[Federal Register Volume 67, Number 233 (Wednesday, December 4, 2002)]
[Notices]
[Pages 72170-72171]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-30471]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2002-0250; FRL-7274-7]


Fenarimol; Availability of the Risk Assessments on FQPA Tolerance 
Reassessment Progress and Tolerance Reassessment Decision (TRED)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the availability of EPA's tolerance 
reassessment decision and related documents for fenarimol including the 
Fenarimol Overview, Fenarimol Summary, Fenarimol Decision Document 
(TRED), and supporting risk assessment documents. EPA has reassessed 
the 42 tolerances, or legal limits, for residues of fenarimol in or on 
raw agricultural commodities. These tolerances are now considered safe 
under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by 
the Food Quality Protection Act (FQPA) of 1996.

DATES: Comments on the tolerance reassessment decision or on the human 
health effects risk assessment for fenarimol, identified by docket ID 
number OPP-2002-0250, must be received by EPA on or before January 3, 
2003. In the absence of substantive comments, the tolerance 
reassessment decision will be considered final.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I. of the SUPPLEMENTARY INFORMATION. To ensure proper 
receipt by EPA, it is imperative that you identify docket ID number 
OPP-2002-0250 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: Tom Myers, Special Review and 
Reregistration Division (7508C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 308-8589; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general, but will be of 
interest to a wide range of stakeholders, including environmental, 
human health, and agricultural advocates; the chemical industry; 
pesticide users; and members of the public interested in the use of 
pesticides. The Agency has not attempted to describe all the persons or 
entities who may be interested in or affected by this action. If you 
have questions in this regard, consult the person listed under FOR 
FURTHER INFORMATION CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/.
    You can obtain copies of the TRED and related documents discussed 
in this notice on EPA's website at http://www.epa.gov/pesticides/reregistration/status.htm. Information on pesticide reregistration and 
tolerance reassessment, including the purpose and status of Agency 
programs to complete Reregistration Eligibility Decisions (REDs), 
Interim REDs, and tolerance reassessment decisions (TREDs), is 
available at http://www.epa.gov/pesticides/reregistration. General 
information is available on the Office of Pesticide Programs' home 
page, http://www.epa.gov/pesticides/.
    2. In person. The Agency has established an official record for 
this action under docket ID numbers OPP-2002-0250. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall 2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
you identify docket ID number OPP-2002-0250 in the subject line on the 
first page of your response.
    1. By mail. Submit your comments to: Public Information and Records 
Integrity Branch (PIRIB), Information Resources and Services Division 
(7502C), Office of Pesticide Programs (OPP), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Information Resources 
and Services Division (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, Rm. 119, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. The PIRIB is open from 8:30 a.m. 
to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB 
telephone number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by 
e-mail to: [email protected], or you can submit a computer disk as 
described in this unit. Do not submit any information electronically 
that you consider to be CBI. Avoid the use of special characters and 
any form of encryption. Electronic submissions will be accepted in 
WordPerfect 6.1/8.0/9.0 or ASCII file format. All comments in 
electronic form must be identified by docket ID number OPP-2002-0250. 
Electronic comments may also be filed online at many Federal Depository 
Libraries.

D. How Should I Handle CBI that I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that

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you submit to EPA in response to this document as CBI 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. In addition to one complete version of the comment that 
includes any information claimed as CBI, a copy of the comment that 
does not contain the information claimed as CBI must be submitted for 
inclusion in the public version of the official record. Information not 
marked confidential will be included in the public version of the 
official record without prior notice. If you have any questions about 
CBI or the procedures for claiming CBI, please consult the person 
listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternative ways to improve the notice or collection 
activity.
    7. Make sure to submit your comments by the deadline in this 
notice.
    8. To ensure proper receipt by EPA, be sure to identify the docket 
ID number assigned to this action in the subject line on the first page 
of your response. You may also provide the name, date, and Federal 
Register citation.

