[Federal Register: August 8, 2007 (Volume 72, Number 152)]
[Notices]
[Page 44510-44511]
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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2007-0434; FRL-8133-9]

2,4-D, 2,4-DP, and 2,4-DB; Decision Not to Initiate Special
Review

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces EPA's Decision Not to Initiate a Special
Review for 2,4-D, 2,4-DB and 2,4-DP. Based on extensive scientific
review of many epidemiology and animal studies, the Agency finds that
the weight of the evidence does not support a conclusion that 2,4-D,
2,4-DB and 2,4-DP are likely human carcinogens. The Agency has
determined that the existing data do not support a conclusion that
links human cancer to 2,4-D exposure. This conclusion applies to 2,4-DB
and 2,4-DP because they were considered for Special Review based solely
on their similarity to 2,4-D. In addition, because they are used
significantly less than 2,4-D, their contribution to exposure is
minimal relative to 2,4-D. Because the Agency has determined that the
existing data do not support a conclusion that links human cancer to
2,4-D exposure, the Agency is not initiating a Special Review of 2,4-D,
2,4-DB and 2,4-DP. This decision was first proposed on March 23, 1988
(53 FR 9590).

FOR FURTHER INFORMATION CONTACT: Richard P. Dumas, Special Review and
Reregistration Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; fax

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides. Since others also may be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established a docket for this action under
docket identification (ID) number EPA-HQ-OPP-2007-0434. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard

copy, at the Office of Pesticide Programs (OPP) Regulatory Public
Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal
Drive Arlington, VA. The hours of operation of this Docket Facility are
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The Facility Docket telephone number is<PHONE_NUMBER>.
    2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/.

II. Background

A. What Action is the Agency Taking?

    On September 22, 1986, the Agency issued a preliminary notification
of Special Review of 2,4-D. Because of their similarity to 2,4-D, on
December 3, 1986, EPA issued preliminary notifications of Special
Review of 2,4-DB and 2,4-DP. These notices were issued because of
concerns for epidemiological links of 2,4-D, 2,4-DB and 2,4-DP to non-
Hodgkin's lymphoma from both occupational and residential exposure. A
proposed decision Not to Initiate Special Review was published on March
23, 1988 ((53 FR 9590; FRL-3353-3)) based on findings that such a link
is not supported by the existing data. Two sets of comments were
received in response to the proposal, both on behalf of the 2,4-D Task
Force. Both sets supported the proposed decision, but questioned the
need for a new cancer study. The latter point is moot because the
registrant ultimately conducted and submitted an acceptable cancer
study. The final decision was deferred until a more comprehensive
review of 2,4-D was completed. This review was completed with the
signature of the Reregistration Eligibility Decision for 2,4-D in June
of 2005.
    To address the potential link of non-Hodgkin's lymphoma to 2,4-D
exposure, a joint Science Advisory Board/Scientific Advisory Panel
Special Joint Committee was convened to review available
epidemiological and other data on 2,4-D. In 1992, the Committee
concluded that ``the data are not sufficient to conclude that there is
a cause and effect relationship between exposure to 2,4-D and non-
Hodgkin's lymphoma.'' 2,4-D was classified as a Group D, ``not
classifiable as to human carcinogenicity.'' To help better inform the
Agency, EPA requested further histopathological examinations of mouse
and rat tissue from previously conducted studies. These exams were
submitted and reviewed, and on March 16, 1999, the Agency notified the
2,4-D Task Force that the EPA would continue to classify 2,4-D as a
Group D carcinogen.
    The Agency has twice recently reviewed epidemiological studies
linking cancer to 2,4-D exposure. In the first review, completed
January 14, 2004, EPA concluded there is no additional evidence that
would implicate 2,4-D as a cause of cancer (EPA, 2004). The second
review of available epidemiological studies occurred in response to
comments received during Phase 3 of the Public Participation Process
for the 2,4-D RED. EPA's report, dated December 8, 2004, found that
none of the more recent epidemiological and animal studies support a
conclusion that 2,4-D, 2,4-DB and 2,4-DP are likely human carcinogens.
Because the Agency has determined that the existing data do not support
a conclusion that links human cancer to 2,4-D exposure, it has decided
not to initiate a Special Review of 2,4-D, 2,4-DB and 2,4-DP.

