FLUORIDE ACTION NETWORK PESTICIDE PROJECT
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Fludioxonil (IR-4 / Syngenta). May 1, 2002. Proposed new tolerances. Federal Register.
Note from FAN; See EPA's Toxicological profile on Fludioxonil published in the Federal Register on December 29, 2000.
http://www.epa.gov/fedrgstr/EPA-PEST/2002/May/Day-01/p10339.htm
[Federal Register: May 1, 2002 (Volume 67, Number 84)]
[Notices]
[Page 21671-21673]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01my02-73]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2002-0012; FRL-6833-4]
Notice of Filing a Pesticide Petition to Establish a Tolerance
for a Certain Pesticide Chemical in or on Food
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces the initial filing of a pesticide
petition proposing the establishment of regulations for residues of a
certain pesticide chemical in or on various food commodities.
DATES: Comments, identified by docket control number OPP-2002-0012,
must be received on or before May 31, 2002.
ADDRESSES: Comments may be submitted by mail, electronically, or in
person. Please follow the detailed instructions for each method as
provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure
proper receipt by EPA, it is imperative that you identify docket
control number OPP-2002-0012 in the subject line on the first page of
your response.
FOR FURTHER INFORMATION CONTACT: By mail: Shaja R. Brothers,
Registration Support Branch, Registration Division (7505C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460; telephone number: (703) 308-3194; e-
mail address: brothers.shaja@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be affected by this action if you are an agricultural
producer, food manufacturer or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:
------------------------------------------------------------------------
Examples of
Categories NAICS Codes potentially
affected entities
------------------------------------------------------------------------
Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide
manufacturing
------------------------------------------------------------------------
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, 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/.
2. In person. The Agency has established an official record for
this action under docket control number OPP-2002-0012. The official
record consists of the documents specifically referenced in this
action, any public comments received during an applicable comment
period, 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 Highway,
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 control number OPP-2002-0012 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),
[[Page 21672]]
Information Resources and Services Division (7502C), Office of
Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119,
Crystal Mall #2, 1921 Jefferson Davis Highway, 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 above. 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 or ASCII file format. All comments in electronic form must be
identified by docket control number OPP-2002-0012. 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 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 identified 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. Make sure to submit your comments by the deadline in this
notice.
7. To ensure proper receipt by EPA, be sure to identify the docket
control 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 received a pesticide petition as follows proposing the
establishment and/or amendment of regulations for residues of a certain
pesticide chemical in or on various food commodities under section 408
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a.
EPA has determined that this petition contains data or information
regarding the elements set forth in section 408(d)(2); however, EPA has
not fully evaluated the sufficiency of the submitted data at this time
or whether the data support granting of the petition. Additional data
may be needed before EPA rules on the petition.
List of Subjects
Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.
Dated: April 15, 2002.
Debra Edwards,
Acting Director, Registration Division, Office of Pesticide Programs.
Summary of Petitions
The petitioner summary of the pesticide petition is printed below
as required by section 408(d)(3) of the FFDCA. The summary of the
petition was prepared by the petitioner and represents the view of the
petitioners. EPA is publishing the petition summary verbatim without
editing it in any way. The petition summary announces the availability
of a description of the analytical methods available to EPA for the
detection and measurement of the pesticide chemical residues or an
explanation of why no such method is needed.
2E6359, 2E6365, 2E6377, and 2E6393
EPA has received pesticide petitions (PP) 2E6359, 2E6365, 2E6377,
and 2E6393 from the Interregional Research Project Number 4 (IR-4), New
Jersey Agricultural Experiment Station, P. O. Box 231 Rutgers
University, New Brunswick, NJ 08903 proposing, pursuant to section
408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part 180.516 by
establishing tolerances for residues of fludioxonil (4-(2,2-difluoro-
1,3- benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile) in or on the
following raw agricultural commodities (RACs) with the respective
tolerance levels in parts per million (ppm): PP 2E6359 proposes the
establishment of a tolerance for the bushberry subgroup, lingonberry,
juneberry, and salal at 2.0 ppm, PP 2E6365 proposes the establishment
of a tolerance for watercress at 7.0 ppm, PP 2E6377 proposes the
establishment of a tolerance for pistachio at 0.10 ppm and PP 2E6393
proposes the establishment of a tolerance for the caneberry subgroup at
5.0 ppm.
This notice includes a summary of petitions prepared by Syngenta
Crop Protection Inc., Greensboro, North Carolina, 27409. EPA has
determined that the petitions contain data or information regarding the
elements set forth in section 408(d)(2) of the FFDCA; however, EPA has
not fully evaluated the sufficiency of the submitted data at this time
or whether the data support granting of the petitions. Additional data
may be needed before EPA rules on these petitions.
A. Residue Chemistry
1. Plant metabolism. The plant metabolism of fludioxonil is
adequately understood for the purpose of the proposed tolerances.
2. Analytical method. Syngenta has developed and validated
analytical methodology for enforcement purposes. This method (Syngenta
Crop Protection Method AG-597B) has passed an Agency petition method
validation for several commodities and is currently the enforcement
method for fludioxonil. This method has also been forwarded to FDA for
inclusion into PAM II. An extensive database of method validation data
using this method on various crop commodities is available.
