Representatives from the chemical industry, state regulatory agencies, and
environmental groups speaking at a public meeting said that the Environmental
Protection Agency's chemical risk assessment program needs to be overhauled but
disagreed over what reforms are needed.
Panelists at the Nov. 13 meeting hosted by EPA agreed the agency needs to
improve its Integrated Risk Information System program to increase the frequency
at which chemical assessments are completed and issued.
Richard Denison, a senior scientist at the Environmental Defense Fund, said
the IRIS program has failed to meet a 2009 goal to complete most or all
assessments within 23 months. No assessments issued since 2009 have met that
goal, and the program also has failed to meet any established deadlines for
individual assessment steps, according to Denison.
Denison said the delays have “profound real-world consequences” because
regulatory decisions that rely on IRIS assessments also are delayed.
Chuck Elkins, president of Chuck Elkins and Associates, said the IRIS program
has “a huge deficit” when it comes to issuing final assessments, and any reforms
should be made with the goal of finalizing assessments much more quickly than
EPA hosted the meeting to hear outside views of the IRIS program, including
scheduled improvements to the program.
Kenneth Olden, director of EPA's National Center for Environmental
Assessment, said in September that the agency plans to solicit advice from all
parties, including the chemical industry, environmental health advocates, and
communities that may be affected by polluted sites, before moving forward with
an IRIS assessment (36 CRR 1005, 9/24/12).
Those parties will be asked for advice on what studies should be used, what
health problems should be focused on, and what data gaps are present before the
assessment is launched, Olden said. Currently, EPA does not solicit comment
until a draft IRIS assessment is released.
Mary Fox, an assistant professor at Johns Hopkins Bloomberg School of Public
Health, said more timely IRIS assessments are needed “to do the work and make
the decisions on the ground every day.”
She said decisionmakers, including state regulatory agencies, need regularly
updated chemical assessments that keep up with the most current science.
Fox suggested that EPA look into realizing some time efficiencies, including
conducting some reviews simultaneously or in parallel, rather than sequentially.
Public comments could be consolidated and assessed in an integrated manner in
order to speed up the IRIS process, she said.
Fox also said putting assessments through two rounds of interagency review
“seems redundant.” She cited a need for “increased transparency” on the
Currently, EPA consults with the White House and other federal agencies on
draft IRIS assessments, as well as on the final, revised assessment.
Linda Birnbaum, director of the National Institute of Environmental Health
Sciences and National Toxicology Program, suggested that EPA take a varied
approach to IRIS assessments.
“I do not think there should be a one-size-fits-all approach for all IRIS
assessments,” she said.
Birnbaum said EPA assessments of certain chemicals could move “relatively
rapidly” to address some exposures that are not of concern. This would give the
agency more time to focus on more complicated exposures, she said.
David Fischer, senior director of the American Chemistry Council, described
the announced changes to IRIS as “relatively modest” and said more enhancements
are needed to improve the scientific quality of assessments and the pace at
which assessments are issued.
Fischer said more transparency is needed, including sharing the criteria used
by EPA in the assessment and the weight of evidence decision, to improve the
IRIS program. He said it is impossible for the chemical industry to reproduce an
IRIS assessment unless the assessment criteria are known.
Fischer also said interested parties should be given the time to present
comments to and have a dialogue with peer review panels convened to review the
IRIS assessments. He cited EPA's recent decision to convert “listening sessions”
held on IRIS assessments to allow for active dialogue between agency officials
and interested parties as a model for improving engagement with peer review
ACC supports Olden's proposal to solicit advice on scoping and problem
formulation before launching an assessment, Fischer said. He said other “quick
fixes” to improve the program could include posting all IRIS documents to a
docket on http://www.regulations.gov
and either applying a systematic approach to data evaluation and weight of
evidence or providing a rationale for not doing so for all IRIS assessments
Elkins said additional engagement would go “a long way toward compensating”
for other flaws in the IRIS program. He said most delays in finalizing IRIS
assessments appear to be the result of needing to conduct assessments multiple
Elkins said that “doing it right the first time” is one model that could
reduce the amount of time it takes for the IRIS program to generate an
He also recommended the agency conduct the IRIS program “in a fishbowl,” with
all documents placed in a public docket, including recordings of every meeting
that takes place between interested parties and EPA staff.
Denison called on EPA to consolidate opportunities for public input during
the IRIS process. He suggested that the agency solicit input at the beginning of
the process and once a draft assessment is completed.
Denison said a “more involved process” not only leads to delays in finalizing
assessments but also “virtually ensures the input received by EPA is
Chemical manufacturers and trade associations have a clear financial interest
in the outcome of each IRIS assessment, so they take advantage of every
opportunity for input, Denison said.
“We must simply stop pretending that there is a level playing field,” he
said. “It is a certitude that the affected industry will be better represented
than other stakeholders at each opportunity for input, and the more such
opportunities, the greater the imbalance becomes.”
Gloria Post, a research scientist at the New Jersey Department of
Environmental Protection, said that EPA must be aware that many interested
parties, including state regulatory agencies, may not have the resources to
fully participate in the IRIS process.
Post said states are “very short staffed” and are unable to submit multiple
rounds of written comments on a single chemical assessment. Reviewing IRIS
assessments is “a very small part of the work” done by state environmental
agencies, while other parties may have staff members dedicated to dealing with
IRIS issues, Post said.
Post recommended that EPA provide funding for states that have interest and
relative expertise to participate in the IRIS process. Post also said the agency
could provide online or in-person training for state risk assessors on new IRIS
processes, which she said are “technically complex.”
Denison also expressed opposition to the EPA Science Advisory Board Reform
Act of 2012 (H.R. 6564), which he said is part of a “chemical industry assault
on independent government science.”
The bill, introduced in October by Republican members of the House Science,
Space, and Technology Committee, would limit the ability of the Science Advisory
Board to offer policy advice to EPA and place limits on the number of agency
grant or contract recipients who could serve on the board at one time (36 CRR
The legislation proposes that at least 10 percent of the advisory board be
made up of representatives of state, local, or tribal governments and to allow a
maximum of 10 percent of members to be recipients of financial assistance from
Denison said the bill would exclude scientists who receive government
research funding. Supporters of the bill falsely claim that government funding
creates a conflict of interest, according to Denison.
Jennifer Sass, a senior scientist with the Natural Resources Defense Council,
described the legislation as “part of a coordinated chemical industry attack” on
EPA science and scientists that receive federal funding. She said participation
of members of the academic community who receive funding from EPA or other
federal agencies is “critical” to the peer review process and operations of the
scientific advisory board.
Fischer said ACC is “very, very supportive of” the reform bill. The industry
group believes the legislation will strengthen the advisory board's process for
reviewing scientific assessments, Fischer said.
By Patrick Ambrosio
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