B. What is the Agency's Authority for Taking this Action?

    A pesticide product may be sold or distributed in the United States
only if it is registered or exempt from registration under the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA) as amended (7 U.S.C.
136 et seq.). Before a product can be registered it must be shown that
it can be used without causing ``unreasonable adverse effects on the
environment,'' FIFRA section 3(c)(5). The term ``unreasonable adverse
effects on the environment'' is defined in FIFRA section 2(bb) as ``any
unreasonable risk to man or the environment, taking into account the
economic, social, and environmental costs and benefits of the use of
any pesticide.'' The burden of proving that a pesticide meets this
standard for registration is, at all times, on the proponent of initial
or continued registration. If at any time the Agency determines that a
pesticide no longer meets this standard, the Administrator may cancel
this registration under section 6 of FIFRA.
    The Special Review process provides a mechanism to permit public
participation in EPA's deliberations prior to issuance of any Notice of
Final

Determination describing the regulatory action which the Administrator
has selected. The Special Review process, which was previously called
the Rebuttable Presumption Against Registration (RPAR) process, is
described in 40 CFR part 154, published in the Federal Register of
November 27, 1985 (50 FR 49003, 49015; FRL-2914-6). The purpose of this
process is to determine whether some or all registrations of a
particular active ingredient or ingredients meet the FIFRA standard for
registration, or whether amendment of the terms and conditions of
registration or cancellation of portions or all of the registrations is
appropriate.
    Prior to formal initiation of a Special Review, a preliminary
notification is sent to registrants and applicants for registration
pursuant to 40 CFR 154.21 announcing that the Agency is considering
commencing a Special Review. Registrants and applicants for
registration are allowed 30 days from receipt of the notification to
comment on the Agency's proposal to commence a Special Review.
    If the Agency determines, after issuance of a notification pursuant
to 40 CFR 154.21, that it will not conduct a Special Review, it is
required under 40 CFR 154.23 to issue a proposed decision to be
published in the Federal Register. That regulation requires that a
period of not less than 30 days be provided for public comment on the
Proposed Decision Not to Initiate a Special Review. Subsequent to
receipt and evaluation of comments on the Proposed Decision Not to
Initiate a Special Review, pursuant to 40 CFR 154.25 the Administrator
must publish in the Federal Register his final decision regarding
whether or not to initiate a Special Review. As discussed above, the
Agency previously published a notice pursuant to 40 CFR 154.23 for
these compounds, considered public comments and has decided not to
initiate the Special Review under 40 CFR 154.25(b).

List of Subjects

    Environmental protection, Pesticides and pest.

    Dated: July 30, 2007.
James B. Gulliford,
Assistant Administrator, Office of Prevention, Pesticides and Toxic
Substances.
[FR Doc. E7-15109 Filed 8-7-07; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register: August 4, 2010 (Volume 75, Number 149)]
[Notices]
[Page 46919-46924]
[DOCID:fr04au10-41]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2010-0565; FRL-8835-1]

Nominations to the FIFRA Scientific Advisory Panel; Request for
Comments

 AGENCY: Environmental Protection Agency (EPA).

 ACTION: Notice.

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SUMMARY:  This notice provides the names, addresses, professional
affiliations, and selected biographical data of persons nominated to
serve on the Scientific Advisory Panel (SAP) established under section
25(d) of the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA). The Panel was created on November 28, 1975, and made a
statutory Panel by amendment to FIFRA, dated October 25, 1988. The
Agency, at this time, anticipates selecting two new members to serve on
the panel as a result of membership terms that will expire this year.
Public comment on the nominations is invited, as these comments will be
used to assist the Agency in selecting the new chartered Panel members.

