Recombinant Bovine Growth Hormone: FDA Approval Should Be Withheld Until the Mastitis Issue Is Resolved

Highlights

Pursuant to a congressional request, GAO reviewed the Food and Drug Administration's (FDA) investigation into the bovine growth hormone and its effects on cows and the food supply.

Recommendations

Recommendations for Executive Action

Agency Affected	Recommendation	Status
Food and Drug Administration	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.	Closed – Implemented The agency reviewed antibiotic relationships.
Food and Drug Administration	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.	Closed – Not Implemented FDA has concluded the human food safety review by examining the antibiotic issue. Although at the time valid, the recommendation is no longer relevant.
Food and Drug Administration	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.	Closed – Implemented 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.
Food and Drug Administration	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.	Closed – Implemented Agency has examined antibiotic risk. It indicates that it will consider indirect risks in its review process.

Full Report

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Topics

Agriculture and Food

Consumer protectionDairy industryFood additivesFood and drug lawFood inspectionLabeling lawLivestock productsProduct safetyProtocolsSafety regulationSafety standards