Vol. 137, No. 13 — June 18, 2003

Registration
SOR/2003-190 29 May, 2003

FOOD AND DRUGS ACT

Regulations Amending the Food and Drug Regulations (1340 — Imidacloprid)

P.C. 2003-772 29 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 (1340 — Imidacloprid).

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1340 — IMIDACLOPRID)

AMENDMENT

1. The portion of item I.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
I.2.1	1-[(6-chloro-3-pyridinyl)methyl]- 4,5-dihydro-N-nitro-1H-imidazol-2-amine, including metabolites containing the 6-chloropicolyl moiety	6	Tomato paste
		3.5	Brassica crops, lettuce
		3	Sour cherries, sweet cherries, tomato purée
		1.5	Grapes
		1	Blueberries, citrus fruits, peppers, tomatoes
		0.6	Pears
		0.5	Apples, cucumbers
		0.3	Potatoes
		0.2	Mangoes
		0.05	Cottonseed oil, mustard seed, pecans, rapeseed (canola)

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

Imidacloprid is registered under the Pest Control Products Act as an insecticide for the control of aphids, Colorado potato beetles, flea beetles, and other insect pests on apples, cucumbers, lettuce, mustard, potatoes, rapeseed (canola) and tomatoes. Maximum Residue Limits (MRLs) have been established under the Food and Drugs Act for residues of imidacloprid and its metabolites resulting from these uses at 6 parts per million (ppm) in tomato paste, 3.5 ppm in lettuce, 3 ppm in tomato purée, 1 ppm in tomatoes, 0.5 ppm in apples and cucumbers, 0.3 ppm in potatoes and 0.05 ppm in rapeseed (canola) and mustard seed. MRLs have also been established at 3.5 ppm in brassica crops, 1.5 ppm in grapes, 1 ppm in citrus fruits and peppers, 0.6 ppm in pears, 0.2 ppm in mangoes and 0.05 ppm in cottonseed oil and pecans imported into Canada, in order to permit the sale of food containing these residues. 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 imidacloprid in order to allow its use for the control of aphids on blueberries, and western cherry fruit fly and black cherry fruit fly on sour cherries and sweet cherries. This regulatory amendment will establish MRLs for residues of imidacloprid and its metabolites resulting from this use in blueberries, sour cherries and sweet cherries, 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 imidacloprid, including its metabolites, of 3 ppm in sour cherries and sweet cherries, and 1 ppm in blueberries 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 ppm unless a higher MRL has been established in Table II, Division 15, of the Food and Drug Regulations. In the case of imidacloprid, establishment of MRLs for blueberries, sour cherries and sweet cherries 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 the responsiveness of the regulatory system, an Interim Marketing Authorization (IMA) was issued on August 24, 2002, to permit the immediate sale of sour cherries and sweet cherries containing residues of imidacloprid with an MRL of 3 ppm while the regulatory process to formally amend the regulation was undertaken.

Benefits and Costs

The use of imidacloprid on blueberries, sour cherries and sweet cherries 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 imidacloprid and its metabolites 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 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 November 9, 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 imidacloprid is adopted.

Contact

• Geraldine Graham
  Alternative Strategies and Regulatory Affairs Division
  Pest Management Regulatory Agency
  Health Canada
  Address Locator 6607D1
  2720 Riverside Drive
  Ottawa, Ontario
  K1A 0K9
  Telephone: (613) 736-3692
  FAX: (613) 736-3659
  E-mail: geraldine_graham@hc-sc.gc.ca

Footnote a 

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

Footnote 1

C.R.C., c. 870

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