DATES:  Comments, identified by docket ID number EPA-HQ-OPP-2010-0565,
must be received on or before September 3, 2010.

ADDRESSES:  Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2010-0565, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions. Direct your comments to docket ID number EPA-HQ-OPP-
2010-0565. If your comments contain any information that you consider
to be CBI or otherwise protected, please contact the Designated Federal
Official (DFO) listed under FOR FURTHER INFORMATION

CONTACT to obtain special instructions before submitting your comments.
EPA's policy is that all comments received will be included in the
docket without change and may be made available on-line at http://
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through regulations.gov or e-mail. The
regulations.gov website is an ``anonymous access'' system, which means
EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an e-mail comment
directly to EPA without going through regulations.gov, your e-mail
address will be automatically captured and included as part of the
comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although, listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.

 FOR FURTHER INFORMATION CONTACT: Joseph E. Bailey, DFO, Office of
Science Coordination and Policy (7201M), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001;
telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
 SUPPLEMENTARY INFORMATION:

 I. General Information

 A. Does this Action Apply to Me?

    This action is directed to the public in general. This action may,
however, be of interest to persons who are or may be required to
conduct testing of chemical substances under the Federal Food, Drug,
and Cosmetic Act (FFDCA), FIFRA, and the Food Quality Protection Act of
1996 (FQPA). Since other entities may also be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the DFO
listed under FOR FURTHER INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

    When submitting comments, remember to:
    1. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    2. Follow directions. The Agency may ask you to respond to specific
questions or organize comments by referencing a Code of Federal
Regulations (CFR) part or section number.
    3. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    4. Describe any assumptions and provide any technical information
and/or data that you used.
    5. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    6. Provide specific examples to illustrate your concerns and
suggest alternatives.
    7. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    8. Make sure to submit your comments by the comment period deadline
identified.

II. Background

    The FIFRA SAP serves as the primary scientific peer review
mechanism of EPA's Office of Chemical Safety and Pollution Prevention
(OCSPP) and is structured to provide scientific advice, information and
recommendations to the EPA Administrator on pesticides and pesticide-
related issues as to the impact of regulatory actions on health and the
environment. The FIFRA SAP is a Federal advisory committee, established
in 1975 under FIFRA, that operates in accordance with requirements of
the Federal Advisory Committee Act (FACA). In accordance with the
statute, the FIFRA SAP is composed of a permanent panel consisting of
seven members who are appointed by the EPA Administrator from nominees
provided by the National Institutes of Health (NIH) and the National
Science Foundation (NSF). FIFRA, as amended by FQPA, established a
Science Review Board consisting of at least 60 scientists who are
available to the SAP on an ad hoc basis to assist in reviews conducted
by the FIFRA SAP. As a peer review mechanism, the FIFRA SAP provides
comments, evaluations and recommendations to improve the effectiveness
and quality of analyses made by Agency scientists. Members of the FIFRA
SAP are scientists who have sufficient professional qualifications,
including training and experience, to provide expert advice and
recommendation to the Agency. The statute further stipulates that the
Agency publish the name, address and professional affiliation in the
Federal Register.
    The Agency, at this time, anticipates selecting two new members to
serve on the panel as a result of membership terms that will expire
this year. The Agency requested nominations of experts to be selected
from the field of environmental risk assessment with experience and
expertise in all phases of the risk assessment process including:
Planning, scoping, and problem formulation, analysis, and
interpretation and risk characterization (including the interpretation
and communication of uncertainty). Nominees should be well published
and current in their field of expertise.

III. Charter

     A Charter for the FIFRA Scientific Advisory Panel dated October
24, 2008, was issued in accordance with the requirements of the Federal
Advisory Committee Act, Public Law 92-463, 86 Stat. 770 (5 U.S.C. App.
I).

