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REGULATIONS RESPECTING THE MAKING OF MEDICATED FEED

Notice is hereby given that the Governor in Council, pursuant to subsection 64^a of the Health of Animals Act^b, proposes to make the annexed Regulations respecting the Making of Medicated Feeds.

Any interested persons may make representations concerning the proposed Regulations within 60 days after the date of publication of this notice. All such representations must be addressed to Ms. Linda Morrison, National Manager - Livestock Feed Program, Animal Health & Production Division, Canadian Food and Inspection Agency, 59 Camelot Drive, Nepean, Ontario K1A 0Y9, 613-225-2342, (Telephone), 613-228-6614 (Facsimile), (E-mail) and cite the Canada Gazette, Part I, and the date of this notice.

^a S.C. 1993, c. 34, s. 76
^b S.C. 1990, c. 21

Marc O’Sullivan
Assistant Clerk of the Privy Council

REGULATIONS RESPECTING THE MAKING OF MEDICATED FEED

Interpretation

1. The definitions in this section apply in these Regulations.

"Act" means the Health of Animals Act. (Loi)

"animal food" includes a medicated feed. (aliments pour animaux)

"batch" means the quantity of animal food resulting from one mixer load that has been made by the addition of ingredients in accordance with a single mixing sheet for that animal food. (charge)

"contamination" means a concentration of a medicating ingredient

(a) in human food in excess of the maximum residue limit set out in Table III to Division 15 of Part B of the Food and Drug Regulations for that ingredient; or

(b) in animal food such that it is likely to result in human food having a residue of that ingredient in excess of the maximum residue limit for that ingredient set out in the table referred to in paragraph (a). (contamination)

"flushing" means the passing of a non-medicated substance through equipment to prevent the carry-over of any residual medicating ingredients from a previous lot of medicated feed. (curage)

"formula" means a list of ingredients and the proportions of ingredients to be used in the making of an animal food. (formule)

"licensed operator" means a person who is authorized, under a licence issued under subsection 6(1), to make medicated feed in an animal food factory that the person operates. (exploitant agréé)

"lot" means the quantity of animal food made in consecutive batches, or continuously, by the addition of animal food ingredients according to a single formula. (lot)

"medicated feed" means animal food that

(a) has a medicating ingredient mixed into it; and

(b) is intended for consumption by animals that are used for food for humans or that produce food for humans. (aliments médicamentés)

"medicating ingredient" means a substance -- other than a vitamin, mineral, protein, amino acid, enzyme, live microbe, carbohydrate, fat, fatty acid or veterinary biologic or a combination of those things -- that

(a) has a drug identification number assigned to it under the Food and Drugs Act, or the sale of which has been authorized under section C.08.005, C.08.011, C.08.012 or C.08.013 of the Food and Drug Regulations; and

(b) is intended to be used

"President" means the President of the Canadian Food Inspection Agency. (président)

"sell" means to distribute or dispose of, or to agree to distribute or dispose of, to a person in any manner for consideration, and includes

(a) to agree to sell;

(b) to offer, advertise, keep, expose, possess, send, convey or deliver for sale or to display in such a manner as to lead to a reasonable belief that the thing so displayed is intended for sale or distribution;

(c) to exchange or agree to exchange; and

(d) to sell by consignment. (vente)

"sequential production" of medicated feed means the production of the feed in successive lots in an order such that it is unlikely that animal food is contaminated. (production séquentielle)

Prohibitions

2. (1) No person, other than a licensed operator, may make a medicated feed.

(2) No person may sell a medicated feed, other than an imported medicated feed, unless it was made by a licensed operator.

(3) No person may sell a medicated feed for the purpose of further mixing unless the purchaser of the medicated feed is a licensed operator.

3. No person may import into Canada or sell in Canada any imported animal food intended for consumption by animals that are used for food for humans or that produce food for humans unless the person demonstrates that the animal food was made

(a) in a country that has

(b) in an establishment that meets the standards of that country for the making of animal food.

Licensing of Operators

4. (1) Every person who wishes to make medicated feed in an animal food factory must have a licence for that purpose.

(2) An application for a licence, or for the renewal of a licence, to make medicated feed in an animal food factory must be made to the President on a form provided by the President, be accompanied by the applicable fee fixed under the Canadian Food Inspection Agency Act and include the following information:

(a) results of the verification tests for the scale and metering devices used in the factory;

(b) results of the verification tests for the mixers used in the factory;

(c) results of all tests for the concentration of medicating ingredients in representative samples of animal food made by the factory; and

(d) if the results referred to in paragraph (c) are not within the tolerances set out in Table 2 to Schedule I to the Feeds Regulations, 1983, or the results indicate that there was contamination of an animal food, reports of investigations to determine the reasons and reports of any corrective measures taken.

