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U.S. ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF INSPECTOR GENERAL
Water Quality
EPA Needs to Provide
Leadership and Better
Guidance to Improve
Fish Advisory Risk
Communications
Report No. 17-P-0174 April 12, 2017
attention
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Report Contributors: Kathlene Butler
Julie Hamann
Johnny Ross
Gerry Snyder
Abbreviations
AWQC
Ambient Water Quality Criterion
CFR
Code of Federal Regulations
CWA
Clean Water Act
EPA
U.S. Environmental Protection Agency
FDA
U.S. Food and Drug Administration
IRIS
Integrated Risk Information System
OIG
Office of Inspector General
ppm
parts per million
RfD
Oral Reference Dose
WQC
Water Quality Criteria
WQS
Water Quality Standards
Cover photo: Fish advisory sign. (EPA photo)
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U.S. Environmental Protection Agency 17.P.0174
\ Office of Inspector General April 12,2017
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At a Glance
Why We Did This Review
The U.S. Environmental
Protection Agency (EPA),
Office of Inspector General
(OIG), conducted this review to
evaluate the extent the EPA
ensures that federal, state and
tribal risk communication efforts
protect the public from mercury
contamination through the
consumption offish. We
focused our evaluation on
determining how effectively fish
consumption advisory
information reached consumers
so that they could make healthy
consumption choices.
Research shows that
consuming fish contaminated
by mercury can lead to
negative health impacts in
humans. The Clean Water Act
(CWA) establishes a goal of
"water quality which provides
for the protection and
propagation offish, shellfish
and wildlife." The EPA
interprets this CWA goal as
supporting water quality that
provides for the protection of
human health related to the
consumption offish.
This report addresses the
following EPA goal or
cross-agency strategy:
• Protecting America's
waters.
Send all inquiries to our public
affairs office at (202) 566-2391
or visit www.epa.gov/oig.
Listing of OIG reports.
EPA Needs to Provide Leadership and Better
Guidance to Improve Fish Advisory
Risk Communications
Without EPA guidance and
assistance, subsistence fishers,
including tribes, will continue to
consume unhealthy amounts of
contaminated fish.
What We Found
Some subsistence fishers, tribes, sport
fishers and other groups consume large
amounts of contaminated fish without
health warnings. Although most states
and some tribes have fish advisories in
place, this information is often confusing,
complex and does not effectively reach those segments of the population.
Fish advisories differ from state to state, between states and tribes, and
across state and tribal borders, which in some cases leads to multiple
advisories with conflicting advice for a single waterbody. In addition,
although the EPA's risk communication guidance recommends evaluations
offish advisories, we found that less than half of states, and no tribes, have
evaluated the effectiveness of their fish advisories. Under the CWA, the EPA
can take a stronger leadership role in working with states and tribes to
ensure that effective fish advisory information reaches all such segments of
the population.
We also found that the EPA has not assessed methylmercury as proposed in
the agency's published Integrated Risk Information System (IRIS) agendas.
The EPA included methylmercury on its 2012 IRIS agenda for assessment,
and on its 2015 IRIS agenda as a priority for assessment. However, to date,
the agency has not commenced the assessment. Currently, the EPA's 2001
reference dose for methylmercury is an agency-supported value that the
EPA continues to accept for decision-making. Because of its importance in
developing water quality standards, and ultimately fish advisories, the RfD
should be accurate to ensure that effective fish advisory information is
communicated.
Recommendations and Planned Agency Corrective Actions
We recommend that the EPA's Office of Water provide updated fish advisory
guidance to states and tribes, work with states and tribes to develop best
practices to evaluate the effectiveness offish advisories, and develop and
implement methods to ensure tribal members receive current fish advisory
information. We recommend that the EPA's Office of Research and Development
conduct an assessment for methylmercury to determine whether the reference
dose requires updating as proposed in the 2012 and 2015 IRIS agendas. After
receiving responses to our draft report from the two EPA offices, we met to
discuss their comments and our recommendations. Based on the follow-up
discussion and supplemental information provided by both offices, we found that
their corrective actions and milestone dates meet the intent of our
recommendations (Appendix C). All recommendations are resolved.
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| 5 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
| VMfJ % WASHINGTON, D.C. 20460
PRO**4,
THE INSPECTOR GENERAL
April 12, 2017
MEMORANDUM
SUBJECT: EPA Needs to Provide Leadership and Better Guidance to Improve
Fish Advisory Risk Communications
Report No. 17-P-01
FROM: Arthur A. Elkins Jr.
TO: Michael H. Shapiro, Acting Assistant Administrator
Office of Water
Robert Kavlock, Acting Assistant Administrator
Office of Research and Development
This report on the evaluation of existing public protections for mercury contamination in fish was
conducted by the Office of Inspector General (OIG) of the U.S. Environmental Protection Agency
(EPA). The project number for this evaluation was OPE-FY15-0061. This report contains findings that
describe the problems the OIG has identified and corrective actions the OIG recommends. This report
represents the opinion of the OIG and does not necessarily represent the final EPA position. Final
determinations on matters in this report will be made by EPA managers in accordance with established
audit resolution procedures.
Action Required
You are not required to provide a written response to this final report because you provided agreed-to
corrective actions and planned completion dates for the report's recommendations. Should you choose to
provide a final response, we will post your response on the OIG's public website, along with our
memorandum commenting on your response. Your response should be provided as an Adobe PDF file
that complies with the accessibility requirements of Section 508 of the Rehabilitation Act of 1973, as
amended. The final response should not contain data that you do not want to be released to the public;
if your response contains such data, you should identify the data for redaction or removal along with
corresponding justification.
We will post this report to our website at www.epa.gov/oig.
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EPA Needs to Provide Leadership and 17-P-0174
Better Guidance to Improve Fish Advisory
Risk Communications
Table of C
Introduction 1
Why We Did This Review 1
Background 1
Responsible Offices 6
Noteworthy Achievements 6
Scope and Methodology 7
Results 8
Advisory Information Does Not Reach Many Subsistence Fishers 8
Advisories Provide Conflicting, Confusing and Complex Advice 10
Minimal Information on Advisory Effectiveness 14
Ensuring That Consumption Advice Uses Up-to-Date Science 15
Conclusion 16
Recommendations 17
Agency Response and OIG Evaluation 17
Status of Recommendations and Potential Monetary Benefits 18
Appendices
A Mercury Fish Advisory for Bad River Band of Lake Superior
Chippewa Tribe 19
B Literature Review of Methylmercury Epidemiological Studies 21
C Agency Response to Draft Report 23
D Distribution 38
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Introduction
Why We Did This Review
The Office of Inspector General (OIG) for the U.S. Environmental Protection
Agency (EPA) conducted this evaluation to determine the extent the EPA ensures
that federal, state and tribal risk communication efforts protect the public from
mercury contamination through the consumption of fish.
Background
About 80 percent of all fish advisories in the United States focus on mercury
contamination. Mercury cycles in the environment as a result of natural and
human activities like coal burning and other industrial and manufacturing
processes. Most released mercury circulates in the atmosphere and travels
thousands of miles from sources of emission. As it cycles between the
atmosphere, land and water, mercury transforms into methylmercury and enters
the aquatic food web through microscopic plants and animals (Figure 1). This
allows methylmercury to accumulate in the food web, becoming most
Figure 1: How mercury cycles through the ecosystem
WATER
SEDIMENT I
Fossil fuel burning
&
waste incinerators
Inorganic
mercury
» Elemental
mercury vapor
Inorganic ^. Organic
mercury —~mercury
| ftncJo'tf A .
fSvftws oui,i
Natural sources
¦ Elemental Inorganic + Organic
mercury mercury t mercury
Q9C\0JiS
Source: Utah Department of Environmental Quality.
I CM
17-P-0174
1
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concentrated in predatory fish (Figure 2). Predatory organisms at the top of the
food web (e.g., swordfish, king mackerel, or tuna) generally have higher
methylmercury concentrations.
Figure 2: Methylmercury bioaccumulation through the aquatic food web
Phytoplankton
(algae)
Predatory
fish
Zooplankton
and Shellfish
Increasing methylmercury concentration
¦>
Source: OIG modification of EPA figure.
Human Health Effects From Mercury
According to an EPA 2001 fact sheet, titled "Water Quality Criterion for the
Protection of Human Health: Methylmercury," humans are exposed to
methylmercury primarily through the consumption of contaminated fish.
Methylmercury causes a number of adverse health effects in humans and animals.
In pregnant women, methylmercury passes through the placenta to the fetus and
fetal brain. Research has shown that high-dose exposure to methylmercury in
humans results in mental retardation, cerebral palsy, deafness, blindness, and
dysarthria in utero; and in sensory and motor impairment in adults. Recent
research has uncovered cardiovascular and immunological effects providing more
evidence of toxicity from low-dose methylmercury exposure.
Eating fish from restaurants and grocery stores generally does not expose the
average consumer to harmful levels of methylmercury from fish. The most
frequently consumed commercial fish contain low levels of methylmercury.
However, some types of commercially sold fish contain high levels of mercury
and should be avoided by women of childbearing age and children. In addition,
wild-caught fish from lakes, rivers or other water bodies may contain high levels
of m ethylmercury, depending on the location, speci es and size of the fish. Further,
subsistence fishers who routinely consume wild-caught fish are exposed to higher
levels of methyl mercury because of their consumption habits. These fishers may
consume fish on a daily basis, not only for subsistence, but as a cultural way of
life. For example, Figure 3 shows that the Suquamish Tribe consumes more than
eight times more fish than the average population on a daily basis.
As a protective measure, federal agencies, states and tribes issue fish consumption
advisories that provide information on segments of the population most at risk;
what fish to avoid; what fish can be consumed; and the amount and frequency of
contaminated fish that should be eaten.
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Figure 3: Comparison of daily average U.S. fish consumption rates for
three Indian tribes in grams per day
grams/day
NationalAvg. Columbia River Tribe Squaxin Island Tribes Suquamish Tribes
Consumption (Adults)
Source: OIG-developed chart based on data from the U.S. Food and Drug Administration
and Polissar et al. (2012).
EPA's Role in Developing Fish Advisories
Fish consumption advisories are issued on a national level for commercially
marketed fish; and on a local level for fish caught directly from lakes, rivers and
other water bodies by individual fishers. The EPA does not have regulatory
responsibility for nationally issued fish advisories. This responsibility falls under
the purview of the U.S. Food and Drug Administration (FDA). The FDA does,
however, collaborate with the EPA when developing national fish advisories.
For locally issued advisories for lakes, rivers and other waterbodies, the EPA,
under the Clean Water Act (CWA), shares responsibility and works collectively
with states and tribes to establish water quality criteria and standards that lead to
fish advisories when warranted. The EPA is responsible for establishing water
quality criteria and contaminant toxicity values that states and tribes use to
develop fish advisories. The agency also provides national leadership to states and
tribes by issuing risk communication and fish advisory guidance. Under the
CWA, states and tribes also have certain responsibilities as shown in Figure 4.