A. Qualifications of Members

     Members are scientists who have sufficient professional
qualifications, including training and experience, to be capable of
providing expert comments as to the impact of pesticides on health and
the environment. No persons shall be ineligible to serve on the Panel
by reason of their membership on any other advisory committee to a
Federal department or agency or their employment by a Federal
department or

agency (except EPA). The Administrator appoints individuals to serve on
the Panel for staggered terms of 4 years. Panel members are subject to
the provisions of 40 CFR part 3, subpart F, Standards of Conduct for
Special Government Employees, which include rules regarding conflicts
of interest. Each nominee selected by the Administrator, before being
formally appointed, is required to submit a confidential statement of
employment and financial interests, which shall fully disclose, among
other financial interests, the nominee's sources of research support,
if any.
     In accordance with section 25(d)(1) of FIFRA, the Administrator
shall require all nominees to the Panel to furnish information
concerning their professional qualifications, educational background,
employment history, and scientific publications.

B. Applicability of Existing Regulations

     With respect to the requirements of section 25(d) of FIFRA that
the Administrator promulgate regulations regarding conflicts of
interest, the Charter provides that EPA's existing regulations
applicable to Special Government Employees, which include advisory
committee members, will apply to the members of the Scientific Advisory
Panel. These regulations appear in 40 CFR part 3, subpart F. In
addition, the Charter provides for open meetings with opportunities for
public participation.

C. Process of Obtaining Nominees

     In accordance with the provisions of section 25(d) of FIFRA, EPA,
on March 11, 2010, requested that the National Institutes of Health
(NIH) and the National Science Foundation (NSF) nominate scientists to
fill vacancies occurring on the Panel. The Agency requested nominations
of experts in the field of environmental risk assessment with
experience and expertise in all phases of the risk assessment process.
NIH and NSF responded by letter, providing the Agency with a total of
16 nominees. Eight of the 16 nominees are interested and available to
actively participate in SAP meetings (see Unit IV. Nominees). The
following eight nominees are not available:
    1. Elizabeth Kelly, Ph.D., Los Alamos National Laboratory, Los
Alamos, NM.
    2. Riana Maier, Ph.D., Department of Soil, Water and Environmental
Science, University of Arizona, Tucson, AZ.
    3. Ronald Melnick, Ph.D., National Institute of Environmental
Health Sciences, National Institutes of Health, Research Triangle Park,
NC.
    4. Eva Oberdorster, Ph.D., Department of Biological Sciences,
Southern Methodist University, Dallas, TX.
    5. Walter Piegorsch, Ph.D., Department of Mathematics, University
of Arizona, Tucson, AZ.
    6. Jim Riviere, Ph.D., Department of Population Health and
Pathobiology, North Carolina State University, Raleigh, NC.
    7. Theodore Slotkin, Ph.D., Department of Pharmacology and Cancer
Biology, Duke University, Durham, NC.
    8. Nigel Walker, Ph.D., National Institute of Environmental Health
Sciences, National Institutes of Health, Research Triangle Park, NC.

