Priority-Setting Workshop for the Endocrine Disruptor Screening Program; Notice of Public Meeting

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

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: TSCA-Hotline@epa.gov.

For technical information contact: For information related to the overall program status of the EDSP: Gary Timm, telephone number: (202) 260-1859, e-mail: timm.gary@epa.gov or Anthony Maciorowski, telephone number: (202) 260-3048, e-mail: maciorowski.anthony@epa.gov, 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: fenner-crisp.penelope@epa.gov, 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: darr.james@epa.gov or Patrick Kennedy, telephone number: (202) 260-3916, e-mail: kennedy.patrick@epa.gov, 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/. 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: “oppt.ncic@epa.gov.” 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

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