a province, the supplier may replace the exempt information with any information specified by those laws.
Subsections 19(3) and (4):
There are two situations where a supplier of a controlled product may use another person's name as the "supplier identifier".
Under subsection 19(3), any distributor of the product, whether the distributor is selling the product to another distributor or to an industrial consumer, may use the manufacturer's or importer's name as the "supplier identifier".
Under subsection 19(4), where the supplier is a manufacturer who is custom packaging the controlled product for a distributor, the distributor's name may be used as the "supplier identifier".
Subsection 19(5):
Under paragraph 19(1)(d), a label of a controlled product must display hazard symbols relevant to all of the classes and divisions into which the product falls. This subsection states the only exception to this rule. In the case of a product that meets the criteria in both Division 1 and Division 2 of Class D, the Division 2 (stylized "T") symbol is not required. For example, if a product meets the criteria in all three Divisions of Class D and the criteria in Class E, the label of the product would require the skull and crossbones symbol, the biohazard symbol and the corrosive symbol.
Subsection 19(6):
Materials which are mixtures of radioactive nuclide(s) and controlled product carrier material(s) are exempt from the inclusion of a supplier identifier, risk phrase(s), precautionary measure(s) and first aid information on the WHMIS supplier label which is distinct and separate from any labelling required under the
Nuclear Safety and Control Act and Regulations.CPR Section 20 - Label Design
Label Design
(1) The label of a controlled product or container in which a controlled product is packaged shall be applied
- within a border that is
- in a colour that contrasts with the background against which it appears, and
- designed as depicted in Schedule III; and
(2) Paragraph (1)(a) does not apply in respect of the sale or importation of a controlled product that is packaged in a container that meets the requirements of section 17. [SOR 88-555; sec. 4]
INTERPRETATION / DISCUSSION of SECTION 20
Non controlled products, use of WHMIS border on ~: While neither the HPA nor CPR preclude a supplier from using the WHMIS border on non-controlled products, this practice conflicts with the intent of the border and is not encouraged; .
Administrative exceptions: As labels placed on the vertical surface of gaz cylinders may be subject to disfiguration during transport due to abrasion from adjacent cylinders, as a policy, it was agreed to permit the use of a modified WHMIS label to fit the contour of the shoulder of compressed gas cylinders. In the case of grinding wheels, a circular label would provide greater surface area in which to disclose the information required by the CPR. Where the controlled product is a grinding wheel and the label is intended to be placed on its surface, the shape of the border referred to in subsection 20(a)(ii) of the CPR may be modified such that a circular label will be acceptable; .
Subsection 20(1):
It is of key importance with any information delivery system that it effectively communicate that information to the recipient. A worker handling dangerous products must be able to quickly consult information on hazards, precautions and first aid. It was thus agreed that information required to be disclosed on the container of a WHMIS controlled product should be grouped together and enclosed within a distinctive border. The use of a border was originally conceived to make a distinction between "controlled" and "uncontrolled" products and thereby facilitate recognition in the workplace.
"Designed as depicted" means that:
- the corners on the border should be square;
- the border hash marks, as shown in the Schedule, should slant in alternate directions on portions of the border that are perpendicular to each other;
- there should be no words written on the border; and
- the border should be of sufficient thickness to easily distinguish the information inside it with other information on the container.
During the development of WHMIS, the original stakeholder representatives had agreed that "to avoid confusion with other information on a container, e.g., TDG Regulations, the WHMIS label information must be clearly distinguishable from, and not in conflict with, other printed information on the container. More specifically: the WHMIS label information would be within a distinctive border".
When interpreting a law, the court will look at the purpose of a law and will not interpret it so restrictively as to defeat the purpose of that law. In other words, if a certain interpretation would defeat the purpose of the law, the court will reject it. This principle is found at section 12 of the Interpretation Act, which states that:
"every enactment is deemed remedial and shall be given such fair, large and liberal construction and interpretation as best insures the attainment of its objects."The "object" of the WHMIS border is to enable users to distinguish between information required by the CPR from information that is not. The IWCC position is that information not required by the CPR shall not be placed within the WHMIS supplier label border; .
Subsection 20(2):
Subsection 20(2), which was added through Amendment No. 1 to the CPR, provides an exemption from applying the WHMIS label border for a controlled product originating from a laboratory supply house, intended for use in a laboratory and packaged in a container in a quantity of less than 10 kilograms. Footnote 3
This exemption is still subject to the requirement that the label on these controlled products includes applicable risk phrases, precautionary measures and first aid measures. The exception permitted for products originating from a laboratory supply house and being used in a laboratory recognizes that persons working in laboratories are typically better informed about the hazards of products used in laboratory settings;
In some cases, products are packaged in containers which have two principal display panels (PDPs); one panel is labelled in English while the other displays the equivalent information in French. Where a separate PDP is used for each official language, the supplier has the option of disclosing the prescribed information in English only on the English panel and in French only on the French panel or the supplier may disclose the French and English versions of the label information on both panels. Where a separate English and French label is used, however, all required hazard symbols must be disclosed on both. In the case where there is only one PDP, all of the information required to be disclosed on the WHMIS label must appear on this PDP in English and French within a single WHMIS border or within a separate WHMIS border for English and for French; .
CPR Section 21 - Legibility of Labels
Legibility of Labels
(1) The information required to be disclosed on the label of a controlled product or container in which a controlled product is packaged shall be clearly and prominently displayed, easily legible and contrasted with other information on the controlled product or container.
(2) A label applied to a controlled product or container in which a controlled product is packaged shall be sufficiently durable and resistant under normal conditions of transport, storage and use to remain attached and legible.
INTERPRETATION / DISCUSSION of SECTION 21
Subsection 21(1):
Information not required by the CPR should not be placed within the WHMIS label border. When WHMIS was being developed, it was agreed that "to avoid confusion with other information on a container, e.g., TDG Regulations, the WHMIS label information must be clearly distinguishable from, and not in conflict with, other printed information on the container. More specifically: The WHMIS label information would be within a distinctive border"; (ref.: Report of the [WHMIS] Steering Committee, p.16).
Subsection 21(2):
WHMIS labels should be durable and clearly display the required information for the life of the product. No recommendation is made for a specific test to determine whether the labelling information will be sufficiently durable to remain legible under normal conditions of transportation, storage, sale and use. However, hazard warnings must remain legible throughout the lifetime of the product, and not fade, run, rub off or peel off under normal use. Print that can be dissolved by the contents, or paper and plastic label sleeves that are easily removable, are not acceptable.
CPR Section 22 - Reproduction of Hazard Symbols
Reproduction of Hazard Symbols
Any hazard symbol required to be displayed on a label shall
- except with respect to size and colour, be an exact reproduction of that hazard symbol as depicted in Schedule II; and
- be displayed in a colour that is not likely to create confusion with a safety mark required by Part V of the Transportation of Dangerous Goods Regulations.
Interpretation / Discussion of Section 22
Paragraph 22(a):
In order to ensure easy recognition of hazards by workers, artistic freedom in the design of hazard symbols is not permitted. Regarding the quality of the reproduction of the required hazard symbols, a degree of flexibility is allowed in recognition of the variance in printers on the market, .
Paragraph 22(b):
If the controlled product is also subject to labelling requirements under the Transportation of Dangerous Goods Regulations (TDGR), the container of the product may require a TDG label (safety mark). Under the TDGR, colours of labels and symbols are specified and, in some cases, a variation in colour for the same symbol indicates different information about the product. Some hazard symbols required under TDG are identical with hazard symbols required under WHMIS. Paragraph 22(b) ensures that workers educated in the TDG label system are not confused by information required by WHMIS.
The following general rules will prevent the use of colours for WHMIS symbols that will create confusion with TDG label information. Where the CPR requires the use of a hazard symbol with a pictogram which is found in the TDGR:
- the WHMIS symbol may be displayed in the same colour combination as required by TDGR for that product;
- the WHMIS symbol may be displayed in any colour combination other than possible colour combinations required under TDGR for that pictogram;
- the WHMIS symbol must not be displayed in a colour combination that is possible under TDGR for that pictogram but not required under TDGR for that product.
If product is flammable, poisonous (toxic) or corrosive, a green-white colour combination cannot be used.
If product is not corrosive, a solid black cylinder on white background cannot be used. However, a black outline of a cylinder with white interior on a white background is acceptable.
The colour yellow cannot be used in any colour combination.
Unless the product, on contact with water, emits flammable gases, the colour blue cannot be used in any colour combination.
The colours red or blue cannot be used in any colour combination of the two colours or with any other colour.
The following are recommendations to suppliers:
- the colour orange should not be used in anyCPR colour combination, since this particular colour is used in the TDGR exclusively for the identification of explosives;
- the same colour combination may be used for the CPR pictogram as that prescribed by the TDGR, where classification of a product under the CPR and the TDGR results in the use of the same pictogram for the CPR hazard symbol and the TDGR label.
CPR Section 23 - Exemption (in respect of importation)
Part III General Exemption
23.(1) The importation of a controlled product that is to be labelled or repackaged in Canada is exempt from the application of section 14 of the Act in respect of the requirements to obtain or prepare a material safety data sheet with respect to the controlled product and to have a label applied to the controlled product or container in which the controlled product is packaged on the following conditions:
- subject to subsection (2), the supplier provides to an inspector in each province into which the controlled product is imported, on or before the date of importation, a statement indicating
- that he intends to import the controlled product,
- the nature of the controlled product to be imported,
- the address of the premises in the province at which the controlled product is to be labelled or repackaged, and
- the provinces into which the controlled product is to be imported; and
- a sample of the controlled product on or before the date of importation,
- the proposed dates and places of importation, and
- the approximate quantity of the controlled product to be imported.
(2) A statement provided in accordance with paragraph (1)(a) is valid in respect of the importation of that controlled product to those premises for a period not exceeding three years from the date the supplier provides the statement to the inspector.
(3) An importer who imports a controlled product in accordance with subsection (1) shall obtain or prepare a material safety data sheet in respect of the controlled product in accordance with the Act and these Regulations before the controlled product is used or sold.
(4) An importer who imports a controlled product in accordance with subsection (1) shall apply a label to the controlled product or to the container in which the controlled product is packaged in accordance with paragraph 14(b) of the Act
- where the controlled product is delivered to the address of the importer for his use or for sale, before the controlled product is used or sold; and
- where the controlled product is imported to the address of the person to whom the importer has sold the controlled product, before the controlled product is used by that person.
(5) Paragraph (4)(b) does not apply where the person to whom the importer sold the controlled product undertakes in writing to apply a label to the controlled product or to the container in which the controlled product is sold in accordance with paragraph 13(b) of the Act.
Interpretation / Discussion of Section 23
A supplier may import a controlled product without labels or MSDSs under the circumstances specified in this section. Subsections 23(1) and (2) relate to obligations on the supplier (i.e., importer) on or before the importation of the product. Subsections 23(3), (4) and (5) relate to obligations on the supplier after importation of a product under this exemption, but prior to selling or using the product.
New Substances Notification: The Domestic Substances List (DSL) identifies substances that, for the purposes of the Canadian Environmental Protection Act, are not subject to the New Substances Notification Regulations. Substances that are not on the DSL are subject to notification and their potential for adverse environmental and human health effects must be assessed before they can be manufactured in, or imported into, Canada. A copy of the reporting guidelines may be obtained by contacting: Domestic Substances List Project, Commercial Chemicals Evaluation Branch, Environment Canada, 14th Floor, Place Vincent Massey, 351 St. Joseph Blvd., Hull, Québec, K1A 0H3; by facsimile at (819) 953-7155 or at the toll free number (1-800) 567-1999.
Subsections 23(1) and (2):
On the date of, or prior to, importation of any controlled product without MSDSs or labels, a supplier must provide an inspector with a notice which includes all of the information listed in subparagraphs 23(1)(a)(i) to (iv). This notice will be sufficient for importations of all products listed in the notice and that are labelled or repackaged at the premises listed in the notice for a period of three years.
The "nature of the product" means the product identifier and a general description of the product such as acid, base, biological hazard, flammable liquid, organic solvent.
The following example illustrates where notices must be sent and the minimum information that must be included in each notice:
Scenario: A supplier intends to import unlabelled controlled products to three centres located in Calgary, Edmonton and Montreal where they will be repackaged and labelled. What steps must the supplier take to comply with this section of the CPR?
Action required: The supplier must provide one notice to an Alberta inspector and one notice to a Quebec inspector. Both notices must state the information in subparagraphs (i) and (ii). The notice to the Alberta inspector must include the repackaging locations in Calgary and Edmonton and reference to the fact that he/she is also importing into Quebec. The notice to the Quebec inspector must include the address of the repackaging plant in Montreal and reference to the fact that he/she is also importing into Alberta.
The notification requirements could also be met for a three year period by preparing a list of all products imported and their nature and destinations and forwarding it to all provinces affected. If additional products are imported and/or new destinations are chosen, then supplementary notification to the provinces would be necessary.
An inspector in any province into which a controlled product is imported under this exemption may request from the supplier a sample of the product as per 23(1)(b)(i) or further importation details as per 23(1)(b)(i) and (ii). The importation details that may be requested are limited to details on products imported into the inspector's province.
Subsections 23(3), (4) and (5):
When a controlled product is imported under the exemption in subsection 23(1) and (2), it must be brought into compliance with WHMIS label and MSDS requirements prior to being used or sold in Canada.
Paragraph 23(4)(b) and subsection 23(5) recognize and allow for the situation where an importer in Canada imports a controlled product not labelled in accordance with WHMIS directly to a third party in Canada to whom he/she has sold the product. In this situation, the supplier (importer) must ensure that the product has WHMIS labels applied to it before the third party uses it. The supplier is relieved of this obligation only if he/she has a written statement from the third party that the product will be labelled by the third party prior to being used.
CPR Section 24 - Manner of Disclosing Information
Manner of Disclosing Information
24.(1) The information required to be disclosed on a material safety data sheet of a controlled product shall be disclosed at the time of the sale of the controlled product in English and in French on a single material safety data sheet or on two material safety data sheets.
(2) Where a supplier transmits a material safety data sheet in respect of a controlled product, the information shall be disclosed on the material safety data sheet in English or in French, or both, in accordance with the request of the person to whom the controlled product is sold or, where the person does not specify the language in which the information shall be transmitted, the information shall be transmitted in English or in French, whichever is used in the course of the sale between the supplier and the person.
(3) The information required to be disclosed on the label of a controlled product or the container in which a controlled product is packaged shall be disclosed in English and in French.
Interpretation / Discussion of Section 24
Section 19 of the CPR specifies the information that must be disclosed on a WHMIS supplier label. As reflected by subsection 6.2.1 of the Report of the WHMIS Steering Committee, the original WHMIS tripartite consensus group agreed that "the supplier label would be in both official languages".
Canada, as a signatory to the World Trade Organization (WTO) Agreement (formerly GATT Agreement) and the NAFTA Agreement has both rights and obligations under the Agreements on Technical Barriers to Trade (TBT Agreements) which are sub-agreements found in both documents. Both the WTO and NAFTA TBT agreements clearly state that members shall ensure that technical regulations are not prepared, adopted or applied with a view to or with the effect of creating unnecessary obstacles to international trade. For this purpose, technical regulations shall not be made more trade-restrictive than necessary to fulfil a legitimate objective, taking account of the risks non-fulfilment would create.
For the purposes of the TBT agreements, "Legitimate Objectives" are defined as inter alia: national security requirements; the prevention of deceptive practices; protection of human health or safety, animal or plant life or health, or the environment. In assessing such risks, relevant elements of consideration are, inter alia: available scientific and technical information, related processing technology or intended end uses of products.
The discussion of this issue prompted Health Canada to investigate the use of Spanish from a legal perspective. The ensuing legal opinion advised that subsection 24(3) of the CPR does not prohibit the use of Spanish within the WHMIS border of a supplier label. This legal opinion would also preclude a CIC policy to the contrary; .
Form of language: The CPR does not specify the specific form of language of English or French that is to be used on labels and MSDSs. Thus, any form of language "option" provided by, for example, common word processing programs would be acceptable.
Subsections 24(1) and (2):
The supplier must provide a MSDS in the official language or languages requested by the purchaser or, when no preference is stated, in the language used in the course of the business transaction. Suppliers must have prepared MSDSs in both English and French by the time they begin selling the product. This is to ensure that there are no delays in transmitting information in one language where it has been requested in that language. A request for an MSDS in both languages can be met by having information in both languages on a single MSDS or two MSDSs, one in English and one in French. Footnote 4
Note: The HPA does not place any obligations on exporters of controlled products to Canada. Section 14 of the HPA places a legal requirement on the Canadian importer of a controlled product to obtain or prepare a MSDS as a condition of importation. If the importer imports a controlled product solely for use in his or her workplace, it is only necessary to obtain or prepare the MSDS in the official language(s) used in the importer's workplace. If, however, the Canadian importer sells the product for use in a workplace in Canada, as required by subsection 24(1), the importer, (who would now be a supplier subject to section 13 of the HPA), must have the MSDS available in both English and French at the time of sale although, as provided for by subsection 24(2), it may be necessary to transmit the MSDS to the purchaser in only one of the official languages.
Subsection 24(3):
Labels must be in both English and French. It is acceptable to have both English and French information within one WHMIS border or to have the English and French information within two separate WHMIS borders. However, if the second option is used, hazard symbols must be disclosed on both the English and the French labels.
The stipulations of this subsection do not preclude the use of other languages in addition to English and French.
CPR Section 25 - [general]; Manner Of Disclosing Information - "Disclaimers"
Manner Of Disclosing Information
25. The Information Required To Be Disclosed On A Material Safety Data Sheet, On A Label Of A Controlled Product Or On A Container In Which A Controlled Product Is Packaged Shall Not Be Disclaimed Or Contradicted By Information In Respect Of The Controlled Product That Is
- not Required Under The Act; And
- disclosed On The Material Safety Data Sheet, The Label, The Controlled Product Or The Container. [sor/97-543; S. 17]
Interpretation / Discussion of Section 25
The prohibition of disclaimers and contradictory statements has been included to ensure that information on containers and MSDSs will not send conflicting messages to users of the product that would lead to confusion about the hazards posed by the product. The prohibition of disclaimer statements was meant to refer to information that directly or indirectly refuted information required on the MSDS. Statements which qualify toxicological test results are allowed under the conditions specified in section13 of the CPR.
The following example of a disclaiming statement is clearly unacceptable:
"Although this product meets the carcinogenicity criteria there is no substantial proof that it causes cancer."
The following are examples of disclaiming statements that are not prohibited under this section:
"The information contained herein is based on data considered accurate. However, no warranty is expressed or implied regarding the accuracy of these data or the results obtained from the use thereof;" and
"This company assumes no responsibility for personal injury or property damage to vendees, users or third parties caused by the material. Such vendees or users assume all risks associated with the use of the material." The fact that the above disclaiming statements are not prohibited under Section 25 is based on an opinion of the status of these statements and not their desirability. (It should be borne in mind that such civil liability disclaimers do not operate to limit or reduce supplier/employer liabilities arising from the HPA statute); . These disclaiming statements, however, do not diminish in any way the responsibility of a supplier under the HPA to provide accurate information.
Qualifying" of risk phrases: The term "risk phrase" is defined in section 2 of the CPR. The following question has been raised: to what extent, if any, can a supplier of a WHMIS controlled product qualify the hazard associated with the controlled product on the label of a controlled product? Subparagraph 19(1)(e)(i) of the CPR requires only that the supplier state risk phrases that identify "a hazard that may arise from the nature of the controlled product" and that are "appropriate to the controlled product".
What is "appropriate" is a question of fact for each product. Therefore, a label that identifies a reasonably foreseeable hazard as determined from the suppliers knowledge of the particular controlled product in question will comply with the requirements of subparagraph 19(1)(e)(i). Additional qualifiers that explain the hazard and indicate the nature and circumstances of the risk that may result from that hazard are not prohibited.
The obligation under subparagraph 19(e)(i) of the CPR to report a hazard is qualified in the definition of "risk phrase" to those hazards that "may arise from the nature of the controlled product". "May" is an auxiliary verb that qualifies the meaning of the verb "arise" by expression ability, competency, possibility, probability or contingency; (ref.: Black's Law Dictionary). Therefore, a supplier would not appear to be obliged to report improbable or impossible hazards or hazards that wold require improbable interventions before they could occur.
Subparagraph 19(e)(i) requires that suppliers disclose risk phrases that are "appropriate to the controlled product" or, in the French version, "qui conviennent au produit contrôlé". Neither "appropriate" nor "convenir à" are defined in the Act or the CPR. "Appropriate" is defined in Webster's New World Dictionary as "right for the purpose; suitable; fit; proper" and has been judicially considered to embrace "a concept of suitableness, proper, and fitting to the particular situation.: Kodellas v. Saskatchewan (Human Rights Commission) (1989) 60 D.L.R. (4 th ) 143 (Sask. C.A.) The word "appropriate as used in the phrase "appropriate advice" was construed in Levitt v. Carr [1992] 4 W.W.R. 160; 8 C.P.C. (3d) 101 (B.C.C.A.) to:
"Refer to the nature of the inquiry to be made as revealed by the facts within the means of the plaintiff's knowledge. In this sense, "appropriate" means suitable in the circumstances of those facts."
Similarly, "convenir à" is defined in Le Robert et Collins Senior as "être appropriée à; être utile à; être agréable à". In Kodellas v. Saskatchewan (Human Rights Commission), supra, the adjective "convenable" was defined as "appropri" and found to convey the meaning of being "appropriate in the circumstances."
The use of the adjective "appropriate" and the adjectival clause "qui convienent au" implies, therefore, that the risk phrase should fulfil the purpose of describing with some accuracy the actual hazards that may foreseeably arise from the nature of that particular controlled product. The work "appropriate" conveys the idea that the risk phrase should reflect the knowledge of the supplier about the product and the circumstances in which the product is to be used and stored. The risk phrase, therefore, should reflect hazards that are reasonable foreseeable in the circumstances in which the controlled product may be expected to be used or stored.
Further, the use of the definite article "the" in the phrase "to the controlled product" also implies that the risk phrase should be determined by the supplier on a case by case basis; that is, the risk phrase must be appropriate to the particular product that is being labelled. Tailoring the risk phrase to the particular product, therefore, would accord with the wording of subparagraph 19(e) (i). The inclusion of qualifying language like "prolonged overexposure" or "when used in a respirable form" in a risk phrase, therefore, would conform with both the letter and the spirit of section 19 of the CPR.
