Docket
ID:
[Docket No. FDA-2009-N-0018]
Report of
Quantitative Risk and Benefit Assessment of Commercial Fish Consumption,
Focusing on Fetal Neurodevelopmental Effects (Measured by Verbal Development in
Children) and on Coronary Heart Disease and Stroke in the General Population,
and Summary of Published Research on the Beneficial Effects of Fish Consumption
and Omega-3 Fatty Acids for Certain Neurodevelopmental and Cardiovascular
Endpoints; Availability
The Food and
Drug Administration (FDA) is announcing the availability of two draft
documents. The first is entitled ``Report of Quantitative Risk and Benefit
Assessment of Commercial Fish Consumption, Focusing on Fetal Neurodevelopmental
Effects (Measured by Verbal Development in Children) and on Coronary Heart
Disease and Stroke in the General Population'' (draft risk and benefit
assessment report). The draft risk and benefit assessment report describes an
analysis done by FDA that results in quantitative estimates of the net effect
on fetal neurodevelopment in children of maternal consumption of commercial
fish, as measured by verbal development and the net effect of eating commercial
fish on coronary heart disease and stroke in the general population. Effects
with respect to each of these health endpoints has been associated in the
scientific literature with methylmercury exposure (which primarily occurs
through fish consumption) and with the consumption of fish and of omega3 fatty
acids, which are found in fish. The second draft document entitled ``Summary of
Published Research on the Beneficial Effects of Fish Consumption and Omega3
Fatty Acids for Certain Neurodevelopmental and Cardiovascular Endpoints''
(draft summary of published research) is a compendium of research prepared by
FDA for use in developing its quantitative risk and benefit assessment. When
peer and public review are complete, the draft risk and benefit assessment
report and the draft summary of published research are intended to add to the
growing body of scientific literature investigating the
[[Page 3616]]
likelihood, magnitude, and direction of health impacts linked to consumption of
commercial fish. FDA is seeking public comment on the draft risk and benefit
assessment report and the draft summary of published research.
Report of
Quantitative Risk and Benefit Assessment of Commercial Fish Consumption, etc.;
Availability
I.
Background
Fish
provides protein, is low in saturated fat, and is rich in many micronutrients;
it also can be a source of certain omega3 fatty acids. As the Institute of
Medicine of the National Academies of Science (IOM) noted in a recent report,
``[i]n the past several years, research has implicated seafood, particularly
its contribution of EPA and DHA [two omega3 fatty acids], in various health
benefits identified for the developing fetus and infants, and also for adults,
including those at risk for cardiovascular disease.'' (Institute of Medicine,
Committee on Nutrient Relationships in Seafood: Selections to Balance Benefits
and Risks. Seafood Choices: Balancing Benefits and Risk. 2006, National Academy
of Sciences, at 1). However, as a result of natural processes and human
activity, aquatic food sources, including fish, can contain methylmercury,
which has been linked to adverse health consequences. Because of the presence
of methylmercury in fish, FDA and the U.S. Environmental Protection Agency
(EPA) issued an advisory to consumers, ``What You Need to Know About Mercury in
Fish and Shellfish'' (http://
www.cfsan.fda.gov/~dms/admehg3.html). The advisory, which was most recently
revised in 2004, recommends that women who may become pregnant, pregnant women,
nursing mothers, and young children avoid some types of fish and eat fish and
shellfish that are lower in methylmercury, as specified in more detail in the
advisory.
Researchers
in the United States and elsewhere have attempted in recent years to develop
approaches to better evaluate the net health impacts of fish consumption; in
other words, to understand the relationship between the risk of not eating fish
(and thus losing any health benefits fish may provide) and the risk of eating
fish that contains methylmercury at the levels currently found in the
commercial fish available to consumers. As the IOM noted in its 2006 report,
``A better way is needed to characterize the risks combined with the benefits
analysis.'' (IOM 2006 at 6). The draft summary of published research and the
draft risk and benefit assessment report were developed by FDA to provide
further scientific information to help address this question for consumers of
commercial seafood in the United States (i.e., fish shipped or sold interstate,
as opposed to fish caught recreationally or for subsistence).
