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Toxicity Testing and Assessment of Environmental Agents

Completed

A committee of the National Research Council (NRC) will conduct a two-part study to assess and advance current approaches to toxicity testing and assessment to meet regulatory data needs. In the first part of the study, the committee will prepare a report reviewing selected aspects of several relevant reports by EPA and others on this topic. In the second part of the study, the committee will prepare a second report presenting a long-range vision and strategic plan for advancing the practices of toxicity testing and human health assessment for environmental contaminants.

Description

A committee of the National Research Council (NRC) will conduct a two-part study to assess and advance current approaches to toxicity testing and assessment to meet regulatory data needs. In the first part of the study (12 months), the committee will prepare a report reviewing selected aspects of several relevant reports by EPA and others on this topic (see below). In the second part of the study (24 months), to be funded separately at the government's option, the committee will prepare a second report presenting a long-range vision and strategic plan for advancing the practices of toxicity testing and human health assessment for environmental contaminants (see below). In developing the vision and strategic plan, the committee will consider evolving regulatory data needs; current toxicity testing guidelines and standards used by EPA and other federal agencies; the use of emerging science and tools (e.g., genomics, proteomics, transgenics, bioinformatics, computational toxicology, in vitro testing, and other alternatives to animal testing); and the challenges of incorporating more complex understanding of toxicity (e.g., toxicokinetics, mechanisms of action, systems biology) into human health risk assessment.Sponsor: U.S. Environmental Protection AgencyApproximate starting date is March 1, 2004Note: The report on the first part of the study is expected to be issued in summer 2005. This will be followed by another report at the end of second part of the study.

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Conflict of Interest Disclosure

Statement of Committee Composition

Disclosure of Conflict of Interest: Abby Li

In accordance with Section 15 of the Federal Advisory Committee Act, the
"Academy shall make its best efforts to ensure that no individual appointed to
serve on [a] committee has a conflict of interest that is relevant to the
functions to be performed, unless such conflict is promptly and publicly
disclosed and the Academy determines that the conflict is unavoidable." We have
concluded that for the committee to accomplish the tasks for which it was
established its membership must include among others: at least one person with
expertise in neurotoxicity testing and as well as experience in the actual
conduct of and use of such tests for risk assessment by regulatory agencies in
the United States and by organizations in other countries.

To meet the need for this expertise and experience, Dr. Abby Li is proposed for
appointment to the committee even though we have concluded that she has a
conflict of interest because she is an employee of Exponent, Inc., which
provides consulting services to chemical manufacturers, including those who
manufacture pesticides and other chemicals that are regulated by EPA.

As stated in her biographical summary, Dr. Li is an internationally recognized
expert on adult and developmental neurotoxicity testing and risk assessment.
Her expertise has been recognized by her participation on U.S. expert teams to
the Organization for Economic Cooperation and Development for neurotoxicity
testing. This familiarity with OECD and its testing programs was specially
suggested for the committee by the EPA. We believe that Dr. Li can serve
effectively as a member of the committee, taking into account the composition
of the committee, the work to be performed, and the procedures to be followed
in completing the work.

After an extensive search, we have been unable to find another individual with
the equivalent combination of scientific credentials and OECD expertise as Dr.
Li. Therefore, we have concluded that this conflict is unavoidable.

Disclosure of Conflict of Interest: Henry Anderson

In accordance with Section 15 of the Federal Advisory Committee Act, the
"Academy shall make its best efforts to ensure that no individual appointed to
serve on [a] committee has a conflict of interest that is relevant to the
functions to be performed, unless such conflict is promptly and publicly
disclosed and the Academy determines that the conflict is unavoidable." We have
concluded that for the committee to accomplish the tasks for which it was
established its membership must include among others: at least one member with
expertise in epidemiology and an understanding of how state governments use
population-based epidemiology and epidemiologic studies for risk assessments to
protect public health. Furthermore, comments received during the public
comment period on the committee membership indicated that the presence of a
state epidemiologist on the committee was important for fulfilling the
committee's task and was a necessary prespective.

To meet the need for this expertise and experience, Dr. Henry Anderson is
proposed for appointment to the committee even though we have concluded that he
has a conflict of interest because, although an employee of the State of
Wisconsin, he owns stock in a company that manufactures products containing
biocides and antimicrobials that are regulated by EPA.

As stated in his biographical summary, Dr. Anderson brings important and
essential experience to the committee based on his current employment as the
state epidemiologist and chief medical officer for occupational and
environmental health for the State of Wisconsin. He has also other critical
experience to bring to this committee, including serving on the EPA Science
Advisory Board subcommittee for environmental health and the subcommittee for
integrated human exposures. As a result, Dr. Anderson is unique in that he has
experience as both a state epidemiologist and an in-depth familiarity with EPA
processes and regulations pertaining to the use of epidemiologic data for the
development of risk assessments on pesticides and industrial chemicals. Dr.
Anderson is also familiar with other organizations that may be affected by EPA
regulations and guidelines on toxicity testing and its use in risk assessments,
such as the Council of Great Lakes Governors and the Council of State and
Territorial Epidemiologists. Dr. Anderson has over 170 publications in the
area of epidemiology and risk assessment. We believe that Dr. Anderson can
serve effectively as a member of the committee, taking into account the
composition of the committee, the work to be performed, and the procedures to
be followed in completing the work.

After an extensive search, we have been unable to find another individual with
the equivalent combination of scientific credentials and state epidemiology and
risk assessment expertise as Dr. Anderson. Therefore, we have concluded that
this conflict is unavoidable.

Committee Membership Roster Comments

NOTE: Effective 09/10/04 there has been a change in committee membership with the resignation of Dr. Joseph Rodricks and Dr. James Swenberg and the addition of a new committee member, Dr. Lauren Zeise.

Effective 09/28/04: There has been a change in the committee membership with the resignation of Dr. George Daston.

Effective 11/10/04 there has been a change to the committee membership with the addition of three new committee members, Dr. Kim Boekelheide, Dr, Karl Kelsey and Dr, George Lucier.

11/30/04: We deeply regret the recent death our dear friend and fellow committee member Dr. Herbert Rosenkranz.

10/07/05: There has been a change in the committee membership with the resignation of Dr. George Lucier.

Sponsors

EPA

Staff

Ellen Mantus

Lead

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