[Federal Register Volume 79, Number 112 (Wednesday, June 11, 2014)]
[Notices]
[Pages 33559-33562]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-13584]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Environmental Protection Agency and Food and Drug Administration 
Advice About Eating Fish: Availability of Draft Update

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of docket; request for comments.

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SUMMARY: In March 2004, the Food and Drug Administration (FDA) and the 
U.S. Environmental Protection Agency (EPA) (the Agencies) jointly 
released a document entitled ``What You Need to Know About Mercury in 
Fish and Shellfish'' (the 2004 advice). FDA and EPA are now announcing 
a draft update that contains both advice and supplemental questions and 
answers for those who want to understand the advice in greater detail. 
FDA and EPA are establishing a public docket and seeking public comment 
on both the substance of the advice and how best to frame the advice 
for consumers so that it is both understandable and influential. In 
addition to inviting public comments, the Agencies intend to seek the 
input of the FDA Advisory Committee on Risk Communication in a meeting 
open to the public. The Agencies may also hold public meetings in 
various locations around the country. Information about any such 
meetings will be published in the Federal Register once dates and 
locations are confirmed.

DATES: The comment period will be open until 30 days after the last 
transcript from the advisory committee meeting and the other meetings 
mentioned previously becomes available. The date for closure of public 
comment will be published in a future notice in the Federal Register.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. FDA will share with EPA all comments submitted to 
the FDA docket.

FOR FURTHER INFORMATION CONTACT: FDA: Philip Spiller, Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740-3835,

[[Page 33560]]

240-402-1428, email: [email protected]; EPA: Jeffrey Bigler, 
MS-4305T, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave. 
NW., Washington, DC 20460, 202-566-0389, email: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Fish and shellfish (referred to collectively in this notice as 
``fish'') provide protein, are low in saturated fat, and are rich in 
many micronutrients; they also provide certain omega-3 fatty acids 
(Ref. 1). 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.
    FDA issued fish consumption advice relating to mercury in 1994, 
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. In March 2004, 
FDA and EPA jointly issued a document entitled ``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'' (Ref. 2). 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 recommends avoiding four types of commercially available fish 
that have the highest average mercury concentrations: Tilefish, shark, 
swordfish, and king mackerel. The advice further recommends 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 recommends 
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 recommends 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.
    The 2004 advice is no longer entirely consistent with the most 
current U.S. Dietary Guidelines for Americans (DGAs), which are issued 
jointly every 5 years by HHS and USDA. HHS and USDA recommend in the 
Dietary Guidelines for Americans 2010 that ``women who are pregnant or 
breastfeeding consume at least 8 and up to 12 ounces per week of a 
variety of seafood per week, from choices lower in methyl mercury'' 
taking into account evidence relating fish consumption to improved 
infant health and developmental outcomes \1\ (Refs. 3 and 4). While the 
2004 advice encourages fish consumption as part of a healthy diet, it 
does not encourage consumption of any particular amount of fish in 
order to improve health and developmental outcomes. As an additional 
matter, quantitative assessments recently performed have produced 
results that support the quantitative recommendations in the 2010 DGAs. 
These assessments estimate risks and benefits to neurodevelopment from 
fish consumption during pregnancy. They estimate ``net effects'' from 
eating fish during pregnancy by estimating both adverse effects from 
mercury and beneficial effects from nutrients in fish. These 
assessments include a 2011 report by the Food and Agriculture 
Organization of the United Nations (FAO) and the World Health 
Organization (WHO) entitled ``Report of the Joint FAO/WHO Expert 
Consultation on the Risks and Benefits of Fish Consumption'' (Ref. 5) 
and a 2014 assessment conducted by FDA entitled, ``A Quantitative 
Assessment of the Net Effects on Fetal Neurodevelopment from Eating 
Commercial Fish (As Measured by IQ and also by Early Age Verbal 
Development in Children)'' (Ref. 6). The FDA assessment was first 
published in draft in 2009 and then recently revised to incorporate 
comments and advice from peer reviewers, the public, and other Federal 
Agencies, including recent comments from EPA. In addition, since 2004 
there have been other publications in the peer reviewed scientific 
literature evaluating the benefits of fish consumption versus risks of 
mercury exposure (Refs. 7 and 8).
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    \1\ A review of the evidence taken into account in the 
development of the fish consumption recommendation in the Dietary 
Guidelines for Americans 2010 can be found on pages 239-241 in the 
``Report of the Dietary Guidelines Advisory Committee on the Dietary 
Guidelines for Americans,'' 2010, at http://www.cnpp.usda.gov/DGAs2010-DGACReport.htm.
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II. What is being proposed in the draft updated advice?

