[Federal Register Volume 82, Number 12 (Thursday, January 19, 2017)]
[Notices]
[Pages 6571-6574]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-01073]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0595]


Advice About Eating Fish, 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: In June 2014, the Food and Drug Administration (FDA) and the 
U.S. Environmental Protection Agency (EPA) (the Agencies) jointly 
released a draft update to a March 2004 document entitled ``What You 
Need to Know About Mercury in Fish and Shellfish.'' FDA and EPA are now 
announcing revised fish advice that contains advice and supplemental 
questions and answers for those who want to understand the advice in 
greater detail.

FOR FURTHER INFORMATION CONTACT: FDA: William R. Jones, Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus 
Dr., College Park, MD 20740-3835, 240-402-1422, 
[email protected]; EPA: Lisa Larimer, U.S. Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW., MS 4305T, Washington, DC 
20460, 202-566-1017, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of June 11, 2014 (79 FR 33559), FDA, in 
coordination with EPA, announced the availability of the draft updated 
fish advice, entitled ``Fish: What Pregnant Women and Parents Should 
Know'' (the notice), and made the draft updated advice available for 
public comment. The draft fish advice was intended to update advice 
previously published by EPA and FDA in March 2004 (Ref. 1), to make it 
consistent with the 2010 Dietary Guidelines for Americans and to modify 
the wording and organization of the 2004 advice to enhance the 
likelihood that it would be followed by the target audience. The 2004 
advice on fish consumption itself was preceded by earlier 
recommendations published by FDA in September 1994 and revised in May 
1995 (http://www.fda.gov/ohrms/dockets/ac/02/briefing/3872_advisory%207.pdf), followed by separate, but simultaneously 
issued, FDA and EPA fish consumption advice in 2001. FDA's 2001 advice 
addressed commercial fish; EPA's 2001 advice addressed locally caught 
fish. The 2014 notice announcing the availability of the draft updated 
fish advice stated that the comment period would be open until 30 days 
after the last transcript became available from either the FDA Risk

[[Page 6572]]

Communication Advisory Committee (RCAC) meeting to be held on the draft 
advice or any other public meeting that the Agencies chose to hold on 
the draft advice (79 FR 33559). The notice also stated that the date 
for closure of public comment would be published in a future notice in 
the Federal Register (id.).
    The RCAC meeting was held on November 3 and 4, 2014, and the 
transcript of the meeting became available on December 2, 2014. The 
meeting addressed the draft updated fish advice in great detail and 
included presentations by the Agencies on both the substance and the 
presentation of the draft updated fish advice, and included 
presentations by invited experts in risk communications. The meeting 
also provided members of the public with an opportunity to express 
their views to the RCAC and to officials of the Agencies who were in 
attendance. FDA and EPA concluded that the thoroughness of this public 
meeting, in addition to the public comments received and still to be 
received, removed the need for additional public meetings, and 
announced in the Federal Register that the comment period for the draft 
updated advice would be closed on March 26, 2015 (80 FR 9732). The 
transcript from the RCAC meeting is available electronically at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/RiskCommunicationAdvisoryCommittee/UCM425352.pdf and http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials. A 
summary table of joint responses from FDA and EPA to the comments we 
received on the draft updated fish advice is available in the docket 
(Ref. 2). The comments themselves are also available in the Docket.
    In August 2016, an external peer review of FDA-EPA's method for 
categorizing species of fish into consumption categories was conducted 
at the request of FDA and EPA. Information on the external peer review 
and FDA's and EPA's responses to the peer review are available at 
http://www.fda.gov/fishadvice (and also on FDA's Completed Peer Reviews 
page at http://www.fda.gov/ScienceResearch/SpecialTopics/PeerReviewofScientificInformationandAssessments/ucm079120.htm) (Refs. 3 
and 4). Fish and shellfish (referred to collectively in this notice as 
``fish'') provide protein, are low in saturated fat, are rich in many 
micronutrients, and provide certain omega-3 fatty acids (Ref. 5). 
However, as a result of natural processes and human activity, fish also 
contain mercury in the form of methylmercury. Methylmercury can 
adversely affect the central nervous system, particularly the 
developing brain of the fetus. After a careful review and consideration 
of the RCAC transcript, the comments received on the draft updated fish 
advice (Ref. 2), and the peer review, EPA and FDA are issuing revised 
fish advice.
    The 2004 advice was issued to help individuals in the target 
population limit their exposure to mercury while still obtaining the 
health benefits of fish consumption. The 2004 advice recommended 
avoiding four types of commercially available fish that have the 
highest average mercury concentrations: Tilefish, shark, swordfish, and 
king mackerel. The advice further recommended that women in the target 
population eat up to--but not exceed--12 ounces per week of most other 
types of commercially available fish. It recommended limiting 
consumption of one species, white (albacore) tuna, to no more than 6 
ounces per week. For local fish caught by family and friends, the 
advice recommended following locally posted fish advisories regarding 
safe catch. Where no such advice exists, it recommends limiting 
consumption of locally caught fish to 6 ounces per week and eating no 
other fish that week.
    While the 2004 advice encourages fish consumption as part of a 
healthy diet, it does not encourage consumption of a minimum amount of 
fish. In June 2014, FDA and EPA issued the draft updated advice to 
encourage women who are pregnant or breastfeeding to consume 8 to 12 
ounces of a variety of fish per week to maximize the potential benefits 
that fish could provide. The Agencies also proposed to modify the 
wording and organization of the 2004 advice in order to enhance the 
likelihood that it will be followed by the target audience.

