Vol. 146, No. 5 — February 29, 2012
Registration
SOR/2012-15 February 9, 2012
FOOD AND DRUGS ACT
Regulations Amending the Food and Drug Regulations (1527 – Maximum Residue Limits for Veterinary Drugs)
P.C. 2012-70 February 9, 2012
His 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 (1527 — Maximum Residue Limits for Veterinary Drugs).
REGULATIONS AMENDING THE FOOD AND DRUG
REGULATIONS (1527 – MAXIMUM RESIDUE
LIMITS FOR VETERINARY DRUGS)
AMENDMENTS
1. Table III to Division 15 of Part B of the Food and Drug Regulations (see footnote 1) is amended by adding the following after item A.01:
| Item No. |
Column I |
Column II |
Column III |
Column IV |
|---|---|---|---|---|
A.02 |
altrenogest |
altrenogest |
0.001 |
Liver of swine |
0.002 |
Kidney of swine |
2. Table III to Division 15 of Part B of the Regulations is amended by adding the following after item C.3:
| ItemNo. |
Column I |
Column II |
Column III |
Column IV |
|---|---|---|---|---|
D.01 |
danofloxacin |
danofloxacin |
0.07 |
Muscle and liver of cattle |
0.4 |
Kidney of cattle |
3. The portion of item F.2 of Table III to Division 15 of Part B of the Regulations in columns III and IV is replaced by the following:
| Item No. |
Column III |
Column IV |
|---|---|---|
F.2 |
0.2 |
Muscle of cattle |
0.25 |
Muscle of swine |
|
0.8 |
Muscle of salmonids |
|
1.4 |
Liver of swine |
|
2.0 |
Liver of cattle |
4. Table III to Division 15 of Part B of the Regulations is amended by adding the following after item M.01:
| Item No. |
Column I |
Column II |
Column III |
Column IV |
|---|---|---|---|---|
M.02 |
melengestrol acetate |
melengestrol acetate |
0.006 |
Liver of cattle |
0.014 |
Fat of cattle |
5. Table III to Division 15 of Part B of the Regulations is amended by adding the following after item T.3.1:
| Item No. |
Column I |
Column II |
Column III |
Column IV |
|---|---|---|---|---|
| T.3.1.1 | trenbolone acetate | β-trenbolone | 0.002 | Muscle of cattle |
α-trenbolone |
0.01 |
Liver of cattle |
6. Table III to Division 15 of Part B of the Regulations is amended by adding the following after T.4:
| Item No. |
Column I |
Column II |
Column III |
Column IV |
|---|---|---|---|---|
Z.1 |
zeranol |
zeranol |
0.002 |
Muscle of cattle |
0.01 |
Liver of cattle |
COMING INTO FORCE
7. 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.)
Issue and objectives
Under the Canadian Food and Drug Regulations (the Regulations), all veterinary drugs must be authorized by Health Canada prior to their sale and administration to prevent and treat diseases in animals. Some drugs are only permitted in certain species not intended to be used for foods while others are used in food-producing animals. These amendments to the Regulations establish safe limits for residues of six veterinary drugs in foods originating from animals treated with these particular drugs. These veterinary drugs are an important tool in the production of healthy animals which are destined for use as food.
Description and rationale
Acceptable limits of residues of veterinary drugs in food commodities are called maximum residue limits (MRLs). MRLs are the maximum concentrations of residues, expressed in parts per million (p.p.m.) on a fresh weight basis, in edible tissues of food-producing animals as a result of the treatment of those animals with veterinary drugs. An MRL is based on the type and amount of residue considered to pose no adverse health effects if ingested daily by humans over a lifetime. There are a number of MRLs already established in Table III to Division 15 of Part B of the Food and Drug Regulations.
In order to determine whether MRLs are safe, Health Canada scientists review the toxicity and residue depletion data submitted by manufacturers, assess the risks and benefits of the resulting use of the drug and the acceptability of the resulting levels of residues of the drug that are found in food products. Only when there is sufficient evidence to demonstrate that the residues found will not pose undue risks to consumers can the drug be permitted for administration to food-producing animals and the related food products sold in Canada. Extensive studies have determined that the food commodities containing the specific veterinary drugs at levels up to the MRLs listed in the amendments are safe for consumption. These MRLs apply to foods produced domestically or imported into Canada.
A joint Health Canada and Canadian Food Inspection Agency (CFIA) policy regarding the use of Administrative MRLs (AMRLs) was established in 2002 as a mechanism for applying limits for authorized drugs prior to their promulgation in the Regulations. In 2004, to further help address this situation, the Veterinary Drugs Directorate (VDD) of Health Canada made a commitment to establish MRLs with every Notice of Compliance (NOC) for food-producing animal drugs. MRLs and AMRLs enhance health protection by identifying and measuring the risks of veterinary drug residues to the health of consumers and, as a result, the appropriate action can be taken to protect Canadians from those risks. AMRLs are scientifically equivalent to MRLs — that is, they result from the scientific evaluation process; they differ only in that AMRLs are not yet promulgated. Once the regulatory process is complete the AMRL is promulgated as an MRL.
