Registration

SOR/2008-181 May 29, 2008

FOOD AND DRUGS ACT

Regulations Amending the Food and Drug Regulations (1369 — Interim Marketing Authorizations)

P.C. 2008-981 May 29, 2008

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 (see footnote b), hereby makes the annexed Regulations Amending the Food and Drug Regulations (1369 — Interim Marketing Authorizations).

REGULATIONS AMENDING THE FOOD AND
DRUG REGULATIONS (1369 — INTERIM
MARKETING AUTHORIZATIONS)

AMENDMENTS

1. Section B.01.001 of the Food and Drug Regulations (see footnote 1) is renumbered as subsection B.01.001(1) and is amended by adding the following:

(2) The definitions in this subsection apply for the purposes of the Act.

“agricultural chemical” has the same meaning as in subsection (1). (produit chimique agricole)

“food additive” has the same meaning as in subsection (1). (additif alimentaire)

2. Section B.01.056 of the Regulations is replaced by the following:

B.01.056. (1) This section applies in respect of interim marketing authorizations that the Minister may issue under subsection 30.2(1) of the Act.

(2) In this section, “food for special dietary use” has the same meaning as in section B.24.001.

(3) The manufacturer of a food or of an agricultural chemical, veterinary drug, food additive, vitamin, mineral nutrient or amino acid present in or on a food may submit an application in writing to the Minister for the issuance of an interim marketing authorization in respect of the food that provides for any matter referred to in subsection 30.2(2) of the Act.

(4) The application shall be accompanied by the following information:

(a) the common name and description of the food;

(b) the reasons for which the interim marketing authorization is requested;

(c) a description of every exemption requested in respect of the food from the application, in whole or in part, of sections 5 to 6.1 of the Act and the applicable requirements of these Regulations;

(d) adequate data, including results of tests and scientific analysis, that demonstrate that the food would not be harmful to the health of the purchaser or consumer;

(e) if the application relates to the addition of vitamins, mineral nutrients or amino acids to the food, a statement, with supporting documentation, indicating that the proposed addition is for one or more of the following purposes:

(i) to restore the levels of vitamins or mineral nutrients to the levels that were present in the food before processing or, in the case of amino acids, to provide protein of a nutritional quality that is equivalent to that which was present in the food before processing,

(ii) to make the food that is intended to be sold as a substitute for another food nutritionally equivalent to the food that it is intended to replace in the diet in respect of

(A) the levels of added vitamins or mineral nutrients, or

(B) the quality of protein provided through the addition of amino acids,

(iii) to prevent or correct a deficiency of vitamins or mineral nutrients in the population or specific population groups, or

(iv) to modify the levels of vitamins, mineral nutrients or amino acids in the food for special dietary use; and

(f) if the application relates to the use of a food additive in or on the food, the information described in section B.16.002.

(5) In addition to the matters that may be provided for in accordance with subsections 30.2(2) and (4) of the Act, an interim marketing authorization shall set out

(a) the common name and description of the food;

(b) the reasons for which the interim marketing authorization is issued; and

(c) the provisions of the Act and of these Regulations in respect of which the food is exempted.

(6) An interim marketing authorization may be cancelled by the Minister if the Minister determines, after reviewing any additional information that comes to his or her attention, that the food for which the authorization was issued is or may be harmful to the health of the purchaser or consumer.

3. Subsection B.15.002(4) of the Regulations is repealed.

COMING INTO FORCE

4. These Regulations come into force on the day on which sections 1 to 4 of An Act to amend the Food and Drugs Act, S.C. 2005, c. 42, come into force, but if they are registered after that day, they come into force on the day on which they are registered.

REGULATORY IMPACT
ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Description

In Canada, the Food and Drugs Act (FDA) and the Food and Drug Regulations (the Regulations) are the primary pieces of legislation relating to food safety. The FDA prohibits the sale of food that has been adulterated (paragraph 4(1)(d) of the FDA) and allows the Governor in Council to make regulations respecting the use of any ingredient or substance in a food and also declaring that a food is adulterated if any prescribed substance is present in the food, has been added to it or has been extracted or omitted from it. The Regulations, made under the FDA, state that foods containing residues of agricultural chemicals and veterinary drugs above the permitted maximum residue limits (MRLs) are adulterated.