5. (1) An animal food factory that is the subject of an application for a licence, or for the renewal of a licence, must be inspected by an inspector to verify

(a) the information specified in subsection 4(2); and

(b) that the factory meets the requirements of these Regulations.

(2) If an inspector is unable to verify the information specified in subsection 4(2), or the inspector determines that the requirements of these Regulations have not been met, the inspector must, within 14 days after the inspection, give the applicant a notice in writing, personally or by registered mail or courier.

(3) The notice must

(a) set out the information that cannot be verified or the requirements that have not been met; and

(b) contain a statement that the applicant may request a re-inspection within 60 days after the date of the notice.

6. (1) If the inspector determines that the information specified in subsection 4(2) is correct and that the animal food factory conforms with these Regulations, the President must issue the licence, or renew the licence, as the case may be.

(2) Subject to sections 7, 9 and 10, the licence is valid for three years after the last day of the month of its issuance.

(3) The licensed operator must post the licence in a conspicuous place in the animal food factory for the period during which the licence remains in force.

7. (1) Subject to subsections (2) and (3), a licence issued to an operator becomes void on the day on which the operator becomes subject to a receivership, becomes bankrupt or ceases to operate the animal food factory that is the subject of the licence.

(2) If an animal food factory that is the subject of a licence is sold or the ownership of the factory is otherwise transferred, the licence may be transferred to the new operator of the factory but becomes void 60 days after the date of the sale or transfer.

(3) If a licensed operator is a corporation and there is an acquisition of control of it, the licence becomes void 60 days after the date of the acquisition of control.

8. If an animal food factory that is the subject of a licence is sold or ownership of the factory is otherwise transferred, or the licensed operator is a corporation and there is an acquisition of control of it, the licensed operator must notify the President within 30 days after the sale or transfer or the acquisition of control.

9. (1) Subject to subsection (2), the President may suspend an operator's licence to make medicated feed in an animal food factory, for the period set out in subsection (7), if

(a) an inspector determines that the factory or the operator does not meet the requirements of the Act or these Regulations; or

(b) the President has reasonable grounds to believe that animal food made in the factory may be contaminated.

(2) The operator's licence may not be suspended unless an inspector has given the operator written notice of suspension of the licence, personally, by registered mail or by courier.

(3) The notice of suspension of the licence must

(a) identify the provision of the Act or these Regulations that has not been complied with or the grounds on which the President believes that the animal food made in the factory may be contaminated;

(b) advise the operator that the licence will be revoked unless, within 30 days after having received the notice, the operator

(c) identify the person whom the operator must notify of any corrective measures taken.

(4) On receipt of a notice of suspension, the operator must surrender the licence to an inspector for the duration of the suspension.

(5) For 30 days after the operator receives a notice of suspension, the operator may make a request to the President to be heard to demonstrate that there is no contravention of the Act or these Regulations or that there is no risk of contamination.

(6) For 30 days after the operator receives a notice of suspension, the operator may request the President to extend, for up to six months, the period during which the necessary corrective measures may be taken and verified by an inspector.

(7) A suspension of a licence under subsection (1) remains in effect from the time the operator is given the notice of suspension until whichever of the following occurs first:

(a) an inspector determines that the necessary corrective measures have been taken;

(b) the President removes the suspension under paragraph 10(1)(a); or

(c) the President revokes the licence under subparagraph 10(1)(b)(ii) or subsection 10(2).

10. (1) If an operator requests to be heard with respect to a suspension, the President must hold a hearing within 30 days after receipt of the request and must, if the President determines

(a) that there has been no contravention of the Act or these Regulations or that there is no risk of contamination, remove the suspension; or

(b) that there has been a contravention of the Act or these Regulations or that there is a risk of contamination,

(2) If the operator does not request to be heard with respect to the suspension, and the necessary corrective measures are not taken within 30 days after receipt of the notice of suspension or the end of the extended period referred to in subsection 9(6), the President must revoke the licence.

11. If an operator whose licence has been suspended notifies the person referred to in paragraph 9(3)(c) that the necessary corrective measures have been taken, an inspector must re-inspect the animal food factory within seven days after the notification.

Standards

12. A licensed operator must ensure that the requirements of sections 13 to 25 are met.

13. (1) All scales and metering devices used in the making of medicated feed must be appropriate for the range of weights or volumes to be measured, and must be tested for accuracy

(a) at the time of installation; and

(b) as frequently as necessary to ensure proper functioning, but not less than once a year.

(2) Every licensed operator must have written procedures for the calibration of scales and metering devices used in the making of medicated feed to ensure that their accuracy is maintained in accordance with

(a) the applicable in-service limits of error for those scales and metering devices set out in Divisions VI and XI of Part V of the Weights and Measures Regulations; or

(b) a performance standard listed in the most recent Device Performance Verification List, published by the Canadian Food Inspection Agency.

