FEDERAL REG

SOR/2016-47: Domestic Substances List — Order 2016-66-04-01 Amending Canadian Environmental Protection Act, 1999

REGISTRATION OF FEDERAL REGULATION - VIA PART II OF THE GAZETTE

Registered
March 17, 2016


REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the orders.) Issues Canadians depend on substances that are used in hundreds of goods, from medicines to computers, fabric and fuels. Under the Canadian Environmental Protection Act, 1999 (CEPA), substances (i.e. chemicals, polymers, nanomaterials and living organisms) “new” to Canada are subject to reporting requirements before ... (Click for more)


Published on March 17, 2016

Bill Summary

SOR/2016-47: Domestic Substances List — Order 2016-66-04-01 Amending Canadian Environmental Protection Act, 1999

REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the orders.) Issues Canadians depend on substances that are used in hundreds of goods, from medicines to computers, fabric and fuels. Under the Canadian Environmental Protection Act, 1999 (CEPA), substances (i.e. chemicals, polymers, nanomaterials and living organisms) “new” to Canada are subject to reporting requirements before they can be manufactured or imported. This limits market access until human health and environmental impacts associated with the new substances are assessed and managed where appropriate. The Government of Canada (the Government) assessed information on 24 new substances reported to the New Substances Program and determined that they meet the necessary criteria for their addition to the Domestic Substances List (DSL). These substances have therefore been added to the DSL. The Government determined that due to human health and environmental concerns, specific information on new activities associated with one of these 24 substances (listed on the DSL under the confidential accession number 18923-5) must be submitted prior to the commencement of such activities in Canada. The Significant New Activity (SNAc) provisions under CEPA have therefore been applied for this substance. In addition, new information provided to the Government indicates that the identity of a substance currently on the confidential portion of the DSL is no longer considered confidential business information. Therefore, the substance identifier has been updated, and the substance was moved from the confidential to the public portion of the DSL. Background Addition of 24 substances to the DSL The DSL is an inventory of substances found in the marketplace in Canada. Substances that are not on the DSL are considered new to Canada and are subject to notification and assessment requirements before they can be manufactured in or imported into Canada. The notification and assessment requirements are set out in subsections 81(1) and 106(1) of CEPA as well as in the New Substances Notification Regulations (Chemicals and Polymers) and the New Substances Notification Regulations (Organisms). These notification and assessment requirements do not apply to substances listed on the DSL. The DSL was published in the Canada Gazette, Part II, in May 1994 (see footnote 2) and is amended on average 10 times a year. These amendments may add or remove substances, or make corrections to the DSL. A substance must be added to the DSL under subsections 87(1) or (5) of CEPA within 120 days once all of the following conditions are met: the Minister of the Environment has been provided with information regarding the substance; (see footnote 3) the Minister of the Environment and the Minister of Health are satisfied that the substance has already been manufactured in or imported into Canada under the conditions set out in section 87 of CEPA by the person who provided the information; the period prescribed for the assessment of the information submitted for the substance has expired; and the substance is not subject to any conditions imposed pursuant to paragraph 84(1)(a) of CEPA on its import or manufacture. Environment Canada and Health Canada assessed information on 24 new substances reported to the New Substances Program and determined that they meet the criteria for addition to the DSL. SNAc requirements on the substance bearing confidential accession number 18923-5 The assessment of this substance identified potential human health concerns related to oral toxicity, reproductive toxicity, and potential mutagenic/genotoxic effects, as well as potential environmental concerns related to toxicity for aquatic species. For these reasons, the significant new activity provisions of CEPA were applied to the substance before its addition to the DSL, pursuant to a notice published in the Canada Gazette, Part I, in October 2015. (see footnote 4) This substance later became eligible for addition and was added to the DSL under the current amendments. In order to maintain the reporting obligations, the SNAc requirements were also added to the DSL. Amendments to a substance identifier To protect confidential business information, a substance bearing the Chemical Abstracts Service Registry Number (CAS RN) 29896-67-1 was added to the DSL in 2008 under the confidential accession number 17918-8. (see footnote 5) In 2015, industry submitted new information indicating that the substance’s identity was no longer considered confidential business information. As a result, the substance identifier has been updated on the DSL, and the substance moved from the confidential portion of the DSL to the public portion. Objectives The objectives of the Order 2016-87-04-01 Amending the Domestic Substances List (the Order 2016-87-04-01) are to comply with the requirements under subsections 87(1) and (5) of CEPA by adding 24 substances to the DSL. These substances are therefore no longer subject to the notification and assessment requirements, as set out in subsection 81(1) of CEPA and in the New Substances Notification Regulations (Chemicals and Polymers); and contribute to the protection of human health and the environment by maintaining the SNAc requirements on the substance confidential accession number 18923-5. The information collected