FEDERAL REG

SOR/2016-267: Domestic Substances List — Order 2016-87-10-01 Amending Canadian Environmental Protection Act, 1999

REGISTRATION OF FEDERAL REGULATION - VIA PART II OF THE GAZETTE

Registered
October 5, 2016


REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Order.) Issues The Government of Canada (the Government) amended the Domestic Substances List (DSL) under the Order 2016-87-10-01 Amending the Domestic Substances List by adding 13 substances to the DSL; maintaining significant new activity (SNAc) (see footnote 2) requirements on one of the 13 substances added to the DSL; and... (Click for more)


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Published on October 5, 2016

Bill Summary

SOR/2016-267: Domestic Substances List — Order 2016-87-10-01 Amending Canadian Environmental Protection Act, 1999

REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Order.) Issues The Government of Canada (the Government) amended the Domestic Substances List (DSL) under the Order 2016-87-10-01 Amending the Domestic Substances List by adding 13 substances to the DSL; maintaining significant new activity (SNAc) (see footnote 2) requirements on one of the 13 substances added to the DSL; and rescinding SNAc requirements related to 16 substances already on the DSL. Background Canadians depend on substances that are used in hundreds of goods from medicines, computers, fabric to 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 DSL is an inventory of substances in the Canadian marketplace. 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. These 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 requirements do not apply to substances listed on the DSL. Under subsection 87(3) or 112(3) of CEPA, reporting obligations may be imposed, varied and rescinded in relation to significant new activities with substances on the DSL, if the Government deems it necessary based on available information. The information submitted enables the Government to assess risks associated with proposed new uses and determine whether additional risk management is required. Decisions to vary or rescind SNAc requirements are based on new information available, such as information received via notifications or updated assessments. The DSL was published in the Canada Gazette, Part II, in May 1994 (see footnote 3) and is amended on average 10 times a year to add or delete substances. A substance must be added to the DSL under subsection 87(1), 87(5) or 112(1) 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 4) 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 or 112 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) or 109(1)(a) of CEPA on its import or manufacture. Order 2016-87-10-01 Amending the Domestic Substances List The Government assessed information on 13 new chemicals and polymers reported to the New Substances Program and determined that they meet the conditions for their addition to the DSL. These substances have therefore been added to the DSL under this Order. The assessment of one of the 13 substances (Chemical Abstracts Service Registry No. [CAS RN] 932742-30-8) identified potential human health concerns related to a strong potential for skin sensitization in humans if the substance is present in a consumer product. For these reasons, the significant new activity provisions of CEPA were applied to the substance in February 2014, (see footnote 5) before it met the conditions for addition to the DSL. This Order added these SNAc requirements to the DSL to maintain the reporting obligations on the substance. The Government also reviewed the SNAc requirements of CEPA for 16 substances already on the DSL. Between 2008 and 2010, SNAc requirements were applied to these substances based on the available information at the time. The substances were either considered to be persistent, bioaccumulative, and inherently toxic to non-human organisms, or were considered to be of potential concern to human health based on their hazardous properties, including carcinogenicity. For these reasons, the SNAc provisions of CEPA were applied to 12 of these 16 substances (CAS RN 2653-64-7; CAS RN 59709-10-3; CAS RN 71720-89-3; CAS RN 73528-78-6; CAS RN 83027-51-4; CAS RN 83027-52-5; CAS RN 85392-21-8; CAS RN 85005-63-6; CAS RN 90218-20-5; CAS RN 90459-02-2; CAS RN 94199-57-2; and CAS RN 114910-04-2) in June 2008, (see footnote 6) to the substance CAS RN 74336-60-0 in March 2009, (see footnote 7) to the substances CAS RN 6407-74-5 and CAS RN 6407-78-9 in June 2010, (see footnote 8) and to the substance CAS RN 6535-42-8 in November 2010. (see footnote 9) In 2014, the aforementioned 16 substances were re- evaluated as part of the Aromatic Azo and Benzidine-based Substance Grouping under the Chemicals Management Plan. (see footnote 10) The final assessments published in May and June 2016 (see footnote 11) indicated that these 16 substances are no longer considered to be persistent, bioaccumulative and inherently toxic to non-human organisms, or are no longer of potential concern to human health. As a result, the SNAc requirements for these substances were removed from the DSL under this Order. Objectives The objectives of this Order are to comply with the requirements under subsection 87(5) of CEPA by adding 13 substances to the DSL, making them 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); contribute to the protection of human health by maintaining the SNAc requirements on the substance CAS RN 932742-30-8 to enable the Government to assess the risks associated with proposed significant new activities involving the substance before they are undertaken in Canada; and rescind the SNAc requirements of CEPA concerning 16 substances, as the assessment conclusions regarding these substances have been updated. Description This Order added a total of 13 substances to the DSL: 3 substances were added to Part 1 of the DSL, one substance to Part 2 of the DSL, and 9 substances to Part 3 of the DSL. To protect confidential business information, 9 of the 13 substances have masked chemical names. (see footnote 12) This Order also indicated that one of the 13 substances (CAS RN 932742-30-8) is subject to the SNAc provisions under CEPA. 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. According to the requirements of subsection 81(3) of CEPA, any person who intends to use, manufacture or import the substance for a significant new activity 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 significant new activities requiring a SNAN submission are defined as any use of the substance in Canada in a quantity greater than 1 000 kg per calendar year in a consumer product to which the Canada Consumer Product Safety Act applies. 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 are 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 13) Information must be provided to the Minister of the Environment 90 days prior to the beginning of the significant new activity. The Department of the Environment and the Department of Health will use the information submitted in the SNAN to conduct human health and environmental assessments within 90 days after the complete information is received. 