FEDERAL REG

SOR/2016-3: Domestic Substances List — Order 2016-87-01-01 Amending Canadian Environmental Protection Act, 1999

REGISTRATION OF FEDERAL REGULATION - VIA PART II OF THE GAZETTE

Registered
January 27, 2016


REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Order.) 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 1999), substances (i.e. chemicals, polymers, nanomaterials, and living organisms) “new” to Canada are subject to reporting requirements be... (Click for more)


Published on January 27, 2016

Bill Summary

SOR/2016-3: Domestic Substances List — Order 2016-87-01-01 Amending Canadian Environmental Protection Act, 1999

REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Order.) 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 1999), 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 14 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 are therefore added to the DSL. The Government assessed information on another substance (Chemical Abstracts Service Registry Number [CAS RN] 1043888-25-0) and determined that specific information on potential new activities associated with this substance must be submitted prior to the commencement of such activities in Canada. The Significant New Activity (SNAc) provisions under CEPA 1999 are therefore applied for this substance through this DSL amendment. The Government reviewed new information for another substance already on the DSL (confidential accession number 17953-7) and determined that the reporting requirements previously applied pursuant to the SNAc provisions of CEPA 1999 are no longer needed. The SNAc reporting requirements for this substance are therefore rescinded. Background Addition of 14 substances to the DSL The DSL is a list of substances that are considered “existing” in Canada for the purposes of CEPA 1999. “New” substances are not on the DSL 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 1999, as well as in the New Substances Notification Regulations (Chemicals and Polymers) and the New Substances Notification Regulations (Organisms). These 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) The DSL is amended 10 times a year, on average; 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 1999 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 1999 by the person who provided the information; the period prescribed for the assessment of the submitted information for the substance has expired; and the substance is not subject to any conditions imposed on its import or manufacture. Environment Canada and Health Canada assessed information on 14 new substances reported to the New Substances Program and determined that they meet the criteria for their addition to the DSL. These substances are therefore added to the DSL. Application of the SNAc provisions under CEPA 1999 on the substance bearing CAS RN 1043888-25-0 The assessment of this substance identified potential human health concerns related to reproductive and developmental toxicity. For this reason, the significant new activity provisions of CEPA 1999 were applied to the substance before its addition to the DSL, pursuant to a notice published in the Canada Gazette, Part I. (see footnote 4) In order to maintain the reporting requirements on the substance, significant new activities are now being added to the DSL. The information required will keep enabling the Government to further assess the substance if it is used in cosmetics or drugs, as defined in section 2 of the Food and Drugs Act, or in natural health products, as defined in subsection 1(1) of the Natural Health Products Regulations. Rescission of SNAc requirements for the substance DSL confidential accession number 17953-7 The SNAc provisions under CEPA 1999 were applied to the substance to collect information on its nanoscale forms. (see footnote 5) These SNAc requirements were considered as part of the ongoing review (see footnote 6) of current SNAc notices under CEPA 1999. The review found that the reporting obligations are no longer needed, as the Government is considering the use of other means to collect information on nanoscale forms of this type of substances. (see footnote 7) The SNAc reporting requirements for this substance are therefore rescinded. Objectives The objectives of the Order 2016-87-01-01 Amending the Domestic Substances List (the Order) are to Comply with CEPA 1999 by adding 14 substances to the DSL. This will facilitate their import or manufacture by removing the notification and assessment requirements under the New Substances Notification Regulations (Chemicals and Polymers); Contribute to the protection of human health and the environment by maintaining the SNAc requirements associated with the substance bearing CAS RN 1043888-25-0. The information collected will enable the Government to assess the substance in relation to the significant new activities and to determine whether further risk management actions are necessary; and Rescind the SNAc requirements associated with the substance DSL confidential accession number 17953-7, as they are no longer needed. The Government is now considering the use of other means to collect this information. Description Addition of 14 substances to the DSL The Order adds 14 substances to the DSL. To protect confidential business information, 7 of the 14 substances will have masked chemical names. Masked names are allowed by CEPA 1999 if the publication of the explicit chemical or biological name of a substance would result in the release of confidential business information. The procedure to be followed for creating a masked name is set out in the Masked Name Regulations under CEPA 1999. Substances with a masked name are added under 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. Application of the SNAc provisions under CEPA 1999 on the substance bearing CAS RN 1043888-25-0 The Order adds this substance to Part 2 of the DSL and indicates that the substance is subject to the SNAc provisions under CEPA 1999. (see footnote 8) This Order has been registered and is now in force. It is therefore mandatory to meet the requirements of subsection 81(3) of CEPA 1999 before manufacturing, importing or using the substance for a significant new activity, as defined in this Order. Applicability of the SNAc requirements: The SNAc requirements apply to any person that intends to use, manufacture or import the substance for a significant new activity. Any person engaging in a significant new activity associated 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 cosmetics or drugs, as defined in section 2 of the Food and Drugs Act, or