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Vol. 137, No. 33 — August 16, 2003 Regulations Amending the Agriculture and Agri-Food Administrative Monetary Penalties RegulationsStatutory Authority Agriculture and Agri-Food Administrative Monetary Penalties Act Sponsoring Agency Canadian Food Inspection Agency REGULATORY IMPACT Description The purposes of the Health of Animals Act and Health of Animals Regulations are: to prevent the introduction of animal diseases into Canada; to control and eliminate diseases in animals that either affect human health or could significantly affect the Canadian economy; and to provide for the humane treatment of animals during transport. The purpose of the Agriculture and Agri-Food Administrative Monetary Penalties Act (the AMPs Act) is to enhance the enforcement options currently available in respect of seven statutes administered by the Canadian Food Inspection Agency. The AMPs Act establishes an alternative to the existing penal system and supplements current enforcement measures such as prosecution. Pursuant to the AMP's Act, the Agriculture and Agri-Food Administrative Monetary Penalties Regulations (the AMPs Regulations) have been implemented to respond to violations of the Health of Animals Act and regulations and the Plant Protection Act and regulations. The AMPs Regulations currently set out provisions of these acts and their regulations, the contravention of which may result in the issuance of monetary penalties ranging from fifty dollars to six thousand dollars. In addition, the AMPs Regulations authorize compliance agreements whereby administrative monetary penalties can be reduced or canceled if persons who commit violations agree to take appropriate steps to ensure future compliance with the law and if these steps include monetary expenditures. In October 2002, a regulatory amendment repealed provisions in the Health of Animals Regulations relating to the feeding of edible residual material to swine. In January 2003, an amendment to the Health of Animals Regulations regarding livestock disease eradication requiring a permit to move cattle and farmed bison from areas of lower status for bovine tuberculosis or brucellosis to areas of higher status came into force. This amendment also resulted in a renumbering of the provisions requiring permits for moving cervids. The proposed amendment incorporates violations for the new provisions into the AMPS Regulations so that the authority exists for CFIA regional directors to issue monetary penalties in the event of non-compliance with the new requirements for permits for moving cattle or farmed bison. As well, this amendment deletes from the AMPS Regulations the violation based on the provision of the Health of Animals Regulations dealing with edible residual material, which has been repealed. Alternatives 1. Status Quo — Do not amend the current AMPs Regulations. The status quo does not provide the CFIA with AMPs as an enforcement option in the case of a violation of the animal disease eradication area provisions or of the cervid movement permit requirements. As well, this alternative would result in a useless provision remaining in the AMPs Regulations. 2. Amend the AMPs Regulations. The benefits of AMPS as an enforcement tool are numerous: AMPs is more efficient and cost effective; it decriminalizes regulatory offences by emphasizing compliance rather than punitive action; it is a more appropriate treatment of violations for which prosecution may be time consuming and costly; it provides for more immediate enforcement and more immediate corrective action; and it provides for the use of negotiated solutions to non-compliance for commercial violations. In the absence of AMPs, these benefits will not be available for the animal disease eradication area program. Benefits and Costs Updating the violations to reflect the current Health of Animals Regulations requirements will allow regional directors to continue to make use of AMPs as an enforcement tool. There are savings to be realized by proceeding with administrative monetary penalties rather than through prosecution of offences. Compliance and Enforcement AMPs provides the CFIA operations staff with an additional option to respond to non-compliance. The CFIA enforcement and compliance policy was developed in 1999 and outlines various enforcement options available under the legislation administered and enforced by the CFIA. Contact Alison Wall, Regulatory Drafting Officer, Regulatory and Intergovernmental Affairs, Canadian Food Inspection Agency, 59 Camelot Drive, Nepean, Ontario K1A 0Y9, (613) 225-2342, extension 4606 (Telephone), (613) 228-6653 (Facsimile). PROPOSED REGULATORY TEXT Notice is hereby given that the Minister of Agriculture and Agri-Food, pursuant to section 4 of the Agriculture and Agri-Food Administrative Monetary Penalties Act, proposes to make the annexed Regulations Amending the Agriculture and Agri-Food Administrative Monetary Penalties Regulations. Interested persons may make representations concerning the proposed amendment within 30 days after the date of publication of this notice. All such representations should cite the Canada Gazette, Part I, and the date of publication of this notice and be sent to Ms. Alison Wall, Canadian Food Inspection Agency, 59 Camelot Drive, Nepean, Ontario, K1A 0Y9. Tel: (613) 225-2342 (ext. 4606); Fax: (613) 228-6653.
