33190 Federal Register / Vol. 75, No. 112 / Friday, June 11, 2010 / Rules and Regulations 

EPA-APPROVED NONREGULATORY PROVISIONS AND QUASI-REGULATORY MEASURES IN THE NEW MEXICO SIP 

Name of SIP provision Applicable geographic or nonattainment area 

State submittal/effective 

date 

EPA approval date Explanation 

*******

Interstate transport for the 

1997 ozone and PM 2.5

NAAQS.

New Mexico ........................... 09/17/07 06/11/10 [insert FR page 

number where the document begins].

06/11/10 Approval for revisions to prohibit significant 

contribution to nonattainment in any other State. 

[FR Doc. 2010–13686 Filed 6–10–10; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0278; FRL–8829–2] 

Trifloxystrobin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation increases 

existing tolerances for residues of 

trifloxystrobin in or on corn, field, 

forage; corn, sweet, forage; and corn, 

sweet, stover. Bayer CropScience 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). Additionally, EPA is 

removing several tolerances which have 

expired. 

DATES: This regulation is effective June 

11, 2010. Objections and requests for 

hearings must be received on or before 

August 10, 2010, 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–2009–0278. All documents in the 

docket are listed in the docket index 

available at http://www.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: 

Tawanda Maignan, Registration 

Division (7505P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (703) 308-8050; e-mail address: 

maignan.tawanda@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). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

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 Get Electronic Access to 

Other Related Information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://www.gpoaccess.gov/ecfr. 

To access the harmonized test 

guidelines referenced in this document 

electronically, please go http:// 

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ 

C. How Can I File an Objection or 

Hearing Request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, 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–2009–0278 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before August 10, 2010. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

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. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2009–0278, 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 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

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Federal Register / Vol. 75, No. 112 / Friday, June 11, 2010 / Rules and Regulations 33191 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of August 19, 

2009 (74 FR 41898) (FRL–8426–7), 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 (PP 8F7487) by Bayer 

CropScience, 2 T.W. Alexander Drive, 

P.O. Box 12014, Research Triangle Park, 

NC 27709. The petition requested that 

40 CFR 180.555 be amended by 

increasing existing tolerances for 

residues of the fungicide trifloxystrobin, 

benzeneacetic acid, (E,E)-a- 

(methoxyimino)-2-[[[[1-[3- 

(trifluoromethyl) 

phenyl]ethylidene]amino]oxy]methyl]- 

methyl ester), in or on corn, field, forage 

at 6.0 parts per million (ppm); corn, 

sweet, forage at 7.0 ppm; and corn, 

sweet, stover at 4.0 ppm. That notice 

referenced a summary of the petition 

prepared by Bayer CropScience, the 

registrant, which is available in the 

docket, http://www.regulations.gov. 

There were no comments received in 

response to the notice of filing. 

Based upon the review of the data 

supporting the petition, the Agency is 

increasing the existing meat, fat and 

meat byproduct of cattle, goats, horses, 

and sheep tolerances to 0.1 ppm. The 

reasons for these changes are explained 

in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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....’’ 

Consistent with section 408(b)(2)(D) 

of FFDCA, and the factors specified in 

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 for trifloxystrobin 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with trifloxystrobin 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. 

Trifloxystrobin exhibits very low 

toxicity following single oral, dermal 

and inhalation exposures. It is a strong 

dermal sensitizer. In repeated dose tests 

in rats, the liver is the target organ for 

trifloxystrobin; toxicity is induced 

following oral and dermal exposure for 

28 days. In the available toxicity studies 

on trifloxystrobin, there was no 

estrogen, androgen, and/or thyroid 

mediated toxicity. The toxicological 

database for trifloxystrobin does not 

show any evidence of treatment-related 

effects on the immune system. Further, 

there was no evidence of neurotoxicity 

at the limit dose in an unacceptable 

acute neurotoxicity study or in the other 

subchronic and chronic studies in the 

database. There is no evidence of 

increased susceptibility following prenatal exposure to rats and rabbits and 

post-natal exposures to rats. 

Trifloxystrobin was determined not to 

be carcinogenic in mice or rats 

following long-term dietary 

administration. Trifloxystrobin is 

positive for mutagenicity in Chinese 

Hamster V79 cells, albeit at cytotoxic 

dose levels. However, trifloxystrobin is 

negative in the remaining mutagenicity 

studies. 

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-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in document 

‘‘Trifloxystrobin. Human Health Risk 

Assessment for a Section 3 Petition 

Proposing Increased Tolerances for 

Residues in/on Field, Sweet and Pop 

Corn’’ at pages 17 to 21 in docket ID 

number EPA–HQ–OPP–2009–0278. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level – generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD) – and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. 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/pesticides/factsheets/ 

riskassess.htm. 

A summary of the toxicological 

endpoints for trifloxystrobin used for 

human risk assessment is shown in the 

following Table. 

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33192 Federal Register / Vol. 75, No. 112 / Friday, June 11, 2010 / Rules and Regulations 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR TRIFLOXYSTROBIN FOR USE IN HUMAN HEALTH RISK

ASSESSMENT

Exposure/Scenario Point of Departure and Uncertainty/ 

Safety Factors 

RfD, PAD, LOC for Risk 

Assessment Study and Toxicological Effects 

Acute dietary (Females 

13–49 years of age) 

NOAEL = 250 milligrams/kilograms/ 

day (mg/kg/day) 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 2.5 mg/kg/day 

aPAD = 2.5 mg/kg/day 

Developmental Toxicity-Rabbit. LOAEL = 

500 mg/kg/day based on increased fetal 

skeletal anomalies. 

Chronic dietary (All populations) NOAEL= 3.8 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.038 mg/ 

kg/day 

cPAD = 0.038 mg/kg/day 

Two-Generation reproduction study-Rat. 

