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sethoxydim (Poast) Pesticide Petition Filing Notice 7/02

ENVIRONMENTAL PROTECTION AGENCY [OPP-2002-0173; FRL-7191-3]
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-2002-0173, must be
received on or before September 6, 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-2002-0173 in the subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Sidney Jackson, Registration
Division (7505C), Office of Pesticide Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;telephone
number: (703) 305-7610; e-mail address: jackson.sidney@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:
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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
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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 ID number OPP-2002-0173. 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-2002-0173 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/ 8.0/9.0 or ASCII file format. All comments
in electronic form must be identified by docket ID number OPP-2002-0173.
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: July 31, 2002. Peter Caulkins, 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 petitioner and represents the view of the
petitioner. 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 (IR-4)
PP 0E6150
EPA has received a pesticide petition PP (0E6150) from the Interregional
Research Project Number (IR-4), Technology Centre of New Jersey,
Rutgers, the State University of New Jersey, 681 U. S. Hwy., #1 South,
North Brunswick, NJ 08902-3390 proposing, pursuant to section 408(d) of
the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part 180 by establishing
tolerances for combined residues of the herbicide, sethoxydim (2-[1-
(ethoxyimino)butyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2-cyclohexen-1-
one) and its metabolites containing the 2-cyclohexen-1- one moiety
(calculated as the herbicide)] in or on the raw agricultural commodities
as follows:
1. Herb subgroup 19A, fresh leaves, except lemongrass at 5.0 parts per
million (ppm).
2. Abarella, atemoya, avocado, acerola, banana, birbira, blimbe,
breadfruit, cacao bean canistel, cherimoya, coconut, custard apple,
date, durian, feijoa, fig, governor's plum, guava, ilama, imbe, imbu,
jaboticaba, jackfruit, kiwifruit, longan, lychee, mamey apple, mango,
marmaladebox, mamey sapote, mangosteen, mountain papaya, papaya,
passionfruit, persimmon, pomegrante, rambutan, rose apple, sapodilla,
black sapote, white sapote, soursop, spanish lime, starfruit, star
apple, surinam cherry, sugar apple, tamarind, ugli fruit, and wax jambu
at 0.5 ppm.
3. Lingonberries, juneberry, and salal at 5.0 ppm.
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. This
notice includes a summary of the petition prepared by BASF Corporation,
P.O. Box 13528, Research Triangle Park, North Carolina.
A. Residue Chemistry
1. Plant metabolism. The qualitative nature of the residues in plants
and animals is adequately understood for the purposes of registration.
2. Analytical method. Analytical methods for detecting levels of
sethoxydim and its metabolites in or on food with a limit of detection
that allows monitoring of food with residues at or above the levels set
in these tolerances were submitted to EPA. The proposed analytical
method involves extraction, partition, and clean-up. Samples are then
analyzed by gas chromatography with sulfur-specific flame photometric
detection. The limit of quantitation (LOQ) is 0.05 ppm.
B. Toxicological Profile
EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the reliability of the sensitivities of
major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by sethoxydim are
discussed in Unit II. A. of the final rule on sethoxydim pesticide
tolerances published in the Federal Register of October 8, 1998 (63 FR
54066) (FRL-6034-1) 1. Animal metabolism. In a rat metabolism study,
excretion was extremely rapid and tissue accumulation was negligible. 2.
Metabolite toxicology. As a condition to registration, BASF had been
asked to submit additional toxicology studies for the hydroxy-
metabolites of sethoxydim. EPA agreed with BASF's recommendation to use
the most abundant metabolite, 5-OH-MSO2, as surrogate for all
metabolites. Based on these data, it was concluded that the
toxicological potency of the plant hydroxy-metabolites is likely to be
equal or less than that of the parent compound. The tolerance expression
for sethoxydim and its metabolites containing the 2- cyclohexen-1-one
moiety, measured as parent. Hence, the hyrdroxy- metabolites are figured
into all tolerance calculations. 3. Endocrine disruption. No specific
tests have been performed with sethoxydim to determine whether the
chemical may have an effect in humans that is similar to an effect
produced by naturally-occurring estrogen or other endocrine effects.
C. Aggregate Exposure
1. Dietary exposure--i. Food. For purposes of assessing the potential
dietary exposure, BASF has estimated aggregate exposure based on the
Theoretical Maximum Residue Contribution (TMRC) from existing and
pending tolerances for sethoxydim. (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 at the tolerance levels.) The TMRC from existing tolerances
for the overall U.S. population is estimated at approximately 44% of the
reference dose (RfD). BASF estimates indicate that dietary exposure will
not exceed the RfD for any population subgroup for which EPA has data.
