FDA and EPA Development of a Joint Advisory
for Methyl mercury-containing Fish Consumption for Women of Childbearing
Age and Children
Summary and Purpose: Between July 29 through July 31, 2003, FDA and EPA held four meetings with interested parties regarding methyl mercury in fish. The meetings were held at the FDA, Center for Food Safety and Applied Nutrition, Harvey W. Wiley Federal Building, College Park, Maryland. FDA and EPA are developing a joint fish consumption advisory about the risks of methyl mercury in commercial and recreational fish for women of childbearing age and young children. As part of this initiative, the two agencies invited selected participants to a series of meetings to obtain stakeholder views on the issues associated with developing this joint federal advisory. FDA and EPA briefed stakeholders on their progress in positively responding to the FDA Food Advisory Committee (FAC) recommendations, the new exposure assessment, and the current approach FDA and EPA are taking to develop the joint advisory.
The meeting consisted of a series of formal presentations
from FDA and EPA followed by a general discussion in which participants provided
comment on the progress toward a joint advisory.
The format for each meeting was the same with the following
agenda:
- Welcome and purpose of the meeting
- Background: 2001 advisory and 2002 FAC
- The "at risk" population as currently defined
- Estimating exposure from consumption data
- The desired "level of protection" issue
- Elements and process for developing a joint federal
message
- General discussion
- Next steps
Note: The complete presentations are posted on the web
at http://www.cfsan.fda.gov/~lrd/pestadd.html and http://www.epa.gov/waterscience/fish.
Summary of the main comments from the
four meetings
FDA and EPA appreciate these comments and interaction and
will as appropriate refer and reflect on those specifically dealing
with the development and implementation of the joint advisory, scientific
review of the exposure assessment and other factors.
Tuesday July 29th, meeting with Industry representatives:
Points of clarification related to the presentations:
- It was stated that the 300 tuna samples will be collected
to measure total mercury, not methyl mercury specifically.
- The age distribution of children in the NHANES data
is 1-5 years of age, with the majority of children surveyed between 2-5
years of age.
- For calculation of a benchmark dose, EPA considered
the lowest 5 percent of response values as abnormal or adverse. This is
not relatively standard for tests of learning or intelligence. A doubling
of the percentage of a population (5 to 10 percent) with abnormal scores
was considered to be above background and indicative of an adverse effect.
- The lowest 5 percent of response values are typically
omitted in neurotoxicity tests, as well as in other intelligence tests:
these lowest values are considered abnormal. So in the models we doubled
the value and used it for the benchmark.
- The NHANES data include mercury effects in children
with in utero exposure.
- The benchmark level is not a "no effect level." The
method used can be referenced through the EPA online in the IRIS entry
for methyl mercury as well as in the Water Quality Criterion for Protection
of Human Health: Methyl mercury .
- The reference dose builds in an uncertainty factor,
not a "safety factor."
- The NHANES data on daily fish consumption includes sensitive
subgroups. Children were oversampled in one year's data.
- The FAC recommended that FDA develop specific recommendations for canned tuna based on
a detailed analysis of what contribution canned tuna makes to overall methylmercury levels in
women.
- Market Survey data is used to estimate the fish consumed
pattern.
- The estimated mean blood mercury levels in the model
scenarios show levels that are similar for scenarios 2, 3, and 4, with
the best difference between scenarios 1 and 2. Scenario 1 is the pre FDA
advisory period. Scenario 2 is the FDA advisory.
- The reference dose is applied to the entire population,
including sensitive subgroups.
- The advisory focus is the developing nervous system,
with the mother considered the vehicle.
- EPA's goal is to reduce exposure to mercury in non-commercial
and subsistence fishing, and to work with FDA to develop a clear message
for both commercial and non-commercial fish.
- The current advisory does not define children by age.
Getting authorities to agree on exact ages for children is not likely at
this point.
- The schedule for the focus groups will be published.
- The FAC recommended bringing commercial and recreational
fish advisories under the same umbrella. EPA and FDA envision it as one
piece of paper-one advisory and they are determining how to merge their
advisories.
- EPA has very limited information on the consuming habits
from noncommercial fishing.
- Some participants commented that the presented timeline
seemed ambitious.
- The distinction was made between the milestones for
announcing the new advisory and implementing the new advisory. The implementation
stages will entail deeper dissemination of the advisory material to more
people, including public health professionals.
Summary of comments following the formal presentations:
- A goal is to use the presented model as a tool to see
effects on different levels.
