[Federal Register Volume 65, Number 235 (Wednesday, December 6, 2000)]
[Notices]
[Pages 76249-76253]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-31058]


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 ENVIRONMENTAL PROTECTION AGENCY

[PF-984; FRL-6755-4]


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 PF-984, must be 
received on or before January 5, 2001.

ADDRESSES:  Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed

[[Page 76250]]

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-984 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: [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:

------------------------------------------------------------------------
                                                          Examples of
           Categories                    NAICS            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-984. 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-984 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-984. 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

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under section 408 of the Federal Food, Drug, and Comestic 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: November 22, 2000.
James Jones,

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.

 Interregional Research Project Number 4

 9E6063 and 7E4865

     EPA has received pesticide petitions (9E6063 and 7E4865) from 
Interregional Research Project Number 4, Technology Centre of New 
Jersey, 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 by 
establishing tolerances for residues of clomazone in or on the raw 
agricultural commodities (RAC) tuberous and corm vegetable (except 
potato) crop subgroup and cucurbit vegetable crop group at 0.05 parts 
per million (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 supports granting of 
the petitions. Additional data may be needed before EPA rules on the 
petitions.

A. Residue Chemistry

    1. Plant metabolism. The metabolism of clomazone in plants is 
adequately understood.
    2.  Analytical method. There is a practical analytical method for 
detecting and measuring levels of clomazone in or on tuberous and corm 
vegetable (except potato) crop subgroup and cucurbit vegetable crop 
group, with a limit of detection that allows monitoring of food for 
residues at or above the levels proposed in this tolerance. Samples are 
analyzed using an analytical method consisting of an acid reflux, a 
C18 solid phase extraction (SPE), a Florisil SPE clean-up 
followed by gas chromatography (GC)-mass selective detection (MSD). The 
method limit of quantitation (LOQ) is 0.05 ppm. The method limit of 
detection (LOD) is 0.01 ppm.
    3. Magnitude of residues. The representative commodity for the 
tuberous and corm vegetable (except potato) subgroup, is sweet potato. 
IR-4 has previously submitted residue data for clomazone use on sweet 
potato (MRID # 40572701). Four field trials, with two different 
applications timings were conducted. No clomazone residues were found 
above the LOQ (0.05 ppm) in any of the treated samples. FMC Corporation 
submitted additional data for clomazone on sweet potatoes (MRID # 
44441405).

B. Toxicological Profile

    1. Acute toxicity. The following mammalian toxicity studies have 
been conducted with clomazone technical (unless noted otherwise) to 
support registrations and/or tolerances of clomazone:
    i. A rat acute oral study with an lethal dose (LD)50 of 
2,077 mg/kg (male) and 1,369 mg/kg (female).
    ii. A rabbit acute dermal lethal concentration (LC)50 of 
> 2,000 mg/kg.
    iii. A rat acute inhalation LC50 of 6.25 mg/L/4 hrs. 
(male), 4.23 mg/L/hrs. (female) and 4.85 mg/L/4 hrs. (combined sexes).
    iv. A primary eye irritation study in the rabbit which showed 
practically no irritation.
    v. A primary dermal irritation study in the rabbit which showed 
minimal irritation.
    vi. A primary dermal sensitization study in the guinea pig which 
showed no sensitization.
    vii. Acute delayed neurotoxicity - clomazone, and its known 
metabolites, are not structurally related to known neurotoxic 
substances.
    2. Genotoxicity. The following genotoxicity tests were all 
negative: Ames Assay; CHO/HGPRT Mutation Assay; and Structural 
Chromosomal Aberration. The Unscheduled DNA Synthesis genotoxicity was 
negative with activation; weakly positive without activation.
    3. Reproductive and developmental toxicity. A 2-generation 
reproduction study was conducted in the rat with a parental systemic no 
observed adverse effect level (NOAEL) of 1,000 ppm (50 mg/kg/day) based 
on decreased body weight and food consumption at 2,000 ppm; and a 
progeny systemic NOAEL of 1,000 ppm (50 mg/kg/day) based on decreased 
pup body weight at 2,000 ppm. The reproductive performance NOAEL was > 
4,000 ppm which was the highest dose tested (HDT). There was an 
unexplained decrease in the fertility index during mating of the F1b 
generation at 4,000 ppm which was not observed in the F1a litter or 
repeated in the F2 generation. Additionally, there was one F2a pup at 
1,000 ppm which had non-functional hindlimbs and one F2b pup at 4,000 
ppm which had extended hindlimbs with no flexion at the ankle. These 
limb abnormalities were not considered treatment-related for the 
following reasons (i) there was no dose response observed, (ii) the 
findings were not statistically significant, (iii) the findings were 
not repeated at the 1,000 ppm dose level in the F2b litter or found in 
the F1a or F1b litters, and (iv) these findings or related hindlimb 
abnormalities were not observed in developmental studies at gavage dose 
levels up to 100 mg/kg/day in the rat or 240 mg/kg/day in the rabbit.
     A developmental toxicity study in rats given gavage doses of 100, 
300 and 600 mg/kg/day and with maternal and fetal NOAELs of 100 mg/kg/
day. The maternal NOAEL is based on decreased locomotion, genital 
staining and runny eyes and the developmental NOAEL is based on 
increased incidence of delayed ossification at 300 mg/kg/day. This 
study was negative for developmental at all doses tested.
     A developmental toxicity study in rabbits given gavage doses of 
30, 240 and 700 mg/kg/day with maternal and fetal NOAELs of 240 mg/kg/
day. The maternal NOAEL is based on a decrease in body weight and the 
developmental NOAEL is based on an increase in the number of fetal 
resorptions at 700 mg/kg/day. This study was negative for 
teratogenicity at all doses tested.
     In all cases, the reproductive and developmental NOAELs were equal 
to the parental NOAELs, thus indicating that clomazone does not pose 
any increased risk to infants or children.
    4. Subchronic toxicity. In a 90-day feeding subchronic study in 
mice the

[[Page 76252]]

NOAEL was 20 ppm (< 2.9 mg/kg/day)based on liver cytomegaly at 20 ppm.
    5. Chronic toxicity. A 12-month feeding study in the dog with a 
NOAEL of 500 ppm (14.0 mg/kg/day for males; 14.9 mg/kg/day for females) 
based on increased blood cholesterol and liver weights at 2,500 ppm.
     A 24-month chronic feeding/carcinogenicity study in the rat with a 
NOAEL of 100 ppm (4.3 mg/kg/day for males; 5.5 mg/kg/day for females) 
based on increased liver weights and increased liver cytomegaly at 500 
ppm. There were no carcinogenic effects observed under the conditions 
of the study.
     A 24-month chronic feeding/carcinogenicity study in the mouse with 
a NOAEL of 100 ppm (15 mg/kg/day) based on an increase in the white 
blood cell count. There were no carcinogenic effects observed under the 
conditions of the study.
     Using the Guidelines for Carcinogen Risk Assessment, it is 
proposed that clomazone be classified as Group E for carcinogenicity 
(no evidence of carcinogenicity) based on the results of 
carcinogenicity studies in rats and mice.
     The reference dose (RfD) for clomazone has been established at 
0.043 mg/kg/day. The RfD for clomazone is based on the 24-Month 
Feeding/Carcinogenicity Study in the Rat with a NOAEL of 4.3 mg/kg/day 
and an uncertainty factor of 100.
    6. Animal metabolism. The metabolism of clomazone in animals is 
adequately understood. Clomazone degrades rapidly and extensively in 
rats, goats and poultry to a variety of metabolites which were readily 
excreted from the body via excreta.
    7. Metabolite toxicology. No clomazone related metabolite residues 
have been identified as being of toxicological concern. The residue of 
significance is parent.
    8. Endocrine disruption. No specific tests have been conducted with 
clomazone to determine whether the herbicide may have an effect in 
humans that is similar to an effect produced by a naturally occurring 
estrogen or other endocrine effects. It should be noted, however, that 
the chemistry of clomazone is unrelated to that of any compound 
previously identified as having estrogen or other endocrine effects. 
Additionally, a standard battery of required studies has been 
completed. These studies include an evaluation of the potential effects 
on reproduction and development, and an evaluation of the pathology of 
the endocrine organs following repeated or long-term exposure. No 
endocrine effects were noted in any of these studies with clomazone.

