Food Safety and Quality:

FDA Surveys Not Adequate to Demonstrate Safety of Milk Supply

RCED-91-26: Published: Nov 1, 1990. Publicly Released: Nov 20, 1990.

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Pursuant to a congressional request, GAO reviewed: (1) the adequacy of the Food and Drug Administration's (FDA) 1988 and 1990 surveys to determine the presence of selected antibiotic drug residues in milk; and (2) whether the survey information provided a sufficient basis for FDA public statements on the safety of the milk supply.

GAO found that the survey results were not representative of the nation's milk supply, since FDA: (1) tested for only a limited number of drugs in comparison to the total number of animal drugs that could have been present in milk products; (2) was unable to detect some drugs at their concern level; (3) and the states did not routinely screen milk for many of the approved or unapproved drugs that might be used by the dairy industry; and (4) oversight efforts were complicated by the extra-label use of unapproved drugs and by questions regarding the basis for setting unofficial concern levels and how to treat such factors as the cumulative effect of closely related drugs and drug metabolites.

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Comments: A new National Drug Residue Milk Monitoring Program was established to increase interaction with states. FDA will share test data with states to provide additional sampling, if warranted.

    Recommendation: The Secretary of Health and Human Services should direct the Commissioner, FDA, to take several incremental actions to provide greater assurance that the milk supply is safe by working closely with the states to confirm, possibly on a random basis, the types and amounts of drug residues found in state screening samples. If this information and confirmatory testing indicates that potential problems exist, FDA should work with the states to further expand testing.

    Agency Affected: Department of Health and Human Services

  2. Status: Closed - Implemented

    Comments: FDA has identified drugs and established priorities for developing test methods. Priorities were based on the degree of toxological concern. Resources for test method development were increased.

    Recommendation: The Secretary of Health and Human Services should direct the Commissioner, FDA, to take several incremental actions to provide greater assurance that the milk supply is safe by prioritizing and expediting its current efforts to develop and evaluate new screening and confirmatory test methods for animal drug residues in milk, possibly according to the health risks they perceive to be associated with the individual drugs involved.

    Agency Affected: Department of Health and Human Services

  3. Status: Closed - Implemented

    Comments: FDA announced the test kit evaluation program in the Federal Register on December 13, 1990 and is evaluating commercially available and in-house screening tests. FDA is also reviewing whether it needs additional premarket approval authority for stand-alone screening tests.

    Recommendation: The Secretary of Health and Human Services should direct the Commissioner, FDA, to take several incremental actions to provide greater assurance that the milk supply is safe by working with the states to evaluate commercially available screening tests and encourage that those found effective for sulfa, tetracycline, and other drugs, be included in the Milk Ordinance as a supplement to the disk assay, which is primarily effective only for penicillins. If FDA determines that it needs additional legislative authority to approve screening tests apart from new drug applications, then it should seek such authority from Congress.

    Agency Affected: Department of Health and Human Services

  4. Status: Closed - Implemented

    Comments: The National Drug Residue Milk Monitoring Program was developed which included an enforcement plan with states. A "third-party" data collection system is also being developed.

    Recommendation: The Secretary of Health and Humans Services should direct the Commissioner, FDA, to take several incremental actions to provide greater assurance that the milk supply is safe by developing more complete information on the incidence of drug residues in milk. FDA should begin by asking the states under their cooperative agreements and the dairy industry to routinely provide them with the results of their screening tests for drug residues in milk, as well as information regarding their sampling plan and the types and sensitivities of test methods employed.

    Agency Affected: Department of Health and Human Services

  5. Status: Closed - Implemented

    Comments: FDA reviewed the extra-label use policy that allows drugs not approved for dairy cows to be used under certain circumstances. Criteria for such use is to be strengthened.

    Recommendation: The Secretary of Health and Human Services should direct the Commissioner, FDA, to take several incremental actions to provide greater assurance that the milk supply is safe by reassessing the appropriateness of its policies on extra-label drug use and its use of concern levels as a trigger for regulatory action, if the additional information developed from increased screening and confirmatory testing indicates that widespread problems exist from the misuse of drugs approved or unapproved for use in dairy cows.

    Agency Affected: Department of Health and Human Services

 

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