LYLE VANCLIEF
REGULATIONS AMENDING THE AGRICULTURE AND AGRI-FOOD ADMINISTRATIVE MONETARY PENALTIES REGULATIONS AMENDMENTS 1. Items 124 and 125 of Division 2 of Part 1 of Schedule 1 to the Agriculture and Agri-Food Administrative Monetary Penalties Regulations (see footnote 1) are replaced by the following:
2. Item 195 of Division 2 of Part 1 of Schedule 1 to the Regulations is repealed. COMING INTO FORCE 3. These Regulations come into force on the day on which they are registered. [33-1-o] Virtual Elimination ListStatutory Authority Canadian Environmental Protection Act, 1999 Sponsoring Department Department of the Environment REGULATORY IMPACT Description Under subsection 65(2) of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers must compile a Virtual Elimination List. The purpose of this initiative is to propose the addition of Hexachlorobutadiene (HCBD) to the List. In December 1995, the Ministers of the Environment and Health published the second Priority Substances List, which includes Hexachlorobutadiene, under the Canadian Environmental Protection Act, which was replaced by its successor legislation, CEPA 1999. CEPA 1999 maintained, in effect, the second Priority Substances List. The scientific assessment of HCBD then followed. The conclusion of the scientific assessment indicates that HCBD is 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. HCBD was therefore concluded toxic as per paragraph 64(a) of CEPA 1999. Summaries of the draft and final Priority Substances Assessment Reports for HCBD were then published in the Canada Gazette on July 1, 2000, and on May 18, 2002, respectively. Subsequently, the proposed Order to add HCBD to Schedule 1 of CEPA 1999 was published in the Canada Gazette on June 1, 2002. The proposed addition of HCBD to the Virtual Elimination List follows recent publication of the final Order adding HCBD to Schedule 1. This substance also meets the criteria for persistence and bioaccumulation according to the Persistence and Bioaccumulation Regulations made under CEPA 1999 and is present in the environment primarily as a result of human activity. Moreover, it is not a naturally occurring radionuclide or a naturally occurring inorganic substance. Therefore, the implementation of virtual elimination was proposed pursuant to subsection 77(4) of CEPA 1999 in the publication of the summaries of the draft and final Priority Substances Assessment Reports for HCBD. Consequently, this initiative proposes the addition of HCBD to the Virtual Elimination List under subsection 65(2) of CEPA 1999. The Virtual Elimination List must also specify a level of quantification (LOQ) for each substance. The term "Level of quantification" is defined in section 65.1 of CEPA 1999 as the lowest concentration that can be accurately measured using sensitive but routine sampling and analytical methods. The LOQ proposed for HCBD in chlorinated solvents is 0.06 ng/ml. Following the 60-day comment period, further to the publication of this initiative in Part I of the Canada Gazette, a final decision will be made whether to add HCBD to the Virtual Elimination List. Hexachlorobutadiene Hexachlorobutadiene (HCBD) has never been commercially produced in Canada. Formerly, the substance was imported into Canada for use as a solvent, but it is no longer imported as a pure chemical. There are no natural sources of HCBD. HCBD releases are expected to be small but possibly numerous. HCBD is generated as a by-product during the production of certain chlorinated chemicals. HCBD is found as a contaminant in certain chlorinated solvents and ferric chloride. As a result, it may be released upon the use of these chemicals. Other possible releases of HCBD in the Canadian environment could be from hazardous landfill leachates and hazardous waste incineration. Long-range transport may also contribute to its presence in the Canadian environment. HCBD may also be a contaminant in by-products generated by the magnesium industry. When HCBD is released into the environment, it migrates to air, soil, water and sediments, but HCBD tends to remain mostly in the environmental compartment to which it was released. If HCBD is emitted into air, more than 98 percent would be found in the air, about 1 percent in soil and less than 1 percent in water and sediments. If released into soil, about 99 percent would be found in the soil and about 1 percent in the air. If released into water, about 70 percent would be found in the water, about 15 percent in each of the air and sediments and less than 1 percent in the soil. HCBD is slowly removed from the atmosphere by photo-oxidation. HCBD biodegrades slowly in aerobic conditions (i.e. in environmental compartments, such as water, sediment or soil, that contain oxygen) but it would persist considerably longer under anaerobic conditions (i.e. in environmental compartments in which the oxygen concentration is depleted). HCBD bioaccumulates in the tissues of freshwater organisms, but it is quite easily metabolized and therefore does not biomagnify through the food chain. The estimated average daily intake by the general population in Canada from environmental sources is less than a Tolerable Intake derived by Health Canada on the basis of a benchmark dose or effect levels for non-cancer effects in the kidney. A Tolerable Intake is the level of intake to which it is believed a person may be exposed daily over a lifetime without deleterious effect. Implementation of Virtual Elimination under CEPA 1999 Subsection 65(1) of CEPA 1999 enacts that virtual elimination means the ultimate reduction of the quantity or concentration of the substance in the release below the level of quantification specified by the Ministers in the Virtual Elimination List. There may be relevant social, economic or technical factors that make it impossible to reach virtual elimination immediately. In these instances, the