The draft
risk and benefit assessment report reflects an effort by FDA to quantify the
impact of eating commercial fish on three human health endpoints: (1) Neurodevelopment,
as measured by verbal development in childhood as assessed by the effect of
prenatal exposure to methylmercury as passed from the mother to the developing
fetus; (2) risk of fatal coronary heart disease; and (3) risk of fatal stroke.
Each of these health endpoints has been associated in the scientific literature
both with adverse effects of methylmercury exposure (including through fish
consumption) and beneficial effects of regular fish consumption. The draft risk
and benefit assessment report provides further scientific information about the
likelihood and magnitude of either beneficial or adverse net effects on health
at current levels of commercial fish consumption and exposure to methylmercury
through fish consumption in the United States. The draft risk and benefit
assessment report should not be construed as altering the existing fish
advisory. Moreover, because this assessment does not distinguish among types of
fish in terms of their beneficial constituents, it is not possible to translate
the results of this analysis into fishspecific advice to consumers about
maximizing benefits.
The
methodology used for the quantitative risk and benefit assessment is novel for
FDA in that, rather than attempting to quantify the risk resulting from the presence
of a particular hazard in a food, it estimates that risk and the benefit from
consumption of the food in the same quantitative analysis. For fetal
neurodevelopment, the assessment estimates this net effect by separately
estimating: (1) The likelihood and size of an adverse contribution from
methylmercury to the net effect; (2) the likelihood and size of a beneficial
contribution to the net effect from fish; and (3) the likelihood, size, and
direction of the net effect. For the methylmercury contribution, the assessment
uses data to derive modeling estimates of the association between methylmercury
and early age verbal skills (as an indicator of neurodevelopment) and then
compares the results against results developed elsewhere on methylmercury's effect
on other aspects of neurodevelopment, including intelligence quotient (IQ). For
the fish contribution, the assessment uses data to derive modeling estimates of
the association between fish consumption during pregnancy and early age verbal
skills. For the net effect, the assessment combines the results from the
methylmercury and fish contributions. This draft risk and benefit assessment
report builds on published work performed previously by FDA scientists on the
estimation of a methylmercury effect, as well as recent articles by other
investigators that have quantitatively assessed this effect. For fatal coronary
heart disease and stroke, the assessment estimates the net effect on risk from
fish consumption without separately modeling a methylmercury contribution and a
fish contribution. Most data on this subject come from studies that measured an
association between fish consumption and these health endpoints without
measuring a methylmercury contribution. The modeling builds in part on
doseresponse functions for these endpoints that have been published in the
scientific literature.
The draft
risk and benefit assessment report identifies and discusses assumptions made
for the scientific models and analyses and sources of uncertainty with respect
to each endpoint analyzed. Subject to the limitations and assumptions set forth
in the analysis, the risk and benefit assessment estimated the net impact of
consumption of different amounts of fish. For example, with respect to fetal
neurodevelopment, we modeled various ``what if'' scenarios, in which we
estimated what would happen if women of childbearing age ate more or less fish,
or if the amount of methylmercury in the fish they ate were reduced.
The results
indicate that consumption of fish species that are low in methylmercury has a
significantly greater probability of resulting in a net benefit, as measured by
verbal development. The highest net benefit
[[Page 3617]]
modeled in our risk and benefit analysis was modest. When we modeled actual
baseline consumption for the range of methylmercury concentrations (low to
high) the assessment indicated a significant probability of a net adverse
effect for 1/10 of 1 percent of children for the central estimate. The highest
estimated net adverse effect was also quite modest. For fatal coronary heart
disease and stroke, commercial fish baseline consumption is averting a central
estimate of over 30,000 deaths per year from coronary heart disease and over
20,000 deaths per year from stroke. The results of our quantitative risk and
benefit assessment are generally consistent with research reported in recent
years in the scientific literature.
The draft
summary of published research identifies primarily secondary analyses of the
large body of scientific research on the impact of fish and omega3 fatty acids
on cardiovascular and neurologic endpoints, including research on both prenatal
and postnatal exposures. In addition to the IOM report, these secondary
analyses include reports by the American Heart Association, the European Food
Safety Authority, the International Society for the Study of Fatty Acids and
Lipids, the World Health Organization and a previous investigation by FDA. This
compendium of research was developed by FDA for use in developing its
quantitative risk benefit assessment and provides background for that document.
