[Federal Register Volume 65, Number 172 (Tuesday, September 5, 2000)]
[Notices]
[Pages 53718-53719]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-22774]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-00677; FRL-6743-2]


FIFRA Scientific Advisory Panel; Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public meeting.

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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 [email protected].

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

[[Page 53719]]

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: ``[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. 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.


    Dated: August 29, 2000.
Steven K. Galson,
Director, Office of Science Coordination and Policy.

[FR Doc. 00-22774 Filed 9-1-00; 8:45 am]
BILLING CODE 6560-50-S