Registration

SOR/2008-218 June 19, 2008

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Polybrominated Diphenyl Ethers Regulations

P.C. 2008-1271 June 19, 2008

Whereas, pursuant to subsection 332(1) (see footnote a) of the Canadian Environmental Protection Act, 1999 (see footnote b), the Minister of the Environment published in the Canada Gazette, Part I, on December 16, 2006 a copy of the proposed Polybrominated Diphenyl Ethers Regulations, substantially in the annexed form, and persons were given an opportunity to file comments with respect to the proposed Regulations or to file a notice of objection requesting that a board of review be established and stating the reasons for the objection;

Whereas, pursuant to subsection 93(3) of that Act, the National Advisory Committee has been given an opportunity to provide its advice under section 6 (see footnote c) of that Act;

And whereas, in the opinion of the Governor in Council, pursuant to subsection 93(4) of that Act, the proposed Regulations do not regulate an aspect of a substance that is regulated by or under any other Act of Parliament in a manner that provides, in the opinion of the Governor in Council, sufficient protection to the environment and human health;

Therefore, Her Excellency the Governor General in Council, on the recommendation of the Minister of the Environment and the Minister of Health, pursuant to subsection 93(1) of the Canadian Environmental Protection Act, 1999 (see footnote d), hereby makes the annexed Polybrominated Diphenyl Ethers Regulations.

POLYBROMINATED DIPHENYL ETHERS REGULATIONS

APPLICATION

1. Subject to sections 2 to 5, these Regulations apply to polybrominated diphenyl ethers that have the molecular formula C₁₂H_(10–n)Br_nO in which 4≤n≤10 and that are specified on the List of Toxic Substances in Schedule 1 to the Canadian Environmental Protection Act, 1999.

EXCEPTIONS

2. These Regulations do not apply to any polybrominated diphenyl ether referred to in section 1 that is contained in a pest control product within the meaning of subsection 2(1) of the Pest Control Products Act.

3. These Regulations do not apply to any polybrominated diphenyl ether referred to in section 1, or to any resin, polymer or other mixture containing a polybrominated diphenyl ether set out in the schedule, that is for use

(a) in a laboratory for analysis;

(b) in scientific research; or

(c) as a laboratory analytical standard.

4. These Regulations do not apply to a product that is formed into a specific physical shape or design during its manufacture and that has, for its final use, a function or functions dependent in whole or in part on its shape or design, if that product contains a polybrominated diphenyl ether referred to in section 1.

5. These Regulations do not apply to any polybrominated diphenyl ether referred to in section 1 that is present as a contaminant in a chemical feedstock used in a process from which there are no releases of the polybrominated diphenyl ether, provided that the polybrominated diphenyl ether is destroyed or completely converted in that process to a substance that is not a polybrominated diphenyl ether.

PROHIBITIONS

6. No person shall manufacture any polybrominated diphenyl ether referred to in section 1 or any resin, polymer or other mixture containing a polybrominated diphenyl ether set out in the schedule.

7. (1) No person shall use, sell, offer for sale or import a polybrominated diphenyl ether set out in the schedule or any resin, polymer or other mixture containing such a substance.

(2) Subsection (1) does not apply to any polybrominated diphenyl ether or resin, polymer or other mixture that is to be

(a) re-processed on-site in a process from which there are no releases of the substance; or

(b) disposed of in accordance with the laws of the jurisdiction where the disposal is to take place.

ANALYSIS BY ACCREDITED LABORATORY

8. The presence of any polybrominated diphenyl ether shall be determined by a laboratory that is accredited under the International Organization for Standardization standard ISO/IEC 17025: 2005, entitled General requirements for the competence of testing and calibration laboratories, as amended from time to time, and whose accreditation includes the analysis of polybrominated diphenyl ethers within its scope of testing.

COMING INTO FORCE

9. These Regulations come into force on the day on which they are registered.

SCHEDULE (Sections 3, 6 and 7)

POLYBROMINATED DIPHENYL ETHERS WHOSE MANUFACTURE, USE, SALE, OFFER FOR SALE OR IMPORTATION IS PROHIBITED

1. Benzene, 1,1′-oxybis-, tetrabromo derivative that has the molecular formula C₁₂H₆Br₄O (tetraBDE)

2. Benzene, 1,1′-oxybis-, pentabromo derivative that has the molecular formula C₁₂H₅Br₅O (pentaBDE)

3. Benzene, 1,1′-oxybis-, hexabromo derivative that has the molecular formula C₁₂H₄Br₆O (hexaBDE)

REGULATORY IMPACT
ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Description

Purpose

The Polybrominated Diphenyl Ethers Regulations (the Regulations) are made under subsection 93(1) of the Canadian Environmental Protection Act 1999 (CEPA 1999). The purpose of the Regulations is to protect Canada’s environment from the risks associated with polybrominated diphenyl ethers (PBDEs) by preventing their manufacture and restricting their use in Canada, thereby minimizing their releases into the environment.

Specifically, the Regulations:

i) prohibit the manufacture of PBDEs (tetraBDE, pentaBDE, hexaBDE, heptaBDE, octaBDE, nonaBDE and decaBDE congeners (see footnote 1)), and;

ii) prohibit the use, sale, offer for sale and import of those specific PBDEs that meet the criteria for virtual elimination under CEPA 1999 (tetraBDE, pentaBDE and hexaBDE congeners), as well as mixtures, polymers and resins containing these substances.

