[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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