[Federal Register: October 10, 2008 (Volume 73, Number 198)]
[Page 60228-60230]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]

                                                Federal Register

This section of the FEDERAL REGISTER contains documents other than rules 
or proposed rules that are applicable to the public. Notices of hearings 
and investigations, committee meetings, agency decisions and rulings, 
delegations of authority, filing of petitions and applications and agency 
statements of organization and functions are examples of documents 
appearing in this section.


[[Page 60228]]


Food Safety and Inspection Service

[Docket No. FSIS-2008-0026]

Product Labeling: Use of the Animal Raising Claims in the 
Labeling of Meat and Poultry Products

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice of public meeting; request for comments.


SUMMARY: The Food Safety and Inspection Service (FSIS) is issuing this 
notice to initiate a public process to review its policies regarding 
the approval of animal raising claims in the labeling of meat and 
poultry products. FSIS evaluates animal raising claims by considering 
information on animal production practices submitted by companies as 
part of their label approval requests. The Agency approves these claims 
if the animal production information submitted with the label 
application supports the claims being made and the claim is truthful 
and not misleading.
    The Agency's recent experience with labeling claims related to the 
raising of poultry have led FSIS to initiate a review of its evaluation 
and approval process for labels of meat and poultry products that 
contain animal raising claims. The Agency is publishing this notice to 
solicit public input and to announce that FSIS and the Agricultural 
Marketing Service will jointly hold a public meeting to discuss these 

DATES: The public meeting will be held on October 14, 2008. Comments on 
this notice and the issues discussed at the public meeting must be 
received by November 14, 2008.

ADDRESSES: The public meeting will be held from 8:30 a.m. to 12:30 p.m. 
at the L'Enfant Plaza Hotel, 480 L'Enfant Plaza, SW., Washington, DC 
20024, (202) 484-1000.
    FSIS will finalize an agenda on or before the meeting date and will 
post it on the FSIS Internet Web page http://www.fsis.usda.gov/News_&_Events/
    The official transcript of the meeting will be available for 
viewing by the public in the FSIS docket room and on the FSIS Web site 
http://www.fsis.usda.gov/News_&_Events/Meetings_&_Events/ when it becomes available.
    FSIS invites interested persons to submit comments on this notice. 
Comments may be submitted by one of the following methods:
    Federal eRulemaking Portal: Go to http://www.regulations.gov. 
Follow the online instructions at that site for submitting comments.
    Mail, including floppy disks or CD-ROMs, and hand- or courier-
delivered items: Send to Docket Clerk, U.S. Department of Agriculture, 
Food Safety and Inspection Service, FSIS Docket Room, 1400 Independence 
Avenue, SW., Room 2534, Washington, DC 20250.
    All submissions received must include the Agency name and docket 
number FSIS-2008-0026. Documents referred to in this notice, and all 
comments submitted in response to this notice, will be available for 
public inspection in the FSIS Docket Room at the address listed above 
between 8:30 a.m. and 4:30 p.m., Monday through Friday, except Federal 
holidays. Comments also will be posted on the Agency's Web site at 
    Individuals who do not wish FSIS to post their personal contact 
information--mailing address, e-mail address, telephone number--on the 
Internet may leave this information off of their comments.

FOR FURTHER INFORMATION CONTACT: For technical information: Charles 
Gioglio, Director, Labeling and Program Delivery Division, Office of 
Policy and Program Development, USDA, FSIS, 1400 Independence Avenue, 
SW., Washington, DC 20250, (202) 205-3625, e-mail: 
    Pre-registration for this meeting is recommended. To pre-register, 
please contact Sheila Johnson by telephone at (202) 690-6498 or by e-
mail at Sheila.Johnson@fsis.usda.gov. Persons requiring a sign language 
interpreter or special accommodations should contact Sheila Johnson as 
soon as possible.



