Advice About Eating Fish: For Those Who Might Become or Are Pregnant or Breastfeeding and Children Ages 1-11 Years, From the Environmental Protection Agency and Food and Drug Administration; Revised Fish Advice; Availability, 60053-60055 [2021-23666]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0595]
Advice About Eating Fish: For Those
Who Might Become or Are Pregnant or
Breastfeeding and Children Ages 1–11
Years, From the Environmental
Protection Agency and Food and Drug
Administration; Revised Fish Advice;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or we) is
announcing the availability of revised
fish advice entitled ‘‘Advice About
Eating Fish: For Those Who Might
Become or Are Pregnant or
Breastfeeding and Children Ages 1–11
Years.’’ The revised advice updates
advice that FDA and the U.S.
Environmental Protection Agency (EPA)
jointly issued in January 2017 and
subsequently revised in July 2019. The
advice is intended to help those who
might become or are pregnant or
breastfeeding, and parents and
caregivers of children make informed
choices about fish that are nutritious
and safe to eat. We are revising the
SUMMARY:
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60053
advice in accordance with a recent
directive from Congress.
DATES: The announcement of the
revised advice is published in the
Federal Register on October 29, 2021.
ADDRESSES: You may submit comments
on the advice at any time. Submit
comments as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2014–N–0595 for ‘‘Advice About Eating
Fish: For Those Who Might Become or
Are Pregnant or Breastfeeding and
Children Ages 1–11 Years.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday, 240–402–7500.
E:\FR\FM\29OCN1.SGM
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60054
Federal Register / Vol. 86, No. 207 / Friday, October 29, 2021 / Notices
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ FDA
will review this copy, including the
claimed confidential information, in its
consideration of comments. The second
copy, which will have the claimed
confidential information redacted/
blacked out, will be available for public
viewing and posted on https://
www.regulations.gov. Submit both
copies to the Dockets Management Staff.
If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
Submit written requests for single
copies of the advice to Division of
Seafood Safety, Office of Food Safety,
Center for Food Safety and Applied
Nutrition, Food and Drug
Administration, 5001 Campus Dr.,
College Park, MD 20740. Send two selfaddressed adhesive labels to assist that
office in processing your request. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance.
FOR FURTHER INFORMATION CONTACT:
Emanuel Hignutt, Jr., Office of Food
Safety (HFS–325), Center for Food
Safety and Applied Nutrition, Food and
Drug Administration, 5001 Campus Dr.,
College Park, MD 20740, 240–402–2469;
or Alexandra Jurewitz, Office of
Regulations and Policy (HFS–024),
Center for Food Safety and Applied
Nutrition, Food and Drug
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18:17 Oct 28, 2021
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Administration, 5001 Campus Dr.,
College Park, MD 20740, 240–402–2378.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of July 9, 2019
(84 FR 32747), FDA, in coordination
with EPA, announced the availability of
revised fish advice entitled ‘‘Advice
About Eating Fish: For Women Who Are
or Might Become Pregnant,
Breastfeeding Mothers, and Young
Children’’ (the ‘‘2019 advice’’). The
2019 advice responded to section 773 of
the Consolidated Appropriations Act,
2019 (Pub. L. 116–6), which directed the
Commissioner of Food and Drugs to, by
July 1, 2019, and following the
regulatory planning and review required
under Executive Order 12866, issue
advice revising the advice announced in
the notice of availability entitled
‘‘Advice About Eating Fish, From the
Environmental Protection Agency and
Food and Drug Administration, Revised
Fish Advice, Availability’’ (82 FR 6571;
January 19, 2017) in a manner that is
consistent with nutrition science
recognized by FDA on the net effects of
seafood consumption. The 2019 advice
encouraged fish consumption by
emphasizing the benefits of eating fish
and helping those who are or might
become pregnant or are breastfeeding,
and parents of children over 2 years
make informed choices among types of
fish. The 2019 advice made clear that
many types of fish are both nutritious
and lower in mercury. The 2019 advice
also discussed the nutritional value of
fish, as outlined in the 2015–2020
Dietary Guidelines for Americans.
