SOR/2016-150: Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999 — Order Adding Canadian Environmental Protection Act, 1999
REGISTRATION OF FEDERAL REGULATION - VIA PART II OF THE GAZETTE
June 18, 2016
REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Order.) Issues The House of Commons unanimously voted on March 24, 2015 that microbeads in consumer products entering the environment could have serious harmful effects, and therefore the Government of Canada (the Government) should take immediate measures to add microbeads to the List of Toxic Substances in Schedule 1 of the... (Click for more)
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Published on June 18, 2016
SOR/2016-150: Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999 — Order Adding Canadian Environmental Protection Act, 1999
REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Order.) Issues The House of Commons unanimously voted on March 24, 2015 that microbeads in consumer products entering the environment could have serious harmful effects, and therefore the Government of Canada (the Government) should take immediate measures to add microbeads to the List of Toxic Substances in Schedule 1 of the Canadian Environmental Protection Act, 1999 (CEPA). In response to the House’s motion, the Department of the Environment (the Department) has reviewed the state of the existing knowledge on the presence of plastic microbeads in the environment and their effects. On July 30, 2015, the Department published a science summary to that effect. This report indicates that plastic microbeads have shown adverse effects in aquatic organisms. In addition, plastic microbeads may reside in the environment for a long time and they are continuously released to the environment resulting in long-term adverse effects on biological diversity and in the ecosystem. As a precautionary step, the Government is adding this substance to the List of Toxic Substances to allow for regulatory development. On June 23, 2015, under the Canadian Council of Ministers of the Environment (CCME), federal, provincial and territorial environment ministers acknowledged efforts by industry to eliminate the use of plastic microbeads from consumer products and supported the Department’s scientific review of plastic microbeads in personal care products. The plastic microbeads of concern are solid plastic particles that are less than or equal to 5 mm (in the largest external dimension) which are added to personal care products to exfoliate or cleanse the human body. A Notice of Intent to regulate microbeads in personal care products was published in the Canada Gazette, Part I, on August 1, 2015, and a consultation document for the proposed Regulations was published on February 10, 2016, followed by a 30-day public comment period. The name of the substance for addition was modified after extensive stakeholder consultations to further align with the Government of Canada’s intentions to control plastic microbeads in personal care products. Background Canadians depend on chemical substances that are used in the manufacture of hundreds of goods, from medicines to computers, fabrics, and fuels. Unfortunately, some chemical substances can have detrimental impacts on human health or the environment when released into the environment. A key element of the Chemicals Management Plan (CMP) is its ability to consider emerging issues. As a result of the vote in the House of Commons on March 24, 2015, plastic microbeads were prioritized for review under the CMP. Following a thorough review of over 130 scientific publications, a Science Summary was produced, which describes the potential impacts of plastic microbeads on the environment, and was used to determine whether plastic microbeads met one or more of the criteria set out in section 64 of CEPA. Specifically, whether plastic microbeads are entering or may enter the environment in a quantity or concentration or under conditions that (a) have or may have an immediate or long-term harmful effect on the environment or its biological diversity; (b) constitute or may constitute a danger to the environment on which life depends; or (c) constitute or may constitute a danger in Canada to human life or health. Based on the review of this existing science, it was concluded that plastic microbeads met the environmental criterion under paragraph 64(a) of CEPA. The science review was peer-reviewed internally and externally by leading experts and published on the Chemical Substances Web site. In addition, a notice on proposed regulatory actions and a proposed order to add plastic microbeads to Schedule 1 of CEPA were published in the Canada Gazette, Part I, on August 1, 2015. These publications signalled the intent of the Minister of the Environment and the Minister of Health (the Ministers) with regards to further risk management activities. (see footnote 2) All the publications mentioned above may be obtained from the Chemical Substances Web site or from the Program Development and Engagement Division, Department of the Environment, Gatineau, Quebec K1A 0H3, 819-938-5212 (fax), or by email at [email protected] Substance descriptions and assessment