[Federal Register Volume 84, Number 249 (Monday, December 30, 2019)]
[Notices]
[Pages 71890-71892]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27993]


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 Notices
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 This section of the FEDERAL REGISTER contains documents other than rules 
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  Federal Register / Vol. 84, No. 249 / Monday, December 30, 2019 / 
Notices  

[[Page 71890]]



DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. FSIS-2018-0048]


Updated Labeling Guideline on Statements That Bioengineered or 
Genetically Modified 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 response to comments.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing 
the availability of an updated version of its guideline on how 
establishments can make label 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 are referred to as 
``negative claims.'' The updated document reflects changes made in 
response to comments received after announcement of the guideline in an 
August 2016 Federal Register notice.

ADDRESSES: A downloadable version of the compliance guideline is 
available to view and print at http://www.fsis.usda.gov/Regulations_&_Policies/Compliance_Guides_Index/index.asp. No hard 
copies of the compliance guideline have been published.

FOR FURTHER INFORMATION CONTACT: Terri Nintemann, Assistant 
Administrator, Office of Policy and Program Development by telephone at 
(202) 205-0495.

SUPPLEMENTARY INFORMATION: 

Background

    Under the Federal Meat Inspection Act, Poultry Products Inspection 
Act, and Egg Products Inspection Act (21 U.S.C. 601 et seq.; 21 U.S.C. 
451 et seq.; 21 U.S.C. 1031 et seq.) (the Acts), FSIS develops and 
implements regulations and policies to ensure that the labels of meat, 
poultry, and egg products are truthful and not misleading. Under the 
Acts, the Secretary of Agriculture, who has delegated this authority to 
FSIS, must approve the labels of meat, poultry, and egg products before 
the products can enter commerce (21 U.S.C. 601(d); 21 U.S.C. 457(c); 21 
U.S.C. 1036(b)).
    FSIS has a prior-approval program for labeling.\1\ FSIS allows 
certain labels that bear only mandatory labeling features and that 
comply with the Agency's labeling regulations to be generically 
approved (9 CFR 412.2(a)(1)). However, a label with a special statement 
or claim,\2\ including a negative claim, must be submitted to FSIS for 
approval before it may be used on a product distributed in commerce (9 
CFR 412.1(c)(3) and 412.1(e)). A label bearing a negative claim must be 
submitted to the Office of Policy and Program Development, Labeling and 
Program Delivery Staff, in FSIS, with necessary documentation to 
support the special statement or claim. Examples of negative claims 
include but are not limited to: ``Product contains no genetically-
modified ingredients,'' and ``Product made from poultry that were not 
fed genetically-engineered feed.''
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    \1\ See FSIS Directive 7221.1 at https://www.fsis.usda.gov/wps/wcm/connect/9a2ebc76-2d43-4658-841a-f810b1f65f04/7221.1.pdf?MOD=AJPERES.
    \2\ Special statements and claims are claims, logos, trademarks, 
and other symbols on labels that are generally not defined in FSIS 
regulations or the Food Standards and Labeling Policy Book. For 
specific examples, see Appendix 1 at https://www.fsis.usda.gov/wps/wcm/connect/bf170761-33e3-4a2d-8f86-940c2698e2c5/Label-Approval-Guide.pdf?MOD=AJPERES.
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    On August 24, 2016, FSIS announced the availability of and 
requested comments on its Labeling Guideline on Statements That 
Bioengineered or Genetically-Modified Ingredients or Animal Feed Were 
Not Used in Meat, Poultry, or Egg Products (81 FR 57879). FSIS 
developed the guideline for establishments that want to make label 
claims concerning the fact that bioengineered or GM ingredients were 
not used in a meat, poultry, or egg product. The guideline also 
provides information on how establishments can make label claims that a 
product was produced from livestock or poultry that were not fed 
bioengineered or GM feed. As stated in the summary, for purposes of 
this guidance document and hereinafter, these claims are referred to as 
``negative claims.''
    After reviewing the comments received, the Agency has revised the 
guideline to clarify that FSIS approves negative claims verified under 
a third-party certifying organization the same way it approves other 
special statements or claims and will not limit claims to those 
consistent with AMS's definition of bioengineering, in Pub. L. 114-216. 
FSIS also added information about the certification and labeling for 
certified organic products. Specifically, certified organic products 
may be labeled with negative claims without additional third-party 
certification or documentation when the negative claim is connected 
with an asterisk or other symbol to the explanatory statement 
``Produced in compliance with the USDA Organic Regulations'' and that 
the website of the certifying entity does not always need to appear on 
the label. The revised guideline is posted at: http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/compliance-guides-index. Although comments will no longer be accepted 
through www.regulations.gov on this guideline, FSIS will update this 
document as necessary if new information becomes available.

