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FIFRA Scientific Advisory Panel; Notice of Public Meeting
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: September 5, 2000 (Volume 65, Number 172)]
[Notices]
[Page 53718-53719]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05se00-80]
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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 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
[[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: ``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.
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