IV. Nominees

     The following are the names, addresses, professional affiliations,
and selected biographical data of nominees being considered for
membership on the FIFRA Scientific Advisory Panel. The Agency
anticipates selecting two of the nominees to fill vacancies occurring
this year.
    1. Lawrence Barnthouse, Ph.D., President and Principle Scientist,
LWB Environmental Services, Inc., Hamilton, OH.
    i. Expertise. Population biology, ecological risk assessment.
    ii. Education. B.A. in Biology, Kenyon College; Ph.D., in Biology
with area of specialty of population biology, University of Chicago.
    iii. Professional experience. Dr. Barnthouse is President and
Principal Scientist of LWB Environmental Services, Inc. He has more
than 30 years of experience in research and assessment projects
involving impacts of energy technologies in freshwater, estuarine, and
marine environments. Prior to founding LWB Environmental Services in
1998, he spent 19 years as a staff scientist at the U.S. Department of
Energy's (DOE) Oak Ridge National Laboratory (ORNL). At ORNL, he led or
participated in dozens of environmental research and assessment
projects involving development of new methods for predicting and
measuring the environmental risks of energy technologies. In 1981, he
became co-principal investigator on EPA's first research project on
ecological risk assessment. Since that time, he has been active in the
development and application of ecological risk assessment methods for
EPA, other federal agencies, state agencies, and private industry. He
has chaired workshops on ecological risk assessment for the National
Academy of Sciences and the Society of Environmental Toxicology and
Chemistry, and served on the peer review panels for the Framework for
Ecological Risk Assessment and the Guidelines for Ecological Risk
Assessment. He continues to support the development of improved methods
for ecological risk assessment as the Hazard/Risk Assessment Editor of
Environmental Toxicology and Chemistry and Associate Editor of
Integrated Environmental Assessment and Management.
    2. Deborah Cory-Slechta, Ph.D., Professor, Environmental Medicine
and Pediatrics, University of Rochester Medical School, Rochester, NY.
    i. Expertise. Neurotoxicology.
    ii. Education. B.S. in Psychology and M.A. in Experimental
Psychology, Western Michigan University; Ph.D. in Experimental
Psychology, University of Minnesota.
    iii. Professional experience. Dr. Cory-Slechta became a faculty
member at the University of Rochester Medical School (URMC) in 1982.
She became Chair of its Department of Environmental Medicine and
Director of the NIEHS Environmental Health Sciences Center in 1998, and
served as Dean for Research from 2000-2002. She then became Director of
the Environmental and Occupational Health Sciences Institute (EOHSI)
and Chair of the Department of Environmental and Community Medicine at
the University of Medicine and Dentistry of New Jersey-Robert Wood
Johnson Medical School from 2003-2007, before returning to URMC as
Professor in Environmental Medicine and Pediatrics. Dr. Cory-Slechta
has served on national review and advisory panels of the National
Institutes of Health, the National Institute of Environmental Health
Sciences, the Food and Drug Administration, the National Center for
Toxicological Research, the Environmental Protection Agency, the
National Academy of Sciences, the Institute of Medicine, and the Agency
for Toxic Substances and Disease Registry, Centers for Disease Control
(CDC). She currently serves on the Science Advisory Board of EPA and on
the Advisory Committee for Childhood Lead Poisoning Prevention of the
CDC. In addition, Dr. Cory-Slechta has served on the editorial boards
of the journals Neurotoxicology, Toxicology, Toxicological Sciences,
Fundamental and Applied Toxicology, Neurotoxicology and Teratology, and
American Journal of Mental Retardation. She has held the elected
positions of President of the Neurotoxicology Specialty Section of the
Society of Toxicology, President of the Behavioral Toxicology Society,
and been named a Fellow of the American Psychological

