Endocrine Disruptor Screening Program; Assay Peer Review Process, 38577-38580 [E7-13672]
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BILLING CODE 6560–50–P
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ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPPT–2007–0493; FRL–8138–4]
Endocrine Disruptor Screening
Program; Assay Peer Review Process
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
SUMMARY: The purpose of this notice is
to announce the approach EPA intends
to take for conducting peer reviews of
the Tier 1 screening assays and Tier 2
testing assays that are being validated by
the Agency’s Endocrine Disruptor
Screening Program (EDSP), as well as
EPA’s approach for conducting the peer
review of the Tier 1 battery. EPA is also
announcing the availability of a
listserver (Listserv) that will allow
interested parties to sign up to receive
e-mail notifications of EDSP peer review
updates, including information on the
availability of peer review materials to
be posted on the EDSP website. These
materials may include the documents to
be peer reviewed, background
documents, the charge to the peer
reviewers, and reports that summarize
the results of peer reviews.
FOR FURTHER INFORMATION CONTACT:
Linda Phillips, Office of Science
Coordination and Policy (7203M),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(202) 564–1264; e-mail address:
phillips.linda@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
This action is directed to the public
in general. You may be potentially
affected by this action if you produce,
manufacture, use, consume, work with,
or import commercial or pesticide
chemicals. To determine whether you or
your business may be affected by this
action, you should carefully examine
section 408(p) of FFDCA, 21 U.S.C.
346a(p). Potentially affected entities,
using the North American Industrial
Classification System (NAICS) codes to
assist you and others in determining
whether this action might apply to
certain entities, may include, but are not
limited to:
• Chemical Manufacturers,
Importers and Processors (NAICS code
325), e.g., entities who manufacture,
import or process chemical substances.
• Pesticide, Fertilizer, and Other
Agricultural Chemical Manufacturing
(NAICS code 3253), e.g., entities who
manufacture, import or process
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38577
pesticide, fertilizer and agricultural
chemicals.
• Scientific Research and
Development Services (NAICS code
5417), e.g., persons who conduct testing
of chemical substances for endocrine
affects.
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. 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. Materials cited in this
notice are available in docket number
EPA–HQ–OPPT–2007–0493. All
documents in the docket are listed in
the regulations.gov index. To access the
electronic docket, go to https://
www.regulations.gov, select ‘‘Advanced
Search,’’ then ‘‘Docket Search.’’ Insert
the docket ID number where indicated
and select the ‘‘Submit’’ button. Follow
the instructions on the regulations.gov
website to view the docket index or
access available documents. Although
listed in the index, some information is
not publicly available, e.g., Confidential
Business Information (CBI) or other
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
will be publicly available only in hard
copy. Publicly available docket
materials are available electronically
athttps://www.regulations.gov, or, if only
available in hard copy, at the OPPT
Docket. The OPPT Docket is located in
the EPA Docket Center (EPA/DC) at Rm.
3334, EPA West Bldg., 1301
Constitution Ave., NW., Washington,
DC. The EPA/DC Public Reading Room
hours of operation are 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding
Federal holidays. The telephone number
of the EPA/DC Public Reading Room is
(202) 566–1744, and the telephone
number for the OPPT Docket is (202)
566–0280. Docket visitors are required
to show photographic identification,
pass through a metal detector, and sign
the EPA visitor log. All visitor bags are
processed through an X-ray machine
and subject to search. Visitors will be
provided an EPA/DC badge that must be
visible at all times in the building and
returned upon departure.
2. Electronic access. You may access
thisFederal Register document
electronically through the EPA Internet
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Federal Register / Vol. 72, No. 134 / Friday, July 13, 2007 / Notices
under the ‘‘Federal Register’’ listings
athttps://www.epa.gov/fedrgstr/.
II. Introduction
A. What Action is the Agency Taking?
EPA is announcing its approach for
conducting peer reviews of Tier 1
screening assays and Tier 2 testing
assays that are being validated by the
Agency’s Endocrine Disruptor Screening
Program (EDSP), as well as its approach
for conducting the peer review of the
Tier 1 battery. EPA is also announcing
the availability of a listserver (Listserv).
To subscribe to the EDSP Listserv send
a blank e-mail message to: joinedsp@lists.epa.gov from the location at
which you normally send or receive
mail. For more information on the
listserv, go tohttps://www.epa.gov/
scipoly/oscpendo. Using the Listserv,
interested parties may sign up to receive
e-mail notifications of EDSP peer review
updates, including information on the
availability of peer review materials to
be posted at the EDSP website. These
materials may include the documents to
be peer reviewed, background
documents, the charge to the peer
reviewers, and reports that summarize
the results of peer reviews. EPA is not
at this time soliciting public comment
on the individual Tier 1 assays. Rather,
EPA will solicit comments on the Tier
1 battery once the individual peer
reviews have been completed as
discussed in Unit IV.D.
B. What is the Agency’s Authority for
Taking this Action?
