[Federal Register Volume 70, Number 55 (Wednesday, March 23, 2005)]
[Rules and Regulations]
[Pages 14546-14551]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-5719]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2005-0049; FRL-7703-1]


Mesotrione; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
mesotrione in or on sweet corn. Syngenta Crop Protection Inc. requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective March 23, 2005. Objections and 
requests for hearings must be received on or before May 23, 2005.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under docket 
identification (ID) number OPP-2005-0049. All documents in the docket 
are listed in the EDOCKET index at http://www.epa.gov/edocket. Although 
listed in the index, some information is not publicly available, i.e., 
CBI or other information whose disclosure is restricted by statute. 
Certain other material, such as copyrighted material, is not placed on 
the Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available either electronically 
in EDOCKET or in hard copy at the Public Information and Records 
Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 S. 
Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to 
4 p.m., Monday through Friday, excluding legal holidays. The docket 
telephone number is (703) 305-5805.

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

[[Page 14547]]

305-6224; and e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural 
workers; commercial applicators; farmers; greenhouse, nursery, and 
floriculture workers; residential users.
    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 this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Access Electronic Copies of this Document and Other 
Related Information?

    In addition to using EDOCKET (http://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/. 
To access the OPPTS Harmonized Guidelines referenced in this document, 
go directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm/.

II. Background and Statutory Findings

    In the Federal Register of August 7, 2002 (67 FR 152) (FRL-7186-5), 
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 
346a(d)(3), announcing the filing of a pesticide petition (2F6443) by 
Syngenta Crop Protection Inc., 410 Swing Road, PO Box 18300, 
Greensboro, NC 27419-8300. The petition requested that 40 CFR 180.571 
be amended by establishing tolerances for residues of the herbicide 
mesotrione, 2-[4-(methylsulfonyl)-2-nitrobenzoyl]-1,3-cyclohexanedione, 
in or on the raw agricultural commodities (RACs) sweet corn ears, sweet 
corn forage, and sweet corn stover at 0.01, 0.50, and 2.0 parts per 
million (ppm); respectively. That notice included a summary of the 
petition prepared by Syngenta Crop Protection Inc., the registrant. 
There were no comments received in response to the notice of filing. 
The tolerances for sweet corn stover is corrected to 1.5 ppm to reflect 
the submitted residue data. Sweet corn ears is corrected to sweet corn 
kernel plus cob with husks removed.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of FFDCA and a complete 
description of the risk assessment process, see the final rule on 
Bifenthrin Pesticide Tolerances of November 26, 1997 (62 FR 62961) 
(FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of FFDCA, for tolerances for residues of mesotrione on sweet 
corn kernel plus cob with husks removed, sweet corn forage, and sweet 
corn stover at 0.01, 0.50, and 1.5 ppm; respectively. EPA's assessment 
of exposures and risks associated with establishing the tolerance 
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
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 variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by mesotrione as well 
as the no observed adverse effect level (NOAEL) and the lowest observed 
adverse effect level (LOAEL) from the toxicity studies reviewed are 
discussed in the Federal Register of June 21, 2001 (66 FR 33187) (FRL-
6787-7).

B. Toxicological Endpoints

    A summary of the toxicological endpoints for mesotrione used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of June 21, 2001 (66 FR 33187) (FRL-
67877).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.571) for the residues of mesotrione, in or on a 
variety of RACs. Risk assessments were conducted by EPA to assess 
dietary exposures from mesotrione in food as follows:
    i. Acute exposure. Acute dietary risk assessments are performed for 
a food-use pesticide if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a one day 
or single exposure. No appropriate study available shows any acute 
dietary effects of concern.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the Dietary Exposure Evaluation Model (DEEM\TM\) analysis 
evaluated the individual food consumption as reported by respondents in 
the United States Department of Agriculture (USDA) 1989-1992 nationwide 
Continuing Surveys of Food Intake by Individuals (CSFII) and 
accumulated exposure to the chemical for each commodity. The following 
assumptions were made for the chronic exposure assessments: Residue 
levels are at the recommended tolerances for field corn, popcorn, sweet 
corn and cranberries