Association. Her research has focused largely on the relationships
between brain neurotransmitter systems and behavior, and how such
relationships are altered by exposures to environmental toxicants,
particularly the role played by environmental neurotoxicant exposures
in developmental disabilities and neurodegenerative diseases. These
research efforts have resulted in over 120 papers and book chapters to
date.
    3. Timothy Gross, Ph.D., Consultant, Environmental Resource
Consultants, Gainsville, FL.
    i. Expertise. Environmental resource management, wildlife biology,
ecotoxicology.
    ii. Education. B.S. and M.S. in Biology, Indiana University of
Pennsylvania; M.A. in Historical Preservation, Savannah College of Art
and Design; Ph.D. in Toxicology/Animal Sciences, University of
Maryland.
    iii. Professional experience. Dr. Gross is a private environmental
resource consultant with over 20 years of experience and expertise in
ecotoxicology. Dr. Gross was previously employed at the University of
Florida from 1992 through 2007 and simultaneously with the U.S.
Department of Interior (U.S. Geological Survey) from 1997-2006,
providing Dr. Gross with a unique background in academia, public
service and industry. Dr. Gross's research expertise has focused on the
assessment of biological effects of environmental stressors across many
levels of biological organization, from the biochemical and molecular
levels to population and community effects. These efforts have examined
the potential effects of single chemicals and complex mixtures in
wildlife using both laboratory-based and field-based assessments.
Efforts have evaluated effects of pesticides, wastewater,
pharmaceuticals, pulp-and paper discharge and other assorted man-made
and natural environmental stressors. Research projects have considered
a wide array of taxonomic impacts, from planktonic and macro-
invertebrate populations to fish, birds, amphibians, and reptiles. Dr.
Gross's research has had broad implication and contribution to the
research area of ``endocrine disruption'' Indeed, Dr. Gross's research
efforts on Lake Apopka and similar sites nationally are among the first
indicators of endocrine modulating effects of environmental
contaminants in wildlife. Dr Gross has mentored many graduate students
and post-docs since 1994 and continues to participate in graduate
education.
    4. Nominee. Mark Harwell, Ph.D., Harwell Gentile and Associates,
L.C., Palm Coast, FL.
    i. Expertise. Ecological risk assessment and ecosystem management.
    ii. Education. B.S. in Biology, Emory University; Ph.D., in Systems
Ecology from University of Miami, Institute of Marine Science.
    iii. Professional experience. Dr. Harwell is an ecosystems
ecologist and is currently a Partner in Harwell Gentile and Associates,
L.C, following a 25-year career in academia at Cornell University, the
University of Miami Rosenstiel School, and Florida A&M University. Dr.
Harwell was a leader in the development of EPA ecological risk
assessment framework and has led several large risk assessments,
including comparative ecological risk assessments of oil spills in
Tampa Bay and the Bay of Fundy; an ecological risk assessment of the
effects of climate change and the South Florida ecosystem restoration
on the Everglades and Biscayne Bay; an ecotoxicological risk assessment
of the Coeur d'Alene River watershed; and an assessment of the current
ecological significance of effects from the Exxon Valdez oil spill on
Prince William Sound. He led a series of interdisciplinary studies on
human interactions with the South Florida environment, including field,
mesocosm, and modeling studies in Biscayne Bay and the Florida Keys
National Marine Sanctuary. He coordinated interdisciplinary studies in
five National Estuarine Research Reserves, developing conceptual models
of coupled human environment systems, and contributing to ecological
assessments using remote sensing and hyperspectral imagery. Dr. Harwell
served for more than a decade as a member of the EPA Science Advisory
Board (SAB), including two terms as Chair of the Ecological Processes
and Effects Committee. He led the ecological risk component of the EPA
Unfinished Business Project, and was a member of the EPA SAB Reducing
Risk project. He chaired the U.S. Man and the Biosphere Human-Dominated
Systems Directorate, and led its project on ecological sustainability,
ecosystem management, and an ecosystem integrity report card framework.
He led the Scientific Committee on Problems of the Environment (SCOPE)
5-year international study to assess the global environmental
consequences of nuclear war (ENUWAR), with emphasis on ecological
responses to climate change. He directed the PAN-EARTH Project, a
series of national-level case studies on the ecological and
agricultural effects of climate variability on Venezuela, India, Japan,
China, and sub-Saharan Africa; he was a member of the U.S. Global
Change Research Program's National Assessment working group on coastal
resources effects; and he serves as an expert reviewer for the
Intergovernmental Panel on Climate Change. He served on the National
Academy of Sciences (NAS) panel on ecological risks in the U.S. and
Poland, and was a member of the NAS panel on risk communications. Dr.
Harwell also served as a member of the NAS Board on Environmental
Studies and Toxicology, and was elected a Fellow of the American
Association for the Advancement of Science.
    5. Stephen J. Klaine, Ph.D., Professor in the Department of
Biological Sciences and Director of the Institute of Environmental
Toxicology (CU-ENTOX), Clemson University, Pendleton, SC.
    i. Education. B.S. in Biology, University of Cincinnati; M.S. and
Ph.D. in Environmental Science, Rice University.
    ii. Expertise. Toxicity and risk assessment of pesticides and
metals
    iii. Professional experience. Dr. Klaine has spent over 25 years
conducting environmental research and educating graduate students. He
has 30 Ph.D. and over 40 MS graduates from his laboratory. He has
served on the board of directors of the Society of Environmental
Toxicology and Chemistry and has been an associate editor for the
journal, Environmental Toxicology and Chemistry for 15 years. He has
been on the editorial board of the journal, Nanotoxicology, since 2009.
From 1995 to 2000 he was the only U.S. participant on a multi-national
International Atomic Energy Agency Cooperative Research Program on
Pesticides in Coastal Tropical Ecosystems. In addition to building
capacity in tropical countries around the world, this group produced
the first book to compile pesticide use and effects information in
tropical countries of which Dr. Klaine was co-editor. He has served on
several EPA Science Advisory Panels and workshops dealing with
pesticide and metal fate, effects, and risk assessment. He has also
served on the panel to review the National Nanotechnology Initiative
Strategy on Environmental and Human Safety Needs for Nanomaterials. He
has served on the National Institute of Environmental Health Sciences
(NIEHS) review panel for the Superfund Basic Research Program since
1995 and chaired the panel in 2007 and 2008. He has served on several
other proposal review panels for EPA, USDA, and NIEHS. He has been a
Sigma Xi National

