Registration
SOR/2005-91 April 5, 2005

FOOD AND DRUGS ACT

Regulations Amending the Food and Drug Regulations (1424 — Fenbuconazole)

P.C. 2005-497 April 5, 2005

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 (1424 — Fenbuconazole).

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1424 — FENBUCONAZOLE)

AMENDMENT

1. Table II to Division 15 of Part B of the Food and Drug Regulations (see footnote 1) is amended by adding the following after item F.02:

item number	I	II	III	IV
Item No.	Common Chemical Name	Chemical Name of Substance	Maximum Residue Limit p.p.m.	Foods
F.03	fenbuconazole	a-[2-(4-chlorophenyl)ethyl]- a-phenyl-1H-1,2,4-triazole-1-propanenitrile, including the metabolites cis-5-(4-chlorophenyl)-dihydro-3-phenyl-3-(1H-1,2,4-triazol-1-ylmethyl)-2-3H-furanone and trans-5-(4-chlorophenyl)-dihydro-3-phenyl-3-(1H-1,2,4-triazol-1-ylmethyl)-2-3H-furanone	0.8	Sour cherries, sweet cherries
			0.5	Dried prune plums, peaches/ nectarines
			0.3	Apricots
			0.1	Plums, prune plums

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

Under authority of the Pest Control Products Act, the Pest Management Regulatory Agency (PMRA), of Health Canada, has approved an application for the registration of the pest control product fenbuconazole as a fungicide for the control of blossom blight and fruit brown rot on apricots, peaches/nectarines, plums, prune plums, sour cherries and sweet cherries, as well as black knot on plums and sour cherries. This regulatory amendment will establish Maximum Residue Limits (MRLs) under the Food and Drugs Act for residues of fenbuconazole and its metabolites resulting from this use in apricots, dried prune plums, peaches/ nectarines, plums, prune plums, sour cherries and sweet cherries, in order to permit the sale of food containing these residues.

Before making a registration decision regarding a new pest control product, the PMRA conducts the appropriate assessment of the risks and value of the product specific to its proposed use. Pest control products will be registered 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 (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 fenbuconazole, including its metabolites, of 0.8 parts per million (ppm) in sour cherries and sweet cherries, 0.5 ppm in dried prune plums and peaches/nectarines, 0.3 ppm in apricots, and 0.1 ppm in plums and prune plums 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 fenbuconazole, establishment of MRLs for apricots, dried prune plums, peaches/nectarines, sour cherries and sweet cherries 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 ppm 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 ppm in Table II, Division 15, of the Regulations, for residues of fenbuconazole in plums and prune plums 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 fenbuconazole on apricots, peaches/nectarines, plums, prune plums, 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 fenbuconazole 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 6, 2004. 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 MRLs for fenbuconazole are adopted.

Contact

Francine Brunet
Alternative Strategies and Regulatory Affairs Division
Pest Management Regulatory Agency
Health Canada
Address Locator 6607D1
2720 Riverside Drive
Ottawa, Ontario
K1A 0K9
Telephone: (613) 736-3678
FAX: (613) 736-3659
E-mail: francine_brunet@hc-sc.gc.ca

Footnote a

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

Footnote 1

C.R.C., c. 870

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