Clean Water Act
The CWA defines EPA, state and tribe responsibilities in the development of
water quality criteria and water quality standards that lead to fish consumption
advisories. One goal of the CWA, as interpreted by the EPA, is "fishable,
swimmable" waters. The EPA interprets "fishable" uses to include, at a minimum,
designated uses providing for the protection of aquatic communities and human
health related to consumption of fish and shellfish.
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Figure 4: Clean Water Act requirements leading to fish
advisories
OR
EPA publishes fish
advisory guidance to
states and tribes.
CWA Section 303:
EPA must approve
WQS.
States and tribes
develop fish
advisories based
on WQC.
CWA Section 303:
EPA develops WQS
for states and tribes.
CWA Section 303:
States and tribes must
develop water quality
standards (WQS)
using EPA WQC or
their own.
CWA Section 304:
EPA must develop
water quality criteria
(WQC). EPA
"recommends" WQC
to states and tribes.
Source: OIG analysis of Clean Water Act sections.
CWA Section 304(a) requires the EPA to
develop water quality criteria (WQC) for
states and tribes to use to develop water
quality standards (WQS). EPA regulations
found in 40 CFR Part 131.11 (a) (1) provide
that WQC must be based on sound scientific
rationale and must contain sufficient
parameters or constituents to protect a
waterbody's designated use—such as
fishable.
CWA Section 303(c) directs states and tribes
to adopt WQS for their waters subject to
EPA approval. CWA Section 303(c)(2)(A),
and the EPA's implementing regulations at
40 CFR Part 131, require that state and tribe
WQS specify appropriate designated uses of
the waters (in this case fishable uses), and
that WQC protect those uses. Along with
other factors, the WQS dictate the need for,
and the content of, fish advisories that define
the amount and rate of consumption of fish
containing methylmercury.
The EPA published a national WQC for
methylmercury in 2001. This criterion
described the concentration of
methylmercury in freshwater and estuarine
fish and shellfish tissue that would protect
consumers of fish and shellfish among the
general population. Because of
methylmercury's unique bioaccumulation
process in fish tissue, this is the first time the
EPA established water quality criterion
based on a contaminant in fish tissue rather
than the amount of a contaminant in the
water column.
Once WQC and WQS are established, states and tribes may use these measures to
develop fish consumption advisories. The EPA does not develop and publish fish
advisories. Local fish advisories for lakes, rivers and other water bodies are
developed and published by states and tribes. However, the EPA does maintain a
searchable database of all fish advisories that the public can access through the
EPA's internet site.
17-P-0174
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EPA Responsibilities Under Federal Indian Policy
The U.S. recognizes tribes as sovereign nations. Tribal sovereignty is recognized
through the government-to-government relationship that tribes have with the
federal government. Like other treaty obligations of the U.S., Indian treaties are
considered to be the supreme law of the land, and they are the foundation upon
which the federal Indian trust relationship is based. The federal Indian trust
responsibility involves a legal obligation under which the U.S. has charged itself
with moral obligations of the highest responsibility and trust toward Indian tribes.
The trust responsibility establishes the federal government's legal fiduciary
obligations to tribes, including the protection of treaty-reserved fishing rights.
Although tribes are sovereign nations, the U.S. has a trust responsibility to protect
tribal resources and treaty right.
Based on the EPA's Federal Indian Policy published in November 1984, the EPA
must recognize tribal governments as sovereign entities with primary authority
and responsibility for the reservation populace; retain responsibility for managing
programs for reservations until tribal governments are willing and able to assume
full responsibility for delegable programs; and encourage communication and
cooperation among tribes, states and local governments.
Many tribes have members who are unique subsistence fishers. They consume
large amounts of contaminated fish. They also have treaty rights that give them
considerable latitude to fish on and off the reservation, and to take large amounts
of fish without restrictions. These fishing rights can be exercised irrespective of
state-owned/controiled land or state borders.
According to EPA's policy, some treaties explicitly name protected rights and
resources. For example, a treaty may reserve or protect the right to hunt, fish or
gather a particular animal or plant in specific areas. Similarly, the policy notes
that an explicit treaty right to hunt, fish or gather may include an implied right to
a certain level of environmental quality to maintain the activity or a guarantee of
access to the activity site.
EPA Supports States and Tribes That Develop Fish Advisories
The EPA assists states and tribes by issuing risk communication and fish advisory
guidance, and by providing leadership in meeting the challenges of fish
contamination. For example, the EPA developed guidance to assist states and
tribes with communicating fish consumption advisories in 1995. This fish
advisory guidance walks users through a five-part process to develop a robust
risk communication program: (1) problem analysis and developing objectives;
(2) audience identification and needs; (3) communication strategy design;
(4) communication strategy implementation; and (5) evaluation. The EPA also
supports state and tribal fish advisory efforts through the periodic National Forum
on Contaminants in Fish.
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Responsible Offices
The EPA's Office of Water, Office of Science and Technology, develops
guidance and conducts advisory and outreach programs designed to assist states
and tribes with fish advisory programs. The Office of International and Tribal
Affairs leads and coordinates agencywide efforts to strengthen public health and
environmental protection in Indian country, with a special emphasis on helping
tribes administer their own environmental programs. The EPA's Office of
Research and Development supports the agency's mission to protect human health
by identifying and characterizing the health hazards of chemicals found in the
environment through its Integrated Risk Information System.
Noteworthy Achievements
The EPA hosts the National Forum on Contaminants in Fish to present and
discuss the latest science and public health policies pertaining to the health risks
and benefits of fish consumption. The EPA has hosted the forum 12 times since
1990. Our review identified the forum as a beneficial gathering that enables state
and tribal representatives to learn about new science, exchange best practices, and
make contacts for the future. The EPA also maintains a series of web-based
advisory and technical resources to further support state and tribal risk
communication efforts. These resources include scientific data, a clearinghouse of
fish tissue data and fish consumption advisories from states, a list of contacts and
partners, and access to past forum proceedings.
Many stakeholders that we interviewed applauded the EPA for hosting the fish
forum and stated that they would like to see the EPA continue to host the forum in
the future. We found that the forum is effective for communicating the risk of
consuming fish contaminated by mercury, and (if possible) we suggest the EPA
continue to conduct the forum on a regular basis in the future.
Scope and Methodology
We conducted this performance audit in accordance with generally accepted
government auditing standards. Those standards require that we plan and perform
the evaluation to obtain sufficient, appropriate evidence to provide a reasonable
basis for our findings and conclusions based on our evaluation objectives. We
believe that the evidence obtained provides a reasonable basis for our findings and
conclusions based on our evaluation objective. We conducted this evaluation from
September 2015 to December 12, 2016.
Our evaluation focused on EPA activities that develop a protective WQC, and
support state and tribal fish advisories for methylmercury contaminated fish. We
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did not evaluate fish consumption advisories for chemicals other than mercury. To
answer our objective question, we conducted a literature review on issues relating
to the hazards of methylmercury, fish consumption rates, and the issuance and
efficacy of state and tribal fish advisories. Based on our literature review, we
focused on the authorities and/or activities used by the EPA, states and tribes to
implement and manage risk communication to the public. We focused on
locations throughout the country that had large or numerous waterbodies used for
subsistence, recreational or sport fishing. We also focused on subpopulations or
groups most vulnerable to methylmercury in fish because of their greater-than-
average fish consumption rates.
We interviewed staff from the EPA and five states regarding their risk
communication efforts to inform the public about the hazards of methylmercury,
fish consumption rates, and fish advisories. Staff we interviewed at EPA
headquarters were from the Office of Water, the Office of Research and
Development, and the Office of Tribal and International Affairs. Staff in EPA
Regions 4, 5 and 10 were interviewed as well. We also interviewed staff from
environmental protection and health departments in Florida, Wisconsin, Oregon,
Minnesota and Washington.
In addition, we interviewed members and representatives from the Miccosukee
Tribe of Indians, Seminole Tribe of Florida, Squaxin Island Tribe, Confederated
Tribes of the Grand Ronde Community of Oregon, and Eastern Band of Cherokee
Indians. Subject-matter experts from academia and other stakeholders, such as the
Great Lakes Indian Fish and Wildlife Commission, and the Columbia River Inter-
Tribal Fish Commission, were also interviewed.
The scope of our work did not include an evaluation of the national fish advisory
because it falls under the purview of the FDA, not the EPA. We also did not
evaluate the consumption of fish-eating mammals.
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Results
Fish advisory information does not effectively reach many subsistence fishers,
including tribes and other groups that consume large amounts of wild-caught fish
on a regular basis. Risk communication efforts are ineffective in many instances
because fish advisory information is conflicting, confusing, too complex and often
not followed. In addition, individual states publish different advisory information
for the same waterbody, and state fish advisory information does not regularly
reach tribes that routinely fish state waters. Consequently, subsistence fishers
consume large amounts of contaminated fish without adequate health warnings.
Further, the EPA, states and tribes may not be aware of the effectiveness of
existing fish advisories, since less than half of states and no tribes have adequately
evaluated the effectiveness of fish advisories as outlined in the EPA's 1995 risk
communication guidance.
The EPA's 2001 oral reference dose (RfD) for methylmercury has not been
assessed as proposed in its published agendas. Based on its Integrated Risk
Information System, the EPA included methylmercury on its 2012 agenda for
assessment, and on its 2015 agenda as a priority for assessment. However, to date,
the agency has not started the assessment. The RfD must be accurate and based on
the best available science to support development of protective fish advisories.
Without effectively developed and communicated fish advisories, consumers may
be exposed to unsafe levels of methylmercury through the consumption of fish.
Advisory Information Does Not Reach Many Subsistence Fishers
Fish advisory information does not reach some groups, such as subsistence fishers
(including tribes), sport fishers, and others that consume higher amounts of fish
than the average population. For example, the San
Francisco Department of Health Services surveyed
subsistence fishers in the Bay area and found that
90 percent of the people i nterviewed ate what they
caught, but 42 percent did not have knowledge of active
fish advisories for those waters, even though many had
fished the same waters for more than 10 years.
Local fisherman at a Florida canal. (EPA OIG photo)
17-P-0174
Although research shows that one of the most effective
ways to provide fish advisory information to these
groups is to post the advisory information at the site
where fish are caught, we did not observe any fish
advisory information posted at fishing sites we visited.
We also found instances where state fish advisory
information did not reach tribal members who routinely
fish state waters adjacent to the reservations.