    FSIS is the public health regulatory agency in the USDA that is 
responsible for ensuring that the nation's commercial supply of meat, 
poultry, and egg products is safe, wholesome, and accurately labeled 
and packaged. FSIS develops and implements regulations and policies to 
ensure that meat, poultry, and egg product labeling is truthful and not 
misleading. Under the Federal Meat Inspection Act (FMIA) (21 U.S.C. 
601, 607) and the Poultry Products Inspection Act (PPIA) (21 U.S.C. 
451, 457), the labels of meat and poultry products must be approved by 
the Secretary of Agriculture, who has delegated this authority to FSIS, 
before these products can enter commerce.
    Section 203(c) of the Agricultural Marketing Act (AMA) of 1946, as 
amended (7 U.S.C. 1622), directs and authorizes the Secretary of 
Agriculture ``to develop and improve standards of quality, condition, 
quantity, grade, and packaging, and recommend and demonstrate such 
standards in order to encourage uniformity and consistency in 
commercial practices.'' The Agricultural Marketing Service (AMS) has 
played a lead role in achieving the objectives of the AMA in part 
through the development of voluntary standards for agricultural 
    As part of its prior approval process for label claims, FSIS has 
been asked to evaluate and approve label claims that highlight certain 
aspects of the way animals used as the source for meat and poultry 
products are raised. Examples of animal raising claims that the Agency 
has approved include ``raised without antibiotics,'' ``not fed animal 
by-products,'' ``free range,'' ``vegetarian fed diet,'' and ``raised 
without added hormones.'' FSIS typically evaluates such claims by 
reviewing testimonials, affidavits, animal production protocols, and 
other relevant documentation provided by animal producers.
    When FSIS evaluates a meat or poultry product label that includes 
an animal raising claim, it reviews the animal production protocol 
submitted in support of the label claim to ensure that it describes 
practices that are accurately reflected in the claim being made. 
Supporting documentation may

[[Page 60229]]

be submitted directly by the establishment seeking approval of the 
label or by producers, growers, or others on the establishment's 
behalf. If a company submits information that demonstrates that an 
animal production claim is truthful and not misleading, FSIS allows 
products derived from animals raised according to the protocol to bear 
the raising claim on their labels.
    In addition to producer testimonials and affidavits, establishments 
or animal producers may also submit certifications from a certifying 
organization or entity to support animal raising claims. FSIS accepts 
these certifications if the Agency has evaluated the certifying 
entity's animal raising standards and determined that they are truthful 
and not misleading and accurately reflect the claim being made. FSIS 
also allows the label of a meat or poultry product to bear a certified 
claim if the claim clearly identifies the certifying entity, e.g., 
``certified free range by * * * (name of certifying entity),'' and the 
Agency determines, based on its review of the entity's standards, that 
the standards truthfully define the claim. FSIS makes this 
determination in consultation with AMS and other agencies with relevant 

Issues Associated With Animal Raising Claims

    It has become clear, however, that the use of animal raising claims 
in the labeling of meat and poultry products presents issues that can 
be difficult for FSIS to address through its pre-market label approval 
    As discussed above, FSIS assesses animal raising claims by 
evaluating supporting documentation that companies submit as part of 
their label approval requests. However, because FSIS does not regulate 
food animal production, the Agency may not always have all the relevant 
information necessary to the proper evaluation of the animal raising 
practices described in a producer's animal production protocol.
    In addition, while FSIS' approval of an animal raising claim 
depends on submissions that describe how the source animals were 
raised, animal producers and certifying entities may have different 
views on the specific animal production practices that qualify a 
product to bare a given animal raising claim on its label. Thus, the 
same animal raising claim may reflect different animal raising 
practices, depending on how an animal producer or certifying entity 
defines the basis for the claim.
    For example, FSIS approves ``free range'' raising claims on the 
labels of poultry products if the producer demonstrates that the birds 
were allowed continuous, free access to the outside for over 51% of 
their lives through a normal growing cycle. Under this standard, some 
producers or certifying organizations may support a ``free range'' 
labeling claim if the source birds for the poultry products were 
allowed access to a yard outside, regardless of whether the birds 
actually use the yard. On the other hand, other producers or certifying 
entities may establish stricter standards for themselves and request 
that FSIS approve a ``free range'' claim only if the source birds 
actually use the yard.
    As with animal producers and certifying entities, consumers often 
have a wide variety of views regarding the meaning of specific animal 
raising claims.

Policy Review and Public Meeting

    FSIS has decided to initiate a review of its policies for 
evaluating and approving animal raising claims on labels. FSIS will 
carry out this policy review in cooperation with AMS.
    To facilitate this review, FSIS is publishing this Federal Register 
notice to solicit public input on ways to improve the Agency's label 
approval policies and practices with respect to raising claims and to 
continue to ensure that approved labels are truthful and not 
    In addition, FSIS and AMS will hold a public meeting on October 14, 
2008, to discuss the development, evaluation, and proposed process for 
animal raising claims. FSIS is collaborating with AMS on these issues 
because AMS has taken a lead in establishing voluntary standards and in 
developing programs, such as Quality System Verification Programs 
(QSVPs) to verify or certify marketing claims that relate to animal 
raising practices.