in natural health products, as defined in subsection 1(1) of the Natural Health Products Regulations. These activities have not been identified as presently occurring in Canada. Activities not subject to the SNAc requirements: The requirements of subsection 81(3) of CEPA 1999 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 1999: 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 are not likely released, impurities, contaminants or partially unreacted intermediates 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 1999. See subsection 81(6) and section 3 of CEPA 1999, and section 3.2 of the Guidelines for the Notification and Testing of New Substances (Chemicals and Polymers) for additional details. (see footnote 9) Information to be submitted: The Order sets out the information that must be provided to the Minister of the Environment 90 days before the day on which 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. Some of the information requirements of this Order reference the New Substances Notification Regulations (Chemicals and Polymers) to describe the specific information being requested. (see footnote 10) Additional guidance on preparing a SNAN can be found in section 1.3 of the Guidelines for the Notification and Testing of New Substances (Chemicals and Polymers). Rescission of the SNAc requirements associated with the substance DSL confidential accession number 17953-7 The Order rescinds the reporting requirements applied previously to this substance pursuant to the SNAC provisions of CEPA 1999, as they are no longer needed. The Government is now considering the use of other means to collect this information. The substance is moved from Part 4 to Part 2 of the DSL. “One-for-One” Rule and small business lens The Order does not trigger the “One-for-One” Rule, as it does not add any additional costs to business. Also, the small business lens does not apply to the Order, as it does not add any administrative or compliance burden to small businesses. Consultation As the Order is administrative in nature and does not contain any information that would be subject to comment or objection by the general public, no consultation is required. Rationale Fourteen substances have met the conditions for addition to the DSL. The Order adds these substances to the DSL and exempts them from the notification and assessment requirements under subsection 81(1) of CEPA 1999. The Order maintains SNAc requirements previously published in Part I of the Canada Gazette for the substance bearing CAS RN 1043888-25-0, as the assessment identified potential human health concerns related to reproductive and developmental toxicity associated with the substance. In addition, the Order rescinds the SNAc requirements for the substance DSL confidential accession number 17953-7, as they are no longer needed. The Government is now considering the use of other means to collect this information. The Order will benefit Canadians by enabling industry to use these substances in larger quantities. The Order will also benefit industry by reducing the administrative burden associated with the regulatory requirements on these substances. As a result, it is expected that there will be no incremental costs to the public, industry or governments associated with the Order. Implementation, enforcement and service standards Associated with the addition of 14 substances to the DSL The DSL identifies substances that, for the purposes of CEPA 1999, 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. Associated with the application of SNAc provisions, under CEPA 1999, on the substance bearing CAS RN 1043888-25-0 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 11) 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. Therefore, 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 in possession of or that has knowledge of the information and is involved in activities with the substance is obligated, under section 70 of CEPA 1999, 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 12) 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. Where individuals have questions concerning their obligations to comply with the Order or believe that they may be out of compliance, or, would like to request a PNC, they are encouraged to contact the Substances Management Information Line. (see footnote 13) The Program will work with the individuals to help them comply with the Order. CEPA 1999 is enforced in accordance with the publicly available Compliance and Enforcement Policy. (see footnote 14) 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 Domestic Substances List. 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, with information about the substances, depends on the class of a substance. The information requirements are set out in the New Substances Notification Regulations (Chemicals and Polymers) under CEPA 1999. Footnote 4 For more information, please visit http://gazette.gc.ca/rp-pr/p1/2015/2015-06-06/html/notice-avis-eng.php. Footnote 5 The SNAc requirements were applied pursuant to the Order 2008-87-12-01 Amending the Domestic Substances List (SOR/2009-39), published in the Canada Gazette, Part II, on March 4, 2009. For more information, please visit http://gazette.gc.ca/rp-pr/p2/2009/2009-03-04/html/sor-dors39-eng.html. Footnote 6 For more information on the review of current SNAc notices, please visit http://www.chemicalsubstanceschimiques.gc.ca/plan/approach-approche/snac-nac/index-eng.php#a2. Footnote 7 Notifiers who intend to manufacture or import a new nanoscale substance should consult the New Substances Program Advisory Note 2014-02: Assessment of nanomaterials under the New Substances Notification Regulations (Chemicals and Polymers). This note provides additional information on the notification requirements for nanoscale substances. For more information, please visit https://www.ec.gc.ca/subsnouvelles-newsubs/default.asp?lang=En&n=53527F9D-1. Footnote 8 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 9 The Guidelines for the Notification and Testing of New Substances (Chemicals and Polymers) are available at http:// publications.gc.ca/site/eng/280464/publication.html. Footnote 10 The New Substances Notification Regulations (Chemicals and Polymers) is available at http://laws-lois.justice.gc.ca/eng/regulations/SOR-2005-247/. Footnote 11 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 12 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 13 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 14 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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