These Regulations target the raw materials, and do not apply to manufactured articles or final products containing PBDEs that are imported or already in use in Canada.

The Regulations come into force on the day on which they are registered.

Background

The Chemicals Management Plan, (see footnote 2) announced in December 2006, is part of the government’s comprehensive environmental agenda. It will further strengthen the degree of protection for Canadians and their environment against chemicals that have not yet undergone scientific assessment. Through an exercise called “categorization,” 4 300 of 23 000 existing substances were identified as requiring further attention by the federal government. This will take the form of further assessment, supported by research and monitoring, and will lead to the management of these priority substances.

A key element of the Chemical Management Plan includes taking immediate action on five substance categories, including PBDEs.

The Regulations represent an important first step in the risk management of PBDEs, with a focus on the PBDE congeners that meet the criteria for virtual elimination. The Regulations are also part of a more comprehensive risk management strategy for all PBDEs. (see footnote 3) Under this strategy, additional measures and activities are being developed to complement these Regulations, including:

• a regulation to control PBDEs in manufactured products;
• a voluntary approach (i.e. Performance Agreement [PA]) to minimize releases to the environment from the use of the DecaBDE commercial mixture in the manufacturing of semi-finished and finished products in Canada;
• a detailed review of newly published science on decaBDE, to determine whether further controls on this form of PBDE are warranted;
• the development of a management strategy for PBDE-containing products at end-of-life, and;
• the monitoring of Canadians’ exposure to PBDEs and concentrations in the environment.

The risk management objective for PBDEs is to prevent the introduction of their manufacture and to minimize their release into the environment from all sources in Canada. Since there is no manufacture of any form of PBDEs in Canada, and the commercial use of tetraBDE, pentaBDE and hexaBDE congeners have been phased out internationally and in Canada since 2006, the Regulations constitute a preventative approach to ensure that these activities are not introduced in Canada.

On July 1, 2006, the Ministers of the Environment and of Health published their final decision on the screening assessment of PBDEs in the Canada Gazette, Part I. (see footnote 4) The screening assessment (see footnote 5) recommended that PBDEs with four or more bromine atoms be added to the List of Toxic Substances in Schedule 1 of CEPA 1999. On December 27, 2006, the order to add these PBDE congeners to the List of Toxic Substances in Schedule 1 of CEPA 1999 was published in the Canada Gazette, Part II. (see footnote 6)

Environment Canada’s Ecological Screening Assessment Report indicated that the greatest potential risks from PBDEs in the Canadian environment are the secondary poisoning of wildlife from the consumption of prey containing elevated concentrations of PBDEs, and effects on benthic (see footnote 7) organisms, which may result from elevated concentrations of certain PBDE congeners in sediments.

The 2006 screening assessment report also concluded that PBDEs are entering the environment in a quantity or concentration, or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity. More specifically, it concluded that tetraBDE, pentaBDE and hexaBDE congeners meet the criteria for persistence and bioaccumulation, as defined by the Persistence and Bioaccumulation Regulations of CEPA 1999. The screening assessment also concluded that their presence in the environment results primarily from human activity (that is, releases from product manufacturing and processing, and throughout the product life cycle). As a result, tetraBDE, pentaBDE and hexaBDE congeners meet the conditions for virtual elimination, as set out in subsection 77(3) of CEPA 1999.

The Health Canada Screening Assessment Report on PBDEs concluded that worst-case estimates of the exposure of Canadians to PBDEs were much less than those that caused health effects in animals. While the assessment concluded that PBDEs were not harmful to human health at current levels of exposure, Health Canada supports Environment Canada’s actions to limit the use of PBDEs so that future levels do not reach a point where they could potentially harm the health of Canadians. Health Canada, as part of its monitoring programs (e.g. the Canadian Health Measures Survey [CHMS]) will continue to observe PBDE concentrations in adults, infants, pregnant women, and umbilical cord blood. These monitoring activities would establish a representative baseline of PBDE concentrations in humans, help identify future trends, and allow comparisons with other countries. Various research studies continue to monitor a range of PBDE congeners in the environment.

PBDE congeners and commercial mixtures

PBDEs are sold in three commercial mixtures: PentaBDE, OctaBDE and DecaBDE. Although the three commercial mixtures vary in composition, each contains a typical mixture of diphenyl ethers with varying degrees of bromination, as summarized in Table 1 below.

Table 1 — Typical compositions of the PBDE commercial mixtures (see footnote 8)

Commercial Mixtures	PBDE Congener Groups
	tetraBDE	pentaBDE	hexaBDE	heptaBDE	octaBDE	nonaBDE	decaBDE
PentaBDE	24-38%	50-62%	4-12%	trace	—	—	—
OctaBDE	—	0.5%	12%	45%	33%	10%	0.7%
DecaBDE	—	—	—	—	trace	0.3-3%	97-98%
PBDE congeners targeted for virtual elimination in bold

For the purposes of this Regulatory Impact Analysis Statement (RIAS), (see footnote 9) the commercial mixture Pentabromodiphenyl Ether, predominantly a mixture of pentaBDE, tetraBDE, and hexaBDE congeners, which may also contain trace levels of heptaBDE and tribromodiphenyl ether (triBDE) congeners, will be referred to as PentaBDE. The commercial mixture Octabromodiphenyl Ether, a mixture composed mainly of heptaBDE, octaBDE and hexaBDE congeners, which may also contain small amounts of pentaBDE, nonaBDE and decaBDE congeners, will be referred to as OctaBDE. The commercial mixture Decabromodiphenyl Ether, predominantly composed of decaBDE, with small amounts of nonaBDE and octaBDE congeners, as well as trace amounts of other PBDEs, will be referred to as DecaBDE.