    FDA and EPA are now proposing to update their 2004 advice to make 
it consistent with the recommendations in the Dietary Guidelines for 
Americans 2010. It is important that advice on fish consumption be 
harmonized across Federal Agencies. Inconsistent advice can cause 
confusion and undermine the public health objectives that the advice is 
intended to accomplish. The Agencies are also proposing 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. 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. 9).
    Consistent with the Dietary Guidelines for Americans 2010, the 
draft updated advice would:
     Recommend that pregnant women, women who might become 
pregnant, and breastfeeding mothers eat at least 8 and up to 12 ounces 
per week of a variety of fish lower in mercury within their calorie 
needs. The draft updated advice also describes this amount as 2 or 3 
servings per week. The 2004 advice translated 12 ounces into 2 servings 
based on an assumption that a single serving is likely to be around 6 
ounces; however, there is variability surrounding serving sizes and 
single servings can often be somewhat smaller than 6 ounces (Refs. 10, 
11, and 12). The proposed consumption target of 8 to 12 ounces per week 
of fish lower in mercury is designed to maximize the potential health 
and developmental benefits that fish could provide. The recommendation 
to stay within calorie needs is aimed at insuring that women who eat 
more fish in order to achieve 8 to 12 ounces of fish per week do not 
inadvertently exceed the number of calories that are appropriate for 
them when they do so.
     Continue to recommend that the target audience avoid 
certain fish with the highest mercury concentrations; those fish are 
tilefish, shark, swordfish, and king mackerel. It would recommend 
avoidance of tilefish only from the Gulf of Mexico, however. Data on 
tilefish from the Atlantic Ocean indicate that these fish have much 
lower levels of mercury on average (Ref. 13).
     Advise members of the target audience that they may eat 
tuna but continue to recommend limiting white (albacore) tuna to 6 
ounces per week.
     Retain the recommendations included in the 2004 advice for 
fish caught in local streams, rivers, and lakes. There are local waters 
where there may have been little or no monitoring and, therefore, the 
extent of potential mercury contamination is unknown. Fish in local 
waters can contain higher levels of mercury than commercially available 
species. Local freshwater fish may also differ in their nutritional 
composition.

[[Page 33561]]

     Continue to extend the recommendations in the 2004 advice 
to young children because their nervous systems are still developing. 
The Dietary Guidelines for Americans 2010 do not provide specific 
feeding recommendations for infants and young children under the age of 
2 years, but they do note that the nutritional value of fish is of 
particular importance in early infancy from maternal consumption and in 
childhood (Ref. 3). The draft updated advice would continue to 
recommend that the portions for children be smaller than those for 
adult women and the accompanying questions and answers (Q & A) would 
provide advice on specific consumption amounts for fish in general and 
for albacore tuna.
     Note that fish provides health benefits for the general 
public. This information is intended for the general public, not just 
for the target audience. The Dietary Guidelines for Americans 2010 
recommend that the general public increase the amount and variety of 
fish consumed.

III. What else are FDA and EPA seeking comment on?

    In addition to requesting comments on the substance of the draft 
updated advice, FDA and EPA are seeking public comment on alternative 
risk communication approaches for conveying the message and its 
supplemental Q & A. The Agencies recognize that how the message is 
conveyed can be highly important to its success. The approach in this 
draft update seeks to balance simplicity of message with specificity of 
information. FDA and EPA believe that public input is required to 
assist in achieving this balance. FDA and EPA anticipate the public 
process will address how best to provide accurate, balanced 
descriptions of the purpose for the updated advice and the potential 
benefits and risks of fish consumption.
    FDA and EPA further anticipate that the public process will address 
whether the questions in the draft supplemental Q & A are appropriate 
and represent those most likely to be asked by consumers, and whether 
the answers are accurate and sufficiently informative to encourage more 
consumption of fish and to guide consumers to fish lower in mercury.
    On a specific matter, the Agencies are interested in public comment 
on whether to add two additional fish to the list of fish that members 
of the target audience should not eat. Because the draft updated advice 
tracks the Dietary Guidelines for Americans 2010, the draft updated 
advice recommends essentially \2\ the same fish to avoid as is 
recommended in the DGAs. They are: (1) Tilefish from the Gulf of Mexico 
(average of 1.45 parts per million (ppm) of mercury); (2) swordfish 
(average of 1.00 ppm of mercury); (3) shark (average of 0.98 ppm of 
mercury); and (4) king mackerel (average of 0.73 ppm of mercury). The 
average mercury concentrations in these fish are notably higher than 
the concentrations in all other commercial species. FDA and EPA are 
seeking comment on whether to add orange roughy and marlin to the list 
of fish to avoid. While orange roughy and marlin are lower in mercury 
than the four fish listed previously (orange roughy averages 0.57 ppm 
mercury, which equals 80 micrograms/4 ounce (oz.) of cooked fish, and 
marlin averages 0.49 ppm mercury, which equals 69 micrograms/4 oz. of 
cooked fish), their mercury concentrations are higher than nearly all 
other commercial fish. Moreover, both orange roughy and marlin can be 
unusually low in omega-3 fatty acids. Omega-3 fatty acids may 
contribute to the healthful effects from fish, although the supporting 
science is not settled on this point. For those reasons, we 
particularly invite comment on whether it would be prudent for pregnant 
women or those who might become pregnant, breastfeeding women, and 
young children, to avoid orange roughy and marlin in addition to the 
four other fish to avoid.
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    \2\ As stated previously, our recommendation for tilefish now 
relates only to tilefish from the Gulf of Mexico and not to Atlantic 
tilefish.
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    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. FDA and EPA used data developed by the USDA to 
estimate the amounts of the omega-3 fatty acids eicosapentaenoic acid 
and docosahexanoic acid in fish.
    Additionally, the Agencies invite comment on the following:
    (1) Whether the final updated advice should track the Dietary 
Guidelines for Americans 2010 more or less closely than the draft of 
that updated advice now does.
    (2) Any new science that has become available since the Dietary 
Guidelines for Americans 2010 were issued that would be relevant to the 
updated advice.
    (3) Information upon which to base advice on young children's fish 
consumption. There have been a number of studies that have examined the 
effects of both postnatal exposure to mercury as well as postnatal fish 
consumption by young children, but this research has not been as 
extensive as the research on prenatal exposures and maternal fish 
consumption.
    (4) As stated previously, suggestions for improving the clarity and 
utility of the advice.
    (5) How to integrate advice from local advisories for those who 
consume fish from local streams, rivers, and lakes.

