FLUORIDE ACTION NETWORK PESTICIDE PROJECT
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Fludioxonil (IR-4). March 29, 2000. Petition for Pesticide Tolerances. Federal Register.
Note from FAN:
We only include the petitions for the organofluorine pesticide Fludioxonil.
http://www.epa.gov/fedrgstr/EPA-PEST/2000/March/Day-29/p7740.htm
[Federal Register: March 29, 2000 (Volume 65, Number 61)]
[Notices]
[Page 16602-16608]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29mr00-67]
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ENVIRONMENTAL PROTECTION AGENCY
[PF-924; FRL-6495-5]
Notice of Filing a Pesticide Petition to Establish a Tolerance
for Certain Pesticide Chemicals in or on Food
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces the initial filing of pesticide
petitions proposing the establishment of regulations for residues of
certain pesticide chemicals in or on various food commodities.
DATES: Comments, identified by docket control number PF-924, must be
received on or before April 28, 2000.
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 PF-924 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, Ariel Rios Bldg.,
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'' 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 PF-924. 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
[[Page 16603]]
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 PF-924 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, Ariel Rios Bldg., 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 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 PF-924. 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 pesticide petitions as follows proposing the
establishment and/or amendment of regulations for residues of certain
pesticide chemicals in or on various food commodities under section 408
of the Federal Food, Drug, and Comestic Act (FFDCA), 21 U.S.C. 346a.
EPA has determined that these petitions contain 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 supports 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: March 15, 2000.
James Jones,
Director, Registration Division, Office of Pesticide Programs.
Summaries of Petitions
The petitioner summaries of the pesticide petitions are printed
below as required by section 408(d)(3) of the FFDCA. The summaries of
the petitions were prepared by the petitioners and represent the views
of the petitioners. EPA is publishing the petition summaries verbatim
without editing them 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.
...
2. Interregional Research Project Number 4 New Jersey Agricultural
Station
8E5026 and 9E6049
EPA has received pesticide petitions (8E5026 and 9E6049) from the
Interregional Research Project Number 4 (IR-4), New Jersey Agricultural
Experiment Station, P.O. Box 231, Rutgers University, New Brunswick, NJ
08903. The petitions propose, pursuant to section 408(d) of the FFDCA,
21 U.S.C. 346a(d), to amend 40 CFR part 180 by establishing tolerances
for residues of fludioxonil 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-
pyrrole-3 carbonitrile).
1. PP 8E5026 proposes the establishment of tolerances for
strawberries at 2.0 ppm; dry bulb onion; great-headed garlic; shallot;
and welsh onion at 0.2 ppm; and green onion and leek at 7.0 ppm.
2 PP 9E6049 proposes the establishment of a tolerance for stone
fruit group at 2.0 ppm.
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 the
petitions. This notice includes a summary of petitions prepared by
Novaris Crop Protection, Inc. (Novartis), Greensboro, North Carolina,
27419.
A. Residue Chemistry
1. Plant metabolism. The metabolism of fludioxonil is adequately
understood
[[Page 16607]]
for the purpose of the proposed tolerances.
2. Analytical method. Novartis, has developed and validated
analytical methodology for enforcement purposes. This method (Novartis
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; acceptable
method validation and concurrent method recovery data on stone fruits,
strawberry, and onions were submitted. The validated limit of
quantitation (LOQ) for residues of fludioxonil in/on stone fruit is
0.05 ppm and in/on strawberry and bulb vegetables is 0.02 ppm. For
residues in/on representative rotational crop matrices is 0.01 ppm.
3. Magnitude of residues. The magnitude of residues for fludioxonil
is adequately understood for the purpose of the proposed tolerances.
B. Toxicological Profile
1. Acute toxicity. Fludioxonil and end use formulations have very
low toxicity to the mammalian species by the oral, dermal, or
inhalation route. The dose needed to kill 50% of animals was calculated
to be greater than 5,000 mg/kg (oral), 2,000 mg/kg (dermal), and 2.6
milligrams/liter (mg/L) (inhalation) in these studies. The eye and skin
irritations seen in animals upon acute exposure indicate that no more
than transient and slight irritation. No sensitizing potential was
noted with either the technical material or the formulated product.
2. Genotoxicity. Mutagenicity potential of fludioxonil was tested
in several studies. In the Chinese hamster ovary (CHO) cell assay, some
clastogenic and polyploidogenic effects were seen at or near the
precipitating concentration of the test substance. However, results
were negative in the Ames assay, CHO V79 cell assay, hepatocyte DNA
repair assay, rat hepatocyte micronucleus test, mouse bone marrow test,
and Chinese hamster bone marrow test. A dominant lethal test conducted
in the mouse was also negative.
3. Reproductive and developmental toxicity. Fludioxonil is not a
developmental toxicant and does not affect reproduction or fertility.
No fetal toxicity was observed even at the HDT in both the rabbit (300
mg/kg) and the rat (1,000 mg/kg) developmental toxicity studies. In a
2-generation rat reproduction study, a reduction of pup body weight was
seen at the highest feeding level of 3,000 ppm in the presence of
maternal toxicity. The NOAEL was 300 ppm for both maternal and fetal
toxicity in this study.