CPR Section 26 - [GENERAL, exemption]; Information in Respect of Exemptions
Information in Respect of Exemptions
26. (1) A supplier who, pursuant to subsection 11(1) of the Hazardous Materials Information Review Act, files a claim for exemption from a requirement to disclose information in respect of a controlled product on a material safety data sheet or on a label shall, in respect of the sale or importation of the controlled product or any controlled product having the same product identifier, disclose on the material safety data sheet and, where applicable, on the label of the controlled product or container in which the controlled product is packaged the date that the claim for exemption was filed and the registry number assigned to the claim under the Hazardous Materials Information Review Act.
(2) The requirements of subsection (1) apply in respect of a supplier who receives notice of a decision that the claim for exemption is valid
(a) if there is no appeal of the decision under subsection 20(1) of the Hazardous Materials Information Review Act, for a period not exceeding 30 days after the expiry of the appeal period; [SOR/2001-254, s. 8] and
(b) if there is an appeal of the decision under subsection 20(1) of the Hazardous Materials Information Review Act, for a period not exceeding 30 days after the expiry of all periods for the making of an appeal or an application for judicial review in respect of the decision on appeal. [SOR/2004-317, s. 1]
Interpretation / Discussion of Section 26
There are a few items of information normally required on MSDSs and labels that a supplier may not have to disclose because he/she has a specific exemption from disclosing that information under the Hazardous Materials Information Review Act (HMIRA). Sections 26 and 27 of the CPR prescribe the information that must be disclosed on the label and MSDS in place of the information which is the subject of a claim for exemption. This replacement information will enable users of the product to determine the status of claims for exemptions. Also, this replacement information may be used in a medical emergency to obtain further information about the product from the Hazardous Materials Information Review Commission (HMIRC).
The supplier may be exempt under the HMIRA for one of two reasons. First, a supplier is exempt during the period that the claim is being processed by the HMIRC (including possible appeals) to ensure that sales of the product are not held up by delays in processing the claims. Second, a supplier will be exempt for a three year period if his/her claim for exemption is granted. An exemption is granted or disqualified as soon as a decision on the claim is reached and the appeal period following that decision expires without an appeal being filed. The replacement information that the supplier is required to disclose will vary depending on the status of the exemption under the HMIRA at the time of sale of the product.
Section 26 deals with the replacement information required if the supplier is exempt because he/she has filed a claim with the HMIRC and the claim is being processed. The supplier must disclose in place of the exempt information: (1) the date of filing; and (2) the registry number of the claim. The date of filing is the date that the HMIRC receives the claim for exemption from the supplier. The HMIRC will assign a registry number that is unique for that claim. The supplier must receive this replacement information from the HMIRC before he/she begins to sell the product with exemptions.
When a claim for exemption is granted, the above-noted replacement information may be used on MSDSs and labels related to sales of that product within 30 days.
Paragraph 26(2)(b) provides that where a decision is made that the claim for exemption is valid but the decision is appealed, subsection 26(1) continues to apply "for a period not exceeding 30 days after the expiry of all appeal periods in respect of the decision on appeal". The reference to the time period for making an "appeal" was intended to also include the time period for the making of an application for judicial review under the Federal Court Act. Paragraph 26(2)(b) is intended to refer to applications for judicial review. Therefore, the reference in paragraph 26(2)(b) to the "expiry of all appeal periods in respect to the decision on appeal" has been amended [SOR/2004-317] to read the "expiry of all periods for the making of an appeal or an application for judicial review in respect of the decision on appeal".
Section 27 specifies what replacement information must be disclosed after this 30 day period.
If a claim for exemption is disqualified, a notice sent by the HMIRC or appropriate appeal body will state the time frame in which the supplier has to comply with the law. If there is no appeal of this decision, for all sales of the product subsequent to this specified time, the supplier must disclose the information for which a claim for exemption was disqualified or cease sale of the product in the Canadian market.
CPR Section 27 - [General]; Information in Respect of Exemptions
27. A supplier who receives notice of a decision made pursuant to the Hazardous Materials Information Review Act that his claim or a portion of his claim for exemption from a requirement to disclose information in respect of a controlled product on a material safety data sheet or a label is valid shall, during the period beginning not more than 30 days after the final disposition of the claim and ending on the last day of the exemption period, in respect of the sale or importation of the controlled product or any controlled product having the same product identifier, disclose on the material safety data sheet and, where applicable, on the label of the controlled product or container in which the controlled product is packaged the following information:
(a) a statement that an exemption has been granted;
(b) the date of the decision granting the exemption;
(c) the registry number assigned to the claim under the Hazardous Materials Information Review Act; [SOR/88-555, s. 5] and
(d) the generic chemical identity of the controlled product or ingredient as required by section 16 of the Act. [SOR/97-543, s. 18]
Interpretation / Discussion of Section 27
This section deals with the replacement information required on an MSDS or label in place of the information the supplier is exempt from disclosing because he/she has been granted an exemption under the HMIRA. For further details refer to the discussion under section 26 of the CPR.
The following replacement information is required on MSDSs and labels of products sold after 30 days following the granting of an exemption and before three years following the date of an unappealed decision that a claim is valid:
- that an exemption is granted;
- the date when the unappealed decision was made that the claim is valid;
- the registry number; and
- the generic chemical identity of the controlled product or ingredient(s).
CPR Section 28 - Identical Product Identifiers
Identical Product Identifiers
28. The product identifier that is disclosed on the label of a controlled product or container in which a controlled product is packaged shall be identical to the product identifier that is disclosed on the material safety data sheet for the controlled product.
Interpretation / Discussion of Section 28
This section has been included to ensure that workers seeking more information for a particular controlled product at the work site will be able to locate the relevant MSDS.
In the case of a generic MSDS (see section 7 of the CPR), more than one product identifier may be disclosed on the MSDS as long as at least one of the names listed is the same as the product identifier on the label of the product.
The CPR specifies no analogous requirement for the "supplier identifier" to be disclosed on the MSDS and label in respect of a controlled product.
CPR Section 29 - Revisions to Material Safety Data Sheets and Labels
Revisions to Material Safety Data Sheets and Labels
29.(1) Where new information in respect of a controlled product or an ingredient of a controlled product becomes available, the supplier shall
(a) revise the material safety data sheet and the date thereof and, where applicable, the label of the controlled product; and
(b) in respect of the revised material safety data sheet and, where applicable, the revised label,
(i) in the case of the sale of the controlled product subsequent to the information becoming available, transmit the revised material safety data sheet and apply the revised label in accordance with section 13 of the Act, and
(ii) in the case of an importation of the controlled product subsequent to the information becoming available, obtain or prepare the revised material safety data sheet and apply the revised label in accordance with section 14 of the Act.
(2) Where no new information in respect of a controlled product or an ingredient of a controlled product becomes available in the three years following the date of preparation of a material safety data sheet of the controlled product, the supplier shall
(a) review the accuracy of the information disclosed on the material safety data sheet and, if necessary, revise the material safety data sheet and, where pplicable, the label of the controlled product;
(b) revise the date of preparation disclosed on the material safety data sheet; and
(c) in respect of the revised material safety data sheet and, where applicable, the revised label of the controlled product,
(i) in the case of the sale of the controlled product after the revision of the material safety data sheet, transmit the revised material safety data sheet and, where applicable, apply the revised label in accordance with section 13 of the Act, and
(ii) in the case of an importation of the controlled product after the revision of he material safety data sheet, obtain or prepare the revised material safety data sheet and, where applicable, apply the revised label in accordance with section 14 of the Act.
Interpretation / Discussion of Section 29
Absence of sale: Section 13 of the HPA places a legal requirement on the Canadian supplier of a controlled product to transmit a MSDS as a condition of sale. (Section 14 of the HPA places a legal requirement on the Canadian importer of a controlled product to obtain or prepare a MSDS as a condition
of importation.) There is no legal obligation on a supplier to provide an "updated" MSDS to a customer in the absence of a subsequent sale to that customer.MSDS Archiving / Record keeping: The HPA does not require a Canadian supplier / Canadian importer to retain ("archive") MSDSs for controlled products which they no longer sell / import. For a company to be in a better position to discuss with their customers any ongoing health and safety concerns, suppliers / importers may wish to ascertain over what period their customers use their product subsequent to a given purchase or, for example, a distributor retains the company's product in the distributor's inventory for subsequent sales. Those marketing controlled products in Canada may also wish to seek advice from their legal advisor.
Subsection 29(1):
All information disclosed on MSDSs and labels, whether it be directly related to health and safety or other information such as, for example, the supplier identifier, must be accurate at the time of sale of the controlled product.
In some cases, new information may become available, for example, as a result of further testing of the product. Revisions to the MSDS and/or label are expected to be made only if the new information is meaningful with respect to health and safety. Thus the supplier will be required to judge the significance of the new information in relation to health and safety.
On all sales or importations of the product subsequent to the new information becoming available, the new label must be applied and the new MSDS must be sent. There is no obligation on the supplier to send the updated label or MSDS to previous customers if there is no subsequent sale. Footnote 7
If changes to a previously issued MSDS are not identified, it is difficult for employers and workers to determine if there have been any significant changes. Changes that have been made to a previously issued MSDS, therefore, need to be identified on the revised MSDS. It is anticipated that the CPR will be amended to require that changes to a previously issued MSDS be identified. Although not explicitly required, suppliers may also wish to disclose the date of the previously issued MSDS. Until the CPR are formally amended, suppliers may still wish to identify changes. The ANSI Standard "Z400.1, Hazardous Industrial Chemicals--MSDS--Preparation", addresses the topic of "Revision Indicators". The standard includes some example methods of indicating MSDS revisions; .
Subsection 29(2):
Suppliers are prohibited from supplying MSDSs that have a MSDS preparation date exceeding three years (3 X 365 days) prior to the sale or importation of a controlled product. Thus, if a supplier has not changed any information on his/her MSDS for three years, he/she must review that information to ensure that it is still accurate and that there is no new available and applicable information that should be disclosed.
If there is new information, it must be disclosed on the MSDS and, if applicable, the label of the product. Whether or not there is new information, the MSDS must be revised so that the date of preparation reflects the date the information was reviewed.
CPR Section 30 - Provision of Information
Provision of Information
30.(1) Any supplier who sells or imports a controlled product intended for use in a work place in Canada shall provide, as soon as is practicable in the circumstances, any information in respect of the controlled product that is referred to in paragraph 13(a) of the Act and is in the possession of the supplier to any physician or nurse who requests that information for the purpose of making a medical diagnosis of, or rendering medical treatment to, a person in an emergency.
(2) Any physician or nurse to whom information is provided by a supplier pursuant to subsection (1) shall keep confidential any information specified by the supplier as being confidential except for the purpose for which it was provided.
Interpretation / Discussion of Section 30
This section ensures that all information that is required to be disclosed under the HPA and that is in a supplier's possession is provided to a physician or nurse in a medical emergency. If a supplier has filed a claim or has an exemption under the Hazardous Materials Information Review Act, he/she must still provide that information in an emergency.
If the physician or nurse receives this information in confidence by the supplier, they must maintain the confidentiality of the information. If they betray that confidence, they will, if convicted, be subject to the penalties listed in subsection 8(1) of the HPA. (For the purposes of these Regulations, the term "nurse" is defined in subsection 2(1) of the CPR.)
CPR Section 31 - Provision of Information
31. Subject to the Hazardous Materials Information Review Act, a supplier who sells or imports a controlled product intended for use in a work place in Canada shall identify as soon as is practicable in the circumstances, on the request of an inspector, any person to whom a controlled product is sold or any user of a controlled product, the source of information for any toxicological data used in the preparation of any material safety data sheet that has been transmitted by the supplier to any person pursuant to paragraph 13(a) of the Act or has been obtained or prepared by the supplier pursuant to paragraph 14(a) of the Act.
Interpretation / Discussion of Section 31
Under paragraph 11(1)(b) of the Hazardous Materials Information Review Act, a supplier may claim an exemption from disclosing "the name of any toxicological study that identifies any ingredient of a controlled product." If a supplier does not have such an exemption and an inspector, purchaser or worker who uses a controlled product requests the source of information for toxicological data stated on an MSDS, the supplier must provide that information.
CPR Section 32 - [Classes of Controlled Products]; Definitions
PART IV CLASSES OF CONTROLLED PRODUCTS - Interpretation
32. In this Part,
"ACGIH" means the American Conference of Governmental Industrial Hygienists; (ACGIH)
"acute lethality" means death of animals immediately or within 14 days after a single administration of or exposure to a toxic substance; (létalité aiguë)
"aerosol container" means a disposable container designed to release pressurized contents by means of a manually operated valve which forms an integral part of the container; (contenant aérosol)
"ASTM" means the American Society for Testing and Materials; (ASTM)
"chronic toxic effect" means an adverse effect to the health of a person or test animal that develops
- over time, following a single exposure to a toxic substance, or
- from prolonged or repeated exposure to a toxic substance under conditions that do not produce that effect from a single exposure; (toxicité chronique)
"dust" means solid airborne particles that are mechanically generated; (poussières)
"flame projection" means the ignited discharge of the pressurized contents of an aerosol container; (projection de la flamme)
"flashback" means that part of a flame projection that extends from its point of ignition back to the aerosol container; (retour de flamme)
"flash point" means the minimum temperature at which a liquid gives off vapour in sufficient concentration to ignite in test circumstances; (point d'éclair)
"fume" means solid particles in the air that are generated by condensation from the vapour of a solid material; (fumée)
"IARC" means the International Agency for Research on Cancer; (CIRC) [SOR/97-543, s. 19]
"mist" means liquid droplets suspended in the air that are produced by the dispersion of a liquid or by the condensation of a vapourized liquid; (brouillard)
"NACE" means the National Association of Corrosion Engineers (U.S.A.); (NACE)
"normal atmospheric pressure" means an absolute pressure of 101.325 kilopascals (1.00 atmosphere) at 20°C (68°F); (pression atmosphérique normale)
"OECD" means the Organization for Economic Co-operation and Development; (OCDE)
"OECD Test Guideline" means a test published in the OECD Standard entitled OECD Guidelines for Testing of Chemicals; (ligne directrice de l'OCDE)
"respiratory tract sensitization" means the development in a non-atopic person of severe asthma-like symptoms on exposure to a substance to which the person has previously been exposed; (sensibilisation des voies respiratoires) [SOR/2001-254, s. 9]
"skin sensitization" means an immunologically-mediated, cutaneous reaction in a non-atopic person or animal on exposure to a substance to which the person or animal has previously been exposed; (sensibilisation de la peau) [SOR/2001-254, s. 9]
"statistically significant" means shown by statistical procedures to have a high probability of being due to something other than chance; (statistiquement significative)
"vapour" means the gaseous form of a substance that is found in a solid or liquid state at normal atmospheric pressure. (vapeur)
INTERPRETATION / DISCUSSION of SECTION 32
Part IV of the Controlled Products Regulations lists the scientific criteria which define controlled products; (see sections 34 to 66).
Definitions for terms used throughout the CPR are found in section 2. Definitions related to classification under WHMIS and, hence, used only in Part IV of the CPR, are found in section 32.
CPR Section 33 - Manner of Establishing Classification
Manner of Establishing Classification
33 (1) For the purpose of establishing that a product, material or substance is included in a class listed in Schedule II of the Act or falls into a division of a class, the supplier shall use, subject to subsection (2),
- results from testing that he has carried out with respect to the product, material or substance in accordance with sections 34 to 66, as applicable; or
- evidence based on established scientific principles with respect to [SOR/2010-38; s. 2]
- the product, material or substance, or
- where appropriate, a product, material or substance that has similar properties.
(2) For the purpose of establishing that a product, material or substance is or is not included in Class D - Poisonous and Infectious Material, the supplier may use, in place of the evidence referred to in subsection (1), one or more of the following:
- results of other testing with respect to the product, material or substance;
- if appropriate, results of testing with respect to a product, material or substance that has similar properties; and
- other evidence based on studies or epidemiological data with respect to
- the product, material or substance, or
- if appropriate, a product, material or substance that has similar properties. [SOR/2010-38; s. 2]
(3) If the evidence referred to in paragraph (1)(b) results from toxicological studies, the studies shall have been carried out in accordance with [SOR/2010-38; s. 2]
- the applicable OECD Test Guideline referred to in this Part; or [SOR/97-543; s. 20]
- where there are no tests carried out in accordance with the applicable OECD Test Guidelines referred to in this Part, one of the following tests or methods:
- in the case of a 90 day test or a chronic test, a test or method described in U.S. Food and Drug Administration (FDA) guidelines or U.S. Environmental Protection Agency (EPA) guidelines, as published in the Federal Register and as amended from time to time,
- in the case of a test for skin or eye irritation, the Draize Test as described in volume 82 of The Journal of Pharmacology and Experimental Therapeutics, dated 1944, at pages 377 to 390,
- in the case of a test for teratogenicity, a test or method described in Principles for the Testing of Drugs for Teratogenicity, Technical Report Series Number 364, published in 1967 by the World Health Organization,
- in the case of a test for mutagenicity, a test or method described by the U.S. Environmental Protection Agency (EPA) in "Proposed Guidelines for Registering Pesticides in the U.S.; Hazard Evaluation: Human and Domestic Animals", as published in volume 43 of the Federal Register (No. 163), dated 1978, at pages 37,336 to 37,403, or
- any other test or method that is carried out in accordance with generally accepted standards of good scientific practice at the time the test is carried out.
Discussion of Section 33
To determine if a product is included in one or more WHMIS classes, the supplier must use the procedures set out in this section of the CPR. If the product is specified by the CPR to fall into one of the classes listed in Schedule II to the HPA, it is a controlled product. The term "controlled product" is defined in section 2 of the HPA. The CPR does not allow a supplier to make the choice as to whether or not the product should be classified into WHMIS. The supplier or importer of the product has the legal responsibility to determine whether the product is a controlled product.
Professional judgement: The extent to which professional judgement is used by a supplier will depend on the specific criteria being considered. The guidelines, which can be accessed from the "CLASSIFICATION" page of the Government of Canada WHMIS Web site, ( www.whmis.gc.ca ), provide guidance on the use of professional judgement in the classification of controlled products under WHMIS.
Structure-activity relationships: If no toxicological information is available for a hazardous substance, a Quantitative Structure Activity Relationship (QSAR) system may be used to obtain information about the potential toxicity of the substance. Data thus obtained can be used for the toxicological classification of a substance about which no toxicological information is available. Where a supplier has access to information generated by a QSAR system, and the information is relevant to the hazardous properties of a substance, the supplier should evaluate that information; .
Sufficiency of evidence: The CPR does not require a supplier to research all of the literature or examine all of the tests that have been carried out. Where a supplier carries out his/her own tests pursuant to paragraph 33(1)(a), he/she must do so in accordance with sections 34 to 66 which, for the most part, set out objective tests. Where, pursuant to paragraph 33(1)(b), a supplier uses evidence based on established scientific principles, he/she must base his/her decision on a reasonable evaluation of test results. "Reasonableness" should be assessed on the basis of a reasonably competent individual, knowledgeable in the appropriate science necessary to evaluate the product, material or substance.
Testing requirements: Neither the HPA nor the CPR impose a requirement for the testing of materials in order to classify them for any of the WHMIS Classes. For example, a supplier is not obliged to conduct additional toxicological testing of a product in order to assess its potential hazard. As a fundamental principle, during the development of WHMIS, all stakeholders agreed that nothing in the hazard criteria, nor any part of WHMIS would require additional toxicological testing. Rather, the WHMIS program was designed to make the best use of existing toxicological data.
Untested mixtures: A classification system based on cut-off presumes that a mixture is hazardous if it contains a hazardous ingredient at a concentration exceeding a specified cut-off. The use of cut-offs is administratively straightforward and can be applied by using available data on the toxicology of ingredients of the mixture. The cut-off values agreed to for WHMIS are:
0.1% for teratogens, embryotoxins, carcinogens, reproductive toxins, respiratory tract sensitizers and mutagens; and
1.0% for all other toxicological effects and tissue corrosivity.Since WHMIS is an information system, the use of cut-off values appeared justifiable as a means of consistently communicating information about hazardous ingredients as contrasted with providing a hazard evaluation of an untested mixture. The numerical values of the cut-offs, however, are necessarily arbitrary and were chosen largely for consistency between Canada and the United States. Footnote 8 Upon transition to the GHS in WHMIS, the cut-off values for the classification of untested mixtures for health hazards should be harmonized with those of Canada's major trading partners with no reduction in the level of worker protection.
Weight of evidence approach: Well conducted, credible studies could point to different conclusions regarding whether the product, material or substance is a controlled product. The supplier must assess the impact of deciding that the product is not a controlled product versus the impact of deciding that it is a controlled product. In the final analysis, the supplier's decision should be both reasonable (in light of the scientific evidence) and responsible (in light of the fact that the supplier is selling or importing potentially hazardous material for use in the workplace). Similar considerations are required when deciding what information should be disclosed on an MSDS. The weight of evidence approach is a cumulative and qualitative (as opposed to quantitative) evaluation of a body of data.
Definitions for "reliability", "relevance" and "adequacy" of data have been proposed in the article "A systematic Approach for Evaluating the Quality of Experimental Toxicological and Ecotoxicological Data"; (ref.: H.-J. Klimisch et. al.; Regulatory Toxicology and Pharmacology 25, 1-5 (1997); article no. RT961076).
For some of the CPR criteria, a weight of evidence approach would not be considered to be appropriate. If, for example, as per subparagraph 61(a)(i) of the CPR, an animal assay carried out in accordance with the specified test produced a response in 30 per cent of the rats tested, even if the same test conducted on mice and guinea pigs elicited responses in less than 30 per cent of each population, it is not appropriate to use a weight of evidence approach in the classification of this substance under the CPR. The three studies do not constitute "replicate studies", i.e., identical species and route. In this case, as this CPR criterion specifies "an assay", i.e., a singular assay, the supplier must consider the product as falling within the criteria for skin sensitization as the CPR criteria do not consider lesser results obtained from additional assays.
Subsection 33(1):
Subsection 33(1) is applicable to all WHMIS classes. A supplier of any product must evaluate his/her product against all of the criteria for controlled products (sections 34 to 66) to determine which criteria, if any, the product meets (unless the product is already exempted under section 12 of the
). This section describes the ways that determine whether a product is included in one or more WHMIS classes.
Paragraph 33(1)(a) states that a supplier may test a product according to the test method, if specified in a criterion, and use the results to determine if his/her product meets that criterion.
