[Federal Register Volume 85, Number 54 (Thursday, March 19, 2020)]
[Notices]
[Pages 15759-15761]
From the Federal Register Online via the Government Publishing Office [http://www.gpo.gov/]
[FR Doc No: 2020-05738]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. FSIS-2019-0008]


Expansion of Use of the Term ``Healthy''

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice and request for comments.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing 
that it will allow establishments to use the implied nutrient content 
claim ``healthy'' on their labels which: (1) Are not low in total fat, 
but have a fat profile makeup of predominantly mono and polyunsaturated 
fats; or (2) contain at least ten percent of the Daily Value (DV) per 
reference amount customarily consumed (RACC) of potassium or vitamin D. 
FSIS is making this announcement to maintain consistent requirements 
for food labels by allowing the same uses of the claim ``healthy'' for 
meat and poultry products as are currently allowed for food products 
under the Food and Drug Administration's (FDA's) jurisdiction.

DATES: This notice is applicable March 19, 2020. Submit comments on or 
before May 18, 2020.

ADDRESSES: FSIS invites interested persons to submit comments on this 
notice. Comments may be submitted by one of the following methods:
    Federal eRulemaking Portal: This website 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, etc.: Send to Docket Clerk, U.S. 
Department of Agriculture, Food Safety and Inspection Service, 1400 
Independence Avenue SW, Mailstop 3758, Room 6065, Washington, DC 20250-
3700.
    Hand- or Courier-Delivered Items: Deliver to 1400 Independence 
Avenue SW, Room 6065, Washington, DC 20250-3700.
    Instructions: All items submitted by mail or electronic mail must 
include the Agency name and docket number FSIS-2019-0008. Written 
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 comments received, 
call

[[Page 15760]]

(202) 720-5627 to schedule a time to visit the FSIS Docket Room at 1400 
Independence Avenue SW, Room 6065, Washington, DC 20250-3700.

FOR FURTHER INFORMATION CONTACT: Jeff Canavan, Deputy Director, 
Labeling and Program Delivery Staff, Office of Policy and Program 
Development, Food Safety and Inspection Service, U.S. Department of 
Agriculture, Stop Code 3784, Patriots Plaza 3, 9-146, 1400 Independence 
Avenue SW, Washington, DC 20250-3700; Telephone (301) 504-0879; Fax 
(202) 245-4792.

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 
and poultry products is safe, wholesome, and accurately labeled and 
packaged. Under the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601-
695, at 607) and the Poultry Products Inspection Act (PPIA) (21 U.S.C. 
451-470, at 457), the labels of meat and poultry products must be 
approved by the Secretary of Agriculture, who has delegated this 
authority to FSIS, before these products can enter commerce. The FMIA 
and PPIA also prohibit the sale or offer for sale by any person, firm, 
or corporation of any article in commerce under any name or other 
marking or labeling that is false or misleading (21 U.S.C. 601(n) and 
607(d); 21 U.S.C. 453(h) and 457(c)).

FSIS Regulations for ``Healthy'' Claims

    FSIS regulations (9 CFR 317.363(b) and 381.463(b) define the 
parameters for the use of the implied nutrient content claim 
``healthy'' or any other derivative of the term ``health'' and similar 
terms on meat and poultry product labeling. The definitions establish 
specific criteria for nutrients to limit in the diet, such as total 
fat, saturated fat, cholesterol, and sodium; and requirements for 
nutrients to encourage in the diet, including vitamin A, vitamin C, 
calcium, iron, protein, and fiber.
    On May 10, 1994, FSIS published a final rule defining the term 
``healthy'' that included new standards for sodium (59 FR 24220). FSIS 
created initial ``first-tier'' sodium standards, and ``second-tier'' 
sodium standards that would become more rigorous after a 24-month time 
period. After extending the first-tier sodium standards in the Federal 
Register (63 FR 7279, 64 FR 72490, and 68 FR 460), FSIS decided, in 
2006, to indefinitely defer to the first-tier sodium standards (71 FR 
1683). Consequently, FSIS continues to apply the original (first-tier) 
levels of sodium established in the 1994 regulation when approving 
labels for ``healthy.''

