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Increasing Transparency For the Tolerance Reassessment Process; Availability of Preliminary Risk Assessments for Five Organophosphates
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: January 8, 1999 (Volume 64, Number 5)]
[Notices]
[Page 1199-1200]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08ja99-68]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-34163; FRL-6055-9]
Increasing Transparency For the Tolerance Reassessment Process;
Availability of Preliminary Risk Assessments for Five Organophosphates
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces the availability of documents that were
developed as part of the Environmental Protection Agency's process for
making reregistration eligibility decisions for the organophosphate
pesticides and for tolerance reassessments consistent with the Federal
Food, Drug, and Cosmetic Act (FFDCA) as amended by the Food Quality
Protection Act of 1996 (FQPA). These documents are the preliminary
human health and ecological risk assessments and related documents for
acephate, disulfoton, methamidophos, oxydemethon methyl, and pirimiphos
methyl. This notice also starts a 60-day public comment period for the
preliminary risk assessments. Comments are to be limited to issues
directly associated with the five organophosphates that have risk
assessments placed in the docket and should be limited to issues raised
in those documents. By allowing access and opportunity for comment on
the preliminary risk assessments, EPA is seeking to strengthen
stakeholder involvement and help ensure our decisions under FQPA are
transparent and based on the best available information. The tolerance
reassessment process will ensure that the United States continues to
have the safest and most abundant food supply. The Agency cautions that
these risk assessments are preliminary assessments only and that
further refinements of the risk assessments will be appropriate for
some, if not all, of these five pesticides. These documents reflect
only the work and analysis conducted as of the time they were produced
and it is appropriate that, as new information becomes available and/or
additional analyses are performed, the conclusions they contain may
change.
DATES: Written comments on these assessments must be submitted on or
before March 9, 1999.
ADDRESSES: By mail, submit written comments in triplicate to: 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. In person,
deliver comments to: Rm. 119, Crystal Mall #2, 1921 Jefferson Davis
Hwy., Arlington, VA.
Information submitted as a comment concerning this notice may be
claimed confidential by marking any part or all of that information as
Confidential Business Information (CBI). Information so marked will not
be disclosed except in accordance with procedures set forth in 40 CFR
part 2. A copy of the comment that does not contain CBI must be
submitted for inclusion in the public record. Information not marked
confidential will be included in the public docket without prior
notice.
To request a copy of any of the preliminary risk assessments and
related documents listed in this notice, contact or visit the OPP
Pesticide Docket at the addresses given in this unit, or call (703)
305-5805. The Docket staff will inform callers as to which of the
documents can be sent directly from the docket and which need to be
requested from the Freedom of Information Act Office due to their bulk.
The public docket is available for public inspection in Rm. 119 at the
Virginia address given in this unit from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays.
Comments and data may also be submitted electronically to: opp-
docket@epa.gov. Follow the instructions under Unit II. of this
document. No CBI
[[Page 1200]]
should be submitted through e-mail. Copies of the preliminary risk
assessments for the five organophosphate pesticides may also be
accessed at: http: www.epa.gov/oppsrrd1/op.
FOR FURTHER INFORMATION CONTACT: Karen Angulo, Special Review and
Reregistration Division (7508C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460;
telephone: (703) 308-8004; e-mail address: angulo.karen@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Background
EPA is making available preliminary risk assessments that have
been developed as part of EPA's process for making reregistration
eligibility decisions for the organophosphate pesticides and for
tolerance reassessments consistent with the FFDCA as amended by the
FQPA. The Agency's preliminary human health and ecological effects risk
assessments for the following five organophosphate pesticides are
available in the individual pesticide dockets: acephate, disulfoton,
methamidophos, oxydemethon methyl, and pirimiphos methyl.
Included in the individual pesticide dockets are the Agency's
preliminary risk assessments. As additional comments, reviews, and risk
assessment modifications become available, these will also be docketed
for the five organophosphate pesticides listed in this notice. The
Agency cautions that these risk assessments are preliminary assessments
only and that further refinements of the risk assessments will be
appropriate for some, if not all, of these five pesticides. These
documents reflect only the work and analysis conducted as of the time
they were produced and it is appropriate that, as new information
becomes available and/or additional analyses are performed, the
conclusions they contain may change.
As the preliminary risk assessments for the remaining
organophosphate pesticides are completed and registrants are given a
30-day review period to identify possible computational or other clear
errors in the risk assessment, these risk assessments and registrant
responses will be placed in the individual pesticide dockets. A notice
of availability for subsequent assessments will appear in the Federal
Register.
To provide users with the most recent information on the five
organophosphates, EPA has also included in each docket the Agency's
July 7, 1998, ``Hazard Assessment of the Organophosphates'' and the
Agency's July 9, 1998, ``FQPA Safety Factor Recommendations for the
Organophosphates.'' In general, these two documents were completed at a
different time than the five individual pesticide preliminary risk
assessments discussed in this notice. The Agency notes that where the
preliminary risk assessments are inconsistent with the Hazard
Assessment and FQPA Assessment, these Assessments will supersede the
relevant portions of the preliminary risk assessments and will be
incorporated into the revised individual pesticide risk assessments.
The Agency also notes that these documents reflect only the work and
analysis conducted as of the time they were produced, and as new
information becomes available and/or additional analyses are performed,
the conclusions they contain may change.
The Agency is providing an opportunity, through this notice, for
interested parties to provide written comments and input to the Agency
on the preliminary risk assessments for the chemicals specified in this
notice. Such comments and input could address, for example, the
availability of additional data to further refine the risk assessments,
such as percent crop treated information or submission of residue data
from food processing studies, or could address the Agency's risk
assessment methodologies and assumptions as applied to these specific
chemicals. Comments should be limited to issues raised within the
preliminary risk assessments and associated documents. EPA will provide
other opportunities for public comment on other science issues
associated with the organophosphate tolerance reassessment program.
Failure to comment on any such issues as part of this opportunity will
in no way prejudice or limit a commenter's opportunity to participate
fully in later notice and comment processes. All comments should be
submitted by March 9, 1999 at the address given under ``ADDRESSES.''
Comments will become part of the Agency record for each individual
pesticide to which they pertain.
II. Public Record and Electronic Submissions
The official record for this notice, as well as the public
version, has been established for this notice under the following
docket control numbers. When submitting written or electronic comments
regarding the five organophosphates, use the following docket control
numbers:
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Chemical OPP Docket no.
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Acephate OPP-34164
Disulfoton OPP-34165
Methamidophos OPP-34166
Oxydemethon methyl OPP-34167
Pirimiphos methyl OPP-34168
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A public version of this record, including printed, paper versions
of electronic comments, which does not include any information claimed
as CBI, is available for inspection from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The official record is
located at the Virginia address in ``ADDRESSES'' at the beginning of
this document.
Electronic comments can be sent directly to EPA at:
opp-docket@epa.gov
Electronic comments must be submitted as an ASCII file avoiding
the use of special characters and any form of encryption. Comment and
data will also be accepted on disks in WordPerfect 5.1/6.1 file format
or ASCII file format. All comments and data in electronic form must be
identified by the appropriate docket control number OPP-34163.
Electronic comments on this notice may be filed online at many Federal
Depository Libraries.
List of Subjects
Environmental protection, Chemicals, Pesticides and pests.
Dated: January 4, 1999.
Jack E. Housenger,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. 99-428 Filed 1-7-99; 8:45 am]
BILLING CODE 6560-50-F