Lecturer, won the Clemson University Sigma Xi researcher of the year in
2007, and won the Clemson University Alumni Award for Outstanding
Research in 2009. He has over 110 peer-reviewed publications on
research ranging from the bioavailability and toxicity of pesticides
and metals to pesticide risk assessment, to the environmental behavior
and toxicity of nanomaterials. Current research in his laboratory
focuses on characterizing: (1) The bioavailablity of metals and
pesticides in aquatic systems; (2) the comparative phytotoxicity of
pesticides; (3) the response of aquatic organisms to episodic
contaminant exposures; (4) the water quality consequences of land use;
(5) the effects of pharmaceuticals on fish behavior; and (6) the
bioavailability and toxicity of colloids and nanoparticles in aquatic
systems.
    6. Charlene McQueen, Ph.D., ATS., W.W. Walker Professor at the
Harrison School of Pharmacy, Auburn University, Auburn, AL.
    i. Education. M.S. in Pharmacology and Toxicology, University of
Arizona; Ph.D. in Human Genetics, University of Michigan.
    ii. Expertise. Pharmacology and toxicology.
    iii. Professional experience. Prior to moving to Auburn in 2007,
Dr. McQueen was a professor in the Department of Pharmacology and
Toxicology at the University of Arizona. Her research in the areas of
pharmacogenomics, toxicogenomics and chemical carcinogenesis
investigates the role of genetic variation in response to chemicals.
Dr. McQueen is particularly interested in the genes that code for N-
acetyltransferases (NAT1 and NAT2), enzymes involved in the metabolism
of aromatic amines and hydrazines. She is using model systems to
understand the mechanisms of the adverse effects of such chemicals
during development and in adults. Dr. McQueen is an American
Association for the Advancement of Science (AAAS) Fellow and a Fellow
in the Academy of Toxicological Sciences (ATS). She has been on
numerous review panels for the National Institutes of Health (NIH) and
served on the Board of Scientific Councillors of the National
Toxicology Program. She is currently a member of the NIH Cancer
Etiology Study Section.
    7. Martha Sandy, Ph.D., Senior Toxicologist/Chief, Cancer
Toxicology and Epidemiology Section, California Environmental
Protection Agency, Oakland, CA.
    i. Expertise. Risk assessment, children's health, carcinogen
exposure.
    ii. Education. M.P.H. and Ph.D., in Environmental Health Science,
University of California; Berkeley School of Public Health.
    iii. Professional experience. Dr. Sandy is a Senior Toxicologist
and Chief of the Cancer Toxicology and Epidemiology Section within the
California Environmental Protection Agency's (Cal/EPA) Office of
Environmental Health Hazard Assessment (OEHHA). Dr. Sandy's section
conducts hazard identification, dose-response assessment, and exposure
assessment of chemical carcinogens. Children's environmental health,
and in particular, cancer risk associated with early life carcinogen
exposures, has been a significant focus in recent years. Her group is
comprised of individuals with expertise in toxicology, epidemiology,
biostatistics and exposure assessment. She conducted research
investigating biochemical and molecular mechanisms of toxicity and
carcinogenicity, and biochemical and genetic susceptibility factors in
Parkinson's disease before joining OEHHA in 1994. Dr. Sandy currently
serves on EPA's Children's Health Protection Advisory Committee and has
served as an ad hoc member of two EPA Scientific Review panels, as a
member of two National Academy committees, as a member of one Report on
Carcinogens Expert panel, and as a peer reviewer for the National
Research Council.