Section 408(p) of FFDCA requires
EPA ‘‘to develop a screening program,
using appropriate validated test systems
and other scientifically relevant
information, to determine whether
certain substances may have an effect in
humans that is similar to an effect
produced by a naturally occurring
estrogen, or such other endocrine effect
as [EPA] may designate.’’ (FFDCA 21
U.S.C. 346a(p)). These test systems are
being validated under EPA’s EDSP.
EPA’s validation process includes peer
review as its final step.
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III. Background
EPA initially set forth the EDSP in the
August 11, 1998, Federal Register
notice (63 FR 42852) (FRL–6021–3) and
solicited public comment on the
program in the December 28, 1998,
Federal Register notice (63 FR 71541)
(FRL–6052–9). The program set forth in
these notices was based on the
recommendations of the Endocrine
Disruptor Screening and Testing
Advisory Committee (EDSTAC), which
was chartered under the Federal
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Advisory Committee Act (FACA), 5
U.S.C. App. 2, section 9(c). The
EDSTAC was comprised of members
representing the commercial chemical
and pesticides industries, Federal and
State agencies, worker protection and
labor organizations, environmental and
public health groups, and research
scientists.
EDSTAC recommended that EPA’s
program address both potential human
and ecological effects; examine effects
on estrogen, androgen, and thyroid
hormone-related processes; and include
non-pesticide chemicals, contaminants,
and mixtures in addition to pesticides
(Ref. 1). Based on these
recommendations, EPA developed a two
tiered approach, referred to as the EDSP.
The purpose of Tier 1 is to identify
substances that have the potential to
interact with the estrogen, androgen, or
thyroid hormone systems using a battery
of relatively short-term screening assays.
The purpose of Tier 2 is to identify and
establish a dose-response relationship
for any adverse effects that might result
from the interactions identified through
the Tier 1 assays. The Tier 2 tests are
multi-generational assays that will
provide the Agency with more
definitive testing data. EDSTAC also
recommended that EPA establish a
priority-setting approach for choosing
chemicals to undergo Tier 1 screening.
EPA currently is implementing its
EDSP in three major parts that are being
developed in parallel and with
substantial work on each well
underway. This document deals only
with the peer review component of the
validation process (item 3 in the
following discussion). EPA is
addressing the other aspects of the EDSP
in separate documents published in the
Federal Register. The three parts are
briefly summarized as follows:
1. Priority setting. EPA is prioritizing
chemicals to undergo screening in the
battery of Tier 1 assays. EPA described
its priority setting approach for the first
50-100 chemicals to be tested in the
Federal Register of September 27, 2005
(70 FR 56449) (FRL–7716–9). The draft
initial list of chemicals to undergo Tier
1 screening was published in the
Federal Register for public review on
June 18, 2007 (72 FR 33486) (FRL–
8129–3). The Agency expects to finalize
this initial list of chemicals before
screening is implemented in 2008. More
information on EPA’s priority setting
approach for the EDSP is available at
https://www.epa.gov/scipoly/oscpendo/
prioritysetting.
2. Procedures. EPA intends to
commence Tier 1 screening of the first
group of pesticide chemicals by issuing
test orders under FFDCA section 408(p)
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to chemical companies identified as the
manufacturer or processor of the
identified chemicals, including the
pesticide registrant. EPA is developing a
draft implementation policy that will
describe the procedures that EPA will
use to issue orders, the procedures that
order recipients would use to respond to
the order, how data protection and
compensation will be addressed in the
test orders, and other related procedures
or policies. In addition, EPA is
developing a draft template for the test
order and a draft information collection
request (ICR) to obtain the necessary
clearances under the Paperwork
Reduction Act (PRA). The Agency
expects to seek public comment on the
draft implementation policy and related
documents in late summer 2007, and
after considering those comments, EPA
expects to finalize the policy by the end
of 2007.
3. Assay validation. EPA is validating
assays that are candidates for inclusion
in the Tier 1 screening battery, selecting
the appropriate screening assays for the
screening battery based on the
validation data, and developing and
validating Tier 2 tests. Validation is
defined as the process by which the
reliability and relevance of test methods
are evaluated for a specific use (Ref. 2).
EPA has implemented the validation
process in several phases (Ref. 3),
including the following:
• Preparation of detailed review
papers (DRPs) that involve a search of
the relevant scientific literature and
development of a document that
discusses the scientific basis of each
assay and critically evaluates candidate
protocols.
• Conduct of pre-validation studies
that demonstrate and optimize the
assay, with the end result being a
standardized protocol for use in the
multi-laboratory validation phase.
• Conduct of validation studies in
multiple laboratories. The purpose of
this phase is to demonstrate the
transferability of the protocol, measure
lab-to-lab variability, and help establish
final performance characteristics for the
assay.
• Peer review of the data to
determine strengths and weaknesses of
the assays. Peer review is the critical
evaluation of scientific and technical
work products by independent experts.