On December 27, 2020, the
Consolidated Appropriations Act, 2021
(Pub. L. 116–260) became law. Section
745 of Public Law 116–260 directs the
Commissioner of Food and Drugs to, by
September 30, 2021, and following the
review required under Executive Order
No. 12866, issue advice revising the
advice announced in the notice of
availability entitled ‘‘Advice About
Eating Fish, From the Environmental
Protection Agency and Food and Drug
Administration; Revised Fish Advice;
Availability’’ (82 FR 6571), in a manner
that is consistent with nutrition science
recognized by FDA on the net effects of
seafood consumption. This notice
announcing the availability of revised
fish advice entitled ‘‘Advice About
Eating Fish: For Those Who Might
Become or Are Pregnant or
Breastfeeding and Children Ages 1–11
Years’’ responds to that directive.
On December 29, 2020, the
Department of Health and Human
Services and the U.S. Department of
Agriculture released the Dietary
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Guidelines for Americans, 2020–2025
(Ref. 1), which, for the first time,
provides dietary patterns for children
under age 2 years. It also provides
additional nutrition information for
caregivers of children and those who are
pregnant or lactating on healthy eating
patterns that can help promote health
and reduce the risk for chronic disease.
The updated edition of the Dietary
Guidelines is supported by a robust
review of the scientific evidence on
seafood and health outcomes across the
populations for which the FDA/EPA
Fish Advice is targeted and also
includes additional evidence that is
now available on the role of seafood, as
part of a healthy eating pattern, in
potentially achieving specific health
benefits.
II. The Revised Fish Advice
The revised fish advice, like the 2019
advice, is intended to encourage fish
and shellfish consumption (collectively
referred to in the advice as ‘‘fish’’) by
emphasizing the benefits of eating fish
and to help those who might become or
are pregnant or breastfeeding and
parents and caregivers of children ages
1 through 11 years make informed
choices among types of fish.
Specifically, the revised advice, now
renamed as ‘‘Advice About Eating Fish:
For Those Who Might Become or Are
Pregnant or Breastfeeding and Children
Ages 1–11 Years,’’ expands the lower
range of the target audience of children
from 2 years to 1 year. The revised
advice further explains that a healthy
eating pattern consists of choices across
all food groups (vegetables, fruits,
grains, dairy, and protein foods, which
includes fish), eaten in recommended
amounts, and within calorie needs, and
that healthy eating patterns include
foods that provide vitamins, minerals,
and other health-promoting components
and have no or little added sugars,
saturated fat, and sodium. Specific to
fish, the revised advice elaborates that
moderate scientific evidence shows that
eating patterns relatively higher in fish
but also in vegetables, fruits, legumes,
whole grains, low- or non-fat dairy, lean
meats and poultry, nuts, and
unsaturated vegetable oils, and lower in
red and processed meats, sugarsweetened foods and beverages, and
refined grains are not only associated
with lower risk of obesity but now also
promotion of bone health and lower risk
of colon and rectal cancers. The revised
advice states that strong evidence shows
that eating fish, as part of a healthy
eating pattern, may have heart health
benefits. The revised advice also makes
clear that many types of fish are both
nutritious and lower in mercury.
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The revised advice also discusses the
nutritional value of fish, as outlined in
the Dietary Guidelines for Americans,
2020–2025 (Ref. 1). Based on
information in the Dietary Guidelines,
the revised advice states that fish are
part of a healthy eating pattern and
provide protein, healthy omega-3 fats
(called docosahexaenoic acid and
eicosapentaenoic acid) and omega-6
fats, vitamins B12 and D, iron, and other
key nutrients like selenium, zinc,
iodine, and choline. In addition, the
revised advice includes statements that
fish provide omega-3 and omega-6 fats,
iron, iodine, and choline, which are key
nutrients during pregnancy,
breastfeeding, and/or early childhood to
support a child’s brain development;
choline also supports the development
of the baby’s spinal cord; and fish also
provide iron and zinc to support
children’s immune systems. The
revisions also include a statement that
fish intake during pregnancy is
recommended, as moderate evidence
shows that it can help a baby’s cognitive
development.