Paragraph 33(1)(b) enables a supplier to evaluate whether a product meets the criteria without actually testing the product on the following condition: the supplier must base the decision on evidence generated according to established scientific principles such as test results with respect to the product or, where relevant, a product with similar properties. For example, the supplier may use test data published in scientific literature on the product or he/she may, if it is appropriate to the criterion, extrapolate published data on the ingredients of a mixture to estimate a property for the mixture. A supplier would not be expected to test for the flashpoint of a product that has no flammable ingredients or to test whether an aqueous solution is a Class A - Compressed Gas.
Subsection 33(1) had stated that "the supplier shall use, subject to subsection (2) evaluation and scientific judgment based on test results with respect to (I) the product, material or substance or (ii) where appropriate, a product, material or substance that has similar properties." The SJCSR concluded that "evaluation and scientific judgment" is too subjective and exceeds the legislative authority of the HPA. To address this issue, this subsection was amended through SOR/2010-38, effective February 23, 2010. As indicated in the Regulatory Impact Analysis Statement that accompanied this and related amendments (which were exempted from pre-publication in Part I of the Canada Gazette):
- ". They [the amendments] will not change the scope of the HPA/CPR nor what is encompassed by the term "controlled product." They do not provide extra powers to the Government nor do they increase the burden for the regulated community" .
Subsection 33(2):
Subsection 33(2) applies to Class D only. This subsection allows a supplier to use test data (including results from testing conducted in accordance with scientifically valid methods other than those specified in sections 34 to 66) and other types of evidence, such as human case reports and epidemiological data, to determine whether or not a product, material or substance should be included within Class D. In the case of a material (pure substance or tested mixture) which does not meet any of the criteria for Very Toxic Material or Toxic Material, but for which there is valid documented evidence based on established scientific principles that the material causes an adverse effect in humans following occupational exposure, this fact, by itself, is sufficient to include that material within this class. In this context, "adverse effects" mean injury to humans resulting from occupational exposure including any reversible or irreversible material impairment to health or irreversible diminished functional capacity.
A supplier does not have to undertake toxicological testing of a product if there is no toxicological data available. However, the supplier should be aware of relevant information from published technical literature, from the Canadian Centre for Occupational Health and Safety and from publications of regulatory agencies, industry or trade associates and labour organizations that are related to occupational health and safety; . Human evidence is also information of which a supplier ought to be aware.
Depending upon the species tested and the route of administration, the toxicological response to a given test substance may vary to a large degree. As a result, it is possible that a test substance may elicit a positive result in the rat via the oral route and a negative result in the mouse via the dermal route. Such results are considered to be neither contradictory nor conflicting. Therefore, the positive result in the rat study should form the basis for determining the appropriate WHMIS classification.
Subsection 33(2) had stated that "the supplier may use information of which the supplier is aware or ought reasonably to be aware in place of the criteria set out in subsection (1)." Similar to what had been their conclusion on subsection 12(11), the SJCSR concluded that the HPA does not provide the authority for the CPR to state "aware or ought reasonably to be aware" . To address this, subsection 33(2) was also amended through SOR/2010-38.
Subsection 33(3):
As for subsection 33(2), subsection 33(3) is also applicable only to Class D. In many cases toxicological testing of a product will not have been carried out in accordance with the OECD Test Guidelines referred to in the criteria for Class D. This section ensures that the wealth of toxicological information derived from testing carried out prior to the establishment of these OECD tests may still be used. However, the testing must have been carried out in accordance with generally accepted standards of scientific practice at the time it was conducted. Subparagraphs 33(3)(b)(i) to (iv) are examples of tests or methods that were considered to be "generally accepted standards of good scientific practice" when they were published. Tests or methods that have been derived from these listed tests or methods are also acceptable. Subparagraph 33(3)(b)(v) also allows the use of "any other test or method that is carried out in accordance with generally accepted standards of good scientific practice at the time the test is carried out."
The deletion of the term "test results" in paragraph 33(1)(b) through SOR/2010-38 necessitated the amendment to subsection 33(3) to replace " Where the test results referred to in paragraph (1)(b)" with " If the evidence referred to in paragraph (1)(b). ".
CPR Section 34 - Class A -- Compressed Gas
Compressed Gas
34. Any product, material or substance contained under pressure, including compressed gas, dissolved gas or gas liquefied by compression or refrigeration, that has any of the following characteristics shall be included in Class A - Compressed Gas listed in Schedule II to the Act:
- a critical temperature of less than 50°C (122°F);
- an absolute vapour pressure greater than 294 kilopascals (2.90 atmospheres) at 50°C (122°F);
- an absolute pressure in the cylinder or other pressure vessel in which it is packaged greater than 275±1 kilopascals (2.71±0.01 atmospheres) at 21.1°C (70°F) or 717±2 kilopascals (7.07±0.02 atmospheres) at 54.4°C (130°F); or
- in a liquid state, an absolute vapour pressure exceeding 275 kilopascals (2.71 atmospheres) at 37.8°C (100°F) as determined by the Standard Test Method for Vapor Pressure of Petroleum Products (Reid Method), ASTM D323-82, dated August 27, 1982. [SOR/97-543; s. 21]
Interpretation / Discussion of Section 34
The controlled products in this class include non-liquified compressed gases (e.g. nitrogen, air); compressed gases liquified under pressure (e.g. butane); compressed gases liquified under refrigeration (e.g. liquid nitrogen); and dissolved gas (e.g. acetylene is dissolved in acetone in a porous material in the acetylene cylinder).
All compressed gases in a cylinder are hazardous because of potential energy due to compression. For example, the force within a "standard" cylinder with an area of 0.954 m 2 (1500 in 2 ) and pressurized to 17,240 kPa (2500 psi) is 16.5 x 10 6 Newtons (3.8 x 10 6 pounds). If this expansive force was suddenly released in an accidental or uncontrolled way, such as through the shearing of a valve, a tremendous amount of energy would be released.
Any one of the four criteria can be used to determine whether a product, material or substance is a com-pressed gas including the "critical temperature" which is the temperature above which a gas cannot be liquified. The "critical pressure" is the pressure required to liquify a gas at its critical temperature.
Because compressed gases may also possess other hazards, the criteria for the other classes should also be examined.
Fire extinguishers: By virtue of paragraph 12(f) of the HPA, a product, material or substance included in Part II of Schedule I to the HPA and packaged as a consumer product is not subject to WHMIS supplier MSDS nor label requirements. The "manufactured article" exemption does not apply to fire extinguishers because, during normal conditions of use, these products do not meet the third criteria in the definition of manufactured article, i.e., that they "will not release or otherwise cause a person to be exposed to a controlled product"; .
CPR Section 35 - CLASS B -- Flammable and Combustible Material
Class B - Flammable And Combustible Material
35.(1) The products, materials and substances referred to in sections 36 to 41 shall be included in Class B - Flammable and Combustible Material listed in Schedule II to the Act.
(2) Divisions 1 to 6 are established as divisions of Class B - Flammable and Combustible Material listed in Schedule II to the Act.
INTERPRETATION / DISCUSSION of SECTION 35
WHMIS Class B - Flammable and Combustible Material, is comprised of six Divisions:
Division 1: Division 2: Division 3: Division 4: Division 5: Division 6:In contrast to the Transportation of Dangerous Goods Regulations, within WHMIS, flammable and combustible materials have been grouped together under a single Class regardless of whether they are in the solid, liquid or gaseous state.
"Flash point" versus "ignition temperature": In the case of Divisions 2 and 3 of Class B, the CPR specify flash point as opposed to ignition temperature. Flash point is a term which is defined in section 32 of the CPR. Ignition temperature is generally understood to mean the lowest temperature at which sustained combustion of a substance can be maintained. "Sustained combustion" is not a criterion for the flash point ranges specified for Divisions 2 and 3.
Explosible Dusts: It is anticipated that Class B will be expanded to include a seventh Division to address the hazards posed by explosible dusts.
CPR Section 36 - Division 1 [of CLASS B] : Flammable Gases
Division 1: Flammable Gases
36. Any product, material or substance falls into Division 1 of Class B - Flammable and Combustible Material if it is a compressed gas included in Class A - Compressed Gas that, at normal atmospheric pressure forms a flammable mixture with air.
(a) when in a concentration of 13 per cent or less by volume; or
(b) over a concentration range of at least 12 per cent by volume.
INTERPRETATION / DISCUSSION of SECTION 36
To ignite a flammable gas, three basic conditions have to be met:
- the concentration of the gas would have to be within the range of concentra-tion that the gas is capable of ignition, i.e. between the lower and upper flammable limits of the gas;
- an oxidizing gas (e.g. air) must be present; and
- a source of ignition has to be available.
The first of these three conditions is specifically addressed by the CPR criteria. The lower flammable limit is the minimum concentration (per cent by volume) of a gas in air below which a flame is not propagated when an ignition source is present; (i.e., the mixture is "too lean" to burn). Similarly, the upper flammable limit is the maximum concentration above which the mixture is "too rich" to burn.
Flammable limits are sometimes also referred to as the "explosive limits". The greater the range over which a gas forms a flammable mixture, the greater the likelihood is that such conditions may occur inadvertently. Similarly, gases which can ignite at relatively low concentrations (13% or less) in air would be particularly hazardous because of the likelihood that a potential flammable mixture can occur such as in the event of a leak. For example, hydrogen, with flammability limits of 4-75%, meets both criteria and 1,3 - butadiene, with flammability limits of 2-12%, meets the first criterion; as a result, both of these substances are included in Division 1 of Class B. Ammonia, with flammability limits of 15-25%, meets neither criteria and, therefore, is not included in Division 1 of Class B.
CPR Section 37 - Division 2 [of CLASS B]: Flammable Liquids
Division 2: Flammable Liquids
37. Any product, material or substance falls into Division 2 of Class B - Flammable and Combustible Material if it is a liquid that has a flash point of less than 37.8°C (100°F), when tested in accordance with the applicable method specified in Schedule IV for that type of liquid.
Interpretation / Discussion of Section 37
The term "flash point" is defined in section 32 of the CPR. A liquid which has a flash point below 37.8°C, (which is approximately the average body temperature), is considered to be a "flammable" liquid under WHMIS.
Liquid vs solid: The kinematic viscosity of a liquid influences the choice of test most appropriate for measuring its flash point. The question as to at what viscosity a substance should no longer be treated as a liquid is addressed in ASTM D4359 which "covers the determination of whether a viscous material is a liquid or a solid for regulatory purposes." ASTM D4359 is considered to be the acceptable test for distinguishing between liquids and solids for the purpose of deciding upon the appropriate test method for flammability; . ASTM standards use units of centistokes or stokes. In Canada, the unit used for kinematic viscosity is millimetre squared per second (mm 2 /sec.). One centistoke equals 1 mm 2 /sec.
Open cup versus closed cup: All of the methods specified in Schedule IV are "closed-cup" techniques in which the vapour is enclosed in the space above the liquid being tested. Open-cup techniques, where the vapour can dissipate, tend to yield flash points with values higher than those obtained with closed-cup methods. For example, the Merck index, thirteenth edition, indicates a flash point of -1°C for open cup and -4 °C for closed cup for n-heptane. Therefore, special attention must be paid when classifying a product against the criteria in this section where the flash point has been determined from an open cup method and the value is only marginally higher than 37.8°C. (See section I of the guidelines on the use of professional judgement in Appendix A of this manual for general guidance when classifying a product in the absence of results from a specified method for non-toxicological criteria that define the limits for a measurable property.)
CPR Section 38 - Division 3 [of CLASS B]: Combustible Liquids
Division 3: Combustible Liquids
38. Any product, material or substance falls into Division 3 of Class B - Flammable and Combustible Material if it is a liquid that has a flash point of 37.8°C (100°F) or more but less than 93.3°C (200°F), when tested in accordance with the applicable method specified in Schedule IV for that type of liquid.
INTERPRETATION / DISCUSSION of SECTION 38
A liquid which has a flash point between 37.8 °C and 93.3 °C is considered to be a "combustible" liquid under WHMIS and is included in Division 3 of Class B.
Liquid vs solid: Please refer to the discussion of section 37 regarding the test method which "covers the determination of whether a viscous material is a liquid or a solid for regulatory purposes".
Open cup versus closed cup: Please refer to the discussion of section 37 regarding the assessment of results of open cup methods.
CPR Section 39 - Division 4 [of CLASS B]: Flammable Solids
Division 4: Flammable Solids
39. Any product, material or substance falls into Division 4 of Class B - Flammable and Combustible Material if it is a solid that
(a) causes fire through friction or through retained heat from manufacturing or processing;
(b) can be ignited readily and when ignited burns so vigorously and persistently as to create a hazard;
(c) ignites readily and burns with a self-sustained flame at a rate of more than 0.254 centimetre (0.1 inch) per second along its major axis, when tested in accordance with the method set out in Schedule V; or
(d) is included in Division 1 of Class 4 of Part III of the Transportation of Dangerous Goods Regulations.INTERPRETATION / DISCUSSION of SECTION 39
A solid which meets any of the criteria in paragraphs (a) through (d) is considered to be a flammable solid under WHMIS. A solid which meets any of these criteria may present a flammability hazard under certain conditions. The first two criteria are the same as for Class 4, Division 1 of the TDG Regulations.
Paragraph (c):
The test described in Schedule V, "Method of Testing for Determining Flammable Solids that Ignite Readily", is essentially identical to that referenced in the OSHA Hazard Communication Standard.
Note: The opening section of Schedule V describes the length and depth dimensions of a rectangular metal boat used to pack samples of granules, powders and pastes. However, there had been no reference to a width dimension. This test method was included in the June 1984 Report of the Criteria Working Group and the method is also referenced in the U.S. OSHA Hazard Communication Standard 16CFR 1500.44. The width dimension specified in both of these documents is 2.54 cm (1 in.). The absence of a width dimension in the CPR was an unintentional omission. The CPR was amended accordingly; .
CPR Section 40 - Division 5 [of Class B]: Flammable Aerosols
Division 5: Flammable Aerosols
40. Any product, material or substance falls into Division 5 of Class B - Flammable and Combustible Material if it is packaged in an aerosol container and, when tested in accordance with the method set out in Schedule VI, yields a flame projection at full valve opening or a flashback at any degree of valve opening.
Interpretation / Discussion of Section 40
This criterion includes a test procedure to determine whether a product contained in an aerosol container is flammable and thereby presents a potential hazard. The terms "aerosol container", "flame projection" and "flashback" are defined in section 32 of the CPR.
The product may ignite because of the flammability of the aerosol itself or the propellant. The test for a flammable aerosol is intended to determine whether there is a flame projection or a flashback. A flame projection is any visible ignition of the aerosol stream at full valve opening. Flashback refers to that part of the flame projection that extends back to the aerosol container at any degree of valve opening. Although the test described in Schedule VI refers to an elaborate apparatus to determine the extent of flame projection, all that is required by the CPR criteria for inclusion in Division 5 of Class B is any length of flame projection or flashback.
The test procedure described in Schedule VI is the same as is used to determine the flammability of aerosol containers sold to consumers under Part I of the Hazardous Products Act, the Food and Drugs Act and the Pest Control Products Act.
CPR Section 41 - Division 6 [of CLASS B]: Reactive Flammable Materialss
Division 6: Reactive Flammable Materials
41. Any product, material or substance falls into Division 6 of Class B - Flammable and Combustible Material if
(a) it is spontaneously combustible and liable to spontaneous heating under normal conditions of use or liable to heat in contact with air to the point where it begins to burn; or
(b) it emits a flammable gas or becomes spontaneously combustible on contact with water or water vapour.Interpretation / Discussion of Section 41
Two distinct groups of hazardous products are addressed by the criteria for Division 6:
- those which react with air (oxygen) and burn; and
- those which react with water or water vapour to produce a flammable gas or become spontaneously combustible.
At present, paragraph 41(b) refers only to emissions of gas in contact with water or water vapour. However, for example, cyanide salt with water produces hydrogen cyanide, a liquid with a boiling point of 25.7°C and a flash point (closed cup) of minus 17.8°C. The controlled product released, in this case, is a vapour and not a gas. To explicitly address situations such as this, paragraph 41(b) will be amended to include "flammable vapours"; .
CPR Section 42 - Class C -- Oxidizing Material
Class C - Oxidizing Material
42. Any product, material or substance shall be included in Class C - Oxidizing Material listed in Schedule II to the Act if
(a) it causes or contributes to the combustion of another material by yielding oxygen or any other oxidizing substance, whether or not the product, material or substance is itself combustible; or
(b) it is an organic peroxide that contains the bivalent 0-0 structure.Interpretation / Discussion of Section 42
These criteria include a wide group of controlled products that either provide oxygen under conditions which are potentially hazardous or that contain the oxygen-oxygen chemical structure which is particularly chemically reactive.
Paragraph 42(a):
Elements and other chemicals may be regarded as "oxidizing" or "reducing" agents based on their reduction potential (E 0 values) relative to the potential of the Standard Hydrogen Electrode. A chemical agent can bring about oxidation by two principal mechanisms. The chemical agent may (i) provide oxygen or another oxidizing agent to the substance undergoing oxidation or (ii) the chemical agent may receive electrons which are transferred by the substance undergoing oxidation. The WHMIS criteria address the first mechanism only. Therefore, for example, although fluorine and chlorine gas are generally regarded as strong oxidizing agents in terms of electron-transfer (with reduction potentials of 2.87 and 1.35, respectively), as neither yield oxygen nor any other oxidizing substance, they are not included in WHMIS Class C.
Paragraph 42(b):
An "organic peroxide" may be considered to be a structural derivative of hydrogen peroxide where one or both of the hydrogen atoms has been replaced by an organic radical.
CPR Section 43 - General [Class D]
Class D - Poisonous And Infectious Material
43.(1) The products, materials and substances referred to in sections 46 to 64 shall be included in Class D - Poisonous and Infectious Material listed in Schedule II to the Act.
(2) Divisions 1 to 3 are established as divisions of Class D - Poisonous and Infectious Material listed in Schedule II to the Act.
(3) Subdivisions A and B are established as subdivisions of Divisions 1 and 2 of Class D -Poisonous and Infectious Material listed in Schedule II to the Act.
(4) A gas included in Division 4 of Class 2 in Part III of the Transportation of Dangerous Goods Regulations does not fall into Division 1 or Division 2 of Class D - Poisonous and Infectious Material.
Interpretation / Discussion of Section 43
Class D - Poisonous and Infectious Materials includes the greatest number of criteria of any of the classes. The criteria have been grouped into three divisions, each of which describe a different type of hazard and require a different symbol as shown in Schedule II of the CPR.
Redundancy of multiple classifications within WHMIS Class D: There are nstances where it would be redundant to include a material within more than one sub-classification within WHMIS Class D. Specifically:
the difference between inclusion in Class D1A and Class D1B relates to the dose needed to cause immediate and serious toxic effects. Different lethal values may be observed if the chemical is tested by different routes of exposure. However, if the acute toxicity is determined for more than one route, the most severe hazard level should be used for classification.
The situation described in the preceding paragraph is similar to that addressed in relation to corrosion vis-à-vis irritation (please refer to Section 60 of the CPR); i.e., materials which fall within the criteria for skin corrosivity will lways meet the CPR criteria for skin irritation. Classification of such materials into both Class E and D2B involves redundancy for D2B information and possible confusion on the part of the users. Since corrosion is an irreversible process, it is more hazardous than irritation, which is typically reversible and therefore of less concern with respect to hazard communication.
This will also apply to chronic toxicity and mutagenicity endpoints. If a chemical falls within the criteria specified in Section 52 of the CPR (Class D2A) and thereby considered "very toxic", no additional information would be provided by also including the substance as meeting the criteria specified in Section 59 of the CPR (Class D2B).
A germ cell mutagen also has the potential to induce somatic cells mutations that may be associated with the subsequent development of cancer or other diseases. Therefore, it would be redundant to classify a chemical in both subclasses i.e. meeting criteria for CPR Section 57 (Class D2A - heritable genetic effects) and CPR Section 62 (Class D2B - somatic cell mutagenicity). The distinction between the two subclasses relies very often on the amount of evidence (i.e test results) available.
Therefore, as a general rule:
- If a product falls into D1A, then it would be redundant to also include it in D1B;
- If a product falls into D2A in relation to a given endpoint, it would be redundant to also include it in D2B. This would be the case for the criteria set out in sections 52/59 and 57/62. However, if a product falls into D2A and D2B based on results to assess different endpoints (for example, carcinogenicity versus skin irritation), then the product would fall into the two subclasses.
Subsection 43(2):
Division 1 of Class D is entitled "Materials Causing Immediate and Serious Toxic Effects" (section 46-51). It includes criteria which describe products that are a danger because of the immediacy of any effect following exposure and because the products can cause death.
Division 2 is entitled "Materials Causing Other Toxic Effects" (sections 52-63). It includes criteria for products which usually do not pose a serious immediate toxic effect upon a single exposure. This includes products that produce immediate but non-lethal effects such as skin sensitization as well as products that can cause serious effects such as cancer or reproductive defects over longer-term exposure.
Division 3 is entitled "Biohazardous Infectious Material" and includes a single criterion; (see section 64 of the CPR).
Subsection 43(3):
Divisions 1 and 2 have been further divided into subdivisions A and B to distinguish products by the severity of hazard they pose. Subdivision A is entitled "Very Toxic Material" and subdivision B is entitled "Toxic Material". In Division 1, the distinction between subdivision A and B products is the quantity of the product that is required to produce a fatal effect.
In Division 2, the distinction between subdivision A and B products is, in some cases, the quantity of product required to produce a toxic effect. Subdivision B also includes products that produce immediate but less serious reversible effects.
TDGR Packing Groups - TDGR packing groups correlate to the primary TDG classification of a substance. Although this has no implication for the criteria set out in CPR 39(d) and 65(d), it does with regard to CPR 47 and 50. The istinction between D1A (CPR 47) and D1B (CPR 50) is based on the packing group of the 6.1 TDG classification. If the 6.1 classification is the subsidiary classification, it can be concluded that the substance falls within D1. However, the scientific literature must be searched to find the L D50/L C50 values that enable the determination of whether a substance falls within the criteria for D1A versus D1B. If available L D50/L C50 data do not enable an assessment against the criteria set out in CPR 46 & 49, then the substance would be included in D1B.
