Mesotrione - Pesticide Petition Filing Notice 7/02
ENVIRONMENTAL PROTECTION AGENCY
Notice of Filing a Pesticide Petition to Establish a Tolerance
for a Certain Pesticide Chemical in or on Food
AGENCY: Environmental Protection Agency (EPA).
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
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:
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:
Categories NAICS codes potentially
Industry 111 Crop production
112 Animal production
311 Food 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
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
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
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: firstname.lastname@example.org, 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
E. What Should I Consider as I Prepare My Comments for EPA?
You may find the following suggestions helpful for preparing your
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
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
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
Dated: July 29, 2002.
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
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 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
2. Analytical method. Adequate analytical methods (HPLC-
fluorescence method and HPLV-MS-MS) are available for enforcement
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
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
2. Non-dietary exposure. Mesotrione is not registered for any non-
food use, and no significant non-dietary, non-occupational exposure is
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
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]