The regulatory prohibitions placed on tetraBDE, pentaBDE and hexaBDE congeners would impact only the PentaBDE and OctaBDE commercial mixtures and will not impact the DecaBDE commercial mixture.

Use profile

Polybrominated diphenyl ethers (PBDEs) are a group of chemical flame retardants that slow the ignition and spread of fire. In general, plastics are the primary end use for flame retardants due to the inherent flammability of many polymers. As such, PBDEs can be found in many items such as building and automobile materials, carpet underlay, furniture foam and electronic equipment.

PBDEs are not manufactured in Canada, but are imported for use:

• as raw materials (e.g. chemical formulations, resins, polymers or substrates);
• in semi-finished articles, materials or components; or
• in finished products.

As noted above, PBDEs are sold in three commercial mixtures, PentaBDE, OctaBDE and DecaBDE, each containing a typical composition of PBDE congeners (see Table 1). The PentaBDE and OctaBDE commercial mixtures have been phased out internationally. The only commercial mixture, DecaBDE, currently available in the market is manufactured in the United States (U.S.). PentaBDE was used almost exclusively in flexible polyurethane foam, which is used as cushioning in upholstered furniture, automotive seating and carpet backing. OctaBDE was predominantly used in acrylonitrile butadiene styrene (ABS) as a flame retardant for computer housings, pipes, appliances and automotive parts.

Based on an Environment Canada use pattern survey, (see footnote 10) in the year 2000, the PentaBDE commercial mixture was imported in the greatest volume, followed by the DecaBDE commercial mixture. Very small quantities of OctaBDE commercial mixture were imported into Canada in 2000. Significant reformulation activity has occurred in recent years related to PentaBDE and OctaBDE. All companies that reported uses of PentaBDE and OctaBDE in 2000 have reported complete phase-out since 2006. The cessation of production by the only U.S. manufacturer of PentaBDE and OctaBDE in December 2004 has also impacted Canadian imports of PBDEs contained in these mixtures. Discussions with industry and industry associations indicate that PentaBDE and OctaBDE were phased out of use due to a number of factors, such as:

• the international regulatory climate;
• the consumer demand for PBDE-free products;
• the availability of cost-effective alternatives; and
• the unavailability of PentaBDE and OctaBDE in the global market after 2005.

The DecaBDE commercial mixture was and continues to be used primarily in polystyrene (PS), particularly High Impact Polystyrene (HIPS), and a number of other resins. The DecaBDE flame retarded resins are predominantly used in electrical and electronic products, as well as upholstery and drapery textiles. As noted above, only the manufacture of decaBDE is prohibited by the Regulations and not the use, sale or import of decaBDE.

International initiatives

The PBDE Regulations represent a first step in aligning Canada with legislative actions taken on PBDEs in the U.S. and Europe. As outlined in Canada’s Risk Management Strategy on PBDEs, additional actions will further align Canada with key international initiatives in the U.S. and Europe (such as the European Union’s Restrictions on Hazardous Substances Directive [RoHS Directive]).

These international initiatives generally prohibit the manufacture, processing, or distribution of a product or part of a product treated with flame retardants that contain more than 0.1% (by mass) of PentaBDE or OctaBDE, with some exemptions. In response to these restrictions on PBDE use, many North American manufacturers have shifted to PBDE alternatives.

The major international legislative actions with respect to PentaBDE, OctaBDE and DecaBDE are presented in Table 2.

Table 2: Key International Initiatives Relevant for PentaBDE, OctaBDE and DecaBDE

