Health Canada is making its first move on new regulations to limit livestock producers’ own-use imports of veterinary drugs, and to tighten veterinary oversight of medicated livestock feed and water.
Proposed changes to the federal Food and Drug Regulations and Feeds Regulations, announced Friday, tie into Health Minister Rona Ambrose’s federal action plan on antimicrobial resistance and use, launched late last month.
Proposed amendments to the Food and Drug Regulations dealing with own-use imports (OUIs) of veterinary drugs have already been published for further consultation in the Canada Gazette for Saturday (April 18).
OUI regulations today let Canadian individuals import drugs — including antimicrobials not approved for sale in Canada — and administer those drugs to animals.
Such a practice, Health Canada said, “may be considered necessary for companion animals travelling with their owners (but) the situation is substantially different for food-producing animals that will enter the food supply after being treated with drugs, including medically important antimicrobials.”
The amendments Health Canada proposes would clarify under what circumstances a person could import a veterinary drug for his or her own use on animals, and would allow the federal health minister to maintain a list of permitted drugs.
A drug would be included on the list for OUIs if it’s approved for sale by “another recognized foreign regulator;” if it’s imported directly from the country of approval; if it’s imported in its final dosage form; and if it contains identical active ingredients for a product that’s already approved for veterinary use in Canada.
But a drug would no longer be allowed for OUIs if it’s required to be sold only by prescription; if it’s a medically important antimicrobial; if Canada hasn’t yet established a maximum residue limit (MRL) for it; or if it’s a medicated premix for use in feed for food-producing animals.
The proposed new regulations would also require active pharmaceutical ingredients (APIs) for veterinary use to be subject to good manufacturing practices (GMPs), similar to the GMPs on drugs made for human use.
To that end it’s also proposed, as per current requirements for human-use APIs, that anyone in Canada wanting to import an API for veterinary use would have to obtain an establishment licence (EL) to do so.
The Canada Gazette posting didn’t give a hard date for the proposed new OUI rule to take effect, but last month’s action plan set a target of sometime in 2017.
Feed and water
Health Canada on Friday said it will also “continue to work with stakeholders” to boost the level of “veterinary oversight” on use of medically-important antimicrobial drugs in livestock drinking water and feeds.
That, the government said, will take further amendments to both the Food and Drug Regulations and the federal Feeds Regulations.
Both Health Canada and the Canadian Food Inspection Agency want more “professional oversight” on the use of existing antimicrobial drugs in food animal production, the government said.
That increased oversight, they said, would be focused on several in-water and in-feed veterinary antimicrobial drugs that were approved as over-the-counter (OTC) products before more stringent microbiological safety standards took effect in 2004.
Last month’s action plan calls for the approach and timing of that regulatory change to line up with a “similar initiative” in the U.S. — and for the new regulations to take effect by December next year.
Rob McNabb, co-chair of Canada’s National Farmed Animal Health and Welfare Council, said in the government’s release Friday that the proposed changes “complement” initiatives the council has been working on.
McNabb, who’s also general manager of operations for the Canadian Cattlemen’s Association, said the proposals are also “consistent with the (CCA’s) existing efforts to encourage prudent drug use.”
Friday’s proposals “reflect our commitment to the important issue of antimicrobial resistance and to keeping our food supply safe,” Ambrose said in the same release. –– AGCanada.com Network