Document ID: EPA-HQ-OPP-2007-0539-0007
Agency: epa
Document Type: Rule
Title: Trifloxystrobin; Pesticide Tolerance
Posted Date: 2007-09-19T04:00Z

[Federal Register: September 19, 2007 (Volume 72, Number 181)]
[Rules and Regulations]               
[Page 53440-53445]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19se07-12]                         

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0539; FRL-8147-3]

 
Trifloxystrobin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes a tolerance for combined residues 
of Trifloxystrobin and the acid metabolite CGA-321113 in or on grass, 
forage and grass, hay. Bayer CropScience requested this tolerance under 
the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective September 19, 2007. Objections and 
requests for hearings must be received on or before November 19, 2007, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2007-0539. To access the 

[[Page 53441]]

http://www.regulations.gov, select ``Advanced Search,'' then ``Docket 

Search.'' Insert the docket ID number where indicated and select the 
``Submit'' button. Follow the instructions on the regulations.gov 
website to view the docket index or access available documents. All 
documents in the docket are listed in the docket index available in 
regulations.gov. Although listed in the index, some information is not 
publicly available, e.g., Confidential Business Information (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 in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 

copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Janet Whitehurst, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-6129; e-mail address: 
whitehurst.janet@epa.gov.

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 those 
engaged in the following activities:
     Crop production (NAICS code 111), e.g., agricultural 
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers 
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 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 to 
provide 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?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document 

electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 

frequently updated electronic version of EPA's tolerance regulations at 
40 CFR part 180 through the Government Printing Office's pilot e-CFR 
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, any person may file an objection 
to any aspect of this regulation and may also request a hearing on 
those objections. You must file your objection or request a hearing on 
this regulation in accordance with the instructions provided in 40 CFR 
part 178. To ensure proper receipt by EPA, you must identify docket ID 
number EPA-HQ-OPP-2007-0539 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 as required by 40 CFR part 178 on or 
before November 19, 2007.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2007-0539, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket Facility telephone number is (703) 305-5805.

II. Petition for Tolerance

    In the Federal Register of August 1, 2007 (72 FR 42072) (FRL-8138-
1), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
6F7024) by Bayer CropScience, P.O. Box 12014, 2 T.W. Alexander Dr., 
Research Triangle Park, NC 27709. The petition requested that 40 CFR 
180.555 be amended by establishing a tolerance for combined residues of 
the fungicide Trifloxystrobin, (benzeneacetic acid, (E,E)-[alpha]-
(methoxyimino)-2-[[[[1-[3-(trifluoromethyl) 
phenyl]ethylidene]amino]oxy] methyl]-methyl ester) and the free form of 
its acid metabolite CGA-321113 (E,E)-methoxyimino-[2-[1-(3-
trifluoromethylphenyl)-ethylideneaminooxymethyl]-phenyl] acetic acid, 
in or on grass, forage at 10 parts per million (ppm) and grass, hay at 
14 ppm. That notice referenced a summary of the petition prepared by 
Bayer CropScience, the registrant, which is available to the public in 
the docket, http://www.regulations.gov. Comments were received on the 

notice of filing. EPA's response to these comments is discussed in Unit 
IV.C. below.
    Based upon review of the data supporting the petition, EPA has 
modified the tolerances proposed for grass, forage and grass, hay. The 
appropriate tolerances for grass forage and hay were calculated to be 
12 and 17 ppm, respectively. Although residue data were also provided 
for grass straw and seed screenings, tolerances are not required on 
these commodities as the Agency no longer considers them to be 
significant livestock feedstuffs. The recommended tolerance levels for 
grass forage and hay were determined considering recent Agency Guidance 
(Guidance for Setting Pesticide Tolerances Based on Field Trial Data).