Jurisdiction	Legislation/ Action	Details	Deadline for Compliance	PBDEs Impacted
EU	EU 24th amendment to the Marketing and Use Directive 76/769/EEC	Prohibits marketing and use in the EU in concentrations higher than 0.1%.	August 15, 2004	PentaBDE OctaBDE
	Restriction of Certain Hazardous Substances to Electrical and Electronic Equipment (RoHS)	Prohibits use in new electrical and electronic equipment,1 with a provision to grant exemptions. Later amended to establish 0.1% as the maximum PBDE concentration.	July 1, 2006	PentaBDE OctaBDE
	Waste from Electrical and Electronic Equipment (WEEE) Directive	Separation of BFR plastics from electric and electronic equipment prior to recovery and recycling.	December 31, 2006	PentaBDE OctaBDE Other BFRs
	Directive 2000/60/EC	Establishes a list of priority substances in the field of water policy that includes PentaBDE, OctaBDE and DecaBDE.	Not applicable	PentaBDE OctaBDE DecaBDE
Sweden		Partial ban of DecaBDE at levels higher than 0.1% in textiles, furniture and some cables.	January 1, 2007	DecaBDE
Norway	Product Regulations	Prohibit the manufacture, import, export, sale and use of substances that contain more than 0.1% of PentaBDE or OctaBDE.	September 2005	PentaBDE OctaBDE DecaBDE
	Waste Regulations	Products containing more than 0.25% PentaBDE, OctaBDE or DecaBDE are classified as hazardous waste and require special treatment.	2004
U.S.	Significant New Use Rule	Requires notification of, and evaluation by, the U.S. EPA of any new use of PentaBDE or OctaBDE commercial mixtures.	January 1, 2005	PentaBDE OctaBDE
	California prohibition	Bill prohibits manufacture, processing or distribution of a product containing more than 0.1% PentaBDE or OctaBDE. DecaBDE removed before signing into law.	June 1, 2006	PentaBDE OctaBDE
	Hawaii prohibition	Legislation prohibits manufacture, processing or distribution of a product containing more than 0.1% PentaBDE or OctaBDE.	January 1, 2006	PentaBDE OctaBDE
	Illinois prohibition	Bill prohibits manufacture, processing or distribution of a product containing more than 0.1% PentaBDE or OctaBDE, with some exemptions.	January 1, 2006	PentaBDE OctaBDE
	Maryland prohibition	Bill prohibits manufacture, processing, sale or distribution of a product containing more than 0.1% of PentaBDE or OctaBDE.	October 1, 2008	PentaBDE OctaBDE
	Maine prohibition	Bill requires phase-out of any product containing 0.1% of PentaBDE or OctaBDE.	January 1, 2006	PentaBDE OctaBDE
		Bill prohibits the use of DecaBDE in household products, with some exemptions, and the sale of products containing more than 1% DecaBDE, if a safer alternative is identified.	January 1, 2008 and January 1, 2010	DecaBDE
	Michigan prohibition	Bill prohibits manufacture, processing, or distribution of a product containing more than 0.1% of PentaBDE or OctaBDE, with some exemptions. Bill prohibits release into the environment or use of any PBDE unless permitted by the department.	June 1, 2006	PentaBDE OctaBDE
	New York prohibition	Bill prohibits the manufacture, processing or distribution of PentaBDE or OctaBDE.	January 1, 2006	PentaBDE OctaBDE
	Oregon prohibition	Bill prohibits the introduction into commerce of any products containing more than 0.1% of PentaBDE or OctaBDE, with some exemptions.	January 1, 2006	PentaBDE OctaBDE
	Rhode Island prohibition	Bill prohibits manufacture and sale of products containing more than 0.1% of PentaBDE or OctaBDE.	July 14, 2006	PentaBDE OctaBDE
	Washington prohibition	Law prohibits manufacture, sale and distribution of noncomestible products containing PBDEs, with some exemptions.	January 1, 2008	PentaBDE OctaBDE
		Law restricts the use of DecaBDE in household products, with some exemptions.	January 1, 2008 and January 1, 2011	DecaBDE
China	Management Methods for the Prevention and Control of Pollution from Electronics Information Products (China’s RoHS)	At the end of February 2006, China promulgated a law similar to the EU’s RoHS Directive. Substances targeted are the same as those targeted in the EU RoHS. Essentially, it will prohibit PentaBDE and OctaBDE use in new electric and electronic equipment when fully implemented.	March 1, 20072	PentaBDE OctaBDE

¹ Legislation states a limit of 0.1% considered a ban by industry.

² Implementation of Phase 1 of the law set for March 1, 2007; the implementation schedule for Phase 2 (full restrictions) is currently unclear but is expected to be implemented in a relatively short time frame, e.g. 1 year after Phase 1. “RoHS in China” Conformity, October 2006, p. 12-17.

Further to these legislative efforts, the private sector has initiated a number of corporate stewardship programs. These voluntary measures include green purchasing tools, such as the U.S. Electronic Product Environmental Assessment Tool (EPEAT) developed to help purchasers identify more environmentally friendly computer products. The brominated flame retardant industry has also developed the Voluntary Emissions Control Action Programme (VECAP) aimed at small and medium-sized enterprises to help manage, monitor and minimize industrial releases of PBDEs. Environment Canada is developing a PA with industry to minimize releases to the environment from the use of the DecaBDE commercial mixture in other Canadian manufacturing sectors. (see footnote 11) This voluntary program is modeled on the EU VECAP program.

In addition to the above, PentaBDE and OctaBDE commercial mixtures are being considered for addition to two international agreements, as the PBDEs contained in these commercial mixtures have the ability to undergo long-range transport, are persistent and bioaccumulative, and cause adverse environmental and/or health effects. Canada is actively involved in the process of adding PentaBDE and OctaBDE to these agreements.

Stockholm Convention on Persistent Organic Pollutants (POPs)

The Stockholm Convention on Persistent Organic Pollutants (POPs) (see footnote 12) entered into force in May 2004 and is an international legally binding agreement which has been ratified by 128 countries, including Canada. Under this Convention, Canada is bound to take action to prohibit the manufacture and import of the chemicals listed on Annex A and B of the Convention.

In November 2007, the Persistent Organic Pollutants Review Committee (POPRC-3) to the Stockholm Convention on POPs adopted the Risk Management Evaluations for PentaBDE. The Review Committee agreed to recommend that the Conference of the Parties (COP) list PentaBDE under Annex A of the Stockholm Convention. Listing on Annex A obliges Parties to the Convention to eliminate the production, use, export and import of the chemical. In addition, the Review Committee adopted a risk profile for OctaBDE and an Ad Hoc Working Group was created to prepare a Risk Management Evaluation for OctaBDE for review at its next meeting (POPRC-4).

Long-Range Transboundary Air Pollution (LRTAP) Convention

The Convention on Long-Range Transboundary Air Pollution (LRTAP) (see footnote 13) entered into force in 1983 and is an international legally binding agreement which has been ratified by 51 countries, including Canada. The Convention requires all Parties to endeavour to limit and, as far as possible, gradually reduce and prevent air pollution, including long-range transboundary air pollution.