- The earlier inquiry whether there is any movement to
look at and incorporate findings from two substantial events, the Seychelles
Study and the WHO JECFA study, which occurred after the 2002 FAC meeting
was raised. There are a number of new pieces of information published and
to consider in developing an advisory. There is also ongoing data mining
on NHANES. Advisories will be revisited periodically and updated as needed.
- A prompt advisory could put to rest some misleading
or confusing information. Emphasis on high, medium, and low categories,
as opposed to specific fish species, could be confusing. An advisory should
consider what alternatives people will be pushed toward if they aren't
eating fish.
- The exact coordination of the umbrella advisory with
state advisories is yet to be worked out; however, the hope is to coordinate
with states.
- The next set of NHANES data and results should provide
an opportunity to examine response to the existing 2001 advisory, but it
is going to take a few years to get data on the impact of any advisory.
- FDA and EPA are not trying to make the message more
complicated or conservative, but trying to make the message clearer through
more details.
- Other plans to get more data and to do more research:
Some options for obtaining data to hone in on these consumers include:
(1) Better mining of NHANES data, (2) revising or adding to questions in
NHANES, or (3) designing a separate study apart from NHANES. However, we
should not wait for more data to issue the next advisory.
- Actual tuna measurement: Presenting tuna amounts in
ounces and not in terms of cans is better. Ounce cans are drained and there
are fewer than 6 consumable ounces in a 6-ounce can. The drained weight,
particularly given the variability (e.g., pouches, small cans) of tuna
on the market, should be the focus. There is a need to communicate messages
clearly and clarify whether it is cooked weight or "as is, right out
of the can."
- Other stakeholder groups, e.g., American Lobster, may
want to be included in future communication. Industry stakeholders will
give thought to other groups that should be included as well.
- The meeting was considered very helpful to help understand
where things are.
Wednesday July 30, 2003, meeting with Consumer groups and
Health Professionals:
Points of clarification related to the presentations:
- Current focus is to respond to FAC recommendations.
- At risk population remains women of childbearing age
and children.
- Clarify and verify that these and only these were the
FAC recommendations.
- FDA has ongoing sampling/testing that includes tuna
and a variety of other species.
- The term "Children" is not defined by age
at this time; divergent views on age span remain.
- FDA and EPA continue to data-mine NHANES.
- Also considering additional changes to NHANES to answer
certain demographic and consumption questions- earliest change will be
2006
- While other mercury clinical data is worthwhile and
important, the NHANES remains the prime data source for FDA and EPA.
- The scenarios were developed based on consuming prescribed
amounts and or varieties of fish; scenarios did not focus on high end consumers.
- Scenario #1, i.e., unrestricted consumption of fish
and varieties, results likely reflect lack of knowledge and or adherence
to FDA's 2001 advisory
- Comparison of probabilistic models routinely range 10-00
x; therefore, the 2X risk exposure model comparison with NHANES is very
favorable.
- The model profiles consumption of varieties of fish;
the model also allowed the methyl mercury to range between its high and
low end.
- The exposure model is available as a poster and submitted
to all participants prior to the meeting; the model and data are currently
undergoing peer review and the authors intend to publish in a scientific
journal this year. Data and model parameters are described in each publication.
- FDA and EPA welcome receipt of additional clinical or
seafood residue data.
- Format of joint message has not been established; and
as much information as can be conveyed will be incorporated.
- The venues and messengers are important features to
an effective message.
- FDA routinely conducts consumer surveys to discern effectiveness
of its regulations and messages. FDA plans to evaluate its methyl mercury
message in this manner.
- Aug 2003 article in an OB and GYN journal showing reduced
fish consumption by women of childbearing age following FDA's 2001 fish
advisory.
- Some questioned the accuracy of the fish tissue mercury
concentration data used in the model. They compared the data to values
in EPA's Report to Congress, and saw that the model values were roughly
half of EPA's values which originated from FDA and NMFS data.
Summary of comments following the formal presentations:
- The goal is for consumers to make smart choices.
- EPA distinguishes between child and adult serving sizes
(2 versus 6 ounces).
- Low level in the model scenarios was set to include
light tuna in this group. This was in response to the FAC's recommendation
to consider distinguishing light from other tuna in an advisory.
- FDA anticipates working triangularly in its outreach
with health professionals and the media to reach consumers.
- California requires grocers to display advisories. FDA
also works with grocers via brochures and other means.
- Some studies of pediatric patients and highly illiterate
groups has indicated that pictorial messages may be very useful in reaching
certain groups.
- The upcoming advisory is part of an iterative process.
It is important that we move forward with advice, knowing that we will
not resolve the complete issue immediately. The advisory role will continue
into the future and be refined over time.
