94-3214. Interim Guidance on the Voluntary Labeling of Milk and Milk Products From Cows That Have Not Been Treated With Recombinant Bovine Somatotropin  

  • [Federal Register Volume 59, Number 28 (Thursday, February 10, 1994)]
    [Unknown Section]
    [Page 0]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 94-3214]
    
    
    [[Page Unknown]]
    
    [Federal Register: February 10, 1994]
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    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
    
    AGENCY: Food and Drug Administration, HHS.
    
    ACTION: Notice.
    
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    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. 
    1-23, 12420 Parklawn Dr., Rockville, MD 20857.
    
    FOR FURTHER INFORMATION CONTACT: Shellee A. Davis, Center for Food 
    Safety and Applied Nutrition (HFS-306), Food and Drug Administration, 
    200 C St. SW., Washington DC 20204, 202-205-4681.
    
    SUPPLEMENTARY INFORMATION: On November 5, 1993, FDA approved a new 
    animal drug application providing for the subcutaneous use of sterile 
    sometribove zinc suspension (recombinant bovine somatotropin (rbST) or 
    a recombinant bovine growth hormone (rbGH)) in lactating dairy cows to 
    increase the production of marketable milk (58 FR 59946, November 12, 
    1993). FDA approved the product because the agency had determined after 
    a thorough review that rbST is safe and effective for dairy cows, that 
    milk from rbST-treated cows is safe for human consumption, and that 
    production and use of the product do not have a significant impact on 
    the environment. In addition, the agency found that there was no 
    significant difference between milk from treated and untreated cows 
    and, therefore, concluded that under the Federal Food, Drug, and 
    Cosmetic Act (the act), the agency did not have the authority in this 
    situation to require special labeling for milk from rbST-treated cows. 
    FDA stated, however, that food companies that do not use milk from cows 
    supplemented with rbST may voluntarily inform consumers of this fact in 
    their product labels or labeling, provided that any statements made are 
    truthful and not misleading. Several States and industry and consumer 
    representatives have asked FDA to provide guidance on the labeling of 
    milk and milk products from cows that have not been treated with rbST.
        FDA agrees that, with the expiration of the congressional 
    moratorium on the commercial sale of rbST on February 3, 1994, the 
    issuance of guidance would help prevent false or misleading claims 
    regarding rbST. FDA views this document primarily as guidance to the 
    States as they consider the proper regulation of rbST labeling claims. 
    Given the traditional role of the States in overseeing milk production, 
    the agency intends to rely primarily on the enforcement activities of 
    the interested States to ensure that rbST labeling claims are truthful 
    and not misleading. The agency is available to provide assistance to 
    the States.
        The guidance presented here reflects FDA's interpretation of the 
    act and may be relevant to States' interpretation of their own similar 
    statutes. This document does not bind FDA or any State, and it does not 
    create or confer any rights, privileges, benefits, or immunities for or 
    on any persons. Furthermore, this document reflects FDA's current views 
    on this matter. FDA may reconsider its position at a later date in 
    light of any comments it receives on this guidance document.
        Interested persons may, on or before March 14, 1994, submit to the 
    Dockets Management Branch (address above) written comments on the 
    interim guidance. Two copies of any comments are to be submitted, 
    except that individuals may submit one copy. Comments are to be 
    identified with the docket number found in brackets in the heading of 
    this document. Received comments may be seen in the office above 
    between 9 a.m. and 4 p.m., Monday through Friday.
        The text of the interim guidance follows:
    
    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.
        FDA believes such misleading implications could best be avoided 
    by the use of accompanying information that puts the statement in a 
    proper context. Proper context could be achieved in a number of 
    different ways. For example, accompanying the statement ``from cows 
    not treated with rbST'' with the statement that ``No significant 
    difference has been shown between milk derived from rbST-treated and 
    non-rbST-treated cows'' would put the claim in proper context. 
    Proper context could also be achieved by conveying the firm's 
    reasons (other than safety or quality) for choosing not to use milk 
    from cows treated with rbST, as long as the label is truthful and 
    nonmisleading.
        States should evaluate any labeling statement about rbST in the 
    context of the complete label and all labeling for the product, as 
    well as of any advertising for the product. Available data on 
    consumers' perceptions of the label statements could also be used to 
    determine whether a statement is 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 inspection 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 17, 1994,
    Michael R. Taylor,
    Deputy Commissioner for Policy.
    [FR Doc. 94-3214 Filed 2-8-94; 9:27 am]
    BILLING CODE 4160-01-F
    
    
    

Document Information

Published:
02/10/1994
Department:
Food and Drug Administration
Entry Type:
Uncategorized Document
Action:
Notice.
Document Number:
94-3214
Dates:
Written comments by March 14, 1994.
Pages:
0-0 (1 pages)
Docket Numbers:
Federal Register: February 10, 1994, Docket No. 94D-0025