[Federal Register Volume 64, Number 128 (Tuesday, July 6, 1999)]
[Notices]
[Pages 36353-36354]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-17005]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-00612; FRL-6090-4]
FIFRA Scientific Advisory Panel; Open Meeting
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of open 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 scientific
issues being considered by the Agency in connection with Burkholderia
cepacia: risk assessment of a biopesticide and possible human
opportunistic pathogen; a consultation on protocol design to assess
acute neurotoxicity following oral administration of pesticides; issues
pertaining to the assessment of exposure to pesticides in residential
and other non-occupational settings; higher tier ecological risk
assessment for chlorfenapyr; and pesticide spray drift--review of
proposed pesticide deposition curves. 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 either Larry Dorsey or Paul Lewis 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 Tuesday, July 20; Wednesday, July
21; Thursday, July 22; and Friday, July 23, 1999, from 8:30 a.m. to
5:30 p.m.
ADDRESSES: The meeting will be held at: Sheraton Crystal City Hotel,
1800 Jefferson Davis Highway, Arlington, VA. The telephone number for
the hotel is: (703) 486-1111.
By mail, submit written comments (one original and 40 copies) to:
The Public Information and Records Integrity Branch (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. In person or by delivery service, bring comments
to: Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington,
VA 22202; telephone: (703) 305-5805.
Comments and data also may be submitted electronically by sending
electronic mail (e-mail) to: opp-docket@epa.gov. No Confidential
Business Information (CBI) should be submitted through e-mail.
Additional information on electronic submissions can be found under
Unit V. of this document.
FOR FURTHER INFORMATION CONTACT: By mail: Larry C. Dorsey or Paul I.
Lewis, Designated Federal Officials, FIFRA Scientific Advisory Panel
(7101C), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460; Office location: Rm. 117T, CM #2,
1921 Jefferson Davis Highway, Arlington, VA; telephone: (703) 305-5369;
e-mail: dorsey.larry@epa.gov or lewis.paul@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Purpose of the Meeting
This SAP meeting includes five distinct sessions. The first session
will be the review of a risk assessment of a biopesticide and possible
human opportunistic pathogen. Some microorganisms used for controlling
pests may be opportunistic human pathogens, or closely related to
opportunistic pathogens. Opportunistic pathogens are microbes that are
capable of causing disease only in people who are immunocompromized or
are otherwise especially susceptible. A critical issue concerns the
pathogenic strains proposed for registration as biopesticides, since
these strains are typically isolated from the environment, for example
agricultural fields, rather than as clinical specimens. As such, these
strains have no history of actually causing disease and may not be able
to do so. Criteria for relatedness between clinical strains and
biocontrol strains and the ability to predict pathogenicity of the
biocontrol strains is therefore vital.
The Agency requests the SAP to address the sufficiency of current
tests used to consider the risk from opportunistic pathogens to
immunocompromized populations. Burkholderia cepacia, a biopesticide
which may cause fatal infections with cystic fibrosis and chronic
granulomatous disease, will be used as a test case to examine the
adequacy of animal models, taxonomic criteria, and criteria using known
virulence genes as predictors of the pathogenic potential of individual
strains, as well as issues related to the importance of levels of
exposure and the nature of susceptible populations.
The second session will be a consultation on a study protocol
design to assess acute neurotoxicity studies following oral
administration of pesticides. Recently, several acute neurotoxicity
studies have been submitted to the Agency employing this protocol
design. This novel design deviates from the standard Agency acute
developmental neurotoxicity protocols. The primary difference is that
the test substance is administered in the diet compared to being
administered as a bolus dose in the standard Agency study design. The
purpose of this session is to consult with the SAP regarding issues
pertaining to this new design.
The third session will be a review of issues pertaining to the
assessment of exposure to pesticides in residential and other non-
occupational settings. When estimating aggregate exposure to a
pesticide substance, the Agency includes exposures that may occur
following use of the pesticide in residential or other non-occupational
settings. This session will focus on several key issues that pertain to
improving procedures for estimating exposure to pesticides from use in
residential or other non-occupational settings and in revising its
standard operating procedures for residential exposure assessments. The
issues include: (1) Calculating percent dislodgeability of available
pesticide residues from lawns, indoor surfaces, and pets; (2) use of
choreographed activities as surrogates for estimating children's dermal
exposure; (3) characterizing hand (or object)-to-mouth activities; (4)
calculating exposure to pesticides that may result from track-in,
drift, bathing or showering; and (5) calculating exposure from use of
pesticides in schools, day-care centers, and other public places.