The draft summary of published research identifies and delineates the lines of
scientific evidence that indicate the association of fish and omega3 fatty acid
consumption with cardiovascular and neurodevelopmental health outcomes. When
available, the compendium of research also identifies reports of quantitative
doseresponse relationships which may be relevant for risk and benefit
assessment modeling. The draft summary of published research describes the
context of the overall body of scientific evidence currently available for
potential application to the risk and benefit assessment modeling and the draft
risk and benefit assessment report.
The agency
designated the draft risk and benefit assessment report and the draft summary
of published research as a ``highly influential scientific assessment'' under
the Office of Management and Budget's (OMB) Final Information Quality Bulletin
for Peer Review (the Bulletin) (70 FR 2664, January 14, 2005). In August 2008,
FDA submitted a draft of the risk and benefit assessment report (which at the
time also incorporated the draft summary of published research) to seven
scientific experts outside the Federal Government, from a range of scientific
disciplines, for purposes of obtaining each expert's independent, written peer
review. The draft risk and benefit assessment report and the draft summary of
published research that are being made available for public comment reflect
revisions made to date in response to the peer reviewers' comments and
suggestions. The Information Quality Act Bulletin for Peer Review requires FDA
to post at its Web site a report of the peer review that: (1) Contains the
names and credentials of the peer reviewers; (2) sets forth the ``charge,''
i.e., the scientific questions asked of the reviewers; (3) provides the
verbatim comments submitted by each reviewer (without attribution); and (4)
discusses what FDA has done to the documents in response to the peer reviewers'
comments. We have posted at our Web site an interim draft of this report that
provides this information at http://
www.cfsan.fda.gov/~dms/mehg109.html, although we expect and plan to
finalize this report after revising our draft risk and benefit assessment
report and the draft summary of published research, in response to further
expert and peer review comments.
Separately,
FDA solicited and received comments from scientists at other Federal agencies,
including EPA, the National Institutes of Health, the Centers for Disease
Control and Prevention, and the National Oceanic and Atmospheric Administration
during a review coordinated by OMB. The draft risk and benefit assessment report
and the draft summary of published research being made available for comment
have been revised to reflect revisions made in response to the interagency
reviewers' comments.
At the same
time we are making these draft documents available for public comment, we plan
to provide a revised draft to the original peer reviewers to enable them to
submit any further comments. We will revise the draft risk and benefit
assessment report and the draft summary of published research as necessary
after considering the public comments and any additional comments from the
independent peer reviewers. We also plan to provide the revised version of the
documents, a summary of the public comments that address significant scientific
issues, and the external peer review report to an FDA scientific advisory
committee.
After public
and advisory committee review of these documents are complete, appropriate risk
management actions will then be considered on the basis of currently available
scientific information. The release of these documents for public comment and
peer review do not in any way modify the recommendations set forth in the 2004
advisory on fish consumption.
Interested
persons may submit to the Division of Dockets Management (see ADDRESSES)
written or electronic comments regarding this document. Submit a single copy of
electronic comments or two paper copies of any mailed comments, except that
individuals may submit one paper copy. Comments are to be identified 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.
The draft
documents described in this notice are available electronically at http://cfsan.fda.gov/~dms/mehg109.html.
IV. Access to Related Documents
All
references listed in the reports are available in FDA's Division of Dockets
Management (see ADDRESSES). Computer programs used in the risk and benefit
assessment modeling are available from Clark Carrington, Center for Food Safety
and Applied Nutrition (HFS301), Food and Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 207403835, 3014361947, email: Clark.Carrington@fda.hhs.gov.
Dated:
January 14, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E91081 Filed 11509; 11:15 am]
BILLING CODE 416001S
Philip
Spiller, Center for Food Safety and Applied Nutrition (HFS002), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 207403835,
3014361428, FAX 3014362668, email: Philip.Spiller@fda.hhs.gov.
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