conclusions Due to their physical and chemical properties, plastic microbeads may slip through wastewater treatment plants and end up in rivers, lakes, seas, and oceans. Available scientific documents indicate that plastic microbeads contribute to the volume of plastic litter in the environment and that the continued use of plastic microbeads in personal care products will result in their increased presence in the environment. Once in the environment, microbeads can be ingested by a wide range of organisms such as fish, seals, and birds. As a result, it is possible for microbeads to enter the food chain. Microplastics, which include microbeads, have been measured in Canadian waters and sediments. In laboratory studies, the substance has shown adverse short-term and long-term effects in aquatic organisms. Additionally, microbeads can adsorb persistent organic pollutants (POPs) such as polychlorinated biphenyls (PCBs) and dichlorodiphenyltrichloroethane (DDT) from the marine environment and are harmful to organisms that eat these microbeads. Plastic microbeads may reside in the environment for a long time, and continuous release of the substance to the environment may result in long term effects on biological diversity and ecosystems. (see footnote 3) According to submissions in response to a 2015 survey issued under section 71 of CEPA, in 2014, approximately 100 000 kg of plastic microbeads in exfoliating and cleansing personal care mixtures and products were imported into Canada. In addition, between 1 000 and 10 000 kg of plastic microbeads were used in Canada in the manufacture of exfoliating and cleansing personal care mixtures and products. The substance is primarily released to the environment from the use of down-the-drain products used by consumers. A review of the scientific literature did not identify studies that indicated concerns for human health related to the presence of plastic microbeads in personal care products. It is expected that plastic microbeads, present in personal care products applied to the skin, are not adsorbed by the body but rather rinsed off and ultimately released to the environment. While questions related to the potential effects on human health through consumption of seafood containing plastic microbeads have been raised by the public, there is limited to no information on this source of exposure and therefore the scope of the Science Summary Report was limited to environmental impacts. Other jurisdictions The province of Ontario is currently considering Bill 75, Microbead Elimination and Monitoring Act, 2015, which would prohibit the manufacture of microbeads and the addition of microbeads to cosmetics, soaps or similar products. In addition, the Bill would require the province to conduct water sampling for microbeads in the Great Lakes. Currently, nine States in the United States (U.S.) [Illinois, Colorado, Wisconsin, Indiana, Maine, Maryland, New Jersey, Connecticut and California] have passed laws that prohibit selling and manufacturing of microbeads in personal care products. Timelines for the coming-into-force of these prohibitions range from 2015 to December 31, 2019. In addition, a U.S. federal bill (H. R. 1321) entitled the “Microbeads-Free Waters Act of 2015” became law (No. 114-114) on December 28, 2015. The federal law will place restrictions on the manufacture or introduction or delivery for introduction into commerce of rinse-off cosmetic products and non-prescription drugs containing microbeads. The restrictions of rinse-off cosmetic products containing microbeads will come into effect on July 1, 2017 for manufacture, and on July 1, 2018 for sale. For non-prescription drugs, the timelines are July 1, 2018 for manufacturing and July 1, 2019 for sale. Plastic microbeads have been identified as a concern by different international organizations. According to the United Nations Environment Programme, plastic ingredients, such as microbeads, in personal care products which are released down-the-drain are released to the environment from raw sewage, treated effluent, biosolids, landfilling or dumping at sea. (see footnote 4) According to a study by the United Nations Joint Group of Experts on the Scientific Aspects of Marine Environmental Protection, microplastics which include microbeads, have been found in a variety of marine organisms and once ingested can affect the organisms’ physiology and potentially compromise their fitness. (see footnote 5) Risk management activities on marine litter, which include microplastics and microbeads, are also underway by the United Nations Environmental Program, Organization for Economic Co-operation and Development, Asia-Pacific Economic Cooperation, United Nations Convention on Biological Diversity, and the G7. In December 2014, at the European Union Environmental Council meeting, Austria, Belgium, the Netherlands, Luxembourg, and Sweden jointly called on European Union member states to ban the addition of microbeads to consumer products, in order to protect the aquatic environment from pollution. According to a petition response issued on April 29, 2015, the European Commission is gathering the necessary information and evidence