Farmscape Article 2224  August 19, 2006

Canadian pork producers are encouraging Health Canada to consider potential trade implications as it addresses the foreign use of Carbadox. Carbadox is an antibiotic which is used mainly to protect against swine dysentery. It was authorized for use in Canada in the early 1970’s.

However in the summer of 2001, Health Canada issued a stop sale order on all products containing Carbadox in Canada because of specific human health concerns. In the spring of 2004, the product’s drug identification numbers (DIN) were withdrawn and deleted from the Compendium of Medicating Ingredients Brochure (CMIB). Now Health Canada is proposing a regulatory amendment to further restrict the use of Carbadox in food producing animals to ensure there are no residues of the drug or its metabolites in pork and pork products.

Research Uncovers Human Health Concerns Related to Residues

“The issue with the drug has been in recent years, the late 80’s and early 90’s, there were some significant findings in terms of studies that were done in lab animals,” states Health Canada’s Veterinary Drugs Directorate (VDD) director general Dr. Siddika Mithani.

“It was demonstrated that there might be a potential for carcinogenicity with one of the metabolites of the drug Carbadox. As a result there has been a potential safety concern from Health Canada’s perspective and as a result Health Canada is looking at ways in which we would be able to further restrict the use of this drug in Canada. The bottom line here is to ensure that safety is not compromised.”

Proposal Would See Carbadox Added to List of Controlled Substances

The Health Canada proposal would see Carbadox included in the list of prohibited substances, which would mean that any Canadian or imported food products with residues of Carbadox or its metabolite would not be permitted to be sold in Canada.

Dr. Mithani notes, “The stop sale of this drug has been effective since 2001 so, as of 2001 the drug has not been sold in Canada so it effectively has not been available in Canada.”

“However,” she explains, “it is also our understanding there are other mechanisms by which the drug can be used or can be imported to Canada. The regulatory action that we are proposing at this point in time is to ensure safety of Canadians and the safety of the food supply in Canada in order to assure that there are no Carbadox residues in the food that is consumed in Canada.”

“It’s important to remember that there are alternatives out there to treat or to prevent dysentery in pigs and, if there is a drug where there is any potential safety concern then I think Health Canada has an obligation to ensure a safe food supply and this is exactly what we are hoping to do,” she says.

Canadian Producers Adjust

Since the withdrawal of Carbadox Canadian producers have adjusted. Canadian Pork Council (CPC) executive Director Martin Rice says, “There have been other products that are available to deal with the conditions that Carbadox was so effective at dealing with. However Carbadox was a very cost effective drug and it has not been without cost implications and so on for producers to have to switch. Because it’s so rare that veterinary drugs these days are coming onto the market due to the cost of registering a drug and quite often because of how long it takes in Canada. Manufacturers simply don't bring them forward for approval.  So certainly for veterinarians and their producer clients, whenever a product is taken away it’s one less effective product that’s available to them.”

Carbadox Already Withdrawn Elsewhere

Canada is not the first country to halt the use of Carbadox. While several countries, most notably the United States and Mexico, continue to permit use of the product, in accordance with clearly defined withdrawal periods, several other nations have also revoked its approval. Included in that list with Canada are Australia, Brazil, the European Union and Japan. Nevertheless, word that Health Canada is planning to tighten regulations pertaining to Carbadox has raised some questions in the United States.

Rice explains, “The pronouncements that Health Canada has made about taking steps to ban it have created some interpretations of the regulatory requirement that Health Canada would put in place that would suggest a burden or a constraint on exporting pork into Canada from a country that still has Carbadox available.”

He adds, “We are continuing to discuss with the department if indeed that is a correct interpretation and how we can avoid unnecessary trade implications from this.”

CPC NPPC In Close Communication on Carbadox Issue

The issue was discussed when representatives of the Canadian, American and Mexican swine industries met in May for trilateral meetings and again last month when officials of the US based National Pork Producers Council (NPPC) took part in the Canadian Pork Council’s (CPC) annual general meeting in Winnipeg.

“Our concern,” explains Joy Philippi president of the National Pork Producers Council, “is that, if Canada does decide to ban the import of the animals or meat treated with Carbadox, it’s not going to be in accordance with the WTO [World Trade Organization] agreement on the application of sanitary and phytosanitary measures and it's also going to be an issue when we talk about the North American FTA [Free Trade Agreement].”