will enable the Government to assess the risks associated with the proposed new activities before they are undertaken. The objective of the Order 2016-66-04-01 Amending the Domestic Substances List (the Order 2016-66-04-01) is to update a substance identifier on the DSL. The substance is no longer identified on the DSL by a confidential accession number and a masked chemical name, but rather by its Chemical Abstracts Service Registry Number. Description Addition of 24 substances to the DSL The Order 2016-87-04-01 added 24 substances to the DSL. To protect confidential business information, 12 of the 24 substances have masked chemical names. Masked names are allowed by CEPA if the publication of the explicit chemical or biological name of a substance would result in the release of confidential business information. (see footnote 6) Substances with a masked name are added on the confidential portion of the DSL. Anyone who wishes to determine if a substance is on the confidential portion of the DSL must file a Notice of Bona Fide Intent to Manufacture or Import with the New Substances Program. SNAc requirements on the substance bearing confidential accession number 18923-5 As noted above, the SNAc was originally published in the Canada Gazette, Part I, in October 2015. The substance was not on the DSL at that time. The substance later became eligible and, as a result, the Order 2016-87-04-01 added this substance to Part 4 of the DSL. The Order also indicated that the substance is subject to the SNAc provisions under CEPA. (see footnote 7) This Order has been registered and is in force. It is therefore mandatory to meet the requirements of subsection 81(3) of CEPA before manufacturing, importing or using the substance for a significant new activity, as defined in this Order. The SNAc requirements apply to any person who intends to use, manufacture or import the substance for a significant new activity. Any person intending to use, manufacture or import the substance for a significant new activity with the substance must submit a Significant New Activity Notification (SNAN) containing all of the information prescribed in the Order at least 90 days prior to the beginning of the significant new activity. The activities associated with this substance requiring a SNAN submission involve any use in quantities greater than 1 000 kg in a calendar year, other than its use as a component of a coating that is applied in an industrial setting and in which the substance becomes part of a solid matrix once the coating has cured; a waterborne floor coating that is a consumer product, as defined in section 2 of the Canada Consumer Product Safety Act, that is not intended to be applied by spraying and in which the substance becomes part of a solid matrix once the coating has cured; and pigment or ink that is contained in a cartridge or refill bottles. The requirements of subsection 81(3) of CEPA do not apply to uses of the substance that are regulated under any of the following Acts of Parliament listed in Schedule 2 of CEPA: the Pest Control Products Act, the Fertilizers Act and the Feeds Act. They also do not apply to transient reaction intermediates that are not isolated and not likely released, impurities, contaminants or partially unreacted materials related to the preparation of a substance or, in some circumstances, to items such as wastes, mixtures or manufactured items. However, it should be noted that individual components of a mixture may be notifiable under subsection 81(3) of CEPA. See subsection 81(6) and section 3 of CEPA, and section 3.2 of the Guidelines for the Notification and Testing of New Substances (Chemicals and Polymers) for additional details. (see footnote 8) Information must be provided to the Minister of the Environment 90 days prior to the beginning of the significant new activity. Environment Canada and Health Canada will use the information submitted in the SNAN to conduct human health and environmental assessments within 90 days after the complete information is received. Amendments to a substance identifier The Order 2016-66-04-01 updated a substance’s identifier by removing the confidential accession number 17918-8 and associated masked chemical name from Part 3 of the DSL, and by adding the CAS RN 29896-67-1 to Part 1 of the DSL. “One-for-One” Rule and small business lens The orders do not trigger the “One-for-One” Rule, as they do not add any additional costs to business. Also, the small business lens does not apply to the orders, as they do not add any administrative or compliance burden to small businesses. Consultation As the orders do not contain any information expected to generate comments or objections by stakeholders, no consultation is deemed necessary. Rationale The Government assessed information on 24 new substances reported to the New Substances Program and determined that they meet the necessary criteria for their addition to the DSL. These substances have therefore been added to the DSL. The Government determined that due to human health and environmental concerns, specific information on new activities associated with one of these 24 substances (listed on the DSL under the confidential accession number 18923-5) must be submitted prior to the commencement of such activities in Canada. The SNAc provisions under CEPA have therefore been applied for this substance. In addition, new information provided to the Government indicated that the identity of a substance currently on the confidential portion of the DSL was no longer considered confidential business information. Therefore, the substance identifier has been updated and the substance moved from the confidential to the public portion of the DSL. The orders will benefit Canadians by enabling industry to have better access to larger quantities of these substances, which is expected to reduce costs associated with their use in products consumed by Canadians. As a result, it is expected that there will be no incremental costs to the public, industry or governments associated with the orders. Implementation, enforcement