The fourth session concerns the review of the Agency's chlorfenapyr
ecological risk assessment. In December, 1994, the Agency received a
request for registration for the use of the pyrrole insecticide
chlorfenapyr on cotton. The Agency is seeking SAP input regarding the
use of available data to characterize the risk of chlorfenapyr use on
cotton to birds in cotton agroenvironments. The Agency requests SAP
comments on its assessment of avian risks and is seeking
[[Page 36354]]
SAP suggestions for how the Agency might use probabilistic risk
assessment techniques to improve its risk assessment. Specifically, the
Agency is seeking guidance on the geographic scale of a probabilistic
risk assessment. The SAP will be queried on what data on chlorfenapyr
fate, residues, effects and cotton agroenvironments would be necessary
to accommodate extrapolations of risks to scales beyond the treated
agroenvironment to much larger scales.
The final session will be a review of pesticide spray drift data
from ground hydraulic and orchard air blast applications. The purpose
of this session is to examine the validity of an approach developed to
place bounds on the Spray Drift Task Force data for ground hydraulic
boom and orchard air blast spraying applications. Curves developed from
bounds are intended to be used in environmental exposure assessments to
estimate deposition over a range of distances, replacing the use of a
fixed estimate. The proposed bounding method is intended to be
adaptable to allow the addition of data from new or existing
application methods.
II. Availability of Review Materials
A meeting agenda is currently available, and copies of EPA
background documents for the meeting will be available no later than
July 6, 1999. The meeting agenda and EPA primary background documents
will be available on the EPA web site -- http://www.epa.gov/pesticides/
SAP/ or may be obtained by contacting the Public Information and
Records Integrity Branch, Information Resources and Services Division
(7502C), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460; Office location: Rm. 119, CM #2,
1921 Jefferson Davis Highway, Arlington, VA; telephone: (703) 305-5805.
III. Written Comments and Oral Presentations at the Meeting
Members of the public wishing to submit comments should contact
either Larry Dorsey or Paul Lewis at the address or the telephone
number given under ``FOR FURTHER INFORMATION CONTACT'' to confirm that
the meeting date and the agenda have not been modified or changed.
Interested persons are permitted to file written statements before the
meeting. To the extent that time permits and upon advanced written
request to either Larry Dorsey or Paul Lewis, interested persons may be
permitted by the Chair of the 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 length 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 should notify either Larry Dorsey or
Paul Lewis and submit 40 copies of the summary information. The Agency
encourages that written statements be submitted before the meeting to
provide Panel Members the time necessary to consider and review the
comments.
IV. Panel Report
Copies of the Panel's report of their recommendations will be
available approximately 30 working days after the meeting and may be
obtained by contacting the Public Information and Records Integrity
Branch at the address or telephone number listed in ``ADDRESSES'' at
the beginning of this document.
V. Public Docket and Submission of Electronic Comments
A public record has been established for this notice under docket
control number ``OPP-00612'' (including comments and data submitted
electronically). A public version of this record, including printed
versions of electronic comments, which does not include information
claimed as CBI, is available for inspection from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The public record is
located in Rm. 119 of the Public Information and Records Integrity
Branch at the address listed in ``ADDRESSES'' at the beginning of this
document.
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption. Comments and data
also will be accepted on disks in WordPerfect in 5.1/6/7/8.0 file
format or ASCII file format. All comments and data in electronic form
must be identified by the docket control number ``OPP-00612.''
Electronic comments may be filed online at many Federal Depository
Libraries.
The official record for this notice, as well as the public version
described above, will be kept in paper form. Accordingly, EPA will
transfer all comments received electronically into printed, paper form
as they are received and will place the paper copies in the official
record which will also include all comments submitted directly in
writing. The official record is the paper record maintained at the
address in ``ADDRESSES'' at the beginning of this document.
Information submitted as a comment in response to this notice may
be claimed confidential by marking any part or all of that information
as CBI. Information marked CBI will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2. An edited copy
of the comment that does not contain the CBI material must be submitted
for inclusion in the public docket. Information not marked confidential
will be included in the public docket. All comments and materials
received will be made part of the public record and will be considered
by the Panel.
List of Subjects
Environmental protection.
Dated: June 29, 1999.
Marcia E. Mulkey,
Director, Office of Pesticide Programs.
[FR Doc. 99-17005 Filed 7-2-99; 8:45 am]
BILLING CODE 6560-50-F