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Fish Advisory Information Is Not Posted
[ MATING WCMS
We visited three reservoirs in North Carolina, a lake in Georgia, three public boat
ramps in Florida, and several Columbia River treaty fishing access sites in Oregon
and Washington.1 All of these waterbodies have state-published fish consumption
advisories; however, we did not find any fish advisory information at these
locations.
Research shows that posting fish advisory
information at the site where fishers enter the
waterbody or where fish are caught are some of
the most effective ways to provide fish advisory
information to fishers.
Information board at a fishing reservoir has no fish
advisory information. (EPA OIG photo)
For example, in 2010, the EPA conducted a
survey on the awareness and effectiveness of the
Mississippi Delta fish consumption advisory. The
agency found that the majority of survey
respondents obtained advisory information from
signs posted at the affected waterbody as opposed
to other methods of communication, including
television news, talk shows or radio.
In a similar report on contaminated fish in San
Francisco Bay, fishers stated that one of the best
methods for getting fish advisory information to
fishers was through posted signs. By posting fish
advisory information at the source location where
fish are caught, states and tribes can more
effectively provide advisory information.
In addition, we identified the use of social media as another promising method for
informing subsistence fishers. An organization that develops its social media
outreach can issue advisories through Facebook and Twitter. Organizations can
then confirm the reach of these posts through analytical tools built into social
media platforms.
Some Tribes Do Not Receive State Advisory Information
During an on-site interview, a tribal representative said tribe members routinely
take fish from state reservoirs adjacent to the reservation, but many tribe members
do not know about state fish advisories for those reservoirs. The tribal
representative said the tribe (because of its sovereignty) does not have a
governance arrangement with the state, wherein fish advisory information would
1 We visited the Hiawassee, Santeetlali. and Fontana reservoirs in North Carolina; Lake Allatoona in Georgia; public
boat ramps along the Tamiami Trail East in Florida; and the North Bonneville, Cooks, Underwood, and White
Salmon treaty fishing access sites along the Columbia River in Washington and Oregon.
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be shared, and the tribe does not issue its own advisories for those reservoirs.
Tribal leaders said they would welcome the EPA or state officials providing
relevant fish advisory information to their chief or community leader, who would
then ensure that the information is passed on to every member of the tribe.
In another state, tribal representatives said tribe members routinely consume
certain fish species as a traditional food source and cultural norm. However, for
most waterbodies, the statewide fish consumption advisory recommends that no
one eat any of this particular fish
species. For example, members of one
Florida tribe eat fish contaminated
with methylmercury at much higher
rates than most Americans. While
Florida has issued fish advisories for
many of the waters on and near the
tribe's reservation, tribe members
have not received this advice, and the
tribe has not communicated its own
fish advisory information to tribe
members.
The EPA does provide fish advisory
guidance and supporting data for
advisories. Through its risk
communication and fish advisory
guidance, the EPA can help states and
tribes identify and address conflicting
fish advisories across borders to
ensure that clear and meaningful
advisory information is provided to
fish consumers.
In situations where state fish consumption information is not reaching tribes, the
EPA can take a leadership role and ensure that vital fish advisory information is
provided to affected tribes. Moreover, the EPA can better protect the health of
subsistence fishers and other groups by identifying the areas where fish
consumption is high and fish advisory information is nonexistent.
Dilemma Between Two Governments
Treaties grant tribal nations unlimited access to
hunt, fish and gather on lands ceded to the U.S.
However, fish advisories place a limit on the
amount of fish to be consumed and frequency of
consumption to avoid adverse health effects. Some
tribes we visited expressed a concern that fish
advisories limit their treaty rights because the tribes
cannot safely consume unlimited amounts of fish.
Tribes suggested that the EPA has a constitutional
obligation to honor tribal rights by protecting fish
resources granted by treaty. However, the U.S.
government cannot control all sources of mercury
entering the atmosphere that cycles through the
environment and ultimately into fish. Consequently,
fish advisories are needed to provide useful health
information about the amount and frequency that
fish should be consumed.
Advisories Provide Conflicting, Confusing and Complex Advice
Fish consumption advisories sometimes provide conflicting and confusing
advisory information from the federal government, and from states that share
common waterbodies. Without clear information, consumers may not know which
fish they should avoid, how much fish they may safely consume, and whether
advisories apply to them specifically or to other groups (e.g., women of child-
17-P-0174
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bearing age, adolescents, adults, etc.). Because the information that advisories are
based on may vary nationally, among states, and between states and tribes, the
EPA can take a leadership role by promoting consistency to help reduce
confusion.
Conflicting and Confusing Advisory Information
Federal agencies publish fish advisories, dietary guidelines for fish consumption,
and varying toxicity levels for safe consumption of fish contaminated with
mercury. These agencies serve different missions and deliver different messages
to their audiences, but these differing messages create confusion for fish
consumers. For example, the FDA issues a national fish advisory; but the advisory
only applies to commercially marketed fish, and only addresses pregnant and
breastfeeding women, those who might become pregnant, and young children.
This national fish advisory is different from local fish advisories issued by states
and tribes.
r
V
The FDA action level and EPA screening values serve different purposes, but
they are often interpreted by the public as the same advice. This leads to
confusion. The FDA established an enforcement action level at 1.0 parts per
million (ppm) for mercury in fish. The FDA can remove any fish with mercury
readings above 1.0 ppm from commercial store shelves. The EPA has developed a
screening value of 0.049 ppm for those individuals who eat a great deal of fish—
commonly referred to as subsistence fishers. In addition, the EPA has determined
that 0.4 ppm is a safe upper limit for mercury in fish when consumption and other
sources of exposure are limited. At levels above 0.4 ppm the EPA recommends
consumption restrictions.
Comments we received from a scientist, a dietician, and an analyst reflect the
confusion they see with advisories that target the fish-consuming public.
• A leading Harvard mercury researcher said: "I feel like
confusion is reigning. The federal fish advisories need clarity
and conflict avoiding messaging."
• A nationally known dietician said: "I think there is a lot of
misinformation out there. I think when it comes to mercury in
fish, people simply don't know where to go for information."
• A Senior Analyst with the Environmental Advocacy Group
said, "The agency needs to focus on separating out the risks
and the benefits of eating fish."
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The U.S. Department of Health and Human Services, and the U.S. Department of
Agriculture jointly publish the "Dietary Guidelines" that advocate for fish and
shellfish consumption because of the health benefits for the general population,
and for women who are pregnant or breastfeeding. The Dietary Guidelines
encourage choosing fish higher in essential nutrients—such as Omega-3s—but
lower in methylmercury.
In 2002, the state of Alabama used the FDA's action level of 1.0 ppm for mercury
to establish its fish consumption advisory instead of the EPA's recommended
maximum level of 0.29 ppm. This meant the state's fish consumption advisory
could allow methylmercury levels three times higher than the maximum levels
recommended by the EPA. Under the CWA, Alabama should have used the
EPA's value of 0.29 ppm or developed their own water quality standard for its
fish advisories. Currently, all EPA Region 4 states, including Alabama, use the
EPA's methylmercury consumption limits when developing fish advisories.
State-to-State Advisories Conflict
Fish advisories across state lines can conflict and lead to unclear advice. A single
waterbody common to different states may have different fish advisories. For
example, the fish advisories for polychlorinated biphenyls (PCBs) from Maryland
to Virginia urge fishers to limit their consumption of the region's most popular
catch—striped bass—because its flesh may contain traces of toxic substances
acquired from other fish and the waters in which the fish swim.
Recommendations vary from "do not eat" for striped bass caught in the
Washington, D.C., portion of the Chesapeake Bay's tidal rivers, to as many as
three servings per month for the same fish caught in the Maryland portion of the
Bay. Meanwhile, Virginia advises fishers to eat no more than two servings per
month of striped bass caught in that state's end of the Chesapeake Bay. For
Washington, D.C., Maryland and Virginia, the difference in consumption advice
reflects the testing methods they use. (Figure 5).
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Figure 5: Conflicting fish advisories in Maryland, Washington, D.C., and Virginia
New York
* **
J
r
\
\
/
i
fir-
\ X-
I
Pennsylvania
\
I
-V C
1
I
i-*
x
J
— >
West Virginia J
3
Maryland
D.cN^'f
Virginia —Two servings per
month.
Maryland— Three
servings per month.
District of Columbia —
Do not eat.
T
/
v i
| t _ J Chesapeake Bay
Watershed
Source: OIG developed, and based on the review of selected state and Washington, D.C., fish
advisories.
Some Fish Advisories Are Complex and Difficult to Understand
States and tribes publish local fish advisories, but those advisories can be complex
and difficult to understand. For example, in the Great Lakes region where 35
federally recognized tribes exist, the Bad River Advisory illustrates the challenge
of creating a simple, easy-to-follow guide for fish consumption (Appendix A).
The Bad River Advisory contains complicated information that a consumer would
need to study and analyze. The advisory includes the following information:
• Two different maps and two different sets of instructions (one for high-
risk and the other for low-risk segments of the populations).
• Different advisories for different lakes (dozens in total).
• Lake-by-lake recommendations on the maximum number of walleye
meals to consume per month.
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• A warning to adjust the number of walleye meals per month, depending on
the size of portions consumed.
• A suggestion to bag and label walleye according to portion size and lake
of origin before freezing the fish.
• A recommendation to avoid certain other fish species altogether.
For tribes that consume large quantities of self-caught fish, avoiding
methylmercury overexposure requires navigating a myriad of complex advisory
information. Through its leadership, the EPA can guide states and tribes to
examples of clearly communicated fish advisories.
Minimal Information on Advisory Effectiveness
The EPA, states and tribes have not
consistently evaluated the effectiveness of fish
advisory information that reaches targeted
audiences. The EPA's 1995 Guidance for
Assessing Chemical Contaminant Data for Use
in Fish Advisories recommends that states and
tribes establish an evaluation component to
help them determine whether their fish
advisories succeed.2 This guidance says that
states and tribes can use evaluations to help
(1) ensure that a health advisory
communication program is designed to meet
the needs of the target audiences and the
objectives of the agency; (2) monitor whether
the communication program is being
implemented as intended; and (3) assess the
extent to which audience needs and agency
objectives have been met.
However, the majority of states and tribes do not have an evaluation system in
place. Since the EPA issued its initial fish advisory guidance to states and tribes in
1995, the agency found that 24 states and no tribes have evaluated the
effectiveness of their advisories on the public's awareness of the hazards
associated with consuming fish contaminated by methylmercury.
Evaluations can identify areas where people do not receive the advisories, where
advisory information is unclear, or where other factors may be essential to
operating an effective risk communication program. Through its leadership and
guidance, the EPA should continue to encourage state and tribe evaluation efforts,
2 The EPA's Office of Water, Office of Science and Technology. Guidance for Assessing Chemical Contaminant
Data for Use in Fish Advisories, Volume 4: Risk Communication. February 1995.
