Growth promotant claims to be removed from antimicrobial products

Thursday, April 17, 2014

by SUSAN MANN

Canada’s efforts to align with the United States’ plans to change labeling on antimicrobials considered important in human medicine may result in some products becoming unavailable for farmers.

Jean Szkotnicki, president of the Canadian Animal Health Institute, says growth promotion claims are to be removed from 140 product labels. The government has also announced its intention to ensure “there’s veterinary oversight of these products. That’s putting them into a prescription-type status,” she says.

The changes are to take place over three years.

The animal health institute represents companies that manufacture animal health products, such as vaccines, pharmaceuticals and feed additives used in food production along with medicines for pets.

Many of the products also have therapeutic claims already on their labels and that won’t change. “Those products will still be on the market with therapeutic claims,” she says.  But “we may lose some products that just have the growth promotion claims if a company chooses not to try to get a therapeutic claim, which is for prevention, control or treatment of disease.”

Szkotnicki says many of the products are old and it’s very expensive to generate new data “in support of a therapeutic claim” so some companies may just take their products off the market. Also, in Canada there isn’t any intellectual property protection so there is very little business incentive to expand the labels.

She didn’t know how much it would cost the industry to remove the growth promotion claims from labels. But it’s going to take a tremendous amount of human resources to make the changes, she says.

The changes won’t necessarily cost farmers more for products but producers might have some added veterinary services that they will need, she says. “I think most of the quality assurance programs farmers are enrolled in do have a requirement for a veterinary-client-patient relationship” already.

Szkotnicki says it’s the antimicrobials critically important to human health, in Categories One, Two and Three “that are going to be part of this program.” Health Canada has ranked various microbial drugs based on their importance in human medicine with Category One being the most important.

Category Four antimicrobials are not included in this change, Szkotnicki says, “because they’re not considered critically important to human medicine.” Neither will veterinary oversight be required for their use. Products in that category, such as the ionophores, which are used in beef production, aren’t used in human medicine “and have no implications that anyone’s aware of relative to resistance.”

Health Canada announced April 11 its Veterinary Drugs Directorate is working with the animal health institute and other stakeholders on this initiative. Impacted stakeholders will be consulted throughout the transition, it said in its press release.

Similar measures are being implemented in the United States, also over three years, Health Canada says in its April 11 press release.

Ontario chief veterinarian Greg Douglas says the Canadian Council of Chief Veterinary Officers urged Health Canada to harmonize its efforts with the United States. The Council had also proposed harmonizing veterinary and microbial drug regulations between Canada and the United States “in a effort to maintain cross-border competitiveness.”

It’s important Canada reduces the use of antimicrobials, especially ones that are vital for human medicine, but it’s equally essential Canadian veterinarians and farmers have access to the same tools as their American competitors and farmers in other countries, he says.

Szkotnicki says the animal health institute has asked the government to include the policies on antimicrobial use under the Regulatory Cooperation Council “with the goal of trying to align the Canadian labels with that of the United States, so we have the same dosage ranges and compatibility claims.”

The goal of the Canada-United States Regulatory Cooperative Council is to better align the two countries’ regulatory systems and boost North America trade and competitiveness.

This winter, Douglas attended the Ontario Pork and Dairy Farmers of Ontario annual meetings to discuss the matter and outline what farmers can do to cut back on antibiotic use in their animals. Last fall and this spring, the agriculture ministry held 14 meetings for various stakeholders to hear their perspectives and opportunities to reduce antimicrobial use while increasing “prudent and judicious use,” he says, adding he will be attending other farm groups’ meetings this year to talk about this.

The overuse of antibiotics and its role in causing antimicrobial resistance in humans has been discussed for a number of years. It’s a worldwide concern, Douglas says.

Szkotnicki says the changes will give consumers with concerns about antimicrobial resistance more confidence in the food supply.

Douglas says government is accumulating data to compare industry’s use of antibiotics from year to year. “It’s important for us to use less antimicrobials in agriculture in the future than we are now. Seventy-five to 80 per cent of antimicrobials are used in Canadian agriculture and “that’s not acceptable for us to continue that trend,” he says.

Last year in Canada, 1.6 million kilograms of antibiotics were used in agriculture, he says, noting that “trend line has been going up for the last few years and it has to start going down.”

Douglas says in the United States “they have started with a voluntary withdrawal of growth-promotion claims on labels and the companies associated with that practice have all agreed to go down that road in a voluntary approach.”

It is particularly important for Canada to have a coordinated approach across the country and with the United States because if the policies aren’t aligned it will cause an un-level playing field and possibly create a black market, he notes.

As for strengthened veterinary oversight of antimicrobial use in food animals, Szkotnicki says it remains to be seen how that will be accomplished. But “there’s a real conscious effort to try and make this process practical in the field.” For example, veterinarians could have access to standardized prescription apps on their smartphones or computer tablets that they could electronically sign and send in to a feed mill.

Douglas says farmers have alternatives to antimicrobial use. For example, in the Canadian chicken industry there’s currently a cull chick project underway “where they’re culling chicks that they otherwise might have treated in the past so they’re not using antibiotics early in the growing system. That’s an example of a production practice change that will contribute to decreasing antimicrobial use and antimicrobial resistance,” he says.

Antimicrobials are still necessary to treat sick animals, he says. “They are a tool and a requirement for us to have healthy animals.” But it is important they only be used therapeutically and “not for growth promotion.”

As for stronger veterinary oversight of antimicrobial use in food animals, many industries’ on-farm food safety and quality assurance programs require farmers to have a relationship with their vet. Farmers should hold their veterinarian accountable for what they’re prescribing and question traditional practices to determine if they’re still valid, he says.

“I know the medical community has challenged their professionals to be more accountable for how they’re using antimicrobials for routine infections and I think the same should hold true in veterinary medicine,” he explains. BF