II. What is in the revised fish advice?

    The revised fish advice is designed to encourage women who are 
pregnant and breastfeeding to consume 8 to12 ounces of a variety of 
fish per week, and it includes further modified wording and 
organization to further enhance the likelihood that it will be followed 
by the target audience. The revised fish advice includes a chart and 
supplemental questions and answers. The chart provides recommendations 
for how often the target audience (pregnant women, women who might 
become pregnant, breastfeeding women, and young children) should eat 
more than 60 different fish, based on mercury concentrations.
    FDA and EPA used sampling data from FDA and, to a limited extent, 
from the U.S. National Marine Fisheries Service as the source for 
mercury amounts in fish (Ref. 6), with support from other sources 
(Refs. 7 through 12). The revised fish advice makes the following 
recommendations for the target audience:
     Eat 2 to 3 servings a week of a variety of fish. The 
revised fish advice translates the consumption target of 8 to 12 ounces 
of a variety of fish per week into 2 to 3 servings a week of a variety 
of fish, with a typical adult serving as 4 ounces. The chart in the 
revised fish advice shows which fish the target audience can eat 2 to 3 
servings a week.
     Eat 1 serving a week of some fish. Since 2004, the advice 
has recommended limiting albacore (``white'') tuna to 1 serving a week 
(or 6 ounces per week). The revised fish advice adds 18 fish with 
similar mercury concentrations to the list of fish to eat 1 serving a 
week.
     Avoid certain fish with the highest mercury 
concentrations. Since 1994, the advice has recommended limiting or 
avoiding shark and swordfish. In 2001, tilefish and king mackerel were 
added to this list of recommended fish to avoid. This revised fish 
advice adds marlin, orange roughy, and bigeye tuna, which have similar 
mercury concentrations. The revised fish advice recommends avoiding 
tilefish only from the Gulf of Mexico, consistent with the draft 
updated fish advice. Data on tilefish from the Atlantic Ocean indicate 
that these fish have much lower levels of mercury on average (Ref. 6).
     Check for advisories for fish caught by family and friends 
and where no advisory exists, limit eating those fish to one serving a 
week and do not eat other fish that week. The revised fish advice 
retains the recommendations included in the 2004 advice for fish caught 
by family and friends. There are waters where there may have been 
little or no monitoring and, therefore, the extent of potential mercury 
contamination is unknown. Fish caught for recreation or subsistence can 
contain higher levels of mercury than commercially available species.

III. How does the revised fish advice differ from the draft updated 
fish advice?

    The revised fish advice presents the recommended consumption for 
more than 60 fish in a color-coded chart. The fish are presented in 
categories of ``Best Choices,'' those which the target audience can eat 
2 to 3 servings a week; ``Good Choices,'' which the target audience can 
eat 1 serving a week; and ``Choices to Avoid.'' See Ref. 13 for a 
description of how FDA and EPA