Subsection 43(4):
During the development of WHMIS, stakeholders had agreed that "a gas which falls in TDG Class 2, Division 4 shall not also be classified as a Very Toxic Material or a Toxic Material in WHMIS" as such materials would already be classified as a WHMIS corrosive material, (ref.: p. 67 of WHMIS Steering Committee report). As a result, Class D of the WHMIS criteria specifically excludes those gases in Division 4 of Class 2 in the Transportation of Dangerous Goods Regulations (TDGR). These gases can have a lethal effect because of the extreme corrosive effect on the tissue of the respiratory tract. Such products will be included under Class A - Compressed Gas and, by virtue of paragraph 65(d) of the CPR, these substances are also included in WHMIS Class E, Corrosive Material.
A subsequent amendment to the TDGR Footnote 10 , however, moved nine of the twelve substances originally included in Division 4 to other Divisions in TDG Class 2. Only (i) ammonia, anhydrous, liquefied or anhydrous ammonia or ammonia solutions, relative density (specific gravity) less than 0.880 at 15°C in water, with more than 50% ammonia, UN 1005 and (ii) ammonia solutions, relative density (specific gravity) less than 0.880 at 15°C in water, with more than 35% but not more than 50% ammonia, UN 2073 retained their 2.4 classifications. The exemption from inclusion in WHMIS Class D, therefore, continues to apply to liquified ammonia only as this is the only gas remaining in Division 4 of TDG Class 2 after the amendment to the TDGR came into effect on October 1, 1994.
The gases which were moved out of Division 4 of TDG Class 2 are boron trichloride, chlorine, hydrogen bromide (anhydrous), hydrogen chloride (anhydrous), hydrogen chloride (refrigerated liquid), hydrogen fluoride (anhydrous), hydrogen iodide (anhydrous), nitrosyl chloride and trifluoroacetyl chloride. The twelfth substance, aerosols containing any quantity of a corrosive gas, became prohibited under the TDG amendment. At the May 1995 meeting of the WHMIS Current Issues Committee, participants agreed that, in order to respect the original consensus agreement, when the CPR are amended, the applicable subsection, 43(4) and paragraph 65(d), will be revised to refer to the substances by name which were included in Division 4 of TDG Class 2 as of October 31, 1988, i.e., when the CPR came into effect. Therefore, the labels of the applicable products must continue to display the Class E symbol but need not depict the skull and cross bones nor "toxic T" symbols whether or not the substance falls within the Class D criteria. The exemption from depicting the Class D symbols on the labels of these products does not exempt suppliers from disclosing any of the MSDS hazard information relevant to these products.
CPR Section 44 - Formulae for Equivalent LC50 [for CLASS D]
Formulae for Equivalent LC50
44. For the purpose of establishing that a product, material or substance falls into Division 1 of Class D - Poisonous and Infectious Material, an LC50 that is obtained in an animal assay at an exposure duration of other than four hours may be converted to an LC50 equivalent to an exposure duration of four hours by using the following formulae:
a) for a gas or vapour,
b) for dust, mist or fume,
Note: Y = actual number of hours of exposure duration.
Interpretation / Discussion of Section 44
Four hour exposure periods are specified in paragraphs 46(c), (d) and (e) and in 49(c) and (d) of the Controlled Products Regulation s. Since LC50 determinations may be conducted over various periods of time measured in minutes to several hours, there is a need to be able to extrapolate such data for four hour exposure periods. These formulae assume a simple linear relationship between times of exposure and concentrations in the animal chamber for dust, mist and fume and a "square root" function for gas and vapour.
CPR Section 45 - Toxicological Evaluation of Mixtures: LD50 and LC50 Data
Toxicological Evaluation of Mixtures: LD50 and LC50 Data
45.(1) Subject to subsection (3), where the LD50 or LC50 of every ingredient of a mixture present at a concentration of one per cent or more is known, the LD50 or LC50 of the mixture shall be determined, taking into account all ingredients present at a concentration of one per cent or more, by using the following formulae:
( a) for a solid or a liquid,
( b) for a gas, vapour, dust, mist or fume,
Note: proportion = the weight of the ingredient divided by the weight of the mixture.
(2) Subject to subsection (3), where the LD50 or LC50 of one or more ingredients of a mixture is not known, the LD50 or LC50 of the mixture is equal to the LD50 or LC50 of the most acutely lethal ingredient that is present in the mixture at a concentration of one per cent or more and for which LD50 or LC50 data is available.
(3) The LD50 or LC50 of a mixture may be determined by testing the mixture.
Interpretation / Discussion of Section 45
Many of the products that will be classified according to the "acute lethality" criteria will be untested mixtures. The formulae included in this section facilitate the calculation of an approximate LD50 or LC50 value providing the relevant data exists for all those constituents present in the mixture at a concentration equal to or greater than 1%.
If the LD50 (or LC50) of a mixture is unknown but the LD50(or LC50) of all the ingredients present at a concentration equal to or greater than 1% are known, then the mixture is considered to be a tested mixture with an LD50 (or LC50) derived from the formula in subsection 45(1). Such a mixture is thus not subject to the untested mixture criteria in sections 48 and 51 of the CP R; . By virtue of subsection 12(10), the MSDS may disclose the LD50 (or LC50) derived from the formula in place of the LD50 (or LC50) of the ingredients for such a mixture.
CPR Section 46 - Acute Lethality [Class D; Division 1, Subdivision A]
Division 1: Materials Causing Immediate and Serious Toxic Effects
Subdivision A: Very Toxic Material
Pure Substances and Tested Mixtures
Acute Lethality46. A pure substance or tested mixture falls into Subdivision A of Division 1 of Class D - Poisonous and Infectious Material if, in an animal assay for acute lethality, it has an
a) LD50 not exceeding 50 milligrams per kilogram of body weight of the animal when tested in accordance with OECD Test Guideline No. 401, "Acute Oral Toxicity", dated May 12, 1981;
b) LD50 not exceeding 200 milligrams per kilogram of body weight of the animal when tested in accordance with OECD Test Guideline No. 402, "Acute Dermal Toxicity", dated May 12, 1981;
c) LC50 not exceeding 2,500 parts per million by volume of gas when tested for four hours in accordance with OECD Test Guideline No. 403, "Acute Inhalation Toxicity", dated May 12, 1981;
d) LC50 not exceeding 1,500 parts per million by volume of vapour when tested for four hours in accordance with OECD Test Guideline No. 403, "Acute Inhalation Toxicity", dated May 12, 1981, and a saturated vapour concentration at normal atmospheric pressure greater than two times the value of that LC50; or
e) LC50 not exceeding 0.5 milligrams per litre or 500 milligrams per cubic metre of dust, mist or fume when tested for four hours in accordance with OECD Test Guideline No. 403, "Acute Inhalation Toxicity", dated May 12, 1981.
Interpretation / Discussion of Section 46
There are two LD50 criteria dealing with oral and dermal exposure and three LC50 criteria dealing separately with gases, vapours and, collectively, dust, mist and fumes. In each case, OECD Test Guidelines are referenced.
Paragraph (a ):
The referenced OECD guideline defines "acute oral toxicity" as the adverse effects occurring within a short time of oral administration of a single dose of a substance or multiple doses given within 24 hours. The term LD50 (median lethal dose) is defined in section 2 of the CPR. The principle of the specified method is that the test substance is administered orally by gavage in graduated doses to several groups of experimental animals, one dose being used per group. Observations of the effects are made. Animals which die during the test are necropsied. At the conclusion of the test, the surviving animals are sacrificed and necropsied as necessary. OECD 401 is directed primarily to studies in rodents.
Fixed Dose Method: The WHMIS Information Bulletin "Acute Oral Toxicity - OECD Fixed Dose Method" Footnote 11 , provides information regarding the use of data from the OECD Test Guideline 420 Fixed Dose Method (FDM) which measures acute oral toxicity in animals. A major factor in the development of this newer method was the desire to minimize the use of laboratory animals for testing chemical products.
The new OECD Test Guideline 420 departs from the referenced method (Test Guideline 401) in two principal ways:
- the FDM considers non-lethal endpoints; and
- the FDM does not develop a quantitative relationship between dose and lethality.
Guideline 420 relies upon clear signs of toxicity ("evident toxicity"), a nonlethal endpoint as well as lethality, as the basis for acute oral toxicity assessment.
At the time of printing of this manual, no equivalent fixed dose methods had been developed for the dermal and inhalation routes of exposure.
Paragraph (b ):
The referenced OECD guideline defines "acute dermal toxicity" as the adverse effects occurring within a short time of dermal application of a single dose of a test substance. The test substance is applied to the skin in graduated doses to several groups of experimental animals, one dose being used per group.
Paragraph (c ):
The referenced OECD guideline defines "acute inhalation toxicity" as the total of adverse effects caused by a substance following a single uninterrupted exposure by inhalation over a short period of time (24 hours or less) to a substance capable of being inhaled. Several groups of experimental animals are exposed for a defined period to the test substance in graduated concentrations, one concentration being used per group. Where a vehicle is used to help generate an appropriate concentration of the substance in the atmosphere, a vehicle control group is normally used.
Paragraph (d ):
The criteria set out in paragraphs 46(d) and 49(c) include specified values of the ratio between the "saturated vapour concentration" (maximum concentration of the vapour in air) and the LC50 (lethal concentration in air). This ratio indicates the potential inhalation hazard of volatile substances which may be spilled in a confined space. A consequence of the formula is that highly volatile liquids such as ethyl formate or 1,1,2-trichloro-1,2,2-trifluoroethane are classified as "A Very Toxic Material" because of their high saturation vapour concentrations even though their high LC50s would normally suggest a relatively low toxicity.
CPR Section 47 - Poisonous Substances as Defined by the Transportation of Dangerous Goods Regulations [Class D; Division 1, Subdivision A]
Poisonous Substances as Defined by the Transportation of Dangerous Goods Regulations
47. A pure substance or tested mixture falls into Subdivision A of Division 1 of Class D - Poisonous and Infectious Material if it is included in Division 3 of Class 2 or in Packing Group I or II of Division 1 of Class 6 in Part III of the Transportation of Dangerous Goods Regulations.
Interpretation / Discussion of Section 47
This section links the criteria described in section 46 of the CPR to the equivalent TDG classes and divisions, i.e., TDG Class 2.3 (poisonous gases) and TDG Class 6.1 Packing Groups I and II for all other physical states (e.g., solids, liquids, vapours and aerosols).
The TDG Regulations specify TDG packing groups for primary but not subsidiary TDG classifications. Therefore, where a substance has a subsidiary TDG classification of 6.1, it cannot be determined if the substances falls into WHMIS D1A versus D1B without assessing the substance against the LD50/LC50 criteria specified in sections 46 and 49 of the CPR.
The distinction between D1A (CPR 47) and D1B (CPR 50) is based on the packing group of the 6.1 TDG classification. If the 6.1 classification is the subsidiary classification, it can be concluded that the substance falls within D1. However, the scientific literature must be searched to find the LD50/LC50 values that enable the determination of whether a substance falls within the criteria for D1A versus D1B. If available LD50/LC50 data do not enable an assessment against the criteria set out in sections 46 and 49 of the CPR then the substance would be included in D1B.
CPR Section 48 - Untested Mixtures [Class D; Division 1, Subdivision A]
Untested Mixtures
48. An untested mixture falls into Subdivision A of Division 1 of Class D - Poisonous and Infectious Material if it contains a product, material or substance that meets any of the criteria applicable to a pure substance or tested mixture referred to in section 46 or 47 and is present at a concentration of one per cent or more.
Interpretation / Discussion of Section 48
Where a mixture has not been tested as a whole to determine its health hazards, for the purposes of classification under the CPR, the mixture is assumed to present the same hazards as the components comprising a specified percentage of the mixture. The percentage specified (0.1 versus 1.0%) depends upon the hazard under consideration. This particular criterion specifies a 1% concentration cut-off for ingredients that meet any of the criteria in sections 46 or 47.
A cut-off of 1.0% is also specified in the United States OSHA Hazard Communication Standard.
CPR Section 49 - Acute Lethality [Class D; Division 1, Subdivision B]
Subdivision B: Toxic Material
Pure Substances and Tested Mixtures
Acute Lethality49. A pure substance or tested mixture falls into Subdivision B of Division 1 of Class D - Poisonous and Infectious Material if, in an animal assay for acute lethality, it has an
( a) LD50 of more than 50 but not exceeding 500 milligrams per kilogram of body weight of the animal, when tested in accordance with OECD Test Guideline No. 401, "Acute Oral Toxicity", dated May 12, 1981;
( b) LD50 of more than 200 but not exceeding 1,000 milligrams per kilogram of body weight of the animal, when tested in accordance with OECD Test Guideline No. 402, "Acute Dermal Toxicity", dated May 12, 1981;
( c) LC50 of more than 1,500 but not exceeding 2,500 parts per million by volume of vapour, when tested for four hours in accordance with OECD Test Guideline No. 403, "Acute Inhalation Toxicity", dated May 12, 1981, and a saturated vapour concentration at normal atmospheric pressure of more than 0.4 times theLC50 ; or
( d) LC50 of more than 0.5 but not exceeding 2.5 milligrams per litre or grams per cubic metre of dust, mist or fume, when tested for four hours in accordance with OECD Test Guideline No. 403, "Acute Inhalation Toxicity", dated May 12, 1981.
Interpretation / Discussion of Section 49
The criteria in this section are closely related to the criteria in section 46. These criteria represent that group of controlled products that are less hazardous in terms of their ability to cause death in a short time. Information relating to the referenced OECD guidelines is provided in the discussion under section 46.
Paragraph 49(a ):
Refer to the interpretation / discussion of paragraph 46(a) for information regarding the use of data from OECD Test Guideline 420 Fixed Dose Method (FDM).
Paragraph 49(c ):
Refer to the interpretation section corresponding to paragraph 46(d) for information regarding the correlation between "saturated vapour concentration" and the LC50.
CPR Section 50 - Poisonous Substances as Defined by the Transportation of Dangerous Goods Regulations [Class D; Division 1, Subdivision B]
Poisonous Substances as Defined by the Transportation of Dangerous Goods Regulations
50. A pure substance or tested mixture falls into Subdivision B of Division 1 of Class D - Poisonous and Infectious Material if it is included in Packing Group III of Division 1 of Class 6 in Part III of the Transportation of Dangerous Goods Regulations.
Discussion of Section 50
This section is analogous to section 47. It links the criteria described in section 49 of the CPR to the equivalent TDG class, division and packing group, i.e., if a substance is included in Packing Group III of TDG Class 6.1, that substance is included in WHMIS D1B.
The TDG Regulations specify TDG packing groups for primary but not subsidiary TDG classifications. Therefore, where a substance has a subsidiary TDG classification of 6.1, it cannot be determined if the substances falls into WHMIS D1A versus D1B without assessing the substance against the LD50 /LC50 criteria specified in sections 46 and 49 of the CPR.
The distinction between D1A (CPR 47) and D1B (CPR 50) is based on the packing group of the 6.1 TDG classification. If the 6.1 classification is the subsidiary classification, it can be concluded that the substance falls within D1. However, the scientific literature must be searched to find the LD50/LC50values that enable the determination of whether a substance falls within the criteria for D1A versus D1B. If available LD50 /LC50 data do not enable an assessment against the criteria set out in sections 46 and 49 of the CPR then the substance would be included in D1B.
CPR Section 51 - Untested Mixtures [Class D; Division 1, Subdivision B]
Untested Mixtures
51. An untested mixture falls into Subdivision B of Division 1 of Class D - Poisonous and Infectious Material if it contains a product, material or substance that meets any of the criteria applicable to a pure substance or tested mixture referred to in section 49 or 50 and is present at a concentration of one per cent or more.
Discussion of Section 51
This section is analogous to section 48 of the Controlled Products Regulations.
Where a mixture has not been tested as a whole to determine its health hazards, for the purposes of classification under the CPR, the mixture is assumed to present the same hazards as the components comprising a specified percentage of the mixture. The percentage specified (0.1 versus 1.0%) depends upon the hazard under consideration. This criterion specifies a 1% concentration cut-off for ingredients that meet any of the criteria in section 49 or 50.
A cut-off of 1.0% is also specified in the United States OSHA Hazard Communication Standard.
CPR Section 52 - Chronic Toxic Effects [Class D; Division 2, Subdivision A]
Division 2: Materials Causing Other Toxic Effects
Subdivision A: Very Toxic Material
Pure Substances and Tested Mixtures
Chronic Toxic Effects52. A pure substance or tested mixture falls into Subdivision A of Division 2 of Class D - Poisonous and Infectious Material if, in an animal assay for chronic toxic effects, it elicits a response of sufficient severity to threaten life or cause serious permanent impairment in a statistically significant proportion of the test population at
- a dose not exceeding 10 milligrams per kilogram of body weight of the animal per day when tested in accordance with
- OECD Test Guideline No. 408, "Subchronic Oral Toxicity --Rodent: 90-day", dated May 12, 1981,
- OECD Test Guideline No. 409, "Subchronic Oral Toxicity -- Non-Rodent: 90-day", dated May 12, 1981, or
- the oral route test in OECD Test Guideline No. 452, "Chronic Toxicity Studies", dated May 12, 1981;
- OECD Test Guideline No. 411, "Subchronic Dermal Toxicity: 90-day", dated May 12, 1981, or
- the dermal route test in OECD Test Guideline No. 452, "Chronic Toxicity Studies", dated May 12, 1981; or
- OECD Test Guideline No. 413, "Subchronic Inhalation Toxicity: 90-day", dated May 12, 1981, or
- the inhalation route test in OECD Test Guideline No. 452, "Chronic Toxicity Studies", dated May 12, 1981.
Discussion of Section 52
The term "chronic toxic effect" is defined in section 32 of the CPR. The criteria in paragraphs (a), (b) and (c) deal with results of animal testing by the three routes of exposure - oral, dermal and inhalation, respectively. OECD Test Guidelines have been referenced as the criteria.
Although the opening statement in this set of criteria refers only to "chronic" effects, several of the referenced OECD guidelines determine effects from "subchronic" studies which are usually conducted for a period of 90 days. Chronic studies usually involve exposing test animals for 10% or more of their normal life span at various dose or concentration levels to determine at what level chronic toxicity occurs. As indicated below, subchronic studies involve the exposure of test animals for a maximum of 10 per cent of their life span.
Guideline 452 is referenced for all three routes of exposure. The introduction section of this guideline states: "The duration of chronic toxicity studies for effects other than neoplasia is still widely debated. Under the conditions of this test, effects such as carcinogenesis and those which are non-specific life shortening, which require a long latent period or are cumulative, may not become manifest. Except for those, the application of these Guidelines should generate data on which to identify the majority of chronic effects and to determine dose-response relationships. Ideally, the design and conduct should allow for the detection of general toxicity including neurological Footnote 12 , physiological, biochemical, and haematological effects and exposure-related morphological (pathology) effects."
Redundancy of multiple classifications within WHMIS Class D: Materials falling within the criteria of Section 52 of the CPR (Class D2A - chronic toxic effects) do not need to be also classified under Section 59, (Class D2B - chronic toxic effects). The difference between inclusion in those two WHMIS classes relates to the dose in relation to the observation of a specified adverse effect. As such, if a chemical falls within the criteria specified in CPR 52 and thereby considered "very toxic", no additional information would be provided by also including the substance in D2B. Please refer to the discussion of Section 43 of the CPR for more information on this issue.
Paragraph (a):
OECD guidelines 408 and 409 define "subchronic oral toxicity" as the adverse effects occurring as a result of the repeated daily oral dosing of a chemical to experimental animals for part (not exceeding 10 per cent) of the life span.
Paragraph (b):
OECD guideline 411 defines "subchronic dermal toxicity" as the adverse effects occurring as a result of the repeated daily dermal application of a chemical to experimental animals for part (not exceeding 10 per cent) of a life span.
Paragraph (c):
OECD guideline 413 defines "subchronic inhalation toxicity" as the adverse effects which follow repeated daily exposure by inhalation for part (not exceeding 10 per cent) of a life span.
CPR Section 53 - Teratogenicity and Embryotoxicity [Class D; Division 2, Subdivision A]
Teratogenicity and Embryotoxicity
53.(1) A pure substance or tested mixture falls into Subdivision A of Division 2 of Class D -Poisonous and Infectious Material, in an animal assay for teratogenicity and embryotoxicity, it is shown to cause injury to the embryo or fetus in a statistically significant proportion of the test population at a concentration that has no adverse effect on the pregnant female when tested in accordance with
(a) OECD Test Guideline No. 414, "Teratogenicity", dated May 12, 1981;
(b) OECD Test Guideline No. 415, "One-Generation Reproduction Toxicity", dated May 26, 1983; or
(c) OECD Test Guideline No. 416, "Two-Generation Reproduction Toxicity", dated May 26, 1983.
(2) In this section, "injury" includes death, malformation, permanent metabolic or physiological disfunction, growth retardation or psychological or behaviourial alteration that occurs during pregnancy, at birth or in the postnatal period.
Discussion of Section 53
These criteria encompass controlled products which cause various injuries to the embryo and fetus that may occur under conditions that would have no effect on the pregnant female.
In OECD Test Guideline No. 414, teratogenicity is defined as "the property of a chemical which causes permanent structural or functional abnormalities during the period of embryonic development". The test substance is administered daily beginning soon after implantation and continuing through organogenesis. One day prior to term, foetuses are delivered by hysterectomy and examined for visceral or skeletal abnormalities.
The oral dose of 1000 mg/kg mentioned in the guideline is not intended to serve as a "limit dose" for developmental toxicity testing. Rather, the 1000 mg/kg is intended to aid in the prioritization of developmental toxicity testing by indicating that if no adverse fetal or maternal effects are observed at 1000 mg/kg, no further testing at higher doses is required to establish the level at which such effects might be produced. However, if in an existing study adverse fetal or maternal toxicity at dose(s) greater than 1000 mg/kg is observed, such data should be evaluated and used to establish the hazards of the material and ultimately the WHMIS classification. Section 4.2.3.3 of Annex VI of the EU Dangerous Substances Directive (4.5.93, No L 110A/45) states the following:
"Annex V to the Directive specifies a limit test in the case of substances of low toxicity. If a dose level of at least 1000 mg/kg orally produces no evidence of effects toxic to reproduction, studies at other dose levels may not be considered necessary. If data are available from studies carried out with doses higher than the above limit, this data must be evaluated together with other relevant data. Under normal circumstances it is considered that effects seen only at doses in excess of the limit dose would not necessarily lead to classification as 'toxic to reproduction'".
The OECD Test Guidelines No.s 415 and 416 are designed to provide general information concerning the effects of a test substance on male and female reproductive performance. Studies carried out in accordance with these guidelines may also provide preliminary information about developmental toxic effects of the test substance, such as neonatal morbidity, mortality, behaviour and teratogenesis. They also serve as a guide for subsequent tests.
