Animal Health - Antibiotics and Antimicrobials

 NCBA Final Comments on the FDA draft guidance: The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals (Aug. 30, 2010)  (40 KB)

Summary:

A top priority for all cattle producers is the health and well-being of their animals. The judicious use of antibiotics are an important technology cattle ranchers use to provide comprehensive herd-health plans to prevent problems and treat issues when they arise.

U.S. cattle producers are recognized as innovative leaders for their ability to produce and maintain a healthy U.S. cattle herd. Ranchers have an obligation to not only protect the health and welfare of their cattle but also protect human health as well because healthy cattle are the foundation of safe, wholesome beef products.

The approval and use of antibiotics to treat sick animals and to maintain animal health is a science-driven process. The Food and Drug Administration (FDA) approves antibiotics to treat specific diseases or conditions at specific dosage rates, and producers are legally required to follow these precise label directions. This stringent approval process was made more stringent in 2003 when FDA finalized an additional safety measure requiring risk assessment to be applied to all new and existing antibiotics (Guidance for Industry Part 152). NCBA supports the role that FDA plays in making science-based decisions regarding the safety and efficacy of antibiotics and antimicrobials used in animal agriculture.

Antimicrobial resistance is a very complex, multi-faceted issue that affects human and animal health. As such, NCBA carefully monitors all international, science-based and peer reviewed research on this issue to ensure our policies and guidelines are consistent with the current knowledge. However, this is no conclusive scientific evidence indicating the judicious use of antibiotics in cattle herds leads to antimicrobial resistance in humans. Unfortunately, some continue efforts to ban the use of certain antibiotics or antimicrobials. Efforts to ban antibiotic and antimicrobial use in the absence of risk assessment and sound science could be harmful to both human and animal health.

Background:

There has been a rising level of scrutiny about the use of antibiotics and antimicrobials in animal agriculture. Some media reports would lead readers to believe that the use of antibiotics and antimicrobials can spur the development of resistance genes in humans making it more difficult to fight human illnesses. 

Several layers of protection have been put in place to ensure antibiotics are used to keep animals healthy without harm to public health. The FDA, the U.S. Department of Agriculture (USDA), along with the veterinary community, animal health companies, producer organizations and other stakeholders have put in place several layers of human health protections during the past decade to reduce any risks associated with antibiotic use in animals.

It’s important for consumers to know that by law, no meat sold in the United States is allowed to contain antibiotic residues that violate FDA standards. Antibiotics used in beef cattle must go through a rigorous scientific testing process before being approved by FDA. This process assures animals remain healthy and the food supply remains safe.

The U.S. Department of Agriculture’s Food Safety & Inspection Service (FSIS) conducts tests to ensure beef products entering the food supply do not contain antibiotic levels that violate FDA standards. This testing protocol has been updated continuously since its inception in 1967.  

In August 2010, NCBA commented on FDA’s draft guidance document titled “Draft Guidance: The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals; Availability.” Specifically, NCBA raised concerns with lack of scientific evidence FDA used in making determinations in the draft guidance. However, cattlemen remain committed to working with FDA on the concerns raised and on any issues regarding the use of antibiotics or antimicrobials in cattle.

Cattlemen have demonstrated a commitment to raising healthy cattle and judiciously using antibiotics and antimicrobials for decades by our own successful initiatives. The industry-led Beef Quality Assurance program (BQA) has been training cattle ranchers about the safe and appropriate use of antibiotics for more than two decades.

NCBA Policy

NCBA policy supports the use of the Producer Guidelines for Judicious Use of Antimicrobials, which has been in place since 1987. The guidelines specifically outline the appropriate use of antibiotics:

• Avoid using antibiotics that are important in human medicine.
• Use a narrow spectrum of antimicrobials whenever possible.
• Treat the fewest number of animals possible.
• Antibiotic use should be limited to prevent or control disease and should not be used if the principle intent is to improve performance.

NCBA policy also advocates the use of antimicrobials as outlined in the Quality Assurance Guidelines for both beef and dairy cattle, as appropriate. The guidelines are based on the American Veterinary Medical Association (AVMA), the American Association of Bovine Practitioners (AABP) and the Academy of Veterinary Consultant’s (AVC) judicious use guidelines and strengthened to include beef producer’s commitment to the importance of human use antimicrobials.

Key Points:

• Antibiotics and antimicrobials are an important and necessary technology in protecting animal health and well-being.
• Resistance to all antibiotics used in animal agriculture is monitored through a USDA and FDA program called the National Antimicrobial Resistance Monitoring System (NARMS). To date, there is no data to indicate a change in the level of resistance to antibiotics currently used in animal agriculture.
• By law, no meat sold in the United States is allowed to contain antibiotic residues that violate FDA standards. Antibiotics used in beef cattle must go through a rigorous scientific testing process before being approved by FDA. This process assures animals remain healthy and the food supply remains safe. 
• NCBA is strongly opposed to congressional action in determining the safety and efficacy of antibiotics. This is the role of FDA and we ask Congress to empower the agency to do its job effectively, based on sound science, in an open, transparent process.
• NCBA supports actions based only on sound, peer-reviewed science and risk assessment relative to the use of antibiotics or other drugs.
• NCBA supports the judicious use of all antimicrobials and encourages proper use through beef quality assurance (BQA) programs.