81_FR_69126 81 FR 68933 - Food Safety and Inspection Service Labeling Guideline on Documentation Needed To Substantiate Animal Raising Claims for Label Submission

81 FR 68933 - Food Safety and Inspection Service Labeling Guideline on Documentation Needed To Substantiate Animal Raising Claims for Label Submission

DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service

Federal Register Volume 81, Issue 193 (October 5, 2016)

Page Range68933-68934
FR Document2016-24067

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.

Federal Register, Volume 81 Issue 193 (Wednesday, October 5, 2016) 
[Federal Register Volume 81, Number 193 (Wednesday, October 5, 2016)]
[Rules and Regulations]
[Pages 68933-68934]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-24067]



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

[[Page 68933]]



DEPARTMENT OF AGRICULTURE

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 
Submission

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 
published.
    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 
20250-3700.
    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.

SUPPLEMENTARY INFORMATION: 

Background

    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 
certificate.
    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: 
http://www.fsis.usda.gov/federal-register.
    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: [email protected].
    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]
 BILLING CODE 3410-DM-P

68933 Rules and Regulations Federal Register Vol. 81, No. 193 Wednesday, October 5, 2016 This section of the FEDERAL REGISTER the on-line instructions at that site for Without Antibiotics,’’ ‘‘Organic,’’ contains regulatory documents having general submitting comments. ‘‘Grass-Fed,’’ ‘‘Free-Range,’’ and ‘‘Raised applicability and legal effect, most of which Mail, including CD–ROMs: Send to without the use of hormones.’’ For most are keyed to and codified in the Code of Docket Clerk, U.S. Department of animal-raising claims, the Federal Regulations, which is published under Agriculture, Food Safety and Inspection documentation typically needed to 50 titles pursuant to 44 U.S.C. 1510. Service, Patriots Plaza 3, 1400 support these claims includes: The Code of Federal Regulations is sold by Independence Avenue SW., Mailstop 1. A detailed written description the Superintendent of Documents. Prices of 3782, Room 8–163B, Washington, DC explaining the controls used for new books are listed in the first FEDERAL 20250–3700. ensuring that the raising claim is valid REGISTER issue of each week. Hand- or courier-delivered submittals: from birth to harvest or the period of Deliver to Patriots Plaza 3, 355 E Street raising being referenced by the claim; SW., Room 8–163A, Washington, DC 2. A signed and dated document DEPARTMENT OF AGRICULTURE 20250–3700. describing how the animals are raised Instructions: All items submitted by (e.g., vegetarian-fed, raised without Food Safety and Inspection Service mail or electronic mail must include the antibiotics, grass-fed), to support that Agency name and docket number FSIS– the specific claim made is truthful and 9 CFR Parts 317, 381, and 412 2016–0021. Comments received in not misleading; [Docket No. FSIS–2016–0021] response to this docket will be made 3. A written description of the available for public inspection and product-tracing and segregation Food Safety and Inspection Service posted without change, including any mechanism from time of slaughter or Labeling Guideline on Documentation personal information, to http:// further processing through packaging Needed To Substantiate Animal www.regulations.gov. and wholesale or retail distribution; Raising Claims for Label Submission Docket: For access to background 4. A written description for the documents or to comment received, go identification, control, and segregation AGENCY: Food Safety and Inspection of non-conforming animals or products; Service, USDA. to the FSIS Docket Room at Patriots Plaza 3, 355 E Street SW., Room 164– and ACTION: Guidance. 