Vol. 137, No. 11 — May 21, 2003

Registration SOR/2003-170 8 May, 2003

FOOD AND DRUGS ACT

Regulations Amending the Food and Drug Regulations (1331 — Permethrin)

P.C. 2003-641 8 May, 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 (1331 — Permethrin).

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1331 — PERMETHRIN)

AMENDMENT

1. The portion of item P.2.1 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:

Item No.	II	III	IV
	Chemical Name of Substance	Maximum Residue Limit p.p.m.	Foods
P.2.1	(3-phenoxyphenyl)methyl 3-(2,2-dichloroethenyl)-2 ,2-dimethylcyclopropanecarboxylate	20	Leaf lettuce, spinach
		10	Head lettuce
		5	Celery
		2	Grapes
		1	Apples, peaches/nectarines, pears
		0.5	Beans, broccoli, Brussels sprouts, cabbage, cucumbers, peppers, plums, tomatoes, wasabi
		0.2 (calculated on the fat content)	Milk and other dairy products
		0.1 (calculated on the fat content)	Fat, meat and meat by-products of cattle and poultry

COMING INTO FORCE

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

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Description

Permethrin is registered under the Pest Control Products Act as an insecticide for the control of numerous pests on a variety of vegetable, fruit and cereal crops. Maximum Residue Limits (MRLs) have been established under the Food and Drugs Act for residues of permethrin resulting from this use at 20 parts per million (ppm) in leaf lettuce, 10 ppm in head lettuce, 2 ppm in grapes, 1 ppm in apples, peaches/nectarines and pears, 0.5 ppm in beans, broccoli, Brussels sprouts, cabbage, cucumbers, peppers, plums and tomatoes, and at 20 ppm in spinach and 5 ppm in celery imported into Canada. MRLs have also been established at 0.2 ppm in milk and other dairy products, and 0.1 ppm in fat, meat and meat by-products of cattle and poultry to cover residues in food derived from animals fed with crops treated with permethrin. By virtue of subsection B.15.002(1) of the Food and Drug Regulations, the MRL for other foods is 0.1 ppm.

The Pest Management Regulatory Agency (PMRA), of Health Canada, has recently approved an application to amend the registration of permethrin in order to allow its use for the control of caterpillars and flea beetles on wasabi. This regulatory amendment will establish an MRL for residues of permethrin resulting from this use in wasabi, in order to permit the sale of food containing these residues.

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 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 permethrin of 0.5 ppm in wasabi would not pose an unacceptable health risk to the public. This regulatory amendment will also amend the chemical name of permethrin 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 ppm unless a higher MRL has been established in Table II, Division 15, of the Food and Drug Regulations. In the case of permethrin, establishment of an MRL for wasabi 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.

As a means to improve responsiveness of the regulatory system, an Interim Marketing Authorization (IMA) was issued on June 1, 2002, to permit the immediate sale of wasabi containing residues of permethrin with an MRL of 0.5 ppm while the regulatory process to formally amend the regulation was undertaken.

Benefits and Costs

The use of permethrin on wasabi will provide joint benefits to consumers and the agricultural industry as a result of improved management of pests. In addition, 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 permethrin in the food 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 Cooperation 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 September 28, 2002. 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 permethrin is adopted.

Contact

Footnote a 

S.C. 1999, c. 33, s. 347

Footnote 1 

C.R.C., c. 870

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