[Federal Register Volume 65, Number 98 (Friday, May 19, 2000)]
[Notices]
[Pages 31900-31902]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-12632]
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ENVIRONMENTAL PROTECTION AGENCY
[OPPTS-42212; FRL-6559-9]
Priority-Setting Workshop for the Endocrine Disruptor Screening
Program; Notice of Public Meeting
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice invites public participation in a workshop to
discuss the development of a priority-setting system for the selection
of chemicals for testing in the Endocrine Disruptor Screening Program
(EDSP). The Agency's 1998 Proposed Statement of Policy for the EDSP
contains a set of principles and a general strategy for setting
priorities for testing. The Agency has developed a draft version of a
priority-setting system and seeks public input on the further design
and implementation of the system. The workshop will also provide an
overall update and invite general comment on other aspects of the EDSP,
including the status of the standardization and validation efforts and
the approach for pesticide active ingredients.
DATES: The meeting will be held on Monday, June 5, 2000, from 10 a.m.
to 5 p.m.; on June 6 from 9 a.m. to 5 p.m.; and on June 7 from 9 a.m.
to 4 p.m. Your request to participate in the meeting must be received
by EPA on or before May 31, 2000.
ADDRESSES: The meeting will be held at Crystal City Hilton, 2399
Jefferson Davis Hwy., Arlington VA, (703) 418-6800. Requests to
participate may be submitted by mail, electronically, or in person.
Please follow the detailed instructions for each method as provided in
Unit III. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by
EPA, your request must identify docket control number OPPTS-42212 in
the subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: For general information contact:
Barbara Cunningham, Director, Office of Program Management and
Evaluation, Office of Pollution Prevention and Toxics (7401),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: (202) 554-1404; e-mail address:
[email protected].
For technical information contact: For information related to the
overall program status of the EDSP: Gary Timm, telephone number: (202)
260-1859, e-mail: [email protected] or Anthony Maciorowski, telephone
number: (202) 260-3048, e-mail: [email protected], Office of
Science Coordination and Policy (7101), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
For information on pesticide activities under the EDSP: Penny
Fenner-Crisp, telephone number: (703) 605-0654, e-mail: [email protected], Office of Pesticide Programs (7501C),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460.
For information on the Endocrine Disruptor Priority-Setting
Database (EDPSD): Jim Darr, telephone number: (202) 260-3441, e-mail:
[email protected] or Patrick Kennedy, telephone number: (202) 260-
3916, e-mail: [email protected], Economics, Exposure, and
Technology Division (7406), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460.
SUPPLEMENTARY INFORMATION:
I. Does this Notice Apply to Me?
This action is directed to the public in general. This action may,
however, be of interest to persons who manufacture, import, or use
chemical substances that are addressed by the EDPSD. The general public
may also have an interest in the design and implementation of the EDPSD
and in other aspects of the Endocrine Disruptor Screening Program
covered at the workshop. 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
technical person listed under FOR FURTHER INFORMATION CONTACT.
II. How Can I Get Additional Information, Including Copies of this
Document or Other Related Documents?
A. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
[[Page 31901]]
To access this document, on the Home Page select ``Laws
and Regulations'' and then look up the entry for this document under
the ``Federal Register--Environmental Documents.'' You can also go
directly to the Federal Register listings at http://www.epa.gov/fedrgstr/.
The EDPSD can be downloaded on or after May 22, 2000, from http://www.ergweb.com/endocrine.
B. In person. The Agency has established an official record for
this meeting under docket control number OPPTS-42212. The official
record consists of the documents specifically referenced in this
notice, any public comments received during an applicable comment
period, and other information related to the EDPSD, including any
information claimed as Confidential Business Information (CBI). This
official record includes the documents that are physically located in
the docket, as well as the documents that are referenced in those
documents. The public version of the official record, which includes
printed, paper versions of any electronic comments that may be
submitted during an applicable comment period, is available for
inspection in the TSCA Nonconfidential Information Center, North East
Mall Rm. B-607, Waterside Mall, 401 M St., SW., Washington, DC. The
Center is open from noon to 4 p.m., Monday through Friday, excluding
legal holidays. The telephone number of the Center is (202) 260-7099.
III. How Can I Request to Participate in this Meeting?
You may submit a request to participate in this meeting through the
mail, in person, or electronically. Do not submit any information in
your request that is considered CBI. Please indicate if you would like
to make oral comments at the meeting so that adequate time can be
reserved on the agenda. To ensure proper receipt by EPA, it is
imperative that you identify docket control number OPPTS-42212 in the
subject line on the first page of your request.