Ministers can set a release limit above the level of quantification, or set out a phased approach with ever-decreasing limits until the level of quantification is reached. The statutory scheme for virtual elimination has four elements under CEPA 1999: I. With respect to a substance which is under the regime of section 77 of CEPA 1999, the publication of a final decision related to the assessment of a substance that is found toxic, persistent, bioaccumulative and is present in the environment primarily as a result of human activity, states that the Ministers intend to propose the implementation of virtual elimination for this substance. II. The substance is added to the Virtual Elimination List under subsection 65(2) of CEPA 1999. The List contains a level of quantification for each substance. III. A regulation is developed, prescribing a quantity or concentration of a substance that may be released, as required under subsection 65(3) of CEPA 1999 for substances on the Virtual Elimination List. This is sometimes referred to as the "release limit." IV. Virtual elimination plans may be required as part of a longer-term strategy to generate information to monitor progress towards virtual elimination and determine if additional measures are required. Alternatives The Assessment Report concludes that HCBD is toxic under paragraph 64(a) of CEPA 1999. HCBD also meets the criteria for persistence and bioaccumulation according to the Persistence and Bioaccumulation Regulations of CEPA 1999 and is present in the environment primarily as a result of human activity. Moreover, it is not a naturally occurring radionuclide or a naturally occurring inorganic substance. Consequently, the Ministers are required by CEPA 1999 to propose the addition of HCBD to the Virtual Elimination List. No other alternative is acceptable in this situation. Benefits and Costs The addition of HCBD to the Virtual Elimination List allows actions to be taken to virtually eliminate HCBD in releases, thereby ensuring the protection of the environment. The decision to add HCBD to the Virtual Elimination List is solely based on a scientific assessment. The Government will assess the potential impacts of implementing virtual elimination of the substance during the risk management phase. Consultation The public and stakeholders were given opportunity to comment during the 60-day comment period following the publication in the Canada Gazette of the summary draft Priority Substances Assessment Report for HCBD on July 1, 2000. A 60-day comment period also followed the publication in the Canada Gazette of the proposed Order to add HCBD to the List of Toxic Substances in Schedule 1 of CEPA 1999 on June 1, 2002. No comment opposed the proposed implementation of virtual elimination stated in these Canada Gazette notices. The CEPA National Advisory Committee and relevant federal government departments were consulted on the Virtual Elimination Approach, the Addition of HCBD to the Virtual Elimination List and also the proposed Risk Management Strategy for HCBD. There were no concerns raised. Stakeholders were also consulted on the proposed Risk Management Strategy for HCBD and the proposed level of quantification during a consultation meeting held in Ottawa in December 2002. One comment was received from industry expressing concern about the LOQ determination for HCBD in chlorinated solvents, proposing that it should be based on more representative samples and possibly a more common analytical method. Environment Canada believes that the selected analytical method is regularly used by organic chemistry labs involved in the analysis of micro-pollutants and the number and type of samples taken were representative. Further discussions will take place with stakeholders prior to publication of the final Order in the Canada Gazette, Part II. Any person still wishing to raise concerns or comments about the proposed Order can do so during the 60-day comment period after the publication of this Order in the Canada Gazette, Part I. Compliance and Enforcement There are no compliance promotion or enforcement requirements associated with the Virtual Elimination List. Contacts Louise Power, Senior Manager, CEPA Toxics Administration, Department of the Environment, Gatineau, Quebec K1A 0H3, (819) 994-2335 (Telephone), louise.power@ec.gc.ca (Electronic mail); and Céline Labossière, Senior Economist, Regulatory and Economic Analysis Branch, Department of the Environment, Gatineau, Quebec K1A 0H3, (819) 997-2377 (Telephone), celine. labossiere@ec.gc.ca (Electronic mail). PROPOSED REGULATORY TEXT Notice is hereby given, pursuant to subsection 332(1) of the Canadian Environmental Protection Act, 1999 (see footnote a) , that the Minister of the Environment and the Minister of Health, pursuant to subsection 65(2) of that Act, propose to compile the annexed Virtual Elimination List, effective on the day on which it is registered. Any person may, within 60 days after the date of publication of this notice, file with the Minister of the Environment comments with respect to the proposed List or a notice of objection requesting that a board of review be established under section 333 of that Act and stating the reasons for the objection. All comments and notices must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to James Riordan, Executive Director, National Office of Pollution Prevention, Toxics Pollution Prevention Directorate, Environmental Protection Service, Department of the Environment, Ottawa, Ontario K1A 0H3. A person who provides information to the Minister of the Environment may submit with the information a request for confidentiality under section 313 of that Act. Ottawa, July 3, 2003
DAVID ANDERSON
VIRTUAL ELIMINATION LIST VIRTUAL ELIMINATION LIST
[33-1-o] SOR/2000-187; SOR/2003-257 S.C. 1999, c. 33 |
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