[[Page 6573]]

decided which fish went in each category. The draft updated fish advice 
recommended eating 8 to 12 ounces of a variety of fish per week and 
choosing fish lower in mercury, but it only mentioned 7 of those fish 
(salmon, shrimp, pollock, tuna (light canned), tilapia, catfish, and 
cod). The revised fish advice also retains the recommendation to eat a 
variety of fish. The revised fish advice adds 18 fish that the target 
audience can eat 1 serving a week (see ``Good Choices'' category in the 
revised fish advice). The draft updated fish advice included only white 
(albacore tuna) as a fish to limit to 6 ounces per week. Another change 
between the draft updated advice and the revised fish advice is that 
the revised fish advice adds marlin, orange roughy, and bigeye tuna to 
the list of fish that the target audience should avoid eating (see 
``Choices to Avoid'' category in the revised fish advice). These fish 
were added because they have comparable mercury levels to fish included 
in the draft updated advice as fish that should be avoided (i.e., 
shark, swordfish, tilefish from the Gulf of Mexico, and king mackerel).
    The Agencies reorganized the questions and answers (Qs and As) into 
topic areas, simplified the responses, and added new questions as a 
result of comments received during the comment period. The chart 
includes a link to two fish advice Web sites (http://www.fda.gov/fishadvice) and http://www.epa.gov/fishadvice), images to show serving 
size, and is designed to make it clear and easy to read for display at 
point of sale, doctors' offices and elsewhere. The Web site contains 
the advice and the Qs and As. Educational and outreach materials will 
be added to the Web site as they are developed.

IV. What comments were received and how does the revised fish advice 
reflect them?

    FDA and EPA received over 200 comments from States, industry, 
academia, various organizations, and concerned individuals. The 
comments covered a range of topics from the scientific basis of the 
advice to communication. There was a wide range of opinions expressed 
in the comments, not all of which were relevant to the advice. The 
majority of the comments pertained to the clarity and effectiveness of 
how the advice was presented. In response to comments, the Agencies 
revised the presentation of the advice, as discussed in part III of 
this document. Other comments suggested a more restrictive set of 
consumption recommendations or disagreed with setting consumption th 
resholds for specific species of fish or for any but the species 
highest in mercury. After reviewing the comments, FDA and EPA adopted 
an approach in which fish species are separated into three categories 
based on average measured mercury content (``Best Choices,'' ``Good 
Choices,'' and ``Choices to Avoid''). An evaluation of available 
information led the Agencies to recommend eating 2 to 3 servings a week 
for some fish and 1 serving a week for others. The advice to eat 2 to 3 
servings of a variety of fish a week is consistent with the 
recommendation in the 2015-2020 Dietary Guidelines for Americans that 
women who are pregnant or breastfeeding consume at least 8 and up to 12 
ounces of a variety of fish lower in mercury per week. Consuming 8 to12 
ounces of fish per week while pregnant or breastfeeding would be a 
significant dietary change for most women. In a survey of over 1,200 
pregnant women conducted by FDA in 2005, median fish consumption was 
1.8 ounces per week (Ref. 14).
    The approach in the revised fish advice differs from that taken in 
the draft updated fish advice not only in that it categorizes more than 
60 fish types, but also in its analytical basis. In categorizing the 
fish species for recommended consumption, the revised fish advice 
compares the reference dose (RfD) developed by EPA (Ref. 15) to the 
predicted exposure from the consumption of different fish species. 
Because the RfD is a rate of exposure that a person can experience over 
a lifetime without appreciable risk of harm and includes a 10-fold 
uncertainty factor to allow for variability among individuals and 
groups, this was a highly protective approach for determining which 
fish belong in each category. Specifically, the RfD for mercury is 
protective of neurodevelopmental effects from a critical window of 
development for a fetus during pregnancy. We believe the new approach 
is more protective of public health. This new approach is also 
consistent with a number of the comments received, and the external 
peer review conducted.

V. What did the peer reviewers say and how did FDA and EPA respond?

    Overall, the reviewers agreed upon the necessity of mercury fish 
advice for pregnant women, those trying to get pregnant, and children, 
to encourage fish consumption while helping to avoid mercury. The 
reviewers were generally supportive of the technical information and 
methodology used to support the scientific basis for the fish 
consumption recommendations. The reviewers made suggestions to improve 
clarity, transparency, and presentation, and to enhance the scientific 
underpinnings of the fish advice. The reviewers suggested supplementing 
FDA's data on mercury levels in seafood with other published sources to 
support the fish categorization for species with small sample sizes 
and/or large variability in mercury levels. The reviewers also provided 
various suggestions of where additional details could be added to aid 
the reader and support the conclusions. FDA and EPA implemented many of 
the reviewers' recommendations. A report of the FDA-EPA response to the 
peer review is available at http://www.fda.gov/fishadvice (and also on 
FDA's Completed Peer Reviews page at http://www.fda.gov/ScienceResearch/SpecialTopics/PeerReviewofScientificInformationandAssessments/ucm079120.htm) (Ref. 
4).

