FIFRA Scientific Advisory Panel; Notice of Public Meeting

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice of public meeting.

SUMMARY:

There will be a 4-day meeting of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Food Quality Protection Act (FQPA) Scientific Advisory Panel (SAP) to review a set of issues being considered by the Agency pertaining to the following topics: 1) Test guidelines for chronic inhalation toxicity and carcinogenicity of fibrous particles; 2) Cumulative hazard assessment of organophosphorous pesticides; 3) Components and methodologies of the Calendex^TM, Lifetime^TM, and REX models, as tools for dietary and residential pesticide exposure and risk assessments; 4) Assessment of pesticide concentrations in drinking water and water treatment effects on pesticide removal and transformation. The meeting is open to the public. Seating at the meeting will be on a first-come basis. Individuals requiring special accommodations at this meeting, including wheelchair access, should contact Larry Dorsey at the address listed under FOR FURTHER INFORMATION CONTACT at least 5 business days prior to the meeting so that appropriate arrangements can be made.

DATES:

The meeting will be held on September 26, 27, 28, and 29 from 8:30 a.m. to 4:30 p.m.

ADDRESSES:

The meeting will be held at the Sheraton Crystal City Hotel, 1800 Jefferson Davis Highway, Arlington, VA. The telephone number for the Sheraton Hotel is (703) 486-1111.

Requests to participate may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, your request must identify docket control number OPP-00677 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

Larry Dorsey or Olga Odiott, Designated Federal Officials, Office of Science Coordination and Policy, (7101C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 305-5369; fax number: (703) 605-0656; e-mail address: dorsey.larry or odiott.olga@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

This action is directed to the public in general. This action may, however, be of interest to those persons who are or may be required to conduct testing of chemical substances under the Federal Food, Drug and Cosmetic Act (FFDCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and the Food Quality Protection Act (FQPA). 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 person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents?

1. Electronically. A meeting agenda is currently available; copies of EPA primary background documents for this meeting will be available by mid September. You may obtain electronic copies of these documents, and certain other related documents that might be available electronically, from the FIFRA SAP Internet Home Page at http://www.epa.gov/scipoly/sap. To access this document on the Home Page select Federal Register notice announcing this meeting. You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/.

2. In person. The Agency has established an administrative record for this meeting under docket control number OPP-00677. The administrative 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 1) Test guidelines for chronic inhalation toxicity and carcinogenicity of fibrous particles; 2) Cumulative hazard assessment of organophosphorous pesticides; 3) Components and methodologies of the Calendex^TM, Lifeline^TM and REX models, as tools for dietary and residential pesticide exposure and risk assessments; 4) Assessment of pesticide concentrations in drinking water and water treatment effects on pesticide removal and transformation, including any information claimed as Confidential Business Information (CBI). This administrative 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 administrative 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 Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2 (CM #2), 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

C. 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. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPP-00677 in the subject line on the first page of your request. Interested persons are permitted to file written statements before the meting. To the extent that time permits, and upon advance written request to the persons listed under FOR FURTHER INFORMATION CONTACT, interested persons may be permitted by the Chair of the FIFRA Scientific Advisory Panel to present oral statements at the meeting. The request should identify the name of the individual making the presentation, the organization (if any) the individual will represent, and any requirements for audiovisual equipment (e.g., overhead projector, 35 mm projector, chalkboard, etc.). There is no limit on the extent of written comments for consideration by the Panel, but oral statements before the panel are limited to approximately 5 minutes. The Agency also urges the public to submit written comments in lieu of oral presentations. Persons wishing to make oral and/or written statements at the meeting should contact the persons listed under FOR FURTHER INFORMATION CONTACT and submit 30 copies of their presentation and/or remarks to the Panel. The Agency encourages that written statements be submitted before the meeting to provide Panel Members the time necessary to consider and review the comments.

1. By mail. You may submit a request to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

2. In person or by courier. Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA. The PIRIB is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

3. Electronically. You may submit your request electronically by e-mail to: “opp-docket@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. Be sure to identify by docket control number OPP-00677. You may also file a request online at many Federal Depository Libraries.