An assessment and management review of PentaBDE and OctaBDE has also been completed by the Parties to the United Nations Economic Commission for Europe (UNECE) LRTAP Convention’s Protocol on POPs. Negotiations to add PentaBDE and OctaBDE to the Protocol began in April 2008.

Existing Canadian initiatives

The Environmental Choice Program — Environment Canada’s ecolabelling program — has established environmental criteria for notebooks and desktop computers. Certification is awarded to those that demonstrate environmental leadership throughout their life cycle and meet the following criteria: reduced use of hazardous substances (including PBDEs), designed for re-use and recycling, energy efficiency, reduced packaging, and ergonomic considerations. The reduction in the use of hazardous substances like PBDEs in products contributes to reducing the concentration of PBDEs in the environment, which in turn contributes towards achieving the risk management objective for PBDEs.

Furthermore, Canada has a number of provincial, regional and national industry Extended Producer Responsibility (EPR) (see footnote 14) programs, some of which are voluntary, although most are mandatory. (see footnote 15) These programs support waste reduction, reuse and recycling, and are designed to encourage reduction in use and pollution prevention related to toxic substances. Although PBDE congeners are not individually identified in the EPRs, these programs could indirectly target products or substances that contain PBDEs.

The Regulations

The Regulations prohibit the manufacture, use, sale, offer for sale and import of tetraBDE, pentaBDE, hexaBDE congeners, and mixtures, polymers and resins containing these substances. The manufacture of heptaBDE, octaBDE, nonaBDE and decaBDE congeners is also prohibited under these Regulations.

The following uses of PBDEs are exempt from the Regulations:

• in laboratories for analysis, scientific research, or as laboratory analytical standards. The quantities used in these applications and the associated releases are very small and represent no risk to the environment.
• in imported manufactured products and manufactured products that are already in use in Canada, such as computers, computer parts and foams. These products will be addressed through additional management actions in the future to complement the Regulations.
• in a chemical feedstock as a contaminant that is used in a process from which there are no releases of PBDEs and the PBDE is destroyed or completely converted into another substance.

Alternatives

The alternatives considered to prevent the introduction of PBDE manufacturing and use as well as to minimize their releases into the environment from all sources in Canada are discussed below.

Status quo

Currently there are no measures in place in Canada to manage the manufacture, use or release of PBDEs or their impacts on the environment and human health. Although PBDEs are not manufactured in Canada, the potential exists for these substances to be manufactured, imported and used in the future. Therefore, in order to prevent these activities in Canada, and address the impact of the potential releases of PBDEs on the environment and human health, the status quo is not a viable option.

Voluntary measures

Voluntary tools can be used to manage PBDE releases from the use of DecaBDE commercial mixture. To this end a PA (see footnote 16) is currently under development targeting the use of the DecaBDE commercial mixture in the manufacturing of semi-finished and finished products in Canada.

Since there are no users in Canada of tetraBDE, pentaBDE and hexaBDE congeners, which are contained in the PentaBDE and OctaBDE commercial mixtures, a voluntary approach for these PBDEs cannot be developed or implemented.

Similarly, voluntary measures to manage releases from PBDE manufacturing cannot be implemented as there are no manufacturers of PBDEs in Canada. Therefore voluntary measures are not being considered any further.

Market-based instruments

Market-based instruments work by encouraging changes in consumer and producer behaviour. These instruments, which under CEPA 1999 include tradeable permit programs and deposit-refund systems were given due consideration. Tradeable permits require the presence of manufacturers or users to establish a market for trading. Therefore, in the absence of manufacture and use of PentaBDE and OctaBDE in Canada, such a program cannot be developed or implemented. A tradeable permits program for releases of PBDEs from products, which are spread over a large number of products, would also be difficult to develop and implement. Releases of PBDEs occur over the life cycle of products containing PBDEs or at the disposal stage. The life cycle of products containing PBDEs vary considerably, the releases from which cannot be effectively controlled or monitored.

A deposit-refund system can be established for products that contain PBDE congeners. However, it would not be possible to identify all products that contain PBDEs. The resource requirements for setting up a deposit-refund system would be high and it would also not ensure that all products containing PBDEs are returned.

As a consequence, the use of market-based instruments was not considered an effective option.

Regulations

From the regulatory options available under CEPA 1999, regulations respecting substances on the List of Toxic Substances were considered to be the most effective, as they would address the key aspects of the substance life-cycle (such as manufacture, import, use, and sale).

Regulatory measures, compared to the other alternatives, prevent the introduction into Canada of the manufacture of PBDEs and the use of PentaBDE and OctaBDE, thereby minimizing their releases into the environment in Canada. As a result, regulations were found to be the most effective option.

Benefits and costs

The key elements of the framework used for the analysis include:

Time frame for analysis: costs are assessed over a 15-year time frame (2008 to 2022).

Accounting stance: incremental costs assessed are those that can directly or indirectly be attributed to the Regulations and accrue in Canada. These are expressed in 2006 Canadian dollars.

Discount rate: where possible, impacts are reported as present values and a discount rate of 5% is used.

