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Vol. 137, No. 22 — October 22, 2003 Registration FOOD AND DRUGS ACT Regulations Amending the Food and Drug Regulations (1348 — Glyphosate)P.C. 2003-1498 2 October, 2003 Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 30(1) (see footnote a) of the Food and Drugs Act, hereby makes the annexed Regulations Amending the Food and Drug Regulations (1348 — Glyphosate). REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1348 — GLYPHOSATE) AMENDMENT 1. The portion of item G.2 of Table II to Division 15 of Part B of the Food and Drug Regulations (see footnote 1) in column IV is replaced by the following:
COMING INTO FORCE 2. These Regulations come into force on the day on which they are registered. REGULATORY IMPACT (This statement is not part of the Regulations.) Description Glyphosate is registered under the Pest Control Products Act as a herbicide for the control of annual and perennial grasses and broadleaf weeds on a wide variety of crops as pre-emergent and pre-harvest treatments. Maximum Residue Limits (MRLs) have been established under the Food and Drugs Act for residues of glyphosate, including the metabolite aminomethylphosphonic acid (AMPA), resulting from these uses at 35 parts per million (p.p.m.) in oat milling fractions, excluding flour, 20 p.p.m. in soybeans, 15 p.p.m. in barley and wheat milling factions, excluding flour, and oats, 10 p.p.m. in barley and rapeseed (canola), 5 p.p.m. in peas and wheat, 4 p.p.m. in beans and lentils, 3 p.p.m. in corn and flax, and 0.5 p.p.m. in asparagus. MRLs have also been established at 2 p.p.m. in kidney of cattle, goats, hogs, poultry and sheep and 0.2 p.p.m. in liver of cattle, goats, hogs, poultry and sheep to cover residues in food derived from animals fed with crops treated with glyphosate. 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 regulatory amendment will increase the MRL for residues of glyphosate, including the metabolite AMPA, in sugar beets, in order to permit the import and sale of food containing these residues. 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 (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 imported food when the pest control product is used according to use instructions in the country of origin and the intake of that food from 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 ARD 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 an MRL for glyphosate, including the metabolite AMPA, of 10 p.p.m. in sugar beets would not pose an unacceptable health risk to the public. This new MRL harmonizes with the one established by the United States Environmental Protection Agency. 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. In the case of glyphosate, establishment of an MRL for sugar beets is necessary to support the import of food containing residues that have been shown to be safe, while at the same time preventing the sale of food with unacceptable residues. Benefits and Costs This 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 glyphosate, including the metabolite AMPA, in the food mentioned above. Resources required are not expected to result in significant costs to the government. Consultation Dietary risk assessments conducted 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. This schedule of amendment was pre-published in the Canada Gazette, Part I, on May 3, 2003. Interested parties were invited to make representations concerning the proposed amendment. No responses were received. Compliance and Enforcement Compliance will be monitored through ongoing domestic and/or import inspection programs conducted by the Canadian Food Inspection Agency when the MRL for glyphosate is adopted. Contact
Geraldine Graham S.C. 1999, c. 33, s. 347 C.R.C., c. 870 |
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