Increasing Transparency for the Tolerance Reassessment Process; Availability of Preliminary Risk Assessments for Nine Organophosphates

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

[Federal Register: August 12, 1998 (Volume 63, Number 155)]
[Notices]
[Page 43175-43177]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12au98-60]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[OPP-34130; FRL-6024-3]

Increasing Transparency for the Tolerance Reassessment Process;
Availability of Preliminary Risk Assessments for Nine Organophosphates

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

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 azinphos-methyl, bensulide, ethion, fenamiphos,
isofenphos, naled, phorate, profenofos, and terbufos. 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 nine organophosphates that have risk assessments placed in the
docket and should be limited to issues raised in those documents. EPA
will provide opportunity for comment on the hazard assessments and FQPA
safety factor assessments for the other organophosphates at a later
date. Opportunity for public comment will also be provided at a later
date for a variety of science issues. Allowing access and comments on
the preliminary risk assessments will 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

[[Page 43176]]

refinements of the risk assessments will be appropriate for some, if
not all, of these nine 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
October 13, 1998.

ADDRESSES: By mail, submit written comments in triplicte 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. 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.
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.

FOR FURTHER INFORMATION CONTACT: Karen Angulo, Special Review and
Reregistration Division (7508W), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Office location, telephone number, and e-mail address: Crystal Station
#1, 3rd Floor, 2800 Crystal Drive, Arlington, VA; (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 nine organophosphate pesticides are available in the
individual pesticide dockets: azinphos-methyl, bensulide, ethion,
fenamiphos, isofenphos, naled, phorate, profenofos, and terbufos. In
addition, the preliminary ecological effects risk assessments for
bensulide, ethion, fenamiphos, isofenphos, naled, phorate, profenofos,
and terbufos have also been docketed. The Hazard Assessment of the
Organophosphates and FQPA Safety Factor Recommendations for the
Organophosphates have also been included in the docket to help the
public in their review of the preliminary risk assessments.
Included in the individual pesticide dockets are the Agency's
preliminary risk assessments, the registrants' comments to this point,
and any successive Agency reviews or related correspondence regarding
the Agency's risk assessment. As additional comments, reviews, and risk
assessment modifications become available, these will also be docketed
for the above nine 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 nine 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 nine
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 nine 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 rm: /diskb/cgi-bin-tmp/TMPBaaaakbCa: No such file or directory
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 October 13, 1998 at 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
nine

[[Page 43177]]

organophosphates, use the following docket control numbers:

azinphos-methyl OPP-34131
bensulide OPP-34132
ethion OPP-34133
fenamiphos OPP-34134
isofenphos OPP-34135
naled OPP-34136
phorate OPP-34137
profenofos OPP-34138
terbufos OPP-34139

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.

List of Subjects

Environmental protection.

Dated: August 6, 1998.
Jack E. Housenger,
Acting Director, Special Review and Reregistration Division, Office of
Pesticide Programs.

[FR Doc. 98-21679 Filed 8-11-98; 8:45 am]
BILLING CODE CODE 6560-50-F

Increasing Transparency for the Tolerance Reassessment Process; Availability of Preliminary Risk Assessments for Nine Organophosphates

Local Navigation