Fisherman preparing his line at the Santeetlah
Reservoir in North Carolina. (EPA OIG photo)
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and provide examples or templates that can be used to establish and operate
effective evaluation programs.
Ensuring That Consumption Advice Uses Up-to-Date Science
The EPA's 2001 reference dose for methylmercury is an agency-supported value
that remains accepted by EPA for decision-making. However, the current
reference dose does not include recent epidemiological studies on mercury health
effects. Since the EPA established the current RfD 15 years ago, several new
scientific studies relating to the impacts of methylmercury on human health have
emerged and added new information to the scientific literature.
We interviewed the research scientist whose work contributed to the EPA's
original RfD. He stated that although the present RfD was acceptable because it
was based on the best available science in 2001, the RfD is in need of an
assessment because additional scientific research has been completed. We also
interviewed another research scientist who made several contributions to the
EPA's National Fish Forum in 2014. He also indicated the RfD was in need of an
assessment and identified 22 additional epidemiological studies related to the
impacts of methylmercury on human health—studies that were conducted
between 2001 and 2015 (Appendix B). According to these scientists, the studies
present up-to-date scientific research on the impacts of methylmercury and may
provide relevant information for the development of a revised RfD. Figure 6
illustrates how the RfD is used to calculate the ambient water quality
criterion (AWQC).
Based on its Integrated Risk Information System, the EPA included
methylmercury on its 2012 agenda for assessment to begin in fiscal year 2014,
and on its 2015 agenda as a priority for assessment. However, to date, the agency
has not started the assessment.
Because the RfD serves as a primary scientific risk assessment factor for deriving
the AWQC, and ultimately determining the content of fish advisories, if the RfD
is too high, the resulting water quality standards and fish advisory information
may not be protective. On the other hand, if the RfD is too restrictive, limiting
fish consumption may also limit the nutritional benefits of fish consumption.
Moreover, the EPA's RfD is used by other federal agencies, states, local health
departments, tribes and other local entities to determine human health impacts;
determine waterbody impairments; and develop local water quality criteria.
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Figure 6: Formula that the EPA, states and tribes use to develop ambient
water quality criterion
The generalized equations for deriving AWQC based on noncancer effects are:
AWQC = RfD ¦ RSC
BW
BI + E (FIj ¦ BAFj)
i=2
AWQC = Ambient Water Quality Criterion (mg/L, or milligrams/Liter)
RfD = Reference dose for noncancer effects (mg/kg-day, or milligram/kilogram-day)
RSC = Relative source contribution factor to account for non-water sources of exposure
BW = Human body weight (default = 70 kg for adults)
DI = Drinking water intake (default = 2 L/day for adults)
FI = Fish intake (defaults = 0.0175 kg/day for general population and sport anglers, and
0.142 kg/day for subsistence fishers)
BAF = Bioaccumulation factor, lipid normalized (L/kg)
Source: EPA Methodology for Deriving Ambient Water Quality Criterion for the Protection
of Human Health (2000).
Without effectively developed and communicated fish advisories, consumers may
be exposed to unsafe levels of methylmercury through the consumption of fish.
The EPA shares the responsibility of protecting public health and the environment
from methylmercury contamination with states and tribes. The criteria and
standards that the EPA develops and approves should ensure that the CWA's goal
of "fishable" waters is obtained, and that fish advisories are based on the best
available science and are routinely evaluated to determine their effectiveness.
Conclusion
Based on its mission to protect human health, and its responsibilities under the
CWA and EPA's Indian Policy, the EPA should take a leadership role in guiding
and working with states and tribes to develop and distribute fish advisories that
provide meaningful information that reaches all segments of the public. The EPA
can act as a bridge connecting federal agencies, states and tribes to ensure that
risk communication efforts are effective in providing the public with relevant
information to help make healthy fish consumption choices.
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Recommendations
We recommend that the Assistant Administrator for Water:
1. Provide updated guidance to states and tribes on clear and effective risk
communication methods for fish advisories, especially for high-risk
groups. This guidance could recommend posting fish advisory information
at locations where fish are caught; and using up-to-date communication
methods that include social media, webinars, emails, newsletters, etc.
2. Working with states and tribes, develop and disseminate best practices
they can use to evaluate the effectiveness of fish advisories in providing
risk information to subpopulations, such as subsistence fishers, tribes and
other high fish-consuming groups.
3. Develop and implement methods to ensure that tribal members receive
current fish advisory information.
We recommend that the Assistant Administrator for Research and Development:
4. Conduct an assessment for methylmercury to determine whether the
reference dose requires updating, as indicated by the Integrated Risk
Information System, and as proposed in the system's 2012 and 2015
agendas.
Agency Response and OIG Evaluation
The EPA provided a consolidated response from Acting Assistant Administrators
for the Office of Water, and the Office of Research and Development. We met
with agency staff to discuss their comments, and we made changes to the report as
appropriate.
The agency agreed with all final report recommendations, and provided
acceptable corrective actions and projected completion dates. The full agency
response can be found in Appendix C. All recommendations are resolved with
corrective actions pending.
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Status of Recommendations and
Potential Monetary Benefits
RECOMMENDATIONS
Rec.
No.
Page
No.
Subject
Status1
Action Official
Planned
Completion
Date
Potential
Monetary
Benefits
(in $000s)
1
17
Provide updated guidance to states and tribes on clear and
effective risk communication methods for fish advisories,
especially for high-risk groups. This guidance could recommend
posting fish advisory information at locations where fish are
caught; and using up-to-date communication methods that
include social media, webinars, emails, newsletters, etc.
R
Assistant Administrator for
Water
Draft
9/30/2018
Final
3/31/2020
2
17
Working with states and tribes, develop and disseminate best
practices they can use to evaluate the effectiveness of fish
advisories in providing risk information to subpopulations, such
as subsistence fishers, tribes and other high fish-consuming
groups.
R
Assistant Administrator for
Water
Draft
9/30/2018
Final
3/30/2020
3
17
Develop and implement methods to ensure that tribal members
receive current fish advisory information.
R
Assistant Administrator for
Water
09/30/2017
4
17
Conduct an assessment for methylmercury to determine whether
R
Assistant Administrator for
12/31/2018
the reference dose requires updating, as indicated by the Research and
Integrated Risk Information System, and as proposed in the Development
system's 2012 and 2015 agendas.
1 C = Corrective action completed.
R = Recommendation resolved with corrective action pending.
U = Recommendation unresolved with resolution efforts in progress.
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Appendix A
Mercury Fish Advisory for Bad River Band of Lake
Superior Chippewa Tribe
Page 1 of 2
This Map is to Help You Find Safe Ogaa (Walleye) in Lakes Harvested by Bad River
CLAM RIVER FL
MILLE LACS
SISKIWIT L
LMINNESUING
/
DOWLING L
DOUGLAS
MIDDLE EAU CLAIRE L
WHITEFISH L
S
r BOND L
MAP FOR USE BY PREGNANT WOMEN, WOME N OF CHILDBE ARING
AGE. AND CHILDREN UNDER 15 YEARS OF AGE.
DO N OT EAT OGAA LARGE R THAN 20 INCHES.
EAT OGAA LESS THAN 20 INCHES AND CHOOSE EVEN SMALLER
OGAA TO FURTHER REDUCE MERCURY EXPOSURE.
RIB L
TAYLOR
UPPER EAU CLAIRE L
J
N TURTLE L
DIAMOND L ASHLAUD
MINERAL L LOAULEE
NAMEKAGON L
WASHBURN
ISLAND l^ US:
CHAIN Lf , , V
jrfLONGL ^
DUNN
HOLCOMBE FL
TAINTER
L
L WISSOTA
Qfc
NELSON L
TEALL
GORDON L ECHO
LOF THE FALLS
LOST LAND L
BUTTERNUTL
SPIDER L
PRESQUE ISLE L CHAIN
HARRIS I ANNABELLE L
TENDERFOOT L
MAMIE L
-------
Page 2 of 2
Recommended Maximum Number of Ogaa Meals per Month for Lakes Harvested by Bad River
SORTING AND LABELING OGAA
PRIOR TO FREEZING
When Cleaning Ogaa:
~ Put ogaa under 20 inches in bags
labeled "under 20 inches."
~ Put ogaa over 20 inches in bags labeled
"over 20 inches."
~ Label bags with the lake name.
~ Foil ow the advi ce below for maximum
number of meals per month.
USING Tins CHART TO FIND SAFER GIIGOONH
MAXIMUM NUMBER OF MEALS PER MONTH
Advice is for all lakes combined. For example, if you eat four meals in a month
from green lakes you should not eat any other meals of ogaa in that month
MEAL SIZE
Meal size is based on 8 ounces. An average 19 inch ogaa will have 8 ounces of
meat. If your meal size is larger you should eat fewer meals of ogaa If it is
smaller you can eat more meals of ogaa
OTHER GIIGOONH
Oiigoonh such as muskellunge, largemouth bass, smallmouth bass, and northern
pike will have more mercury than giigoonh such as lake whitefish, herring,
blue gill, sunfish, crappie or perch. Try to choose safer giigoonh.
Women of
childbearing
age and
children less
than 15
Women
beyond
childbearing
years and
men 15 and
older
Maximum
Maximum
number of
number of
LAKE
COUNTY
meals per
month
meals p
montl*
ier |
ANNABELLE L
VILAS
0
2 I
BEAR L
ASHLAND
|
BIRCH L
VILAS
2 1
BLACKOAKL
VILAS
BOND L
DOUGLAS
Efl
BUTTERNUT L
PRICE
II
H
CHAIN L
RUSK
;
PC'tl
CLAM R FL
BURNETT
Not Enough Information
CONNORS L
SAWYER
zj
El
CRAB L
VILAS
jj
2
DAIRYLAND RESERVOIR
RUSK
2
DIAMOND L
BAYFIELD
~
2
DOWLING L
DOUGLAS
.
2
DUROY L
PRICE
pq
ECHO L
IRON
JJ
ENGLISH L
ASHLAND
ZJ
FISHER L
IRON
I Not Enough Informatic
" 1
FOREST L
VILAS
~
4
GORDON L
ASHLAND
| Not Enough Information |
HARRIS L
VILAS
~
JJ
m
HEMLOCK L
BARRON
I Not Enouqh Information 1
HIGH L
VILAS
.1 1
HOLCOMBE FL
CHIPPEWA
ISLAND L
RUSK
m
L GALILEE
ASHLAND
[dl
L MINNESUING
DOUGLAS
[ 2 I
L OF THE FALLS
IRON
z
o
m
ouqh Information 1
L OWEN
BAYFIELD
_D
-i 1
L WISSOTA
CHIPPEWA
4
LAC SAULT DO RE
PRICE
1 2 1
4 1
LONG L
CHIPPEWA
2 |
LONG L
IRON
2]
LP'--"! CAMQEL
LOST LAND L
MIDDLE EAU CLAIRE L
MILI..E: LA':.