IV. How To Submit Comments

    Interested persons may submit either electronic comments regarding 
the draft documents to http://www.regulations.gov or written comments 
regarding the draft documents to the Division of Dockets Management 
(see ADDRESSES). It is only necessary to send one set of comments. 
Identify comments with the docket number found in brackets in the 
heading of this document. Received comments may be seen in the Division 
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, 
and will be posted to the docket at http://www.regulations.gov.

V. How To Access the Draft Documents

    The draft documents described in this notice are available 
electronically at http://www.fda.gov/Food/FoodborneIllnessContaminants/Metals/ucm393070.htm and at http://water.epa.gov/scitech/swguidance/fishshellfish/fishadvisories/index.cfm.

VI. References

    FDA has placed the following references on display in FDA's 
Division of Dockets Management (see ADDRESSES). You may see them 
between 9 a.m. and 4 p.m., Monday through Friday, and online at http://www.regulations.gov. (FDA has verified all the Web site addresses in 
this reference section, but FDA is not responsible for any subsequent 
changes to Web sites after this document publishes in the Federal 
Register.)

1. 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.
2. ``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.
3. U.S. Departments of Agriculture and Health and Human Services, 
(2010). Dietary Guidelines for Americans 2010, chapter 4, ``Foods 
and Nutrients to Increase,'' available at

[[Page 33562]]

http://health.gov/dietaryguidelines/2010.asp.
4. ``Report of the Dietary Guidelines Advisory Committee on the 
Dietary Guidelines for Americans,'' 2010 to the Secretary of 
Agriculture and the Secretary of Health and Human Services, 
available at http://www.cnpp.usda.gov/DGAs2010-DGACReport.htm.
5. FAO/WHO, (2011). ``Report of the Joint FAO/WHO Expert 
Consultation on the Risks and Benefits of Fish Consumption,'' Rome, 
25-29 January 2010. FAO Fisheries and Aquaculture Report No. 978 
FIPM/R978(En).
6. ``A Quantitative Assessment of the Net Effects on Fetal 
Neurodevelopment From Eating Commercial Fish (As Measured by IQ and 
also by Early Age Verbal Development in Children).'' Available at: 
http://www.fda.gov/Food/FoodborneIllnessContaminants/Metals/ucm393211.htm.
7. Cohen, J.T., DC Bellinger, W.E. Connor, et al., (November 2005). 
``A Quantitative Risk-Benefit Analysis of Changes in Population Fish 
Consumption,'' American Journal of Preventive Medicine, vol. 29(4), 
pp. 325-334.
8. Ginsberg, C.L. and B.F. Toal, (2009). Quantitative Approach for 
Incorporating Methylmercury Risks and Omega-3 Fatty Acid Benefits in 
Developing Species-Specific Fish Consumption Advice. Environmental 
Health Perspectives, vol. 117(2), pp. 267-275.
9. Lando, A.M., S.B. Fein, and C.J. Choini[egrave]re, (2012). 
``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.
10. Daniels, J.L., M.P. Longnecker, A.S. Rowland, J. Golding, and 
the ALSPAC Study Team University of Bristol Institute of Child 
Health, (July 2004). ``Fish Intake During Pregnancy and Early 
Cognitive Development of Offspring,'' Epidemiology, vol. 15(4), pp. 
394-402.
11. FAO/WHO, (2011). ``Report of the Joint FAO/WHO Expert 
Consultation on the Risks and Benefits of Fish Consumption,'' Rome, 
January 25-29, 2010. FAO Fisheries and Aquaculture Report No. 978 
FIPM/R978(En) (see page 26).
12. Institute of Medicine, Committee on Nutrient Relationships in 
Seafood: ``Selections to Balance Benefits and Risks,'' (2006). 
Seafood Choices, Balancing Benefits and Risks. The National 
Academies Press, Washington, DC. (see page 240).
13. ``Mercury Levels in Commercial Fish and Shellfish 1990-2010,'' 
available at: http://www.fda.gov/Food/FoodborneIllnessContaminants/Metals/ucm115644.htm.

    Dated: June 6, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13584 Filed 6-10-14; 8:45 am]
BILLING CODE 4160-01-P