Maternal toxicity: When developmental effects are found in the presence of maternal toxicity, the primary cause is often left to speculation. Without sufficient evidence to support the premise that developmental toxicity is always a secondary toxic effect in the presence of maternal toxicity, a default is needed.
Inconsistency in the manner by which maternal toxicity data are evaluated has lead to variance in the WHMIS classification of and MSDS disclosure for several substances. The term "maternal toxicity" is not defined in the CPR. The Intergovernmental WHMIS Coordinating Committee (IWCC) has adopted the following as policy regarding maternal toxicity:
Indicators of Maternal Toxicity
Guidelines for developmental toxicity evaluation have been published by the US EPA [1] and the California EPA [2]. Both of these documents provide specific guidance concerning the assessment of maternal toxicity in teratology and reproductive toxicity bioassays.
Developmental toxicity can occur in the presence or absence of maternal toxicity. In addition, toxic effects on the female reproductive system in the pregnant female may also be direct or secondary to other toxic effects. Since the prenatal environment for the conceptus is provided by the maternal reproductive system, the developing organism is potentially subject to direct toxic effects of the agent; to toxic effects which directly impair the supportive functions of the female reproductive system; and to other toxic effects in the dam which secondarily affect the conceptus or female reproductive system. Where effects occur both in the developing organism and in the mother, developmental effects may be caused by any of these factors, or by some interaction between them [2].
In its assessment of developmental toxicity hazard, California EPA has adopted the following position regarding maternal toxicity in teratology or reproductive toxicity bioassays:
Developmental effects which occur in the presence of maternal toxicity are considered to be evidence of developmental toxicity, unless it can be unequivocally demonstrated that the developmental effects are secondary to maternal toxicity [2].
The IWCC Guidelines for the Disclosure of Toxicological Information on MSDSs [3] state that:
In animal bioassays, adverse effects on fetal development or parental reproductive functions may occur at doses above or below those producing signs of toxicity in the parent animals. For the purpose of hazard disclosure, any indication of an adverse effect on fetal development or reproductive parameters should be disclosed on the MSDS. Such disclosure is required because the handling, storage or use of controlled products may occasionally produce exposures resulting in mild parental toxicity, thereby resulting in potential developmental or reproductive toxicity hazards.
For the purposes of section 53(1) and subitem 7(9) of Schedule I of the CPR, the following indicators of maternal toxicity [1,2] shall be evaluated when determining whether embryo-fetal or developmental toxicity has occurred at "a concentration that has no adverse effect on the pregnant female":
a. Mortality - The observation of an increase over the control in the incidence of maternal mortality among the treated dams should be considered evidence of maternal toxicity if the increase occurs in a dose-related manner, and is attributed to the systemic toxicity of the test material (with disease being ruled out). In the case of gavage studies, care must be taken in determining if maternal deaths were due to errors in the dosing procedure rather than the systemic toxicity of the test material.
b. Maternal Body Weight - The observation of a statistically significant decrease in the average maternal body weight of the treated dams relative to those in the control group during the treatment period, or on the day of necropsy, may be considered evidence of maternal toxicity. It should be stressed that body weight changes may provide more information than does daily body weight measured during or following treatment [1]. Consideration of the maternal body weight change and/or corrected maternal body weight should be included in the evaluation of maternal toxicity whenever such data are available. Body weight data may not be as useful an indicator of maternal toxicity in rabbits as it is for other species because rabbit body weight changes are usually more variable. Also, in some strains of rabbits, bodyweight is not a good indicator of pregnancy status [1].
c. Maternal Body Weight Change - The observation of a statistically significant decrease in the average maternal body weight gain in the treated dams relative to those in the control group over the gestation period and/or during the treatment period, may be considered evidence of maternal toxicity. However, consideration of the corrected maternal body weight change should be included, whenever possible, in the evaluation. Changes in maternal body weight corrected for gravid uterine weight at sacrifice may be a better indicator of whether an effect is primarily maternal or intrauterine. For example, a significant reduction in maternal body weight gain throughout gestation, without a concomitant change in corrected maternal weight gain, would indicate an intrauterine effect in the absence of maternal toxicity. An alternate, although less desirable, estimate of corrected maternal weight change during gestation can be obtained by subtracting the sum of the weights of the fetuses (however, this weight does not include the uterine and placental tissue nor the amniotic fluid)[1].
d. Organ Weights - The observation of a statistically significant change in the average weight (absolute or relative) of suspected target organ(s) of treated dams, relative to those in the control group, may be considered evidence of maternal toxicity. Whenever possible, changes in organ weights should be supported by findings of adverse histopathological effects in the affected organ(s), and/or changes in other biologically relevant parameters, such as hematology or clinical chemistry.
e. Food and Water Consumption - The observation of a statistically significant decrease in the average food or water consumption in treated dams relative to the control group may be useful in evaluating maternal toxicity, particularly when the test material is administered in the diet or drinking water. Changes in food or water consumption should be evaluated in conjunction with maternal body weights when determining if the effects noted are reflective of maternal toxicity.
f. Clinical Observations of Toxicity - The observation of a statistically significant increase in the incidence of significant clinical signs of toxicity in treated dams relative to the control group may be useful in evaluating maternal toxicity. If this is to be used as the basis for the assessment of maternal toxicity, the types, incidence, degree and duration of clinical signs should be reported in the study. Examples of significant clinical signs of maternal intoxication include: coma, prostration, loss of righting reflex, ataxia, or laboured breathing.
References cited in the IWCC policy on maternal toxicity:
[1] US EPA. Guidelines for Developmental Toxicity Risk Assessment. Federal Register 56(234):63798-63826, Dec. 5. 1991.
[2] California Department of Health Services, Health Hazard Assessment Division. Draft Guidelines for Hazard Identification and Dose-response Assessment of Agents Causing Developmental and/or Reproductive Toxicity. April 3, 1991.
[3] IWCC Guidelines for the Disclosure of Toxicological Information on a Material Safety Data Sheet; (accessible from "MSDSs" page on the Health Canada WHMIS website: www.hc-sc.gc.ca/whmis
CPR Section 54 - Carcinogenicity [Class D; Division 2, Subdivision A]
Carcinogenicity
54. A pure substance or tested mixture falls into Subdivision A of Division 2 of Class D - Poisonous and Infectious Material if it is listed in
(a) section Ala, Alb or A2 of Appendix A of the Threshold Limit Values for Chemical Substances and Physical Agents in the Work Environment, published by the ACGIH, as amended from time to time; or
(b) Group 1 or Group 2 in the IARC Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans, published by the World Health Organization, as amended from time to time.
Discussion of Section 54
To determine whether or not a material is or contains a carcinogen, reference is made to two different documents: the TLV booklet published by ACGIH, and the IARC list of carcinogens. The substances included by reference to these publications are considered to be carcinogens under the CPR.
In 1987, the ACGIH modified Appendix A of their referenced publication to eliminate the designations A1a and A1b and replace them by the designation A1. This modification also removed listings of carcinogens from Appendix A to the Table of Chemical Substances with Adopted TLVs.
The applicable portion of the ACGIH publication was modified again breaking what had been four groupings into five. In March 1996, the WHMIS Current Issues Committee agreed that paragraph 54(a) be revised to include categories A1, A2 and A3; .
Note: As the proposed revision to paragraph 54(a) has not been published in the Canada Gazette Part II, if a controlled product does not otherwise fall within any other Class D criteria specified in the CPR, a supplier would not be legally obliged to depict the symbol corresponding to Division 2 of Class D (i.e., the stylized "T") on the sole basis that it is included in ACGIH A3; (i.e., inclusion in A3 would not constitute the sole criterion for classification as a controlled product in the absence of a regulatory amendment.)
In general, if an IARC monograph does not specifically address a chemical or group of chemicals, the results of the assessment described in the monograph may not apply. The chemical or group of chemicals would not necessarily, as a consequence of the chemical or group of chemicals sharing a common element or functional group with a substance that has been assessed, fall within the criteria specified in paragraph 54(b) of the CPR.
Note: for the purposes of classification under CPR 54, posting of an IARC classification on the IARC Web site is considered sufficient for inclusion in the applicable IARC Group irrespective of the whether the official monograph has been published.
Similarly if a chemical or a group of chemicals is not specifically encompassed under ACGIH A1, A2 nor A3, the chemical or group of chemicals would not, as a consequence of the chemical or group of chemicals sharing a common element or functional group with a substance that has been assessed, necessarily fall within the criteria specified in paragraph 54(a) of the CPR.
Note: Consistent with section 33 of the CPR, the fact that a product or a group of products was not specifically addressed in the IARC monograph nor classified under group A1, A2, or A3 by the ACGIH does not relieve the supplier or importer of his / her obligation to consider other evidence that carcinogenic (or other health) effects may result from exposure to the substance(s).
Substances assessed for carcinogenicity: A list of substances assessed for carcinogenicity by the American Conference of Governmental Industrial Hygienists (ACGIH), the California Environmental Protection Agency (Cal-EPA), the International Agency of Research on Cancer (IARC), the European Union (E.U.), and the National Toxicology Program (NTP) is posted on the "Hazard-specific" section of the Heatlh Canada WHMIS web site.
CPR Section 55 - Reproductive Toxicity [Class D; Division 2, Subdivision A]
Reproductive Toxicity
- there is evidence that shows that it causes sterility or an adverse effect on reproductive capability in persons following exposure to it in the work place; or
- sterility or an adverse effect on reproductive capability is shown in an animal assay for reproductive toxicity carried out in accordance with
- OECD Test Guideline No. 415, "One-Generation Reproduction Toxicity", dated May 26, 1983, or
- OECD Test Guideline No. 416, "Two-Generation Reproduction Toxicity", dated May 26, 1983.
Interpretation / Discussion of Section 55
This section deals with human and laboratory animal evidence of adverse effects on reproduction. The OECD Test Guidelines No.s 415 and 416 are designed to provide general information concerning the effects of a test substance on male and female reproductive performance such as:
Reproductive toxicity and systemic toxicity: In contrast to the CPR criteria specified in section 53 for teratogenicity and embryotoxicity, there are no analogous criteria nor mention of systemic toxicity in relation to the CPR criteria for reproductive toxicity. However, in relation to CPR Schedule I Subitem 7(8) -" Reproductive toxicity", and Subitem 7(9) - "Teratogenicity", The Intergovernmental WHMIS Coordinating Committee's "Guidelines for the Disclosure of Toxicological Information on a Material Safety Data Sheet" states:
In animal bioassays, adverse effects on fetal development or parental reproductive functions may occur at doses above or below those producing signs of toxicity in the parent animals. The handling, storage or use of controlled products may occasionally produce exposures resulting in mild parental toxicity thereby resulting in potential developmental or reproductive toxicity hazards. For the purpose of MSDS disclosure, any indication of an adverse effect on fetal development or reproductive parameters must be disclosed on the MSDS irrespective of whether or not there is an adverse effect on the pregnant female. Any relevant epidemiological evidence must also be disclosed.
Therefore, as per the Guidelines, toxicity in the parent animals would address both endpoints. However, since there is no reference to systemic toxicity in Section 55 of the CPR, a chemical could be classified as a reproductive toxin in the presence of systemic toxicity. Professional judgement will be required to assess whether the data are adequate and to determine the extent or impact systemic toxicity has on reproductive parameters.
CPR Section 57 - Mutagenicity [Class D; Division 2, Subdivision A]
Mutagenicity
57.(1) A pure substance or tested mixture falls into Subdivision A of Division 2 of Class D - Poisonous and Infectious Material if
- there is epidemiological evidence that shows a causal connection between exposure of persons to the substance or mixture and heritable genetic effects; or
-
positive results in a study that measures mutations transmitted to offspring, or
(2) The evidence referred to in paragraph (1)(b) shall be obtained
- in accordance with test methods described in the "Introduction to the OECD Guidelines on Genetic Toxicology Testing and Guidance on the Selection and Application of Assays", dated March 1, 1987, published in the Third Addendum to the OECD Guidelines for Testing of Chemicals; and
Interpretation / Discussion of Section 57
The criteria in this section encompass human epidemiological evidence as well as results from laboratory animal studies showing a causal connection between exposure to a substance and heritable genetic effects. The criteria include evidence that a genetic change (mutation) has been transmitted to offspring by exposure of eggs or sperm (i.e., germ cells) and evidence of chemical interaction with germ cells when genetic effects occur in cells other than germ cells (i.e., somatic cells).
Redundancy of multiple classifications within WHMIS Class D: Materials falling within the criteria of Section 57 of the CPR do not need to be also classified under Section 62. A germ cell mutagen also has the potential to induce somatic cells mutations that may be associated with the subsequent development of cancer or other diseases. Therefore, it would be redundant to classify a chemical in both subclasses i.e. meeting criteria for Section 57 (Class D2A - heritable genetic effects) and Section 62 (Class D2B - somatic cell mutagenicity). The distinction between the two subclasses relies very often on the amount of evidence (i.e test results) available. Please refer to the discussion of Section 43 of the CPR for more information on this issue.
Which mutagenicity assays should be considered?: Paragraphs 57(2)(a) and 62(a) of the CPR reference OECD test guidelines for genetic toxicology testing. Some of the OECD test methods (OECD test guidelines 474, 475, 478, 483, 484, and 485) list intra peritoneal as one of the route of administration of the chemical which is not considered a normal route of occupational exposure.
- As specific assays are not listed in the CPR, this has lead to differing application of the Regulations. For example, the applicability of test data acquired via the intra peritoneal route has led to disputes and/or inconsistences in the classification of controlled products.
- The "Harmonized Integrated Hazard Classification System for Human Health and Environmental Effects of Chemical Substances" (November 98) states that the "relevance of the route of exposure of the study of the chemical compared to the route of human exposure should also be taken into account".
For the purpose of determining which assays should be considered when assessing mutagenicity, it is recommended that results from the assays listed in the following chart (1)(2) be adopted as a general minimum guideline:
general minimum guideline
Assay Gene Mutation Chromosome Aberrations in vitro Test in vivo Test CPR 57-Criteria for Germ Cell Effects (3) WHMIS - D2A CPR 62-Criteria for Somatic Effects (4) WHMIS - D2B Dominant Lethal
Assayx x x Mammalian Germ Cell
Cytogeneticx x x Heritable
Translocation Assayx x x Mouse Spot Test x x x Micronucleus Test x x x Cytogenic Assay in
Animalsx x x Unscheduled DNA
Synthesis in Animalsx x DNA Adduct
Formation in Animalsx x Sister Chromatid
Exchange in Animalsx x Salmonella
typhimurium Reverse
Mutation (AMES) (5)x x Gene Mutation in
Yeast or Mammalian
Cells (5)x x Cytogenic Assay in
Cultured Cells (5)x x (1) Adaptation from Regulatory Toxicology and Pharmacology 27, 61-74 (1998)
(2) These are recommended minimum guidelines which do not preclude consideration of other assays not referred to in this table
(3) If present in concentration ≥0.1%
(4) If present in concentration ≥1.0%
(5) While these tests do not explicitly relate to WHMIS classification for mutagenicity, the results should be disclosed on the MSDS. Regarding, for example, the Ames as a stand alone test, Appendix 10-1 "Basis for Development of the WHMIS Ingredient Disclosure List" of the Report of the WHMIS Project Steering Committee states the following:"if sufficient evidence exists to indicate a potential and justifiable cause for concern, then the material in question will be included in the list, subject to:
- peer review to confirm that the evidence is sufficient to warrant a justifiable cause for concern; and
-
Justifiable cause for concern means a technical assessment according to scientific principles of a multiplicity of tests covering a range of effects which takes into account the naturally occurring defence mechanisms which exist in mammals.
CPR Section 58 - Untested Mixtures [Class D; Division 2, Subdivision A]
Untested Mixtures
58. An untested mixture falls into Subdivision A of Division 2 of Class D - Poisonous and Infectious Material if it contains a product, material or substance that meets the criteria applicable to a pure substance or tested mixture referred to in
- any of sections 53 to 57, if the product, material or substance is present at a concentration of 0.1 per cent or more; or
- section 52, if the product, material or substance is present at a concentration of one per cent or more.
Interpretation / Discussion of Section 58
Where a mixture has not been tested as a whole to determine its health hazards, for the purposes of classification under the CPR, the mixture is assumed to present the same hazards as the components comprising a specified percentage of the mixture. The percentage specified (0.1 versus 1.0%) depends upon the hazard under consideration. This section specifies a 0.1% concentration cut-off for ingredients that meet any of the criteria for teratogenicity and embryotoxicity, carcinogenicity, reproductive toxicity, respiratory tract sensitization and mutagenicity specified in sections 53 to 57, respectively, and 1.0% for ingredients that meet any of the criteria for chronic toxicity specified in section 52.
Cut-offs of 0.1 and 1.0% are also specified in the United States OSHA Hazard Communication Standard (HCS). Under the HCS, however, a cut-off of 0.1% is limited to carcinogens.
CPR Section 59 - Chronic Toxic Effects [Class D; Division 2; Subdivision B]
Subdivision B: Toxic Material
Pure Substances and Tested Mixtures
Chronic Toxic Effects59. A pure substance or tested mixture falls into Subdivision B of Division 2 of Class D - Poisonous and Infectious Material if, in an animal assay for chronic toxic effects, it elicits a response of sufficient severity to threaten life or cause serious permanent impairment in a statistically significant proportion of the test population at
(a) a dose of more than 10 but not exceeding 100 milligrams per kilogram of body weight of the animal per day, when tested in accordance with
(i) OECD Test Guideline No. 408, "Subchronic Oral Toxicity -- Rodent: 90-day", dated May 12, 1981,
(ii) OECD Test Guideline No. 409, "Subchronic Oral Toxicity -- Non-Rodent: 90-day", dated May 12, 1981, or
(iii) the oral route test in OECD Test Guideline No. 452, "Chronic Toxicity Studies", dated May 12, 1981;
(b) a dose of more than 20 but not exceeding 200 milligrams per kilogram of body weight of the animal per day, when tested in accordance with
(i) OECD Test Guideline No. 411, "Subchronic Dermal Toxicity: 90-day", dated May 12, 1981, or
(ii) the dermal route test in OECD Test Guideline No. 452, "Chronic Toxicity Studies", dated May 12, 1981; or
(c) a concentration of more than 25 but not exceeding 250 parts per million by volume of gas or vapour, or more than 10 but not exceeding 100 micrograms per litre or more than 10 but not exceeding 100 milligrams per cubic metre, of dust, mist or fume, when tested in accordance with
(i) OECD Test Guideline No. 413, "Subchronic Inhalation Toxicity: 90-day", dated May 12, 1981, or
(ii) the inhalation route test in OECD Test Guideline No. 452, "Chronic Toxicity Studies", dated May 12, 1981.
Interpretation / Discussion of Section 59
As in section 52, this section deals with chronic toxic effects. These criteria address materials which require a higher dose or concentration level to elicit the specified adverse effect(s).
Refer to the interpretation of section 52 for further information.
CPR Section 60 - Skin or Eye Irritation [Class D; Division 2, Subdivision B]
Skin or Eye Irritation
60. A pure substance or tested mixture falls into Subdivision B of Division 2 of Class D - Poisonous and Infectious Material if, in an animal assay,
(a) it causes an effect graded at a mean of two or more for erythema formation or two or more for edema formation, when tested in accordance with OECD Test Guideline No. 404, "Acute Dermal Irritation/Corrosion", dated May 12, 1981, as measured at any of the times specified in the test; or
(b) it causes an effect graded at a mean of two or more for corneal damage, one or more for iris damage or 2.5 or more for conjunctival swelling or redness, when tested in accordance with OECD Test Guideline No. 405, "Acute Eye Irritation/Corrosion", dated May 12, 1981, as measured at any of the times specified in the test.
Interpretation / Discussion of Section 60
These criteria include materials with which, at concentrations that do not react chemically with biological tissue (i.e. are not corrosive), a recognizable and physiological effect occurs. Although irritation (a physiological effect) and corrosion (chemical reactivity) are distinguishable, in actual fact, many substances may exhibit both properties depending on the concentration and the duration of exposure. Irritants usually generate their effects acutely.
In contrast to corrosive substances, the effects of irritation are generally considered to be reversible. The extent of irritation, especially for the eye, depends on the degree of penetration into the tissue and the severity of the inflammatory response. Unlike sensitization, which is a systemic condition, irritation is a local (topical) phenomenon. In most cases, the effects of irritation ameliorate when the irritant is removed.
Physical abrasives: As any insoluble particulate matter can cause eye or skin irritation, products should not be classified as skin and eye irritants solely on the basis of physical abrasiveness; .
Irritation versus corrosion - classification?: Materials which fall within the criteria for skin corrosivity will always also meet the criteria for skin and eye irritation. Classification of such materials into both Class E and D2B involves redundancy for D2B information and possible confusion on the part of users. It was agreed, therefore, that materials meeting criteria for Section 65(b), (d), or (e) (Class E - Corrosive Material) need not also be classified under Section 60. However, materials meeting criteria for Section 65(a) (ie., Metal Corrosives - Class E) which do not meet criteria for Section 65(b), (d), or (e) and do meet Section 60 criteria (Class D2B - Skin and Eye Irritants) will be classified under both Class E and Subdivision D2B; . It is anticipated that the CPR will, therefore, be amended by replacing the period at the end of paragraph (b) with a semicolon and adding:
(c) where the effects described in paragraphs (a) and (b) have been shown to be caused solely by physical abrasiveness due to the presence of insoluble particulates;" nor
(d) where it is a controlled product that meets the criteria referred to in paragraph 65(b), paragraph (d) or paragraph (e).
OECD Test Guideline No. 404, revision: On July 17, 1992, the Council adopted an updated version of the original 1981 OECD guideline 404. The main differences between this and the referenced original version are as follows:
i) the inclusion of data from in vitro tests in the information on which a decision not to proceed to an in vivo test can be based; and
ii) the possibility to use one animal in a first step of the in vivo procedure allowing certain chemicals to be exempted from further testing.
The "Initial Considerations" section of the revised OECD guideline 404 states the following:
"In the interests of animal welfare, it is important that the unnecessary use of animals is avoided, and that any testing which is likely to produce severe responses in animals is minimized. Consequently, test materials meeting any of the following criteria should not be tested in animals for dermal irritation/corrosion:
i) materials that have predictable corrosive potential based on structure-activity relationships and/or physiochemical properties such as strong acidity or alkalinity, e.g., when the material to be applied has a pH of 2 or less or 11.5 or greater (alkaline or acidic reserve Footnote 13 should also be taken into account);
ii) materials which have been shown to be highly toxic by the dermal route;
iii) materials which, in an acute dermal toxicity test, have been shown not to produce irritation of the skin at the limit test dose level of 2000 mg/kg body weight.