- The current advisory does not specifically address the
high-fish consumption by various groups. More advice could be provided
to the fisheries industry so that they will catch fewer high-mercury-level
fish.
- While neurotoxicity is the current sentinel endpoint
for mercury, other endpoints may be considered in the future.
- Since pregnant women are bombarded with advice about
what to do and what to avoid in their first prenatal visit, it is most
motivating for them to adjust their behavior accordingly when there is
clear information about what happens if they don't adhere to the advice.
The example of listeriosis was used. What happens if the advisory is not
followed seems to be missing from the current advisory.
- The proposed timeline seemed ambitious to some; it could
shorten coordination capabilities with states and others. Since states
help coordinate health professional and WIC information, it will be important
for there to be federal and state consistency.
- The historical nature of tuna data and data on other
fish species were discussed.
- Suggested FDA consider issues raised outside the FAC
meeting
- Suggested advisory recommend higher consumption levels
(> 12 oz/week) if people eat low mercury containing fish
- Asked to see scenario where all the population ate 12
oz fish/week.
Thursday, July 31, 2003, meeting with States
Points of clarification related to the presentations:
- While "children" have not yet been defined,
many state advisory programs, including the Gulf of Mexico Mercury Advisory
Taskforce, have defined ages for "young children."
- The 300 tuna samples collected will distinguish light
versus other tuna.
- NHANES data do not distinguish commercial from non-commercial
fish consumed.
- The 7.8 percent figure for the estimated portion of
the population with blood mercury levels above the reference dose is based
on a larger data sample than an earlier estimate of 10 percent. NHANES
data are most robust considered as 2-year blocks.
- The model showed that only 3.9 percent of the fish-consuming
public would have blood mercury levels above the reference dose by comparison
to the NHANES measured figure of 7.8 percent above the reference dose.
This is considered good for such modeling exercises. However, some states
still see this as a concern.
- The data on high-quantity fish consumers was not teased
out. NHANES data may be further mined to provide basis for further revisions
to the advisory.
- It would be useful to model as a covariant the impact
of reduced fish consumption on omega-3-fatty acid consumption.
- A "wish list" for further analysis and advice
would include that it reflect variation in regions, servings, etc.
- The trade off of decreasing fish consumption, particularly
regarding omega-3-fatty acids, should be considered.
- It was recommended that the analysis and advisory focus
on decreasing certain types of fish, i.e., those with high mercury levels,
instead of decreasing overall fish consumption.
- No single-species consumption, e.g., children eating
a tuna sandwich every day, analysis was performed. The goal was to model
what happens in retail. It is possible to run the model for one species.
However, scenarios did try to account for consumption of fish distributed
across light, canned, albacore, and fresh tuna.
- The advisory will be disseminated using a multifaceted
approach: to physicians, health and women's magazines, nurse midwives,
grocers, media, and states.
- North Carolina is following the current advisory and
is recommending that pregnant women avoid seven species listed as having
high mercury levels.
- Any message should be carefully crafted not to discourage
people from consuming fish in general.
- One option for advice is to say something like "If
you eat more than 12 ounces of fish a week, then eat these fish...."
- State advisories generally follow a species-specific
approach (as opposed to a mixed-fish diet scenario), and by considering
all contaminants such as mercury, PCBs, banned pesticide levels, and other
contaminants.
- State advisories follow species by PCB levels and other
factors.
- The proposed timeline seemed ambitious to some, not
allowing enough time for review for the advisory.
Summary of comments following the formal presentations:
- Data are available from a food survey of 23,000 people
in Florida.
- Maine tells residents to follow state advisories. Any
federal advisory should not override state advisories.
- A comprehensive advisory on PCBs, omega-3-fatty acids,
etc., to use in informing pregnant women about seafood consumption would
be useful.
- Should report advisory as meals rather than weight.
- Suggest using focus groups convened by Maine as one
of our focus groups.
- Suggest advice for school age children.
- Need to consider regional differences I fish.
Thursday, July 31, 2003, meeting with Tribes
Points of clarification related to the presentations:
- The model can be used by others.
- There are data from a 5-year study of Chippewa tribe
fish consumption with lake, species, harvest information, and size data.
The data can be shared. The data include commercial fish for 3 years.
- Another 3-year STAR grant will commence soon (PIs are
Jeff Forham and Neil Kimasec).
Summary of comments following the formal presentations:
There were no additional questions or comments.
Presentation: FDA and EPA Development of a Joint Advisory for Methylmercury-containing Fish Consumption for Women of Childbearing Age and Children July 2003
List of Meeting Attendees