The addition of new MRLs for veterinary drugs to Table III to Division 15 of the Regulations can only be accommodated by regulatory amendment. These amendments list new MRLs for altrenogest, danoflaxacin, florfenicol, melengestrol acetate, trenbolone acetate and zeranol. Ractopamine was included in the regulatory amendment published in the Canada Gazette, Part Ⅰ, on November 10, 2007, but has since been removed because there is ongoing discussion on proposed MRLs for ractopamine at the international level (Codex Alimentarius Commission).
The amendments permit the regulated sale of food containing residues of veterinary drugs up to the specified level, as a result of use of these drugs to prevent and treat diseases in food-producing animals. These amendments benefit both industry and the consumer by reducing potential losses in production, increasing quality of products, improving availability of certain foods, and supporting the trade of safe and high quality products derived from animals.
A number of these MRLs are harmonized with MRLs for veterinary drugs already established by Canada’s major trading partners such as the United States. In addition, these amendments include MRLs that are compatible with levels established by the Joint Food and Agriculture Organization of the United Nations/World Health Organization Food Standards Programme Codex Alimentarius Commission and adopted by the European Union and the United States.
There is no anticipated increase in cost to government from the administration of these amendments to the Regulations. Compliance costs would not be a factor as the use of these drugs at the production level is optional.
Consultation
Prior to pre-publication in the Canada Gazette, Part Ⅰ, on November 10, 2007, consultations on the MRLs for the veterinary drugs included in these amendments were conducted with the following groups: 13 producer associations (e.g. Canadian Cattlemen’s Association, Dairy Farmers of Canada, Canadian Pork Council, Canadian Aquaculture Industry Alliance, Canadian Poultry & Egg Processors Council), 11 professional associations (e.g. Canadian Veterinary Medical Association), 4 veterinary colleges and universities, 8 federal/provincial/territorial departments and agencies (e.g. Canadian Food Inspection Agency, Agriculture and Agri-Food Canada, Fisheries and Oceans Canada, Department of Foreign Affairs and International Trade), 5 members of the drug manufacturing industry (e.g. Canadian Animal Health Institute, Pfizer Canada Inc.) and 7 other organizations (e.g. Canadian Council on Animal Care, Environmental Defence Canada, Consumer Interest Alliance Inc.).
There were 19 responses received as a result of the above consultations, the majority of which were supportive. Questions were also raised with respect to harmonization with trading partners and trade implications, the monitoring residue surveillance program and the warning statements for certain drugs. Health Canada responded in writing to each of these issues indicating that no trade issues were anticipated, that CFIA is responsible for laboratory testing and monitoring MRLs in food products and should be contacted for further information, and that Health Canada requires manufacturers of hormonal growth promotants to include a statement on the drug label that the use of these products is prohibited in veal calves.
These amendments were also pre-published in the Canada Gazette, Part Ⅰ, on November 10, 2007, followed by a 75-day comment period. One comment was received following prepublication indicating concerns about trade and wanting to know more about the methodology used to set the MRLs in question. Health Canada responded that trade concerns are unlikely to occur and explained the MRL calculation process. Also, as mentioned above, the proposed MRLs for ractopamine have been removed from this amendment.
Implementation, enforcement and service standards
The CFIA enforces compliance with the MRLs appearing in Table III to Division 15 of Part B of the Food and Drug Regulations. Where no regulatory MRL has been established, the CFIA may use the AMRL in its monitoring and compliance program so long as the AMRL is in the public domain and has been published on the VDD Web site. By adopting the use of AMRLs, the CFIA is better equipped to focus the risk-based enforcement of efforts regarding these veterinary drugs and thus make a greater contribution to ensuring the safety of food in the Canadian marketplace. Cases where neither an MRL nor an AMRL have been established are individually assessed. For more information on established AMRLs and MRLs currently in the legislative process, consult the VDD Web site at www.hc-sc.gc.ca/dhp-mps/vet/mrl-lmr/mrl-1mr_versus_new-nouveau-e.html.
Compliance is monitored by ongoing domestic and import inspection programs conducted by the CFIA. If levels of drug residues in excess of these limits are found in food products derived from food animals intended for human consumption, the product will be considered “adulterated,” in accordance with Section 4 of the Food and Drugs Act. The CFIA is authorized under the Food and Drugs Act to take compliance action, when they find violative residues. The CFIA’s regulatory activities help to maintain consumer and market confidence in Canada’s food supply.
Contact
Daniel Chaput
Director General
Veterinary Drugs Directorate
Health Products and Food Branch
Health Canada
11 Holland Avenue
Address Locator: 3000A
Ottawa, Ontario
K1A 0K9
Fax: 613-954-5694
Email: vetdrugs-medsvet@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