Its purpose is to improve the quality,
credibility, and acceptability of
regulatory decisions. According to
EPA’s Peer Review Handbook (Ref. 4),
peer review is an important component
of the scientific process. It provides a
focused, objective evaluation of a
research proposal, publication, risk
assessment, health advisory, guidance
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or other document submitted for review.
The criticisms, suggestions and new
ideas provided by the peer reviewers
ensure objectivity, stimulate creative
thought, strengthen the reviewed
document and confer scientific
credibility on the product.
Comprehensive, objective peer review
leads to good science and product
Tier 1 Assays
acceptance within the scientific
community.
EPA plans to peer review the
following EDSP work products:
Tier 1 Assay Battery
Adult Male
Androgen Receptor Binding
Aromatase
Estrogen Receptor Binding
Female Pubertal
Fish Screen
Frog Metamorphosis
Hershberger1
Male Pubertal
Steroidogenesis H295R
Uterotrophic2
38579
Tier 2 Assays
Battery To be Determined
Amphibian Growth and Reproduction
Two-generation Avian
Two-generation Fish
Two-generation Mysid
1The Hershberger assay has been peer reviewed by the Organization for Economic Cooperation and Development (OECD). EPA will not conduct a separate peer review of this assay.
2The Uterotrophic assay has been peer reviewed by OECD. EPA will not conduct a separate peer review of this assay.
The primary product to be peer
reviewed for each assay will be an
Integrated Summary Report (ISR) that
summarizes and synthesizes the
information compiled from the
validation process (i.e., DRPs, prevalidation studies, and inter-lab
validation studies, with a major focus
on inter-laboratory validation results).
IV. Peer Review Process
The approaches that EPA intends to
use for conducting peer reviews of the
Tier 1 and Tier 2 assays, and the Tier
1 battery are described in the following
sections.
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A. Tier 1 Assays
The mechanism that will be used to
peer review Tier 1 Assays will be an
external letter review organized under
an EPA peer review contract. The
procedures used for peer review of the
Tier 1 assays will be in accordance with
EPA’s Peer Review Handbook (Ref. 4).
For each assay, the contractor will
compile a list of qualified peer review
candidates who are independent of
those who performed the work or who
have been involved in the development
or refinement of the protocol, including
those who have provided EPA with
expert advice throughout the validation
process. The potential peer reviewers
will be identified from among academia,
government, and the private sector,
based on their subject matter expertise,
availability, and lack of conflict of
interest or past involvement in the
project. From this pool of candidate
reviewers, the contractor will establish
a balanced peer review panel consisting
of 3 to 10 peer reviewers. EPA will be
notified of the identity of the peer
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reviewers, but will not have contact
with them before or during the peer
review process to ensure that an
independent review is performed. The
contractor will provide the reviewers
with the ISR for the assay to be
reviewed and any supporting
documentation that is needed for the
peer review, along with a list of charge
questions that will be developed by
EPA. The ISR will summarize and
synthesize the information compiled
from the validation process (i.e., DRPs,
pre-validation studies, and inter-lab
validation studies), with a major focus
on inter-laboratory validation results.
The charge to the reviewers will be
designed to address the following types
of issues:
1. Clarity of the stated purpose of the
assay.
2. Clarity, comprehensiveness, and
consistency of the data interpretation
with the stated purpose of the assay.
3. Biological and toxicological
relevance of the assay as related to its
stated purpose.
4. Clarity and conciseness of the
protocol in describing the methodology
of the assay such that the laboratory can:
a. Comprehend the objective;
b. Conduct the assay;
c. Observe and measure prescribed
endpoints;
d. Compile and prepare data for
statistical analyses; and
e. Report the results.
5. Strengths and/or limitations of the
assay.
6. Impacts of the choice of:
a. Test substances,
b. Analytical methods, and
c. Statistical methods in terms of
demonstrating the performance of the
assay.
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7. Repeatability and reproducibility of
the results obtained with the assay,
considering the variability inherent in
biological and chemical test methods.
The panel will review and comment
on the assay, and the contractor will
compile the peer review record. The
peer review record will include the peer
review document and all supporting
materials given to the peer reviewers;
the instructions/charge to the peer
reviewers; all comments, information,
and materials received from the peer
reviewers; and names, affiliations,
qualifications of the peer review panel
members. EPA will use the peer review
record to make a final determination as
to a Tier 1 assay’s suitability for use in
the screening program, and finalize the
assay for consideration for inclusion in
the Tier 1 battery. EPA plans to begin
peer reviewing Tier 1 assays by mid2007. This schedule is dependent upon
the successful completion of studies
that are currently underway.
B. Tier 1 Battery
As recommended by the Endocrine
Disruptor Screening and Testing
Advisory Committee (EDSTAC), EPA’s
EDSP testing strategy will consist of a
battery of Tier I assays. The battery is
expected to be comprised of screening
assays that, when used in combination,
will identify substances that have the
potential to interact with the estrogen,
androgen, and thyroid hormone
systems.
