Washington - The National Pork Producers Council (NPPC) said the Food and Drug Administration Center for Veterinary Medicine (FDA-CVM) had allowed “belief” to supplant sound science in its proposed new Framework governing the process by which antimicrobials are approved for use in the livestock industry. The Framework outlines a new regulatory program for evaluating the safety of antimicrobial drugs intended for use in food-producing animals.
“FDA's proposed Framework will have the effect of drastically scaling back the number of antimicrobials available to livestock producers,” NPPC President Donna Reifschneider said. “Ironically, this could well lead to increased antimicrobial resistance and a decrease in food safety, because producers will be forced to rely on a very limited, narrow supply of products. The proposed FDA-CVM Framework will have an effect on the ability of our pork producers to be competitive and stay in business. Our producers' livelihoods depend on the outcome of this issue.”
Pork producers need timely, economical availability and access to effective products so they can keep their animals healthy.
“This is the right thing to do from the perspective of animal welfare, the environment, and doing all we can do to provide a product that is safe and wholesome,” said Reifschneider, a producer from Smithton, Ill.
In comments delivered this week at the FDA-CVM meeting, Barb Determan, a pork producer from Early, Iowa, and chair of NPPC's Pork Safety Committee, said FDA's proposal lacked “adequate scientific justification to substantiate such a broad encompassing program. Because of this, there is a concern that it will not result in an effective mechanism for protecting public health.”
An adequate assessment of the risk to public health from antimicrobial resistance is needed before instituting an extensive, costly regulatory program without scientific justification.
Multiple scientific bodies have said the hazard exists but the risk is not quantified or imminent. In the most recent review of antimicrobial resistance, the National Research Council (NRC) of the National Academy of Sciences (NAS) in 1998 concluded the benefits of animal antimicrobials, while not without some problems, outweighed the risks. NAS went on to say antimicrobial usage “does not appear to constitute an immediate public-health concern.”
Determan said while pork producers support strong measures to safeguard public health, it is doubtful that the proposed Framework will achieve its goal because:
- The proposed categorization of antimicrobials is subjective and by the document's own admission, will be changing according to whomever is the decision maker;
- Only research can quantify a link between the number and characteristics of bacteria coming into the packing plant in the intestine of animals and any risk to human health from bacterial resistance; and
- Legitimate concerns about the logistics, cost and threats to farm biosecurity posed by a post-approval monitoring program make the proposal unworkable.
Determan said pork producers support a scientifically defensible National Antimicrobial Resistance Monitoring (NARMS) program that specifically monitors bacteria for resistance. Money and resources need to be dedicated, she said, to ensure a NARMS program that is statistically significant and meaningful.
Determan pointed out that pork producers have a strong record of support for successful food safety programs and have been active in the development of the AVMA's Judicious Use Principles for antimicrobials. Pork producers have funded extensive antimicrobial resistance and pre-harvest food safety research. The pork industry also has an accepted Pork Quality Assurance (PQA) Program. More than 40,000 producers are certified at PQA Level III.
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