The revised advice continues to
provide information to help those who
might become or are pregnant or
breastfeeding, and parents and
caregivers of children choose varieties
of fish that are lower in mercury. The
revised advice now includes a
recommended serving size of about 1
ounce of ‘‘Best Choices,’’ to be
consumed twice a week, for children
age 1 year.
Finally, the revised advice also
provides information on how the
recommendations of the Healthy U.S.Style Dietary Patterns for children in the
Dietary Guidelines for Americans could
be met when those recommendations
include more ounces of fish per week
than the amounts in the FDA/EPA
advice. The revised advice provides a
list of the subset of ‘‘Best Choices’’ of
fish identified in Tables 2–1 and A3–1,
Footnote E of the Dietary Guidelines for
Americans, 2020–2025 that are at or
below the mean methylmercury
concentration that supports exposures at
or under the methylmercury Reference
Dose, when the amounts recommended
in the Healthy U.S.-Style Dietary Pattern
in the Dietary Guidelines are greater
than the amount of all ‘‘Best Choices’’
in the FDA/EPA advice.
III. Consolidated Appropriations Act,
2021
The fish advice provides information
for use by consumers. It is not intended
to have the force and effect of law, does
not implement, interpret, or prescribe
law or policy, and does not describe
procedural or practice requirements.
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Consistent with section 745 of Public
Law 116–260, the revised advice was
reviewed by the Office of Management
and Budget.
The advice was revised in accordance
with the directive in section 745 of
Public Law 116–260 that the advice be
updated in a manner that is consistent
with nutrition science recognized by
FDA on the net effects of seafood
consumption. The overall changes we
made include revised evidence
statements on fish consumption and
health benefits, as outlined in the
Dietary Guidelines for Americans,
2020–2025, including new information
about when and how to introduce fish
to infants, and terminology changes for
inclusivity. Specifically, with respect to
health benefits, the revised advice now
highlights that there is moderate
scientific evidence regarding favorable
measures of cognitive development in
young children associated with fish
intake in pregnancy as well as lower
risk of additional diet-related conditions
associated with consuming fish as part
of a total eating pattern.
The primary focus of the revisions is
to align the revised advice with the
Dietary Guidelines for Americans,
2020–2025, which establishes Federal,
evidence-based policy on diet and
health. The revised advice supports the
recommendations of the Dietary
Guidelines for Americans, 2020–2025,
which reflects current science on
nutrition to help promote health and
reduce chronic disease. The Dietary
Guidelines for Americans focuses on
dietary patterns and the effects of food
and nutrient characteristics on health.
FDA recognizes the nutrition science
that is reflected in the Dietary
Guidelines for Americans and the
preceding Scientific Report of the 2020
Dietary Guidelines Advisory Committee
(Ref. 2), including the nutrition science
described therein that considered the
net effects of seafood consumption on
growth and development, as well as
health. In addition, the Dietary
Guidelines for Americans recommends
eating fish as part of a healthy eating
pattern because there are benefits in
doing so.
EPA is in the process of updating its
Integrated Risk Information System
Assessment for Methylmercury. FDA
will consider the final products from
this effort, as appropriate, in any future
updates to the fish advice.
IV. Paperwork Reduction Act of 1995
This revised advice contains no
collection of information. Therefore,
clearance by the Office of Management
and Budget under the Paperwork
Reduction Act of 1995 is not required.
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V. Electronic Access
Persons with access to the internet
may obtain the advice at either https://
www.fda.gov/food/resources-you-food
or https://www.regulations.gov. Use the
FDA website listed in the previous
sentence to find the most current
version of the advice.
VI. References
The following references are on
display at the Dockets Management Staff
(see ADDRESSES) and are available for
viewing by interested persons between
9 a.m. and 4 p.m., Monday through
Friday; they are also available
electronically at https://
www.regulations.gov. FDA has verified
the website addresses, as of the date this
document publishes in the Federal
Register, but websites are subject to
change over time.