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the

[[Page 53442]]

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 the 
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....'' These provisions were added to the 
FFDCA by the Food Quality Protection Act (FQPA) of 1996.
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), 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 for the petitioned-for tolerance 
for combined residues of Trifloxystrobin, (benzeneacetic acid, (E,E)-
[alpha]-(methoxyimino)-2-[[[[1-[3-(trifluoromethyl) 
phenyl]ethylidene]amino]oxy] methyl]-methyl ester) and the free form of 
its acid metabolite CGA-321113 (E,E)-methoxyimino-[2-[1-(3-
trifluoromethylphenyl)-ethylideneaminooxymethyl]-phenyl] acetic acid 
(hereinafter referrred to as Trifloxsytrobin) on grass, forage at 12 
ppm and grass, hay at 17 ppm. 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. Specific information on the studies received and the nature 
of the adverse effects caused by Trifloxystrobin as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies can be found in the 
Trifloxystrobin: Human Health Risk Assessment for Section 3 
Registration for the Proposed Uses on Grasses Grown for Seed. at http://www.regulations.gov.
 The referenced document is available in the 

docket established by this action, which is described under ADDRESSES, 
and is identified as EPA-HQ-OPP-2007-0539 in that docket.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the toxicological level of concern (LOC) is derived 
from the highest dose at which no adverse effects are observed (the 
NOAEL) in the toxicology study identified as appropriate for use in 
risk assessment. However, if a NOAEL cannot be determined, the lowest 
dose at which adverse effects of concern are identified (the LOAEL) is 
sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the LOC to take into account uncertainties 
inherent in the extrapolation from laboratory animal data to humans and 
in the variations in sensitivity among members of the human population 
as well as other unknowns. Safety is assessed for acute and chronic 
risks by comparing aggregate exposure to the pesticide to the acute 
population adjusted dose (aPAD) and chronic population adjusted dose 
(cPAD). The aPAD and cPAD are calculated by dividing the LOC by all 
applicable UFs. Short-term, intermediate-term, and long-term risks are 
evaluated by comparing aggregate exposure to the LOC to ensure that the 
margin of exposure (MOE) called for by the product of all applicable 
UFs is not exceeded.
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk and estimates risk in terms 
of the probability of occurrence of additional adverse cases. 
Generally, cancer risks are considered non-threshold. For more 
information on the general principles EPA uses in risk characterization 
and a complete description of the risk assessment process, see http://www.epa.gov/oppfead1/trac/science; http://www.epa.gov/pesticides/

ides/

aggregate.pdf
    A summary of the toxicological endpoints for Trifloxystrobin used 
for human risk assessment can be found at http://www.regulations.gov in 

document Trifloxystrobin: Human Health Risk Assessment for Section 3 
Registration for the Proposed Uses on Grasses Grown for Seed. Petition 
No: 6F7024 at page 16 in docket ID number EPA-HQ-OPP-2007-0539.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to Trifloxystrobin, EPA considered exposure under the 
petitioned-for tolerances as well as all existing Trifloxystrobin 
tolerances in (40 CFR 180.555). EPA assessed dietary exposures from 
Trifloxystrobin in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and 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 1-day or single exposure.
    In estimating acute dietary exposure, EPA used food consumption 
information from the U.S. Department of Agriculture (USDA) 1994-1996 
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII). As to residue levels in food, EPA assumed 100% crop treated 
(CT) and tolerance level residues for each commodity.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. As to residue levels in food, EPA assumed 100% CT and 
tolerance level residues for each commodity.
    iii. Cancer. The Agency classified trifloxystrobin as a ``not 
likely carcinogen;'' therefore, quantification of human cancer risk is 
not required and a cancer dietary assessment was not performed.
    iv. Anticipated residue and percent crop treated (PCT) information. 
The Agency did not use anticipated residue estimates or PCT information 
in the trifloxystrobin dietary exposure assessment.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring data to complete a comprehensive dietary exposure 
analysis and risk assessment for Trifloxystrobin 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 environmental 
fate characteristics of Trifloxystrobin. Further information regarding 
EPA drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.