C. Aggregate Exposure

    1. Dietary exposure--i. Food For purposes of assessing the 
potential dietary exposure, EPA has estimated aggregate exposure based 
on the Theoretical Maximum Residue Contribution (TMRC) from the 
established tolerances for clomazone. The TMRC is a ``worst case'' 
estimate of dietary exposure since it is assumed that 100 percent of 
all crops for which tolerances are established are treated and that 
pesticide residues are present at the tolerance levels. Dietary 
exposure to residues of clomazone in or on food will be limited to 
residues on cabbage (0.1 ppm), cottonseed (0.05 ppm), cucurbit 
vegetables (0.05 ppm), succulent peas (0.05 ppm), peppers (0.05 ppm), 
soybeans (0.05 ppm), sweet potato (0.05 ppm), snap beans (0.05 ppm) 
rice (0.05 ppm), sugar (from cane) (0.05 ppm) and residues on tuberous 
and corm vegetable (except potato) (0.05 ppm each). As noted above, 
this exposure assessment is based on very conservative assumptions, 
i.e., 100% of crops treated will contain clomazone residues and those 
residues would be at the level of the tolerance. It is FMC's opinion 
that these assumptions result in an overestimate of human exposure.
    ii. Drinking water. It is unlikely that there will be exposure to 
residues of clomazone through drinking water supplies. A field mobility 
study was conducted at a loamy sand location. Clomazone was found only 
in the top 0-1 ft. soil samples during the 61 day study period. No 
clomazone residue 
(< 0.02 ppm) was detected in the deeper soil levels (1-2, 2-3 and 3-4 
ft.). Detectable residues of clomazone were found only in the 0-6 
horizon. Should movement into surface water occur, potential for 
clomazone residues to be detected in drinking water supplies at 
significant levels is minimal. Accordingly, there is no reasonable 
expectation that there would be an additional incremental aggregate 
dietary contribution of clomazone through groundwater or surface water.
    2. Non-dietary exposure. Clomazone is only registered for use on 
food crops. Since the proposed use on the tuberous and corm vegetable 
(except potato) crop subgoup and cucurbit vegetable crop group is 
consistent with existing registrations, there will be no non-dietary, 
non-occupational exposure.

D. Cumulative Effects

     Clomazone is an isoxazolidinone herbicide. No other registered 
chemical exists in this class of chemistry. Therefore, given 
clomazone's unique chemistry low acute toxicity, the absence of 
genotoxic, oncogenic, developmental or reproductive effects, and low 
exposure potential (see Sections A and C), the expression of cumulative 
human health effects with clomazone and other natural or synthetic 
pesticides is not anticipated.

E. Safety Determination

    1. U.S. population. Using the conservative exposure assumptions 
described above, based on the completeness and reliability of the 
toxicology data, it is concluded that aggregate exposure due to 
existing registered uses, and pending uses, of clomazone will utilize 
less than 1% of the RfD for the U.S. population. Additionally, an 
analysis concluded that aggregate exposure to clomazone adding use on 
cucurbit vegetable crop group and tuberous and corm vegetable (except 
potato) crop subgroup at a 0.05 ppm will utilize a negligible (i.e., 
0.011% or less for cucurbits and 0.002% or less for these root crops) 
percent of the RfD for the U.S. population. EPA generally has no 
concern for exposures below 100% of the RfD because the RfD represents 
the level at or below which daily aggregate dietary exposure over a 
lifetime will not pose appreciable risks to human health. It is 
concluded that there is a reasonable certainty that no harm will result 
from aggregate exposure to residues of clomazone, including all 
anticipated dietary exposure.
    2. Infants and children. Based on the current toxicological data 
requirements, the data base relative to prenata and postnatal effects 
for children is complete (See Section B.3). Further, for clomazone, the 
NOAEL in the two year feeding study which was used to calculate the RfD 
(0.043 mg/kg/day) is already lower than the NOAELs from the 
reproductive and developmental studies by a factor of more than 10-
fold. Therefore, it can be concluded that no additional uncertainty 
factors are warranted and that the RfD at 0.043 mg/kg/day is 
appropriate for assessing aggregate risk to infants and children as 
well as adults.
     Using the conservative exposure assumptions described above, FMC 
has concluded that < 1% of the RfD will be utilized by aggregate 
exposure to residues of clomazone in/on tuberous and corm vegetable 
(except potato) crop subgroup and cucurbit vegetable crop group for 
non-nursing infants (< 1 year old), the population subgroup most 
sensitive.
     Based on the above information, FMC has concluded that there is a 
reasonable

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certainty that no harm will result to infants, children or adults from 
dietary food consumption exposure to clomazone residues from tuberous 
and corm vegetable (except potato) crop subgroup and cucurbit vegetable 
crop group plus all other clomazone treated human dietary food sources.

F. International Tolerances

     There are Codex residue limits for residues of clomazone in or on 
oilseed rape, potatoes, tobacco, soybeans, rice, cottonseed, sugarcane 
and peas.
[FR Doc. 00-31058 Filed 12-5-00; 8:45 am]
BILLING CODE 6560-50-S