4. Subchronic toxicity. In a 90-day dietary toxicity study the
kidney and liver have been identified as target organs. In a subchronic
study in rats, the NOAEL was 10 ppm based on liver toxicity. In a
subchronic study in mice, the NOAEL was 100 ppm based on blue urine (a
metabolite); the maximum tolerated dose was 7,000 ppm. In a subchronic
study in dogs, the NOAEL was 200 ppm based on clinical observations;
the maximum tolerated dose was 8,000 ppm.
5. Chronic toxicity. In an 1-year chronic toxicity study in dogs,
the NOAEL was 100 ppm based on body weight effects; the maximum
tolerated dose was 8,000 ppm. Two 18-month dietary carcinogenicity
studies were performed in mice. While a NOAEL of 1,000 ppm was clearly
established in the first study, its highest feeding level (3,000 ppm)
did not meet the criteria for a maximum tolerated dose. In the second
18-month study, the maximum tolerated dose was determined to be 5,000
ppm based on kidney effects. There were no treatment-related increases
in neoplasia at any dose level tested in either study. In a combined
chronic toxicity/carcinogenicity study in rats, the incidence of liver
tumors in top-dose females (3,000 ppm) was marginally higher than the
concurrent controls but within historical control range. The NOAEL for
chronic toxicity was 1,000 ppm in both sexes.
6. Animal metabolism. The metabolism of fludioxonil in rats is
adequately understood.
7. Metabolite toxicology. The residues of concern for tolerance
setting purposes is the parent compound. Consequently, there is no
additional concern for toxicity of metabolites.
8. 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--i. Food. For purposes of assessing the
potential dietary exposure under the proposed tolerance, Novartis has
estimated aggregate exposure based on a Tier I assessment from the
proposed tolerance level of 2.0 ppm in or on stone fruit and strawberry
and 8.0 ppm in or on bulb vegetables including in these petitions, a
pending 1.0 ppm grape tolerance, and all the currently established
fludioxonil tolerances. This is deemed a worse case estimate of dietary
exposure since it is assumed that 100% of all crops for which
tolerances are proposed or established are treated except for
strawberry and bulb vegetables where 50% and 28% market share estimates
were utilized. Further, it was assumed that pesticide residues are
present at the tolerance levels.
ii. Drinking water. Exposure of the general population to residues
of fludioxonil from drinking water is considered unlikely since field
dissipation studies demonstrate the movement of fludioxonil into ground
water does not occur. In addition, EPA has not established a maximum
contaminant level for residues of fludioxonil in drinking water.
2. Non-dietary exposure. Non-occupational exposure for fludioxonil
has not been calculated since the current registration for fludioxonil
is limited to commercial crop production. Since the chemical is not
used in or around the home, Novartis considers the potential for non-
occupational exposure to the general population to be non-existent.
D. Cumulative Effects
Consideration of a common mechanism of toxicity is not appropriate
at this time since Novartis is unaware of any reliable information that
indicates that toxic effects produced by fludioxonil would be
cumulative with those of any other chemical compounds. Consequently,
Novartis is considering the potential risks of only fludioxonil in its
aggregate exposure assessment.
E. Safety Determination
1. U.S. population--i. Acute risk. The risk from acute dietary
exposure to fludioxonil is considered to be very low. Using an acute
reference dose (RfD) of 0.1 mg/kg taken from the maternal toxicology
NOAEL from a rabbit teratology study and a 100 fold safety factor and
highly conservative exposure assumptions, 43.4% of the aRfD is utilized
for the general U.S. population.
ii. Chronic risk. Based on the available chronic toxicity data, EPA
has set the RfD for fludioxonil at 0.03 mg/kg/day. This RfD is based on
a 1-year feeding study in dogs with a NOAEL of 3.3 mg/kg/day (100 ppm)
and an uncertainty factor of 100. No additional uncertainty factor was
judged to be necessary as body weight was the most sensitive indicator
of toxicity in that study. Based on the highly conservative exposure
assumptions described above, only 7.5% of the RfD will be utilized by
the U.S. general population. Therefore,
[[Page 16608]]
based on the completeness and reliability of the toxicity data
supporting these petitions, there is a reasonable certainty that no
harm will result from aggregate exposure to residues of fludioxonil as
a result of these requested tolerances.
2. Infants and children. Infants and children are not expected to
show any particular sensitivity to fludioxonil. This can be
demonstrated by referencing several data points, including the
equivalence of the maternal and fetal toxicity NOAEL in the fludioxonil
2-generation rat study.
i. Acute risk. The risk from acute dietary exposure to fludioxonil
is considered to be very low. Under the highly conservative exposure
assumptions of residue levels being at tolerance level and 100% market
share for the majority of crops with proposed and established
fludioxonil registrations, the utilization of the acute RfD of the most
exposed group is 83.4% (children, 1-6 years).
ii. Chronic risk. Using highly conservative aggregate exposures
23.0% and 19.2% of the RfD were obtained for the most sensitive sub-
populations, non-nursing infants ( 1-year old) and children (1-6
years), respectively. Therefore, a reasonable certainty exists that no
harm will result from aggregate exposure to fludioxonil if the proposed
uses are registered.
F. International Tolerances
There are no Codex maximum residue levels established for residues
of fludioxonil in or on strawberrry, dry bulb onion, green onion, and
stone fruit crop fruit.
[FR Doc. 00-7740 Filed 3-28-00; 8:45 am]
BILLING CODE 6560-50-F