1. U.S. Department of Agriculture and U.S.
Department of Health and Human
Services. Dietary Guidelines for
Americans, 2020–2025, 9th Edition,
December 2020. Available at https://
www.dietaryguidelines.gov.
2. Dietary Guidelines Advisory Committee.
2020. Scientific Report of the 2020
Dietary Guidelines Advisory Committee:
Advisory Report to the Secretary of
Agriculture and the Secretary of Health
and Human Services. U.S. Department of
Agriculture, Agricultural Research
Service, Washington, DC. Available at
https://www.dietaryguidelines.gov/2020advisory-committee-report.
Dated: October 26, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–23666 Filed 10–28–21; 8:45 am]
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Request for Public Comment: 30-Day
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Indian Health Service, HHS.
Notice and request for
comments. Request for extension of
approval.
AGENCY:
ACTION:
In compliance with the
Paperwork Reduction Act of 1995
(PRA), the Indian Health Service (IHS)
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SUMMARY:
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]]>Agencies
[Federal Register Volume 86, Number 207 (Friday, October 29, 2021)]
[Notices]
[Pages 60053-60055]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23666]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0595]
Advice About Eating Fish: For Those Who Might Become or Are
Pregnant or Breastfeeding and Children Ages 1-11 Years, From the
Environmental Protection Agency and Food and Drug Administration;
Revised Fish Advice; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of revised fish advice entitled ``Advice About Eating
Fish: For Those Who Might Become or Are Pregnant or Breastfeeding and
Children Ages 1-11 Years.'' The revised advice updates advice that FDA
and the U.S. Environmental Protection Agency (EPA) jointly issued in
January 2017 and subsequently revised in July 2019. The advice is
intended to help those who might become or are pregnant or
breastfeeding, and parents and caregivers of children make informed
choices about fish that are nutritious and safe to eat. We are revising
the advice in accordance with a recent directive from Congress.
DATES: The announcement of the revised advice is published in the
Federal Register on October 29, 2021.
ADDRESSES: You may submit comments on the advice at any time. Submit
comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2014-N-0595 for ``Advice About Eating Fish: For Those Who Might
Become or Are Pregnant or Breastfeeding and Children Ages 1-11 Years.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
[[Page 60054]]
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' FDA will review
this copy, including the claimed confidential information, in its
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information to be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
Submit written requests for single copies of the advice to Division
of Seafood Safety, Office of Food Safety, Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740. Send two self-addressed adhesive labels to
assist that office in processing your request. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance.
FOR FURTHER INFORMATION CONTACT: Emanuel Hignutt, Jr., Office of Food
Safety (HFS-325), Center for Food Safety and Applied Nutrition, Food
and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-
402-2469; or Alexandra Jurewitz, Office of Regulations and Policy (HFS-
024), Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of July 9, 2019 (84 FR 32747), FDA, in
coordination with EPA, announced the availability of revised fish
advice entitled ``Advice About Eating Fish: For Women Who Are or Might
Become Pregnant, Breastfeeding Mothers, and Young Children'' (the
``2019 advice''). The 2019 advice responded to section 773 of the
Consolidated Appropriations Act, 2019 (Pub. L. 116-6), which directed
the Commissioner of Food and Drugs to, by July 1, 2019, and following
the regulatory planning and review required under Executive Order
12866, issue advice revising the advice announced in the notice of
availability entitled ``Advice About Eating Fish, From the
Environmental Protection Agency and Food and Drug Administration,
Revised Fish Advice, Availability'' (82 FR 6571; January 19, 2017) in a
manner that is consistent with nutrition science recognized by FDA on
the net effects of seafood consumption. The 2019 advice encouraged fish
consumption by emphasizing the benefits of eating fish and helping
those who are or might become pregnant or are breastfeeding, and
parents of children over 2 years make informed choices among types of
fish. The 2019 advice made clear that many types of fish are both
nutritious and lower in mercury. The 2019 advice also discussed the
nutritional value of fish, as outlined in the 2015-2020 Dietary
Guidelines for Americans.