This exposure assessment relies on very conservative assumptions 100% of
crops will contain sethoxydim residues and those residues would be at
the level of the tolerance which results in an overestimate of human
exposure. Other potential sources of exposure of the general population
to residues of pesticides are residues in drinking water and exposure
from non-occupational sources. ii. Drinking water. Based on the
available studies submitted to EPA for assessment of environmental risk,
BASF does not anticipate exposure to residues of sethoxydim in drinking
water. There is no established maximum concentration level (MCL) for
residues of sethoxydim in drinking water under the safe drinking water
act (SDWA). 2. Non-dietary exposure. BASF has not estimated
non-occupational exposure for sethoxydim. Sethoxydim is labeled for use
by homeowners on and around the following use sites: Flowers,
evergreens, shrubs, trees, fruits, vegetables, ornamental groundcovers,
and bedding plants. Hence, the potential for non-occupational exposure
to the general population exists. However, these use sites do not
appreciably increase exposure. Protective clothing requirements,
including the use of gloves, adequately protect homeowners when applying
the product. The product may only be applied through hose-end sprayers
or tank sprayers as a 0.14% solution. Sethoxydim is not a volatile
compound so inhalation exposure during and after application would be
negligible. Dermal exposure would be minimal in light of the protective
clothing and the low application rate. According to BASF, post-treatment
(re-entry) exposure would be negligible for these use sites as contact
with treated surfaces would be low. BASF concludes that the potential
for non-occupational exposure to the general population is
insignificant.
D. Cumulative Effects
BASF also considered the potential for cumulative effects of sethoxydim
and other substances that have a common mechanism of toxicity. BASF is
aware of one other active ingredient which is structurally similar,
clethodim. However BASF believes that consideration of a common
mechanism of toxicity is not appropriate at this time. BASF does not
have any reliable information to indicate that toxic effects produced by
sethoxydim would be cumulative with clethodim or any other chemical;
thus BASF is considering only the potential risks of sethoxydim in its
exposure assessment.
E. Safety Determination
1. U.S. population. RFD using the conservative exposure assumptions
described above, BASF has estimated that aggregate exposure to
sethoxydim will utilize 44% of the RfD for the U.S. population. EPA
generally has no concern for exposures below 100% of the RfD. Therefore,
based on the completeness and reliability of the toxicity data, and the
conservative exposure assessment, BASF concludes that there is a
reasonable certainty that no harm will result from aggregate exposure to
residues of sethoxydim, including all anticipated dietary exposure and
all other non-occupational exposures. 2. Infants and children--i.
Developmental toxicity was observed in a developmental toxicity study
using rats but was not seen in a developmental toxicity study using
rabbits. In the developmental toxicity study in rats a maternal no
observed adverse effect level (NOAEL) of 180 milligrams/kilograms/day
(mg/kg/day) and a maternal lowest observed adverse effect level (LOAEL)
of 650 mg/kg/day (irregular gait, decreased activity, excessive
salivation, and anogenital staining) was determined. A developmental
NOAEL of 180 mg/ kg/day and a developmental lowest effect level (LEL)--
of 650 mg/kg/day (21 to 22% decrease in fetal weights, filamentous tail
and lack of tail due to the absence of sacral and/or caudal vertebrae,
and delayed ossification in the hyoids, vertebral centrum and/or
transverse processes, sternebrae and/or metatarsals, and pubes). Since
developmental effects were observed only at doses where maternal
toxicity was noted, the developmental effects observed are believed to
be secondary effects resulting from maternal stress. ii. Reproductive
toxicity. A 2-generation reproduction study with rats fed diets
containing 0, 150, 600, and 3,000 ppm (approximately 0, 7.5, 30, and 150
mg/kg/day) produced no reproductive effects during the course of the
study. Although the dose levels were insufficient to elicit a toxic
response, the Agency has considered this study usable for regulatory
purposes and has established a free-standing NOAEL of 3,000 ppm
(approximately 150 mg/kg/day), Proposed Rule of March 15, 1995, (60 FR
13941) (FRL-4936-1) iii. Reference dose. Based on the demonstrated lack
of significant developmental or reproductive toxicity BASF believes that
the RfD used to assess safety to children should be the same as that for
the general population, 0.09 mg/kg/day. Using the conservative exposure
assumptions described above, BASF has concluded that the most sensitive
child population is that of children ages 1 to 6. BASF calculates the
exposure to this group to be approximately 96% of the RfD for all uses
(including those proposed in this document). Based on the completeness
and reliability of the toxicity data and the conservative exposure
assessment, BASF concludes that there is a reasonable certainty that no
harm will result to infants and children from aggregate exposure to the
residues of sethoxydim, including all anticipated dietary exposure and
all other non-occupational exposures.
F. International Tolerances
A maximum residue level has not been established by the Codex
Alimentarius Commission for residues of sethoxydim on the crops included
in this proposal.
[FR Doc. 02-19983 Filed 8-6-02; 8:45 am]