Coalition for Animal Health
March 28, 2006

Senator John Nutting
Representative John Piotti
Joint Standing Committee on Agriculture, Conservation and Forestry
2 State House Station
Augusta, Maine 04333-0002

Dear Senator Nutting and Representative Piotti:

The undersigned organizations represent the animal producers, veterinarians, feed and animal health companies working together to ensure antibiotics are available and safely used to keep food animals healthy and produce a safe food supply.

We have read with great interest the report submitted to you on the issue of antibiotic use to keep animals healthy, and would like to offer our perspective and suggestions.

We wholeheartedly agree with the two major principles outlined in the report. Every day we seek to practice good antimicrobial stewardship by selecting the right antibiotic for the specific condition and using it in a way that maximizes animal health and minimizes potential adverse consequences. It addition, the principle of control and prevention is at the heart of the practice of veterinary medicine: We work to first keep animals healthy, but in the event of a disease outbreak we are forced to use drugs for treating the outbreak. We consider this a sound animal welfare practice. Our responsibility to keep animals healthy is an important factor in providing consumers with the safest food supply possible.

Some of the recommendations in the report seem to overlook the various science-based layers of protection currently in place to ensure the safe development, rigid regulation and responsible use and monitoring of antibiotic use in animals. These are safeguards accepted by the food chain, but are perhaps little understood by the general public. We would appreciate your careful review of these safeguards and would be pleased to provide you additional details or more information sources about these safeguards:

1. The Food and Drug Administration reviews and approves all antibiotics before they can be used. Antibiotics administered to animals are approved for four distinct purposes: Disease treatment, disease control, disease prevention and growth promotion or health maintenance. Disease treatment, control and prevention are widely considered to be “therapeutic” uses by such organizations as the American Veterinary Medical Association (AVMA) and the World Organization for Animal Health (OIE). Thus, the term “non-therapeutic” that is often associated with prevention in your report carries no legitimacy with animal health authorities worldwide.

In order to protect both animal and human health, the statutory standard of “safe and effective” is the same for animal antibiotics as for human antibiotics, and the requirements for submitting data to demonstrate safety and efficacy are the same for both. However, there are at least three ways in which the process for animal antibiotics is more stringent than that for human antibiotics:
• Sponsors of antibiotics used in animals must also submit data demonstrating the meat from animals that have been administered antibiotics is safe for human consumption.
• FDA weighs the benefits of a human antibiotic against its risks; there is no consideration of benefits in the review of antibiotics administered to animals. This means that the risk to humans for products under review must be exceptionally low because FDA does not consider any benefits to animals to counterbalance risks.
• FDA issued Guidance for Industry #152 in late 2003 requiring sponsors to use a qualitative risk assessment process to evaluate the potential for adverse human health effects from antimicrobial resistance for all proposed antibiotic products. This process is heavily weighed towards protecting human health first. Importantly, FDA is in the process of re-examining all existing, approved antibiotics used in animals using this same risk assessment process. In fact, Congress has, as suggested in the report, provided funding that is being used specifically for these risk assessments.

2. Monitoring and surveillance programs ensure that the safeguards that are part of the review process are working to protect public health. We are supportive of these programs and collectively we have lobbied the U.S. Congress to provide funding for them.
• USDA’s Food Safety & Inspection Service (FSIS) tests meat in processing plants to ensure there are no violative antibiotic residues.
• The Food Animal Residue Avoidance Databank (FARAD) is a computer-based decision support system designed to provide livestock producers, extension specialists, and veterinarians with practical information on how to avoid drug residue problems.
• The National Antimicrobial Resistance Monitoring System (NARMS), coordinated by FDA, monitors the incidence of antibiotic resistant food borne pathogens in animals, human and retail meat samples. This information provides an early-warning system about the potential emergence of antibiotic resistant pathogens.

3. The animal health industry pioneered the application of quantitative risk assessment to measure the risk to humans of antibiotics administered to animals. This methodology is essential to making sound public policy decisions and gives decision-makers more precise information about risks. Quantitative risk assessments done by sponsors have been published in peer-reviewed journals, and FDA has completed such an assessment on an antibiotic used in animals. To date, all of these have shown very low levels of risk. Notably, the FDA risk assessment, in which the agency concluded the potential risk of a person even carrying an antibiotic-resistant bacteria as a result of use on the farm was in the range of seven chances in a billion to 14 in 100 million over one year was done on a product that would likely be affected by the purchasing preference recommended in the report.

4. AVMA, species-specific veterinary groups, feed and producer groups have all worked with public agencies including FDA to produce guidelines for safe and judicious use of antibiotics. These guidelines are used as the basis for producer education programs and represent an important effort on the part of the animal agriculture community to ensure that antibiotics are used properly. Many producers have used these guidelines to create standard operating procedures for antibiotic use on the farm.

As you can see, there is much in the report with which we agree and we have worked to institute programs reflecting this intent. However, we do not support implementation of a purchasing preference for several reasons. First, it will be an undue burden on Maine agencies and will unnecessarily stigmatize producers who rely on these FDA-approved safe and effective tools to maintain the health of their herds and flocks. It could be used to deny critical treatment options to animals, threatening animal health and welfare and food safety. Finally, without establishment of an auditing and enforcement system to verify compliance it would be meaningless. Nor do we support federal or state legislative efforts to limit antibiotic use because we believe in the efficacy of the science-based review process at FDA, and we do not believe it is good policy to undermine confidence in that process.

Again, we would be happy to provide more detailed information on any of the issues mentioned above. Should you desire more information, please contact Ron Phillips at the Animal Health Institute, 202-662-4130 or rphillips@ahi.org.

Sincerely,

American Association of Bovine Practitioners
American Association of Swine Veterinarians
American Feed Industry Association
American Sheep Industry Association
American Veterinary Medical Association
Animal Health Institute
National Cattlemen’s Beef Association
National Chicken Council
National Pork Producers Council
National Turkey Federation