The Regulations must be amended to provide for the sale of foods containing new or changed amounts of agricultural chemicals (including pest control products) and veterinary drug residues, food additives, vitamins, mineral nutrients or amino acids after Health Canada has concluded that the sale of these foods will not be harmful to the health of Canadian consumers. The process to amend the Regulations is lengthy and can cause delays in the availability of safe and beneficial food products to the consumer. Until 1997, there was no mechanism under the Regulations to allow the sale of safe food products before the regulatory process had been completed and the appropriate regulatory amendments had come into effect to permit the sale of the food.

On July 3, 1997, the Regulations were amended by the addition of section B.01.056 to give the Director, defined in the Regulations as the Assistant Deputy Minister (ADM) of the Health Products and Food Branch, the authority to issue Notices of Interim Marketing Authorizations (NIMAs) that would allow manufacturers to sell a food product containing agricultural chemicals, veterinary drugs, food additives, vitamins, mineral nutrients or amino acids not in compliance with specific provisions of the Regulations while the Regulations were being amended (SOR/97-313). This amendment was introduced as an important regulatory reform initiative to bridge the time between the completion of a thorough scientific evaluation, which concluded that the sale of the food would not be harmful to the health of the consumer, and the date when the regulatory amendments would come into force.

Consideration for issuing a NIMA could only be given as part of a formal request for specific types of amendments (listed below). Once the request had been made by a distributor or manufacturer, NIMAs could be issued only when the scientific evaluation concluded that the consumption of the food would not be harmful to the health of the consumers and Health Canada had made the decision to propose a regulatory amendment for:

A. the extension of use of a food additive already permitted in other foods into a new food or the change of a permitted maximum level of use;

B. residues of an agricultural chemical (including pest control products) or veterinary drug where the Regulations already permit these substances in other foods, or the change of permitted MRLs; or

C. the addition of vitamins, mineral nutrients or amino acids at different levels or to new foods.

On April 7, 1999, the Standing Joint Committee for the Scrutiny of Regulations (SJCSR) first expressed concerns about the amendments to the Regulations concerning the issuance of NIMAs, including that the provisions transformed a legislative power conferred by Parliament on the Governor in Council into an administrative discretion to be exercised by the Director. The SJCSR maintained that the amendments to the Regulations concerning the issuance of NIMAs were ultra vires, that is beyond the authority of the FDA.

On November 29, 2004, Bill C-28 (An Act to amend the Food and Drugs Act) was tabled in the House of Commons to amend the FDA for two purposes. The first purpose is to provide the Minister of Health with specific authority to issue Interim Marketing Authorizations (IMAs) for foods containing specified substances. The second purpose is to amend section 4 of the FDA to provide that foods containing certain substances, including pest control products regulated under the Pest Control Products Act (PCPA), at or below certain amounts are not considered to be adulterated. Bill C-28 received Royal Assent on November 25, 2005, and will come into force on June 16, 2008.

In order to bring the amendments to the FDA respecting IMAs into force, amendments are required to the regulatory framework in section B.01.056 of the Regulations. These regulatory amendments will replace section B.01.056 of the Regulations so that the text of the Regulations will:

— reference the new portions of the FDA relevant to the issuance of IMAs;

— state the information that must be included by the manufacturer of a food or of a food additive, agricultural chemical, veterinary drug, vitamin, mineral nutrient or amino acid present in or on a food when the manufacturer requests the Minister of Health to issue an IMA. In regard to requests for IMAs for vitamins, mineral nutrients or amino acids, the former requirement for consistency with the General Principles for the Addition of Essential Nutrients to Foods adopted by the Joint Food and Agriculture Organization of the United Nations/World Health Organization Codex Alimentarius Commission is replaced by new text. In order to simplify the application and interpretation of the Regulations, the new text explicitly states the purposes for the issuance of an IMA with regard to vitamins, mineral nutrients or amino acids. These purposes are consistent with the General Principles for the Addition of Essential Nutrients to Foods. In brief, these purposes are: restoration of vitamins, mineral nutrients or amino acids lost during processing, nutritional equivalence of substitute foods with respect to specific vitamins, mineral nutrients or amino acids, fortification for the prevention or correction of a deficiency, and to ensure the appropriate composition in vitamins, mineral nutrients or amino acids of a food for special dietary use. A request for an IMA relating to the addition of vitamins, mineral nutrients or amino acids will be required to be consistent with one or more of these purposes;

— state the information to be contained in an IMA; and

— specify that the Minister may cancel an IMA if there is information to the effect that the food is or may be harmful to the health of the purchaser or consumer.