[[Page 14548]]

and 100% of the crops are treated with mesotrione. The %cPAD for the 
general U.S. population is 3% and for the most sensitive population 
subgroups, children 3-5 years old, is 7% of the cPAD.
    iii. Cancer. Acceptable oral rat and mouse carcinogenicity studies 
showed no evidence of carcinogenic or mutagenic potential. Therefore, 
no exposure assessment is needed to access cancer risk.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for mesotrione in drinking water. 
Because the Agency does not have comprehensive monitoring data, 
drinking water concentration estimates are made by reliance on 
simulation or modeling taking into account data on the physical 
characteristics of mesotrione.
    The Agency uses the Generic Estimated Environmental Concentration 
(GENEEC) or the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) to estimate pesticide concentrations in surface 
water and SCI-GROW, which predicts pesticide concentrations in ground 
water. In general, EPA will use GENEEC (a Tier 1 model) before using 
PRZM/EXAMS (a Tier 2 model) for a screening-level assessment for 
surface water. The GENEEC model is a subset of the PRZM/EXAMS model 
that uses a specific high-end runoff scenario for pesticides. GENEEC 
incorporates a farm pond scenario, while PRZM/EXAMS incorporate an 
index reservoir environment in place of the previous pond scenario. The 
PRZM/EXAMS model includes a percent crop (PC) area factor as an 
adjustment to account for the maximum percent crop coverage within a 
watershed or drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a screen for sorting out pesticides for which it is 
unlikely that drinking water concentrations would exceed human health 
levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs), which are the model estimates of a 
pesticide's concentration in water. EECs derived from these models are 
used to quantify drinking water exposure and risk as a percent 
reference dose (%RfD) or percent adjusted dose (%PAD). Instead drinking 
water levels of comparison (DWLOCs) are calculated and used as a point 
of comparison against the model estimates of a pesticide's 
concentration in water. DWLOCs are theoretical upper limits on a 
pesticide's concentration in drinking water in light of total aggregate 
exposure to a pesticide in food, and from residential uses. Since 
DWLOCs address total aggregate exposure to mesotrione they are further 
discussed in the aggregate risk sections in Unit E.
    Based on the GENEEC and SCI-GROW models, the EECs of mesotrione for 
acute exposures are estimated to be 20 parts per billion (ppb) for 
surface water and 0.15 ppb for ground water. The EECs for chronic 
exposures are estimated to be 4.3 ppb for surface water and 0.15 ppb 
for ground water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Mesotrione is not registered for use on any sites that would result 
in residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to mesotrione and any other 
substances and mesotrione does not appear to produce a toxic metabolite 
produced by other substances. For the purposes of this tolerance 
action, therefore, EPA has not assumed that mesotrione has a common 
mechanism of toxicity with other substances. For information regarding 
EPA's efforts to determine which chemicals have a common mechanism of 
toxicity and to evaluate the cumulative effects of such chemicals, see 
the policy statements released by EPA concerning common mechanism 
determinations and procedures for cumulating effects from substances 
found to have a common mechanism on EPA's web site at http://www.epa.gov/pesticides/cumulative/.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines based on reliable data that a different margin of 
safety will be safe for infants and children. Margins of safety are 
incorporated into EPA risk assessments either directly through use of a 
margin of exposure (MOE) analysis or through using uncertainty (safety) 
factors in calculating a dose level that poses no appreciable risk to 
humans. In applying this provision, EPA either retains the default 
value of 10X when reliable data do not support the choice of a 
different factor, or, if reliable data are available, EPA uses a 
different additional safety factor value based on the use of 
traditional uncertainty factors and/or special FQPA safety factors, as 
appropriate.
    2. Prenatal and postnatal sensitivity. 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 effects.
    3. Conclusion. The FQPA safety factor (10x) is retained in 
assessing the risk posed because there is quantitative evidence of 
increased susceptibility of the young exposed to mesotrione in the 
prenatal developmental toxicity studies in mice, rats, and rabbits and 
in the multi-generation reproduction study in mice, there is 
qualitative evidence of increased susceptibility of the young exposed 
to mesotrione in the multi-generation reproduction study in rats; and a 
developmental neurotoxicity study is required to assess the effects of 
tyrosinemia on the developing nervous system exposed to mesotrione.

E. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against EECs. DWLOC values are 
not regulatory standards for drinking water. DWLOCs are theoretical 
upper limits on a

[[Page 14549]]

pesticide's concentration in drinking water in light of total aggregate 
exposure to a pesticide in food and residential uses. In calculating a 
DWLOC, the Agency determines how much of the acceptable exposure (i.e., 
the PAD) is available for exposure through drinking water e.g., 
allowable chronic water exposure (mg/kg/day) = cPAD - (average food + 
residential exposure). This allowable exposure through drinking water 
is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the EPA's Office of Water are used to calculate 
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 
1L/10 kg (child). Default body weights and drinking water consumption 
values vary on an individual basis. This variation will be taken into 
account in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
Acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, EPA concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which EPA has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because EPA considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, EPA will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. Acute doses and endpoints were not identified for 
the general U.S. population (including infants and children) or the 
females 13-50 years old population subgroup for mesotrione; therefore, 
mesotrione is not expected to pose an acute dietary risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
mesotrione from food will utilize 3% of the cPAD for the U.S. 
population, 4% of the cPAD for all infants (> 1 year old), and 7% of 
the cPAD for children 3-5 years old. There are no residential uses for 
mesotrione that result in chronic residential exposure to mesotrione. 
After calculating DWLOCs and comparing them to the EECs for surface and 
ground water, EPA does not expect the aggregate exposure to exceed 100% 
of the cPAD, as shown in following Table 1:

