[Federal Register Volume 81, Number 193 (Wednesday, October 5, 2016)]
[Rules and Regulations]
[Pages 68933-68934]
From the Federal Register Online via the Government Publishing Office 
[FR Doc No: 2016-24067]

Rules and Regulations
                                                Federal Register

This section of the FEDERAL REGISTER contains regulatory documents 
having general applicability and legal effect, most of which are keyed 
to and codified in the Code of Federal Regulations, which is published 
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents. 
Prices of new books are listed in the first FEDERAL REGISTER issue of each 


Federal Register / Vol. 81, No. 193 / Wednesday, October 5, 2016 / 
Rules and Regulations

[[Page 68933]]


Food Safety and Inspection Service

9 CFR Parts 317, 381, and 412

[Docket No. FSIS-2016-0021]

Food Safety and Inspection Service Labeling Guideline on 
Documentation Needed To Substantiate Animal Raising Claims for Label 

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Guidance.


SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing 
the availability of an updated version of the Agency's compliance 
guideline on documentation needed to support animal-raising claims on 
product labels that must be submitted for Agency approval before they 
can be used on product labels. The updated guideline reflects FSIS's 
current position and procedures for reviewing animal-raising claims and 
includes explanations of animal-raising claims that FSIS may approve 
and the types of supporting documentation that the Agency requires to 
be submitted to support these claims.

DATES: Submit comments on or before December 5, 2016.

ADDRESSES: A downloadable version of the compliance guideline is 
available to view and print at http://www.fsis.usda.gov/wps/wcm/connect/6fe3cd56-6809-4239-b7a2-bccb82a30588/RaisingClaims.pdf?MOD=AJPERES once copies of the guideline have been 
    FSIS invites interested persons to submit comments on this 
guidance. Comments may be submitted by one of the following methods:
    Federal eRulemaking Portal: This Web site provides the ability to 
type short comments directly into the comment field on this Web page or 
attach a file for lengthier comments. Go to http://www.regulations.gov/. Follow the on-line instructions at that site for 
submitting comments.
    Mail, including CD-ROMs: Send to Docket Clerk, U.S. Department of 
Agriculture, Food Safety and Inspection Service, Patriots Plaza 3, 1400 
Independence Avenue SW., Mailstop 3782, Room 8-163B, Washington, DC 
    Hand- or courier-delivered submittals: Deliver to Patriots Plaza 3, 
355 E Street SW., Room 8-163A, Washington, DC 20250-3700.
    Instructions: All items submitted by mail or electronic mail must 
include the Agency name and docket number FSIS-2016-0021. Comments 
received in response to this docket will be made available for public 
inspection and posted without change, including any personal 
information, to http://www.regulations.gov.
    Docket: For access to background documents or to comment received, 
go to the FSIS Docket Room at Patriots Plaza 3, 355 E Street SW., Room 
164-A, Washington, DC 20250-3700 between 8:00 a.m. and 4:30 p.m., 
Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Dr. Daniel L. Engeljohn, Assistant 
Administrator, Office of Policy and Program Development; Telephone: 
(202) 205-0495.



    A federally inspected meat or poultry establishment is required to 
use labels that are in compliance with the Federal Meat Inspection Act 
(FMIA; 21 U.S.C. 601 et seq., 607), the Poultry Products Inspection Act 
(PPIA; 21 U.S.C. 451 et seq., 457), and the implementing regulations. 
Requirements include all mandatory labeling requirements as prescribed 
in Title 9 of the Code of Federal Regulations section 317.2 and 381 
Subpart N.
    All labels with special claims, including animal-raising claims, 
need to be submitted to FSIS prior to being used on the product under 9 
CFR 412.1(c)(3). As with all labels with special claims, labels with 
animal-raising claims must be submitted to the Labeling and Program 
Delivery Staff, Office of Policy and Program Development in FSIS with 
specific documentation to support all such claims that appear on that 
label. Examples of animal-raising claims include, but are not limited 
to: ``Raised Without Antibiotics,'' ``Organic,'' ``Grass-Fed,'' ``Free-
Range,'' and ``Raised without the use of hormones.'' For most animal-
raising claims, the documentation typically needed to support these 
claims includes:
    1. A detailed written description explaining the controls used for 
ensuring that the raising claim is valid from birth to harvest or the 
period of raising being referenced by the claim;
    2. A signed and dated document describing how the animals are 
raised (e.g., vegetarian-fed, raised without antibiotics, grass-fed), 
to support that the specific claim made is truthful and not misleading;
    3. A written description of the product-tracing and segregation 
mechanism from time of slaughter or further processing through 
packaging and wholesale or retail distribution;
    4. A written description for the identification, control, and 
segregation of non-conforming animals or products; and
    5. If a third party certifies a claim, a current copy of the 
    FSIS previously issued a compliance guideline on animal-raising 
claims in 2002. The changes included in this version of the guideline 
include definitions for frequently used animal-raising claims, the 
detailed supporting documentation required for each specific claim that 
appears on the label, additional information regarding the claim grass 
fed, information required for duplicating raising claims from purchased 
product, and examples of labels bearing claims.
    This guideline represents FSIS's current position and procedures 
for approving animal-raising claims, and although FSIS is requesting 
comments on this guideline and may update it in response to comments, 
FSIS encourages establishments that wish to submit request for 
approvals of animal raising claims on product labels to begin using 
this guideline.

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, FSIS will announce this Federal 
Register publication on-line through the FSIS Web page located at: 
    FSIS also will make copies of this publication available through 
the FSIS Constituent Update, which is used to

[[Page 68934]]

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 available on the FSIS Web 
page. Through the Web page, FSIS is able to provide information to a 
much broader, more diverse audience. In addition, FSIS offers an email 
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/subscribe. Options range from recalls to 
export information, regulations, directives, and notices. Customers can 
add or delete subscriptions themselves, and have the option to 
password-protect their accounts.

USDA Nondiscrimination Statement

    No agency, officer, or employee of the USDA shall, on the grounds 
of race, color, national origin, religion, sex, gender identity, sexual 
orientation, disability, age, marital status, family/parental status, 
income derived from a public assistance program, or political beliefs, 
exclude from participation in, deny the benefits of, or subject to 
discrimination, any person in the United States under any program or 
activity conducted by the USDA.
    To file a complaint of discrimination, complete the USDA Program 
Discrimination Complaint Form, which may be accessed online at: http://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your 
authorized representative.
    Send your completed complaint form or letter to USDA by mail, fax, 
or email:
    Mail: U.S. Department of Agriculture, Director, Office of 
Adjudication, 1400 Independence Avenue SW., Washington, DC 20250-9410.
    Fax: (202) 690-7442.
    Email: program.intake@usda.gov.
    Persons with disabilities who require alternative means for 
communication (Braille, large print, audiotape, etc.) should contact 
USDA's TARGET Center at (202) 720-2600 (voice and TDD).

    Done at Washington, DC on: September 29, 2016.
Alfred V. Almanza,
Acting Administrator.
[FR Doc. 2016-24067 Filed 10-4-16; 8:45 am]