[Federal Register Volume 63, Number 248 (Monday, December 28, 1998)]
[Notices]
[Pages 71568-71570]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-34299]
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ENVIRONMENTAL PROTECTION AGENCY
[OPPTS-42207; FRL-6052-8]
Endocrine Disruptor Screening Program; Priority-Setting Workshop
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 recommendations of the Endocrine Disruptor Screening and
Testing Advisory Committee (EDSTAC) and the Agency's subsequent
Statement of Policy contain a set of principles and a general strategy
for setting priorities for testing. The Agency is now commencing the
detailed design phase of the priority-setting system and seeks public
input on the design of the system.
DATES: The workshop will be held on Wednesday, January 20, 1999, from
10 a.m. to 5 p.m. and Thursday, January 21, 1999, from 9 a.m. to 4 p.m.
Comments may be submitted during the workshop or after the workshop
until February 22, 1999.
ADDRESSES: The workshop will be held at the Crystal City Marriott
Hotel, 1999 Jefferson Davis Hwy., Arlington, VA; telephone (703) 413-
5500, toll-free reservation line (800) 228-9290.
Comments should be sent to Patrick Kennedy or James Darr and to the
OPPTS Document Control Officer. Comments may be sent electronically or
by mail to: Patrick Kennedy, e-mail address: kennedy.patrick@epa.gov or
Jim Darr, e-mail address: darr.james@epa.gov; Office of Pollution
Prevention and Toxics (7406), Environmental Protection Agency, 401 M
St., SW., Washington, DC 20460.
Each comment must bear the docket control number OPPTS-42207. All
comments should be sent in triplicate to: OPPT Document Control Officer
(7407), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 401 M St., SW., Room G-099, East Tower, Washington,
DC 20460.
Comments and data may also be submitted electronically to: oppt.
ncic@epa.gov. Follow the instructions under Unit V. of this notice. No
Confidential Business Information (CBI) should be submitted through e-
mail.
All comments which contain information claimed as CBI must be
clearly marked as such. Three sanitized copies of any comments
containing information claimed as CBI must also be submitted and will
be placed in the public record for this rulemaking. Persons submitting
information on any portion of which they believe is entitled to
treatment as CBI by EPA must assert a business confidentiality claim in
accordance with 40 CFR 2.203(b) for each such portion. This claim must
be made at the time that the information is submitted to EPA. If a
submitter does not assert a confidentiality claim at the time of
submission, EPA will consider this as a waiver of any confidentiality
claim and the information may be made available to the public by EPA
without further notice to the submitter.
FOR FURTHER INFORMATION CONTACT: For information related specifically
to the workshop: Patrick Kennedy, telephone: (202) 260-3916, e-mail
address: kennedy.patrick@epa.gov or Jim Darr, telephone: (202) 260-
3441, e-mail address: darr.james@epa.gov; Office of Pollution
Prevention and Toxics (7406), Environmental Protection Agency, 401 M
St., SW., Washington, DC 20460. For general information or copies of
the ESTAC Report: TSCA Hotline, Environmental Assistance Division
(7408), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460; telephone
(202) 554-1404, TDD (202) 554-0551; e-mail address: TSCA-
Hotline@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The Agency first set forth the basic components of the EDSP in an
August 11, 1998 (63 FR 42852) (FRL-6021-3) Federal Register notice. A
more detailed Statement of Policy has been developed and is published
elsewhere in this issue of the Federal Register.
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 (EAT).
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 EAT effects.
[[Page 71569]]
5. Hazard assessment, a weight-of-evidence evaluation of Tier 1
and Tier 2 results.
It is expected that the sorting will result in a relatively small
number of chemicals proceeding directly to Tier 2 testing or hazard
assessment and that the vast majority of chemicals will be placed in
priority setting for Tier 1 screening.
II. Purpose and Structure
The purpose of the workshop is to provide stakeholders and experts
in exposure and health and ecological effects an opportunity for input
into the design and implementation of the priority-setting system. The
focus of the workshop is to discuss the basic structure and functioning
of the priority-setting system. Specifically, the workshop will address
principles and approaches for developing rankings within compartments
and for assigning overall weighting factors to the various compartments
and information-related categories. The Agency does not intend to
either present or react to specific lists of chemicals that could
result from the various approaches that may be discussed.
The workshop will be structured around the discussion of specific
issues 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 the meeting or
after the meeting. No formal registration for the workshop is required,
but persons planning to attend are encouraged to notify the Agency
contacts listed under ``FOR FURTHER INFORMATION CONTACT'' in this
notice, preferably via e-mail, because space may be limited.
III. Issues for Discussion
The EDSTAC recommended a ``compartment-based priority setting
strategy'' that builds upon distinct exposure- and effects-related
information categories and criteria as well as a category of specially
targeted priorities. The EDSTAC listed the following information-
related categories and subcategories of information that should be
considered in developing the compartment-based approach.
A. Exposure-Related Information
1. Biological sampling data
2. Environmental, occupational, consumer product, and food-related
data (sampling and/or use data)
3. Environmental releases
4. Production volume
5. Fate and transport data and models
B. Effects-Related Information
1. Toxicological laboratory studies and data bases
2. Epidemiologic and field studies and data bases
3. Predictive biological activity or effects models (e.g. SAR,
QSAR)
4. Results of high throughput pre-screening (HTPS)
C. Integrated Effects and Exposure Information
D. Specially Targeted Priorities
1. Mixtures
2. Naturally occurring non-steroidal estrogens (NONEs)
3. Nominations
The EDSTAC did not reach agreement on the definition or weighting
of specific compartments. Following the basic framework and guiding
principles laid out in the EDSTAC Report, EPA has developed an initial
``strawman'' proposal for a compartment-based system. In developing the
strawman proposal, EPA adopted the following working definition of a
compartment:
All chemicals within a compartment share the feature(s) that define
the compartment (e.g. chemicals with TRI release data). The defining
feature(s) of the compartment should, whenever possible, allow for
sorting chemicals within the compartment into a rank-ordered list.