              Table 1.--Aggregate Risk Assessment for Chronic (Non- Cancer) Exposure to mesotrione
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                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     %cPAD      Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                       0.0007            3          4.3         0.15           24
----------------------------------------------------------------------------------------------------------------
All infants (> 1 year old)                           0.0 007            4          4.3         0.15          6.7
----------------------------------------------------------------------------------------------------------------
Children (3-5 years old)                              0.0007            7          4.3         0.15          6.5
----------------------------------------------------------------------------------------------------------------

    3. Short-term risk + intermediate-term risk. Short-term + 
intermediate-term aggregate exposure takes into account residential 
exposure plus chronic exposure to food and water (considered to be a 
background exposure level).
    Mesotrione is not registered for use on any sites that would result 
in residential exposure. Therefore, the aggregate risk is the sum of 
the risk from food and water, which do not exceed the Agency's level of 
concern.
    4. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to mesotrione residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography) is available 
to enforce the tolerance expression. The method may be requested from: 
Chief, Analytical Chemistry Branch, Environmental Science Center, 701 
Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; 
e-mail address: [email protected].

B. International Residue Limits

    There are no CODEX, Canadian, or Mexican tolerances/Maximum Residue 
Levels for mesotrione residues. Thus, harmonization is not an issue at 
this time.

C. Conditions

    Conversion of the mesotrione registration to unconditional under 
section 3(c)(5) of Federal Insecticide and Fungicide Act (FIFRA) as 
amended may be considered upon submission of developmental 
neurotoxicity study in the mouse, and an 28-day inhalation study.

V. Conclusion

    Therefore, the tolerances are established for residues of 
mesotrione, 2-[4-(methylsulfonyl)-2-nitrobenzoyl]-1,3-cyclohexanedione, 
in or on the RACs sweet corn kernel plus cob with husks removed, sweet 
corn forage, and sweet corn stover at 0.01, 0.50, and 1.5 ppm; 
respectively.

VI. Objections and Hearing Requests

    Under section 408(g) of FFDCA, as amended by FQPA, any person may 
file an objection to any aspect of this regulation and may also request 
a hearing on those objections. The EPA procedural regulations which 
govern the submission of objections and requests for hearings appear in 
40 CFR part 178. Although the procedures in those regulations require 
some modification to reflect the amendments made to FFDCA by FQPA, EPA 
will continue to use those procedures, with appropriate adjustments, 
until the necessary modifications can be made. The new section 408(g) 
of FFDCA provides essentially the same process for persons to 
``object'' to a regulation for an exemption from the requirement of a 
tolerance issued by EPA under new section 408(d) of FFDCA, as was 
provided in the old sections 408 and 409 of FFDCA. However, the period 
for filing objections is now 60-days, rather than 30-days.

[[Page 14550]]

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2005-0049 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before May 23, 
2005.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential 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. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900L), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW., 
Washington, DC 20005. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
    2. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in ADDRESSES. Mail your 
copies, identified by docket ID number OPP-2005-0049, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in ADDRESSES. You may also send an electronic copy of 
your request via e-mail to: [email protected]. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose 
any enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104-4). Nor does it require any special considerations under Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994); or OMB review or any Agency action under Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does 
not involve any technical standards that would require Agency 
consideration of voluntary consensus standards pursuant to section 
12(d) of the National Technology Transfer and Advancement Act of 1995 
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of FFDCA, such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications'' as 
described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
Order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct

[[Page 14551]]

effects on tribal governments, on the relationship between the Federal 
Government and Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes, as 
specified in Executive Order 13175. Thus, Executive Order 13175 does 
not apply to this rule.

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: March 14, 2005.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.571 is amended by alphabetically adding the following 
commodities to the table in paragraph (a) to read as follows:


Sec.  180.571  Mesotrione; tolerances for residues.

    (a) * * *

----------------------------------------------------------------------------------------------------------------
                       Commodity                                            Parts per million
----------------------------------------------------------------------------------------------------------------
                                                    * * * * *
Corn, sweet, forage...................................                                                       0.5
Corn, sweet, kernel plus cob with husks removed.......                                                      0.01
Corn, sweet, stover...................................                                                       1.5
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 05-5719 Filed 3-22-05; 8:45 am]
BILLING CODE 6560-50-S