[Federal Register Volume 63, Number 174 (Wednesday, September 9, 1998)]
[Notices]
[Pages 48213-48215]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-24177]


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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-
[email protected]. 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: [email protected].

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:
    [email protected]


    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