and service standards Addition of 24 substances to the DSL and amendments to a substance identifier The DSL identifies substances that, for the purposes of CEPA, are not subject to the requirements of the New Substances Notification Regulations (Chemicals and Polymers) or the New Substances Notification Regulations (Organisms). Developing an implementation plan and a compliance strategy or establishing a service standard is not required when adding substances to the DSL or updating a substance identifier on the DSL. SNAc requirements on the substance bearing confidential accession number 18923-5 When assessing whether or not a particular activity meets the definition of significant new activities on the DSL, a person is expected to make use of information in their possession or to which they ought to have access. (see footnote 9) The phrase “to which they ought to have access” means information in any of the company’s offices worldwide or other locations where the notifier can reasonably have access to the information. For example, manufacturers are expected to have access to their formulations, while importers or users of a substance, mixture, or product, are expected to have access to import records, usage information and the relevant Safety Data Sheet (SDS). Although an SDS is an important source of information on the composition of a purchased product, it should be noted that the goal of the SDS is to protect the health of workers in the workplace from specific hazards of chemical products. In this regard, an SDS may not list all substances that may be subject to SNAc provisions due to public health or environmental concerns. Any person requiring more detailed information on product composition is encouraged to contact his or her supplier. If any information becomes available that reasonably supports the conclusion that the substance is toxic or capable of becoming toxic, the person who obtains the information and is involved in activities with the substance is obligated, under section 70 of CEPA, to provide that information to the Minister of the Environment without delay. A company can submit a SNAN on behalf of its clients. For example, in cases where a person receives possession and control of the substance from another person, he or she may not be required to submit a SNAN, under certain conditions, if his or her activities were covered by the original SNAN. The Substances Management Advisory Note, Clarification in relation to the submission of Significant New Activity Notifications in application of the Canadian Environmental Protection Act, 1999, provides more detail on this subject. (see footnote 10) A pre-notification consultation (PNC) is recommended for notifiers who wish to consult with the New Substances Program during the planning or preparation of their SNAN to discuss any questions or concerns they have about the prescribed information and test plans. Individuals who have questions concerning their obligations to comply with the Order, who believe they may be out of compliance or who would like to request a PNC are encouraged to contact the Substances Management Information Line. (see footnote 11) The Program will work with the individuals to help them comply with the Order. CEPA is enforced in accordance with the publicly available Compliance and Enforcement Policy. (see footnote 12) In instances of non-compliance, consideration is given to factors such as the nature of the alleged violation, potential harm, intent and history of compliance. Contact Greg Carreau Executive Director Program Development and Engagement Division Environment Canada Gatineau, Quebec K1A 0H3 Substances Management Information Line: 1-800-567-1999 (toll-free in Canada) 819-938-3232 (outside of Canada) Fax: 819-938-5212 Email: [email protected] Footnote a S.C. 1999, c. 33 Footnote b SOR/94-311 Footnote c S.C. 1999, c. 33 Footnote 1 SOR/94-311 Footnote 2 The Order 2001-87-04-01 Amending the Domestic Substances List (SOR/2001-214), published in the Canada Gazette, Part II, in July 2001, establishes the structure of the DSL. For more information, please visit http://publications.gc.ca/gazette/archives/p2/2001/2001-07-04/pdf/g2-13514.pdf. Footnote 3 The most comprehensive package depends on the class of a substance. The information requirements are set out in the New Substances Notification Regulations (Chemicals and Polymers) made under CEPA. Footnote 4 For more information, please visit: http://gazette.gc.ca/rp-pr/p1/2015/2015-10-03/html/notice-avis-eng.php. Footnote 5 The Order 2008-87-08-02 Amending the Domestic Substances List (SOR/2008-295) was published in the Canada Gazette, Part II, in November 2008. For more information, please visit: http://publications.gc.ca/gazette/archives/p2/2008/2008-11-12/pdf/g2-14223.pdf. Footnote 6 The procedure to be followed for creating a masked name is set out in the Masked Name Regulations made under CEPA at http://laws-lois.justice.gc.ca/PDF/SOR-94-261.pdf. Footnote 7 The policy on the use of SNAc provisions is available at http://www.ec.gc.ca/ese-ees/default.asp?lang=En&n=5CA18D66-1. Footnote 8 The Guidelines for the Notification and Testing of New Substances (Chemicals and Polymers) is available at http://publications.gc.ca/site/eng/280464/publication.html. Footnote 9 A comprehensive listing of substances that are subject to SNAc provisions is available at http://www.ec.gc.ca/subsnouvelles-newsubs/default.asp?lang=En&n=0F76206A-1. Footnote 10 The Advisory Note Clarification in relation to the submission of Significant New Activity Notifications in application of the Canadian Environmental Protection Act, 1999 is available at http://www.ec.gc.ca/subsnouvelles-newsubs/default.asp?lang=En&n=CC526AE6-1. Footnote 11 The Substances Management Information Line can be contacted at [email protected] (email), 1-800-567-1999 (toll-free in Canada), 819-938-3232 (outside of Canada). Footnote 12 The Compliance and Enforcement Policy is available at https://www.ec.gc.ca/alef-ewe/default.asp?lang=en&n=AF0C5063-1.

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