Prior to initiating testing, EPA intends
to propose a battery of Tier 1 screening
assays. The battery will be peer
reviewed by the Scientific Advisory
Panel (SAP) established under the
Federal Insecticide, Fungicide, and
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Federal Register / Vol. 72, No. 134 / Friday, July 13, 2007 / Notices
Rodenticide Act (FIFRA). The FIFRA
SAP is structured to provide scientific
advice, information and
recommendations to EPA 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 FACA. 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 and the National
Science Foundation. In addition, FIFRA,
as amended by the FQPA of 1996,
established a Science Review Board
consisting of at least 60 scientists who
are available to the FIFRA SAP on an ad
hoc basis to assist in reviews conducted
by the Panel. 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. More
information about the FIFRA SAP is
available at https://www.epa.gov/scipoly/
sap.
The proposed battery along with the
materials supporting its composition
will be provided to a panel of
approximately 15 to 20 SAP reviewers.
Some of the panel members may be
individuals who participated in review
of one or more Tier 1 assays, and some
individuals will be new to the EDSP
peer review process. Use of some of the
same reviewers for both the Tier 1
assays and the Tier 1 battery is intended
to ensure that individuals familiar with
the individual assays are represented
when the battery is discussed. This
should not present a conflict of interest
because the context of the review and
the questions being asked of the battery
reviewers will differ from what is asked
of the reviewers for the individual Tier
1 assays (e.g., questions posed to the
SAP reviewers would pertain to
whether the proposed battery
adequately covers the endpoints of
interest for estrogen, androgen, and
thyroid while questions posed to the
Tier 1 assay reviewers would focus on
the strengths and weaknesses of
individual assays.
C. Tier 2 Assays
The peer review strategy for the Tier
2 assays will follow a pattern similar to
that used for Tier 1 battery. These assays
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will be peer reviewed by the FIFRA
SAP.
D. Public Comment
The formal peer review process
described above is intended to ensure a
systematic and unbiased review of the
scientific basis for including an assay in
the EDSP. Although the Agency
recognizes that other qualified scientists
may also wish to offer opinions to the
Agency on the merits of the assays, EPA
is not soliciting public comments during
the period in which the individual Tier
1 assays are being peer reviewed.
Instead, the Agency will accept
comments on the overall Tier 1 battery
from the public when the composition
of the Tier 1 battery is being peer
reviewed by the SAP. A separateFederal
Register notice will announce the SAP
review of the Tier 1 battery and provide
information on opportunities for public
comment.
V. Listserv
The EDSP has created a listserver
(Listserv) or ‘‘mailing group.’’ A Listserv
is an electronic mailing list that makes
it possible to reach all individuals in a
mailing group with a single e-mail
message sent over the Internet. By
adding your name to the EDSP Listserv,
you will periodically receive an e-mail
announcing the availability of materials
on the EDSP website and other timely
information. To subscribe to the EDSP
Listserv send a blank e-mail message to:
join-edsp@lists.epa.gov from the
location at which you normally send or
receive mail.
VI. References
The following is a list of the
documents that are specifically
referenced in this document. These
references are available in the docket as
identified under ADDRESSES.
1. U.S. EPA. Endocrine Disruptor
Screening and Testing Advisory
Committee Final Report. August 1998.
Available at:https://www.epa.gov/
scipoly/oscpendo/edspoverview/
finalrpt.htm.
2. National Institute of Environmental
Health Sciences (NIEHS). Validation
and Regulatory Acceptance of
Toxicological Test Methods, A Report of
the ad hoc Interagency Coordinating
Committee on the Validation of
Alternative Methods. Research Triangle
Park, NC. NIH Report 97-3981. March
1997.
3. U.S. EPA. Validation of Screening
and Testing Assays Proposed for the
EDSP, Draft Version 5.3. October 23,
2006. Available at:https://www.epa.gov/
scipoly/sap/meetings/2007/february/
edsp-validation-paper.pdf.
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4. U.S. EPA. Science Policy Council
Handbook: Peer Review, 3rd Edition.
Office of Science Policy, U.S.
Environmental Protection Agency,
Washington, DC. EPA/100/B-06/002.
Available at: https://www.nheerl.epa.gov/
nheerllscience/peer/aboutlpeer/files/
3rdlEditionlPRlHandbook.pdf.
List of Subjects
Environmental protection, Chemicals,
Endocrine disruptors, Pesticides.
Dated: July 2, 2007.
James B. Gulliford,
Assistant Administrator for Prevention,
Pesticides and Toxic Substances.
[FR Doc. E7–13672 Filed 7–12–07; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[Docket Nos. EPA–R04–SFUND–2007–0542;
FRL–8439–3]
Georgia-Pacific Hardwood Site,
Plymouth, Washington County, NC;
Notice of Settlement
Environmental Protection
Agency.
