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Policy Updates as of December 2010

FDA Guidance
Food safety bill


APUA continues to support passage of the Preservation of Antibiotics for Medical Treatment Act (PAMTA), introduced by Rep. Louise M. Slaughter and the late Sen. Ted Kennedy on March 17, 2009. Passage of PAMTA would require the “phased elimination of nontherapeutic use in animals of critical antimicrobial animal drugs important for human health.” Critical drugs include: any kind of penicillin, tetracycline, macrolide, lincosamide, streptogramin, aminoglycoside, sulfonamide, or any other drug used to treat or prevent diseases in humans caused by microorganisms.

On April 28, 2010, Rep. Slaughter submitted testimony to the Committee on Energy and Commerce describing the need for passage of PAMTA. On July 13, 2010, she chaired a Rules Committee hearing on the legislation. Another hearing followed on “Antibiotic Resistance and the Use of Antibiotics in Animal Agriculture,” held by the Committee on Energy and Commerce. Stuart B. Levy, M.D. was amongst a group of experts who presented testimonies in support of Congressional action on this issue and advocating for the passage of PAMTA.

As of December 6, 2010, PAMTA is endorsed by 377 organizations representing various interests (health, consumer, agricultural, environmental, and humane). The legislation has 125 co-sponsors in the House and 17 in the Senate. Although this is twice the amount of co-sponsors PAMTA had in the previous four Congresses, it needs 218 to pass. Since the 111th Congress is coming to a close, PAMTA, or similar legislation, will need to be introduced again in the next Congress.

FDA Draft Guidance

On June 28, 2010, the FDA issued a draft guidance, “The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals,” concluding that the unnecessary or inappropriate use of medically important antimicrobials in food animal production is not beneficial to public health. In agreement with APUA, the FDA recommends that antibiotics be used with veterinary oversight. The FDA does not consider use for growth promotion or improvement of feed efficiency to be judicious. However, it does consider antimicrobial use for treatment, control, and prevention of disease to be “necessary for assuring the health of food-producing animals.” APUA believes that prevention should not fall under this category because it provides a loophole that may be taken advantage of by food producers.

The FDA will work with various stakeholders such as drug companies and members of the veterinary, public health, and animal agriculture communities to implement these recommendations. APUA founder, Dr. Stuart B. Levy, APUA vice president, Dr. Thomas F. O’Brien, and APUA Executive Director, Kathleen Young, submitted comments applauding this step forward. Furthermore, they stressed the limitations of these guidelines and the need for termination of all non-therapeutic use of antibiotics in food animal production and establishment of a system to monitor compliance. Nearly 100,000 additional comments were sent to the FDA.

Food Safety Bill

Following several food-related outbreaks in the past few years, the Senate recently passed the Food Safety Modernization Act on November 30, 2010 by a vote of 73 to 25. This bill would allow the government to increase inspections of food processing facilities, recall tainted foods, enforce stricter standards for imported foods, create new safety regulations for high-risk produce, and require large food processors and manufacturers to register with the FDA and establish new food safety plans. This shift in focus to prevention will help the FDA to stop outbreaks before they occur. In response to concerns over the impact this bill would have on small farms, senators agreed to exempt some of them from costly food safety plans. They have also eliminated fees and reduced the amount of money spent on FDA inspectors, which differentiates this bill from a House version passed in July 2009.

The likelihood of this bill’s passage is not clear. Due to a parliamentary mistake, the bill has to be approved by the House of Representatives, then sent back to the Senate to be approved again before reaching President Obama. Many Senate Republicans have stated that they will not address any legislation until the debate over expiring tax cuts is settled.

If passed, this bill will help protect consumers from dangerous food pathogens and show the government’s commitment to improving food safety and the health of its people.


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