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Vol. 137, No. 47 — November 22, 2003 Regulations Amending the Food and Drug Regulations (1372 — Trimethylsulfonium Cation)Statutory Authority Food and Drugs Act Sponsoring Department Department of Health REGULATORY IMPACT Description Glyphosate, formulated as trimethylsulfonium salt, is registered under the Pest Control Products Act as a herbicide for the control of annual and perennial grasses, and broadleaf weeds in a wide variety of crops as pre-plant incorporated, pre-emergent and post-emergent treatments, and for pre-harvest management. Maximum Residue Limits (MRLs) have been established under the Food and Drugs Act for residues of trimethylsulfonium cation resulting from this use at 15 parts per million (p.p.m.) in barley and oat milling fractions, excluding flour, 10 p.p.m. in oats and rapeseed (canola), 3 p.p.m. in flax, peas and wheat, 1 p.p.m. in beans and 0.5 p.p.m. in lentils. An MRL has also been established at 0.5 p.p.m. in kidney and liver of cattle, goats, hogs, poultry and sheep to cover residues in food derived from animals fed with crops treated with glyphosate, formulated as trimethylsulfonium salt. By virtue of subsection B.15.002(1) of the Food and Drug Regulations, the MRL for other foods is 0.1 p.p.m. The Pest Management Regulatory Agency (PMRA) of Health Canada has recently approved an application to amend the registration of glyphosate, formulated as trimethylsulfonium salt, in order to allow its use for the control of annual and perennial grasses, and broadleaf weeds in soybeans as pre-plant incorporated, pre-emergent and post-emergent treatments, and for pre-harvest management. This proposed regulatory amendment would establish MRLs for residues of trimethylsulfonium cation resulting from this use in soybeans in order to permit the sale of food containing these residues. The proposed regulatory amendment would also establish MRLs in eggs; kidney of horses; meat and meat by-products of cattle, goats, hogs, horses and sheep; meat of poultry; and milk to cover residues in food derived from animals fed with crops treated with glyphosate, formulated as trimethylsulfonium salt. The proposed regulatory amendment would also increase the MRL for lentils from 0.5 p.p.m. to 1.5 p.p.m., increase the MRL for kidney of cattle, goats, hogs and sheep from 0.5 p.p.m. to 1 p.p.m., and decrease the MRL for kidney and liver of poultry from 0.5 p.p.m. to 0.1 p.p.m. as a result of the evaluation of additional data submitted in connection with this application. Before making a registration decision regarding a new use of a pest control product, the PMRA conducts the appropriate assessment of the risks and value of the product specific to its proposed use. The registration of the pest control product will be amended if the data requirements for assessing value and safety have been adequately addressed, the evaluation indicates that the product has merit and value, and the human health and environmental risks associated with its proposed use are acceptable. The human health risk assessment includes an assessment of dietary risks posed by expected residues of the pest control product, as determined through extensive toxicological studies. An acceptable daily intake (ADI) and/or acute reference dose (ARD) is calculated by applying a safety factor to a no observable adverse effect level or, in appropriate cases, by applying a risk factor which is calculated based on a linear low-dose extrapolation. The potential daily intake (PDI) is calculated from the amount of residue that remains on each food when the pest control product is used according to the proposed label and the intake of that food from both domestic and imported sources in the diet. PDIs are established for various Canadian subpopulations and age groups, including infants, toddlers, children, adolescents and adults. Provided that the PDI does not exceed the ADI or ARD for any subpopulation or age group and that the lifetime risk is acceptable, the expected residue levels are established as MRLs under the Food and Drugs Act to prevent the sale of food with higher residue levels. Since, in most cases, the PDI is well below the ADI and lifetime risks are very low when MRLs are originally established, additional MRLs for the pest control product may be added in the future. After the review of all available data, the PMRA has determined that MRLs for residues of trimethylsulfonium cation of 13 p.p.m. in soybeans, 1.5 p.p.m. in lentils, 1 p.p.m. in kidney of cattle, goats, hogs, horses and sheep, 0.5 p.p.m. in meat and meat by-products of cattle, goats, hogs, horses and sheep, and milk, 0.1 p.p.m. in kidney and liver of poultry, 0.05 p.p.m. in meat of poultry and 0.02 p.p.m. in eggs would not pose an unacceptable health risk to the public. Alternatives Under the Food and Drugs Act, it is prohibited to sell food containing residues of pest control products