81 FR 57879 - Statements That Bioengineered or Genetically Modified (GM) Ingredients or Animal Feed Were Not Used in the Production of Meat, Poultry, or Egg Products
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service Federal Register Volume 81, Issue 164 (August 24, 2016)
Food Safety and Inspection Service
Federal Register Volume 81, Issue 164 (August 24, 2016)
| Page Range | 57879-57880 | |
| FR Document | 2016-20227 |
[Federal Register Volume 81, Number 164 (Wednesday, August 24, 2016)] [Notices] [Pages 57879-57880] From the Federal Register Online [www.thefederalregister.org] [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
![Federal Register / Vol. 81, No. 164 / Wednesday, August 24, 2016 / Notices 57879
influential within the young U.S. grain- SUMMARY: The Food Safety and Docket: For access to background
fed cattle population, as the vast Inspection Service (FSIS) is announcing documents or to comments received, go
majority of cattle presented for grading the availability of the Agency’s to the FSIS Docket Room at Patriots
in U.S. beef processing facilities are less compliance guidance on how Plaza 3, 355 E Street SW., Room
than 30 MOA and USDA ‘‘A’’ or ‘‘B’’ companies can make label or labeling 164–A, Washington, DC 20250–3700
maturity. It is important to note that the claims concerning the fact that between 8:00 a.m. and 4:30 p.m.,
population of fed beef cattle in the U.S. bioengineered or genetically modified Monday through Friday.
has changed significantly over the last (GM) ingredients or animal feed were FOR FURTHER INFORMATION CONTACT: Dr.
several decades. Today, there is greater not used in the production of meat, Daniel L. Engeljohn, Assistant
consistency within the cattle herd, poultry, or egg products. For purposes Administrator, Office of Policy and
improved genetics, a relatively young of this guidance document, these claims Program Development; Telephone: (202)
slaughter population, more widespread will be referred to as ‘‘negative claims.’’ 205–0495.
use of growth promoting technologies DATES: Comments must be received by
SUPPLEMENTARY INFORMATION:
that are known to effect bone October 24, 2016.
ossification, and much higher carcass ADDRESSES: A downloadable version of Background
weights at slaughter which may also the compliance guidance is available to FSIS is the public health regulatory
have skeletal implications. These view and print at http://www.fsis.usda. agency in the USDA that is responsible
market and production changes, along gov/wps/portal/fsis/topics/regulatory- for ensuring that the nation’s
with recent research, could indicate that compliance/labeling/claims-guidance/ commercial supply of meat, poultry,
physiological maturity is less influential procedures-nongenetically-engineered- and egg products is safe, wholesome,
on palatability than in the past. statement. No hard copies of the and accurately labeled and packaged.
Request for Comments compliance guidance have been FSIS develops and implements
published. regulations and policies to ensure that
AMS is soliciting comments from FSIS invites interested persons to
stakeholders about whether changes in meat, poultry, and egg product labeling
submit comments on this notice. is not false or misleading. Under the
the methodology for determining Comments may be submitted by one of
maturity grouping assessment for the Federal Meat Inspection Act (FMIA) (21
the following methods: U.S.C. 601–695, at 607), the Poultry
purposes of official USDA quality Federal eRulemaking Portal: This
grading should be made. This change Products Inspection Act (PPIA) (21
Web site provides the ability to type
would have no effect on the role that U.S.C. 451–470, at 457), and the Egg
short comments directly into the
maturity groupings have upon USDA Products Inspection Act (21 U.S.C.
comment field on this Web page or
quality grade determination, simply 1031–1056, at 1036) the labels of meat,
attach a file for lengthier comments. Go
how carcasses are placed into those poultry, and egg products must be
to http://www.regulations.gov/. Follow
maturity groupings. AMS also invites approved by the Secretary of
the on-line instructions at that site for
comments about how those changes Agriculture, who has delegated this
submitting comments.
would be implemented in the current Mail, including CD–ROMs: Send to authority to FSIS, before these products
beef grading system. If, after analyzing Docket Clerk, U.S. Department of can enter commerce.
the comments, AMS determines that Agriculture, Food Safety and Inspection Compliance Guide
changes are warranted, a notice will be Service, Patriots Plaza 3, 1400
FSIS is announcing that it has
published in the Federal Register Independence Avenue SW., Mailstop
developed a compliance guide for
proposing specific changes to the 3782, Room 8–163B, Washington, DC
20250–3700. companies that seek to make label or
United States Standards for Carcass
Hand- or courier-delivered submittals: labeling claims concerning the fact that
Beef. Interested parties will have an
Deliver to Patriots Plaza 3, 355 E Street bioengineered or GM ingredients were
opportunity to comment prior to a final
SW., Room 8–163A, Washington, DC not used in a meat, poultry or egg
decision adopting any changes.
