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Carbadox is an antibiotic approved in the 1970s for use in swine to prevent
and treat disease as well as to maintain weight gain during periods of
stress, such as weaning. It has been shown that the drug, and the
by-products of the drug that occur when the drug is metabolized in the body,
can cause cancer in rats. However, when an appropriate withdrawal period
(i.e stopping the administration of the drug before slaughter) is observed,
the drug and its breakdown products are not found in the food derived from
the treated animal.
Carbadox was approved on the basis that this specified 35-day withdrawal
period be strictly observed. However, reports of misuse and accidental
contamination, combined with a better scientific capacity to detect
breakdown products of carbadox,
resulted in serious concerns about the safety of the product. The first
reported incident occurred in the fall of 2000 when pigs at a farm in Quebec
were accidentally fed carbadox and slaughtered without respecting the
withdrawal period. All affected product was recalled and removed from store
shelves and an investigation into the incident was launched. The
investigation was then broadened to review the use of carbadox throughout
the Canadian pork industry.
In February 2001, responding to the European Union Fall 2000 audit of the
Canadian Program for the Control of Residues, Canada made a public
commitment to reassess the use of carbadox in pigs. Based on the
reassessment, Health Canada proposed to amend the Food and Drug Regulations
to ban the sale of any drug containing carbadox for administration to
food-producing animals. As part of this regulatory process, Health Canada
advised manufacturers of its human safety concerns and asked them to provide
evidence to respond
to these concerns. The manufacturers provided information, which was
reviewed
carefully by experts in health risk assessment.
Health Canada concluded that this information does not satisfy its concerns
for safety and is proceeding immediately with a stop sale order. The stop
sale order protects consumers until the completion of the regulatory process
that might lead to a permanent ban. As part of this process, Health Canada
will continue its review of carbadox.
Swine producers, feed mill manufacturers, veterinarians and other affected
groups are being informed of the decision. Health Canada will monitor
compliance with the order. The Canadian Food Inspection Agency is continuing
to monitor for the presence of residues in food and animal feed.
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