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Increasing Transparency for the Tolerance Reassessment Process; Availability of Preliminary Risk Assessments for Seven Organophosphates
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: September 9, 1998 (Volume 63, Number 174)]
[Notices]
[Page 48213-48215]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09se98-60]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-34141; FRL-6030-2]
Increasing Transparency for the Tolerance Reassessment Process;
Availability of Preliminary Risk Assessments for Seven Organophosphates
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This Notice announces the availability of documents which were
developed as part of EPA's process for making reregistration
eligibility decisions for the organophosphate pesticides and for
tolerance reassessments consistent with the Federal Food, Drug, and
Cosmetic Act as amended by the Food Quality Protection Act of 1996
(FQPA). These documents are the preliminary risk assessments and
related documents for cadusafos, dimethoate, ethoprop, fenthion,
sulfotepp, temephos, and tribuphos. 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 seven
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
the Agency's decisions under FQPA are transparent, and based on the
best available information. The tolerance reassessment process will
ensure that the U.S. 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 seven
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 by
November 9, 1998.
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, CM #2, 1921 Jefferson Davis Highway,
Arlington, VA.
Comments and data may also be submitted electronically to: opp-
docket@epamail.epa.gov. Follow the instructions under Unit II. of this
document. No Confidential Business Information (CBI) should be
submitted through e-mail.
Information submitted as a comment concerning this document may be
claimed confidential by marking any part or all of that information as
CBI.
[[Page 48214]]
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 by EPA without prior notice. The public docket is available for
public inspection in Rm. 119 at the Virginia address given above, from
8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays.
Copies of the preliminary risk assessments for the seven
organophosphate pesticides can be accessed from the internet at: http:
www.epa.gov/oppsrrd1/op.
To request a copy of any of the above listed preliminary risk
assessments and related documents, contact the OPP Pesticide Docket,
Public Information and Records Integrity Branch, in Rm. 119 at the
address given above 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.
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: angulo.karen@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Background
EPA is making available preliminary risk assessments which 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 Federal Food, Drug, and
Cosmetic Act as amended by the Food Quality Protection Act of 1996
(FQPA). The Agency's preliminary health effects risk assessments for
the following seven organophosphate pesticides are available in the
individual pesticide dockets: cadusafos, dimethoate, ethoprop,
fenthion, sulfotepp, temephos, and tribuphos. In addition, the
preliminary ecological effects risk assessments for dimethoate,
fenthion, and tribuphos have also been docketed.
Included in the individual pesticide dockets are the Agency's
preliminary risk assessments and the registrants' comments to this
point. As additional comments, reviews, and risk assessment
modifications become available, these will also be docketed for the
above seven organophosphate pesticides. 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 seven 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 seven
organophosphates, EPA has also included in each docket the Agency's
July 7, 1998 ``Hazard Assessment of the Organophosphates'' and the
Agency's August 6, 1998 ``FQPA Safety Factor Recommendations for the
Organophosphates.'' In general, these two documents were completed
after the seven individual pesticide preliminary risk assessments
discussed above. The Agency notes that where the preliminary risk
assessments are inconsistent with the Hazard Assessment and FQPA Safety
Factor Recommendation these latter 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 November 9, 1998 to the address given above. 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 action, as well as the public version,
has been established for this action under the following docket control
numbers. When submitting written or electronic comments regarding the
seven organophosphates, use the following docket control numbers:
cadusafos OPP-34142
dimethoate OPP-34143
ethoprop OPP-34144
fenthion OPP-34145
sulfotepp OPP-34146
temephos OPP-34147
tribuphos OPP-34148
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@epamail.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 or ASCII file
format. All comments and data in electronic form must be identified by
the appropriate docket control number. Electronic comments on this
document may be filed online at many Federal Depository Libraries.
[[Page 48215]]
List of Subjects
Environmental protection.
Dated: September 3, 1998.
Jack E. Housenger,
Acting Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. 98-24177 Filed 9-8-98; 8:45 am]
BILLING CODE 6560-50-F