[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]


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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.

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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