Cost to industry

As discussed above, PentaBDE and OctaBDE are no longer manufactured, imported or used in Canada. Recent information collected from the industry indicates that historical uses of PentaBDE and OctaBDE have been completely phased out — there were some minor remaining uses in 2005, but complete phase-out was achieved by 2006. Furthermore, it is essentially impossible to buy PentaBDE and OctaBDE, (see footnote 17) at the present time. Drop-in (see footnote 18) substitutes for PentaBDE and OctaBDE are available and have been adopted by the industry. Therefore, the industry is not expected to experience any incremental costs as a result of the regulatory requirements.

While the manufacture of decaBDE congeners is prohibited, their import, sale and use are not subject to the Regulations. Since there is no manufacture of decaBDE in Canada and imports are still allowed, the industry will not experience any incremental cost as a result of the manufacturing prohibition on decaBDE.

Costs to government

The costs to the federal government would be as a result of enforcement and compliance promotion activities related to the Regulations. Enforcement and compliance promotion activities are likely to decrease due to international actions being taken to prohibit the manufacture and use of PentaBDE and OctaBDE.

With respect to enforcement costs, for the first year following the coming into force of the Regulations, a one-time amount of $75,000 will be required for the training of enforcement officers.

In addition, for years one through five following the delivery of the training, the enforcement costs require an estimated undiscounted annual budget of $4,350 for inspections (which includes operations and maintenance costs, transportation and sampling costs), $14,330 for investigations and $552 for measures to deal with alleged violations (including environmental protection compliance orders and injunctions).

For the subsequent years (that is years 6 through 15), the undiscounted enforcement costs are estimated to require a total budget of $29,486, broken down as follows: $13,500 for inspections (which includes operations and maintenance costs, transportation and sampling costs), $14,330 for investigations, and $1,656 for measures to deal with alleged violations.

Compliance promotion activities are intended to encourage the regulated community to achieve compliance with the Regulations. Compliance promotion costs would require an estimated undiscounted annual budget of $46,500 in the first year. In the following two years, an estimated annual budget of $12,190 will be required. For subsequent years, no additional compliance promotion activity is expected, and therefore, total undiscounted compliance promotion costs are estimated at $70,880. Compliance promotion activities could include mailing the Regulations, developing and distributing promotional materials (i.e. a fact sheet, web material), attendance at association conferences and workshops/information sessions to explain the Regulations. This could also include responding to and tracking inquiries, in addition to contributing to the compliance promotion database.

The present value of total incremental enforcement and compliance promotion costs over the 15-year time frame are estimated to be $238,400 (discounted at 5%).

Total costs

There will be no incremental cost to industry as a result of the Regulations, since PentaBDE and OctaBDE have been voluntarily substituted with other flame retardants. Therefore, the total incremental cost of the Regulations is comprised of government enforcement and compliance promotion activities, which are in the order of $238,400 over the 15-year time frame.

Benefits to Canadians

PentaBDE and OctaBDE contain congeners that are persistent, bioaccumulative, and have been declared toxic under CEPA 1999. PBDEs have also been detected in a variety of species worldwide and evidence from many studies indicates that levels of certain PBDE congeners in biota in North America (including the Canadian Arctic) are increasing steadily and substantially over time. These factors are indicators of the threat of serious or irreversible damage which can be difficult and costly to remediate.

As PentaBDE and OctaBDE have already been phased out, the incremental benefits from the discontinuation of PentaBDE and OctaBDE manufacture, import and use cannot be directly attributed to the Regulations. However, the Regulations minimize the potential risks from PBDE manufacture, import and use, by ensuring that the PentaBDE and OctaBDE commercial mixtures are not re-introduced in Canada in the future. While it is not possible to estimate the preventative benefits of the Regulations in quantitative terms, the Regulations avoid environmental remediation costs in the event that these PBDEs are manufactured, imported, used or sold in Canada in the future.

Consultation

The public and stakeholders were given opportunity to comment during the 60-day comment period following the publication in the Canada Gazette, Part I, of the proposed Order to add the substances to the List of Toxic Substances in Schedule 1 of CEPA 1999 on July 1, 2006. The comments were generally supportive of the proposal to add the substances to Schedule 1 of CEPA 1999.

The CEPA National Advisory Committee (CEPA NAC) and relevant federal government departments were consulted on the proposed Order, as well as the Risk Management Strategy for PBDEs. No concerns were raised by CEPA NAC.

Stakeholders were also consulted on the Risk Management Strategy (see footnote 19) for PBDEs through the posting of the Strategy on Environment Canada’s CEPA Registry Web site. Comments received from stakeholders on the Strategy indicate that stakeholders are supportive of the regulatory action on the manufacture of the seven PBDE congener groups in Canada and on the manufacture, use, sale and import of tetraBDE, pentaBDE and hexaBDE congeners.

Comments following pre-publication in the Canada Gazette, Part 1, on December 16, 2006

A total of four submissions were received from industry stakeholders during the 60-day comment period. Stakeholders included manufacturing associations of brominated flame retardants, vehicles, and electronic, electrical and telecommunication products, and environmental non-government organizations.

The specific comments from industry stakeholders, and Environment Canada’s response to them, are as follows:

Manufacturing prohibition on decaBDE

A number of stakeholders expressed the view that decaBDE should not be included in the Canadian manufacturing ban in the Regulations, based on a perceived lack of justification concerning the nature and extent of the danger posed by decaBDE.