N TURTLE L
NAMEKAGONL
PRESQUE ISLE L CHAIN
RAINBOW FL
S TURTLE L
SOLBERG L
TENDERFOOT L
TURTLE-FLAMBEAU FL
UPPER EAU CLAIRE L
WHITEFISH L
MILLE LACS
Women of
child bearing
age and
children less
than 15
Maximum
number of
meals per
month
Women
beyond
childbearing
years and
men 15 and
older
Maximum
number of
meals per
month
Not Enough Information
For many native people, giigoonh are part of a traditional and healthy diet If you rely on
giigoonh, choose safer giigoonh with lower levels of mercury by following the advice on this
map.
RISKS AND BENEFITS
Risk: Mercury can damage the nervous system, especially the brain Fetuses and babies are
the most at risk because their nervous systems are rapidly developmg. Children exposed to
unsafe levels while in the womb have been found to experience delayed development in
walking and talking, even though the mother was not affected. Mercury cannot be removed by
trimming or cooking.
Benefit: Eating even as few as two to three meals of giigoonh a month may reduce your risk
of death due to heart disease
Mb
If you have questions about finding safer ogaa, call GLIFWC at 1-715-682-6619.
To learn more about mercury in ogaa, visit GLIFWC's website at www.glilwc.org/lVIercury/mercury.html
Source: Supreme Court, Brief of Amid- Curiae National Congress of American Indians, federally
recognized Indian Tribes, and Inter-Tribal Fish Commissions in Support of Respondents.
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Appendix B
Literature Review of Methyimercury Epidemiological
Studies
We reviewed reports from health and environmental publications for information about potential
public health and environmental impacts. Many additional studies have been conducted on the
effects of eating fish contaminated with mercury since the EPA's methyimercury RfD dose was
issued in 2001. Some of these studies are listed below.
• Boucher O, Jacobson SW, Plusquellec P, Dewailly E, Ayotte P, Forget-Dubois N,
Jacobson JL, Muckle G. 2012. Prenatal Methyimercury, Postnatal Lead Exposure, and
Evidence of Attention Deficit/Hyperactivity Disorder among Inuit Children in Arctic
Quebec. Environ Health Perspect 120:1456-1461; http://dx.doi.org/10.1289/ehp.1204976
• Freire., C., R. Ramos, M.Espinosa, S. Diez., J. Vioque, F. Ballester, M. Fernandez. 2010.
Hair mercury levels, fish consumption, and cognitive development in preschool children
from Granada, Spain, Environmental Research 110 (2010) 96-104.
• Haugen, M., 2014. Prenatal Exposure to Mercury and Language Development at 3 years,
ISEE Conference, Seattle, August 26, 2014.
• Jacobson. J.. G. Muckle. P. Ayotte. E. Dewailly. S. Jacobson. K. Vejrup,
A. Brantsaeter, H. Knutsen, P. Magnus, J. Alexander, H. Kvalem, H. Meltzer, M.
Haugen. 2013. Relation of Prenatal Methyimercury Exposure from Environmental
Sources to Childhood IQ, Environ Health Perspect. 2015 Aug;123(8):827-33.
• Jedrychowski, W. F. Perera. J. Jankowskic, V. Rauh, E. Flak, K. Caldwell, R. Jones, A.
Pac, I. Lisowska-Miszczyk. 2007. Fish consumption in pregnancy, cord blood mercury
level and cognitive and psychomotor development of infants followed over the first three
years of life Krakow epidemiologic study. Environment International 33 (2007) 1057-
1062.
• Jedrychowski W, Jankowski J, Flak E, Skarupa A, Mroz E, Sochacka-Tatara E,
Lisowska-Miszczyk I, Szpanowska-Wohn A, Rauh V, Skolicki Z, Kaim I, Perera F.
2006. Effects of prenatal exposure to mercury on cognitive and psychomotor function in
one-year-old infants: epidemiologic cohort study in Poland. Ann Epidemiol. 16(6): 439-
47.
• Effects of Prenatal Exposure to Mercury on Cognitive and Psychomotor Function in One-
Year-Old Infants: Epidemiologic Cohort Study in Poland, Ann Epidemiol 2006; 16:439-
447.
• Tai F. Fok, Hugh S. Lam, Pak C. Ng, Alexander S.K. Yip, Ngai C. Sin, Iris H.S. Chan,
Goldie J.S. Gu, Hung K. So, Eric M.C. Wong, Christopher W.K. Lam. 2007. Fetal
methyimercury exposure as measured by cord blood mercury concentrations in a mother-
infant cohort in Hong Kong. Environ. Int. 33(1) 84-92.
• Lederman, S. A., Jones, R. L., Caldwell, K. L., Rauh, V., Sheets, S. E., Tang, D., ...
Perera, F. P. (2008). Relation between Cord Blood Mercury Levels and Early Child
Development in a World Trade Center Cohort. Environmental Health Perspectives,
116(8), 1085-1091. http://doi.org/10.1289/ehp.10831.
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• Katsuyuki Murata, Pal Weihe, Esben Budtz-j0rgensen, Poul J J0rgensen, Philippe
Grandjean. 2004. Delayed brainstem auditory evoked potential latencies in 14-year-old
children exposed to methylmercury. J. Pediatrics. 144(2) 177-183.
• Ng, S., C.Lin, S. Jeng, Y. Hwang, W. Hsieh, P. Chen. 2015. Mercury, APOE, and child
behavior, Chemosphere 120 (2015) 123-130.
• Oken, E., Guthrie, L. B., Bloomingdale, A., Platek, D. N., Price, S., Haines, J., ...
Wright, R. O. (2013). A pilot randomized controlled trial to promote healthful fish
consumption during pregnancy: The Food for Thought Study. Nutrition Journal, 72, 33.
http://doi.org/10.1186/1475-2891-12-33.
• Oken, E., Radesky, J. S., Wright, R. O., Bellinger, D. C., Amarasiriwardena, C. J.,
Kleinman, K. P., ... Gillman, M. W. (2008). Maternal fish intake during pregnancy,
blood mercury, and child cognition at age 3 years in a US cohort. American Journal of
Epidemiology, 167(10), 1171-1181. http://doi.org/10.1093/aie/kwn034.
• Oken, E., Wright, R. O., Kleinman, K. P., Bellinger, D., Amarasiriwardena, C. J., Hu, H,
... Gillman, M. W. (2005). Maternal Fish Consumption, Hair Mercury, and Infant
Cognition in a U.S. Cohort. Environmental Health Perspectives, 113(10), 1376-1380.
http://doi.org/10.1289/ehp.8041.
• Orenstein ST, Thurston SW, Bellinger DC, Schwartz JD, Amarasiriwardena CJ, Altshul
LM, Korrick SA. 2014. Prenatal organochlorine and methylmercury exposure and
memory and learning in school-age children in communities near the New Bedford
Harbor Superfund Site, Massachusetts. Environ Health Perspect 122:1253-1259;
http://dx.doi.org/10.1289/ehp.1307804.
• Sagiv, S. K., Thurston, S. W., Bellinger, D. C., Amarasiriwardena, C., & Korrick, S. A.
(2012). Prenatal exposure to mercury and fish consumption during pregnancy and
ADHD-related behavior in children. Archives of Pediatrics & Adolescent Medicine,
166(12), 1123-1131. http://doi.org/10.1001/archpediatrics.2012.1286.
• Suzuki, K. and K. Nakaia, T. Sugawara, T. Nakamura, T. Ohba, M. Shimada, T.
Hosokawa, K. Okamura, T. Sakai, N. Kurokawa, K. Murata, C. Satoh, H. Satoh. 2010.
Neurobehavioral effects of prenatal exposure to methylmercury and PCBs, and seafood
intake: Neonatal behavioral assessment scale results of Tohoku study of child
development. Environmental Research 1 10 (2010) 699-704.
• Wu , J., T. Ying, Z. Shen, H. Wang. 2014. Effect of Low-Level Prenatal Mercury
Exposure on Neonate Neurobehavioral Development in China, Pediatric Neurology 51
(2014) 93-99.
• XinHua Hospital affiliated to Shanghai Jiao Tong University School of Medicine,
Shanghai Institute for Pediatric Research, Shanghai Key Laboratory of Children's
Environmental Health, Shanghai 200092, China. 2007. Prenatal exposure to mercury and
neurobehavioral development of neonates in Zhoushan City, China, Environ Res. 2007
Nov;105(3):390-9. Epub 2007 Jul 25.
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Received on February 28, 2017
Appendix C
Agency Response to Draft Report
MEMORANDUM
SUBJECT: Response to Office of Inspector General Draft Report No. OPE-FY15-0061 —
EPA Needs to Provide Leadership and Better Guidance to Improve Fish Advisory
Risk Communications, dated December 2016
FROM: Michael Shapiro
Acting Assistant Administrator
Office of Water
Robert Kavlock
Acting Assistant Administrator
Office of Research and Development
TO:
Carolyn Copper
Assistant Inspector General
Office of Inspector General
Thank you for the opportunity to respond to the issues and recommendations in the subject audit
report. Following is a summary of the agency's overall position, along with its position on each
of the report recommendations. We have provided high-level intended corrective actions and
estimated completion dates to the extent we can. For your consideration, we have included a
Technical Comments Attachment to supplement this response.
AGENCY'S OVERALL POSITION
EPA appreciates being provided with the opportunity to share the most current information on
fish advisories and efforts to reevaluate the oral reference dose (RfD) for methylmercury. This
response includes comments from the Office of Water (Headquarters; Regions 4, 5, 6, and 10;
and the Great Lakes National Program Office) and the Office of Research and Development.
EPA generally agrees with the findings in this report, pending suggested changes noted in this
memo and in a Technical Comments Attachment that corrects some errors we found during our
review and suggests some clarifications. We have concerns with some of the OIG's
recommendations and conclusions and believe modifications are needed to improve clarity and
avoid a misrepresentation of both the fish advisory and IRIS processes. Adjusting the second,
third and fourth recommendations as suggested will result in more meaningful corrective actions
and ultimately, better public health protection for those who eat fish.
17-P-0174
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EPA would like to alert you to an example of recent leadership regarding fish advisory
communications. EPA and FDA released their joint national-level fish advisory on January 18,
2017. This easy-to-understand advisory provides information for the high-risk groups of women
of child-bearing age and children, and it is consistent with other federal messages, such as those
found in the 2015-20 Dietary Guidelines for Americans. We also appreciate your support for our
leadership of the National Forum on Contaminants in Fish and our web-based advisory and
technical resources which are included in the "Noteworthy Achievement" section of the report.
We request that you include the entirety of this response as an appendix to the OIG final report.