    8. Coby Schal, Ph.D., Blanton J. Whitmire Distinguised Professor of
Structural Pest Management, North Carolina State University, Raleigh,
NC.
    i. Education. B.S. in Biology, State University of New York at
Albany; Ph.D. in Entomology, University of Kansas - Lawrence; post-
doctoral training in chemical ecology, University of Massachusetts-
Amherst.
    ii. Expertise. Entomology, pest management.
    iii. Professional experience. Dr. Schal is co-founder and member of
the Executive Committee of the W. M. Keck Center for Behavioral
Biology, on the Executive Committee of the Genetic Pest Management
Program, and member of the Agromedicine Institute. Between 1984 and
1993, Dr. Schal was Assistant and Associate Professor and Extension
Specialist of Urban Entomology at Rutgers University, New Jersey. He is
a leading authority on cockroach and bed bug behavior, chemical
ecology, physiology, toxicology, biochemistry and molecular biology.
His research has resulted in publications, patents, and tools for pest
management. Dr. Schal's research on chemical ecology has delineated
pheromone-mediated communication in cockroaches, oviposition
attractants in mosquitoes and the evolution of pheromone communication
in moths. His team also characterized the role that juvenile hormone
plays in regulating sexual behavior and sexual maturation in insects
and studies the function and regulation of cuticular waxes in various
insects. Research in urban entomology in the last decade has
concentrated on the biology of cockroach-produced allergens and
intervention strategies to mitigate their pervasiveness in the indoor
environment; profiles and mechanisms of insecticide resistance that
form the basis for recommendations to the pest control industry;
optimization of bait delivery systems, developing and testing
repellents against urban pests, and assessing the impact of these
approaches on pest behavior, humans, and the environment; and practical
integrated solutions (IPM) to cockroach problems in livestock
production facilities that emphasize reduced-risk approaches. Dr.
Schal's research has been funded by EPA, NIH, NSF, USDA, private
foundations and industry, and he has published over 200 refereed
papers. He has served as subject editor of the Journal of Economic
Entomology and Pest Management Science, and on the editorial boards of
Archives of Insect Biochemistry and Physiology, Journal of Chemical
Ecology, Journal of Insect Science, and Psyche. Dr. Schal also served
on several EPA panels and as panelist and panel manager for USDA grants
panels, and has been an active volunteer with the Entomological Society
of America, the Entomological Foundation, and the International Society
of Chemical Ecology. He has directed 24 graduate students and 26 post-
doctoral researchers, and mentored high school and undergraduate
students. Dr. Schal teaches a graduate course in Insect Behavior,
graduate seminars in Urban Entomology and Chemical Ecology, and
contributes to a team-taught Professional Development course. Recent
honors include Lifetime Honorary Membership in the North Carolina Pest
Management Association, Distinguished Achievement Award in Urban
Entomology from the National Conference on Urban Entomology, Fellow of
the Entomological Society of America, Fellow of the American
Association for the Advancement of Science, and North Carolina State
University's Research Friend of Extension Award and Alumni Association
Outstanding Research Award.

List of Subjects

     Environmental protection, Pesticides and pests.

    Dated: July 20, 2010.
 Frank Sanders,
Director, Office of Science Coordination and Policy.
[FR Doc. 2010-18900 Filed 8-3-10; 8:45 am]
BILLING CODE 6560-50-S