[Federal Register: December 4, 2002 (Volume 67, Number 233)]
[Notices]
[Page 72170-72171]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04de02-71]
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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:
myers.tom@epa.gov.
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: opp-docket@epa.gov, 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
[[Page 72171]]
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