ACTION: Notice of settlement.
AGENCY:
SUMMARY: Under Section 122(h) of the
Comprehensive Environmental
Response, Compensation and Liability
Act (CERCLA), the United States
Environmental Protection Agency has
entered into a settlement for
reimbursement of past response
concerning the Georgia-Pacific
Hardwood Site located in Plymouth,
Washington County, North Carolina.
DATES: The Agency will consider public
comments settlement until August 13,
2007. The Agency will consider all
comments received and may modify or
withdraw its consent to the settlement
if comments received disclose facts or
considerations which indicate that the
settlement is inappropriate, improper,
or inadequate.
ADDRESSES: Copies of the settlement are
available from Ms. Paula V. Batchelor.
Submit your comments, identified by
Docket ID No. EPA–R04–SFUND–2007–
0542 or Site name Georgia-Pacific
Hardwood Superfund Site by one of the
following methods:
• https://www.regulations.gov: Follow
the online instructions for submitting
comments.
• E-mail: Batchelor.Paula@epa.gov.
• Fax: 404/562–8842/Attn Paula V.
Batchelor.
• Mail: Ms. Paula V. Batchelor, U.S.
EPA Region 4, SD–SEIMB, 61 Forsyth
Street, SW., Atlanta, Georgia 30303. ‘‘In
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]]>Agencies
[Federal Register Volume 72, Number 134 (Friday, July 13, 2007)]
[Notices]
[Pages 38577-38580]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-13672]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2007-0493; FRL-8138-4]
Endocrine Disruptor Screening Program; Assay Peer Review Process
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The purpose of this notice is to announce the approach EPA
intends to take for conducting peer reviews of the Tier 1 screening
assays and Tier 2 testing assays that are being validated by the
Agency's Endocrine Disruptor Screening Program (EDSP), as well as EPA's
approach for conducting the peer review of the Tier 1 battery. EPA is
also announcing the availability of a listserver (Listserv) that will
allow interested parties to sign up to receive e-mail notifications of
EDSP peer review updates, including information on the availability of
peer review materials to be posted on the EDSP website. These materials
may include the documents to be peer reviewed, background documents,
the charge to the peer reviewers, and reports that summarize the
results of peer reviews.
FOR FURTHER INFORMATION CONTACT: Linda Phillips, Office of Science
Coordination and Policy (7203M), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(202) 564-1264; e-mail address: phillips.linda@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
This action is directed to the public in general. You may be
potentially affected by this action if you produce, manufacture, use,
consume, work with, or import commercial or pesticide chemicals. To
determine whether you or your business may be affected by this action,
you should carefully examine section 408(p) of FFDCA, 21 U.S.C.
346a(p). Potentially affected entities, using the North American
Industrial Classification System (NAICS) codes to assist you and others
in determining whether this action might apply to certain entities, may
include, but are not limited to:
Chemical Manufacturers, Importers and Processors (NAICS
code 325), e.g., entities who manufacture, import or process chemical
substances.
Pesticide, Fertilizer, and Other Agricultural Chemical
Manufacturing (NAICS code 3253), e.g., entities who manufacture, import
or process pesticide, fertilizer and agricultural chemicals.
Scientific Research and Development Services (NAICS code
5417), e.g., persons who conduct testing of chemical substances for
endocrine affects.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. 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. Materials cited in this notice are available in docket
number EPA-HQ-OPPT-2007-0493. All documents in the docket are listed in
the regulations.gov index. To access the electronic docket, go to
https://www.regulations.gov, select ``Advanced Search,'' then ``Docket
Search.'' Insert the docket ID number where indicated and select the
``Submit'' button. Follow the instructions on the regulations.gov
website to view the docket index or access available documents.
Although listed in the index, some information is not publicly
available, e.g., Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available
electronically athttps://www.regulations.gov, or, if only available in
hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution
Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of
operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
Federal holidays. The telephone number of the EPA/DC Public Reading
Room is (202) 566-1744, and the telephone number for the OPPT Docket is
(202) 566-0280. Docket visitors are required to show photographic
identification, pass through a metal detector, and sign the EPA visitor
log. All visitor bags are processed through an X-ray machine and
subject to search. Visitors will be provided an EPA/DC badge that must
be visible at all times in the building and returned upon departure.
2. Electronic access. You may access thisFederal Register document
electronically through the EPA Internet
[[Page 38578]]
under the ``Federal Register'' listings athttps://www.epa.gov/fedrgstr/.
II. Introduction
A. What Action is the Agency Taking?
EPA is announcing its approach for conducting peer reviews of Tier
1 screening assays and Tier 2 testing assays that are being validated
by the Agency's Endocrine Disruptor Screening Program (EDSP), as well
as its approach for conducting the peer review of the Tier 1 battery.