AGENCY'S RESPONSE TO REPORT RECOMMENDATIONS
Agreements
Recommendation 1: "Provide updated guidance to states and tribes on clear and effective risk
communication methods for fish advisories, especially for high-risk groups. This guidance could
recommend posting fish advisory information at locations where fish are caught; and using up-
to-date communication methods that include social media, webinars, emails, newsletters, etc."
Response: Develop a draft updated version of Volume 4: Risk Communication of the Guidance
for Assessing Chemical Contaminant Data for Use in Fish Advisories.
Recommendation 2: "Working with states and tribes, develop and disseminate best practices
they can use to measure the effectiveness of fish advisories in providing risk information to
subpopulations, such as subsistence fishers, tribes and other high fish-consuming groups."
Response: EPA concurs with the end goal of the recommendation - making sure high-risk
subpopulations receive information on risks of eating certain fish. EPA understands the benefits
of evaluating the effectiveness of fish advisory programs and agrees that working with the states
and tribes in that area would benefit the fish advisory programs as well as the fishing population.
Recommendation 3: "Develop and implement methods to ensure that tribal members receive
current fish advisory information."
Response: EPA agrees with the goal of tribes receiving fish advisory information and thinks
EPA can facilitate that communication.
Recommendation 4: "Conduct an assessment for methylmercury to determine whether the
reference dose requires updating, as indicated by the Integrated Risk Information System, and as
proposed in the system's 2012 and 2015 agendas."
Response: Following discussion with OIG, we have come to an understanding of OIG's use of
the term "assessment" as presented in the existing recommendation. ORD generally concurs
with the recommendation pending clarifications to the report language, including OIG
conclusions as noted below and in the Technical Comments Attachment.
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EPA disagrees with the OIG's conclusion that the EPA's oral RfD for methylmercury is overdue
for an update because methylmercury was included as a priority in the 2012 and 2015 multi-year
agendas. The OIG correctly reports that methylmercury was included in the 2015 multi-year
agenda and was among the 6 chemicals listed as highest priority for evaluation. However,
inclusion of a chemical on the multi-year agenda does not indicate a determination of whether
any specific toxicity value, such as the RfD, requires updating. Importantly, IRIS has not yet
determined that the RfD for methylmercury requires updating. Updating or reassessing a toxicity
value within the IRIS assessment development process can be made after scoping (to identify
Agency partner needs) and problem formulation (to frame scientific questions in the assessment)
are conducted. Only then can a determination be made that the methylmercury RfD should be
reassessed to update the reference dose (among other toxicity values).
In addition, EPA does not agree with the OIG determination that since the current RfD for
methylmercury does not include recent epidemiological studies on mercury health effects, it is
therefore overdue for reassessment. This presumption incorrectly focuses on making a
determination whether the RfD requires updating based on the identification of selected scientific
literature that post-dates the 2001 IRIS methylmercury RfD. We recognize that the publication
of epidemiological studies on mercury health effects has added information to the scientific
literature. However, the existence of new literature does not automatically trigger a need for a
reassessment, nor does it necessarily discredit an existing IRIS value. Determination of whether
new literature provides information that warrants reassessment of the RfD can be made after
scoping and problem formulation are conducted.
Accordingly, ORD respectfully requests the OIG conclusions be clarified, as well as state that
the IRIS Program has not yet made a determination on whether the RfD requires updating.
Actions and Timeframes to Respond to OIG Recommendations
No.
Recommendation
(including proposed revision)
EPA
Office
High-Level Intended
Corrective Action(s)
Estimated
Completion by
Quarter and FY
1
Provide updated guidance to states and
tribes on clear and effective risk
communication methods for fish
advisories, especially for high-risk
groups. This guidance could
recommend posting fish advisory
information at locations where fish are
caught; and using up-to-date
communication methods that include
social media, webinars, emails,
newsletters, etc.
OW
Develop a draft updated
version of Volume 4:
Risk Communication of
the Guidance for
Assessing Chemical
Contaminant Data for
Use in Fish Advisories.
Release final version.
Draft: 4th Q
FY2018
Final: 2nd Q
FY2020
2
Working with states and tribes, develop
and disseminate best practices they can
use to measure the effectiveness of fish
ow
Develop draft guidance
that identifies best
practices to measure the
Draft: 4th Q
FY2018
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No.
Recommendation
(including proposed revision)
EPA
Office
High-Level Intended
Corrective Action(s)
Estimated
Completion by
Quarter and FY
advisories in providing risk information
to subpopulations, such as subsistence
fishers, tribes and other high fish-
consuming groups.
effectiveness of fish
advisories.
Release final version.
Final: 2nd Q
FY2020
3
Develop and implement methods to
ensure that tribal members receive
current fish advisory information.
OW
Send EPA's fish advisory
program newsletter to
tribes.
Work with Regions and
OITA to share current
fish advisory information
with tribes.
3rd Q FY 2017
4fe Q FY 2017
4
Conduct an assessment for
methylmercury to determine whether
the reference dose requires updating, as
indicated by the Integrated Risk
Information System, and as proposed in
the system's 2012 and 2015 agendas.
ORD
Within the broader IRIS
assessment development
process, identification of
whether a specific
toxicity value (such as
the reference dose)
requires updating is
accomplished following
scoping and problem
formulation. The IRIS
Program will complete
scoping and problem
formulation for
methylmercury and
determine whether the
reference dose needs to
be updated.
1st Q FY 2019
CONTACT INFORMATION
If you have any questions regarding this response, please contact Laura Drummond, Audit
Follow-up Coordinator of the Office of Water at 202-564-6561 or Drummond.laura@epa.gov or
Maureen Hingeley, Audit Follow-up Coordinator of the Office of Research and Development at
(202) 564-1306 or Hingelev.maureen@epa.gov .
Attachment
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Technical Comments
CC: Arthur Elkins
Charles Sheehan
Benita Best-Wong
Tim Fontaine
Sharon Vazquez
Laura Drummond
Tina Bahadori
Louis D'Amico
Heather Cursio
Maureen Hingeley
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Technical Comments Attachment
EPA Comments on the Draft December 2016 OIG Report: EPA Needs to Provide Leadership
and Better Guidance to Improve Fish Advisory Risk Communications
The following table compiles errors and areas needing clarification found during the Office of
Water's review of the draft report. Suggestions provided by the Office of Research and
Development follow the table.
Page Suggestion
type
2 Clarification
Clarification
Clarification
Correction
Correction
Correction
Correction
Clarification
Correction
Suggestion and Rationale
In the first sentence in the first paragraph of the Human Health Effects From
Mercury section, you may want to specify that the 2001 criterion is for
methylmercury. EPA has more than 100 water quality criteria just to protect
human health, with 60 more to protect aquatic life.
In the second paragraph of the Human Health l'jfects From Mercury section, it
discusses that the most frequently consumed commercial fish contain low
levels of methylmercury, which is true. However, you may want to mention
that 7 types of commercially available fish contain high levels of
methylmercury, and women of childbearing age and young children should
avoid eating them. It is not just wild-caught fish that have high levels of
mercury.
In the second paragraph of the Human Health Effects From Mercury section,
please clarify that wild-caught fish may contain high levels of methylmercury
depending on location, species, and size of the fish since methylmercury tends
to be higher in older, larger, predatory species.
We suggest using an EPA source for average fish consumption rates in Figure
3. If that source is used, the Suquamish Tribe consumes 7.5 times more fish
than the average population on a daily basis.
In Figure 3, we suggest using an EPA source for average fish consumption
rates: Estimated Fish Consumption Rates for the U.S. Population and Selected
Subpopulations (NHANFS 2003-2010), which can be found at
https://www.epa.aov/fish-tech/estiinated-fish-consumption-rates-reports. EPA
has used a fish consumption rate of 22 grams per day, found in that document
and is the freshwater and estuarine (or nearshore) 90th percentile rate for all
consumers, in its human health criteria recommendations since 2015.
Non-national advisories are done at both the state and local levels, not just
local. It is not uncommon to have state-wide advisories.
Neither EPA nor FDA has a statutory or regulatory requirement to issue a
national-level fish advisory. The joint collaboration is a voluntary effort.
The report indicates that EPA is responsible for local fish advisories. Fish
consumption advisories are generally produced by state health departments,
which are not the state environmental agencies EPA usually interacts with.
Water quality criteria, whether developed by EPA or the states, are not used to
develop fish advisories. Instead, states and tribe use the reference dose for non-
carcinogenic compounds like mercury and the cancer potency factor and the
maximum acceptable risk level for carcinogenic compounds. The reference
dose is used in an equation that calculates maximum allowable consumption
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Page Suggestion
type
3-4 Correction
4
4
Correction
Clarification
Correction
Correction
4
4
Typographic
Clarification
4
5
Clarification
Clarification
Suggestion and Rationale
rates. Please see chapter 3 of Guidance for Assessing Chemical Contaminant
Data for Use in T'ish Advisories: Volume 2 - Risk Assessment and T'ish
Consumption I Am its, Third Edition for more information.
EPA establishes water quality criteria recommendations. States and tribes are
not required to adopt EPA's recommendations; they can submit criteria for
approval that they developed. Because criteria are not used in developing fish
advisories, we recommend removing all text referring to water quality criteria
and water quality standards, including Figure 4.
EPA's Office of Research and Development derives the contaminant toxicity
values in IRIS that are used in fish advisories. Those toxicity values are not
developed under the purview of the Clean Water Act.
We recommend including a citation to CWA § 101(a)(2) when you first
mention the goal of"fishable, swimmable,, waters.
In Figure 4, EPA develops water quality standards for states and tribes only
where the Administer determines they are necessary.
Water quality standards do not dictate the content of or need for fish advisories.
While fish advisories and water quality criteria use similar risk assessment
tools, a water quality criterion or standard does not trigger a fish advisory. An
advisory is the amount of fish that can be safely consumed for a given
contaminant level found in fish tissue from a particular waterbody. A water
quality criterion is a regulatory value that specifies acceptable levels of a
chemical in the nation's waters.
"Protest" should be "protect."
While states and tribes may use water quality criteria and water quality
standards to develop fish consumption advisories, they are not obligated to and
they often identify other action levels to use instead. In addition, water quality
criteria are based on exposure from multiple sources whereas fish advisories
focus solely on exposure from eating fish.
EPA has not updated its searchable database of fish advisories since 2011.
The topic of tribal treaty rights and fish consumption is a little more nuanced
than as expressed in the third paragraph in the "EPA Responsibilities Under
Federal Indian Policy" section. EPA suggests something like: "Many tribes
consume higher amounts of fish and shellfish than the general population.
Some tribes hold reserved rights to take fish for subsistence, ceremonial,
religious, and commercial purposes, including in waters under state
jurisdiction. Their consumption habits may or may not be affected by health
warnings about contaminated fish."