VI. How can I access the documents?

    The revised fish advice and supplemental questions and answers are 
available electronically at http://www.fda.gov/fishadvice and http://www.epa.gov/fishadvice.

VII. References

    The following references are on display in the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852 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 http://www.regulations.gov. 
FDA has verified the Web site addresses, as of the date this document 
publishes in the Federal Register, but Web sites are subject to change 
over time.

1. ``What You Need to Know About Mercury in Fish and Shellfish; 2004 
EPA and FDA Advice for: Women Who Might Become Pregnant, Women Who 
are Pregnant, Nursing Mothers, Young Children,'' available at http://www.fda.gov/food/foodborneillnesscontaminants/buystoreservesafefood/ucm110591.htm.
2. Summary Table of Responses to Public Comments on EPA's and FDA's 
Draft Updated Advice About Eating Fish (Docket No. FDA-2014-N-0595).
3. External Peer Review of FDA/EPA's ``Technical Information on the 
Development of Fish Consumption Advice,'' available at http://www.fda.gov/fishadvice and http://www.fda.gov/ScienceResearch/SpecialTopics/PeerReviewofScientificInformationandAssessments/ucm079120.htm.
4. FDA and EPA's Response to External Peer

[[Page 6574]]

Review on the FDA-EPA's Technical Information on the Development of 
Fish Consumption Advice, available at http://www.fda.gov/fishadvice 
and http://www.fda.gov/ScienceResearch/SpecialTopics/PeerReviewofScientificInformationandAssessments/ucm079120.htm.
5. Institute of Medicine, Committee on Nutrient Relationships in 
Seafood: ``Selections to Balance Benefits and Risks,'' (2007). 
Seafood Choices, Balancing Benefits and Risks. The National 
Academies Press, Washington, DC.
6. ``Mercury Levels in Commercial Fish and Shellfish 1990-2010,'' 
available at http://www.fda.gov/Food/FoodborneIllnessContaminants/Metals/ucm115644.htm.
7. Karimi, R., Fitzgerald, T.P., and Fisher, N.S. (2012). ``A 
Quantitative Synthesis of Mercury in Commercial Seafood and 
Implications for Exposure in the United States.'' Environ Health 
Perspect 120, 1512-1519, available at http://ehp.niehs.nih.gov/1205122/.
8. U.S. Environmental Protection Agency (U.S. EPA) 2003. Mercury in 
Marine Life Database. Office of Wetlands, Oceans and Watersheds, 
available at https://cfpub.epa.gov/si/si_public_record_Report.cfm?dirEntryId=58213.
9. U.S. Environmental Protection Agency. (U.S. EPA) (2016). National 
Coastal Assessment (NCA): Northeast 2000-2006 Summary Data, 
available at https://archive.epa.gov/emap/archive-emap/web/html/index-124.html.
10. U.S. Environmental Protection Agency (U.S. EPA). (2016). 
National Coastal Condition Assessment (NCCA) Office of Water & 
Office of Research Development, EPA 841-R-15-006, Washington, DC. 
2010 Results, available at https://www.epa.gov/national-aquatic-resource-surveys/national-coastal-condition-assessment-2010-results.
11. Health Canada, (2007) Human Health Risk Assessment of Mercury in 
Fish and Health Benefits of Fish Consumption, Bureau of Chemical 
Safety Food Directorate Health Products and Food Branch, Ottawa, 
Ontario, Canada.
12. Cladis, D.P., Kleiner, A.C., and Santerre, C.R. (2014). 
``Mercury Content in Commercially Available Finfish in the United 
States.'' J Food Prot 77, 1361-1366, available at http://www.ncbi.nlm.nih.gov/pubmed/25198598.
13. FDA-EPA Fish Advice: Technical Information, available at http://www.fda.gov/fishadvice.
14. Lando, A.M., S.B. Fein, and C.J. Choini[egrave]re, ``Awareness 
of Methylmercury in Fish and Fish Consumption Among Pregnant and 
Postpartum and Women of Childbearing Age in the United States,'' 
Environmental Research, vol. 116, pp. 85-92, 2012.
15. U.S. Environmental Protection Agency's Integrated Risk 
Information System (IRIS), available at http://www.epa.gov/iris/subst/0073.htm.

    Dated: January 11, 2017.
Jeremy Sharp,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-01073 Filed 1-18-17; 8:45 am]
BILLING CODE 4164-01-P