Comments and FSIS Responses

    FSIS received 201 comments on the Labeling Guideline on Statements 
That Bioengineered or Genetically-Modified Ingredients or Animal Feed 
Were Not Used in Meat, Poultry, or Egg Products. Most comments were 
submitted by individuals who strongly supported food labeling for 
genetically engineered foods. In addition, FSIS received 12 comments 
from consumer-advocacy organizations, agriculture-specific trade 
coalitions/associations, organic farmers, and a trade association 
representing the poultry industry.
    Many of the issues raised in the more detailed comments concerned 
how the statutory definition of ``bioengineering'' in Pub. L. 114-216 
\3\ should be interpreted and applied by USDA's Agricultural Marketing 
Service (AMS). FSIS believes these comments are beyond the scope of the 
guideline.

[[Page 71891]]

However, the same issues were raised in responses to questions posted 
in 2017 by AMS as part of the development of the proposed National 
Bioengineered Food Disclosure Standard (NBFDS). On December 21, 2018, 
AMS addressed these and other issues in the NBFDS final rule (83 FR 
19860).\4\
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    \3\ Available at https://www.congress.gov/bill/114th-congress/senate-bill/764.
    \4\ Available at https://www.govinfo.gov/content/pkg/FR-2018-12-21/pdf/2018-27283.pdf.
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    Following is a summary of the relevant issues raised in the 
comments and FSIS's responses.

Applicability

    Comment: Comments from consumer-advocacy organizations and 
agriculture-specific trade coalitions/associations strongly opposed the 
statement in the 2016 guidance document--``FSIS will utilize the 
definition of ``bioengineering'' in Public Law 114-216 when evaluating 
negative claims'' (AMS's definition). The comments said FSIS should not 
use AMS's definition because it directly conflicts with Section 294(c) 
of Public Law 114-216, creates consumer confusion, and may complicate 
international trade. According to the comments, FSIS should instead use 
the Food and Drug Administration's (FDA's) definition of ``modern 
biotechnology.'' They said the FDA definition is widely accepted and 
matches the definition recognized by key trade partners.
    Response: It was never FSIS's intention to limit negative claims to 
those consistent with the definition of ``bioengineering'' in Public 
Law 114-216. FSIS has been and will continue to approve negative claims 
verified by a third-party certifying organization with standards based 
on FDA's definition of ``modern biotechnology'' or with standards based 
on AMS's definition of ``bioengineering.'' However, in response to 
these comments, FSIS has updated the guideline by removing the 
statement in question and to clarify that we approve negative claims 
consistent with our longstanding practice for other special statements 
and claims verified by a third-party certifying organization. If the 
negative claim is truthful and the producing establishment submits 
documentation demonstrating that the third-party certifying 
organization's program for the claim is being followed, FSIS will 
approve the negative claim.
    Comment: Several comments contained details about how AMS's 
definition of ``bioengineering'' differs from FDA's definition of 
``modern biotechnology.'' The comments said that because of the 
differences, the same negative claim may reflect different standards 
depending on which definition the third-party certifier's program is 
based. They argued this results in negative claims that are 
inconsistent and potentially misleading to consumers.
    Response: FSIS recognizes that negative claims may reflect 
different standards depending on the certifying entity's standards for 
the claim. However, FSIS disagrees that these differences result in 
claims that are misleading or confusing to consumers.
    As noted above, the labeling requirements for meat, poultry, and 
egg products in the Acts and implementing regulations are aimed at 
preventing product misbranding. To prevent labeling claims that are 
false and misleading, any label with a special statement or claim, 
including a negative claim, must be submitted to FSIS for prior-
approval (9 CFR 412.1(c)(3) and 412.1(e)). FSIS comprehensively 
evaluates label approval applications on a case-by-case basis. Further, 
FSIS often consults with its Federal partners, e.g., the AMS and FDA, 
to decide whether the documentation submitted in support of a claim 
provides the level of detail needed to ensure that the claim is 
truthful and not misleading.
    For FSIS to approve a label with a negative claim related to 
bioengineering, the producing establishment must submit documentation 
that supports it is complying with standards established by a third-
party certifying organization, the third-party certifier's standards 
must be publicly available on a website, and the label must disclose a 
website address where consumers can obtain additional information 
regarding the claim and the third-party's certification process.\5\
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    \5\ Products certified as ``organic'' would not need to disclose 
a website address on the label, except when the address is required 
under 7 CFR part 205.
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    FSIS considers its current procedure of comprehensively evaluating 
approval requests for labels bearing negative claims on a case-by-case 
basis as sufficient to provide assurance that these labels are truthful 
and not misleading. Moreover, under the conditions described in the 
guideline, the labeling includes the information that consumers need to 
determine whether the negative claim meets their expectations for the 
claim.
    We note establishments do not have to use any of the negative 
claims listed in the guideline, and that an establishment's decision to 
use a particular third-party certifier is a voluntary business 
decision.
    Comment: Comments from consumer-advocacy organizations and 
agriculture-specific trade coalitions/associations argued FSIS should 
only allow negative claims on products that do not contain 
bioengineered ingredients and that are derived from livestock or 
poultry that were not fed bioengineered or GM feed because it reflects 
consumer expectations for these claims.
    Response: FSIS disagrees. The guideline explains that, for FSIS to 
approve a negative claim on product labeling, the label must also bear 
a website address where consumers can obtain additional information 
regarding the claim and the third-party organization's certification 
process. With this approach, the labeling includes the information 
consumers need if unaware of the specific standards on which the 
negative claim is based. Thus, FSIS will continue allowing negative 
claims on products that do not contain bioengineered ingredients and/or 
that are derived from livestock or poultry that did not consume 
bioengineered feed when the producing establishment provides evidence 
that substantiates the claim. Likewise, FSIS will continue to allow the 
use of synonymous terms such as ``genetically engineered'' or ``GE.''
    Comment: Comments from a trade association representing the poultry 
industry and consumers urged FSIS to clarify in the guideline that an 
animal is not considered genetically engineered merely because it 
consumed genetically engineered feed.
    Response: Public Law 114-216 prohibits a food derived from an 
animal ``to be considered a bioengineered food solely because the 
animal consumed feed produced from, containing, or consisting of a 
bioengineered substance'' (7 U.S.C. 1639b(b)(2)(A)). FSIS agrees this 
means that the animal from which the meat or poultry component was 
derived would not be considered bioengineered solely on the basis of 
the animal's feed. However, FSIS believes this information is outside 
the scope of the guideline, as the guideline provides only for negative 
claims that pertain to the non-animal ingredients, e.g., ``no GMO 
ingredients'' or ``made without GE ingredients.''

