[Federal Register Volume 84, Number 131 (Tuesday, July 9, 2019)]
[Notices]
[Pages 32747-32749]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14524]


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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 Women Who Are or Might Become 
Pregnant, Breastfeeding Mothers, and Young Children, 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 Women Who Are or Might Become Pregnant, Breastfeeding 
Mothers, and Young Children.'' The revised advice updates advice that 
FDA and the U.S. Environmental Protection Agency (EPA) jointly issued 
in January 2017. The advice is intended to help women who are or might 
become pregnant, breastfeeding mothers, and parents of children over 2 
years 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. FDA is seeking public comment on the development of 
educational materials on the updated fish advice for women who are or 
might become pregnant, breastfeeding mothers, and parents of young 
children.

DATES: Although you can comment on the fish advice at any time, to 
ensure that FDA considers your comments on the development of 
educational materials before it begins work on such materials, submit 
either electronic or written comments on the requested information by 
September 9, 2019.

ADDRESSES: You may 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 Women Who Are or 
Might Become Pregnant, Breastfeeding Mothers, and Young Children.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential

[[Page 32748]]

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.
     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.gpo.gov/fdsys/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.

FOR FURTHER INFORMATION CONTACT: William R. Jones, Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus 
Dr., College Park, MD 20740, 240-402-1422, William.Jones@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of January 19, 2017 (82 FR 6571), FDA, in 
coordination with EPA, announced the availability of revised advice 
entitled ``Advice About Eating Fish'' (the ``2017 advice''). The 2017 
advice encourages women who are pregnant and breastfeeding to consume 8 
to 12 ounces of a variety of fish per week, from choices that are lower 
in mercury. The 2017 advice presents recommendations for how often the 
target audience should consume different fish, using a color-coded 
chart of more than 60 different fish. The chart presents fish in 
categories of ``Best Choices,'' from which we recommend the target 
audience eat a variety of 2 to 3 servings a week; ``Good Choices,'' 
from which we recommend the target audience eat 1 serving a week; and 
``Choices to Avoid.''
    On February 15, 2019, the Consolidated Appropriations Act, 2019 
(Pub. L. 116-6) became law. Section 773 of Public Law 116-6 directs the 
Commissioner of Food and Drugs to, by July 1, 2019, and ``following the 
review required under Executive Order 12866 (5 U.S.C. 601 note; 
relating to regulatory planning and review),'' issue ``advice revising 
the advice'' provided 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 Women Who Are or Might Become Pregnant, 
Breastfeeding Mothers, and Young Children'' responds to that directive.

II. The Revised Fish Advice

    The revised fish advice, like the 2017 advice, is intended to 
encourage fish consumption by emphasizing the benefits of eating fish 
and to help women who are or might become pregnant, breastfeeding 
mothers, and parents of children over 2 years make informed choices 
among types of fish. Specifically, the revised advice, now renamed as 
``Advice About Eating Fish: For Women Who Are or Might Become Pregnant, 
Breastfeeding Mothers, and Young Children,'' includes a statement that 
eating fish when pregnant or breastfeeding can provide health benefits 
and states that fish and other protein-rich foods have nutrients that 
can help children's growth and development. The revisions also include 
a statement that, as part of a healthy eating pattern, eating fish may 
offer heart health benefits and lower the risk of obesity. The revised 
advice also makes clear that many types of fish are both nutritious and 
lower in mercury.
    The revised advice also discusses nutritional value of fish, as 
outlined in the 2015-2020 Dietary Guidelines for Americans. 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), 
more vitamin B12 and vitamin D than any other type of food, iron, and 
other minerals like selenium, zinc, and iodine.
    Finally, the revised advice continues to provide information to 
help women who are or might become pregnant, breastfeeding mothers, and 
parents of children over 2 years choose varieties of fish that are 
lower in mercury.
    You may submit comments on the advice at any time.

III. Consolidated Appropriations Act, 2019

    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. As required by section 773 of Public Law 116-
6, the revised advice was reviewed by the Office of Management and 
Budget under Executive Order 12866.
    The advice was revised in accordance with the directive in section 
773 of Public Law 116-6 that the advice be updated ``in a manner that 
is consistent with nutrition science recognized by FDA on the net 
effects of seafood consumption.'' FDA considered the totality of the 
evidence, including nutrition science on the net effects of seafood 
consumption, when updating the fish advice. The overall changes we made 
include clarifying the target audience to make clear it applies to 
women who could become or are pregnant, women who are breastfeeding, 
and parents who are feeding children 2 years and older and adding 
highlights of key consumer messages, including that eating fish can 
provide health benefits when pregnant or breastfeeding, that many types 
of fish are both nutritious and lower in mercury, and that the 
consumption advice is based on mercury levels. Specifically, with 
respect to health benefits, the advice now highlights benefits related 
to risk of heart disease and obesity, benefits supporting children's 
growth and development, and the substantive nutritional contributions 
to a healthy diet from protein, omega-3 fats, vitamin B12, vitamin D, 
iron, selenium, zinc, and iodine.
    The primary focus of the revisions is to further align the advice 
with the 2015-2020 Dietary Guidelines for Americans, which establishes 
Federal, evidence-based policy on diet and health. The revised advice 
supports the

[[Page 32749]]

recommendations of the 2015-2020 Dietary Guidelines for Americans, 
developed for people 2 years and older, which reflects current science 
on nutrition to improve public health. 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 guidelines, including nutrition 
science that was based on scientific analysis that considered evidence 
regarding the net effects of seafood consumption. In addition, the 
guidelines recommend eating fish as part of a healthy eating pattern 
because there are benefits in doing so.
    The process to develop the 2020-2025 Dietary Guidelines is under 
way, and per the Agricultural Act of 2014, will include a comprehensive 
review of scientific evidence and development of guidance for infants 
and toddlers from birth to 24 months, as well as for women who are 
pregnant. Additionally, EPA is in the process of updating its 
Integrated Risk Information System (IRIS) Assessment for Methylmercury. 
FDA will consider the final products from these efforts, as 
appropriate, in any future updates to the fish advice.

IV. Request for Comments

    FDA intends to develop educational materials such as simple 
factsheets, posters, infographics, and social media tool-kits on the 
updated fish advice for women who are or might become pregnant, 
breastfeeding mothers, and parents of young children. Specific 
materials will also be developed for health care professionals, health 
educators, nutritionists, and dietitians. These resources will be 
printable and could be used in physician's offices, public health 
clinics, and stores.
    FDA is seeking public comment on:
    (1) Additional target populations that should be considered who may 
benefit from this advice;
    (2) Additional information that should be included in these 
educational resources; and
    (3) Additional effective means of disseminating and broadening the 
reach of this information.
    While FDA welcomes comment at any time, we would appreciate 
comments on these questions by September 9, 2019.

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.

    Dated: July 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-14524 Filed 7-8-19; 8:45 am]
 BILLING CODE 4164-01-P