The final ecological and human health screening assessment indicated that all seven PBDE congener groups, including decaBDE, have or may have an immediate or long-term harmful effect on the environment or its biological diversity. Although concentrations of decaBDE in the environment did not appear to exceed known effect thresholds, Environment Canada concluded that there were environmental concerns. These concerns were based on the overall persistence of decaBDE and their potential transformation to bioaccumulative forms, as well as observed commercial and environmental trends. Environment Canada continues to examine newly published science on decaBDE to determine whether further risk management measures are warranted.

Stakeholders also expressed a concern about the impact of the manufacturing ban on consumers and the auto industry, as DecaBDE is used to meet Canadian and American fire safety standards [specifically, the Canadian Motor Vehicle Safety Standard (CMVSS) 302 and the Federal Motor Vehicle Safety Standard (FMVSS) 302].

Environment Canada has adopted a risk management strategy, which addresses the use and release of PBDEs from various sources. As one of the first measures of this strategy, these Regulations prohibit the manufacture of all seven PBDE congener groups, including decaBDE. DecaBDE has never been manufactured in Canada, primarily due to the lack of bromine resources to make manufacturing economically and technically feasible. The prohibition on the manufacture of decaBDE ensures that it is not introduced in Canada in the future. This will ensure that there are no future releases of PBDEs from the manufacture of decaBDE. The import, sale, offer for sale and use of decaBDE is not prohibited under these Regulations. Therefore, the use of DecaBDE commercial mixture to meet the existing fire safety standards will not be impacted.

Risk Management Strategy

A stakeholder commented that the Risk Management Strategy for PBDEs was flawed as it established the manufacturing ban as the risk management objective and not the risk management tool.

The environmental objective as stated in the Risk Management Strategy is to “…reduce the concentration of PBDEs in the Canadian environment to the lowest level possible.” To achieve the environmental objective, more specific risk management objectives were developed. The risk management objective for all seven PBDE congener groups, as stated in the Risk Management Strategy, is to “…prevent the introduction of their manufacture in Canada and to minimize their releases into the environment from all sources in Canada.” These Regulations, by prohibiting the manufacture of PBDEs, ensures that there are no future releases from these sources.

Harmonization with the European Union

Stakeholders suggested that the development of future PBDE risk management measures should be consistent with the European Union’s Restrictions on Hazardous Substances (RoHS) Directive (the RoHS Directive specifies which substances should be restricted in the design of electronic and electrical equipment). The comments indicated that due to the nature of global supply chains, and due to the fact that the global community is moving toward a universal set of restrictions on the manufacture, sale and disposal of products containing PBDEs, any move by Environment Canada to place a Canadian specific and more restrictive limitations on the use of PBDEs could prove unnecessarily disruptive to the industry.

Harmonization with environmental legislation of international jurisdictions, notably the RoHS Directive, is a useful objective. Environment Canada will endeavour to harmonize Canadian risk management measures with environmental legislations of other international jurisdictions, notably the RoHS Directive (for the Regulations to address manufactured products under development). The advantages and appropriateness of the extent of harmonization will be determined within the Canadian context.

Impacts on the recycling industry

Stakeholders expressed concerns on the potential adverse impacts of the Regulations currently under development to address PBDEs in products on the refurbishment industry and the responsible recycling of plastics and electronics in Canada.

The Department recognizes that PBDEs have been used in a large range of consumer and industrial products, and that it may be difficult and costly to test and assess which products destined for recycling (or disposal) contain restricted PBDEs. In light of this complexity, as part of the development process for the product-based regulatory measure, the Department will carefully analyze provisions that may impact the recycling and refurbishment industry, and will consult with all affected stakeholders to address any potential adverse impacts.

Regulatory Impact Analysis Statement (RIAS)

Stakeholders also commented that the RIAS did not consider the impact on business interests of brominated flame retardants manufacturers as a result of the manufacturing ban on decaBDE. The stakeholders were of the opinion that other international jurisdictions may adopt a similar manufacturing ban without a rigorous analysis. As a consequence, the business interests of companies manufacturing decaBDE in international jurisdictions could be adversely affected.

The purpose of the RIAS is to assess the Canadian costs and benefits of the regulatory action. It should be noted that Canada, when aligning regulatory measures with those of other jurisdictions (e.g. United States), adapts the requirements to the Canadian context.

Notice of objection

A notice of objection on the proposed Regulations was filed by four environmental non-profit organizations, stating that the actions taken to address risk to environment and human health posed by these chemicals are inadequate. A more comprehensive ban on all PBDE congeners, especially decaBDE, was recommended. The Notice also requested the establishment of a Board of Review under subsection 332(2) and section 333 of CEPA 1999.

Environment Canada has conducted a comprehensive review of newly published science (post-2005) on decaBDE, resulting in the preparation of a draft State of the Science Report on the Bioaccumulation and Transformation of Decabromodiphenyl Ether. A scientific peer review of this draft report ended on January 8, 2008. It is anticipated that the draft report will be released for public comment in the summer of 2008, thereby ensuring transparent consultation with all stakeholders. When finalised, the Report will assist the Minister with his decision on whether to establish a Board of Review, and whether further controls on decaBDE are required. These Regulations are being implemented as a first step in the PBDE risk management strategy. Furthermore, a number of actions have already been taken to respond to issues raised in the Notice, including a revision to the Regulations with respect to the exemption for recycling of raw materials containing PBDEs.

Further information on the notice of objection and Government of Canada response will be posted on the CEPA Registry at the following link: www.ec.gc.ca/CEPARegistry/participation.

