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AFIA SUBMITTS COMMENTS TO FDA REGARDING ANTIMICROBIAL ANIMAL DRUG SALES REPORTING
Source: American Feed Industry Association news release

Earlier this week, AFIA submitted comments to the U.S. Food and Drug Administration (FDA) advance notice of proposed rulemaking on antimicrobial animal drug sales and distribution reporting, 77 Fed. Reg. 44,177 (Jul. 27, 2012). Antimicrobial drugs used in food-producing animals are often administered by means of medicated feed. AFIA's comments are limited to the medicated feed use of antimicrobial drugs.

In the relevant part, FDA sought:

Public input on alternative methods for assessing antimicrobial use the Agency can employ within its existing authority that may further support the analysis of factors related to the development and spread of antimicrobial resistance in connection with the use of medically important antibiotics in food-producing animals.

AFIA conferred with its legal counsel, who have advised us that FDA can only inspect and copy distribution records that feed manufacturers are required to maintain under the medicated feed current good manufacturing practice regulations. These records might have some bearing on the actual usage of antimicrobial drugs in different animal species.

Legal authority aside, a feed manufacturer would not have accurate information on the actual amount of an antimicrobial animal drug that is fed to different species of animals. Frequently, feed manufacturers sell medicated feed to retail dealers or downstream distributors, not to end users.

Even when direct sales to end users are involved, in some cases a feed manufacturer would not know the actual intended use of a medicated animal feed that is approved for use in multiple species. In addition, a feed manufacturer does not have accurate information on how much of a medicated feed it has distributed is actually fed to animals.

Particularly with regard to medicated feeds delivered in bulk, feed manufacturers generally do not accept returns except in the case of apparent product manufacturing defects or quality issues. Thus, unused medicated feed is typically disposed of without the knowledge of the feed manufacturer.

Without established goals and objectives by FDA for how any additional usage data would be utilized by the agency, it will be very difficult for FDA create a system to collect and analyze such data that will have any real impact on protecting public health. AFIA encouraged FDA to continue to work with the stakeholders and other government research agencies to design an appropriate research project rather than spend resources to collect additional information just to say it has been collected.

For questions on this issue, contact Richard Sellers, AFIA's vice president of feed regulation and nutrition, at (703) 558-3569.


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