for developing options to achieve a reduction of microplastics in cosmetic products. Voluntary industry phase-out Many producers of personal care products containing plastic microbeads have pledged to phase out the use of plastic microbeads in the next few years. Of the 14 members of the Canadian Cosmetic, Toiletry, and Fragrance Association (CCTFA) that responded to a voluntary survey for companies that had previously used or were using microbeads in 2015, 5 had already eliminated the use of plastic microbeads and 9 had committed to do the same by 2018 or 2019. CCTFA member companies account for the majority of plastic microbeads in personal care products in Canada. Objective The objective of the Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999 is to enable the Minister of the Environment (the Minister) to propose risk management instruments under CEPA to manage environmental risks posed by plastic microbeads, should such instruments be deemed necessary. Description The Order adds plastic microbeads (see footnote 6) that are ≤ 5 mm in size to Schedule 1 of CEPA (the List of Toxic Substances). “One-for-One” Rule The “One-for-One” Rule does not apply, as the Order will not impose any administrative burden on business. Small business lens The small business lens does not apply, as the Order will not impose any compliance or administrative costs on small business. Consultation On July 31, 2015, the Ministers published a Science Summary Report on plastic microbeads, which outlined the current state-of-the-science associated with plastic microbeads in the environment and recommended that plastic microbeads be considered to meet the environmental criterion as set out in paragraph 64(a) of CEPA. This Report was peer-reviewed by experts in the area of fate and effects of microbeads. On August 1, 2015, the Ministers published in the Canada Gazette, Part I, a proposed order to recommend that the substance be added to Schedule 1 to the Act. In addition, the Ministers also published a Notice of Intent in the Canada Gazette, Part I to initiate the development, under CEPA, of proposed regulations to prohibit the manufacture, import, sale and offer for sale of microbeadcontaining personal care products that are used to exfoliate or cleanse. During the 60-day comment period, comments on the proposed Order were received from two non-governmental organizations, thirteen industry associations and companies, one province, and two from the general public. Based on the written comments and subsequent consultations, the proposal was refined. Below is a summary of comments received: Microbeads, when proposed for addition to Schedule 1 of CEPA on August 1, 2015, were listed as “synthetic polymer particles that, at the time of their manufacture, are greater than 0.1 µm and less than or equal to 5 mm in size”. Eight industry associations and three companies expressed concerns with the proposed Order and provided a number of specific suggestions. Industry stakeholders indicated that the proposed listing name was too broad and that its scope would capture all polymers/plastics, which may lead to unintended stigmatization and over-regulation of the polymers/plastics supply chain in Canada. They further noted that the proposed listing name went beyond the House of Commons resolution, which focused on microbeads in consumer products, and beyond the scope of the Science Summary Report by targeting almost all polymers. Stakeholders suggested that the listing name be focused on end-use applications for microbeads, such as exfoliants and cleansers, or that the listing name specifies intended release to the environment. Response: The Department acknowledges the concerns raised by industry, including the risk of stigmatization. However, the House of Commons unanimously voted in favour of a motion to add microbeads to the List of Toxic Substances because microbeads in consumer products entering the environment could have serious harmful effects. The Department has engaged stakeholders, since prepublication, to communicate that it is not possible to constrain this listing based on source or end-use application (e.g. personal care products). However, the Government has clarified that the microbeads of concern are those in personal care products that are used to exfoliate or cleanse, and that proposed risk management would focus on microbeads in these products. 2. Industry stakeholders noted that the original term “polymer” would encompass other polymers in the same size range used for other applications and functions such as binders, bulking agents, viscosity control agents, etc. Response: The term “microbeads” has been added to the listing name as it is commonly used by the cosmetics sector and the term “plastic” has also been added as it excludes other types of microbeads (e.g. silica), which were not part of the scope of the Science Summary Report. These changes more accurately reflect the plastic microbeads used in personal care products. 