Certification by Certifying Entities, Request for Comments

    The use of animal raising claims in the labeling of meat and 
poultry products is an important issue for members of the industry that 
want to use these claims to differentiate their meat or poultry 
products from other similar products in the marketplace. It is also an 
important issue for consumers that prefer to purchase products derived 
from animals raised under certain conditions.
    FSIS wants to ensure that its policies for evaluation and approval 
of animal raising claims will create a level playing field for 
companies that want to use such claims in marketing their products and 
that will allow consumers to use animal raising claims information to 
assist in their purchase decisions.
    One approach under consideration is to rely on outside certifying 
entities. A certifying entity would evaluate a company's animal 
production protocol to determine whether those practices meet the 
certifying entities standards for certifying the claim. The certifying 
entity would define and publish its standards. FSIS would review the 
certifying entities standards to determine whether they would in any 
way render the claim false or misleading. For example, poultry ``raised 
without antibiotics'' claims certified by a certifying entity whose 
standards covered only on the period post-hatch, and allowed the 
administration of antibiotics in ovo would be considered misleading by 
the Agency and not approved for label use.
    The certifying entity would also conduct audits to verify that the 
animals used as the source for meat and poultry products bearing the 
raising claims were raised according to those standards. Companies 
interested in using animal raising claims in the labeling of their meat 
or poultry products would submit documentation of the certification as 
part of their label approval requests.
    If FSIS were to adopt this approach, companies could use the 
services of a private certifying entity or request that USDA's AMS 
establish a voluntary audit-based program on specific animal raising 
claims. For example, AMS's Livestock and Seed (LS) Program offers 
verification services through QSVPs to substantiate claims that cannot 
be determined by direct examination of livestock, their carcasses, or 
component parts, thus allowing the product to be labeled as ``Verified 
by USDA'' (http://www.ams.usda.gov/ARCaudits). One specific QSVP is the 
USDA Process Verified Program, which allows a supplier to make 
marketing claims about feed practices or other raising practices, and 
then label and market their product as ``USDA Process Verified''.
    FSIS and AMS are interested in comments on the use of certification 
provided by certifying entities to verify animal raising claims and 
other possible approaches for approving the use of such claims in the 
labeling of meat and poultry products. The agencies plan to discuss 
this and the other issues related to animal raising claims at the 
October 14, 2008, public meeting.
    The agencies are interested in public input on the following 
questions concerning the use of certifying entities in evaluating and 
approving animal raising claims in the labeling of meat and poultry 

[[Page 60230]]

    1. Should FSIS continue to approve label claims based on animal 
raising standards developed by private certifying entities and by 
companies themselves if FSIS has reviewed the standards and determines 
that they would not render a claim false or misleading?
    2. Should FSIS establish any performance criteria or standards for 
private certifying entities? Should the Agency require that private 
certifying entities be reviewed and approved by AMS?
    3. Should FSIS establish minimum standards that companies would 
have to achieve to qualify to use certain animal raising claims?
    4. For those animal raising claims for which AMS has adopted 
standards, should FSIS adopt the AMS standards as the minimum 
    5. Would the approach outlined in this document create any 
inequities or create any problems for companies interested in using 
animal raising claims on the labels of their meat or poultry products?
    6. What other approaches should FSIS consider for evaluating and 
approving animal raising claims?

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, in an effort to ensure that the 
public and, in particular, minorities, women, and persons with 
disabilities, are aware of this notice, FSIS will announce it on-line 
through the FSIS Web page located at http://www.fsis.usda.gov/
    FSIS also will make copies of this Federal Register publication 
available through the FSIS Constituent Update, which is used to provide 
information regarding FSIS policies, procedures, regulations, Federal 
Register notices, FSIS public meetings, and other types of information 
that could affect or would be of interest to our constituents and 
stakeholders. The Update is communicated via Listserv, a free e-mail 
subscription service consisting of industry, trade, and farm groups, 
consumer interest groups, allied health professionals, scientific 
professionals, and other individuals who have requested to be included. 
The Update also is available on the FSIS Web page. Through Listserv and 
the Web page, FSIS is able to provide information to a much broader, 
more diverse audience.
    In addition, FSIS offers an e-mail subscription service which 
provides automatic and customized access to selected food safety news 
and information. This service is available at http://www.fsis.usda.gov/
    Options range from recalls to export information to regulations, 
directives and notices. Customers can add or delete subscriptions 
themselves and have the option to password protect their account.

    Done at Washington, DC, on: October 7, 2008.
Alfred V. Almanza,
 [FR Doc. E8-24191 Filed 10-7-08; 4:15 pm]