at a level greater than 0.1 p.p.m. unless a higher MRL has been established in Table II, Division 15, of the Food and Drug Regulations. Also under the Food and Drugs Act, the sale of food containing residues of pest control products at a level less than or equal to 0.1 p.p.m. is permitted unless a lower MRL has been established in Table II, Division 15, of the Food and Drug Regulations. In the case of trimethylsulfonium cation, the establishment of MRLs for eggs; kidney, meat and meat by-products of cattle, goats, hogs, horses and sheep; lentils; meat of poultry; milk; and soybeans is necessary to support the additional use of a pest control product which has been shown to be both safe and effective, while at the same time preventing the sale of food with unacceptable residues. Even though the sale of food containing residues of pest control products at a level greater than 0.1 p.p.m. would already be prohibited by virtue of subsection B.15.002(1) of the Food and Drug Regulations, the establishment of an MRL of 0.1 p.p.m. in Table II, Division 15, of the Regulations for residues of trimethylsulfonium cation in kidney and liver of poultry would provide more clarity regarding the applicable MRL and would clearly indicate that the appropriate risk assessment has been completed. This is in keeping with current trends towards increased openness and transparency of regulatory processes and is consistent with current practices of most pesticide regulatory agencies throughout the world. Benefits and Costs The use of glyphosate, formulated as trimethylsulfonium salt, on soybeans will provide joint benefits to consumers and to the agricultural industry as a result of improved management of pests. In addition, this proposed regulatory amendment will contribute to a safe, abundant and affordable food supply by allowing the importation and sale of food commodities containing acceptable levels of pesticide residues. Some costs may be incurred related to the implementation of analytical methods for analysis of trimethylsulfonium cation in the foods mentioned above. Resources required are not expected to result in significant costs to the Government. Consultation Registration decisions, including dietary risk assessments, made by the PMRA are based on internationally recognized risk management principles, which are largely harmonized among member countries of the Organization for Economic Co-operation and Development. Individual safety evaluations conducted by the PMRA include a review of the assessments conducted at the international level as part of the Joint Food and Agriculture Organization of the United Nations/World Health Organization Food Standards Programme in support of the Codex Alimentarius Commission, as well as MRLs adopted by other national health/regulatory agencies. Compliance and Enforcement Compliance will be monitored through ongoing domestic and/ or import inspection programs conducted by the Canadian Food Inspection Agency when the proposed MRLs for trimethylsulfonium cation are adopted. Geraldine Graham, Alternative Strategies and Regulatory Affairs Division, Pest Management Regulatory Agency, Health Canada, Address Locator 6607D1, 2720 Riverside Drive, Ottawa, Ontario K1A 0K9, (613) 736-3692 (Telephone), (613) 736-3659 (Facsimile), geraldine_graham@hc-sc.gc.ca (Electronic mail). Notice is hereby given that the Governor in Council, pursuant to subsection 30(1) (see footnote a) of the Food and Drugs Act, proposes to make the annexed Regulations Amending the Food and Drug Regulations (1372 — Trimethylsulfonium Cation). Interested persons may make representations with respect to the proposed Regulations within 75 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Geraldine Graham, Alternative Strategies and Regulatory Affairs Division, Pest Management Regulatory Agency, Department of Health, Address Locator 6607D1, 2720 Riverside Drive, Ottawa, Ontario K1A 0K9 (Tel.: (613) 736-3692; Fax: (613) 736-3659; E-mail: geraldine_graham@hc-sc.gc.ca). Persons making representations should identify any of those representations the disclosure of which should be refused under the Access to Information Act, in particular under sections 19 and 20 of that Act, and should indicate the reasons why and the period during which the representations should not be disclosed. They should also identify any representations for which there is consent to disclosure for the purposes of that Act. Ottawa, November 19, 2003
EILEEN BOYD
REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1372 — TRIMETHYLSULFONIUM CATION) AMENDMENT 1. The portion of item T.9 of Table II to Division 15 of Part B of the Food and Drug Regulations (see footnote 1) in columns III and IV is replaced by the following:
COMING INTO FORCE 2. These Regulations come into force on the day on which they are registered. [47-1-o] S.C. 1999, c. 33, s. 347 C.R.C., c. 870 |
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