Recent Changes to Regulations and Policy

    In December 2015, USDA and the U.S. Department of Health and Human 
Services (HHS) published the 2015-2020 Dietary Guidelines for 
Americans.\1\ The Dietary Guidelines were designed for professionals to 
help all individuals consume a healthy and nutritionally-adequate diet. 
Specific recommendations in the Dietary Guidelines have evolved over 
time, as nutrition science has advanced. For example, scientific 
understanding and nutrition guidance has shifted from recommending 
diets low in total fat to recommending keeping overall fat intake 
within the age-appropriate acceptable macronutrient distribution ranges 
(AMDR), and instead prioritizing replacing saturated fats with 
polyunsaturated and monounsaturated fats and keeping trans fat intake 
as low as possible.
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    \1\ https://health.gov/dietaryguidelines/2015/resources/2015-2020_Dietary_Guidelines.pdf.
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    On May 27, 2016, FDA issued two final rules updating the Nutrition 
Facts label and serving size information for packaged foods (81 FR 
33742 and 81 FR 34000). The above-mentioned 2015-2020 Dietary 
Guidelines for Americans served as the scientific basis for these two 
FDA final rules that included changes in the individual nutrients that 
must be declared on the Nutrition Facts label and changes to the DV of 
other individual nutrients. The changes reflected the most recent 
nutrition and public health research and recent dietary recommendations 
from expert groups. These rules also improved the presentation of 
nutrition information on the Nutrition Facts label to help consumers 
make more informed choices and maintain healthy dietary practices. 
Consistent with FDA's final rules, FSIS has proposed to change its 
nutrition labeling regulations (82 FR 6732). In November 2016, FSIS 
published a Federal Register notice allowing FSIS products to 
voluntarily adopt the FDA Nutrition Facts label format (81 FR 80631). 
The notice explained that at least one label sketch with the FDA 
nutrition format must be submitted to FSIS before that format could be 
generically approved for other products.
    On September 28, 2016, FDA announced in the Federal Register that 
it was requesting comments on the use of the term ``healthy'' in the 
labeling of human food products (81 FR 66562). According to this 
Federal Register notice, FDA published the notice in accordance with 
the FDA Foods and Veterinary Medicine Program's 2016-2025 Strategic 
Plan and in response to a citizen petition requesting that FDA update 
the nutrient content claim regulations to be consistent with current 
Federal dietary guidance. Specifically, FDA's notice stated that the 
petitioner requested that the Agency amend the regulation defining 
``healthy'' as it relates to total fat intake and to emphasize whole 
food and dietary patterns rather than specific nutrients.
    Additionally, in the same Federal Register publication, FDA 
announced the availability of a guidance document for industry entitled 
``Use of the Term `Healthy' in the Labeling of Human Food Products: 
Guidance for Industry'' (81 FR 66527). According to FDA, the science 
supporting public health recommendations for the intake of various 
nutrients had evolved, as evidenced in the 2015-2020 Dietary 
Guidelines. FDA also announced the Agency's intention to temporarily 
exercise enforcement discretion with respect to some of the criteria 
for bearing the implied nutrient content claim ``healthy'' until 21 CFR 
101.65(d)(2) is amended through rulemaking.
    In the Federal Register notice, FDA explained that it intended to 
exercise enforcement discretion with respect to the current requirement 
that any food bearing the nutrient content claim ``healthy'' meet the 
low-fat requirement provided that: (1) The amounts of mono- and 
polyunsaturated fats are declared on the label; and (2) the amounts of 
mono- and polyunsaturated fats declared constitute most of the fat 
content.
    FDA also stated, in the notice, that it intends to exercise 
enforcement discretion with respect to the current requirement that any 
food bearing the nutrient content claim ``healthy'' contain at least 
ten percent of the DV per RACC of vitamin A, vitamin C, calcium, iron, 
protein, or fiber, if the food instead contains at least ten percent of 
the DV per RACC of potassium or vitamin D. FDA's guidance document is 
available at https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM521692.pdf.

