[Federal Register Volume 81, Number 164 (Wednesday, August 24, 2016)]
[Notices]
[Pages 57879-57880]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-20227]


-----------------------------------------------------------------------

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. FSIS-2016-0027]


Statements That Bioengineered or Genetically Modified (GM) 
Ingredients or Animal Feed Were Not Used in the Production of Meat, 
Poultry, or Egg Products

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice of availability and opportunity for comment.

-----------------------------------------------------------------------

SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing 
the availability of the Agency's compliance guidance on how companies 
can make label or labeling claims concerning the fact that 
bioengineered or genetically modified (GM) ingredients or animal feed 
were not used in the production of meat, poultry, or egg products. For 
purposes of this guidance document, these claims will be referred to as 
``negative claims.''

DATES: Comments must be received by October 24, 2016.

ADDRESSES: A downloadable version of the compliance guidance is 
available to view and print at http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/labeling/claims-guidance/procedures-nongenetically-engineered-statement. No hard copies of the compliance 
guidance have been published.
    FSIS invites interested persons to submit comments on this notice. 
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, docket number FSIS-2016-0027, and the document 
title: Statements that Bioengineered or Genetically Modified (GM) 
Ingredients or Animal Feed Were not Used in the Production of Meat, 
Poultry, or Egg Products. 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.
    For additional information about FSIS labeling policies and 
programs, including Generic Label Approval, please review the FSIS Web 
site at: http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/labeling/ or contact the Labeling and Program Delivery Staff 
at (301) 504-0878 or (301) 504-0879.
    Docket: For access to background documents or to comments 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

    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 not false or 
misleading. Under the Federal Meat Inspection Act (FMIA) (21 U.S.C. 
601-695, at 607), the Poultry Products Inspection Act (PPIA) (21 U.S.C. 
451-470, at 457), and the Egg Products Inspection Act (21 U.S.C. 1031-
1056, at 1036) the labels of meat, poultry, and egg products must be 
approved by the Secretary of Agriculture, who has delegated this 
authority to FSIS, before these products can enter commerce.

Compliance Guide

    FSIS is announcing that it has developed a compliance guide for 
companies that seek to make label or labeling claims concerning the 
fact that bioengineered or GM ingredients were not used in a meat, 
poultry or egg product. This guidance also provides information on how 
companies can make label or labeling claims that a product was produced 
from livestock or poultry that were not fed bioengineered or GM feed. 
For purposes of this guidance document, these claims will be referred 
to as ``negative claims.''
    FSIS has approved negative claims through its prior label approval 
process. Because FSIS does not have the ability to independently verify 
negative claims for ingredients or feed, FSIS has required 
establishments that make these claims to comply with standards 
established by a third-party certifying organization. FSIS currently 
requires that the third-party certifying organization's standards be 
publicly available on a Web site and the label or labeling disclose the 
Web site address of the third-party certifying organization. FSIS 
currently requires that the establishment demonstrate that its

[[Page 57880]]

claims of third-party certification are truthful and not misleading.
    As a policy matter, prior to issuing this guidance document, FSIS 
has not allowed the use of the terms ``genetically modified organism'' 
or ``GMO'' in negative claims. FSIS has allowed the use of the terms 
``genetically modified organism'' or ``GMO'' on product labels or 
labeling only if the name of the third-party certifying organization 
contains these terms (e.g. ``Non-GMO Project''). However, recent 
legislation was enacted (Pub L 114-216) requiring the Secretary of 
Agriculture to develop and implement a mandatory national bioengineered 
food disclosure standard within 2 years. This legislation also 
addresses negative claims, providing that ``a food may not be 
considered to be `not bioengineered' or `non-GMO', or any other similar 
claim describing the absence of bioengineering in the food solely 
because the food is not required to bear a disclosure that the food is 
bioengineered under this subtitle.'' (Pub. L. 114-216, section 294(c)). 
Therefore, FSIS has reconsidered its position and will allow the use of 
the terms ``genetically modified organism'' or ``GMO'' in negative 
claims provided that the label or labeling is otherwise truthful and 
not misleading.
    Effective immediately, FSIS will begin approving negative claims 
for meat, poultry and egg products that do not contain bioengineered 
ingredients or that are derived from livestock that do not consume 
bioengineered feed and that contain the terms ``genetically modified 
organism'' or ``GMO''. In evaluating such claims, FSIS will utilize the 
definition of ``bioengineering'' in Public Law 114-216. In that law, 
the term ``bioengineering'' refers to a food that contains genetic 
material that has been modified through in vitro recombinant 
deoxyribonucleic acid (DNA) techniques and for which the modification 
could not otherwise be obtained through conventional breeding or found 
in nature.
    Consistent with past practice, FSIS will continue to allow the use 
of synonymous terms such as ``genetically engineered.'' If FSIS has 
approved an organic claim on the product label, establishments may add 
an applicable negative claim of the kind discussed in the guidance.
    FSIS encourages companies to follow this guidance. This guidance 
represents FSIS's current thinking, and FSIS welcomes comment on this 
compliance guidance and will update it as necessary to reflect comments 
received and any additional information that becomes available.

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).

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, in an effort to ensure that 
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/wps/portal/fsis/topics/regulations/federal-register/federal-register-notices. 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, recalls, and other types of information that could affect or 
would be of interest to constituents and stakeholders. The update is 
communicated via Listserv, a free electronic mail subscription service 
for industry, trade and farm groups, consumer interest groups, allied 
health professionals, and other individuals who have asked to be 
included. The update is available on the FSIS Web page. Through the 
Listserv and Web page, FSIS is able to provide information to a much 
broader and 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 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 August 19, 2016.
Alfred V. Almanza,
Acting Administrator.
[FR Doc. 2016-20227 Filed 8-23-16; 8:45 am]
 BILLING CODE 3410-DM-P