[Federal Register Volume 67, Number 152 (Wednesday, August 7, 2002)]
[Notices]
[Pages 51267-51270]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-19983]


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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: 
[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
------------------------------------------------------------------------
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.

[[Page 51268]]

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: [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/
8.0/9.0 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

[[Page 51269]]

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

[[Page 51270]]

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]
BILLING CODE 6560-50-S