A. By mail. You may submit a written request to: Document Control
Office (7407), Office of Pollution Prevention and Toxics (OPPT),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460.
B. In person or by courier. You may deliver a written request to:
OPPT Document Control Office (DOC) in the East Tower Rm. G-099,
Waterside Mall, 401 M St., SW., Washington, DC. The DOC is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the DOC is (202) 260-7093.
C. Electronically. You may submit your request electronically by e-
mail to: ``[email protected].'' Do not submit any information
electronically that you consider to be CBI. Use WordPerfect 6.1/8.0 or
ASCII file format and avoid the use of special characters and any form
of encryption. All comments in electronic form must be identified by
docket control number OPPTS-42212. You may also file a request online
at many Federal Depository Libraries.
IV. Background Information on the Workshop
The Agency described the major elements of a proposed EDSP and the
Agency's plan for implementation in a December 28, 1998, Federal
Register notice (63 FR 42208) (FRL-6052-9). The EDSP has five major
components:
1. Sorting, in which chemicals are classified according to the
availability of information on each chemical's endocrine disrupting
potential.
2. Priority Setting, in which EPA will determine the priority order
for entry into Tier 1 Screening.
3. Tier 1 Screening, a battery of in vitro and in vivo assays
designed to identify those chemicals that are not likely to interact
with the estrogen, androgen, or thyroid hormone systems.
4. Tier 2 Testing, a battery of assays designed to determine
whether a chemical may have an effect in humans similar to that of
naturally occurring hormones and to identify, characterize, and
quantify those effects for estrogen, androgen, and thyroid hormone
effects.
5. Hazard Assessment, a weight-of-evidence evaluation of Tier 1 and
Tier 2 results.
It is expected that the Sorting step will result in a relatively
small number of chemicals proceeding directly to Tier 2 Testing or to
Hazard Assessment and that the vast majority of chemicals will be
placed in Priority Setting for Tier 1 Screening. The universe of
chemicals of concern to EPA as potential endocrine disruptors is
estimated to number more than 87,000 and includes pesticides,
commercial chemicals, cosmetic ingredients, food additives, nutritional
supplements, and certain mixtures. The Agency's initial priority-
setting efforts are focusing on two groups of chemicals:
1. Pesticide active ingredients (900 chemicals).
2. High production volume chemicals used as inert ingredients in
pesticides (HPV Inerts, 620 chemicals).
The EDPSD is being developed to help set Tier 1 priorities. At
present, the EDPSD contains data on potential endocrine-related
toxicity for only HPV Inerts. The Agency plans to incorporate
predictions of toxicity based on quantitative structure-activity
relations (QSAR) into the EDPSD when appropriate QSAR models are agreed
upon. Incorporation of QSAR data will allow the EDPSD to rank a much
larger number of chemicals on both effects and exposure factors. The
Agency plans to hold a workshop on the use of QSAR in the EDSP later
this year. Hazard and exposure data on pesticide active ingredients may
be included in future versions of the EDPSD as a means of increasing
the accessibility of these data, but there are no near-term plans to
use the EDPSD to set testing priorities for pesticide active
ingredients. The EDPSD will undergo a formal peer review after
implementation of final decisions regarding its scope and content.
The EDPSD utilizes a ``compartment-based priority-setting
strategy'' that builds upon distinct compartments of exposure- and
effects-related information and criteria as well as a category of
specially targeted priorities. The EDPSD presently contains the
following compartments:
Exposure Data Compartments
Human Biological Monitoring Data
Ecological Biological Monitoring Data
Chemicals in Food and Drinking Water
Chemicals in Consumer/Cosmetic Products
Occupational Exposure Chemicals
Surface Water Monitoring Data
Indoor Air Monitoring Data
Outdoor Air Monitoring Data
Sediments/Soil Monitoring Data
Superfund Data
Environmental Releases/Environmental Fate
Production/Import Volumes/Environmental Fate
Exposure Multi-Hit Compartment
Effects Data Compartments
Epidemiological and Clinical Data on Endocrine-Related Effects
Reproductive/Developmental Toxicity in Laboratory Animals
Chronic/Subchronic Toxicity in Laboratory Animals
Carcinogenicity in Endocrine Target Tissues in Laboratory
Animals
Ecotoxicity Effects
Effects Multi-Hit Compartment
Combined Compartments
Rank in Human Biological Monitoring x Highest Rank in Any Health
Effects Compartment
Highest Rank in Any Other Human Exposure Compartment x Highest
Rank in Any Health Effect Compartment
Rank in Ecological Biological Monitoring Compartment x Highest
Rank in a Related Ecotoxicity Effects Compartment
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Highest Rank in Any Other Ecological Exposure Compartment x
Highest Rank in a Related Ecotoxicity Effects Compartment
Specially Targeted Priorities
Mixtures
Naturally Occurring Non-Steroidal Estrogens
Nominations
V. Purpose and Structure of the Workshop
The first day of the workshop will provide an overview of the EDSP,
including a discussion of the Agency's overall approach to priority
setting, how pesticide active ingredients are being addressed
differently than other chemicals, the current status of standardization
and validation activities, and the projected time lines for chemical
selection and testing. The second and third days of the workshop will
focus on the EDPSD. The Agency held a workshop in January 1999, to
discuss the basic design of the EDPSD. The EDPSD is now a functional
database and the Agency seeks comment on the specific hazard and
exposure data elements included in the database, the ranking
algorithms, and the priority lists that result from various ranking
options.