Minimum Standards

    Comment: Comments from consumer-advocacy organizations, 
agriculture-specific trade coalitions/associations, and individuals 
said FSIS should set minimum standards in the guideline for negative 
claims and not allow negative claims on products that do not meet these 
standards.
    Response: FSIS does not regulate biotechnologies and, thus, does 
not have the expertise to determine whether a particular third-party 
certifying

[[Page 71892]]

organization's standards should represent a particular negative claim. 
To ensure negative claims continue to accurately reflect the standards 
on which they are based, FSIS will continue to evaluate labels bearing 
these claims on a case-by-case basis and, when needed, consult with 
Federal agencies with expertise in the matter. FSIS will approve a 
negative claim if it is truthful and adequately substantiated by the 
producing establishment.

Organic Certification

    Comment: Comments from organic farmers and agriculture-specific 
trade associations urged FSIS to update the guideline to clarify that 
the Organic Certificate is sufficient support for negative claims, such 
as ``non-GMO'' and ``not bioengineered.'' The comments also said a 
website is unnecessary on certified-organic product labels.
    Response: FSIS agrees. For food certified under the USDA organic 
regulations, Public Law 114-216 states, ``the certification shall be 
considered sufficient to make a claim regarding the absence of 
bioengineering in the food, such as ``not bioengineered'', ``non-GMO'', 
or another similar claim.'' Furthermore, certified-organic products 
would not need to disclose a website address on the label, except when 
the address is required under 7 CFR part 205. FSIS has updated the 
guideline by adding this information.

Congressional Review Act

    Pursuant to the Congressional Review Act at 5 U.S.C. 801 et seq., 
the Office of Information and Regulatory Affairs has determined that 
this notice is not a ``major rule,'' as defined by 5 U.S.C. 804(2).

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, FSIS will announce this Federal 
Register publication online 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 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 Constituent 
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 Non-Discrimination 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.

How To File a Complaint of Discrimination

    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 in Washington, DC.
Carmen M. Rottenberg,
Administrator.
[FR Doc. 2019-27993 Filed 12-27-19; 8:45 am]
BILLING CODE 3410-DM-P