    Based on the First Index Reservoir Screening Tool (FIRST), 
Screening Concentration in Ground Water (SCI-GROW) models, and rice 
paddies

[[Page 53443]]

method the estimated environmental concentrations (EECs) of 
Trifloxystrobin and the metabolite CGA-321113 for acute exposures are 
estimated to be 92 parts per billion (ppb) for surface water and 3.4 
ppb for ground water. The EECs for chronic exposures are estimated to 
be 140 ppb for surface water and 3.4 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 92 ppb was used to access 
the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 140 ppb was used to access 
the contribution to drinking 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).
    Trifloxystrobin is currently registered for the following 
residential non-dietary sites: Turfgrass and ornamentals. EPA assessed 
residential exposure using the following assumption: Non-occupational 
postapplication contact with trifloxystrobin following Compass[reg] use 
on turfgrass is the most common and worst case contributor to such 
exposures.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the 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 Trifloxystrobin and any 
other substances and Trifloxystrobin 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 Trifloxystrobin 
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 EPA's website at http://www.epa.gov/pesticides/cumulative
.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of the FFDCA provides that EPA shall 
apply an additional (``10X'') 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 database on toxicity and 
exposure unless EPA determines based on reliable data that a different 
margin of safety will be safe for infants and children. This additional 
margin of safety is commonly referred to as the FQPA safety factor. 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 FQPA 
safety factor value based on the use of traditional UFs and/or special 
FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. In the prenatal 
developmental study in rats there was no developmental toxicity at the 
Limit Dose. In the prenatal developmental study in rabbits, 
developmental toxicity was seen at a dose that was higher than the dose 
that caused maternal toxicity. In the 2-generation reproduction study, 
there was no offspring toxicity at the highest dose tested.
    3. Conclusion. EPA has determined that reliable data show that it 
would be safe for infants and children to reduce the FQPA safety factor 
to 1X. That decision is based on the following findings:
    i. The toxicity database for Trifloxystrobin is complete except for 
an acute neurotoxicity study which is classified as unacceptable. The 
toxicity database contains developmental toxicity studies in two 
species (rats and rabbits) and a 2-generation reproduction study in 
rats which are adequate to assess pre and/or post natal susceptibility 
to infants and children. Although the available, submitted acute 
neurotoxicity study was found to be unacceptable, based on a weight-of-
the evidence review of the available data, the lack of this study does 
not impact the Agency's ability to make an FQPA safety factor decision. 
Given that there was no evidence of neurotoxicity in this study at the 
Limit Dose nor in the other subchronic and chronic studies in the 
database there is not an uncertainty concerning neurotoxic effects and 
EPA has reliable data to show that removal of the FQPA safety factor is 
safe for children. Additionally, these data demonstrate that a 
developmental neurotoxicity study is not required for this pesticide.
    ii. There is no residual concern for pre- or post-natal toxicity or 
increased sensitivity in infants and children. In both the rat 
developmental study and the 2-generation reproduction study there were 
no effects in fetal animals or offspring at the highest dose tested. 
Although developmental effects were seen in the rabbit developmental 
study, there was a clear NOAEL identified for these effects and that 
NOAEL was used in setting the aPAD. Moreover, adverse effects were seen 
in the adult animals in this study at a lower level.
    iii. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100% CT and tolerance-level residues Conservative ground water and 
surface water modeling estimates were used. Similarly conservative 
Residential SOPs were used to assess post-application exposure to 
children as well as incidental oral exposure of toddlers. These 
assessments will not underestimate the exposure and risks posed by 
Trifloxystrobin].

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing 
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and 
cPAD are calculated by dividing the LOC by all applicable UFs. For 
linear cancer risks, EPA calculates the probability of additional 
cancer cases given aggregate exposure. Short-term, intermediate-term, 
and long-term risks are evaluated by comparing aggregate exposure to 
the LOC to ensure that the MOE called for by the product of all 
applicable UFs is not exceeded.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to Trifloxystrobin will occupy < 1% of the aPAD for the population group 
(females 13-49 years old) receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
Trifloxystrobin from food and water will utilize 81% of the cPAD for 
the population group (children 1-2 years old, the most highly exposed 
subgroup). Based on the use pattern, chronic residential exposure to 
residues of Trifloxystrobin is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Trifloxystrobin is currently registered for uses that could result 
in short-term

