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Don’t Tamper With Own-Use Import Rules

An article in the April 2009 issue of the Canadian Medical Association Journal said the government allows unrestricted imports of unapproved and untested antibiotics used in meat production that contribute to antibiotic resistance in humans. The CMAJ article tried to relate the importation of animal health products by producers under the “own use importation” provision to cephalosporin and fluoroquinolone usage in livestock and antimicrobial resistance to the same class of drugs in humans. Immediately the CBC and the Globe and Mail picked up the CMAJ article. Articles like these are based on misinformation and damage the reputation of the Canadian cattle and beef industry, as well as the Canadian government. Health Canada’s Veterinary Drug Directorate is currently reviewing changes to the “own use importation” policy for veterinary drugs. Stories like the one published in the CMAJ can lead to political pressure to make regulatory changes that are not based on facts or scientifically sound risk assessments of animal and food safety.

The main reason producers have been importing some veterinary animal health products into Canada is price. USDA-FDA approved generic ivermectins have been as much as 75 per cent lower in price than similar products in Canada. Growth implants have been as much as 40 per cent lower in the U. S. versus Canada. Due to a much smaller market in Canada and regulatory impediments associated with the Canadian approval/registration process, pharmaceutical companies do not try to license some products, including generics, in Canada. Competition is needed in the pharmaceutical marketplace to keep prices reasonable and to help Canadian cattle producers and veterinarians remain competitive in a global beef market. This is going to become even more difficult because of the ongoing consolidation of the pharmaceutical industry, with Merial purchasing Schering-Plough Intervet and Pfizer purchasing Wyeth (Fort Dodge). These two new worldwide companies will control the majority of the marketplace in veterinary products. Thus, Canadian livestock producers should have the ability to import USDA-FDA approved over the counter (OTC) veterinary animal health products and Canadian veterinarians should have the ability to import USDA-FDA approved OTC and prescription veterinary animal health products.

Regarding comments in the CMAJ article on cephalosporin and fluoroquinolone resistance, it must be remembered that these are prescription drugs in Canada and the U. S. Cephalosporins are better known to cattle producers as the veterinary drugs Excenel (Naxcel in the USA) and Excede. Fluoroquinolones used in cattle are Baytril and A180.

Prescription drugs cannot be imported by producers under the own-use provision so antimicrobial resistance to cephalosporins and fluoroquinolones in cattle, beef or the environment, has nothing to do with the own-use provision. It is simply a red herring.

In any event, routine annual surveys by the Public Health Agency of Canada have found a very low incidence of bacteria resistant to cephalosporins and fluoroquinolones on beef carcasses or retail beef. And there has been no apparent increase in resistance to these drugs over time. We were involved in a study looking into the incidence of antimicrobial resistance in feedlot cattle, beef carcasses and the feedlot environment (see Documenting foodborne bacteria in Alberta feedlots, Canadian Cattlemen May 2009, and the Jan. 2009 issue of Canadian Veterinary Journal (CVJ). We found no antimicrobial resistant bacteria on beef carcasses. The incidence of bacteria resistant to cephalosporins in feedlot manure, soil or catch basin water was very low and none were resistant to fluoroquinolones. A 2003 study in federal beef packing plants found simi-

TO LEARN MORE:

CBC News Article http://www.cbc.ca/consumer/story/2009/04/08/animal-antibiotics.html.

Health Canada — Veterinary Directorate — Proposed policy changes on “own use importation”

www.lett-eng. hc-vet/php. sc.gc.consultations/ca/dhp-mps/oui-http://consultation/iup/

Public Health Agency of Canada — CIPARS: antimicrobial resistance surveillance gc.ca/cipars-http://picra/surv-www.eng. phac-php. aspc.

lar resistance levels in generic bacteria on beef carcasses (CVJ; Vol 44: Sept 2003); less than one per cent to cephalosporins and zero for fluoroquinolones.

The comment in the CMAJ article that “there is no scrutiny from safety regulators on products imported under the own use importation provision,” is false. Own-use imports are regulated by Canada Customs, CFIA, and Health Canada. Canada Customs requires an invoice and an approved product label before a product can even be imported. The product codes and volumes are entered in the Canada Customs database and tracked by the government. This information should be made available to the industry so we can objectively evaluate what is being imported, from where, and what potential risks may be associated with the importation of different veterinary drugs. Factual data is needed to help the industry work with the government to reduce unacceptable levels of risks to animal or public health and to deal quickly with misleading stories like that in CBC, the Globe and Mail, and Canadian MediCal assoCiation Journal.

Importation of veterinary drugs from countries like the U.S. where the products are tested and approved by USDA-FDA, pose no risk to animal or public health in Canada. Canada imported 130,500 tonnes of beef from the U.S. in 2008. If USDA-FDAapproved veterinary products were unsafe for animal or human safety, then American beef should not be imported.

If there is any potential for abuse it is with the import of bulk amounts of active pharmaceutical ingredients (API) for repackaging in Canada or veterinary products from countries that do not have equivalent animal or food safety systems to Canada and the United States. These are the loopholes that should be closed, not a producer’s access to cheaper products cleared by a food safety system equivalent to Canada’s. changes on “own use importation” http://www.hc-sc.gc.ca/dhp-mps/consultation/vet/consultations/oui-iup/lett-eng.php.

— Rick Paskal and Dr. Joyce Van Donkersgoed

Rick Paskal is a feedlot operator and chairman of the National Cattle Feeders Association; and Dr. Joyce Van Donkersgoed is a feedlot veterinarian based in Coaldale, Alta.

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