3. This Order also rescinded the SNAc requirements applied previously to 16 substances by moving the substances from Part 2 to Part 1 of the DSL. Consultation As this Order does not contain any information expected to generate comments by stakeholders, no further consultation is deemed necessary. Rationale The Government assessed information on 13 new substances reported to the New Substances Program and determined that they met the conditions for their addition to the DSL. These substances have therefore been added to the DSL. One of the 13 substances was subject to SNAc requirements before it met the DSL conditions. The assessment of the substance identified a potential human health concern if it is present in consumer products. SNAc requirements have therefore been maintained and added to the DSL for the substance. This will enable the Government to assess the risks associated with significant new activities involving the substance before they are undertaken. The Government reviewed the significant new activity requirements of CEPA for 16 substances already on the DSL. The review concluded that these substances are no longer considered to be persistent, bioaccumulative and inherently toxic to non-human organisms, or are no longer of potential concern to human health. Therefore the SNAc requirements for these substances were removed from the DSL. The Order will benefit Canadians by enabling industry to have better access to larger quantities of these substances while keeping SNAc requirements on one of them to enable the Government to assess risks associated with activities using the substance before they can be undertaken. Overall, the Order is expected to reduce costs associated with products consumed by Canadians. It is also expected that there will be no incremental costs to the public, industry or governments associated with the Order. “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. Implementation, enforcement and service standards 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). Reporting obligations may be imposed, varied or rescinded in relation to significant new activities with substances on the DSL under the SNAc provisions of CEPA. Developing an implementation plan, a compliance strategy, or establishing a service standard is not required when adding substances to the DSL, maintaining SNAc requirements on substances being added to the DSL or rescinding SNAc requirements. When assessing whether or not a particular activity meets the definition of significant new activity 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 14) 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 their 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, they may not be required to submit a SNAN, under certain conditions, if their 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 15) 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 a person has questions concerning their obligations to comply with the Order or believes they may be out of compliance, or, would like to request a PNC, they are encouraged to discuss their particular circumstances with the Program by contacting the Substances Management Information Line. (see footnote 16) CEPA is enforced in accordance with the publicly available Compliance and Enforcement Policy. (see footnote 17) 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 Department of the Environment 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 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 3 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 4 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) and the New Substances Notification Regulations (Organisms) made under CEPA. Footnote 5 For more information, please visit http://canadagazette.gc.ca/rp-pr/p1/2014/2014-02-22/html/notice-avis-eng.php#d104. Footnote 6 The Order 2008-87-01-01 Amending the Domestic Substances List (SOR/2008-192) was published in the Canada Gazette, Part II, on June 25, 2008. Under this Order, the SNAc provisions of CEPA were applied to a total of 145 substances. The Government is considering a broader review of this Order relating to the SNAc requirements on the remaining 128 of the original 145 substances based on the availability of new data. Should stakeholders have new information or commercial interest in any of these substances, they are encouraged to contact the New Substances Program through the Substances Management Information Line at [email protected] (email), 1-800-567-1999 (toll free in Canada) or 819-938-3232 (outside of Canada). For more information please visit http://publications.gc.ca/site/archivee-archived.html?url=http://publications.gc.ca/gazette/archives/p2/2008/2008-06-25/pdf/g214213.pdf. Footnote 7 The Order 2009-87-01-01 Amending the Domestic Substances List (SOR/2009-82) was published in the Canada Gazette, Part II, on March 18, 2009. For more information, please see SOR/DORS/2009-82 at http://publications.gc.ca/gazette/archives/p2/2009/2009-03-18/pdf/g2-14306.pdf. Footnote 8 The Order 2010-87-03-03 Amending the Domestic Substances List (SOR/2010-66) was published in the Canada Gazette, Part II, on June 25, 2010. For more information, please see SOR/DORS/2010-66 at http://publications.gc.ca/gazette/archives/p2/2010/2010-03-31/pdf/g2-14407.pdf. Footnote 9 The Order 2010-87-08-03 Amending the Domestic Substances List (SOR/2010-249) was published in the Canada Gazette, Part II, on November 10, 2010. For more information, please see SOR/DORS/2010-249 at http://publications.gc.ca/ gazette/archives/p2/2010/2010-11-10/pdf/g2-14423.pdf. Footnote 10 For more information, please visit http://www. chemicalsubstanceschimiques.gc.ca/group/azo_benzidine/index- eng.php. Footnote 11 For more information, please visit http://www.gazette.gc.ca/rp-pr/p1/2016/2016-05-28/html/notice-avis-eng.php#nb1; http://www.gazette.gc.ca/rp-pr/p1/2016/2016-05-28/html/notice-avis-eng.php#nb4; http://www.gazette.gc.ca/rp-pr/p1/2016/2016-05-28/html/notice-avis-eng.php#nb2; and http://www.gazette.gc.ca/rp-pr/p1/2016/2016-06-18/html/notice-avis-eng.php#na3. Footnote 12 Masked names are allowed by CEPA to protect confidential business information. The procedure for creating a masked name is set out in the Masked Name Regulations. Anyone who wishes to determine if a substance is on the DSL under a masked name must file a Notice of Bona Fide Intent to Manufacture or Import with the New Substances Program. Footnote 13 The Guidelines for the Notification and Testing of New Substances (Chemicals & Polymers) are available at http:// publications.gc.ca/site/eng/280464/publication.html. Footnote 14 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 15 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 16 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 17 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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