20250–3700. product. This guidance also provides
Dated: August 19, 2016. information on how companies can
Instructions: All items submitted by
Elanor Starmer, mail or electronic mail must include the make label or labeling claims that a
Administrator, Agricultural Marketing Agency name, docket number FSIS– product was produced from livestock or
Service. 2016–0027, and the document title: poultry that were not fed bioengineered
[FR Doc. 2016–20254 Filed 8–23–16; 8:45 am] Statements that Bioengineered or or GM feed. For purposes of this
BILLING CODE 3410–02–P Genetically Modified (GM) Ingredients guidance document, these claims will
or Animal Feed Were not Used in the be referred to as ‘‘negative claims.’’
Production of Meat, Poultry, or Egg FSIS has approved negative claims
DEPARTMENT OF AGRICULTURE Products. Comments received in through its prior label approval process.
response to this docket will be made Because FSIS does not have the ability
Food Safety and Inspection Service to independently verify negative claims
available for public inspection and
[Docket No. FSIS–2016–0027] posted without change, including any for ingredients or feed, FSIS has
personal information, to http:// required establishments that make these
Statements That Bioengineered or www.regulations.gov. claims to comply with standards
Genetically Modified (GM) Ingredients For additional information about FSIS established by a third-party certifying
or Animal Feed Were Not Used in the labeling policies and programs, organization. FSIS currently requires
mstockstill on DSK3G9T082PROD with NOTICES
Production of Meat, Poultry, or Egg including Generic Label Approval, that the third-party certifying
Products please review the FSIS Web site at: organization’s standards be publicly
AGENCY: Food Safety and Inspection http://www.fsis.usda.gov/wps/portal/ available on a Web site and the label or
Service, USDA. fsis/topics/regulatory-compliance/ labeling disclose the Web site address of
labeling/ or contact the Labeling and the third-party certifying organization.
ACTION: Notice of availability and
Program Delivery Staff at (301) 504– FSIS currently requires that the
opportunity for comment.
0878 or (301) 504–0879. establishment demonstrate that its
VerDate Sep<11>2014 20:16 Aug 23, 2016 Jkt 238001 PO 00000 Frm 00003 Fmt 4703 Sfmt 4703 E:\FR\FM\24AUN1.SGM 24AUN1](https://thefederalregister.org/doc/81_FR_58043/page/1.svg)
![57880 Federal Register / Vol. 81, No. 164 / Wednesday, August 24, 2016 / Notices
claims of third-party certification are USDA Nondiscrimination Statement which provides automatic and
truthful and not misleading. No agency, officer, or employee of the customized access to selected food
As a policy matter, prior to issuing safety news and information. This
USDA shall, on the grounds of race,
this guidance document, FSIS has not service is available at http://
color, national origin, religion, sex,
allowed the use of the terms www.fsis.usda.gov/subscribe. Options
gender identity, sexual orientation,
‘‘genetically modified organism’’ or range from recalls to export information
disability, age, marital status, family/
‘‘GMO’’ in negative claims. FSIS has to regulations, directives and notices.
parental status, income derived from a
allowed the use of the terms Customers can add or delete
public assistance program, or political
‘‘genetically modified organism’’ or subscriptions themselves and have the
beliefs, exclude from participation in,
‘‘GMO’’ on product labels or labeling option to password protect their
deny the benefits of, or subject to
only if the name of the third-party account.
certifying organization contains these discrimination, any person in the
United States under any program or Done at Washington, DC, on August 19,
terms (e.g. ‘‘Non-GMO Project’’). 2016.
However, recent legislation was enacted activity conducted by the USDA.
To file a complaint of discrimination, Alfred V. Almanza,
(Pub L 114–216) requiring the Secretary Acting Administrator.
of Agriculture to develop and complete the USDA Program
implement a mandatory national Discrimination Complaint Form, which [FR Doc. 2016–20227 Filed 8–23–16; 8:45 am]
bioengineered food disclosure standard may be accessed online at: http://www. BILLING CODE 3410–DM–P
within 2 years. This legislation also ocio.usda.gov/sites/default/files/docs/
addresses negative claims, providing 2012/Complain_combined_6_8_12.pdf,
or write a letter signed by you or your DEPARTMENT OF AGRICULTURE
that ‘‘a food may not be considered to
be ‘not bioengineered’ or ‘non-GMO’, or authorized representative.