In addition, it may not be necessary to test in vivo materials for which corrosive properties are predicted on the basis of results from in vitro tests."
OECD Test Guideline No. 405, proposed revision: The "Initial Considerations" section of the March 2000 draft states the following:
"Consideration should be given to all available information on a substance to minimize in vivo testing, especially if the substance is likely to produce severe reactions. Therefore, before an in vivo eye irritation/corrosion test is performed, all available information on a test material should be reviewed. Preliminary decisions can often be made from existing information as to whether a substance is corrosive or irritating to the eye, or is likely to be irritating or corrosive, in the absence of specific animal testing. Consequently, substances meeting any of the following criteria should not be tested in animals for eye irritation/corrosion without specific justification.
i) When there is sufficient human data from the test substance, it may not need to be tested in animals.
ii) Historical experience (including human data) or testing of structurally related chemicals should be evaluated. If there are sufficient data to indicate the eye irritancy/corrosivity potential of a chemical or mixture from analogues, the test substance can be presumed to produce similar responses. SAR experiences should be interpreted cautiously when evaluating non-irritating/corrosive substances.
iii) Strongly acidic or alkaline substances which can be expected to result in a pH in the eye of 2 or less, or 11.5 or greater, may not need to be tested owing to their probable corrosive properties. Buffering capacity (alkaline or acidic reserve) should also be taken into consideration.
iv) Substances that have demonstrated severe skin irritancy or corrosivity in a single application dermal study may not need to be tested for eye irritancy and corrosion. It can be presumed that such substances will produce similar severe effects on the eyes.
v) If a substance is highly toxic by the dermal route, it need not be tested in the eyes because it can be assumed to be highly toxic by this route as well.
vi) Substances that have demonstrated the potential in an in vitro or ex vivo study to be corrosive or a severe irritant may not need to be tested for irritation and corrosion in vivo. It can be presumed that such substances will produce similar severe effects on the eyes.
vii) If there is insufficient evidence with which to evaluate the potential eye irritation/corrosivity of a substance from the preceding information, a skin irritation/corrosion test (Guideline 404) should be performed first. If the substance is shown to produce severe skin irritation or corrosion, it can be presumed that it would also produce similar effects in the eyes, so that an in vivo eye test need not be performed.
viii) If a determination of eye irritancy or corrosivity cannot be made using SAR, in vitro, or other non-animal procedures, or from the results of a dermal test, an in vivo eye test should be considered."
CPR Section 61 - Skin Sensitization [Class D; Division 2, Subdivision B]
Skin Sensitization
61. A pure substance or tested mixture falls into Subdivision B of Division 2 of Class D -Poisonous and Infectious Material if
(a) in an animal assay carried out in accordance with OECD Test Guideline No. 406, "Skin Sensitization", dated May 12, 1981,
(i) it produces a response in 30 per cent or more of the test animals, when using one of the techniques incorporating the use of an adjuvant, or
(ii) it produces a response in 15 per cent or more of the test animals, when using one of the techniques not incorporating the use of an adjuvant; or
(b) evidence shows that it causes skin sensitization in persons following exposure in a work place.
Interpretation / Discussion of Section 61
For the purposes of classification, "skin sensitization" is a term which is defined by section 32 of the CPR. The criteria in this section, therefore, exclude skin sensitization observed only in persons who are "atopic".
There are two types of criteria in this section. One involves animal testing and the other is evidence observed in workers previously exposed.
OECD Test Guideline No. 406, revision: On July 17, 1992, the Council adopted an updated version of the original 1981 OECD guideline 406. When the CPR are next amended, paragraph 61(a) will be modified to refer to the July 17, 1992 version.
According to the general principle of the OECD guideline, test animals are initially exposed to the test substance by intradermal injection and/or epidermal application (induction exposure). Following a rest period of 10 to 14 days (induction period), during which an immune response may develop, the animals are exposed to a "challenge" dose to determine if the test population reacts in a hypersensitive manner. The extent and degree of skin reaction to the challenge exposure in the test population is compared with that of the control population which did not receive the induction exposure.
Atopy / atopic: refer to the discussion under section 56.
Adjuvant / adjuvanticity: Subparagraphs 61(a)(i) and (ii) refer to "adjuvant". Adjuvanticity is the ability to modify the immune response. An adjuvant is commonly used to elicit a cell mediated immunity (delayed hypersensitivity) as well as antibody formation.
Local Lymph Node Assay (LLNA): is a test method for assessing the skin sensitization potential of chemicals and mixtures. The definition of a positive result in the LLNA is a 3-fold or greater increase in the lymph node cell proliferation over concurrent vehicle control. In the past, positive results from the LLNA were accepted as criteria for classification of a product as a skin sensitizer (D2B). Negative results were not accepted as stand alone criteria when assessing a substance for skin sensitization; i.e., negative results needed to be confirmed by alternate methods such as OECD 406 "Skin Sensitization". The LLNA has been formally adopted by the OECD as Test Guideline No. 429. Under appropriate situations, negative as well as positive LLNA responses can be accepted without the need for further testing in the guinea pig.
- Significant work has been conducted to determine the correlation between LLNA test outcomes and test outcomes in the guinea pig test and in humans. An evaluation of the relevance and reproducibility of the LLNA was conducted by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). The method was found to be valid as a stand-alone test for skin sensitization (i.e. for appropriate testing situations, a negative as well as a positive response could be accepted without the need for additional testing in the guinea pig).
Subject to human evidence and/or positive results from other studies, when assessing skin sensitization of pure substances or mixtures, the LLNA is acceptable as a "stand alone" method irrespective of whether the results are positive or negative; .
Sensitization: For information on "sensitization" in general and respiratory tract sensitization, refer to the interpretation / discussion corresponding to section 56 of the CPR.
Sensitization versus irritation: Skin irritation is distinguishable from skin sensitization on physiological grounds but, in general, such a determination would have to be carried out by an expert.
Sufficiency of evidence - proportion of affected persons: Please see discussion / interpretation of section 56 of the CPR.
CPR Section 62 - Mutagenicity [Class D; Division 2, Subdivision B]
Mutagenicity
62. A pure substance or tested mixture falls into Subdivision B of Division 2 of Class D - Poisonous and Infectious Material if evidence of mutagenicity in mammalian somatic cells in vivo is obtained in a test to assess either gene mutation or chromosomal aberration carried out
(a) in accordance with test methods described in the "Introduction to the OECD Guidelines on Genetic Toxicology Testing and Guidance on the Selection and Application of Assays" published in the Third Addendum to the OECD Guidelines for Testing of Chemicals, dated March 1, 1987; and
(b) using testing strategies described in the Guidelines on the Use of Mutagenicity Tests in the Toxicological Evaluation of Chemicals, dated 1986, published by authority of the Minister of Health and the Minister of the Environment. [SOR/97-543; s. 25]
Interpretation / Discussion of Section 62
These criteria differ from the previous mutagenicity criteria (Section 57) in that genetic changes are shown to occur in somatic (non-germ) cells. Such changes would not be expected to have any effect on subsequent generations. Products included in Class D by virtue of these criteria are, consequently, falls into Subdivision B as opposed to Subdivision A of Division 2 of Class D.
CPR Section 63 - Untested Mixtures [Class D; Division 2, Subdivision B]
Untested Mixtures
63. An untested mixture falls into Subdivision B of Division 2 of Class D - Poisonous and Infectious Material if it contains a product, material or substance that meets any of the criteria applicable to a pure substance or tested mixture referred to in any of sections 59 to 62 and is present at a concentration of one per cent or more.
Interpretation / Discussion of Section 63
Where a mixture has not been tested as a whole to determine its health hazards, for the purposes of classification, the mixture is assumed to present the same hazards as the components comprising a specified percentage of the mixture. The percentage specified (0.1 versus 1.0%) depends upon the hazard under consideration.
This section establishes that an untested mixture that contains at least one ingredient, at 1% or greater, that meets any of the criteria within the previous four sections for chronic toxic effects, skin or eye irritation, skin sensitization and mutagenicity, respectively, is also included in Subdivision B of Division 2 of Class D.
A cut-offs of 1.0% is also specified in the United States OSHA Hazard Communication Standard.
CPR Section 64 - Division 3: Biohazardous Infectious Material [Class D]
Division 3: Biohazardous Infectious Material
64. An organism that has been shown to cause disease or to be a probable cause of disease in persons or animals and the toxins of that organism shall be included in Division 3 of Class D - Poisonous and Infectious Material. [SOR/2010-38; s. 3]
Discussion of Section 64
An organism that causes disease in persons or animals as well as the toxins of such organisms are included in Division 3 of WHMIS Class D. A material which contains such an organism and/or its toxin and is sold or imported into Canada for the reason that the organism or its toxin is present is subject to the WHMIS requirements of the HPA.
The SJCSR had concluded that the HPA does not provide the authority for section 64 of the CPR to state that "an organism that has been show to cause disease or is reasonably believed to cause disease in persons or animals and the toxins of such an organism fall in Division 3 of Class D. " Therefore, this section was amended through SOR/2010-38 which came into effect on February 23, 2010.
As for the Pest Control Products Regulations, for the purposes of Division 3 of WHMIS Class D, "organism means any biological entity living or non-living, cellular or non-cellular". Thus, the criteria includes a bacterium or a virus "that has been shown to cause disease. ".
MSDSs for and labelling of infectious agents: See section 9 and 16, respectively, of the CPR.
Diagnostic specimens: The HPA applies to the sale and importation of a controlled product. Internal distribution of a substance, such as from one hospital to another, both of which operate under the auspices of a given Ministry of Health, is outside of the scope of the HPA/CPR. As for other employer generated substances which are not sold in Canada, enquiries relating to an employer's obligations regarding labelling and other information requirements for diagnostic specimens should be directed to the occupational safety and health agency having jurisdiction.
Transportation of Dangerous Goods: A "Guide to Risk Group Assignments" is included as Appendix 3 in Part 2 of the Transportation of Dangerous Goods Regulations as published in the supplement to the Canada Gazette, Part II, August 15, 2001.
CPR Section 65 - Class E - Corrosive Material
65. A product, material or substance shall be included in Class E - Corrosive Material listed in Schedule II to the Act if
(a) it corrodes SAE 1020 steel or 7075-T6 non-clad aluminum surfaces at a rate exceeding 6.25 millimetres per year at a test temperature of 55oC when tested in accordance with Test Method, Laboratory Corrosion Testing of Metals for the Process Indus-tries, NACE Standard TM-01-69 (1976 Revision);
(b) it is corrosive to skin when tested in accordance with OECD Test Guideline No. 404, "Acute Dermal Irritation/Cor-rosion", dated May 12, 1981;
(c) it is included in Class 8 in Part III of the Transporta-tion of Dangerous Goods Regulations;
(d) it is a gas included in Division 4 of Class 2 in Part III of the Transportation of Dangerous Goods Regulations;
(e) there is evidence that it causes visible necrosis of human skin tissue; or
(f) it is an untested mixture containing a product, material or substance that meets the criteria referred to in paragraph (b) or (e) and is present at a concentration of at least one per cent.
Interpretation / Discussion of Section 65
The criteria in this section address the corrosive properties of a product, material or substance on biological tissue (human and laboratory animal) as well as on metal. The WHMIS criteria also includes "goods" in Class 8 and 2.4 of the TDG Regulations.
Concrete and concrete mixtures: Unhardened concrete has been shown to pose a significant hazard to workers in terms of its corrosive properties. The sale/importation of concrete mixtures is not exempt from HPA/CPR requirements; .
Corrosion versus irritation - classification?: Refer to the interpretation / discussion corresponding to section 60 of the CPR.
pH as a criterion for inclusion in Class E: OECD Test Guideline No. 404 states that: "Strongly acidic or alkaline substances, for example, with a demonstrated pH of 2 or less or 11.5 or greater, need not be tested for primary dermal irritation, owing to their predictable corrosive properties". This infers that such substances may be viewed as corrosive based simply on a pH test and need not be subject to the full test in accordance with the guidelines. Therefore, (to avoid discrepancies in classifying controlled products) it is recommended that a product, material or substance with a demonstrated pH of 2 or less or 11.5 or greater be considered to be included in Class E, unless test data in accordance with OECD Guideline 404, or, as per subparagraph 33(3)(b)(v) of the CPR, any other test or method that is carried out in accordance with generally accepted standards of good scientific practice demonstrates this is not to be the case; . It is anticipated that the CPR will be amended to explicitly state that a material within this pH range is included in WHMIS Class E unless there is evidence which demonstrates that the material is not corrosive.
Use of in vitro methods: The U.S. Department of Labor's Occupational Safety and Health Administration (OSHA) permits the use of a U.S. Department of Transport-approved in vitro method for evaluating skin corrosivity for compliance of OSHA's Hazard Communication Standard. As reflected in the "Harmonized Integrated Hazard Classification System for Human Health and Environmental Effects of Chemical Substances - Harmonized System for the Classification of Chemicals which cause Skin Irritation/Corrosion" (OECD, November 1998), when considering results from in vitro methods, a hierarchal approach has been agreed upon internationally. When considering results from in vitro methods, (such as, for example, "CORROSITEX®") , as agreed to for the Globally Harmonized System, a positive result constitutes criteria for inclusion in WHMIS Class E; negative or inconclusive results cannot be considered the sole basis for classification and further testing may be required; .
Paragraph 65(a):
The NACE standard referenced in this paragraph does not specify the concentration of the solution to be used when determining whether or not a solid meets this criterion. In order to have a common baseline, should a supplier wish to use the NACE method for solids, it is recommended that a saturated solution be used, i.e., not a solution based on the recommended usage.Regarding the duration of this test, many corrosion resistant materials form a protective layer. Short duration tests on such materials would indicate a high corrosion rate which may be very misleading. Short duration tests can also give misleading results on alloys that form passive films such as some stainless steels. For such materials, a more prolonged test may be required to permit the breakdown of the passive layer. Tests run for a longer period may provide a more accurate indication of the corrosivity of a substance than tests run for shorter periods.
Paragraph 65(b):
The referenced OECD guideline specifies pH ranges. See above for information regarding "pH as a criterion for inclusion in Class E".
Paragraph 65(c):
As with the Canadian TDGR, the U.S. Department of Transport's (DOT) regulations are based on the United Nations Recommendations on the Transport of Dangerous Goods. Following DOT's authorization of the use of CORROSITEX to determine classification and packing groups for Class 8 hazards, the seventh session of the U.N. Subcommittee of Experts on the Transport of Dangerous Goods voted to delete the word "animal" in paragraph 8.3 of the U.N. recommendations, thereby permitting in vitro tests to be used internationally.
Paragraph 65(d):
Refer to the interpretation / discussion corresponding to subsection 43(4) for information regarding amendments to the TDGR which affected the TDG classification of substances originally included in TDG 2.4 when the CPR came into effect.
Paragraph 65 (f):
Where a mixture has not been tested as a whole to determine its health hazards, for the purposes of classification under this section of the CPR, the mixture is assumed to present the same hazards as any component meeting the criteria in paragraphs (b) or (e) if that component comprises 1.0% or greater of the untested mixture.
CPR Section 66 - Class F -- Dangerously Reactive Material
Class F - Dangerously Reactive Material
66. A product, material or substance shall be included in Class F - Dangerously Reactive Material listed in Schedule II to the Act if it
(a) undergoes vigorous polymerization, decomposition or condensation;
(b) becomes self-reactive under conditions of shock or increase in pressure or temperature; or
(c) reacts vigorously with water to release a gas that has an LC50 not exceeding 2,500 parts per million by volume of gas, when tested for four hours in accordance with OECD Test Guideline No. 403, "Acute Inhalation Toxicity", dated May 12, 1981.
Interpretation / Discussion of Section 66
In order to accurately assign a substance to Class F, there must be a clear understanding of the physical and chemical properties influencing reactivity. The degree of saturation, proximity of unsaturated bonds to each other, chemical composition and stability should all be considered. Bretherick's Handbook of Reactive Chemical Hazards may provide a useful reference in the assessment of chemicals against the WHMIS Class F criteria. The criteria described in paragraphs (a) to (c) correlate with the definitions of "unstable (reactive)" and "water-reactive" in the OSHA Hazard Communication Standard.
Gas versus vapour - inclusion in Class F?: Section 66 covers a wide range of chemically reactive materials, including self-reactive materials and substances which react with water to form a toxic gas as described by paragraph 46(c) of the CPR. At present, section 66 correlates only with paragraph 46(c); i.e., paragraph 66(c) refers only to emissions of a "gas" in contact with water or water vapour. This implies the exclusion of flammable vapours and vapours with an LC50 not exceeding 1,500 ppm as per paragraph 46(d) and vapours with an LC50 between 1,500 and 2,500 ppm as per paragraph 49(c) of the CPR. Therefore, it has been agreed that section 66 of the CPR be amended to include the following two paragraphs:
"(d) reacts vigorously with water to release a vapour that has an LC50 not exceeding 1,500 ppm by volume of vapour, when tested for four hours in accordance with OECD Test Guideline 403, "Acute Inhalation Toxicity", dated May 12, 1981, and a saturated vapour concentration at normal atmospheric pressure greater than two times the value of that LC50"; or
(e) reacts vigorously with water to release a vapour that has an LC50 of more than 1,500 but not exceeding 2,500 ppm by volume of vapour, when tested for 4 hours in accordance with OECD Test Guideline No. 403, "Acute Inhalation Toxicity", dated May 12, 1981, and a saturated vapour concentration at normal atmospheric pressure of more than 0.4 times the LC50"; .
Paragraph (a):
Many substances can undergo polymerization, condensation or decomposition which are not considered dangerously reactive chemical reactions. The term "vigorous", then, is an integral part of this criterion. Although the term "vigorous" is not defined in the CPR, it may be interpreted to mean uncontrolled and potentially hazardous.
Polymerization: Polymerization is a reaction in which one or more small molecules (monomers) combine to form larger molecules (polymers). Uncontrolled reactions can be triggered by a variety of factors including contamination by substances known to initiate polymerization, the presence of oxygen, an increase in temperature and depletion of inhibitors. Styrene, 1,3-butadiene and methyl acrylate are examples of widely used monomers that have the potential to undergo vigorous polymerization.
Condensation: During condensation, a small molecule, such as water or an alcohol, is generated as a by-product when the link is established between two molecules. Polymers can also be produced through condensation which is a type of addition reaction. Polyesters and polyamides are products of condensation reactions in which water is generated as a by-product.
Decomposition: Decomposition is a reaction in which a substance breaks down into two or more substances. Although most of these reactions are not considered hazardous, substances should be classified as dangerously reactive if significant quantities of heat are released or if the decomposition products are hazardous. Many compounds formed through endothermic reactions are "energy-rich" and possess a tendency to vigorously decompose. Often these compounds are unsaturated (such as acetylene).
Paragraph (b):
Some materials become self-reactive when triggered by shock (such as mechanical impact), increases in pressure or increases in temperature. Nitromethane can become self-reactive under all three of the conditions specified in paragraph (b) and has been detonated by high velocity transfer through pipes where flow was obstructed. Chlorine dioxide can become self-reactive and can explode violently if heated.
Paragraph (c):
Next to air, water may be the substance most likely to come into contact with reactive materials. Many compounds will react vigorously with water and release acutely toxic gases.
For example, chlorosulphonic acid, which is used primarily as a sulphonating agent for production of detergents as well as a catalyst, reacts vigorously with water (including water vapour in air) to yield sulphuric acid and hydrogen chloride. This reaction may result in the formation of a dense white acid mist which can be lethal if inhaled. Anhydrous aluminum chloride, another common catalyst used in the production of a wide range of organic compounds, can also react vigorously with water releasing heat and hydrogen chloride.
CPR Schedule I - Information to be Disclosed on a Material Safety Data Sheet
SCHEDULE I - (Section 12)
Information in respect of controlled products
Hazardous Ingredients (1) Information required by subparagraphs13(a)(i) to (iv) of the Act
(2) CAS registry number and product identification number
(3) LD50 (species and route) (4) LC50 (species and route)
(4) LC50 (species and route)(1) Name and phone number of the group, department or party
responsible for the preparation of the material safety data sheet
(2) Date of preparation of the material safety data sheetThe nine required headings may be given different prominence on the MSDS (i.e., some may appear as subheadings under another heading. However, all nine headings must appear on the MSDS; .
Discussion of Schedule I
A product, material or substance is a controlled product if it meets any of the hazard criteria specified in Part IV of the CPR. A controlled product may be a "pure" substance, a tested mixture or an untested mixture. Section 33 of the CPR sets out the procedures for a supplier to establish whether or not a substance is a controlled product and does not apply to the determination of the information that must be disclosed on the MSDS.
Note: Although the classification criteria specified in sections 34-66 of the CPR may provide a useful guideline for certain MSDS information, it is section 12 and Schedule I to the CPR which set out what information must be disclosed on a MSDS; paragraph 13(a) of the HPA sets out what ingredients are subject to disclosure on the MSDS; section 4 of the CPR specifies the concentration above which those ingredients must be disclosed.
The general format and content of material safety data sheets (MSDSs) is described in Section 12 of the CPR. The acceptability and use of the ILO 16 heading MSDS and equivalents is also described under Section 12. For information regarding changes or revisions to MSDSs, please refer to Section 29 of the CPR.
The Column II headings in this Schedule may be combined to form one heading provided that the information contained under the combined heading includes subheadings which are similar to the heading specified in Column II of Schedule I. A combined heading such as "Preparation and Product Information" is discouraged since preparation information relates to the MSDS preparation and not the product preparation. For example, "Fire and Explosion Hazard" may appear as a subheading under the heading "Physical Data"; . Additional headings to describe categories of information other than the nine listed categories may appear on a MSDS.
The CPR will be amended to explicitly require that all Column III subitems which appear on an MSDS be addressed by disclosing the relevant information or by declaring that the information is "not available" or "not applicable", as appropriate. Simply disclosing "no" could be misleading and is not considered acceptable if the decision was based on the unavailability of information rather than on professional judgement; (see subsection 12(6) of the CPR). If a Column III subitem such as 5(7) is renamed from "Hazardous combustion products" to, for example, "Products evolved due to heat or combustion", then the MSDS should disclose the products evolved through heat as well as through combustion.