On December 27, 2020, the Consolidated Appropriations Act, 2021
(Pub. L. 116-260) became law. Section 745 of Public Law 116-260 directs
the Commissioner of Food and Drugs to, by September 30, 2021, and
following the review required under Executive Order No. 12866, issue
advice revising the advice announced in the notice of availability
entitled ``Advice About Eating Fish, From the Environmental Protection
Agency and Food and Drug Administration; Revised Fish Advice;
Availability'' (82 FR 6571), in a manner that is consistent with
nutrition science recognized by FDA on the net effects of seafood
consumption. This notice announcing the availability of revised fish
advice entitled ``Advice About Eating Fish: For Those Who Might Become
or Are Pregnant or Breastfeeding and Children Ages 1-11 Years''
responds to that directive.
On December 29, 2020, the Department of Health and Human Services
and the U.S. Department of Agriculture released the Dietary Guidelines
for Americans, 2020-2025 (Ref. 1), which, for the first time, provides
dietary patterns for children under age 2 years. It also provides
additional nutrition information for caregivers of children and those
who are pregnant or lactating on healthy eating patterns that can help
promote health and reduce the risk for chronic disease. The updated
edition of the Dietary Guidelines is supported by a robust review of
the scientific evidence on seafood and health outcomes across the
populations for which the FDA/EPA Fish Advice is targeted and also
includes additional evidence that is now available on the role of
seafood, as part of a healthy eating pattern, in potentially achieving
specific health benefits.
II. The Revised Fish Advice
The revised fish advice, like the 2019 advice, is intended to
encourage fish and shellfish consumption (collectively referred to in
the advice as ``fish'') by emphasizing the benefits of eating fish and
to help those who might become or are pregnant or breastfeeding and
parents and caregivers of children ages 1 through 11 years make
informed choices among types of fish. Specifically, the revised advice,
now renamed as ``Advice About Eating Fish: For Those Who Might Become
or Are Pregnant or Breastfeeding and Children Ages 1-11 Years,''
expands the lower range of the target audience of children from 2 years
to 1 year. The revised advice further explains that a healthy eating
pattern consists of choices across all food groups (vegetables, fruits,
grains, dairy, and protein foods, which includes fish), eaten in
recommended amounts, and within calorie needs, and that healthy eating
patterns include foods that provide vitamins, minerals, and other
health-promoting components and have no or little added sugars,
saturated fat, and sodium. Specific to fish, the revised advice
elaborates that moderate scientific evidence shows that eating patterns
relatively higher in fish but also in vegetables, fruits, legumes,
whole grains, low- or non-fat dairy, lean meats and poultry, nuts, and
unsaturated vegetable oils, and lower in red and processed meats,
sugar-sweetened foods and beverages, and refined grains are not only
associated with lower risk of obesity but now also promotion of bone
health and lower risk of colon and rectal cancers. The revised advice
states that strong evidence shows that eating fish, as part of a
healthy eating pattern, may have heart health benefits. The revised
advice also makes clear that many types of fish are both nutritious and
lower in mercury.
[[Page 60055]]
The revised advice also discusses the nutritional value of fish, as
outlined in the Dietary Guidelines for Americans, 2020-2025 (Ref. 1).
Based on information in the Dietary Guidelines, the revised advice
states that fish are part of a healthy eating pattern and provide
protein, healthy omega-3 fats (called docosahexaenoic acid and
eicosapentaenoic acid) and omega-6 fats, vitamins B12 and D, iron, and
other key nutrients like selenium, zinc, iodine, and choline. In
addition, the revised advice includes statements that fish provide
omega-3 and omega-6 fats, iron, iodine, and choline, which are key
nutrients during pregnancy, breastfeeding, and/or early childhood to
support a child's brain development; choline also supports the
development of the baby's spinal cord; and fish also provide iron and
zinc to support children's immune systems. The revisions also include a
statement that fish intake during pregnancy is recommended, as moderate
evidence shows that it can help a baby's cognitive development.
The revised advice continues to provide information to help those
who might become or are pregnant or breastfeeding, and parents and
caregivers of children choose varieties of fish that are lower in
mercury. The revised advice now includes a recommended serving size of
about 1 ounce of ``Best Choices,'' to be consumed twice a week, for
children age 1 year.
