Docket Management
Docket: 01N-0284 - Import Tolerances
Comment Number: EC -6

Accepted - Volume 1

Comment Record
Commentor Dr. John MacMillan Date/Time 2002-03-11 10:36:29
Organization National Aquaculture Association
Category Association

Comments for FDA General
1. General Comments March 8, 2002 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 RE: Docket No. 01N-0284 The following comments are from the National Aquaculture Association (NAA) and are intended to provide general and specific comment to the agency’s drug residue tolerances (import tolerances) for imported food products Docket No. 01N-0284. The NAA is a major US aquaculture trade association representing a diversity of aquatic animal producers and equipment suppliers in the US. General Comment: The NAA is opposed to any import drug tolerances for drugs which fish producers in the US do not also have access to or for which there is no US FDA label. Consequently, we are in favor of requirements as stringent as currently required for a NADA in the US. The pharmacologic properties of drugs in fishes is poorly understood so that unknown metabolites might be present that could only be detected by testing as currently required for NADAs in the US. We are concerned that other countries without demonstration of US drug approval or regulatory equivalency would circumvent adequate studies. The analytical tools used to measure parent drug or metabolite residues may not be readily transferred from homeothermic to poikilothermic animals without adequate testing. Should an import tolerance be established we recommend that the exporting country or importer be required to test product for drug residues and provide proof of testing and results to FDA inspectors prior to product import into the US. The US consumer does not currently differentiate very well between seafoods from one country vs another. For example, should shrimp from one country be found to contain hazardous residues, all shrimp may be avoided by US consumers. This could have a profoundly negative impact on US seafood consumption. Issue 1. Question: FDA asks which approach for determining a safe import tolerance is preferred? We believe that the regulatory control practices in many countries are inadequate. Recent European Union concerns about chloramphenicol in shrimp from China or other Asian countries highlight deficiencies in those countries regulatory oversight. We believe it is essential that for any import tolerance requested, the FDA examine all aspects of toxicity and residue data from demonstrably well controlled studies and build in a conservative safety factor. We suggest that the country or exporter seeking to deliver fish to the US completely fund these efforts by the FDA. Issue 2. Question: Are there analytical techniques or other approaches that would allow FDA to determine whether a residue is due to use of the drug product for which the tolerance is approved? We fail to understand why it would be important to determine whether residue is due to use of a drug product or not. If a residue tolerance is approved why is it important to know if the residue occurs because of drug use versus some other process? Unless the drug residue tolerance is intended to be merely a marker of other potential residues that are not measurable, this question seems immaterial. Regardless, the NAA believes it is most appropriate to require adequate testing of imported product to ensure drug tolerances are not violated. We believe it is most appropriate that other countries or the export authority provide adequate evidence that the product being exported meets US drug tolerance requirements. Such proof would entail results of controlled testing. Issue 3. Questions. a. Should we disclose to the public that we are considering an import tolerance for a new animal drug? b. If so, when? c. How should we do so? d. How much detail should we provide? The NAA supports full disclosure to the public that FDA is considering an import tolerance for a new animal drug for a specific food animal. We suggest the import tolerance for a new animal drug be disclosed as soon as the request for tolerance if filed and that the most appropriate place for disclosure is the federal register. Such notice should include as much detail as currently allowed under US statutes. Issue 4. Question: Will import tolerances have a significant effect on the environment? The NAA believes it is generally difficult to determine whether an import tolerance will have a significant effect on the environment so consideration of each import tolerance must be provided on a case-by-case basis. Factors to consider would be how the animal products bearing a drug residue are discarded, whether waste materials are consumed by other animals and whether the drug residues are excreted by consumers in sufficient concentration to pose an environmental risk. The country of origin or sponsor should have the burden of proof that there is no environmental risk. We appreciate the opportunity to provide comment. Sincerely, John R. MacMillan, Ph.D. President

EC -6