FSIS's Policy

    To maintain consistent requirements for food labels, FSIS has used 
its enforcement discretion to allow the same uses of the claim 
``healthy'' for meat and poultry products as are

[[Page 15761]]

allowed for food products under FDA jurisdiction under FDA's 2016 
guidance. There are few labels that qualify for the ``healthy'' claim 
under the allowances in this notice that wouldn't qualify otherwise. 
According to FSIS's Label Submission and Approval System (LSAS) \2\ 
data, the types of products utilizing FDA's guidance for the claim 
``healthy'' are mostly products that meet the definition of meal-type 
in 317.313(l)/381.413(l). Egg product labels are not affected by this 
policy because FSIS inspected egg products are required by regulation 
to use the FDA nutrition requirements in 21 CFR part 101 in compliance 
with 9 CFR 590.411(e)--as such, egg product labeling follows the FDA 
nutrition panel and the FDA enforcement discretion even though FSIS's 
Labeling and Program Delivery Staff (LPDS) reviews and approves FSIS 
inspected egg product label applications. Because FSIS has received 
multiple questions from industry about our policy, FSIS is announcing 
in this Federal Register notice that it will continue to recognize 
FDA's 2016 guidance to alleviate consumer confusion and promote 
uniformity in the marketplace.
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    \2\ FSIS's Label Submission and Approval System (LSAS) is a web-
based software application that integrates and implements an 
electronic label application process for establishments to submit 
label applications to FSIS.
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    Specifically, FSIS has allowed and will continue to allow the 
implied nutrient content claim ``healthy'' on foods that have a fat 
profile of predominantly mono and polyunsaturated fats (i.e. sum of 
monounsaturated fats and polyunsaturated fats are greater than the 
total saturated fat content of food), but do not meet the regulatory 
definition of ``low fat,'' as specified in 9 CFR 317.363(b)(1)/
381.463(b)(1) or that contain at least ten percent of the DV per RACC 
of potassium or vitamin D as one of the options in 9 CFR 317.363(b)(4) 
and 381.463(b)(4), provided the remaining criteria for healthy in 9 CFR 
317.363 and 381.463 have been met.
    FSIS's LPDS has reviewed many proposed labels referencing FDA's 
``healthy'' notice, and most have contained errors and needed 
correction. If a company wishes to use FDA's ``healthy'' claim, they 
will first need to submit at least one label sketch to LPDS for 
approval.
    A corporation's parent-company only needs to submit one label 
application for a product produced in multiple establishments that are 
owned by the corporation. Subsequent similar labels for other products 
that use FDA's ``healthy'' claim can be generically approved. 
Submitting one label and receiving approval helps ensure that the rest 
of the labels are in compliance with FDA and FSIS regulations. Labels 
using the modified ``healthy'' claim must be submitted to LPDS in the 
new FDA nutrition panel format.
    FSIS will continue to allow the use of implied nutrient content 
claim ``healthy'' on foods that have a fat profile of predominantly 
mono and polyunsaturated fats (i.e., sum of monounsaturated fats and 
polyunsaturated fats are greater than the total saturated fat content 
of food), but do not meet the regulatory definition of ``low fat,'' as 
specified in 9 CFR 317.363(b)(1) and 381.463(b)(1) or that contain at 
least ten percent of the DV per RACC of potassium or vitamin D as one 
of the options in 9 CFR 317.363(b)(4) and 381.463(b)(4), provided the 
remaining criteria for healthy in 9 CFR 317.363 and 381.463 have been 
met until FSIS's ``healthy'' regulations (9 CFR 317.363(b) and 
381.463(b)) are amended through rulemaking. FSIS will continue to 
coordinate with FDA on any changes to these regulations.

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 will also announce and 
provide a link to it 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.

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).

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.

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 at Washington, DC.
Paul Kiecker,
Administrator.
[FR Doc. 2020-05738 Filed 3-18-20; 8:45 am]
 BILLING CODE 3410-DM-P