Finally, the revised advice also provides information on how the
recommendations of the Healthy U.S.-Style Dietary Patterns for children
in the Dietary Guidelines for Americans could be met when those
recommendations include more ounces of fish per week than the amounts
in the FDA/EPA advice. The revised advice provides a list of the subset
of ``Best Choices'' of fish identified in Tables 2-1 and A3-1, Footnote
E of the Dietary Guidelines for Americans, 2020-2025 that are at or
below the mean methylmercury concentration that supports exposures at
or under the methylmercury Reference Dose, when the amounts recommended
in the Healthy U.S.-Style Dietary Pattern in the Dietary Guidelines are
greater than the amount of all ``Best Choices'' in the FDA/EPA advice.
III. Consolidated Appropriations Act, 2021
The fish advice provides information for use by consumers. It is
not intended to have the force and effect of law, does not implement,
interpret, or prescribe law or policy, and does not describe procedural
or practice requirements. Consistent with section 745 of Public Law
116-260, the revised advice was reviewed by the Office of Management
and Budget.
The advice was revised in accordance with the directive in section
745 of Public Law 116-260 that the advice be updated in a manner that
is consistent with nutrition science recognized by FDA on the net
effects of seafood consumption. The overall changes we made include
revised evidence statements on fish consumption and health benefits, as
outlined in the Dietary Guidelines for Americans, 2020-2025, including
new information about when and how to introduce fish to infants, and
terminology changes for inclusivity. Specifically, with respect to
health benefits, the revised advice now highlights that there is
moderate scientific evidence regarding favorable measures of cognitive
development in young children associated with fish intake in pregnancy
as well as lower risk of additional diet-related conditions associated
with consuming fish as part of a total eating pattern.
The primary focus of the revisions is to align the revised advice
with the Dietary Guidelines for Americans, 2020-2025, which establishes
Federal, evidence-based policy on diet and health. The revised advice
supports the recommendations of the Dietary Guidelines for Americans,
2020-2025, which reflects current science on nutrition to help promote
health and reduce chronic disease. The Dietary Guidelines for Americans
focuses on dietary patterns and the effects of food and nutrient
characteristics on health. FDA recognizes the nutrition science that is
reflected in the Dietary Guidelines for Americans and the preceding
Scientific Report of the 2020 Dietary Guidelines Advisory Committee
(Ref. 2), including the nutrition science described therein that
considered the net effects of seafood consumption on growth and
development, as well as health. In addition, the Dietary Guidelines for
Americans recommends eating fish as part of a healthy eating pattern
because there are benefits in doing so.
EPA is in the process of updating its Integrated Risk Information
System Assessment for Methylmercury. FDA will consider the final
products from this effort, as appropriate, in any future updates to the
fish advice.
IV. Paperwork Reduction Act of 1995
This revised advice contains no collection of information.
Therefore, clearance by the Office of Management and Budget under the
Paperwork Reduction Act of 1995 is not required.
V. Electronic Access
Persons with access to the internet may obtain the advice at either
https://www.fda.gov/food/resources-you-food or https://www.regulations.gov. Use the FDA website listed in the previous
sentence to find the most current version of the advice.
VI. References
The following references are on display at the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the website addresses, as of the date this document publishes
in the Federal Register, but websites are subject to change over time.
1. U.S. Department of Agriculture and U.S. Department of Health and
Human Services. Dietary Guidelines for Americans, 2020-2025, 9th
Edition, December 2020. Available at https://www.dietaryguidelines.gov.
2. Dietary Guidelines Advisory Committee. 2020. Scientific Report of
the 2020 Dietary Guidelines Advisory Committee: Advisory Report to
the Secretary of Agriculture and the Secretary of Health and Human
Services. U.S. Department of Agriculture, Agricultural Research
Service, Washington, DC. Available at https://www.dietaryguidelines.gov/2020-advisory-committee-report.
Dated: October 26, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-23666 Filed 10-28-21; 8:45 am]
BILLING CODE 4164-01-P