3. Magnitude of residues. Complete residue data for caneberry
subgroup, bushberry subgroup, lingonberry, juneberry, salal, pistachio
and watercress have been submitted. The requested tolerances are
adequately supported.
B. Toxicological Profile
The nature of the toxic effects caused by fludioxonil are discussed
in unit II.B of the Federal Register on December 29, 2000 (65 FR 82927)
(FRL-6760-9).
1. Animal metabolism. The metabolism of fludioxonil in rats is
adequately understood.
2. Metabolite toxicology. The residues of concern for tolerance
setting purposes is the parent compound. Consequently,
[[Page 21673]]
there is no additional concern for toxicity of metabolites.
3. Endocrine disruption. Fludioxonil does not belong to a class of
chemicals known for having adverse effects on the endocrine system. No
estrogenic effects have been observed in the various short- and long-
term studies conducted with various mammalian species.
C. Aggregate Exposure
1. Dietary exposure. The dietary exposure evaluation was made using
the Dietary Exposure Evaluation Model (DEEM, version 7.76)
from Novigen Sciences, Inc. DEEM default processing factors
were used along with USDA's Continuing Survey of Food Intake by
Individuals (CSFII) with the 1994-96 consumption database and the
Supplemental CSFII children's survey (1998) consumption database.
DEEM inputs for all currently registered uses, pending uses,
and proposed uses. Secondary residues in animal commodities were not
considered in this evaluation since calculations showed that residue
transfers from fed items to livestock and milk were minimal and
resulted in negligible exposures.
i. Food. This chronic assessment utilized established tolerance
values for the current uses and proposed tolerance values for the added
proposed uses. This assessment assumes 100% crop treated for all
commodities except strawberries and bulb vegetables. For strawberries
and bulb vegetables, projected percent crop treated values of 50% and
28%, respectively, were calculated as a percent of base acres divided
by the total planted acres.
ii. Drinking water. Estimated Environmental Concentrations (EEC's)
of fludioxonil in drinking water were determined for the highest use
rate of fludioxonil, which is turfgrass. SCI-GROW (Version 2.1) used to
determine acute and chronic estimated environmental concentrations in
ground water. FIRST (Version 1.0) was used to determine acute and
chronic estimated environmental concentrations in surface water.
Based on model outputs, the estimated environmental concentrations
of fludioxonil are 0.0553 parts per billion (ppb) for acute and chronic
exposure to ground water and 70 ppb and 33 ppb for acute and chronic
exposure, respectively, to surface water.
2. Non-dietary exposure. There is a potential residential post-
application exposure to adults and children entering residential areas
treated with fludioxonil. Since the Agency did not select a short-term
endpoint for dermal exposure, only intermediate-term dermal exposures
were considered. Based on the residential use pattern, no long-term
post-application residential exposure is expected.
D. Cumulative Effects
EPA does not have, at this time, available data to determine
whether fludioxonil has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
fludioxonil does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has not assumed that fludioxonil has a common mechanism of toxicity
with other substances.
E. Safety Determination
1. U.S. population. The chronic dietary exposure analysis showed
that exposure from the established tolerances and proposed new
tolerances for the general U.S. population would be 8% of the RfD.
Chronic exposures to the U.S. population resulted in a margin of
exposure (MOE) of 1445. The benchmark MOE for this assessment is 100.
Therefore, results from the %RfD based risk analysis showed acceptable
safety margins with respect to chronic exposures incurred by the
dietary consumption of fludioxonil-treated commodities.
2. Infants and children. The chronic reference dose (RfD) for
fludioxonil is 0.03 milligrams/kilograms (mg/kg) body weight/day and is
based on a one year dog study with a no observed adverse effect level
(NOAEL) of 3.3 mg/kg body weight/day and a safety factor of 100X. No
additional FQPA safety factor was applied. The chronic dietary exposure
analysis showed that exposure from the established tolerances and
proposed new tolerances for Non-Nursing Infants <1 years old (the
subgroup with the highest exposure) would be 34% of the RfD. The most
sensitive subpopulation in the chronic assessment was non-nursing
infants (<1 year old) with a MOE of 329. The benchmark MOE for this
assessment is 100. Therefore, the estimates of dietary exposure clearly
indicate adequate safety margins for the overall U.S. population.
Chronic Drinking Water Levels of Comparison (DWLOC) were calculated
based on a chronic RfD of 0.03 mg/kg/day. For the chronic assessment,
the non-nursing infant subpopulation generated the lowest chronic DWLOC
of approximately 200 ppb. This gave a corresponding MOE value of 1,000.
The chronic DWLOC of 200 ppb is considerably higher than the chronic
EEC of 33 ppb and the MOE far exceeds the benchmark MOE of 100.
F. International Tolerances
There are no Codex Maximum Residue Levels established for
fludioxonil.
[FR Doc. 02-10339 Filed 4-30-02; 8:45 am]
BILLING CODE 6560-50-S