Food and Drug Administration (Docket No. 94D-0025) “Interim Guidance on the Voluntary Labeling of Milk and Milk Products from Cows That Have Not Been Treated with Recombinant Bovine Somatotropin,” Federal Register

Interim Guidance on the Voluntary Labeling of Milk and Milk Products from Cows that have not been Treated with Recombinant Bovine Somatotropin

Food and Drug Administration (Docket No.94D-0025)
Federal Register, February 14, 1994
Agency: Food and Drug Administration, HHS [Health and Human Services]
Action: Notice

Summary: The Food and Drug Administration (FDA) is publishing interim guidance on the labeling of milk and milk products from cows that have not been treated with recombinant bovine somatotropin. Several states and industry and consumer representatives have requested guidance from FDA on this issue. This interim guidance is intended to respond to these requests.

Dates: Written comments by March 14, 1994.

Addresses: Submit written comments on the interim guidance to the Dockets Management Branch (HFA-305), Food and Drug Administration, Rm. I -23, 12420 Parklawn Dr., Rockville, MD 20857.

For further information contact: Shellee A. David, Center for Food Safety and Applied Nutrition (HFS)-306). Food and Drug Administration, 200 C St., SW, Washington, DC 20204; (202) 205-4G81.

The Text of the Interim Guidance

Interim Guidance on the Voluntary Labeling of Milk and Milk Products from Cows That Have Not Been Treated with Recombinant Bovine Somatotropin

Appropriate Labeling Statements

At the federal level, statements about rbST in the labeling of food shipped in interstate commerce would be reviewed under sections 403(a) and 201(n) of the act. Under section 403(a) of the act, a food is misbranded if statements on its label or in its labeling are false or misleading in any particular. Under section 201 (n), both the presence and the absence of information are relevant to whether labeling is misleading. That is, labeling may be misleading if it fails to disclose facts that are material in light of representations made about a product or facts that are material with respect to the consequences that may result from use of the product. Thus, certain labeling statements about the use of rbST may be misleading unless they are accompanied by additional information. This guidance is based on the use of the false or misleading standard in the federal law, which is incorporated in many states’ food and drug laws. States may also have additional authorities that are relevant in regulating such claims.

Because of the presence of natural bST in milk, no milk is “bST-free,” and a bST-free labeling statement would be false. Also, FDA is concerned that the term “rbST-free” may imply a compositional difference between milk from treated and untreated cows rather than a difference in the way the milk is produced. Instead, the concept would better be formulated as “from cows not treated with rbST” or in other similar ways. However, even such a statement, which asserts that rbST has not been used in the production of the subject milk, has the potential to be misunderstood by consumers. Without proper context, such statements could be misleading. Such unqualified statements may imply that milk from untreated cows is safer or of higher quality than milk from treated cows. Such an implication would be false and misleading.

Substantiation of Labeling Claims

There is currently no way to differentiate analytically between naturally occurring bST and recombinant bST in milk, nor are there any measurable compositional differences between milk from cows that receive supplemental bST and milk from cows that do not. Therefore, to ensure that claims that milk comes from untreated cows are valid, states could require that firms that use such claims establish a plan and maintain records to substantiate the claims, and make those records available for inspections by regulatory officials. The producer of a product labeled with rbST claims should be able to demonstrate that all milk-derived ingredients in the product are from cows not treated with rbST. Failure to maintain records would make it difficult for a firm to defend itself in the face of circumstantial evidence that it is using rbST or selling milk from treated cows. In some situations (e.g., dairy cooperatives that only process milk from untreated cows), states may decide that affidavits from individual farmers and processors are adequate to document that milk or milk products received by the firm were from untreated cows.

States should consider requiring that firms that use statements indicating that their product is “certified” as not from cows treated with rbST be participants in a third party certification program to verify that the cows have not been injected with rbST. States could seek to ensure that certification programs contain the following elements:

Participating dairy herds should consist of animals that have not been supplemented with rbST.

The program should be able to track each cow in the herd over time.

Milk from non-rbST herds should be kept separate from other milk by a physical segregation, verifiable by a valid paper trail, throughout the transportation and processing steps until the finished milk or dairy product is in final packaged form in a labeled container.

The physical handling and recordkeeping provisions of such a program would be necessary not because of any safety concerns about milk from treated cows, but to ensure that the labeling of the milk is not false or misleading.

Dated: February 7, 1994 Michael Taylor Deputy Commissioner for Policy