The workshop will be structured around discussion of the specific
issues listed in the agenda by invited participants. A limited amount
of time will be allotted for additional comment by other meeting
attendees. Participants may also submit written comments during or
after the meeting. Please submit comments no later than 30 days
following the workshop. Comments should be sent to the docket address
listed in Unit III. and should reference the docket control number
OPPTS-42212.
VI. Agenda
Monday, June 5 Overview of the Endocrine Disruptor Screening Program
10:00 a.m. Welcome
10:15 a.m. Overview of the Endocrine Disruptor Screening Program
10:45 a.m. Standardization and Validation Activities
11:00 a.m. Overview of Priority Setting
11:15 a.m. Questions
11:30 a.m. OPP Activities to Prioritize Pesticide Active
Ingredients
12:00 noon Questions on Prioritization of Active Ingredients
12:15 p.m. Lunch
1:30 p.m. Public Comments on the Endocrine Disruptor Screening
Program, Standardization/Validation Activities, or the OPP Actives
Approach
3:00 p.m. Break
3:15 p.m. Demo of EDPSD version 2
5:00 p.m. End of Demo
Tuesday, June 6 Panel Discussion of the Priority Setting Database
(Exposure and Effects)
9:00 a.m. Overview of the Current Status of the EDPSD
9:15 a.m. Completeness of Data Sources used in Exposure
Compartments
10:30 a.m. Break
10:45 a.m. Ranking Algorithms Used in Exposure Compartments
12:00 noon Lunch
1:30 p.m Quality of the Data in Exposure Compartments
2:30 p.m. Break
2:45 p.m. Completeness of Data Sources used in Effects
Compartments
4:00 p.m. Ranking Algorithms Used in Effects Compartments
5:00 p.m. End of day
Wednesday, June 7 Panel Discussion of the Priority Setting Database
(Effects, Combined Exposure and Effects Compartments, and Weights)
9:00 a.m. Quality of the Data in Effects Compartments
10:00 a.m. Definition and Ranking Procedure of the Combined
Compartments
10:45 a.m. Break
11:00 a.m. Discussion of Database Default Weights and Ranked
List of HPV/Inerts
12:00 noon Lunch
1:30 p.m. Continue Discussion of Database Default Weights and
Ranked List of HPV/Inerts
3:00 p.m. Public Comments on EDPSD
4:00 p.m. End of Workshop
The overall objective of the panel discussions is to address the
key issues that bear upon the ability of the EDPSD to accomplish its
intended purpose of setting Tier 1 priorities. These issues include:
Are the exposure and effects data sources adequate? Are any
important data sources missing?
Are the compartment definitions clear? Should any compartments be
added? Should any existing compartments be split or combined?
Does the ranking algorithm for each compartment make sense, e.g.,
rank based on average concentration in monitoring compartments, rank
based on lowest observed adverse effect level (LOAEL) in effects
compartments?
Certain compartments have a lot of ties in their rankings. How
should you break ties in rankings in the chemical selection process,
e.g., if you want to pick the top 10 chemicals from a given compartment
and there are 15 chemicals tied at rank #6, what do you do?
With respect to the EPA default scenario: Do the overall category
weightings make sense, i.e., cumulative weights for exposure vs.
effects vs. combined compartments? Do the cumulative weights for human
health vs. ecological concerns make sense? Do the individual
compartment weights make sense? Suggested alternatives?
Is the EDPSD sufficiently transparent in terms of its operation and
documentation, i.e., is the basis of the ranking readily understandable
to the user?
List of Subjects
Environmental protection, Chemicals, Endocrine disruptors,
Pesticides.
Dated: May 15, 2000.
Stephen L. Johnson,
Acting Assistant Administrator, Office of Prevention, Pesticides and
Toxic Substances.
[FR Doc. 00-12632 Filed 5-16-00; 1:33 pm]
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