II. What Action is the Agency Taking?

    EPA has reassessed the risks associated with current food uses of 
the pesticide fenarimol, reassessed 42 existing tolerances, and reached 
a tolerance reassessment and risk management decision. The Agency is 
issuing for comment the resulting report on FQPA tolerance reassessment 
progress, including the Fenarimol Overview, Fenarimol Summary, 
Fenarimol Decision Document (TRED), and supporting risk assessment 
documents.
    EPA must review tolerances and tolerance exemptions that were in 
effect when FQPA was enacted in August 1996, to ensure that these 
existing pesticide residue limits for food and feed commodities meet 
the safety standard established by the new law. Tolerances are 
considered reassessed once the safety finding has been made or a 
revocation occurs. EPA has reviewed and made the requisite safety 
finding for the tolerances and exemptions included in this notice. EPA 
approved registration of products containing fenarimol as an active 
ingredient prior to the 1996 enactment of the Food and Quality 
Protection Act; therefore, while no reregistration decision is required 
at present, risks from non-occupational exposure to fenarimol through 
food, drinking water, and residential uses must be reassessed. The 
Agency has evaluated the dietary risk associated with fenarimol and has 
determined that there is a reasonable certainty, with appropriate 
mitigation, that no harm to any population subgroup will result from 
aggregate exposure to fenarimol when considering dietary exposure and 
all other non-occupational sources of pesticide exposure for which 
there is reliable information. Residential post-application exposure 
was of concern for children and infants from fenarimol products applied 
in residential settings. To mitigate this risk, the registrant has 
agreed to remove the residential uses from their labels until they 
conduct a special developmental toxicity study that will assess 
possible effects of fenarimol on the adult and juvenile rat hormonal 
systems. Once these data are submitted and reviewed, the Agency will 
make a determination regarding the reinstatement of the residential 
uses. For chronic drinking water risk from surface water, potential 
(average) estimated environmental concentrations (EECs) of fenarimol 
(84 parts per billion (ppb)) exceeds the chronic drinking water level 
of comparison (DWLOC) for all populations.
    The 84 ppb value includes all residential uses and the golf course 
use of fenarimol. However, with the residential uses removed from the 
label, a correction factor of 0.31 can be applied to the 84 ppb surface 
water number to account for the use of fenarimol only on tees, greens, 
and fairways on golf courses. This would reduce the chronic EEC to 26 
ppb. Infants and children, the most sensitive population subgroups 
would still exceed the chronic DWLOC of 20. However, the chronic EECs 
were estimated using Tier I modeling and only slightly exceed the 
DWLOC. Additional data are being required that will provide important 
information on the mobility of fenarimol and its degradates. These 
studies will help to refine the chronic surface water, ground water, 
and drinking water risk assessments. The Agency has reassessed all 42 
tolerances for fenarimol and can make a FQPA safety determination. In 
addition, available residue chemistry data support the establishment of 
a 0.02 part per million (ppm) permanent tolerance for fenarimol 
residues in filberts under 40 CFR 180.421 (a). The Agency has 
sufficient residue data for reassessing the tolerances for fenarimol. 
The chronic dietary exposure assessment for fenarimol is highly refined 
using anticipated residues based on 1996-1999 Food and Drug 
Administration (FDA) monitoring data for apples, bananas, cherries, 
grapes, and pears. Field trial residue data were used for pecans and 
filberts. Percent crop treated information and processing factors, 
where available, were used in the assessment. There were no U.S. 
Department of Agriculture Pesticide Data Program monitoring data 
available for fenarimol. Residues of fenarimol per se were non-
detectable (below the method limit of detection (LOD)) in all 1996-1999 
FDA monitoring samples of apples, bananas, grapes, and pears (a total 
of more than 3,000 samples). Out of 214 cherry samples, three had 
detectable residues. Residues of fenarimol per se were non-detectable