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clomazone (Command) Pesticide Petition Filing 7/02

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
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-2002-0131. 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: 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 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 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.
    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]