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dicofol (Kelthane) Reregistration Eligibility Decision Document 12/98



[Federal Register: December 16, 1998 (Volume 63, Number 241)]
[Notices]               
[Page 69282-69284]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16de98-60]

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ENVIRONMENTAL PROTECTION AGENCY

[OPP-34156; FRL-6050-2]

 
Availability of the Dicofol Reregistration Eligibility Decision 
Document for Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability.

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 SUMMARY: This notice announces the availability of and starts a 60-day 
public comment period of the Reregistration Eligibility Decision (RED) 
document for the active ingredient dicofol. The RED for this chemical 
is the Agency's formal regulatory assessment of the health and 
environmental database of the subject

[[Page 69283]]

chemical and presents the Agency's determination regarding which 
pesticidal uses are eligible for reregistration.
DATES: Written comments on the RED decisions must be submitted by 
February 16, 1999.

ADDRESSES: Three copies of comments identified with the docket control 
number OPP-34156 and the case number (noted below), should be submitted 
to: By mail: Public Information and Records Integrity Branch, 
Information Resources and Services Division (7506C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. In person, deliver comments to the docket on the 
first floor (Room 119), CM #2, 1921 Jefferson Davis Highway, Arlington, 
VA.
     Comments and data may also be submitted electronically by 
following the instructions under ``SUPPLEMENTARY INFORMATION'' of this 
document. No Confidential Business Information (CBI) should be 
submitted through e-mail.
     Information submitted as a comment in response to this notice 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 docket. Information not marked confidential will be included 
in the public docket without prior notice (including comments and data 
submitted electronically). The public docket and docket index, 
including printed paper versions of electronic comments, which does not 
include any information claimed as CBI will be available for public 
inspection on the first floor (Room 119) at the address given above, 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays.
    FOR FURTHER INFORMATION CONTACT: Technical questions on the RED 
document should be directed to the appropriate point-of-contact:

----------------------------------------------------------------------------------------------------------------
                                                       Point of
             Chemical Name                Case No.      Contact       Telephone No.          e-mail Address
----------------------------------------------------------------------------------------------------------------
Dicofol................................       0021      Phil Budig      703-308--8029  budig.phil@epa.gov
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    To request a copy of the above listed RED document, or a specific 
RED Fact Sheet, contact the OPP Pesticide Docket, Public Information 
and Records Integrity Branch, first floor (Room 119), at the address 
given above or call (703) 305-5805.

SUPPLEMENTARY INFORMATION:

I. Electronic Availability

    Electronic copies of this document and various support documents 
are available from the EPA home page at the Federal Register-
Environmental Documents entry for this document under ``Laws and 
Regulations'' (http://www.epa.gov/fedrgstr/).
    Electronic copies of the REDs and RED fact sheets can be downloaded 
from the Pesticide Special Review and Reregistration Information System 
at (703) 308-7224, and also can be reached on the Internet via EPA's 
website at: http://www.epa.gov/REDs.

II. Reregistration Eligibility Decision

    The Agency has issued a Reregistration Eligibility Decision (RED) 
document for the pesticidal active ingredient dicofol. Under the 
Federal Insecticide, Fungicide, and Rodenticide Act, as amended in 
1988, EPA is conducting a reregistration program to reevaluate existing 
pesticides to make sure they meet current scientific and regulatory 
standards. The data base to support the reregistration of dicofol is 
substantially complete.
    All registrants of products containing the above listed active 
ingredient have been sent the Dicofol RED document and must respond to 
labeling requirements and product specific data requirements within 8 
months of receipt. Products containing other active ingredients will 
not be reregistered until those other active ingredients are determined 
to be eligible for reregistration.
    The reregistration program is being conducted under congressionally 
mandated time frames, and EPA recognizes both the need to make timely 
reregistration decisions and to involve the public. Therefore, EPA is 
issuing this RED as a final document with a 60-day comment period. 
Although the 60-day public comment period does not affect the 
registrant's response due date, it is intended to provide an 
opportunity for public input and a mechanism for initiating any 
necessary amendments to the RED. All comments will be carefully 
considered by the Agency.

III. Background Information

     EPA has determined that products containing dicofol may be 
eligible for reregistration, as specified in the dicofol RED, 
contingent upon results of a dermal toxicity study due to the Agency in 
December 1998. EPA has identified a possible unacceptable occupational 
risk in the dicofol RED. However, the Agency believes that the 
assumptions used to arrive at this conclusion may have led to an 
overestimation of that risk (e.g., 100% dermal absorption). Therefore, 
EPA has found that it is not appropriate to declare dicofol ineligible 
at this time. One key consideration is the fact that the registrants 
will be submitting the dermal toxicity study mentioned above, which may 
be a more appropriate study for regulatory purposes than data currently 
used. Although the Agency would not normally delay a decision for a 
study voluntarily conducted by a registrant outside the RED timeframe, 
three factors make this appropriate here. First, the data will be 
delivered to the Agency very shortly. Second, the registrants have 
committed to significant risk mitigation measures to be implemented 
immediately (listed below), which address risk concern while the new 
data are being developed and evaluated. Third, the registrants have 
submitted a voluntary cancellation request, which will immediately go 
into effect for any dicofol use which is found to have unacceptable 
risk after consideration of the dermal toxicity study. EPA believes 
this process will address dicofol risk in a timeframe that is 
comparable or more rapid than what EPA could achieve through its own 
regulatory process.
    In sum, dicofol risk will be addressed in the interim in the 
following manner:
    To address risks to homeowners, residents, and children:
    \ All residential uses have been eliminated from labels and will be 
voluntarily canceled.
    To address risks to handlers:
    \ Mixers/loaders/applicators must wear additional personal 
protective equipment (PPE), and use enclosed cabs and cockpits.
    \ All wettable powder formulations produced after December 31, 1998 
must be placed in water soluble packaging.
    \ Application with handheld equipment is eliminated for liquid 
formulations.
    \ Liquid formulations produced after December 31, 1998 must bear 
labeling

[[Page 69284]]

requiring closed mixing systems for dry beans.
    To address risks to workers (persons entering treated areas 
following applications of dicofol):
    \ A revised Restricted Entry Interval (REI) will be set, based on 
Dislodgeable Foliar Residue (DFR) data submitted in October, 1998, and 
on the dermal toxicity study being submitted in December, 1998.
    To protect the environment and wildlife:
    \ Dicofol applications are limited to no more than one per year. 
Previously, for some uses, the number of applications allowed per year 
was either unrestricted or limited to 2 or 3 applications per year.
    \ Dicofol applications on citrus will not exceed 3 pounds a.i./acre 
per year. This has been reduced from 8 pounds a.i./acre per year.
    \ Dicofol applications on strawberries will not exceed 2 pounds 
a.i./acre per year. This has been reduced from 2.4 pounds a.i./acre per 
year.
    \ A spray drift and Runoff Caution Statement is being added to the 
label. Also, a statement prohibiting application directly to water is 
being added to the label.

IV. Public Record and Electronic Submissions

    The official record for this notice, as well as the public version, 
has been established for this notice under docket control number OPP-
34156 (including comments and data submitted electronically as 
described below). 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 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 6.1 file format or ASCII 
file format. All comments and data in electronic form must be 
identified by the docket control number (OPP-34156). Electronic 
comments on this notice may be filed online at many Federal Depository 
Libraries.

List of Subjects

    Environmental protection.

    Dated: December 4, 1998.

Jack E. Housenger,
Acting Director, Special Review and Reregistration Division, Office of 
Pesticide Programs.

[FR Doc. 98-33334 Filed 12-15-98; 8:45 am]
BILLING CODE 6560-50-F