CPR Schedule I - Information to be Disclosed on a Material Safety Data Sheet
Item 1 - Hazardous Ingredients
(1) Information required by subparagraphs 13(a)(i) to (iv) of the Act - Please refer to Section 13 of the Hazardous Products Act and the interpretation / discussion there under.
(2) CAS registry number and product identification number - The CAS registry number must be disclosed for every ingredient that is subject to disclosure if one is available. A product identification number, PIN, (if available) is required for the product as a whole, i.e., not for individual ingredients; . The terms "CAS registry number" and "product identification number" are defined in section 2 of the CPR. CAS numbers are assigned to a specific chemical or grouping of chemicals sequentially. The CAS numbers enable a precise means of identifying a substance.
(3) LD50 (species and route) - The definition in section 2 of the CPR states that the LD50 "means the single dose of a substance. ". A "greater than" LD50 or LC50 value is not, technically, a "single dose" and is usually the result of a "limit test". Greater than values, as per CPR 12(11), are considered to be other hazard information of which a supplier ought reasonably to be aware. Where a specific LD50 value is not available, suppliers may wish to disclose greater than values under this subitem and, in the case of a greater than LC50, under subitem 1(4). If applicable and available, "less than" values may also be disclosed under these subitems.
As required by subsection 12(10) of the CPR, "where the LD50 or LC50 of a controlled product that is a mixture is determined by testing the mixture, the supplier shall disclose, on the MSDS for the controlled product, that LD50 or LC50 in place of the LD50 or LC50 of the ingredients of the mixture."
Although not mandatory, suppliers may wish to disclose "percent death" values if specific LD50 or LC50 values are not available.
(4) LC50 (species and route) - For the formulae to convert an exposure duration of other than four hours to an LC50 equivalent to a four hour exposure, please refer to section 44 of the CPR.
CPR Schedule I - Information to be Disclosed on a Material Safety Data Sheet
Item 2 - Preparation Information
This item requires the disclosure of information regarding preparation of the MSDS and not the product. To avoid confusion, therefore, this heading should not be combined with the next item, i.e., "Product Information", to form a single heading.
(1) Name and phone number of the group, department or party responsible for the preparation of the material safety data sheet - This subitem requires the disclosure of information in respect of those responsible for the preparation of the MSDS--not preparation of the controlled product.
(2) Date of preparation of the material safety data sheet - As required by paragraph 29(2)(b) of the CPR, the date disclosed here may not exceed three years from the time of sale or importation.
CPR Schedule I - Information to be Disclosed on a Material Safety Data Sheet
Item 3 - Product Information
(1) Manufacturer's name, street address, city, province, postal code and emergency telephone number - Please refer to subsections 12(8) and 12(9) of the CPR for a description of the circumstances where the name and particulars of the manufacturer need not be disclosed. An emergency telephone number must be disclosed if it is available, i.e., this subitem does not require a manufacturer to establish an emergency telephone number, . If an emergency number is disclosed, it would also be helpful to users if the hours of operation and time zone are specified. It is not acceptable to disclose an emergency telephone number for which the caller will not be able to acquire information on the product.
(2) Supplier identifier, the supplier's street address, city, province, postal code and emergency telephone number - Please refer to subsection 12(7) of the CPR for a description of the circumstance where the supplier identifier and particulars of the distributor need not be disclosed. An emergency telephone number must be disclosed if it is available, i.e., this subitem does not require a supplier to
establish an emergency telephone number. It is not acceptable to disclose an emergency telephone number for which the caller will not be able to acquire information on the product.(3) Product identifier - As required by section 28 of the CPR, the product identifier that is disclosed on the label of the controlled product or container in which the controlled product is packaged must be identical to the product identifier that is disclosed on the MSDS for the controlled product. (The CPR does not stipulate an analogous requirement for the supplier identifier.) The term "product identifier" is defined in section 2 of the CPR. ( Note: PINs have been replaced by "UN Number" in the Clear Language version of the Transportation of Dangerous Goods Regulations and it is anticipated that the definition for "product identification number" in the CPR will be replaced with "UN number" has the meaning assigned to that term by the Transportation of Dangerous Goods Regulations. (numéro UN)".
(4) Product use - The MSDS must specify the product use(s) intended by the manufacturer or supplier of the controlled product. (As suppliers cannot anticipate all possible uses of their products, thorough information on toxicological properties should be provided without limiting such information to the hazards
based on presumed use.(*) Product Identification Number - When the CPR are amended, this Schedule will be amended to clarify that the CAS numbers are to be disclosed in respect of the ingredients and the PIN is to be disclosed in respect of the product; i.e., the reference to the PIN in subitem 1(2) will be deleted and added as subitem 3(5).
CPR Schedule I - Information to be Disclosed on a Material Safety Data Sheet
Item 4 - Physical Data
The physical data that must be disclosed, if available and applicable, is in respect of the product as a whole, not in respect of individual ingredients of the controlled product. It is not unusual to see physical data reported over a specific range of values or by using the terms "greater than" or "less than" a specific value since some tests are terminated after pertinent cut-off values are reached. Physical data must be disclosed to the degree of accuracy and precision that have been obtained from tests conducted on the product or as determined from the literature. The acceptability of the degree of accuracy reported for a physical measurement must be determined on a case-by-case basis.
Although values for "critical temperature" and "critical pressure" for compressed gases are readily available in the literature, the disclosure of such values is not mandatory.
(1) Physical state (i.e. gas, liquid or solid) - The physical state of the controlled product (solid, liquid or gas) at room temperature (20°C) must be disclosed. More precise descriptors may also be disclosed such as, for example, powder, paste or gel.
(2) Odour and appearance - Odour is a very subjective property, especially in the case of mixtures, and is subject to professional judgement. To ensure some degree of consistency, at least in the case of pure substances, suppliers should consult available literature such as the Harper List of Terms for Scaling Odour Quality.
(3) Odour threshold - is the lowest concentration, often expressed in ppm, of a material in air that can be detected by odour. Odour thresholds (OTs) are generally two to three orders of magnitude lower than mucous membrane irritation thresholds and therefore, from a health perspective, the use of OTs represents a more conservative approach. This approach also compensates for the hypoadditivity of odours.
(4) Specific gravity - is the ratio of the weight of a volume of a substance to the weight of an equal volume of water (usually at 4°C unless otherwise specified). Insoluble materials which have a specific gravity greater than 1.0 will sink in water. The majority of flammable liquids have a specific gravity of less than 1.0 and, if insoluble, will float on water. This can be a vital consideration for fire suppression and spill cleanup. Regarding the French version of Schedule I, «Densité» will be changed to read «Poids spécifique» when the CPR are amended.
(5) Vapour pressure - is the pressure exerted by a saturated vapour above its own liquid or a volatile solid in a closed vessel. It is a characteristic associated with liquids and some solids, like iodine, which have a tendency to sublime. Vapour pressure is usually expressed in millimetres of mercury (mm Hg) at 20°C and normal atmospheric pressure. A material with a high vapour pressure such as ether (440 mm Hg) will tend to evaporate more readily than one with a low vapour pressure such as water (17.5 mm Hg).
(6) Vapour density - is the weight of a given volume of vapour or gas compared to the weight of an equal volume of air. Materials lighter than air have vapour densities of less than 1.0. Materials heavier than air have vapour densities greater than 1.0.
(7) Evaporation rate - is the rate at which a material will vapourize in air from the liquid or solid state relative to the rate of vapourization of a reference material. The reference material is usually normal butyl acetate with an evaporation rate designated as 1.0. For gases, "evaporation rate" is not applicable; for liquified gases, the rate of evaporation is rapid enough so as to render the term meaningless for such substances.
(8) Boiling point - is normally determined at 760 mm Hg and is the temperature at which a liquid becomes a gas; it is the temperature at which the vapour pressure is equal to 760 mm Hg. The disclosure of the sublimation point in respect of a solid is not considered to be required information.
(9) Freezing point - is the temperature at which a material changes from a liquid to a solid at 760 mm Hg pressure, i.e., the temperature at which the liquid and solid phases of a substance are in equilibrium at normal pressure. The term melting point is used when the equilibrium temperature is approached by heating a solid. The terms freezing point and melting point are used interchangeably depending on whether the substance is being heated or cooled.
(10) pH - is a measurement of the acidity or basicity of a solution ranging on a scale from 0 (acidic) to 7 (neutral) to 14 (basic), as contrasted with the total quantity of acid or base in a substance. The pH is the logarithm to the base 10 of the reciprocal of the hydronium (H3O + ) ion concentration expressed in molarity. Although pH is usually determined from relatively dilute aqueous solutions, the pH can also be measured for concentrated organic systems/organic liquids. Its reliability as an indicator of corrosivity, however, is less certain for such organic materials. pH is not applicable to a controlled product that is a solid; the disclosure of the pH of a solution of the solid should be considered optional. If, however, the pH of a solution of the solid is disclosed, the MSDS must also disclose the concentration of the solution on which the pH was determined.
(11) Coefficient of water/oil distribution - (also known as the water-octanol (n-octanol) partition coefficient), is the ratio, (and thereby unitless), which provides a relative measure of a substance's solubility in water versus oil. A substance with a coefficient greater than one indicates better solubility in water and thereby, a potentially greater tendency for the substance to be absorbed by the mucosal tissues of the eyes or lungs. A substance with a coefficient less than one indicates better solubility in oil and thereby, a potentially greater tendency for the substance to be absorbed by the fatty tissue under the skin.
CPR Schedule I - Information to be Disclosed on a Material Safety Data Sheet
Item 5 - Fire or Explosion Hazard
The fire or explosion data that must be disclosed, if available and applicable, is in respect of the product as a whole, not in respect of individual ingredients of the controlled product. However, if, for example, a product separates upon normal storage to form a distinct solvent layer, information in respect of the solvent may be applicable to the product as a whole and may be disclosed in this section.
(1) Conditions of flammability - The MSDS should disclose all conditions of flammability during reasonable foreseeable use including unintentional misuse.
(2) Means of extinction - Some chemicals react violently with water. The MSDS must disclose the appropriate type of fire extinguisher and/or extinguishing method for the controlled product.
(3) Flash point and method of determination - The flash point is the lowest temperature at which a flammable or combustible liquid will give off sufficient vapour to form an ignitable mixture with air just above the surface of the liquid. Four methods for determining flash point are referenced in Schedule IV to the CPR.
(4) Upper flammable limit - The upper flammable limit (UFL), also known as the upper explosive limit (UEL), is the highest concentration of a flammable gas or vapour that will burn or explode in the presence of a source of ignition. Concentrations above the UFL are too "rich" to burn.
(5) Lower flammable limit - The lower flammable limit (LFL), also known as the lower explosive limit (LEL), is the lowest concentration of a flammable gas or vapour that will burn or explode in the presence of a source of ignition. Concentrations below the LFL are too "lean" to burn.
(6) Auto-ignition temperature - The minimum temperature to which a substance must be heated without application of a flame or spark to cause that substance to ignite. Materials with low auto-ignition temperatures, such as the vapours of diethyl ether (160°C), can present fire risks. The majority of flammable and combustible liquids in common use have an auto-ignition temperature ranging between 250 to 600°C. For a pure substance, either the lowest value or range may be disclosed. The auto-ignition temperature of the ingredient of an untested mixture having the lowest value may not be applicable to the controlled product as a whole.
(7) Hazardous combustion products - The MSDS must disclose the hazardous combustion products to the degree of specificity that is available and applicable. The disclosure of an overly generic class of substances such as "oxygen containing hydrocarbons" is not considered useful.
(8) Explosion data -sensitivity to mechanical impact - The MSDS must disclose if the material can explode if subjected to mechanical impact such as being dropped or impact during transportation. Metal azides, for example, are sensitive to physical shock.
(9) Explosion data -sensitivity to static discharge - The MSDS must disclose if the material may explode if it comes in contact with a spark generated by static electricity. When it is prudent to ground containers of flammable liquids or gases during transfer in order to guard against potential fire or explosion hazards, this information must be disclosed on the MSDS. The need for grounding will be influenced by the quantity of material.
CPR Schedule I - Information to be Disclosed on a Material Safety Data Sheet
Item 6 - Reactivity Data
(1) Conditions under which the product is chemically unstable - This includes conditions under which the controlled product will undergo vigorous polymerization, decomposition, condensation, polycondensation or otherwise become self-reactive.
(2) Name of any substance or class of substance with which the product is incompatible - The MSDS may disclose a "class" of substance. If, for example, the MSDS discloses that a controlled product such as sodium hypochlorite or sodium cyanide in an aqueous alkaline solution is "incompatible with mineral acids", it is not necessary to name specific mineral acids. A substance is considered incompatible with the controlled product if the two substances, upon contact, react dangerously (see section 66 of the CPR) and produce a flammable, toxic or corrosive gas or vapour meeting the criteria in CPR 36, 41, 46(c) or (d), 49(c) or 65(b) to (e); excessive heat; or they explode.
(3) Conditions of reactivity - The MSDS should disclose the conditions under which the controlled product will self-react or react with other materials to produce undesirable effects such as pressure build-up, temperature increase or formation of hazardous byproducts.
(4) Hazardous decomposition products - The MSDS must list the hazardous substances that will be released by the controlled product upon, for example, aging, heating and oxidation.
CPR Schedule I - Information to be Disclosed on a Material Safety Data Sheet
Item 7 - Toxicological Properties
Under the OSHA Hazard Communication Standard Footnote 6 , where at least one positive scientific study exists which is statistically significant and demonstrates adverse health effects, the MSDS must disclose the adverse health effects identified through the study. Recognizing that not all toxicity studies are designed to demonstrate "statistical significance", this rule of thumb can be used as a general guideline for WHMIS MSDS disclosure; i.e., MSDS disclosure is not limited to the CPR criteria which determine a product's classification under WHMIS . For example, the fact that the CPR do not specify ocular corrosivity as a criterion for inclusion in Class E does not preclude the supplier's obligation to disclose this hazard on the MSDS if applicable. The MSDS, however, need not disclose information on studies that show that the product produces virtually no toxic effect; the disclosure of such information is at the discretion of the supplier. (Refer to the interpretation of section 13 of the CPR for information regarding MSDS disclosure for "conflicting" studies, etc.).
Depending upon the species tested and the route of administration, the toxicological response to a given test substance may vary to a large degree. As a result, it is possible that a test substance may elicit a positive result in the rat via the oral route and a negative result in the mouse via the dermal route. Such results are considered to be neither contradictory nor conflicting. Therefore, the positive result in the rat study should form the basis for determining the appropriate MSDS disclosure.
Most products are mixtures as opposed to being "pure" substances. Any toxicological information resulting from tests on a mixture must be disclosed if available and applicable to the mixture. In the absence of scientific evidence to the contrary, it should be assumed that, taking into account possible synergistic interactions, the toxicological properties to be disclosed for an untested mixture are the same as those of the mixture's ingredients which are subject to disclosure. Information relating to ingredients subject to disclosure must be disclosed if this information is applicable to the mixture. The information disclosed on the MSDS should correlate the toxicological information to the ingredient with which the adverse effect is associated.
The Intergovernmental WHMIS Coordinating Committee's "Guidelines for the Disclosure of Toxicological Information on a MSDS" can be accessed from the " MSDSs" page on the Health Canada WHMIS website; ( www.hc-sc.gc.ca/whmis ). Much of the information from these guidelines has been incorporated into this section of the reference manual.
(1) Route of entry, including skin contact, skin absorption, eye contact, inhalation and ingestion - Of these five potential routes of entry, those routes which can present health risks to workers during reasonable foreseeable use must be specified. These routes of entry will relate to the nature and properties of the substance under consideration as well as its uses; for example:
Toxicological Properties
Substance Route of Entry silica inhalation n-hexane inhalation, skin absorption acetone inhalation, skin absorption, eye contact phosphoric acid skin and eye contact sodium fluoride ingestion, inhalation If available, the MSDS must disclose significant human health effects reported in epidemiological studies, and case reports in the literature, relevant to occupational exposure. Since evidence of health effects to humans is typically not available, it is reasonable to disclose information, considered statistically significant, based on "relevant" animal testing. Relevant testing relates to the normal routes of occupational exposure such as inhalation, ingestion, skin and eye contact, and skin absorption as opposed to routes such as intraperitoneal, intramuscular, subcutaneous, etc.
(2) Effects of acute exposure to product - The classification criteria for acute lethality is set out in sections 33 and 46 to 51 of the CPR. The term "acute lethality" is defined in section 32 of the CPR. The MSDS must disclose the adverse health effects resulting from short-term exposure to the controlled product. A "short-term" exposure is generally considered to be a single or multiple exposure within a 24- hour time frame. Acute toxicity relates to toxic effects provided by a single or multiple exposure to a substance by any route for a short period of time. The MSDS must disclose both immediate and delayed effects resulting from short-term exposure; for example, skin corrosion (immediate) or pulmonary edema (delayed) from exposure to nitric acid. The information that must be disclosed on the MSDS is not limited to the results of tests for acute lethality specified in the classification section of the CPR.
(3) Effects of chronic exposure to product - Sections 33(3)(b)(i), 52 and 59 of the CPR set out the classification criteria for chronic toxic effects. The term "chronic toxic effect" is defined in section 32 of the CPR. The effects of "subchronic" exposure must also be disclosed under this subitem.
Chronic toxic effects include any target organ effects from prolonged, repeated or seasonal exposures. The MSDS must disclose significant human health effects reported in epidemiological studies and case reports in the literature. Since human evidence of health effects is typically not available, it is reasonable to disclose information based on mammalian animal testing which is judged to report significant information on toxicological properties. It is important to include the route of exposure when disclosing the effects of chronic exposure.
For chronic toxicity animal studies, the exposure time is considered to be approximately 80 percent of the life-span; for subchronic toxicity, the exposure time is approximately 10 percent of the life-span. In the absence of data on chronic or subchronic exposure, the results of studies of shorter duration (i.e., "subacute" studies) should be evaluated.
(4) Exposure limits - The supplier must specify which type of exposure limit is disclosed on the MSDS. The CPR will be amended to require that whatever exposure limit is used, the limit is to be qualified by indicating the source of the exposure limit and that a statement to the effect "consult local authorities for acceptable exposure limits" appears on the MSDS. Up to the present time, no source, North American or other, has been identified as publishing unacceptable exposure limits, .
Exposure limits are recommended by bodies such as the American Conference of Governmental Industrial Hygienists (ACGIH) and National Institute for Occupational Safety and Health (NIOSH) or are legislated by federal, provincial and territorial agencies responsible for occupational safety and health. Various types of exposure limits, short-term and long-term, may be applicable depending on the working conditions. The MSDS must disclose appropriate values for the controlled product. The MSDS should also disclose values for ingredients of a mixture if this information is applicable to the mixture.
Since 1946, Threshold Limit Values (TLVs) have been devised and published by the ACGIH. The ACGIH publication Threshold Limit Values and Biological Exposure Indices, states that "TLVs refer to airborne concentrations of substances and represent conditions under which it is believed that nearly all workers may be repeatedly exposed day after day without adverse effect." In 1971, the United States Occupational Health and Safety Administration (OSHA) adopted the ACGIH's 1968 TLVs as official workplace standards called PELs (permissible exposure limits). The National Institute for Occupational Safety and Health (NIOSH) provides scientific advice to OSHA. In the last 25 years, NIOSH has developed and published RELs (Recommended Exposure Limits) for over 160 chemicals.
The American Industrial Hygiene Association (AIHA) sets guidelines for Workplace Environmental Exposure Levels (WEELs) for chemicals for which neither a PEL nor a TLV has been developed. The AIHA have included the WEELs in their handbook "Emergency Response Planning Guidelines and Workplace Environmental Exposure Level Guides" which can be ordered from their customer service line (703) 849-8888.
The ACGIH has defined three principal types of exposure limits:
- Time Weighted Average (TWA) - the concentration at which the majority of workers can be repeatedly exposed without adverse effect for an 8 hour workday or 40 hour workweek.
- Short-term Exposure Limit (STEL) - the maximum concentration for a continuous exposure period of 15 minutes (with a maximum of four such periods per day, with at leat 60 minutes between exposure periods and provided that the daily TWA is not exceeded).
- Ceiling Limit (C) - the concentration that should never be exceeded in the workplace.
For the precise definition of these terms, the ACGIH's Threshold Limit Values and Biological Exposure Indices should be consulted.
If exposure limits are not available from the ACGIH or other jurisdictional authorities but are recommended by the supplier, the appropriate bodies recommending those limits should be disclosed on the MSDS. Up to the present time, no source, North American or other, has been identified as publishing unacceptable exposure limits. The CPR will be amended to require that whatever exposure limit is used, the limit is to be qualified by indicating the source of the exposure limit and that a statement to the effect "consult local authorities for acceptable exposure limits" appears on the MSDS. Disclosure of the term: "TLV (TWA) -10ppm" would suffice as all "TLVs" are issued by the ACGIH, and consequently the ACGIH is the source of all TLVs. (The term "TLV" is a registered trade mark of the ACGIH). In the case of other exposure limits, the MSDS should disclose the source.
Where it is known that the use of the product could give rise to potentially lethal conditions, such as high airborne concentrations of solvent vapours from use of degreasers or furniture strippers, the supplier should disclose an IDLH limit if available. IDLH is the acronym for I mmediately D angerous to L ife and H ealth. The IDLH is the concentration at which, in the event of respirator failure, a worker could evacuate within 30 minutes without experiencing any escape-impairing or irreversible health effects.
(5) Irritancy of product - Sections 33(3)(b)(ii) and 60 of the CPR set out the classification criteria for irritation. The information disclosed on the MSDS must indicate the severity of the irritant effect, i.e., whether the effect is slight/mild, moderate or severe. A product will fall within the classification criteria for eye or skin irritation if the irritant effect is greater than "slight". The effect relates only to chemical reaction, not to the effect of mechanical abrasion.
Numerical irritation scores, such as those obtained through testing in accordance with OECD Test Guidelines 404 (Acute Dermal Irritation/Corrosion) and 405 (Acute Eye Irritation/ Corrosion) or the Draize test, may be disclosed but this information is not generally comprehensible to the majority of MSDS users.
(6) Sensitization to product - Sections 56 and 61 of the CPR set out the respective criteria for "respiratory tract sensitization" and "skin sensitization" . The terms "respiratory tract sensitization" and "skin sensitization" are defined in section 32 of the CPR. It is probable that any chemical, natural or synthetic, is capable of causing an allergic reaction in some individuals. However there are chemicals that cause sensitization in a "substantive proportion of exposed" individuals who come into contact with these substances such as, for example, formaldehyde. Whether or not to disclose information related to the fact that one individual has been sensitized when exposed at the workplace must be determined through professional judgement on a case-by-case basis.