EPA is also announcing the availability of a listserver (Listserv). To
subscribe to the EDSP Listserv send a blank e-mail message to: join-
edsp@lists.epa.gov from the location at which you normally send or
receive mail. For more information on the listserv, go tohttps://
www.epa.gov/scipoly/oscpendo. Using the Listserv, interested parties
may sign up to receive e-mail notifications of EDSP peer review
updates, including information on the availability of peer review
materials to be posted at the EDSP website. These materials may include
the documents to be peer reviewed, background documents, the charge to
the peer reviewers, and reports that summarize the results of peer
reviews. EPA is not at this time soliciting public comment on the
individual Tier 1 assays. Rather, EPA will solicit comments on the Tier
1 battery once the individual peer reviews have been completed as
discussed in Unit IV.D.
B. What is the Agency's Authority for Taking this Action?
Section 408(p) of FFDCA requires EPA ``to develop a screening
program, using appropriate validated test systems and other
scientifically relevant information, to determine whether certain
substances may have an effect in humans that is similar to an effect
produced by a naturally occurring estrogen, or such other endocrine
effect as [EPA] may designate.'' (FFDCA 21 U.S.C. 346a(p)). These test
systems are being validated under EPA's EDSP. EPA's validation process
includes peer review as its final step.
III. Background
EPA initially set forth the EDSP in the August 11, 1998, Federal
Register notice (63 FR 42852) (FRL-6021-3) and solicited public comment
on the program in the December 28, 1998, Federal Register notice (63 FR
71541) (FRL-6052-9). The program set forth in these notices was based
on the recommendations of the Endocrine Disruptor Screening and Testing
Advisory Committee (EDSTAC), which was chartered under the Federal
Advisory Committee Act (FACA), 5 U.S.C. App. 2, section 9(c). The
EDSTAC was comprised of members representing the commercial chemical
and pesticides industries, Federal and State agencies, worker
protection and labor organizations, environmental and public health
groups, and research scientists.
EDSTAC recommended that EPA's program address both potential human
and ecological effects; examine effects on estrogen, androgen, and
thyroid hormone-related processes; and include non-pesticide chemicals,
contaminants, and mixtures in addition to pesticides (Ref. 1). Based on
these recommendations, EPA developed a two tiered approach, referred to
as the EDSP. The purpose of Tier 1 is to identify substances that have
the potential to interact with the estrogen, androgen, or thyroid
hormone systems using a battery of relatively short-term screening
assays. The purpose of Tier 2 is to identify and establish a dose-
response relationship for any adverse effects that might result from
the interactions identified through the Tier 1 assays. The Tier 2 tests
are multi-generational assays that will provide the Agency with more
definitive testing data. EDSTAC also recommended that EPA establish a
priority-setting approach for choosing chemicals to undergo Tier 1
screening.
EPA currently is implementing its EDSP in three major parts that
are being developed in parallel and with substantial work on each well
underway. This document deals only with the peer review component of
the validation process (item 3 in the following discussion). EPA is
addressing the other aspects of the EDSP in separate documents
published in the Federal Register. The three parts are briefly
summarized as follows:
1. Priority setting. EPA is prioritizing chemicals to undergo
screening in the battery of Tier 1 assays. EPA described its priority
setting approach for the first 50-100 chemicals to be tested in the
Federal Register of September 27, 2005 (70 FR 56449) (FRL-7716-9). The
draft initial list of chemicals to undergo Tier 1 screening was
published in the Federal Register for public review on June 18, 2007
(72 FR 33486) (FRL-8129-3). The Agency expects to finalize this initial
list of chemicals before screening is implemented in 2008. More
information on EPA's priority setting approach for the EDSP is
available at https://www.epa.gov/scipoly/oscpendo/prioritysetting.
2. Procedures. EPA intends to commence Tier 1 screening of the
first group of pesticide chemicals by issuing test orders under FFDCA
section 408(p) to chemical companies identified as the manufacturer or
processor of the identified chemicals, including the pesticide
registrant. EPA is developing a draft implementation policy that will
describe the procedures that EPA will use to issue orders, the
procedures that order recipients would use to respond to the order, how
data protection and compensation will be addressed in the test orders,
and other related procedures or policies. In addition, EPA is
developing a draft template for the test order and a draft information
collection request (ICR) to obtain the necessary clearances under the
Paperwork Reduction Act (PRA). The Agency expects to seek public
comment on the draft implementation policy and related documents in
late summer 2007, and after considering those comments, EPA expects to
finalize the policy by the end of 2007.
3. Assay validation. EPA is validating assays that are candidates
for inclusion in the Tier 1 screening battery, selecting the
appropriate screening assays for the screening battery based on the
validation data, and developing and validating Tier 2 tests. Validation
is defined as the process by which the reliability and relevance of
test methods are evaluated for a specific use (Ref. 2). EPA has
implemented the validation process in several phases (Ref. 3),
including the following:
Preparation of detailed review papers (DRPs) that involve
a search of the relevant scientific literature and development of a
document that discusses the scientific basis of each assay and
critically evaluates candidate protocols.