Send your completed complaint form Foreign Agricultural Service
any other similar claim describing the
absence of bioengineering in the food or letter to USDA by mail, fax, or email: Assessment of Fees for Dairy Import
solely because the food is not required Mail: U.S. Department of Agriculture, Licenses for the 2017 Tariff-Rate
to bear a disclosure that the food is Director, Office of Adjudication, 1400 Import Quota Year
bioengineered under this subtitle.’’ Independence Avenue SW.,
(Pub. L. 114–216, section 294(c)). Washington, DC 20250–9410. AGENCY: Foreign Agricultural Service,
Therefore, FSIS has reconsidered its Fax: (202) 690–7442. USDA.
position and will allow the use of the Email: program.intake@usda.gov. ACTION: Notice.
terms ‘‘genetically modified organism’’ Persons with disabilities who require
alternative means for communication SUMMARY: This notice announces a fee of
or ‘‘GMO’’ in negative claims provided $250 to be charged for the 2017 tariff-
that the label or labeling is otherwise (Braille, large print, audiotape, etc.)
should contact USDA’s TARGET Center rate quota (TRQ) year for each license
truthful and not misleading. issued to a person or firm by the
Effective immediately, FSIS will begin at (202) 720–2600 (voice and TDD).
Department of Agriculture authorizing
approving negative claims for meat, Additional Public Notification the importation of certain dairy articles,
poultry and egg products that do not
Public awareness of all segments of which are subject to tariff-rate quotas set
contain bioengineered ingredients or
rulemaking and policy development is forth in the Harmonized Tariff Schedule
that are derived from livestock that do
important. Consequently, in an effort to (HTS) of the United States.
not consume bioengineered feed and
ensure that minorities, women, and DATE: August 24, 2016.
that contain the terms ‘‘genetically
modified organism’’ or ‘‘GMO’’. In persons with disabilities are aware of FOR FURTHER INFORMATION CONTACT:
evaluating such claims, FSIS will utilize this notice, FSIS will announce it on- Abdelsalam El-Farra, Dairy Import
the definition of ‘‘bioengineering’’ in line through the FSIS Web page located Licensing Program, Import Policies and
Public Law 114–216. In that law, the at http://www.fsis.usda.gov/wps/portal/ Export Reporting Division, STOP 1021,
term ‘‘bioengineering’’ refers to a food fsis/topics/regulations/federal-register/ U.S. Department of Agriculture, 1400
that contains genetic material that has federal-register-notices. FSIS also will Independence Avenue SW.,
been modified through in vitro make copies of this Federal Register Washington, DC 20250–1021 or
recombinant deoxyribonucleic acid publication available through the FSIS telephone at (202) 720–9439 or email at
(DNA) techniques and for which the Constituent Update, which is used to abdelsalam.el-farra@fas.usda.gov.
modification could not otherwise be provide information regarding FSIS SUPPLEMENTARY INFORMATION: The Dairy
obtained through conventional breeding policies, procedures, regulations, Tariff-Rate Import Quota Licensing
or found in nature. Federal Register notices, FSIS public Regulation promulgated by the
Consistent with past practice, FSIS meetings, recalls, and other types of Department of Agriculture and codified
will continue to allow the use of information that could affect or would at 7 CFR 6.20–6.36 provides for the
synonymous terms such as ‘‘genetically be of interest to constituents and issuance of licenses to import certain
engineered.’’ If FSIS has approved an stakeholders. The update is dairy articles that are subject to TRQs
organic claim on the product label, communicated via Listserv, a free set forth in the HTS. Those dairy articles
establishments may add an applicable electronic mail subscription service for may only be entered into the United
negative claim of the kind discussed in industry, trade and farm groups, States at the in-quota TRQ tariff-rates by
the guidance. consumer interest groups, allied health or for the account of a person or firm to
FSIS encourages companies to follow professionals, and other individuals whom such licenses have been issued
mstockstill on DSK3G9T082PROD with NOTICES
this guidance. This guidance represents who have asked to be included. The and only in accordance with the terms
FSIS’s current thinking, and FSIS update is available on the FSIS Web and conditions of the regulation.
welcomes comment on this compliance page. Through the Listserv and Web Licenses are issued on a calendar year
guidance and will update it as necessary page, FSIS is able to provide basis, and each license authorizes the
to reflect comments received and any information to a much broader and more license holder to import a specified
additional information that becomes diverse audience. In addition, FSIS quantity and type of dairy article from
available. offers an email subscription service a specified country of origin. The use of
VerDate Sep<11>2014 20:16 Aug 23, 2016 Jkt 238001 PO 00000 Frm 00004 Fmt 4703 Sfmt 4703 E:\FR\FM\24AUN1.SGM 24AUN1](https://thefederalregister.org/doc/81_FR_58043/page/2.svg)
Document Created: 2016-08-24 03:02:18
Document Modified: 2016-08-24 03:02:18
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability and opportunity for comment. | |
| Dates | Comments must be received by October 24, 2016. | |
| Contact | Dr. Daniel L. Engeljohn, Assistant Administrator, Office of Policy and Program Development; Telephone: (202) 205-0495. | |
| FR Citation | 81 FR 57879 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR