[Federal Register Volume 67, Number 27 (Friday, February 8, 2002)]
[Notices]
[Pages 6028-6032]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-2987]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-1067; FRL-6821-2]


Notice of Filing Pesticide Petitions to Establish Tolerances 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-1067, must be 
received on or before March 11, 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 PF-1067, in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: Shaja R. Brothers, 
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: 
[email protected].

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:

[[Page 6029]]



------------------------------------------------------------------------
                                                          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-1067. 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 PF-1067 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 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: [email protected], 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-1067. 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: January 26, 2002.
Peter Caulkins,
Acting 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

[[Page 6030]]

were prepared by Tomen Agro, Inc., the registrant, and represents the 
view of Tomen Agro. EPA is publishing the petition summaries verbatim 
without editing them in any way. The petition summaries announce 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.

Interregional Research Project Number 4

PP 1E6339, 1E6341, and 1E6343

    EPA has received pesticide petitions (1E6341, 1E6339, and 1E6343), 
from the Interregional Research Project Number 4 (IR-4), 681 U.S. 
Highway #1 South, North Brunswick, NJ 08902-3390 proposing, pursuant to 
section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a(d), to amend 40 CFR part 180.553 by establishing tolerances 
for residues of fenhexamid, (N-2,3-dichloro-4-hydroxyphenyl)-1-
methylcyclohexanecarboxamide) in or on the following raw agricultural 
commodities: Caneberry at 20.0 parts per million (ppm), the bushberry 
subgroup, juneberry, loganberry and Salal at 5.0 ppm, and pistachio at 
0.02 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 the petition prepared by 
Tomen Agro, Inc., 100 First Street, Suite 1700, San Francisco, CA 
94105.

A. Residue Chemistry

    1. Plant metabolism. The qualitative nature of fenhexamid residues 
in plants is adequately understood.
    2. Analytical method. An adequate method for purposes of 
enforcement of the proposed fenhexamid tolerances in plant commodities 
is available.
    3. Magnitude of residues. The magnitude of residues for fenhexamid 
on the proposed commodities is adequately understood.

B. Toxicological Profile

    1. Acute toxicity. The acute oral toxicity study resulted in a 
lethal dose (LD50) of > 5,000 milligrams/kilograms (mg/kg) 
for both sexes. The acute dermal toxicity in rats resulted in an 
LD50 of greater than 5,000 mg/kg for both sexes. The acute 
inhalation was investigated in two studies in rats. Inhalation by 
aerosol at the maximum technically possible concentration of 0.322 
milligram/liter (mg/L) resulted in no deaths or symptoms lethal 
concentration (LC50) > 0.322 mg/L). A dust inhalation study 
resulted in an LC50 > 5.057 mg/L. Fenhexamid was not 
irritating to the skin or eyes after a 4-hour exposure period. The 
Buehler dermal sensitization study in guinea pigs indicated that 
fenhexamid is not a sensitizer. Based on these results, fenhexamid 
technical is placed in toxicity Category IV, and does not pose any 
acute dietary risks.
    2. Genotoxicity. The potential for genetic toxicity of fenhexamid 
was evaluated in six assays, including two Ames tests, an HGPRT forward 
mutation assay, an unscheduled DNA synthesis (UDS) assay, an in vitro 
chromosomal aberration assay in Chinese hamster ovary (CHO) cells, and 
a micronucleus test in mice. The compound was found to be devoid of any 
mutagenic activity in each of these assays; including those tests that 
investigated the absence or presence of metabolic activating systems. 
The weight of evidence indicates that fenhexamid technical does not 
pose a risk of mutagenicity or genotoxicity.
    3. Reproductive and developmental toxicity--i. In a 2-generation 
reproduction study (one mating per generation), 30 Sprague-Dawley rats 
per sex per dose were administered 0, 100, 500, 5,000, or 20,000 ppm of 
fenhexamid in the diet. The reproductive toxicity no observed adverse 
effect level (NOAEL) was 20,000 ppm. The neonatal NOAEL was 500 ppm, 
and the lowest observed adverse effect level (LOAEL) was 5,000 ppm 
based on decreased pup body weight. The parental toxicity NOAEL was 500 
ppm based on lower adult pre-mating body weights at 5,000 and 20,000 
ppm, lower gestation body weights at 20,000 ppm, lower lactation body 
weights at 5,000 and 20,000 ppm, and statistically significant changes 
in clinical chemistry parameters, terminal body weights, and organ 
weights at 5,000 and 20,000 ppm. Based on this study, it is clear that 
the only toxic effects in the neonates occurred at parentally toxic 
doses.
    ii. In rats, fenhexamid was administered by gavage at doses of 0 or 
1,000 mg/kg for gestation days 6-15. No maternal toxicity, 
embryotoxicity, fetotoxicity, or teratogenic effects were observed at 
the limit dose of 1,000 mg/kg/day. Therefore, the NOAEL for maternal 
and developmental toxicity was 1,000 mg/kg/day.
    iii. In rabbits, fenhexamid was administered by gavage at doses of 
0, 100, 300, and 1,000 mg/kg for gestation days 6-18. Body weight gain, 
and feed consumption of the dams were reduced at the two top doses. One 
abortion occurred in each of the top two dose groups, and two total 
resorptions occurred in the top dose group. The placental weights were 
slightly decreased at 300 mg/kg/day and above. In the 1,000 mg/kg/day 
group, slightly decreased fetal weights and a slightly retarded 
skeletal ossification were observed. All other parameters investigated 
in the study were unaffected. Therefore, the NOAELs for maternal and 
developmental toxicity were 100 mg/kg/day in this study.
    Based on the 2-generation reproduction study in rats, fenhexamid is 
not considered a reproductive toxicant and shows no evidence of 
endocrine effects. The data from the developmental toxicity studies on 
fenhexamid show no evidence of a potential for developmental effects 
(malformations or variations) at doses that are not maternally toxic. 
The NOAEL for both maternal and developmental toxicity in rats was 
1,000 mg/kg/day, and for rabbits the NOAEL for both maternal and 
developmental toxicity was 100 mg/kg/day.
    4. Subchronic toxicity--i. Fenhexamid was administered in the diet 
to rats for 13 weeks at doses of 0, 2,500, 5,000, 10,000, and 20,000 
ppm. The NOAEL was 5,000 ppm (415 mg/kg/day in males and 549 mg/kg/day 
in females). Reversible liver effects were observed at 10,000 ppm.
    ii. Fenhexamid was administered in the diet to mice for 
approximately 14 weeks at doses of 0, 100, 1,000, and 10,000 ppm. The 
NOAEL was 1,000 ppm (266.6 mg/kg/day in males and 453.9 mg/kg/day in 
females). Increased feed and water consumption and kidney and liver 
effects were observed at 10,000 ppm.
    iii. Fenhexamid was administered in the diet to beagle dogs for 13 
weeks at doses of 0, 1,000, 7,000, and 50,000 ppm. The NOAEL was 1,000 
ppm (33.9 mg/kg/day in males and 37.0 mg/kg/day in females). Increased 
Heinz bodies were observed at 7,000 ppm.
    5. Chronic toxicity.--i. Fenhexamid was administered in the feed at 
doses of 0, 500, 3,500, or 25,000 ppm to 4 male and 4 female beagle 
dogs per group for 52 weeks. A systemic NOAEL of 500 ppm (an average 
dose of 17.4 mg/kg/day over the course of the study) was observed based 
on decreased food consumption, and decreased body weight gain at 25,000 
ppm, decreased erythrocyte, hemoglobin and hematocrit values at 25,000 
ppm, increased Heinz bodies at 3,500 ppm and above, and a

[[Page 6031]]

dose-dependent increase of alkaline phosphatase at 3,500 ppm and above. 
There were no treatment-related effects on either macroscopic or 
histologic pathology.
    ii. A combined chronic/carcinogenicity study was performed in 
Wistar rats. Fifty animals/sex/dose were administered doses of 0, 500, 
5,000, or 20,000 ppm for 24 months in the feed. A further 10 animals/
sex/group received the same doses and were sacrificed after 52 weeks. 
The doses administered relative to body weight were 0, 28, 292, or 
1,280 mg/kg/day for males and 0, 40, 415, or 2067 mg/kg/day for 
females. The NOAEL in the study was 500 ppm (28 mg/kg/day for males and 
40 mg/kg/day for females) based on body weight decreases in females at 
5,000 ppm and above, changes in biochemical liver parameters in the 
absence of morphological changes in both sexes at 5,000 ppm and above, 
and caecal mucosal hyperplasia evident at 5,000 ppm and above.
    The NOAEL in the chronic dog study was 17.4 mg/kg/day based on body 
weight, hematology and clinical chemistry effects. The lowest NOAEL in 
the 2-year rat study was determined to be 28 mg/kg/day based on body 
weight, clinical chemistry parameters in the liver, and caecal mucosal 
hyperplasia.
    6. Animal metabolism.--i. A lactating goat was dosed at 10 
milligrams (mg) 14C-fenhexamid per kilograms/bodyweight on 3 
consecutive days at 24-hour intervals. Fenhexamid was rapidly and 
almost completely absorbed, distributed and eliminated (24.9% in urine, 
38.6% in feces, and 0.03% in milk). The half-life of biliary-fecal 
elimination (primary pathway) was 0.5 hour. The primary residues in 
tissues were unreacted fenhexamid, its glucuronide derivative and the 
4-hydroxy derivative.
    ii. Rats were administered radiolabeled fenhexamid (a single oral 
low dose of 1 mg/kg, a single oral high dose of 100 mg/kg, or 15 
repeated low doses of 1 mg/kg/day). Radiolabeled fenhexamid was rapidly 
eliminated and tissue residues declined rapidly. After 48 hours the 
total radioactivity residue in the body excluding the GI tract, was > 
0.3% of the administered dose in all dose groups. Excretion was rapid, 
and almost complete with feces as the major route of excretion. 
Approximately 62-84% of the recovered radioactivity was found in feces, 
and 15-36% in urine within 48 hours post-dosing. Metabolite 
characterization studies showed that the main components detected in 
excreta were the unchanged parent compound (62-75%) and the glucuronic 
acid conjugate of the parent compound (4-23%). The proposed major 
pathway for biotransformation is via conjugation of the aromatic 
hydroxyl group with glucuronic acid. Identification of radioactive 
residues ranged from 88% to 99% and was independent of dose and sex.
    7. Metabolite toxicology. As the primary residues found in rats and 
goat were the parent compound fenhexamid, and its glucuronic acid 
conjugate, no additional metabolite toxicology studies are warranted.
    8. Endocrine disruption. Fenhexamid has no endocrine-modulation 
characteristics as demonstrated by the lack of endocrine effects in 
developmental, reproductive, subchronic, and chronic studies.