Conduct of pre-validation studies that demonstrate and
optimize the assay, with the end result being a standardized protocol
for use in the multi-laboratory validation phase.
Conduct of validation studies in multiple laboratories.
The purpose of this phase is to demonstrate the transferability of the
protocol, measure lab-to-lab variability, and help establish final
performance characteristics for the assay.
Peer review of the data to determine strengths and
weaknesses of the assays. Peer review is the critical evaluation of
scientific and technical work products by independent experts. Its
purpose is to improve the quality, credibility, and acceptability of
regulatory decisions. According to EPA's Peer Review Handbook (Ref. 4),
peer review is an important component of the scientific process. It
provides a focused, objective evaluation of a research proposal,
publication, risk assessment, health advisory, guidance
[[Page 38579]]
or other document submitted for review. The criticisms, suggestions and
new ideas provided by the peer reviewers ensure objectivity, stimulate
creative thought, strengthen the reviewed document and confer
scientific credibility on the product. Comprehensive, objective peer
review leads to good science and product acceptance within the
scientific community.
EPA plans to peer review the following EDSP work products:
------------------------------------------------------------------------
Tier 1 Assay
Tier 1 Assays Battery Tier 2 Assays
------------------------------------------------------------------------
Adult Male Battery To be Amphibian Growth
Androgen Receptor Binding....... Determined and Reproduction
Aromatase....................... Two-generation
Estrogen Receptor Binding....... Avian
Female Pubertal................. Two-generation
Fish Screen..................... Fish
Frog Metamorphosis.............. Two-generation
Hershberger\1\.................. Mysid
Male Pubertal...................
Steroidogenesis H295R...........
Uterotrophic\2\.................
------------------------------------------------------------------------
\1\The Hershberger assay has been peer reviewed by the Organization for
Economic Cooperation and Development (OECD). EPA will not conduct a
separate peer review of this assay.
\2\The Uterotrophic assay has been peer reviewed by OECD. EPA will not
conduct a separate peer review of this assay.
The primary product to be peer reviewed for each assay will be an
Integrated Summary Report (ISR) that summarizes and synthesizes the
information compiled from the validation process (i.e., DRPs, pre-
validation studies, and inter-lab validation studies, with a major
focus on inter-laboratory validation results).
IV. Peer Review Process
The approaches that EPA intends to use for conducting peer reviews
of the Tier 1 and Tier 2 assays, and the Tier 1 battery are described
in the following sections.
A. Tier 1 Assays
The mechanism that will be used to peer review Tier 1 Assays will
be an external letter review organized under an EPA peer review
contract. The procedures used for peer review of the Tier 1 assays will
be in accordance with EPA's Peer Review Handbook (Ref. 4). For each
assay, the contractor will compile a list of qualified peer review
candidates who are independent of those who performed the work or who
have been involved in the development or refinement of the protocol,
including those who have provided EPA with expert advice throughout the
validation process. The potential peer reviewers will be identified
from among academia, government, and the private sector, based on their
subject matter expertise, availability, and lack of conflict of
interest or past involvement in the project. From this pool of
candidate reviewers, the contractor will establish a balanced peer
review panel consisting of 3 to 10 peer reviewers. EPA will be notified
of the identity of the peer reviewers, but will not have contact with
them before or during the peer review process to ensure that an
independent review is performed. The contractor will provide the
reviewers with the ISR for the assay to be reviewed and any supporting
documentation that is needed for the peer review, along with a list of
charge questions that will be developed by EPA. The ISR will summarize
and synthesize the information compiled from the validation process
(i.e., DRPs, pre-validation studies, and inter-lab validation studies),
with a major focus on inter-laboratory validation results. The charge
to the reviewers will be designed to address the following types of
issues:
1. Clarity of the stated purpose of the assay.
2. Clarity, comprehensiveness, and consistency of the data
interpretation with the stated purpose of the assay.
3. Biological and toxicological relevance of the assay as related
to its stated purpose.
4. Clarity and conciseness of the protocol in describing the
methodology of the assay such that the laboratory can:
a. Comprehend the objective;
b. Conduct the assay;
c. Observe and measure prescribed endpoints;
d. Compile and prepare data for statistical analyses; and
e. Report the results.
5. Strengths and/or limitations of the assay.
6. Impacts of the choice of:
a. Test substances,
b. Analytical methods, and
c. Statistical methods in terms of demonstrating the performance of
the assay.
7. Repeatability and reproducibility of the results obtained with
the assay, considering the variability inherent in biological and
chemical test methods.
The panel will review and comment on the assay, and the contractor
will compile the peer review record. The peer review record will
include the peer review document and all supporting materials given to
the peer reviewers; the instructions/charge to the peer reviewers; all
comments, information, and materials received from the peer reviewers;
and names, affiliations, qualifications of the peer review panel
members. EPA will use the peer review record to make a final
determination as to a Tier 1 assay's suitability for use in the
screening program, and finalize the assay for consideration for
inclusion in the Tier 1 battery. EPA plans to begin peer reviewing Tier
1 assays by mid-2007. This schedule is dependent upon the successful
completion of studies that are currently underway.