In addition to contamination, suppression may play a role in impeding treaty
rights regarding fish. As noted by the National Environmental Justice Advisory
Council in the 2002 publication Fish Consumption and Environmental Justice,
"a suppression effect may arise when fish upon which humans rely are no
longer available in historical quantities (and kinds), such that humans are
unable to catch and consume as much fish as they had or would. Such depleted
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Page Suggestion
type
Correction
7
7
9
10
Typographic
Correction
Typographic
Correction
Clarification
Clarification
Clarification
Typographic
Clarification
Typographic
Clarification
Suggestion and Rationale
fisheries may result from a variety of affronts, including an aquatic
environment that is contaminated, altered (due, among other things, to the
presence of dams), overdrawn, and/or overfished. Were the fish not depleted,
these people would consume fish at more robust baseline levels. ... In the
Pacific Northwest, for example, compromised aquatic ecosystems mean that
fish are no longer available for tribal members to take, as they are entitled to do
in exercise of their treaty rights.''
EPA does not have data to back up the statement that tribes "consume large
amounts of contaminated fish." The levels of fish contamination vary by
location, species of fish, age of the fish, size of the fish, and where it exists on
the food chain. Cultural norms may influence consumption of fish species that
are typically low in mercury. Tribal consumption of fish may be low because
of lifestyle changes from a historical fishing-dependent lifestyle, restrictions to
accessing waterways, and other factors that may reduce tribal fish consumption
rates.
The sentence at the top of the page needs a period.
The last paragraph should be corrected to reflect that neither FDA nor EPA
have regulatory requirements to conduct the national fish advisory.
The sentence at the bottom of the page needs a period. In addition, it restates
the assertion that the OIG did not evaluate contaminants other than
methylmercury, which was stated two paragraphs earlier.
Like the comment on a similar sentence on page 5, EPA does not have data to
back up the statement that "subsistence fishers consume large amounts of
contaminated fish without health warnings."
In the first paragraph in the "Results" section, it would be clearer to state that
only about half have adequately evaluated the effectiveness of their advisories.
We would like the OIG to provide a listing of these states as an appendix to the
report.
While the RfD is important in developing water quality standards, because
standards are not used to develop fish advisories, it would be less confusing if
the statement "Because of its importance in developing water quality
standards" was deleted.
Is the fisher in the photo truly a subsistence fisher or just a recreational one?
In the last paragraph, "group" needs an "s".
It would be helpful to identify specific situations where tribes do not receive
advisory information. In some areas of the country (e.g., the Pacific
Northwest), all of the tribes are very aware of contaminants in the water.
However, some tribal members may decide that spiritual, cultural, and
economic reasons for eating fish outweigh the risk any contaminants pose.
In the third paragraph, "effected" should be "affected."
In the "Tribes Do Not Receive State Advisory Information" section, it would
be helpful and more balanced to mention that EPA describes new and revised
advisories that are posted by states in its monthly Fish and Shellfish Program
Newsletter. Currently about one dozen tribes receive the newsletter.
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Page Suggestion
type
10- Clarification
12
Clarification
Correction
Correction
Clarification
Correction
Correction
Clarification
Clarification
Suggestion and Rationale
In the "Advisories Provide Conflicting . . . Advice" section, it is entirely
appropriate that fish advisories for specific fish and waterbodies should differ
from advice regarding consumption of fish on a national scale. Contaminant
levels within particular waterbodies differ, and these differences result in
different advisories.
While technically the national-level effort by FDA and EPA is an advisory, the
agencies refer to it as "advice" to reduce its likelihood to scare the general
public.
The joint FDA-EPA advice is not exclusive to commercial fish. It also
mentions locally caught fish and tells people to look for local advisories and
what to do if they can't find advisory information.
EPA disagrees that the federal agencies publishing the fish advice, dietary
guidelines, and toxicity levels deliver conflicting information. The reason FDA
and EPA issue the fish advice jointly is to eliminate potential confusion by the
public from potentially conflicting information from agencies with different
missions. When USDA and HHS were developing the Dietary Guidelines
2015-20, they were in touch with FDA and EPA to make sure that the
information in the Dietary Guidelines did not conflict with the joint fish advice
and that both products were delivering a consistent message. See
https://www.epa.izov/fish-tech/epa-fda-advice-about-eatina-fish-and-shellfish.
EPA does not see the importance of the point regarding FDA's action level and
EPA's screening values as it is unlikely the general public knows about these
values. More importantly, the public has access to and will easily understand
the updated joint FDA-EPA fish advice, of which the most recent version is
clear and easy to understand.
There is no federal statute or regulation that requires consumption restrictions
for the average consumer if mercury concentrations in fish exceed a certain
level.
There is a fundamental misunderstanding about the methylmercury criterion
(0.3 ppm) and fish advisories. The report falsely equates the methylmercury
criterion with the fish tissue concentration that would generate an advisory.
The 2010 implementation guidance for methylmercury explains how and why
the criterion differs from a recommended screening value for a fish advisory
limit for mercury in sections 5.4.3 and 5.4.4. In section 5.4.2 it states that
someone eating fish at the average rate of consumption (17.5 g/d at the time)
would not exceed the RfD for methylmercury if the fish tissue concentration
were 0.4 mg/kg, not 0.3 ppm as stated in the report.
A criterion is a regulatory value that does not balance risks and benefits; it is
only concerned with preventing unacceptable risk. An advisory may consider
benefits and risks when providing consumption advice.
A screening value is the concentration of a contaminant in fish tissue that is of
public health concern and is used as a threshold value against which tissue
residue levels can be compared (p. 1-5, Vol. 2: Risk Assessment and fish
Consumption Limits). The calculation of consumption limits is based upon
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Page Suggestion
type
12 Correction
12 Clarification
12 Correction
12 Correction
Correction
Clarification
Suggestion and Rationale
multiple factors - reference dose, body weight, meal size, time period, and
contaminant concentration in fish tissue. The table of monthly consumption
limits based on methylmercury (p. 4-5, Vol 2) shows that fish with
concentrations of 0.049 ppm (a potential screening value for subsistence
fishers) can be eaten 16 times per month, or approximately 4 times per week.
The Alabama example is incorrect - according to Region 4, the number should
be 0.29 ppm (not 0.029), resulting in a level 3 times higher, not 30. In any case,
the example is confusing. According to our guidance, a mercury level of 1 ppm
should result in an advisory of 0.5 meals/month or one meal every other month
and 0.029 ppm is appropriate for unlimited consumption. Without knowing
what consumption limit Alabama set for that 1 ppm concentration, it is difficult
to determine if it were inappropriate. In addition, it is unclear why the example
is included since states can set their own risk levels and the last sentence
implies that Alabama changed their consumption limits and is now consistent
with all the other states in EPA Region 4.
As stated in Section 5.4.2 of the implementation guidance for the
methylmercury criterion, "Advisory limits can differ from one state or tribe to
another. This inconsistency is due to a host of reasons, some of which speak to
the flexibility states and authorized tribes have to use different assumptions
(chemical concentrations, exposure scenarios and assumptions) to determine
the necessity for issuing an advisory. The nonregulatory nature of fish
advisories allows such agencies to choose the risk level deemed appropriate to
more accurately reflect local fishing habits or to safely protect certain
subpopulations (e.g., subsistence fishers)." Given the range of feasible policy
choices that government agencies can make, it would not be surprising to find
instances where state advisories differ.
The consumption restriction in Maryland and Virginia for striped bass is due to
PCB contamination. The report repeatedly stresses it is focused solely on
methylmercury, so EPA questions the inclusion of this example.
The Chesapeake Bay is not a homogeneous body of water and as such is not a
good example to use for "conflicting" advisories. Contamination occurs in "hot
spots" and different rivers (with differing mercury concentration levels) feed
into different sections of the bay, so it would not be unusual to have different
consumption rate recommendations in different parts of the bay as shown in
Figure 5.
The Florida example is not one where tribe and state advisories disagree; from
the way it is written it sounds like it is an example of a tribe not getting fish
advisory information. Please consider including a better or clearer example.
The Florida example is confusing for another reason. An advisory identifies the
amount of fish that can be safely consumed given a particular level of
contamination. The advisory is not affected by the consumption patterns of
different groups that may consume fish from the waterbody. If one group eats
fish at a rate higher than the advisory, it has unacceptable risk. If another group
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Page Suggestion
type
15 Correction
15 Clarification
15-
16
Clarification
Correction
Correction
Clarification
Suggestion and Rationale
eats fish at a lower rate than the advisory, then its risks is acceptable. The
advisory does not change based on potential audiences.
24 evaluations, almost half of U.S. states, is not "few states or tribes." As stated
earlier, EPA requests a list of those states in an appendix to the final report.
EPA regions and program offices actively engage and collaborate with state
and tribal fish advisory programs. For example, the Great Lakes National
Program Office has funded activities that assess the efficiency of fish
consumption messaging to different populations within the Great Lakes basin.
In addition, GLNPO is funding a "point in time" survey which will assess
knowledge and understanding of fish advisories across the basin. Region 10
has some success stories where effective advisories have and are being
developed, for example at the Palos Verdes Superfund site
(http://iournals.saizepub.coin/doi/abs/10.1080/15245000903528381) and the
lower Duwamish Waterway
(http://www.kimzcountv.izov/depts/dnrp/newsrooin/newsreleases/2014/Septemb
er/09-30-Duwamish-Fisher-Survev.aspx).
As a result of the EPA 2008-9 survey on the effectiveness of the Mississippi
Delta fish advisory, which may be what the IG report is referring to in "EPA
examined this question in 2010", Mississippi used the survey results to
improve their outreach campaigns in the Delta.
As noted previously, the water quality criterion for methylmercury is not used
in developing fish advisories, so suggest removing Figure 6 and the sentence
referencing it on page 15. Similarly, please remove "ultimately" in the
paragraph after Figure 6 to unlink the AWQC and fish advisories. To reduce
confusion, you could delete all references to water quality criteria and
standards in that paragraph.
Because fish advisories do not rely on water quality criteria, it would be more
relevant to the report to include the equations used in fish advisories. See
Equation 3-3 in EPA's Guidance for Assessing Chemical Contaminant Data
for Use in Fish Advisories: Volume 2 - Risk Assessment and Fish Consumption
Limits, Third lidition.
If a health department wishes to balance the benefits of fish consumption with
risk, it may do so as a risk management decision so any perceived leniency or
restrictiveness of the RfD could be compensated for in the advisory.
