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]

Download as PDF Federal Register / Vol. 86, No. 207 / Friday, October 29, 2021 / Notices derived from the generic drug applicant program fee would increase from 35 percent in GDUFA II to 36 percent in GDUFA III. E. Impact of GDUFA III Enhancements on User Fee Revenue To implement the proposed enhancements for GDUFA III, funding for a total of 128 new full-time equivalent staff is proposed for FY 2023. IV. Public Meeting Information khammond on DSKJM1Z7X2PROD with NOTICES A. Purpose and Scope of the Meeting fda.hhs.gov no later than November 11, 2021. No commercial or promotional material will be permitted to be presented or distributed during the virtual public meeting. Streaming Webcast of the Public Meeting: The Zoom Webinar ID for this public meeting is 160 003 0426. The webcast link for this public meeting, which should allow you to enter the webinar directly, can be found here: https://fda.zoomgov.com/j/1600030426? pwd=YThMd0swe XNQOVNOdVpYZHMrdVFSUT09. If Zoom asks for a passcode, please use the following case-sensitive passcode: GDUFa3! Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at https://www.fda.gov/ industry/fda-user-fee-programs/genericdrug-user-fee-amendments and in this docket at https://www.regulations.gov. It may also be viewed at the Dockets Management Staff (see ADDRESSES). The meeting will include presentations by FDA and panels representing different stakeholder groups identified in the statute (such as patient and consumer advocacy groups and regulated industry). For members of the public who would like to make verbal comments on the proposed enhancements (see instructions below), there will be a public comment period at the end of the meeting. We will also provide an opportunity for individuals to submit written comments to the docket before and after the meeting. Dated: October 22, 2021. Lauren K. Roth, Associate Commissioner for Policy. B. Participating in the Public Meeting [FR Doc. 2021–23499 Filed 10–28–21; 8:45 am] Registration: Registration is optional to attend this virtual meeting. However, registering will allow FDA to provide you with email updates if any meeting details change. Persons interested in registering for this public meeting must register online by 11:59 p.m. Eastern Time on November 15, 2021, at https:// www.eventbrite.com/o/fda34063199905. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone. Opportunity for Public Comment: If you wish to present during the public comment session, please submit your request to GenericDrugPolicy@ fda.hhs.gov by 11:59 p.m. Eastern Time on November 8, 2021. Your email should contain which topic(s) you wish to address and include complete contact information, including name, title, affiliation, address, and email address. We will do our best to accommodate requests to make public comments. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation. Following the close of registration, we will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin, and will select and notify participants by November 9, 2021. If selected for presentation, any presentation materials must be emailed to GenericDrugPolicy@ BILLING CODE 4164–01–P VerDate Sep<11>2014 18:17 Oct 28, 2021 Jkt 256001 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: PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 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 29OCN1 khammond on DSKJM1Z7X2PROD with NOTICES 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 VerDate Sep<11>2014 18:17 Oct 28, 2021 Jkt 256001 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 PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 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. E:\FR\FM\29OCN1.SGM 29OCN1 Federal Register / Vol. 86, No. 207 / Friday, October 29, 2021 / Notices khammond on DSKJM1Z7X2PROD with NOTICES 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. VerDate Sep<11>2014 18:17 Oct 28, 2021 Jkt 256001 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. PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 60055 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] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service Request for Public Comment: 30-Day Notice for Extension of the Indian Health Service Loan Repayment Program (LRP) 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) invites the general public to take this opportunity to comment on the information collection Office of Management and Budget (OMB) Control Number 0917–0014, titled, ‘‘IHS Loan Repayment Program (LRP).’’ The IHS is requesting OMB to approve an SUMMARY: E:\FR\FM\29OCN1.SGM 29OCN1

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]


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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.

-----------------------------------------------------------------------

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]
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