AFACT: American Farmers for the Advancement and Conservation of Technology

Post Approval Monitoring and Review Ensures Continued Safe Use of Antibiotics

Post Approval Monitoring and Review Ensures Continued Safe Use of Antibiotics

Like human medicines, all animal medicines - including antibiotics - are subject to careful monitoring after they have been approved and marketed by the Food and Drug Administration (FDA).

Risk assessment is an important tool that federal agencies use to make public policy decisions about health and safety. It allows policymakers to measure and quantify the risks involved in a particular action. The FDA, company sponsors, and researchers have conducted post-approval risk assessments on many antibiotic compounds used in animal agriculture. Their findings consistently demonstrate very low risk to human health as a result of using medicines, like antibiotics, on animals to help them recover from illness, prevent illness or maintain their health:

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Researchers at the University of Georgia found that carcasses from harvested poultry were more likely to be contaminated with E. coli and Campylobacter if they were sick with airsacculitis. This could lead to a greater number of food borne infections (Russell SM., Poultry Science 2003; 82 (8): 1326-1331).

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Using the Russell data, a follow-up risk assessment found that withdrawing antibiotics for animals can cause far more human illness days than it would prevent. The estimated BENEFIT:RISK health ratio for humans for the impact of continued animal antibiotic use on human health exceeds 1000:1 in many cases. (Cox LA Jr, Popken DA, Risk Analysis 2006; 26(1): 135-46)

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Georgetown University researchers performed a risk assessment on the use of fluoroquinolones in beef cattle. The resulting human health risk of fluoroquinolone resistant Campylobacter on beef is an estimated 40 additional hospitalizations and 1 case of mortality over 10 years of use in cattle (Anderson SA, et. al., Food C0ntrol 2001; 12(1):13-15.)

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An FDA risk assessment on the use of fluoroquinolones in poultry estimated a risk level of 0.0019% for the average U.S. citizen. This work was used to remove a fluoroquinolone product that treats airsacculitis in poultry from the market. (Vose, et al, http://www.fda.gov/cvm/Documents/RevisedRA/pdf.)

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University researchers conducted a risk assessment of macrolide antibiotics used in animal agriculture, using the general outline of the FDA’s Guidance 152. They found that risk probabilities are less than 1 in 107 million humans for macrolide-resistant Campylobacter infections from macrolides use in pigs. (Hurd, HS, et. al, Journal of Food Protection 2004; 67:980-992)

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The FDA conducted a risk assessment on the use of Virginiamycin, concluding that, “assuming a food pathway attribution of 10%, the average risk to a random member of the US population of having SREF (streptogramin-resistant E. faecium) attributable to animal uses of virginiamycin and that may result in impaired Synercid therapy, ranges from 7 chances in 1 billion to 14 chances in 100 million in one year.” http://www.fda.gov/cvm/Documents/SREF_RA_FinalDraft.pdf

Risk assessment, when combined with risk communication, is the proper tool for making public policy decisions (risk management decisions) about the use of antibiotics in animal agriculture. Risk analysis, the combination of risk assessment, risk communication, and risk management allows policymakers to measure the potential consequences of actions. Actions taken without using risk analysis are likely to result in negative consequences.

A recent report by the Institute of Food Technologists (Comprehensive Reviews in Food Science and Food Safety, Vol. 5, 2006) made the following recommendation: “Determine the public health impact of antimicrobial resistance on the basis of risk assessment, and consider resistance on the basis of an individual microorganism exposed to a specific agent under a specific condition of use.”

As with medicines used in humans, the FDA collects and analyzes adverse reactions to marketed animal medicinal products. When appropriate, this information is used to require companies to change the label directions or marketing patterns of the product.