[[Page 53444]]

residential exposure and the Agency has determined that it is 
appropriate to aggregate chronic food and water and short-term 
exposures for Trifloxystrobin.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food, water, and residential 
exposures aggregated result in aggregate MOEs greater than 100 for 
adults and children 1-2 years. Therefore, the Agency does not consider 
short term aggregate risk to be of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Though residential exposure could occur intermediate-term aggregate 
risk is not expected based on the short soil half-life (about 2 days). 
Therefore, an intermediate-term aggregate risk assessment was not 
performed.
    5. Aggregate cancer risk for U.S. population. The Agency classified 
trifloxystrobin as a ``not likely'' human carcinogen. Therefore, 
trifloxystrobin is not expected to pose a cancer risk.
    6. 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 or to infants and children from aggregate 
exposure to trifloxystrobin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (Gas Chromatography with a 
nitrogen phosphorus detector (GC/NPD method (Method AG-659A)) 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: residuemethods@epa.gov.

B. International Residue Limits

    There are currently no Canadian Maximum Residue Levels (MRLs) for 
trifloxystrobin. Codex and Mexican MRLs have been established for 
trifloxystrobin in/on various commodities; however, there are no MRLs 
for the commodities associated with the proposed use of trifloxystrobin 
in/on grasses grown for seed. Also, the residue definition for both 
Codex and Mexican MRLs includes only parent compound in plant 
commodities, but the definition for Codex MRLs in livestock commodities 
includes parent and the acid metabolite, CGA321113. Therefore, 
harmonization in plant commodities is not possible at this time as the 
current U.S. tolerance definition includes the combined residues of 
trifloxystrobin and its free acid metabolite. Harmonization of the 
tolerance level in meat by-products of cattle, goats, and sheep is not 
possible at this time as the U.S. tolerance in meat by-products 
reflects higher potential exposures to various feedstuffs.

C. Response to Comments

    One comment was received from B. Sachau. Ms. Sachau's comments 
regarding general exposure to pesticides contained no scientific data 
or evidence to rebut the Agency's conclusion that there is a reasonable 
certainty that no harm will result from aggregate exposure to 
trilfoxystrobin, including all anticipated dietary exposures and other 
exposures for which there is reliable information. This comment as well 
as her comments regarding animal testing have been responded to by the 
Agency on several occasions. For examples, see the Federal Register 
issues of January 7, 2005 (70 FR 1349) (FRL-7691-4) and October 29, 
2004 (69 FR 63083) (FRL-7681-9).

V. Conclusion

    Therefore, the tolerance is established for combined residues of 
Trifloxystrobin, (benzeneacetic acid, (E,E)-[alpha]-(methoxyimino)-2-
[[[[1-[3-(trifluoromethyl) phenyl]ethylidene]amino]oxy] methyl]-methyl 
ester) and the free form of its acid metabolite CGA-321113 (E,E)-
methoxyimino-[2-[1-(3-trifluoromethylphenyl)-ethylideneaminooxymethyl]-
phenyl] acetic acid in or on grass, forage at tolerance level 12 ppm 
and grass, hay at tolerance level 17 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of the 
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, 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) or Executive Order 13045, entitled Protection of Children 
from Environmental Health Risks and Safety Risks (62 FR 19885, April 
23, 1997). 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., 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).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of the 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.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of the FFDCA. As such, the Agency has determined 
that this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 6, 2000) do not apply to this rule. In addition, This 
rule does not 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).
    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).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and

[[Page 53445]]

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: September 10, 2007.
Daniel J. Rosenblatt,
Acting 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 180.555 is amended by alphabetically adding the following 
commodities in the table in paragraph (a):

Sec.  180.555  Trifloxystrobin; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Grass, forage........................................                 12
Grass, hay...........................................                 17
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. E7-18371 Filed 9-18-07; 8:45 am]

BILLING CODE 6560-50-S