An amendment to section B.01.001 of the Regulations will define the terms “agricultural chemical” and “food additive” for the purposes of the FDA.

These regulatory amendments will not change the scope or operation of the IMA mechanism. There will be no changes to the requirement for a stringent safety assessment and the conclusion that the sale of the food under an IMA will not be harmful to the health of the consumer. In addition, it is important to note that there will be no new requirements for industry to address when requesting the Minister to issue an IMA.

Alternatives

Departmental officials considered the following options to address the SJCSR concerns:

(1) maintaining the existing scheme until it can be addressed through the Department’s renewal of its legislative framework;

(2) amending the Regulations to replace the NIMA provision with a case-by-case authorization scheme;

(3) revoking the NIMA provisions;

(4) amending the FDA.

Option 1 was not viable as the current initiative to review the legislative framework would not be completed in the near future. Therefore, the concerns of the SJCSR would not be addressed in a timely fashion.

Option 2 could minimize the risk of the new IMA scheme being considered ultra vires and provide an alternative mechanism to the food industry to request interim marketing authorizations to sell their products immediately should the original NIMA scheme be revoked. However, this option would result in a resource intensive mechanism because of the need to issue an interim marketing authorization for each product and manufacturer/petitioner. It could also be perceived as not providing a level playing field to all manufacturers that would be interested in the sale of identical products.

Option 3 would address the SJCSR concerns. However, the revocation of the provisions, namely section B.01.056 and subsection B.15.002(4), would raise serious concerns from the food industry who benefits from the NIMA provision through the immediate sale of the product which would otherwise be delayed while the Regulations were being amended. Consumers also benefit from the NIMA provision through access to new food products particularly those with improved nutritional quality. Since this option would require time for development of mitigative measures, there could be a delay in the availability of some new food products in the Canadian marketplace which, in some cases, have improved the nutritional quality of the food supply.

Option 4 was considered the most appropriate course of action. By amending the FDA, the Minister is provided with clear authority to issue IMAs and also the amendments provide that foods that contain certain substances, including pest control products, at or below certain levels are not considered to be adulterated. These regulatory amendments are necessary to implement the recent amendments to the FDA and ensure the continuation of the IMA mechanism which is seen to be in the public interest.

Consultation

A letter was sent to food industry stakeholders on November 29, 2004, when Bill C-28 was introduced in the House of Commons. This letter was accompanied by a copy of the Bill, a clause-by-clause analysis, and a fact sheet on the Bill. These documents were also posted on the Health Canada Web site. No objections or concerns were expressed by stakeholders about the Government action to ensure the continued availability of the IMA mechanism.

Compliance and enforcement

The Canadian Food Inspection Agency (CFIA) is responsible for the compliance and enforcement of the FDA and the Regulations with respect to foods, including foods sold under an IMA. The CFIA uses a science-based risk management approach to set its food safety priorities. Using this approach as its foundation, the CFIA would plan its inspection and testing programs for foods, including those sold under an IMA, taking into account the degree of risk associated with a particular sector and would concentrate its resources where risk is greatest. The frequency of inspection would depend on the history of compliance of a particular product, the history of compliance of the manufacturer and the food safety risk.

Contact

William Ross
Director
Bureau of Food Regulatory, International and Interagency Affairs
Health Canada
200 Tunney’s Pasture Driveway
Address Locator: 0702C1
Ottawa, Ontario
K1A 0K9
Telephone: 613-946-4591
Fax: 613-941-3537
Email: sche-ann@hc-sc.gc.ca

Footnote a
S.C. 2005, c. 42, s. 2

Footnote b
R.S., c. F-27

Footnote 1
C.R.C., c. 870

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