C. Aggregate Exposure

    1. Dietary exposure--i. Food. Dietary exposure to fenhexamid is 
limited to the established tolerances for residues of fenhexamid on 
grapes at 4.0 ppm, raisins at 6.0 ppm, strawberries at 3.0 ppm, almond 
nutmeat at 0.02 ppm, almond hulls at 2.0 ppm, stone fruit at 5.0 ppm, 
pear at 15 ppm and the proposed tolerances in the current submission 
which are as follows: Bushberry at 5.0 ppm, caneberry at 20 ppm, and 
pistachios at 0.02 ppm.
    ii. Drinking water. Review of the environmental fate data indicates 
that fenhexamid is relatively immobile and rapidly degrades in the soil 
and water. Fenhexamid dissipates in the environment via several 
processes. Therefore, a significant contribution to aggregate risk from 
drinking water is unlikely.
    2. Non-dietary exposure. There is no significant potential for non-
occupational exposure to the general public. The proposed uses are 
limited to agricultural and horticultural use.

D. Cumulative Effects

    Consideration of a common mechanism of toxicity is not appropriate 
at this time since it has a unique mode of action. Moreover, there is 
no significant toxicity observed for fenhexamid. Even at toxicology 
limit doses, only minimal toxicity is observed for fenhexamid. 
Therefore, only the potential risks of fenhexamid are considered in the 
exposure assessment.

E. Safety Determination

    1. U.S. population. Considering that the percent of the chronic PAD 
utilized by grape, strawberry and raisin uses was determined to be 1.8% 
for the U.S. population (May 28, 1999, 64 FR 28917) (FRL-6082-7); 
considering further the percent contribution to total exposure of 
grapes, strawberries, caneberry, bushberry, and pistachios (June 1, 
2000, 65 FR 35069) (FRL-6559-3), and their set or proposed tolerances 
(grapes: 4 ppm; caneberry: 20 ppm; bushberry: 5 ppm; pistachio: 20 
ppm); the percent of the chronic PAD utilized by caneberry, bushberry, 
and pistachio is estimated to be = 0.25% for the U.S. population. 
Therefore, the estimates of dietary exposure clearly indicate adequate 
safety margins for the overall U.S. population.
    2. Infants and children. Considering that the percent of the 
chronic PAD utilized by grape, strawberry and raisin uses were 
determined to be 6.6% for nursing infants and 4.8 % for children, (May 
28, 1999, 64 FR 28917); considering further the percent contribution to 
total exposure of grapes, strawberries, caneberry, bushberry, and 
pistachios and their set or proposed tolerances; the percent of the 
chronic PAD utilized by caneberry, bushberry, and pistachio is 
estimated to be = 1.1% for infants; and = 0.33% for children.
    In assessing the potential for additional sensitivity of infants 
and children to residues of fenhexamid, the available developmental 
toxicity and reproductive toxicity studies and the potential for 
endocrine modulation by fenhexamid were considered.
    1. Developmental toxicity studies in two species indicate that 
fenhexamid does not impose additional risks to developing fetuses and 
is not a carcinogenic.
    2. The 2-generation reproduction study in rats demonstrated that 
there were no adverse effects on reproductive performance, fertility, 
fecundity, pup survival, or pup development at non-maternally toxic 
levels. Maternal and developmental NOAELs and LOAELs were comparable, 
indicating no increase in susceptibility of developing organisms. No 
evidence of endocrine effects was noted in any study. It is therefore 
concluded that fenhexamid poses no additional risk for infants and 
children and no additional uncertainty factor is warranted.

F. International Tolerances

    International caneberry tolerances are in effect in the following 
countries: Belgium, Slovenia, and Switzerland (3.0 ppm), Netherlands 
and other EU countries (5.0 ppm). Bushberry (currant and gooseberry) 
tolerances are as follows: Belgium and Netherlands (3.0 ppm), Slovenia, 
and other EU countries (5.0 ppm). Austrian tolerances (5.0 ppm) have 
been drafted for berries, including small fruit. German tolerances (5 
ppm)

[[Page 6032]]

are in effect for berries, excluding strawberries.
[FR Doc. 02-2987 Filed 2-7-02; 8:45 am]
BILLING CODE 6560-50-S