5. If a third party certifies a claim, a A, Washington, DC 20250–3700 between 8:00 a.m. and 4:30 p.m., current copy of the certificate. SUMMARY: The Food Safety and FSIS previously issued a compliance Inspection Service (FSIS) is announcing Monday through Friday. guideline on animal-raising claims in the availability of an updated version of FOR FURTHER INFORMATION CONTACT: Dr. 2002. The changes included in this the Agency’s compliance guideline on Daniel L. Engeljohn, Assistant version of the guideline include documentation needed to support Administrator, Office of Policy and definitions for frequently used animal- animal-raising claims on product labels Program Development; Telephone: (202) raising claims, the detailed supporting that must be submitted for Agency 205–0495. documentation required for each approval before they can be used on SUPPLEMENTARY INFORMATION: specific claim that appears on the label, product labels. The updated guideline additional information regarding the reflects FSIS’s current position and Background claim grass fed, information required for procedures for reviewing animal-raising A federally inspected meat or poultry duplicating raising claims from claims and includes explanations of establishment is required to use labels purchased product, and examples of animal-raising claims that FSIS may that are in compliance with the Federal labels bearing claims. approve and the types of supporting Meat Inspection Act (FMIA; 21 U.S.C. This guideline represents FSIS’s documentation that the Agency requires 601 et seq., 607), the Poultry Products current position and procedures for to be submitted to support these claims. Inspection Act (PPIA; 21 U.S.C. 451 et approving animal-raising claims, and DATES: Submit comments on or before seq., 457), and the implementing although FSIS is requesting comments December 5, 2016. regulations. Requirements include all on this guideline and may update it in ADDRESSES: A downloadable version of mandatory labeling requirements as response to comments, FSIS encourages the compliance guideline is available to prescribed in Title 9 of the Code of establishments that wish to submit view and print at http://www.fsis. Federal Regulations section 317.2 and request for approvals of animal raising usda.gov/wps/wcm/connect/6fe3cd56- 381 Subpart N. claims on product labels to begin using 6809-4239-b7a2-bccb82a30588/Raising All labels with special claims, this guideline. Claims.pdf?MOD=AJPERES once copies including animal-raising claims, need to of the guideline have been published. be submitted to FSIS prior to being used Additional Public Notification FSIS invites interested persons to on the product under 9 CFR 412.1(c)(3). Public awareness of all segments of submit comments on this guidance. As with all labels with special claims, rulemaking and policy development is Comments may be submitted by one of labels with animal-raising claims must important. Consequently, FSIS will the following methods: be submitted to the Labeling and announce this Federal Register ehiers on DSK5VPTVN1PROD with RULES Federal eRulemaking Portal: This Program Delivery Staff, Office of Policy publication on-line through the FSIS Web site provides the ability to type and Program Development in FSIS with Web page located at: http:// short comments directly into the specific documentation to support all www.fsis.usda.gov/federal-register. comment field on this Web page or such claims that appear on that label. FSIS also will make copies of this attach a file for lengthier comments. Go Examples of animal-raising claims publication available through the FSIS to http://www.regulations.gov/. Follow include, but are not limited to: ‘‘Raised Constituent Update, which is used to VerDate Sep<11>2014 15:06 Oct 04, 2016 Jkt 241001 PO 00000 Frm 00001 Fmt 4700 Sfmt 4700 E:\FR\FM\05OCR1.SGM 05OCR1