14. (1) The performance of all mixers used in the making of medicated feed must be verified

(a) at the time of installation; and

(b) as frequently as necessary to ensure proper functioning, but not less than once a year.

(2) Every licensed operator must have written procedures to ensure that all mixers used in the making of medicated feed are maintained to ensure their proper functioning using

(a) the standard mixer test protocol set out in the American Society of Agricultural Engineers Standard ASAE S303.3, such that the coefficient of variation does not exceed the applicable coefficient of variation set out in the most recent Device Performance Verification List, published by the Canadian Food Inspection Agency; or

(b) a performance standard listed in the most recent Device Performance Verification List, published by the Canadian Food Inspection Agency.

15. Within 30 days after any change in the equipment referred to in section 13 or 14, the licensed operator must notify the President of the change.

16. All medicated feeds and medicating ingredients for the making of animal food must be received, inspected, identified, handled and stored in the animal food factory in such a manner that their potency and purity are preserved.

17. (1) Subject to subsection (3), the making of medicated feed by a licensed operator must be by sequential production.

(2) Every licensed operator must have written procedures respecting sequential production, flushing and the cleaning of equipment used in the making of medicated feed.

(3) Medicated feed may be made by means other than by sequential production if, between lots of medicated feed or lots of medicated feed and other animal food, all equipment, including any equipment used for making, storing, processing or packing animal food, that comes in contact with the medicated feed is vacuumed, swept, washed or flushed in a manner that prevents contamination.

18. All dust collector materials, animal food for reprocessing and recovered materials from vacuuming, sweeping, washing or flushing, and all animal food required by paragraph 23(c) to be dealt with under this section, that contain medicating ingredients must be

(a) identified and stored in a manner to prevent contamination;

(b) used as an ingredient in animal food containing the same medicating ingredients; or

(c) disposed of in such a manner that they will not be fed to animals that are used for food for humans or that produce food for humans.

19. Every licensed operator must have written procedures that ensure that medicated feed contains its intended level of medicating ingredient.

20. On each day on which a licensed operator uses medicating ingredients or medicated feed in the making of medicated feed, the licensed operator must complete an inventory that demonstrates that the correct medicating ingredients or medicated feed, in the correct quantities, are used in the making of medicated feed.

21. Every licensed operator that sells medicated feed must identify each lot of animal food made in the operator's animal food factory with an individual lot number, or the date of its making, applied to the label, package, invoice or shipping document.

Procedure in Case of Discrepancy or Contamination

22. If the inventory required by section 20 shows a discrepancy between the actual amounts of medicating ingredients used and the amounts that should have been used according to the formula for the medicated feed, or if the licensed operator otherwise finds that there has been a failure to follow the formula for the medicated feed or that animal food made in the operator's animal food factory is likely to be contaminated, the licensed operator

(a) must stop selling and using all lots of animal food that are likely to be affected by the discrepancy, the failure or the contamination until paragraph (b) is complied with; and

(b) must promptly conduct an investigation and take the necessary corrective measures.

23. If the investigation conducted under paragraph 22(b) shows that any animal food made in the animal food factory is contaminated or if the licensed operator otherwise becomes aware that any animal food made in the factory is contaminated, the operator must

(a) promptly notify persons who have purchased or received any animal food that is likely to be contaminated, and persons who have purchased or received animals that have been fed any animal food that is likely to have been contaminated, as to the nature of the contamination and the precautionary measures to be taken to prevent the production of contaminated food for humans;

(b) promptly recall any animal food that is likely to have been contaminated; and

(c) deal with the contaminated animal food in accordance with section 18.

24. The operator must have written procedures to be followed in order to comply promptly with section 23.

Records

25. Every licensed operator must keep, for at least three years, any documents respecting the making of animal food, including

(a) reports of investigations of non-compliant samples under paragraph 4(2)(d);

(b) the inventory required by section 20;

(c) reports of investigations made, and corrective measures taken, as required by paragraph 22(b);

(d) records respecting test results;

(e) distribution records; and

(f) any other documents that demonstrate that the requirements of these Regulations in respect of a lot of medicated feed have been complied with.

Coming into Force and Application

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

27. (1) Section 3 begins to apply on April 1, 2001.

(2) Section 2, subsection 4(1) and sections 9 to 25 begin to apply on April 1, 2001, with respect to animal food factories that sell medicated feed.

(3) Section 2, subsection 4(1) and sections 9 to 25 begin to apply on June 30, 2002, with respect to animal food factories that

(a) make medicated feed using medicating ingredients; but

(b) do not sell the medicated feed that they make.

(4) Section 2, subsection 4(1) and sections 9 to 25 begin to apply on December 31, 2002, with respect to animal food factories that

(a) make medicated feed using other medicated feed;

(b) do not make medicated feed using medicating ingredients; and

(c) do not sell the medicated feed that they make.