[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]


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 

AGENCY: Food and Drug Administration, HHS.

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. 
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 

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 
    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]