NPPC Convinced Carbadox is Safe

Philippi stresses, “Carbadox has been approved for use for 35 years. It’s one of the drugs that we believe is the safest and the best to be used in the nursery phase. It has a 42 day withdrawal period that we believe producers abide by.”

She points out “Carbadox is actually fed in the earlier stages of life for pigs, that being in the nursery phase. We know, because of the 42 day withdrawal period, there’s no residue from that drug in the meat at slaughter.”

She suggests, “I feel comfortable to be able to look at testing standards as opposed to a ban of the products.”

She believes, “The one thing that seems to be overlooked is Carbadox is not a cheap drug to feed but it’s the drug of choice in the early stages of life. It’s one that we know works well in those pigs. As far as the economic impact on our feeding costs, there might be other drugs out there but when you’ve got something that works efficiently you don’t mind spending just a little more to make it work.”

“The other side of it is, if we can’t export meat into Canada that has been fed Carbadox, it’ll have a tremendous impact on the U.S. pork industry as far as our economic viability. We have a lot of pork that goes into the country in Canada. It’s a good market for us and we believe it’s one of the things that has made us good trading partners in the past.”

Carbadox Issue Could Impact Canada U.S. Cooperation

An additional concern is that this issue has the potential to disrupt efforts to better harmonize and coordinate the North American swine industry.

“We’ve had some tremendous things happen in the last couple of years as far as our relationship to create a North American pork industry that’s stronger,” Philippi notes. “Something like this could totally upset everything and make it impossible to even carry out some of the things we’ve done.”

Health Canada Confident Proposed Action Will be Trade Neutral

“It’s our understanding that the proposed regulatory action, that we are hoping to take or that we are currently considering, will not have any trade implications,” states Dr. Mithani.

“At this point in time,” she explains, “because there is a stop sale, there isn’t a legal authority in terms of being able to ensure that imported product should not contain Carbadox. Therefore the proposed regulatory amendment that we’ve been contemplating at this point in time will provide us that authority. If we include it into the list of restricted substances it will provide us the authority to be able to ensure there will be no imported products as well as domestic products that would contain Carbadox residues.”

She stresses, “Clearly there have [been concerns] and that is the reason we are going to the next step. [Despite] having put into effect a stop sale and removing the DIN (drug identification number), which essentially means that the drug is not available in Canada, there had been situations in which there was product in Canada that was found with Carbadox residues. As a result Health Canada is therefore contemplating further regulatory action in order to ensure the bottom line, which is that safety should not be compromised.”

Other Alternatives Also to be Considered

At the same time, Dr. Mithani adds, “If there are other ways to assure there will not be any Carbadox residues in the food supply in Canada, whether it’s imported or domestic, then it’s something that Health Canada will consider.”

She notes, “We do have a meeting with our interested stakeholders next week and that is when we will be discussing the regulatory options… and based on that, if there are any other options, the other options will be explored.”

NPPC Supports Residue Testing Rather than Prohibition

Philippi indicates the NPPC will be anxious to find out the result of that meeting which will involve the CPC and other stakeholders and whether U.S. producers will be able to stick with their testing regimen.

She says, “We feel comfortable that we’re doing the right thing with the testing. We’d even live with whatever changes they’d [Health Canada] come up with in testing but to completely remove this from our feeding practices could be really tough on everybody.”

Actual Regulatory Amendments At Least A Year Away

Rice notes, while Health Canada has indicated its intent to initiate the regulatory process starting this year, putting forward a proposal then getting comments back and then making a change can be expected to take at least a year.

He adds, “We would see further dialogue with Health Canada and they have been cooperating in sitting down with interested parties to examine some of these ideas.”

“If it is considered that the proposed regulatory amendment is the best way to go,” Dr. Mithani explains, “it gets published in Canada Gazette - Part One. There’s a time provision where people are able to send comments to Health Canada. These comments will be reviewed. The final publication [in Canada Gazette - Part Two] will take awhile so you’re looking at a fairly long time line with an opportunity for commentary and any concerns that can be communicated to Health Canada will be considered as we move forward. Our meeting next week will explore other options, if that is possible, but recognizing that the bottom line is the safety of the food supply in Canada.”

Staff Farmscape.Ca