[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
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
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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