[Federal Register Volume 67, Number 152 (Wednesday, August 7, 2002)]
[Notices]
[Pages 51270-51272]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-19804]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2002-2139; FRL-7186-5]


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-2002-2139, 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-2002-2139 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: Joanne I. Miller, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 305-6224; 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.

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/. A frequently updated electronic 
version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html a beta site currently 
under development.
    2. In person. The Agency has established an official record for 
this action under docket ID number OPP-2002-2139. 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

[[Page 51271]]

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-2002-2139 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-2002-2139. 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 29, 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 Syngenta Crop Protection Inc. and represents 
the view of Syngenta. 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.

Syngenta Crop Protection, Inc.

Interregional Research Project Number #4

PP 2F6443, PP 2E6465

    EPA has received pesticide petitions 2F6443 and from Syngenta Crop 
Protection, Inc., P.O. Box 18300, Greensboro, NC 27419-8300 and 2E6465 
from the Interregional Research Project Number #4, 681 U.S. Highway #1 
South, North Brunswick, NJ 08902 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 a tolerance for residues of 
mesotrione, 2-[4-(methylsulfonyl)-2-nitrobenzoyl]-1,3-cyclohexanedione, 
in or on the raw agricultural commodities popcorn, sweet corn ears, 
sweet corn forage, and sweet corn stover at 0.01, 0.01, 0.50, and 2.0 
parts per million (ppm); respectively. 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 
support granting of the petition. Additional data may be needed before 
EPA rules on the petitions.

A. Residue Chemistry

    1. Plant metabolism. The nature of the residue of mesotrione in 
plants is

[[Page 51272]]

adequately understood. Mesotrione is rapidly and completely metabolized 
in corn. No single extract or component accounted for greater than 0.01 
ppm in grain. Numerous components were characterized in forage and 
fodder, including the metabolite 2-amino-4-methylsulfonyl benzoic acid 
(AMBA) and its conjugates and 4-methylsulfonyl-2-nitrobenzoic acid 
(MNBA).
    2. Analytical method. Adequate analytical methods (HPLC- 
fluorescence method and HPLV-MS-MS) are available for enforcement 
purposes.
    3. Magnitude of residues. The appropriate number of field residue 
studies were conducted with popcorn and sweet corn grown in 12 states. 
These trials were conducted in the major U.S. growing areas for popcorn 
and sweet corn.

B. Toxicological Profile

     A full description of the studies describing the toxicity, animal 
metabolism, metabolite toxicology, and endocrine disruption of 
mesotrione can be found in the posting for its first tolerances in the 
Federal Register of June 21, 2001 (66 FR 33187) (FRL-6787-7)

C. Aggregate Exposure

    1. Dietary exposure. For purposes of assessing the potential 
dietary exposure under the proposed tolerance, Syngenta estimated 
aggregate exposure based on the theoretical maximum residue 
concentration (TMRC) in popcorn, field corn, and sweet corn. The TMRC 
is calculated by multiplying the proposed tolerance levels for corn by 
the consumption data which estimate the amount of the commodity 
consumed by various population subgroups. Exposure was calculated only 
for the chronic exposures, since EPA has previously determined that 
mesotrione is not acutely toxic and no toxic reference dose was 
selected.
    i. Food. Chronic exposure to mesotrione is negligible. Syngenta has 
conservatively assumed that 100% of all popcorn, field, and sweet corn 
used for human consumption would contain tolerance level residues of 
mesotrione. The potential dietary exposure to mesotrione was calculated 
on the basis of the proposed tolerance of the LOQ, 0.01 ppm, in corn. 
Residues in milk, meat and eggs due to the feeding of popcorn, field, 
and sweet corn commodities are not expected and tolerances for milk, 
meat and eggs are not required. However, exposure estimates took into 
consideration the transfer of minute residues from feed commodities 
into meat and dairy products. Calculated on this basis, the dietary 
exposure of the general U.S. population to mesotrione would correspond 
to 2.5% of the chronic reference dose. The percent of the reference 
dose that will be utilized by dietary exposure to residues of 
mesotrione is 1.4% for nursing infants less than 1 year old, 5.8% for 
non-nursing infants and 6.2% for children 1 to 6 years old. It is 
concluded, there is reasonable certainty that no harm will result from 
the additional tolerances on popcorn, and sweet corn.
    ii. Drinking water. Based on EPA's ``Interim Guidance for 
Conducting Drinking Water Exposure and Risk Assessments'' document 
(December 2, 1997), chronic drinking water levels of comparison (DWLOC) 
for mesotrione were calculated. The calculated DWLOCs for the U.S. 
population in general was 24.45 parts per billion (ppb). The most 
sensitive sub population was children between 1 to 6 years old with a 
chronic DWLOC of 6.96 ppb. The highly conservative model estimated 
water concentrations by FQPA Index Reservoir Screening Tool (FIRST) 
were 27 to 95 times lower than all the DWLOCs including the most 
sensitive group. It is, therefore, concluded that the potential impact 
of mesotrione residues in drinking water derived from either surface 
water or ground water on the aggregate risk to human health is 
negligible.
    2. Non-dietary exposure. Mesotrione is not registered for any non-
food use, and no significant non-dietary, non-occupational exposure is 
anticipated.

D. Cumulative Effects

     Mesotrione is the only registered pesticide from the triketone 
chemical class, and mesotrione does not produce a toxic metabolite 
produced by other substances. For the purposes of this tolerance 
action, mesotrione does not have a common mechanism of toxicity with 
other substances.

E. Safety Determination

    1. U.S. population. Mesotrione is not acutely toxic, no acute PAD 
has been selected, and no acute assessment is warranted. Under the most 
conservative estimates, the dietary exposure of the general U.S. 
population to mesotrione would be no more than 2.5% of the chronic 
reference dose. Highly conservative model estimated water 
concentrations by FIRST were 27 to 95 times lower than all the DWLOCs 
including the most sensitive group. It is, therefore, concluded that 
the potential impact of mesotrione residues derived from either dietary 
or water sources on the aggregate risk to human health is negligible.
    2. Infants and children. EPA previously determined that there is 
quantitative evidence of increased susceptibility demonstrated in the 
oral prenatal developmental toxicity studies in rats, mice, and 
rabbits. Delayed ossification was seen in the fetuses at doses below 
those at which maternal toxic effects were noted. Maternal toxic 
effects in the rat were decreased body weight gain during treatment and 
decreased food consumption and in the rabbit, abortions and 
gastrointestinal (GI) effects. The Food Quality Protection Act (FQPA) 
10x safety factor was retained. Syngenta has summarized new data in the 
popcorn, and sweet corn petition to support the position that the 
default FQPA safety factor of 10x should not be applied to mesotrione. 
There is direct evidence that has been accepted by EPA that the mouse 
is the most appropriate model for predicting potential effects of 
mesotrione-induced elevation of tyrosine in humans, based on the 
similarity of the key tyrosine catabolism enzyme, tyrosine 
aminotransferase (TAT), in mice and humans. Furthermore, there is 
direct evidence to indicate that all the biological processes needed to 
regulate tyrosine levels in neonates are developed at birth, and TAT 
levels are comparable to the degree of expression in adults. Therefore, 
there is no compelling evidence to indicate that developing organisms 
are more sensitive to mesotrione administration than adults.

F. International Tolerances

     There are no codex maximum residue levels established for residues 
of mesotrione on popcorn, and sweet corn, nor are there maximum residue 
levels established in Canada or Mexico.
[FR Doc. 02-19804 Filed 8-6-02; 8:45 am]
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