Compliance and enforcement

Since the Regulations would be made under CEPA 1999, enforcement officers will, when verifying compliance with the Regulations, apply the Compliance and Enforcement Policy implemented under the Act. The Policy also sets out the range of possible responses to violations, including: warnings, directions, environmental protection compliance orders, ticketing, ministerial orders, injunctions, prosecution, and environmental protection alternative measures (which are an alternative to a court trial after the laying of charges for a CEPA 1999 violation). In addition, the Policy explains when Environment Canada will resort to civil suits by the Crown for costs recovery.

When, following an inspection or an investigation, an enforcement officer discovers an alleged violation, the officer will choose the appropriate enforcement action based on the following factors:

• Nature of the alleged violation: This includes consideration of the damage, the intent of the alleged violator, whether it is a repeat violation, and whether an attempt has been made to conceal information or otherwise subvert the objectives and requirements of the Act.
• Effectiveness in achieving the desired result with the alleged violator: The desired result is compliance within the shortest possible time and with no further repetition of the violation. Factors to be considered include the violator’s history of compliance with the Act, willingness to co-operate with enforcement officers, and evidence of corrective action already taken.
• Consistency: Enforcement officers will consider how similar situations have been handled in determining the measures to be taken to enforce the Act.

Contacts

Lyne Monastesse, Eng.
Manager
Chemicals Management Division
Environment Canada
351 Saint-Joseph Boulevard, 17th Floor,
Gatineau, Quebec
K1A 0H3
Telephone: 819-953-1121
Fax: 819-994-0007
Email: RiskManagementPrograms@ec.gc.ca

Markes Cormier
Senior Economist
Impact Analysis and Instrument Choice Division
Environment Canada
10 Wellington Street, 24th Floor
Gatineau, Quebec
K1A 0H3
Telephone: 819-953-5236
Fax: 819-997-2769
Email: Markes.Cormier@ec.gc.ca

Footnote a
S.C. 2004, c. 15, s. 31

Footnote b
S.C. 1999, c. 33

Footnote c
S.C. 2002, c. 7, s. 124

Footnote d
S.C. 1999, c. 33

Footnote 1
PBDEs are a family of chemicals with a common structure of a borminated diphenyl ether molecule, which may have anywhere from one to ten attached bromine atoms. Each individual PBDE variant, distinguished from others by both the number of bromine atoms and the placement of those atoms, is referred to as a congener. For example, there are 42 tetrabromodiphenyl ether (tetraBDE) congeners, each with four bromine atoms in different configurations. Approximate percentages of the main congeners in these commercial mixtures are shown in Table 1.

Footnote 2
For further information, visit the Web site at: http://www.chemicalsubstanceschimiques.gc.ca/plan/index_e.html.

Footnote 3
The Risk Management Strategy for PBDEs can be found at the following Web site address: http://www.ec.gc.ca/Toxics/docs/substances/PDBE/PDBE_RMS/EN/toc.cfm.

Footnote 4
The notice for this substance is available on the CEPA Registry Web site at: http://www.ec.gc.ca/Ceparegistry/documents/notices/g1-14026_n3.pdf.

Footnote 5
The screening assessment reports for this substance are available on the CEPA Registry Web site at: www.ec.gc.ca/CEPARegistry/subs_list/assessments.cfm.

Footnote 6
The Order for this substance is available on the CEPA Registry Web site at: http://www.ec.gc.ca/CEPARegsitry/orders/OrderText.cfm?intOrder=306&intDocument=717.

Footnote 7
Organisms living in the sea or lake bottoms.

Footnote 8
For the purposes of this document, PBDE commercial mixtures are capitalized to distinguish from the congeners they contain (i.e. “PentaBDE” vs. “pentaBDE”).

Footnote 9
For the purposes of this document, PBDE commercial mixtures are capitalized to distinguish from the congeners they contain (i.e. “PentaBDE” vs. “pentaBDE”).

Footnote 10
The notice under section 71(1)(a) and 71(1)(b) of CEPA 1999 published on November 17, 2001 is available on the CEPA Registry Web site at: http://www.ec.gc.ca/Ceparegistry/documents/notices/g1-13546_n1.pdf.

Footnote 11
Draft title (March 2008) — “Performance Agreement to Control, Monitor and Minimize the Release of DecaBDE from Canadian Facilities Where DecaBDE is Used or Handled”.

Footnote 12
For further information visit the Web site at: http://www.pops.int/.

Footnote 13
For further information, visit the Web site at: www.unece.org/env/lrtap/pops_h1.htm.

Footnote 14
Extended Producer Responsibility has been defined by the OECD as “an environmental policy approach in which a producer’s responsibility, physical and/or financial, for a product is extended to the post-consumer stage of a product’s life cycle” (OECD, 2001).

Footnote 15
For further information, please visit Environment Canada’s Extended Producer Responsibility and Stewardship Web site: www.ec.gc.ca/epr/.

Footnote 16
See footnote 9.

Footnote 17
There is no production of PentaBDE and OctaBDE in North America or in Europe. Possibility of suppliers of the chemicals in other regions (e.g. Asia) was investigated and no other suppliers could be identified.

Footnote 18
In this context a “drop-in” substitute is one that can be used to replace the regulated substance without requiring any change to any other components of the product.

Footnote 19
The Risk Management Strategy for PBDEs can be found at the following Web site address: http://www.ec.gc.ca/Toxics/docs/substances/PBDE/PBDE_RMS/EN/toc.cfm.

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