II. Background

A. Purpose of the Meeting

This 4-day meeting concerns several scientific issues undergoing consideration within the EPA, Office of Prevention, Pesticide and Toxic Substances (OPPTS), as follows:

1. Test guidelines for chronic inhalation toxicity and carcinogenicity of fibrous particles: The Agency's current health effects test guidelines for chronic inhalation toxicity and/or carcinogenicity studies of chemicals are considered not specific enough for the testing of fibrous substances. Through an interagency working group, a workshop was conducted to obtain input from the scientific community on a number of issues related to fiber testing. Based on the recommendations from the workshop panel and participants, EPA/OPPT has developed a proposed standardized study protocol for respirable fibers which was announced in the Federal Register of July 28, 1999 (64 FR 40871) (FRL-6078-6), for public comments. All public comments have been evaluated and a revised draft guideline with some of the public comments incorporated has been prepared. This scientific advisory panel is charged to review the EPA draft test guidelines, advise on remaining issues on the study protocol for the health effects testing of fibrous particles, and provide EPA with an opinion about the scientific validity of the testing guidance.

2. Cumulative hazard assessment of organophosphorous pesticides: The Agency is presenting an approach to assess and select common mechanism endpoints for accumulating hazard and a method for determining relative potencies for organophosphate pesticides. The relative potencies will be used in a cumulative risk assessment of multiple organophosphate pesticides. The FIFRA SAP is being asked to advise on advantages and disadvantages of the method used to assess cumulative hazard and rank the pesticides.

3. Components and methodologies of the Calendex^TM, Lifeline^TM and REX models, as tools for dietary and residential pesticide exposure and risk assessments: The purpose of this session is to describe the algorithms, input data requirements, and output reports associated with the Residential Exposure (REX) model, and the Calendex software. REX is a spreadsheet (EXCEL) based model which allows aggregation of multiple routes (dermal, inhalation, oral) and pathways (product use scenarios) to estimate exposure and risk from pesticides used in a residential setting.

A major requirement of the FQPA is that exposures to pesticides across various pathways and routes (e.g., dermal exposure through turf uses) be appropriately combined such that an “aggregate” exposure assessment can be performed. The Agency currently uses Calendex software from Novigen Sciences to perform this aggregation. The purpose of this session is to describe the components and methodologies used by the Calendex software the basic concepts and assumptions behind Calendex and its algorithms and procedures.

Aggregate and cumulative exposure assessments to pesticides must capture the correlation in residues that occur from both additive and exclusionary processes resulting from use of pesticides. The analysis also requires a quantitative mechanism for evaluating risks associated with exposures to time-varying mixtures of pesticides. The purpose of this presentation is to describe an analysis of aggregate exposures and risks associated with exposures to a hypothetical pesticide, Alpha, and the cumulative exposure to and risk from three hypothetical pesticides, Alpha, Beta, and Gamma. The cumulative risks are evaluated by determining the systemic (absorbed) doses that result from inhalation, dermal, and oral exposures to the pesticides. A “toxicity equivalent” model of cumulative risk is used to quantitatively evaluate cumulative risks. Assessments were performed using LifeLine^TM Version 1.0. This model simulates pesticide exposure using an individual-based approach where daily exposures are evaluated for each person, season, and location.

4. Assessment of pesticide concentrations in drinking water and water treatment effects on pesticide removal and transformation: The purpose of this session is to present to the Panel a progress report of ongoing activities associated with the estimation of pesticide concentrations in drinking water for FQPA aggregate exposure assessments and the assessment of water treatment effects on pesticide removal and transformation. Progress reports will be provided on regression modeling efforts, status of the national drinking water monitoring program, and preliminary literature survey and evaluation of different water treatment processes employed in drinking water production facilities.

B. Panel Report

Copies of the Panel's report of their recommendations will be available approximately 45 working days after the meeting, and will be posted on the FIFRA SAP web site or may be obtained by contacting the Public Information and Records Integrity Branch at the address or telephone number listed in Unit I.C. of this document.

List of Subjects

• Environmental protection