[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: [email protected] or 
Jim Darr, e-mail address: [email protected]; 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. 
[email protected]. 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: [email protected] or Jim Darr, telephone: (202) 260-
3441, e-mail address: [email protected]; 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-
H[email protected].

  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
----------------------------------------------------------------------------------------------------------------
                                                                                                       Exposure
      Specially targeted priorities                  Exposure                      Effects           and effects
----------------------------------------------------------------------------------------------------------------
 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        ........................
----------------------------------------------------------------------------------------------------------------

     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


 
------------------------------------------------------------------------
                 Activity                               Time
------------------------------------------------------------------------
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.
------------------------------------------------------------------------


January 21


 
------------------------------------------------------------------------
                 Activity                               Time
------------------------------------------------------------------------
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.
------------------------------------------------------------------------

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:

    [email protected].

    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