3. Industry stakeholders questioned the validity of the upper size limit of 5 mm and noted that plastic microbeads used in personal care products are generally less than this upper limit. Response: On February 9, 2016, the Government published a consultation document on the proposed Regulations for Microbeads in Personal Care Products Used to Exfoliate or Cleanse. This document presented a revised listing name with an upper size limit of 2 mm and a lower size limit of 0.5 µm. Several comments have been submitted by various organizations recommending that the Government align with current U.S. legislation. The Department has consulted with other jurisdictions and, while the majority of microbeads in personal care products will be captured by the 2 mm limit, there is uncertainty about products containing microbeads above 2 mm. Therefore, the Department is maintaining the 5 mm upper limit from the proposed listing and removed the lower bound to allow for regulatory alignment with the United States. 4. Six industry associations raised concerns with the limited consultation on the development of the proposed Order. It was noted that the process followed for the proposed Order on microbeads is not consistent with that under the Chemicals Management Plan (CMP). Response: The process for the development of the proposed Order is different than the typical CMP publications because microbeads were prioritized as part of the CMP based on the House of Commons unanimous Resolution. The Department used the quickest reliable option to conform with the Resolution. In addition, the Science Summary published on microbeads underwent external peer-review, and the findings are supported by subject-matter experts. 5. One industry association noted that political considerations and not science led to the proposed Order on microbeads. Response: The House’s Resolution led the Government to prioritize the assessment of microbeads under the CMP but the Science Summary Report provides the scientific basis for the conclusion that microbeads meets the statutory criterion for toxicity set out in paragraph 64(a) of CEPA. Rationale Based on the Science Summary Report, it has been recommended that plastic microbeads constitute a danger to the environment as per the criterion set out under paragraph 64(a) of CEPA. The Government is adding plastic microbeads that are ≤ 5 mm in size to the List of Toxic Substances in Schedule 1 of CEPA. The addition will enable the proposal of risk management instruments under CEPA to manage environmental risks posed by plastic microbeads in down-the-drain personal care products that are used to exfoliate or cleanse the human body should such instruments be deemed necessary. The addition of a substance to Schedule 1 of CEPA does not result in any incremental impacts (benefits or costs) on the public or on industry, since there are no compliance requirements. Accordingly, there is no compliance or administrative burden on small businesses or businesses in general. The Minister will assess the costs and benefits and consult with the public and other stakeholders during the development of risk management proposals under CEPA for this substance. In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a strategic environmental assessment under the CMP was completed. Please see: http://www. chemicalsubstanceschimiques.gc.ca/plan/sea-ees-eng.php. Implementation, enforcement and service standards Adding the substance to Schedule 1 of CEPA enables the development of regulatory instruments and non-regulatory instruments under CEPA, to manage the environmental risks posed by the substance. Developing an implementation plan, a compliance strategy or establishing service standards are not considered necessary for this Order. An appropriate assessment of implementation, compliance and enforcement will be undertaken during the development of proposed risk management instrument(s) respecting preventive or control actions for this substance. The development of the evaluation will take into consideration products regulated under the Food and Drugs Act and the Canada Consumer Product Safety Act. Contacts Greg Carreau 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) 1-819-938-3232 (outside of Canada) Fax: 819-938-5212 Email: [email protected] Yves Bourassa Regulatory Analysis and Valuation Division Department of the Environment Gatineau, Quebec K1A 0H3 Telephone: 873-469-1452 Email: [email protected] Footnote a S.C. 2004, c. 15, s. 31 Footnote b S.C. 1999, c. 33 Footnote c S.C. 1999, c. 33 Footnote 1 S.C. 1999, c. 33 Footnote 2 For more information on these publications, please visit http://www.chemicalsubstanceschimiques.gc.ca/plan/approach-approche/microb-eng.php. Footnote 3 For more information on the environmental assessment, please see the Science Summary Report at http://www.ec.gc.ca/ese-ees/ADDA4C5F-F397-48D5-AD17-63F989EBD0E5/Microbeads_Science%20Summary_EN.pdf. Footnote 4 “Plastic in Cosmetics: Are we polluting the environment through personal care” Fact Sheet. UNEP, 2015. Footnote 5 “Microplastics in the ocean: A global assessment” GESAMP, 2015. Footnote 6 For the purposes of the Order, microbeads are particles which can vary in composition, size, shape and density. See http://www.ec.gc.ca/ese-ees/ADDA4C5F-F397-48D5-AD17-63F989EBD0E5/Microbeads_Science%20Summary_EN.pdf.
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