A statement summarizing the results from the tests specified in sections 56 and 61 of the CPR (or from other relevant animal tests) must be disclosed on the MSDS if available. Positive human experience data must also be disclosed on the MSDS. It is important that the disclosed information identify the sensitizing agent. Non-occupational situations may be included if considered relevant.
(7) Carcinogenicity - Section 54 of the CPR sets out the classification criteria. Information to be disclosed on the MSDS is not limited to the classification criteria; (i.e., to the IARC and ACGIH lists). Other sources which are considered applicable include:
- lists of carcinogens from other countries;
- the U.S. National Toxicology Program list and related studies;
- academic studies;
- unpublished studies.
Information from these other sources must be disclosed on the MSDS if it is available to the supplier and applicable to the controlled product.
(8) Reproductive toxicity - Section 55 of the CPR sets out the classification criteria for reproductive toxicity. Reproductive toxicity relates to effects on the parents such as sterility or other impairment of reproductive capability in either males or females. In animal bioassays, adverse effects on parental reproductive functions may occur at doses above or below those producing signs of toxicity in the parent animals. The handling, storage or use of controlled products may occasionally produce exposures resulting in mild parental toxicity thereby resulting in potential reproductive toxicity hazards. For the purpose of MSDS disclosure, any indication of an adverse effect on reproductive parameters must be disclosed on the MSDS irrespective of whether or not there is an adverse effect on the parents. Any relevant epidemiological evidence must also be disclosed.
(9) Teratogenicity - Subparagraph 33(3)(b)(iii) and section 53 of the CPR sets out the classification criteria for "teratogenicity and embryotoxicity". Developmental toxicity relates to toxicity and abnormalities in offspring, e.g., teratogenicity (malformations), embryotoxicity and fetotoxicity. In animal bioassays, adverse effects on fetal development may occur at doses above or below those producing signs of toxicity in the parent animals. The handling, storage or use of controlled products may occasionally produce exposures resulting in mild parental toxicity thereby resulting in potential developmental toxicity hazards. For the purpose of MSDS disclosure, any indication of an adverse effect on fetal development must be disclosed on the MSDS irrespective of whether or not there is an adverse effect on the pregnant female. Any relevant epidemiological evidence must also be disclosed.
"The four major manifestations of an effect on the developing organism are death, structural anomaly, altered or retarded growth, and functional deficiency. For many substances, these manifestations are related to dosage and to the development timing and duration of exposure. While high doses produce death, low doses that permit survival may produce malformed, retarded, or functionally deficient offspring. When developmental effects are found in the presence of maternal toxicity, the primary cause is often left to speculation. Without sufficient evidence to support the premise that developmental toxicity is always a secondary toxic effect in the presence of maternal toxicity, a default is needed. Developmental effects that occur in the presence of minimal maternal toxicity are thus considered to be evidence of developmental toxicity, unless it can be established that the developmental effects are unquestionably secondary to the maternal effects;" .
(The Motherisk Program at the Hospital for Sick Children in Toronto was created in 1985 to provide evidence-based information and guidance concerning the potential risks to the developing fetus or infant, from exposure to drugs, chemicals, diseases, radiation and environmental agents: www.motherisk.org).
(10) Mutagenicity - Subparagraph 33(3)(b)(iv) and sections 57 and 62 of the CPR set out classification criteria for mutagenicity. These criteria are limited to:
- epidemiology results for human populations, or
- in vivo tests carried out on living mammals.
Positive results from studies that meet the above criteria must be disclosed. Results of tests on bacteria (e.g. Ames Salmonella Mutation Test), insects (e.g. Drosophila) or cells studied in cultures outside the living animals, must also be disclosed on the MSDS if this information is available to the supplier and applicable to the controlled product.
(11) Name of toxicologically synergistic products - The MSDS must list any substances, materials or products which interact with the controlled product to produce a toxic effect greater than the sum of their separate effects.
A synergistic effect occurs when the combined toxicological effect of two chemicals is greater than the sum of the effect caused by each agent alone. For example, both carbon tetrachloride and ethanol are hepatotoxic compounds. Together they produce much more liver injury than the sum of their individual effects on the liver would suggest. Available relevant information regarding toxicological interactions between the product, including its ingredients, and other chemicals must be disclosed if applicable to the controlled product. Exposure to two or more chemical agents may result in various types of toxicological interaction other than synergism, including additivity, antagonism and potentiation:
Additivity: An additive effect occurs when the combined toxicological effect of two chemicals is equal to the sum of the effect caused by each agent alone. For example, when two organic phosphate insecticides are given together, the cholinesterase inhibition is usually additive.
Antagonism (or Inhibition): Antagonism occurs when two chemicals interfere with each other's actions or when one chemical interferes with the action of the other chemical, the net effect being a reduction in toxicity. For example, the prevention of absorption of a toxicant by ipecac or charcoal.
Potentiation: A potentiator is a substance which produces no toxic effects itself but when administered in conjunction with another substance which does cause toxic effects, it makes the latter much more toxic. For example, isopropanol is not hepatotoxic but when isopropanol is administered in addition to carbon tetrachloride, the hepatotoxicity of carbon tetrachloride is much greater than when administered in isolation.
CPR Schedule I - Information to be Disclosed on a Material Safety Data Sheet
Item 8 - Preventive Measures
(1) Personal protective equipment to be used - The employer has the ultimate responsibility for providing a worker with the appropriate PPE. For example, depending on workplace conditions and, thus, potential exposure levels and routes, it is the employer who must provide safety glasses, hand gloves and a labcoat versus a face shield, gauntlet gloves and a rubber suit, (note: for chemicals, faceshields should only be worn over primary eye protection). The information disclosed on the MSDS, however, must be consistent with the intended use of the product.
If gloves are recommended, the MSDS should specify the material (e.g., polyvinyl chloride (PVC), neoprene, polyvinyl alcohol (PVA), nitrile (NBR), natural rubber, etc.), with which the controlled product is resistant. The MSDS should also disclose with which materials the product is not resistant. Usually, the effectiveness of materials to protect against chemicals is based on their resistance to penetration, degradation and permeation. As a general guideline, the best protective material against a specific chemical is one that has a low permeation rate (if any) and a long breakthrough time. However, as these two properties do not always correlate, to err on the side of safety, a long breakthrough time is usually desired. For mixtures and formulated products (unless specific test data are available), a glove should be selected on the basis of the chemical component with the shortest breakthrough time since it is possible for solvents to carry active ingredients through polymeric materials.
Before purchasing a particular type of glove, it is the employer who should request documentation from the manufacturer demonstrating that the gloves meet the appropriate test standard(s) for the anticipated hazard(s).
Suppliers have indicated that employer versus supplier obligations regarding PPE are unclear. The CPR provide no indication of the specificity with which information relating to PPE must be disclosed on the supplier MSDS. The Intergovernmental WHMIS Coordinating Committee has adopted the following as enforcement policy in relation to MSDS disclosure of PPE information:
Under general duties specified in provincial and federal (non-WHMIS) occupational safety and health legislation, the employer has the ultimate responsibility for the use and selection of PPE. Proper selection of PPE must be determined on a case by case basis taking into account the identity and physical form of the material(s) being handled and their potential biological effects on the worker based on the expected conditions of workplace handling, use and disposal. Considerations should include the identification of all other potential hazards, duration of use, performance characteristics of the PPE, the limitations of the PPE and how to properly wear and adjust PPE. Employers must also ensure worker training for the proper use, care, maintenance and disposal of PPE.
Information disclosed on the supplier MSDS regarding the selection of PPE can serve as the starting point from which employers can determine when, where and what PPE will be required. Alternately, an employer may determine that the PPE recommended by the supplier MSDS does not adequately address the potential hazards of a particular task and may choose alternate means to reduce worker exposure. Employers may also contact the supplier for additional information. Employers should discuss their particular circumstances with manufacturers or vendors of PPE in order to determine which one of their materials or products will provide the best performance. For example, a recommended glove material, if purchased from two different manufacturers, may not provide similar protection with the same product due to material grade, thickness, etc.
As part of an effective workplace safety and health program, employers must adapt information provided by suppliers on MSDSs to their particular workplace circumstances. Since the recommended PPE may only be applicable to the "product use" disclosed on the supplier MSDS (under the Product Information Section of the MSDS), other uses may pose additional risks to workers. OSHA recommends that employers should select the protective equipment which ensures a level of protection greater than the minimum required to protect employees from the hazards; (ref.: OSHA 1910.138).
Since conditions of use are uncertain, liability considerations might preclude suppliers from providing categorical statements, particularly where a variety of acceptable equipment would be appropriate under specific conditions.
In conjunction with the "Factors to Consider for Each Form of PPE for Suppliers and Employers" (see below), the following has been adopted as enforcement policy by Canadian WHMIS regulatory agencies:
- Recommend PPE for each applicable route of entry (skin, eye/face, inhalation).
- Emphasize the importance of minimizing or preventing contact with or exposure to the product.
- Base the recommendations on the specific properties and hazards of the controlled product coupled with a general note on the circumstances requiring the recommended PPE.
- Disclose at least the minimum PPE required to protect workers from the hazards of the controlled product consistent with the "product use" disclosed on the MSDS.
- If appropriate, explain recommendation for varying circumstances, i.e., for emergency situations, accidental release or where exposure levels have not been established.
- If appropriate, add a statement that since local conditions of use and exposure are not known, users should reassess PPE recommendations for differing conditions.
- Provide specific or qualified terms where possible.
- Assume employers are trained in respirator selection and use.
Factors to Consider for Each Form of PPE for Suppliers and Employers:
GLOVES: If gloves are recommended because the product is, for example, a dermal irritant which may come in contact with skin during use, the MSDS should specify materials which are resistant to the product. It should also indicate which materials are not resistant. Glove materials may include polyvinyl chloride (PVC), neoprene, polyvinyl alcohol (PVA), nitrile (NBR), natural rubber, etc. The use of the term "impermeable or impervious gloves" should be not be used since there are no protective materials that are completely impermeable. Generally, any "chemical resistant" gloves can be used for dry powders; (ref.: OSHA 1910.138).
The best protective material against a specific chemical is one that has a low permeation rate (if any) and a long breakthrough time. Tests are usually conducted using pure substances as opposed to mixtures. Since it is possible for solvents to carry active ingredients through polymeric materials, unless specific test data are available, for mixtures and formulated products, gloves should be selected on the basis of the chemical component with the shortest breakthrough time, (ref.: OSHA 1910.138).
Important local factors which fall within the domain of employers include quantity of product handled, process equipment, ventilation, confined space conditions, contact time, temperature, material grade and humidity.
In addition to manufacturers' data, a general reference for the selection of CPC is the ACGIH 1991 Guidelines for the Selection of Chemical Protective Clothing. This guideline includes degradation and permeation test data from manufacturers, vendors and independent labs with recommendations for over 300 chemicals. As no analogous guideline has been published in Canada, many organizations in Canada use the ACGIH guideline as a reference.
FOOTWEAR: Where normal footwear is not appropriate, suppliers should specify the material of the footwear, height on the lower leg, nature of tread, etc..
CLOTHING/OTHER: If appropriate, other types of clothing may also be recommended such as aprons, vests, coveralls, suits, etc., and material type, e.g., neoprene, nylon, etc.
EYE/FACE: If the product is likely to pose an eye hazard, eye protection should be recommended. CSA Standard Z94.3-M1982 "Industrial Eye and Face Protectors" provides selection information for eye and facewear.
RESPIRATOR: A supplier's recommendation for respiratory protection should also be consistent with the "product use" disclosed on the MSDS and should afford a level of protection against overexposure to the chemical or product (i.e., to prevent exceeding regulated exposure limits).
Important local conditions to be considered by the employer include: period of time the respirator is required, chemical concentration, activity level of workers, functional capabilities and limitation of respirators of various types, respirator protection factors, respirator fit, etc..
The Canadian Standards Association (CSA) has published Z94.4-93, Selection, Use and Care of Respirators. This standard has been adopted by the federal government and by most provinces. In general, this standard states criteria that must be considered in the selection of respirators. It also describes the suitability of a particular respiratory protective device for oxygen deficient or immediately dangerous to life or health (IDLH) atmospheres.
Canadian and OSHA regulations require the use of an approved respirator. In the U.S., respirators are tested at the NIOSH Testing Laboratory in Morgantown, West Virginia, in accordance with the requirements of 42 CFR Part 84 (previously 30 CFR Part II). Under the new Part 84 (effective July 10, 1995), respirators are now approved solely by NIOSH. Under the old Part II, respirators were jointly approved by NIOSH and the Mine Safety and Health Administration (MSHA). CSA recognizes the NIOSH approvals.
Factors to Consider for Each Form of PPE for Suppliers and Employers:
-
A NIOSH approved air purifying respirator with an organic vapour cartridge or canister may be permissible under certain circumstances where air borne concentrations are expected to exceed exposure limits. Protection provided by air purifying respirators is limited. Use a NIOSH approved positive pressure air supplied respirator if there is any potential for an uncontrolled release, exposure levels are not known, or any other circumstances where air purifying respirators may not provide adequate protection.
(2) Specific engineering controls to be used - The ACGIH publication "Industrial Ventilation: A Manual of Recommended Practice" provides recommended dilution factors (volumes) for several organic solvents. Information related to the type of package in which the product is used may also require specific precautions. When, for example, it is prudent to ground containers of flammable gases or liquids during transfer or use, in order to guard against potential fire or explosion hazards, the supplier should disclose this type of information either under this or another MSDS subitem, such as 5(9).
(3) Procedures to be followed in case of leak or spill - This subitem requires the disclosure of protective equipment for emergency workers; neutralizing, adsorbing or other control materials; specific clean-up procedures, etc.
(4) Waste disposal - Where a supplier is aware that specific requirements do apply, the MSDS may disclose, at the supplier's discretion, a statement such as "waste disposal regulations do apply in some jurisdictions in Canada; contact local authorities to ensure full compliance". The following references may be useful:
-
Environment Canada- Environment Canada Enquiry Centre: (819) 997-2800;http://www.ec.gc.ca/ecocycle
- Competing Leaner, Keener and Greener: A Small Business Guide to ISO 14000 (Cat. #PLUS 1117)
- Environmental Management in Canada (Cat. # 5618)
- First Steps to Environmentally Responsible Management: A Comprehensive Workbook for EnvironmentalPolicy Development (Cat. # PLUS 1113)
- User's Guide to Environmental Life Cycle Assessment: Conceptual LCA in Practice (Cat. # PLUS 1107)
- Life Cycle Review (LCR) (Cat. # Plus 1115)
- Life Cycle Assessment (Cat. # Z760-94)
- Design for the Environment (Cat. # Z762-95)
- Guideline for Pollution Prevention (Cat. # Z754-94)
- Environmentally Responsible Procurement (ERP) (Cat. # Z766-95)
- Guideline on Environmental Labelling (Cat. # Z761-93)
- Environmental Terminology for Canadian Business (Cat. # PLUS 1109)
- Environmental Management Systems
- Environmental Auditing
- Environmental Labelling
- Environmental Performance Evaluation
- Life Cycle Assessment
- Terms and Definitions
- Environmental Aspects of Product Standards
(5) Handling procedures and equipment - This subitem requires the disclosure of the procedures and equipment necessary to protect workers from the hazards posed by the controlled product during use.
(6) Storage requirements - Information for safe storage must be disclosed relating to, for example, temperature, isolation from sources of ignition, separation from incompatible products, etc..
(7) Special shipping information - The disclosure of the TDG classification or classification under any other domestic or foreign regulatory program is optional and at the discretion of the supplier.
CPR Schedule I - Information to be Disclosed on a Material Safety Data Sheet
Item 9 - First Aid Measures
(1) Specific first aid measures - The intent of this section is to provide information necessary for the immediate on-site treatment of a person who has experienced adverse acute effects resulting from an accident with or overexposure to the controlled product. If applicable, the first aid measures disclosed must be specific to the route of entry, i.e., inhalation versus skin or eye contact, etc..
The MSDS must disclose first aid measures if they are applicable to the product. If the product's toxicity is negligible, first aid measures would not be applicable and the MSDS should disclose "not applicable". If the toxicity is low, first aid advice must be provided that is applicable to the product. The first aid measures should be consistent with the physical state of the product as sold, i.e., to distinguish between, for example, the specific first aid measures to be administered in the event of contact with a solid versus a solution of the solid.
The use of professional judgement will be required on a case-by-case basis to determine the appropriate first aid measures that should be disclosed for controlled products subject to the labelling and MSDS requirements of the Hazardous Products Act and Controlled Products Regulations. The following
guidelines, which are based on those developed by the Canadian Centre for Occupational Health and Safety (CCOHS) as reflected in their report The Material Safety Data Sheet, A Practical Guide to First Aid (CCOHS - P91-E), are recommendations as opposed to compliance guidelines. Depending on the hazards of the product, other first aid measures, such as those set out in ANSI Z129, may also be acceptable / preferable.A. Inhalation Exposure
- The MSDS for a controlled product that is corrosive, severely irritating, or interferes with the body's use of oxygen should disclose a statement that conveys the following information:
- remove source of contamination or move victim to fresh air;
- obtain medical attention immediately.
- if breathing has stopped, trained personnel should begin artificial respiration immediately;
- if the heart has stopped, trained personnel should begin cardiopulmonary resuscitation (CPR)immediately;
- obtain medical attention immediately.
B. Dermal Exposure
- The MSDS for a controlled product that is a moderate to severe irritant should disclosestatements that convey the following information:
- wash gently and thoroughly with water (and non-abrasive soap, for non-water soluble products) for 20 minutes or until chemical is removed;
- under running water, remove contaminated clothing, shoes and leather goods;
- obtain medical advice immediately.
C. Eye Exposure
- The MSDS for a controlled product that is a moderate or severe irritant should disclose statements that convey the following information:
- immediately flush the contaminated eye(s) with lukewarm gently flowing water for 20 minutes or until chemical is removed, while holding eyelid(s) open;
- take care not to rinse contaminated water into the unaffected eye or face (on a case by case basis, depending upon the actual MSDS disclosure);
- obtain medical advice immediately.
- immediately flush contaminated eye(s) continuously with lukewarm, gently flowing water for at least 20-60 minutes, while holding the eyelid(s) open;
- take care not to rinse contaminated water in to the unaffected eye or face(on a case by case basis, depending upon the actual MSDS disclosure);
- obtain medical advice immediately.
D. Ingestion Exposure
Note: Following the recommendation from a Poison Control Centre specialist that administration of and/or milk following ingestion should only be performed under medical supervision, this practice was deleted from the guideline below.
- The MSDS for a controlled product that is corrosive should disclose statements that convey the following information:
- never give anything by mouth if victim is rapidly losing consciousness, unconscious or convulsing;
- do not induce vomiting (Note: it may be appropriate to induce vomiting in some cases when the LD50 of the product is low or severe systemic toxicity can be expected in cases of accidental ingestion; this will have to be assessed on a case-by-case basis;
- if vomiting occurs naturally, have victim lean forward to reduce risk of aspiration;
- obtain medical advice immediately.
- if breathing has stopped, trained personnel should begin artificial respiration immediately;
- if the heart has stopped, trained personnel should begin cardiopulmonary resuscitation (CPR) immediately;.
- obtain medical attention immediately
CPR Schedule I.1 - Physical Containment Requirements for Low Risk Agents
Physical Containment Requirements for Low Individual or Community Risk Agents
- In this Schedule, "low individual or community risk agents" includes microorganisms, bacteria, fungi, viruses, and parasites that are unlikely to cause disease in healthy persons or animals.
- The physical requirements for a basic laboratory for handling low individual or community risk agents are those of a well-designed and functional laboratory and, in particular, include the following:
- the room in which the laboratory is located must be separated from any public area by a door;
- if the room opens onto a public area or a heavily traveled corridor, the door to the room in which the laboratory is located must remain closed except when being used to enter or leave the laboratory;
- the finished surface of the walls, ceiling, furniture and floors of the laboratory must be washable;
- all working areas and containment equipment must be located away from windows that may be opened and that must be equipped with fly screens;
- hand washing facilities must be provided, preferably at a location near the exit to the corridor or to any public area; and
- laboratory coats must be hung in a separate area from the place where street clothing is hung.
Interpretation / Discussion of Schedule I.1
Paragraphs CPR 10.1(a)(ii)(C) and 17.1(a)(ii)(C) limit the respective MSDS and label exemptions to infectious materials that can be handled in accordance with the physical containment requirements set out in this Schedule; i.e., these exemptions are limited to infectious materials included in Risk Group 1 which pose a relatively low individual or community risk.
Schedule I.1 is an extract from the Health Canada Laboratory Biosafety Guidelines, 1996, 2 nd edition, Chapter 5: Physical Containment Levels Subchapter 5.1: Containment Level 1 for Risk Group 1 microorganisms (or low individual or community risk agents):
Since it is not permissible to incorporate by reference a Health Canada policy document nor guideline into a regulation, the applicable section of the Biosafety Guidelines was reproduced as Schedule I.1 to the CPR.
Section 1 of the French version of Schedule I.1 was amended (SOR/2004-317) to provide a greater degree of correlation between the French and English versions. The English version states that "low individual or community risk agents" includes microorganisms, bacteria, fungi, viruses and parasites that are unlikely to cause disease in healthy persons or animals, while the French version stated that this term means ("s'entend") microorganisms, bacteria, fungi, viruses and parasites that are unlikely to cause disease in healthy persons or animals. The French version indicated that the definition is exhaustive, while the English version indicates that other agents than those enumerated are also "low individual or community risk agents". Therefore, the French version was amended to read "Dans la présente annexe, « agents présentant un faible risque pour l'individu ou la collectivité » s'entend notamment des micro-organismes, bactéries, champignons, virus et parasites non susceptibles de causer des maladies chez les personnes et les animaux en santé".
CPR Schedule II - Hazard Symbols
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Matières ayant des effets toxiques immédiats et graves
- OECD Test Guideline No. 415, "One-Generation Reproduction Toxicity", dated May 26, 1983, or
- the information referred to in section 26 or 27, or
- risk phrases that are appropriate to the controlled product or to the classes, divisions or subdivisions into which the controlled product falls,
- is present in an amount that is
- is present in an amount that is
- unknown to the secondary supplier, or
- the Hazardous Materials Information Review Act, or