Proposed Compartments for EDSP Priority Setting
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Exposure
Specially targeted priorities Exposure Effects and effects
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Nominations............................ Human Biological Monitoring Epidemiology and clinical
Data. data on endocrine target
organ effects..
EDSTAC Recommended Mixtures............ Ecological Biological Reproductive/developmental
Monitoring Data. toxicity--no observed
adverse effect levels
(NOAELs)/lowest observed
adverse effect levels
(LOAELs) from studies in
laboratory animals..
EDSTAC Recommended NONES............... Chemicals in food and Carcinogenicity--positive/
drinking water. negative results in
endocrine target tissues.
Chemicals in consumer and Subchronic toxicity--
cosmetic products NOAELs/LOAELs for
endocrine targets.
Occupational exposure High Throughput Screen
chemicals test results (degree of
receptor binding).
Environmental monitoring Quantitative Structure--
data--Surface and ground Activity Relationships
water (QSARs) for estrogen
receptor binding.
Environmental monitoring Ecotoxicity--field and
data--Indoor and outdoor laboratory studies.
air
Environmental monitoring ........................
data-- Sediments/soil
Persistence ........................
Bioaccumulation potential ........................
Environmental releases ........................
Production/import volume ........................
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The Agency has identified several key issues related to the design
of a compartment-based priority-setting system. The Agency welcomes
comment on these issues:
1. Do the exposure and effects compartments in the strawman
proposal make sense? Are there other compartments that should be added?
Should certain compartments be combined, and if so, which?
2. How should exposure and effects data be integrated, combined in
the exposure/effects category?
[[Page 71570]]
3. How should each of the major information-related categories
(i.e. Exposure, Effects, and Exposure and Effects) be weighted? If they
are not weighted equally, how much weight should each receive?
4. How should the compartments within each information-related
category be prioritized relative to each other? What factors should be
considered and how should they be used?
5. Do the exposure compartments allow for adequate consideration
of disproportionately exposed and susceptible populations? How can this
best be done?
6. Should a fraction of the chemicals screened be given priority
status based solely on ecological concerns (as opposed to human health
concerns)?
7. How should chemicals that occur in multiple compartments be
treated, i.e. should the ranking system somehow take into account
frequency of occurrence across all compartments?
8. Should the specially targeted priorities, i.e. nominations,
mixtures, and NONES, be included in the priority-setting system or
should they be handled outside of the system?
9. What are the best data sources for the priority-setting system
in terms of accessibility, reliability, and format?
IV. Agenda
January 20
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Activity Time
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Welcome.................................. 10-10:15 a.m.
Background............................... 10:15-10:30 a.m.
EPA Strawman............................. 10:30-10:45 a.m.
General Comments and Questions on the 10:45-11:15 a.m.
Strawman.
Break.................................... 11:15-11:30 a.m.
Biological and Environmental Monitoring 11:30-12:15 p.m.
Data Compartments.
Lunch.................................... 12:15-1:30 p.m.
Persistence and Bioaccumulation 1:30-2:15 p.m.
Compartments.
Chemicals in Drinking Water and Food 2:15-3 p.m.
Compartment.
Break.................................... 3-3:15 p.m.
Consumer/Cosmetic and Occupational 3:15-4 p.m.
Compartments.
Relative Weights of Exposure Compartments 4-4:30 p.m.
Audience Comments........................ 4:30-5 p.m.
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January 21
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Activity Time
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Epi/Repro/Cancer/Subchronic Health 9-10 a.m.
Compartments.
Ecological Effects Compartments.......... 10-11 a.m.
Break.................................... 11-11:15 a.m.
QSAR..................................... 11:15-12 noon
Lunch.................................... 12 noon-1:15 p.m.
Relative Weights of Effects Compartments. 1:15-1:45 p.m.
Combining Exposure and Effects........... 1:45-2:45 p.m.
Break.................................... 2:45-3 p.m.
Specially Targeted Chemicals............. 3-3:15 p.m.
Audience Comments........................ 3:15-4 p.m.
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V. Public Record and Electronic Submissions
The official record for this notice, as well as the public
version, has been established for this notice under docket control
number OPPTS-42207 (including comments and data submitted
electronically as described in this unit). A public version of this
record, including printed, paper versions of electronic comments, which
does not include any information claimed as CBI, is available for
inspection from 12 noon to 4 p.m., Monday through Friday, excluding
legal holidays. The official record is located at the address in
``ADDRESSES'' at the beginning of this notice.
Electronic comments can be sent directly to EPA at:
oppt-ncic@epa.gov.
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption. Comment and data
will alsobe accepted on disks in Wordperfect 5.1/6.1 or ASCII file
format. All comments and data in electronic form must be identified by
the docket control number OPPTS-42207. Electronic comments on this
notice may be filed online at many Federal Depository Libraries.
List of Subjects
Environmental protection, Chemicals, Drinking water, Endocrine
disruptors, Hazardous substances, Health and safety, Pesticides and
pests.
Dated: December 21, 1998.
Lynn R. Goldman,
Assistant Administrator, Office of Prevention, Pesticides and Toxic
Substances.
[FR Doc. 98-34299 Filed 12-23-98; 9:49 am]
BILLING CODE 6560-50-F