68934 Federal Register / Vol. 81, No. 193 / Wednesday, October 5, 2016 / Rules and Regulations provide information regarding FSIS DEPARTMENT OF THE TREASURY (g) * * * policies, procedures, regulations, Example 10. * * * Federal Register notices, FSIS public Internal Revenue Service * * * * * meetings, and other types of information (iv) The factors described in this paragraph that could affect or would be of interest 26 CFR Part 1 (g) Example 10 (iii)(A) through (C) and (iii)(E) to our constituents and stakeholders. through (H) support the conclusion that the [TD 9784] isolation valves and vents and pressure The Update is available on the FSIS control and relief valves are structural RIN 1545–BM05 Web page. Through the Web page, FSIS components of REIT J’s pipelines within the is able to provide information to a much Definition of Real Estate Investment meaning of paragraph (d)(3) of this section broader, more diverse audience. In Trust Real Property; Correction and, therefore, are real property. * * * addition, FSIS offers an email * * * * * subscription service which provides AGENCY: Internal Revenue Service (IRS), (v) * * * The meters and compressors do automatic and customized access to Treasury. not serve the pipelines in their passive selected food safety news and ACTION: Correcting amendment. function of providing a conduit for the natural gas, and are used in connection with information. This service is available at: SUMMARY: This document contains the production of income from the sale and http://www.fsis.usda.gov/subscribe. corrections to final regulations (TD transportation of natural gas, rather than as Options range from recalls to export 9784) that were published in the consideration for the use or occupancy of information, regulations, directives, and Federal Register on Wednesday, August space within the pipelines. notices. Customers can add or delete 31, 2016 (81 FR 59849). The final * * * * * subscriptions themselves, and have the regulations that clarify the definition of option to password-protect their real property for purposes of real estate Martin V. Franks, accounts. investment trust provisions of the Chief, Publications and Regulations Branch, Internal Revenue Code (Code). Legal Processing Division, Associate Chief USDA Nondiscrimination Statement Counsel (Procedure and Administration). DATES: This correction is effective [FR Doc. 2016–23991 Filed 10–4–16; 8:45 am] No agency, officer, or employee of the October 5, 2016 and is applicable on or BILLING CODE 4830–01–P USDA shall, on the grounds of race, after August 31, 2016. color, national origin, religion, sex, FOR FURTHER INFORMATION CONTACT: gender identity, sexual orientation, Julanne Allen of the Office of Associate Chief Counsel (Financial Institutions DEPARTMENT OF HOMELAND disability, age, marital status, family/ SECURITY parental status, income derived from a and Products) at (202) 317–6945 (not a public assistance program, or political toll-free number). Coast Guard beliefs, exclude from participation in, SUPPLEMENTARY INFORMATION: deny the benefits of, or subject to Background 33 CFR Part 100 discrimination, any person in the The final regulations (TD 9784) that [Docket Number USCG–2016–0887] United States under any program or are the subject of this correction are activity conducted by the USDA. RIN 1625–AA08 under section 856 of the Internal To file a complaint of discrimination, Revenue Code. Special Local Regulation; Arkansas complete the USDA Program River; Little Rock, AR Need for Correction Discrimination Complaint Form, which may be accessed online at: http:// As published, the final regulations AGENCY: Coast Guard, DHS. www.ocio.usda.gov/sites/default/files/ (TD 9784) contain errors that may prove ACTION: Temporary final rule. docs/2012/Complain_combined_6_8_ to be misleading and are in need of 12.pdf, or write a letter signed by you clarification. SUMMARY: The Coast Guard is or your authorized representative. List of Subjects in 26 CFR Part 1 establishing a temporary special local regulation controlling movement of Send your completed complaint form Income taxes, Reporting and vessels for certain waters of the or letter to USDA by mail, fax, or email: recordkeeping requirements. Arkansas River. This rule is necessary to Mail: U.S. Department of Agriculture, Correction of Publication provide for the safety of life on Director, Office of Adjudication, 1400 navigable waters during a rowing regatta Accordingly, 26 CFR part 1 is Independence Avenue SW., on October 14 and 15, 2016. This corrected by making the following Washington, DC 20250–9410. regulation prohibits entry by all vessels, correcting amendments: mariners, and persons into the event Fax: (202) 690–7442. PART 1—INCOME TAXES area, a 1.2 mile stretch of the Arkansas Email: program.intake@usda.gov. River extending 25-yards from the left Persons with disabilities who require ■ Paragraph 1. The authority citation descending bank. All vessels transiting alternative means for communication for part 1 continues to read in part as the regulated area outside of the 25-yard (Braille, large print, audiotape, etc.) follows: zone will be limited to slowest speed for should contact USDA’s TARGET Center Authority: 26 U.S.C. 7805 * * * safe navigation to minimize wake unless at (202) 720–2600 (voice and TDD). specifically authorized by the Captain of ■ Par. 2. Section 1.856–10(g) is the Port Memphis. Done at Washington, DC on: September 29, amended by revising the first sentence ehiers on DSK5VPTVN1PROD with RULES DATES: This rule is effective from 7 a.m. 2016. of Example 10 paragraph (iv) and revising the fourth sentence of Example on October 14, 2016 until 7 p.m. on Alfred V. Almanza, October 15, 2016. Acting Administrator. 10 paragraph (v) to read as follows: ADDRESSES: To view documents [FR Doc. 2016–24067 Filed 10–4–16; 8:45 am] § 1.856–10 Definition of real property. mentioned in this preamble as being BILLING CODE 3410–DM–P * * * * * available in the docket, go to VerDate Sep<11>2014 18:09 Oct 04, 2016 Jkt 241001 PO 00000 Frm 00002 Fmt 4700 Sfmt 4700 E:\FR\FM\05OCR1.SGM 05OCR1


Document Created: 2016-10-05 03:29:29
Document Modified: 2016-10-05 03:29:29
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionGuidance.
DatesSubmit comments on or before December 5, 2016.
ContactDr. Daniel L. Engeljohn, Assistant Administrator, Office of Policy and Program Development; Telephone: (202) 205-0495.
FR Citation81 FR 68933 
CFR Citation9 CFR 317
9 CFR 381
9 CFR 412
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