Summary
Although the Food and Drug Administration (FDA) has followed critical review guidelines for animal safety and drug efficacy in approving the use of recombinant bovine growth hormone to boost milk production, FDA has skirted the issue of whether the animal drug might pose indirect health risks for people. Such risks are not covered by FDA guidelines and have not been addressed in the case of recombinant bovine growth hormone. The increased milk production triggered by the hormone has lead to an outbreak of mastitis among cows, and increased residues of the antibiotics used to treat this condition could be showing up in milk and beef. Also, food products from cows treated with the hormone have been commercially processed and sold to consumers without any warning labels. FDA does not require the labeling of food products derived from animals involved in drug treatment trials.
GAO found that: (1) recombinant bovine growth hormone (rBGH) is orally inactive and species specific; (2) the structure of rBGH is significantly different from that of humans, making it inactive and unharmful in humans; (3) FDA considers additional rBGH research on human safety risks to be unnecessary; (4) FDA guidelines sufficiently addressed animal safety requirements, but reproductive issues remain unresolved; (5) the critical drug efficacy guidelines for rBGH have been met; (6) FDA studies and other reports show that rBGH increases the mastitis rate in cows by as much as 33 percent; (7) increased mastitis leads to increases in bovine antibiotic treatment, which greatens the potential of antibiotic residues in milk and beef; (8) FDA and drug sponsors have not tested for or addressed human tolerances of increased antibiotic residues in milk or beef; (9) rBGH sponsors often fail to adhere to FDA protocol study guidelines; (10) FDA lack of labelling requirements during the investigational research phase of review allows rBGH treated products to be marketed without adequate public knowledge; and (11) the lack of a systematic tracking procedure to monitor firms and drug dosages compromises efficiency and effectiveness of the FDA review process.
Recommendations
Our recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.
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Recommendations for Executive Action
Recommendation: The Commissioner, FDA, should examine the indirect effects of rBGH specific to rBGH products--before approval--to answer specific questions about its safety for human food consumption. That is, given the incidence of mastitis occurring in cows treated with rBGH, FDA should study the degree to which antibiotics must be used to treat these cows and the incremental effects of rBGH treatment on the nation's milk and beef supply.
Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration
Status: Closed - implemented
Comments: The agency reviewed antibiotic relationships.
Recommendation: The Commissioner, FDA, should discontinue the marketing of food products from rBGH-tested animals until the potential risk concerning increased antibiotic levels has been evaluated.
Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration
Status: Closed - not implemented
Comments: FDA has concluded the human food safety review by examining the antibiotic issue. Although at the time valid, the recommendation is no longer relevant.
Recommendation: The Commissioner, FDA, should study the feasibility of labelling food products derived from animals being tested with drugs so as to provide the public with information concerning the nature of such products.
Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration
Status: Closed - implemented
Comments: FDA has held a public hearing on food labelling. FDA is considering whether labelling should be used for all food products, that is, not simply require labelling of food products coming from animals in experimental trials.
Recommendation: The Commissioner, FDA, should avoid potentially dangerous shortfalls of information in human food safety reviews of animal drugs by ensuring that indirect risks are explicitly considered and examined.
Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration
Status: Closed - implemented
Comments: Agency has examined antibiotic risk. It indicates that it will consider indirect risks in its review process.
