Expansion of Use of the Term “Healthy”, 15759-15761 [2020-05738]
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Federal Register / Vol. 85, No. 54 / Thursday, March 19, 2020 / Notices
information is estimated to average 15
minutes per response.
Respondents: Respondents are eligible
certified organic handlers.
Estimated Number of Respondents:
210.
Estimated Number of Total Annual
Responses: 210.
Estimated Number of Responses per
Respondent: 1.
Estimated Total Annual Burden on
Respondents: 52.5 hours.
Comments are invited on: (1) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the Agency,
including whether the information will
have practical utility; (2) the accuracy of
the Agency’s estimate of the burden of
the proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
ways to enhance the quality, utility and
clarity of the information to be
collected; and (4) was to minimize the
burden of the collection of information
on those who are to respond, including
through the use of appropriate
automated, electronic, mechanical, or
other technological collection
techniques or other forms of information
technology.
Dated: March 12, 2020.
Bruce Summers,
Administrator, Agricultural Marketing
Service.
[FR Doc. 2020–05507 Filed 3–18–20; 8:45 am]
BILLING CODE 3410–02–P
DEPARTMENT OF AGRICULTURE
Submission for OMB Review;
Comment Request
jbell on DSKJLSW7X2PROD with NOTICES
March 16, 2020.
The Department of Agriculture has
submitted the following information
collection requirement(s) to OMB for
review and clearance under the
Paperwork Reduction Act of 1995,
Public Law 104–13. Comments are
required regarding; whether the
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility; the accuracy of the
agency’s estimate of burden including
the validity of the methodology and
assumptions used; ways to enhance the
quality, utility and clarity of the
information to be collected; and ways to
minimize the burden of the collection of
information on those who are to
respond, including through the use of
appropriate automated, electronic,
mechanical, or other technological
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17:05 Mar 18, 2020
Jkt 250001
collection techniques or other forms of
information technology.
Comments regarding this information
collection received by April 20, 2020
will be considered. Written comments
and recommendations for the proposed
information collection should be
submitted within 30 days of the
publication of this notice on the
following website www.reginfo.gov/
public/do/PRAMain. Find this
particular information collection by
selecting ‘‘Currently under 30-day
Review—Open for Public Comments’’ or
by using the search function.
An agency may not conduct or
sponsor a collection of information
unless the collection of information
displays a currently valid OMB control
number and the agency informs
potential persons who are to respond to
the collection of information that such
persons are not required to respond to
the collection of information unless it
displays a currently valid OMB control
number.
Farm Service Agency
Title: Wildfires and Hurricanes
Indemnity Program Pluses (WHIP+).
OMB Control Number: 0560–0294.
Summary of Collection: The
Additional Supplemental
Appropriations for Disaster Relief Act,
2019 (Disaster Relief Act; Pub. L. 116–
20) authorized $3 billion in assistance
for losses to crops, trees, bushes, and
vines due to 2018 and 2019 hurricanes,
floods, tornadoes, typhoons, volcanic
activity, snowstorms, and wildfires. The
Disaster Relief Act requires all
participants who receive WHIP+
payments to purchase crop insurance or
NAP coverage for the applicable crop
years for which they are requesting
assistance.
Need and Use of the Information: The
information submitted by respondents
on the various forms will be used by
FSA to determine eligibility and
distribute payments to eligible
producers under WHIP+. Failure to
solicit application will result in failure
to provide payments to eligible
producers as intended by the Disaster
Relief Act.
Description of Respondents: Farms.
Number of Respondents: 26,592.
Frequency of Responses: Reporting;
Other (one-time).
Total Burden Hours: 18,405.
Ruth Brown,
Departmental Information Collection
Clearance Officer.
[FR Doc. 2020–05736 Filed 3–18–20; 8:45 am]
BILLING CODE 3410–05–P
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15759
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
[Docket No. FSIS–2019–0008]
Expansion of Use of the Term
‘‘Healthy’’
Food Safety and Inspection
Service, USDA.
ACTION: Notice and request for
comments.
AGENCY:
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 https://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 https://
www.regulations.gov.
Docket: For access to background
documents or comments received, call
SUMMARY:
E:\FR\FM\19MRN1.SGM
19MRN1
15760
Federal Register / Vol. 85, No. 54 / Thursday, March 19, 2020 / Notices
(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)).
jbell on DSKJLSW7X2PROD with NOTICES
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 24month 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 firsttier sodium standards (71 FR 1683).
VerDate Sep<11>2014
17:05 Mar 18, 2020
Jkt 250001
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 nutritionallyadequate 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.
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).
1 https://health.gov/dietaryguidelines/2015/
resources/2015-2020_Dietary_Guidelines.pdf.
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Frm 00003
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Sfmt 4703
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 monoand 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/Guidance
DocumentsRegulatoryInformation/
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
E:\FR\FM\19MRN1.SGM
19MRN1
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Federal Register / Vol. 85, No. 54 / Thursday, March 19, 2020 / Notices
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.
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
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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17:05 Mar 18, 2020
Jkt 250001
‘‘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: https://
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:
https://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
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15761
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: https://
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: program.intake@usda.gov.
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
DEPARTMENT OF AGRICULTURE
Rural Business-Cooperative Service
Rural Housing Service
Rural Utilities Service
Notice of Solicitation of Applications
(NOSA) for the Strategic Economic and
Community Development Program for
Fiscal Year (FY) 2020; Amendment
Rural Business-Cooperative
Service, Rural Housing Service, and
Rural Utilities Service, USDA (Rural
Development).
ACTION: Notice of Solicitation of
Applications; Amendment.
AGENCY:
E:\FR\FM\19MRN1.SGM
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Agencies
[Federal Register Volume 85, Number 54 (Thursday, March 19, 2020)]
[Notices]
[Pages 15759-15761]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05738]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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 https://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.
---------------------------------------------------------------------------
\1\ https://health.gov/dietaryguidelines/2015/resources/2015-2020_Dietary_Guidelines.pdf.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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:
https://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: https://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: https://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