[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