[Federal Register Volume 67, Number 137 (Wednesday, July 17, 2002)]
[Notices]
[Pages 46981-46984]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-17689]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2002-0131; FRL-7185-8]


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 ID number OPP-2002-0131, must be 
received on or before August 16, 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 ID 
number OPP-2002-0131 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

[[Page 46982]]

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 codes         potentially
                                                       affected entities
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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-2002-0131. 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 ID number OPP-2002-0131 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 ID number OPP-2002-0131. 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 
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 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

[[Page 46983]]

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: July 2, 2002.
Debra Edwards,
Acting Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    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 Interregional Research Project Number 4 
and represents the view of the Interregional Research Project Number 4. 
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

PP 2E6407

    EPA has received a pesticide petition [2E6407] from the 
Interregional Research Project Number 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 180.425 by establishing a tolerance for 
residues of the herbicide clomazone, 2-(2-chlorophenyl)methyl-4,4-
dimethyl-3-isoxazolidinone in or on the raw agricultural commodities 
peppermint tops and spearmint tops at 0.05 part per million (ppm). This 
notice includes a summary of the petition prepared by FMC, Agricultural 
Products Group, Philadelphia, PA 19103. EPA has determined that the 
petition contains 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 petition. Additional data may be needed before 
EPA rules on the petition.

A. Residue Chemistry

    1. Plant metabolism. The metabolism of clomazone in plants is 
adequately understood.
    2. Analytical method. Samples were 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). Mint oil samples were partitioned with 
hexane followed by clean-up with two Florisil columns. Analysis was 
conducted using GC/MS. The method limit of quantitation (LOQ) is 0.05 
ppm. The method limit of detection (LOD) is 0.01 ppm.
    3. Magnitude of residues. IR-4 conducted a residue study consisting 
of five trials, located in EPA Regions 5 and 10, to determine the 
magnitude of the residue of clomazone in/on mint and mint oil after 
Command 3ME was applied once as a pre-emergence broadcast spray at 0.5 
pound active ingredient/acre (lb. ai/acre), or at 1.0 lb. ai/acre for 
processing into mint oil. No quantifiable residues of clomazone were 
observed in the mint stems or leaves or mint oil.

B. Toxicological Profile

     The nature of the toxic effects caused by clomazone is discussed 
in unit II.B. of the Federal Register on March 28, 2001 (66-FR-16917) 
(FRL-6775-4).
    1. 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.
    2. Metabolite toxicology. No clomazone related metabolite residues 
have been identified as being of toxicological concern. The residue of 
significance is parent. Clomazone, has been thoroughly investigated in 
a full battery of studies including acute, genetic, reproduction, 
developmental and oncogenic tests. These studies have demonstrated that 
clomazone has low acute toxicity, an overall absence of genotoxicity 
and does not cause reproductive toxicity, developmental toxicity, or 
carcinogenicity.
    3. 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. 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% of all crops for which 
tolerances are established are treated and that pesticide residues are 
present at the tolerance levels.
    i. Food. Dietary exposure to residues of clomazone in or on food 
will be limited to residues on cabbage (0.1 ppm), cottonseed (0.05 
ppm), cucumber (0.1 ppm), succulent peas (0.05 ppm), peppers (0.05 
ppm), pumpkins (0.1 ppm), soybeans (0.05 ppm), winter squash (0.1 ppm), 
summer squash (0.1 ppm), sweet potato (0.05 ppm), snap beans (0.05 
ppm), rice (0.05 ppm), sugar (from cane) (0.05 ppm), tanier, cassava, 
yams, arracacha (0.05 ppm), and mint (0.05 ppm). Various feedstuffs 
from cotton, soybeans and sugarcane are fed to animals, thus exposure 
of humans to residues might result if such residues carry through to 
meat, milk, poultry, or eggs. No tolerances are proposed for meat, 
milk, poultry, or eggs since no detectable residues from clomazone have 
been found in animal feed items from these crops.
    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 ground water or surface 
water. For further information see Unit II.C. of the Federal Register.

[[Page 46984]]

    2. Non-dietary exposure. Clomazone is only registered for use on 
food crops. Since the proposed use on mint 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, carcinogenic, developmental or reproductive effects, and low 
exposure potential, 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 TMRC (a conservative exposure 
assumption), and 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 mint 
(spearmint tops and peppermint tops) at 0.05 ppm tolerance level will 
utilize a negligible 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. Therefore, 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-- Safety factor. Based on the current 
toxicological data requirements, the data base relative to prenatal and 
postnatal effects for children is complete. Further, for clomazone, the 
no observed adverse effect level (NOAEL) in the 2-year feeding study 
which was used to calculate the reference dose (RfD) milligrams/
kilogram/day (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 the percent of the RfD that will be utilized by 
aggregate exposure to residues of clomazone in/on mint (spearmint tops 
and peppermint tops) for non-nursing infants (<1 year old), the 
population subgroup most sensitive, is negligible (i.e., 0.00) and the 
percent of the RfD that will be utilized by the children (1-6 years 
old) population subgroup is also negligible (0.00). The percent of the 
RfD utilized for infants and children for mint (spearmint tops and 
peppermint tops), plus all other current clomazone tolerances is 0.8 
and 0.5 respectively.
     Based on the above information, FMC has concluded that there is a 
reasonable certainty that no harm will result to infants, children or 
adults from dietary food consumption exposure to clomazone residues 
from mint (spearmint tops and peppermint tops) 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. 02-17689 Filed 7-16-02; 8:45 am]
BILLING CODE 6560-50-S