Technical Comments from the Office of Research and Development
At A Glance
"We also found that the EPA's 2001 oral reference dose (RfD) for methylmercury is overdue
for review. Through its Integrated Risk Information System (IRIS), the EPA has recognized
the need to revise its 2001 RfD for methylmercury, and the agency proposed a revision in 2012
and again in 2015." (What We Found)
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These sentences are not accurate. Addition of a chemical to the IRIS agenda does not constitute
starting the assessment. Projected start dates are subject to change depending on Agency
resources and priorities, and should not be used to determine whether an assessment has begun
development, or if an assessment is overdue. Inclusion of a chemical on the agenda does not
indicate whether any specific toxicity value has been identified as needed to be revised.
Suggested Revision: ORD suggests replacing these two sentences with: "EPA included
methylmercury on its 2012 and 2015 agendas for the Integrated Risk Information System (IRIS)
Program. Although the EPA's 2001 RfD for methylmercury is an agency-supported value that
remains accepted by EPA for decision-making..."
"We recommend that the EPA's Office of Research and Development conduct an assessment
for methylmercury to determine whether the reference dose requires updating as proposed in
the 2012 and 2015 IRIS agendas." (Recommendations)
As discussed earlier in the memorandum, the recommendation should be clarified to indicate
when in the assessment development process the determination is made whether a specific
toxicity value (in this case, the RfD) may be impacted by new literature and a reassessment is
warranted.
Suggested Revision: ORD suggests replacing this sentence with "We recommend that the EPA's
Office of Research and Development conduct scoping and problem formulation to determine
whether a reassessment to update the reference dose is required, consistent with methylmercury's
inclusion in the IRIS Program's 2012 and 2015 agendas."
Report
Page 7: The Scope and Methodology section should be clarified to indicate that it did not
include an evaluation of the IRIS assessment development process, or the process for developing
the IRIS 2015 multi-year agenda, which was developed with extensive involvement of the
program and regional offices to reflect their priority needs.
Suggested Revision: ORD suggests adding language to Scope and Methodology section that
includes: "the scope of our work did not include an evaluation of the IRIS assessment
development process, or the process for developing the IRIS 2015 multi-year agenda."
Page 8: The report states: "The EPA's 2001 oral reference dose (RFD) for methylmercury is
overdue for review. Through its Integrated Risk Information System (IRIS) process, the EPA has
recognized that a revision of the methylmercury RfD is due, but to date the revision process has
not started." As noted earlier, the IRIS assessment for methylmercury is not overdue. Addition of
a chemical to the IRIS agenda does not constitute starting the assessment. Projected start dates
are subject to change depending on Agency resources and priorities, and should not be used to
determine whether an assessment has begun development, or if an assessment is overdue.
Inclusion of a chemical on the agenda does not indicate whether any specific toxicity value has
been identified as needed to be revised.
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Suggested Revision: ORD suggests replacing these two sentences with: "The publication of
epidemiological studies on mercury health effects has added information to the scientific
literature. ORD should determine whether this and other new literature would warrant a
reassessment to update the 2001 oral reference dose (RfD) for methylmercury."
Page 15: The report includes a section titled "Consumption Advice Is Not Based on Up-to-Date
Science " which is misleading and could be interpreted as undermining the current RfD. The
availability of new literature published after the 2001 RfD does not indicate that the value or the
science is outdated, nor does it automatically trigger a need for a reassessment or discredit an
existing IRIS value. This misrepresents the scientific approaches used to develop toxicity values
such as RfDs. Determination of whether new literature provides information that warrants
reassessment of the RfD can be made after scoping and problem formulation are conducted.
Suggested Revision: ORD suggests revising this title as follows: "Ensuring Up-to-Date Science
for Consumption Advice."
Page 15: The OIG evaluation's scope including OIG interviews with two scientists did not
include a comprehensive evaluation of the methylmercury literature. As noted in the report, the
scientists indicate their studies "may [emphasis added] provide relevant information for the
development of a revised RfD. " The existence of new literature does not automatically trigger a
need for a reassessment, nor does it discredit an existing IRIS value.
Suggested Revision: ORD requests that additional text be included that clarifies the limitations
and uncertainties in the analysis of selected references for methylmercury.
Page 15: In the report, OIG states, "Through its IRIS process, the EPA recognized that a
revision of the methylmercury RfD is due. In 2012, the EPA included methylmercury on its IRIS
agenda for revision by the end offiscal year 2014, but this did not occur. " As noted previously,
inclusion of a chemical on the IRIS agenda does not constitute a determination that a specific
toxicity value need to be updated. Additionally, projected start dates are subject to change
depending on the Agency's resources and priorities, and should not be used to determine whether
an assessment has begun development, or if an assessment is overdue.
Suggested Revision: ORD suggests revising these sentences as follows: "Through its IRIS
process, EPA prioritized initiating a number of assessments, including methylmercury, as
indicated by the IRIS 2015 agenda."
Page 21: Bullet 1 is an incomplete citation.
Suggested Revision: Boucher O, Jacobson SW, Plusquellec P, Dewailly E, Ayotte P, Forget-
Dubois N, Jacobson JL, Muckle G. 2012. Prenatal Methylmercury, Postnatal Lead Exposure, and
Evidence of Attention Deficit/Hyperactivity Disorder among Inuit Children in Arctic Quebec.
Environ Health Perspect 120:1456-1461; http://dx.doi.org/10.1289/ehp.1204976
Page 21: Bullet 3 is a citation for a conference presentation. Presentations and posters are not
peer reviewed, and would not inform the development of an IRIS assessment.
Suggested Revision: Please remove citation.
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Page 21: Bullet 6 is an incomplete citation.
Suggested Revision: Jedrychowski W, Jankowski J, Flak E, Skarupa A, Mroz E, Sochacka-
Tatara E, Lisowska-Miszczyk I, Szpanowska-Wohn A, Rauh V, Skolicki Z, Kaim I, Perera F.
2006. Effects of prenatal exposure to mercury on cognitive and psychomotor function in one-
year-old infants: epidemiologic cohort study in Poland. Ann Epidemiol. 16(6): 439-47.
Page 21: Bullet 8 includes two references, one incomplete.
Suggested Revision: Tai F. Fok, Hugh S. Lam, Pak C. Ng, Alexander S.K. Yip, Ngai C. Sin, Iris
H.S. Chan, Goldie J.S. Gu, HungK. So, EricM.C. Wong, Christopher W.K. Lam. 2007. Fetal
methylmercury exposure as measured by cord blood mercury concentrations in a mother-infant
cohort in Hong Kong. Environ. Int. 33(1) 84-92.
Page 21: Bullet 9 is an incomplete citation.
Suggested Revision: Lederman, S. A., Jones, R. L., Caldwell, K. L., Rauh, V., Sheets, S. E.,
Tang, D., ... Perera, F. P. (2008). Relation between Cord Blood Mercury Levels and Early Child
Development in a World Trade Center Cohort. Environmental Health Perspectives, 116(8),
1085-1091. http://doi.org/10.1289/ehp.10831.
Page 22: Bullet 1 is an incomplete citation.
Suggested Revision: Katsuyuki Murata, Pal Weihe, Esben Budtz-j0rgensen, Poul J J0rgensen,
Philippe Grandjean. 2004. Delayed brainstem auditory evoked potential latencies in 14-year-old
children exposed to methylmercury. J. Pediatrics. 144(2) 177-183.
Page 22: Bullet 3 is an incomplete citation.
Suggested Revision: Oken, E., Guthrie, L. B., Bloomingdale, A., Platek, D. N., Price, S.,
Haines, J., ... Wright, R. O. (2013). A pilot randomized controlled trial to promote healthful fish
consumption during pregnancy: The Food for Thought Study. Nutrition Journal, 12, 33.
http://doi.org/10.1186/1475-2891-12-33.
Page 22: Bullet 4 is an incomplete citation.
Suggested Revision: Oken, E., Radesky, J. S., Wright, R. O., Bellinger, D. C.,
Am arasi ri warden a, C. J., Klein man, K. P., ... Gill man, M. W. (2008). Maternal fish intake
during pregnancy, blood mercury, and child cognition at age 3 years in a US cohort. American
Journal of Epidemiology, 167(10), 1171 1181. http://doi.org/10.1093/ai e/kwn034.
Page 22: Bullet 5 is an incomplete citation.
Suggested Revision: Oken, E., Wright, R. O., Kleinman, K. P., Bellinger, D., Amarasiriwardena,
C. J., Hu, H., ... Gillman, M. W. (2005). Maternal Fish Consumption, Hair Mercury, and Infant
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Cognition in a U.S. Cohort. Environmental Health Perspectives, 113(10), 1376-1380.
http://doi.org/10.1289/ehp.8041.
Page 22: Bullet 6 is an incomplete citation.
Suggested Revision: Orenstein ST, Thurston SW, Bellinger DC, Schwartz JD,
Amarasiriwardena CJ, Altshul LM, Korrick SA. 2014. Prenatal organochlorine and
methylmercury exposure and memory and learning in school-age children in communities near
the New Bedford Harbor Superfund Site, Massachusetts. Environ Health Perspect 122:1253-
1259; http://dx.doi.org/10.1289/ehp.1307804.
Page 22: Bullet 7 is an incomplete citation.
Suggested Revision: Sagiv, S. K., Thurston, S. W., Bellinger, D. C., Amarasiriwardena, C., &
Korrick, S. A. (2012). Prenatal exposure to mercury and fish consumption during pregnancy and
ADHD-related behavior in children. Archives of Pediatrics & Adolescent Medicine, 166(12),
1123-1131. http://doi.org/10.1001/archpediatrics.2012.1286.
Page 22: Bullet 9 is an incomplete citation. Only the authors are listed and not the data source.
Suggested Revision: Identify the appropriate source.
Page 22: Bullet 10 has a typo.
Suggested Revision: Should be "93-99," not "93e99."
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Appendix D
Distribution
The Administrator
Assistant Administrator for Water
Assistant Administrator for Research and Development
Assistant Administrator for International and Tribal Affairs
Regional Administrator, Region 4
Regional Administrator, Region 5
Regional Administrator, Region 10
Agency Follow-Up Official (the CFO)
Agency Follow-Up Coordinator
General Counsel
Associate Administrator for Congressional and Intergovernmental Relations
Associate Administrator for Public Affairs
Principal Deputy Assistant Administrator, Office of Water
Associate Director for Science, Office of Research and Development
Principal Deputy Assistant Administrator, Office of International and Tribal Affairs
Deputy Assistant Administrator for Management, Office of Research and Development
Deputy Regional Administrator, Region 4
Deputy Regional Administrator, Region 5
Deputy Regional Administrator, Region 10
Audit Follow-Up Coordinator, Office of the Administrator
Audit Follow-Up Coordinator, Office of Water
Audit Follow-Up Coordinator, Office of Research and Development
Audit Follow-Up Coordinator, Office of International and Tribal Affairs
Audit Follow-Up Coordinator, Region 4
Audit Follow-Up Coordinator, Region 5
Audit Follow-Up Coordinator, Region 10
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