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Vol. 138, No. 51 — December 18, 2004 Regulations Amending the Food and Drug Regulations (1419 — Glufosinate-ammonium)Statutory authority Food and Drugs Act Sponsoring department Department of Health REGULATORY IMPACT (This statement is not part of the Regulations.) Description Glufosinate-ammonium is registered under the Pest Control Products Act as a herbicide for the control of a wide variety of broadleaf weeds and grasses, and as a dessicant in apples, asparagus, carrots, dry beans, flax, grapes, lentils, lettuce, onions, peaches, pears, peas, plums, potatoes, rapeseed (canola), raspberries, soybeans and wheat as a pre-plant incorporated, pre-emergent or post-emergent treatment or for pre-harvest management. Maximum Residue Limits (MRLs) have been established under the Food and Drugs Act for residues of glufosinate-ammonium and its metabolite resulting from these uses at 6 parts per million (p.p.m.) in lentils, 3 p.p.m. in dry peas and rapeseed (canola), 0.5 p.p.m. in dry white beans, 0.4 p.p.m in potatoes, and 0.2 p.p.m. in corn and wheat. An MRL has also been established at 1 p.p.m. in liver and kidney of cattle, goats, hogs, poultry and sheep to cover residues in food derived from animals fed with crops treated with glufosinate-ammonium. 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. This proposed regulatory amendment would establish MRLs for residues of glufosinate-ammonium and its metabolite in imported cottonseed oil and rice, and amend the MRL for soybeans, in order to permit the import and sale of food containing these residues. The amendment would also establish MRLs in eggs, in fat, meat and meat by-products of cattle, goats, hogs, poultry and sheep, and in milk to cover residues in food derived from animals fed with crops treated with glufosinate-ammonium. In order to determine whether proposed MRLs are safe, the Pest Management Regulatory Agency (PMRA) of Health Canada conducts a dietary risk assessment. An acceptable daily intake (ADI) and/or acute reference dose (ARfD) 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 the PDI does not exceed the ADI or ARfD for any subpopulation or age group, and 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 glufosinate-ammonium, including its metabolite, of 3.5 p.p.m. in cottonseed oil, 2 p.p.m. in soybeans, 1 p.p.m. in rice, 0.1 p.p.m. in eggs and fat, meat and meat by-products of cattle, goats, hogs, poultry and sheep, and 0.04 p.p.m. in milk would not pose an unacceptable health risk to the public. This proposed regulatory ammendment would also amend the chemical name of glufosinate-ammonium in order to comply with international nomenclature conventions. 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 glufosinate-ammonium, the establishment of MRLs for cottonseed oil, milk, rice and soybeans is necessary to support the 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 glufosinate-ammonium and its metabolite in eggs and fat, meat and meat by-products of cattle, goats, hogs, poultry and sheep 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 This proposed regulatory amendment will provide joint benefits to consumers, the agricultural industry and importers of agricultural products as a result of improved management of pests and 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 glufosinate-ammonium and its metabolite 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 Organisation 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 glufosinate-ammonium are adopted. Cameron Laing, Alternative Strategies and Regulatory Affairs Division, Pest Management Regulatory Agency, Health Canada, 2720 Riverside Drive, Address Locator 6607D1, Ottawa, Ontario K1A 0K9, (613) 736-3665 (telephone), (613) 736-3659 (facsimile), cameron_laing@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 (1419 — Glufosinate-ammonium). 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 Cameron Laing, 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) 736-3665; fax: (613) 736-3659; e-mail: cameron_laing@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, December 13, 2004 EILEEN BOYD REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1419 — GLUFOSINATE-AMMONIUM) AMENDMENT 1. The portion of item G.1 of Table II to Division 15 of Part B of the Food and Drug Regulations (see footnote 1) in columns II to IV is replaced by the following:
COMING INTO FORCE 2. These Regulations come into force on the day on which they are registered. [51-1-o] S.C. 1999, c. 33, s. 347 C.R.C., c. 870 |
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