B. Tier 1 Battery
As recommended by the Endocrine Disruptor Screening and Testing
Advisory Committee (EDSTAC), EPA's EDSP testing strategy will consist
of a battery of Tier I assays. The battery is expected to be comprised
of screening assays that, when used in combination, will identify
substances that have the potential to interact with the estrogen,
androgen, and thyroid hormone systems.
Prior to initiating testing, EPA intends to propose a battery of
Tier 1 screening assays. The battery will be peer reviewed by the
Scientific Advisory Panel (SAP) established under the Federal
Insecticide, Fungicide, and
[[Page 38580]]
Rodenticide Act (FIFRA). The FIFRA SAP is structured to provide
scientific advice, information and recommendations to EPA 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 FACA. 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 and the National Science Foundation. In addition, FIFRA, as
amended by the FQPA of 1996, established a Science Review Board
consisting of at least 60 scientists who are available to the FIFRA SAP
on an ad hoc basis to assist in reviews conducted by the Panel. 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.
More information about the FIFRA SAP is available at https://
www.epa.gov/scipoly/sap.
The proposed battery along with the materials supporting its
composition will be provided to a panel of approximately 15 to 20 SAP
reviewers. Some of the panel members may be individuals who
participated in review of one or more Tier 1 assays, and some
individuals will be new to the EDSP peer review process. Use of some of
the same reviewers for both the Tier 1 assays and the Tier 1 battery is
intended to ensure that individuals familiar with the individual assays
are represented when the battery is discussed. This should not present
a conflict of interest because the context of the review and the
questions being asked of the battery reviewers will differ from what is
asked of the reviewers for the individual Tier 1 assays (e.g.,
questions posed to the SAP reviewers would pertain to whether the
proposed battery adequately covers the endpoints of interest for
estrogen, androgen, and thyroid while questions posed to the Tier 1
assay reviewers would focus on the strengths and weaknesses of
individual assays.
C. Tier 2 Assays
The peer review strategy for the Tier 2 assays will follow a
pattern similar to that used for Tier 1 battery. These assays will be
peer reviewed by the FIFRA SAP.
D. Public Comment
The formal peer review process described above is intended to
ensure a systematic and unbiased review of the scientific basis for
including an assay in the EDSP. Although the Agency recognizes that
other qualified scientists may also wish to offer opinions to the
Agency on the merits of the assays, EPA is not soliciting public
comments during the period in which the individual Tier 1 assays are
being peer reviewed. Instead, the Agency will accept comments on the
overall Tier 1 battery from the public when the composition of the Tier
1 battery is being peer reviewed by the SAP. A separateFederal Register
notice will announce the SAP review of the Tier 1 battery and provide
information on opportunities for public comment.
V. Listserv
The EDSP has created a listserver (Listserv) or ``mailing group.''
A Listserv is an electronic mailing list that makes it possible to
reach all individuals in a mailing group with a single e-mail message
sent over the Internet. By adding your name to the EDSP Listserv, you
will periodically receive an e-mail announcing the availability of
materials on the EDSP website and other timely information. To
subscribe to the EDSP Listserv send a blank e-mail message to: join-
edsp@lists.epa.gov from the location at which you normally send or
receive mail.
VI. References
The following is a list of the documents that are specifically
referenced in this document. These references are available in the
docket as identified under ADDRESSES.
1. U.S. EPA. Endocrine Disruptor Screening and Testing Advisory
Committee Final Report. August 1998. Available at:https://www.epa.gov/
scipoly/oscpendo/edspoverview/finalrpt.htm.
2. National Institute of Environmental Health Sciences (NIEHS).
Validation and Regulatory Acceptance of Toxicological Test Methods, A
Report of the ad hoc Interagency Coordinating Committee on the
Validation of Alternative Methods. Research Triangle Park, NC. NIH
Report 97-3981. March 1997.
3. U.S. EPA. Validation of Screening and Testing Assays Proposed
for the EDSP, Draft Version 5.3. October 23, 2006. Available at:https://
www.epa.gov/scipoly/sap/meetings/2007/february/edsp-validation-
paper.pdf.
4. U.S. EPA. Science Policy Council Handbook: Peer Review, 3rd
Edition. Office of Science Policy, U.S. Environmental Protection
Agency, Washington, DC. EPA/100/B-06/002. Available at: https://
www.nheerl.epa.gov/nheerl_science/peer/about_peer/files/3rd_
Edition_PR_Handbook.pdf.
List of Subjects
Environmental protection, Chemicals, Endocrine disruptors,
Pesticides.
Dated: July 2, 2007.
James B. Gulliford,
Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
[FR Doc. E7-13672 Filed 7-12-07; 8:45 am]
BILLING CODE 6560-50-S
