[Federal Register Volume 63, Number 155 (Wednesday, August 12, 1998)]
[Notices]
[Pages 43175-43177]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-21679]


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

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-
[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. 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: [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 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 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:
    [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.

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