LOAEL = 55.3 mg/kg/day based on decreases in body weight, body weight 

gains, reduced food consumption and 

histopathological lesions in the liver, kidneys and spleen. 

Incidental Oral Short- (1 to 

30 days) and 

Intermediate- (1-6 

months) Term 

Offspring NOAEL= 3.8 mg/kg/day 

UFA = NA 

UFH = NA 

FQPA SF = NA 

LOC for MOE = 100 Two-Generation reproduction study-Rat. 

LOAEL = 55.3 mg/kg/day based on reduced pup body weights during lactation. 

Dermal Short- (1 to 30 

days) and Intermediate- 

(1 to 6 months) Term 

Dermal study NOAEL = 100 mg/kg/ 

day 

UFA = NA 

UFH = NA 

FQPA SF = NA 

LOC for MOE = 100 28-Day Dermal Toxicity Study-Rat. LOAEL = 

1,000 mg/kg/day based on increases in 

mean absolute and relative liver and kidney weights. 

Inhalation Short- (1 to 30 

days), and Intermediate- 

(1 to 6 months) Term 

Oral study NOAEL= 3.8 mg/kg/day 

(inhalation absorption rate = 

100%) 

UFA = NA 

UFH = NA 

FQPA SF = NA 

LOC for MOE = 100 Two-Generation reproduction study-Rat. 

LOAEL = 55.3 mg/kg/day based on decreases in body weight, body weight 

gains, reduced food consumption and 

histopathological lesions in the liver, kidneys and spleen. 

Cancer (oral, dermal, inhalation) Trifloxystrobin is classified as ‘‘Not Likely Human Carcinogen’’ based on the lack of evidence of carcinogenicity in 

mouse and rat cancer studies. 

UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population 

(intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference 

dose. MOE = margin of exposure. LOC = level of concern. 

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 

for females 13 to 49 years old, EPA 

conducted an analysis using the Dietary 

Exposure Evaluation Model 

(DEEMTM7.81), which 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). EPA used tolerance 

level residues. EPA assumed all 

commodities with established or 

proposed tolerances were treated with 

trifloxystrobin. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998, 

CSFII to be included in DEEM. As to 

residue levels in food, EPA used 

tolerance level residues for all 

commodities with the exception of 

apples, oranges and grapes. For these 

commodities EPA used anticipated 

residues. EPA assumed all commodities 

with established or proposed tolerances 

were treated with trifloxystrobin. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that trifloxystrobin does not 

pose a cancer risk to humans. Therefore, 

a dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

iv. Anticipated residue and percent 

crop treated (PCT) information. Section 

408(b)(2)(E) of FFDCA authorizes EPA 

to use available data and information on 

the anticipated residue levels of 

pesticide residues in food and the actual 

levels of pesticide residues that have 

been measured in food. If EPA relies on 

such information, EPA must require 

pursuant to FFDCA section 408(f)(1) 

that data be provided 5 years after the 

tolerance is established, modified, or 

left in effect, demonstrating that the 

levels in food are not above the levels 

anticipated. For the present action, EPA 

will issue such data call-ins as are 

required by FFDCA section 408(b)(2)(E) 

and authorized under FFDCA section 

408(f)(1). Data will be required to be 

submitted no later than 5 years from the 

date of issuance of these tolerances. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for trifloxystrobin in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

trifloxystrobin. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

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Federal Register / Vol. 75, No. 112 / Friday, June 11, 2010 / Rules and Regulations 33193 

can be found at http://www.epa.gov/ 

oppefed1/models/water/index.htm. 

Based on the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS), GENeric 

Estimated Exposure Concentration 

(GENEEC), and/or Screening 

Concentration in Ground Water (SCIGROW) models, the estimated drinking 

water concentrations (EDWCs) of 

trifloxystrobin for the proposed new 

application are higher than those 

previously assessed for corn; however, 

the EDWCs for both corn rates are less 

than those previously estimated, via 

GENEEC, for turf use. 

Based on the PRZM/EXAMS, 

GENEEC, and/or SCI-GROW models, the 

EDWCs of trifloxystrobin plus its major 

degradation product, CGA-321113 for 

acute exposures are estimated to be 

47.99 parts per billion (ppb) and 47.31 

ppb for chronic exposures. Modeled 

estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, 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 uses that could result 

in residential exposures: ornamentals 

and turfgrass. EPA assessed residential 

exposure using the following 

assumptions: adult post application 

dermal exposure; child’s post 

application dermal and/or hand to 

mouth. Further information regarding 

EPA standard assumptions and generic 

inputs for residential exposures may be 

found at http://www.epa.gov/pesticides/ 

trac/science/trac6a05.pdf. 

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.’’ 

EPA has not found trifloxystrobin to 

share a common mechanism of toxicity 

with 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 

assumed that trifloxystrobin does not 

have 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(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) 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 (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

There is no indication of increased 

susceptibility of rat or rabbits to 

trifloxystrobin. 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 two generation reproduction 

study, there was no offspring toxicity at 

the highest dose tested. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1x. That decision is 

based on the following findings: 

i. The toxicity database for 

trifloxystrobin is complete except for 

neurotoxicity and immunotoxicity 

testing. Recent changes to 40 CFR part 

158 make neurotoxicity and 

immunotoxicity testing required for 

pesticide registration; however, the 

existing data are sufficient for endpoint 

selection for exposure/risk assessment 

scenarios, and for evaluation of the 

requirements under the FQPA. 

Although acute and subchronic 

neurotoxicity and immunotoxicity 

studies are needed to complete the 

database, there are no concerns for 

immunotoxicity or neurotoxicity based 

on the results of the existing studies. 

The toxicological database for 

trifloxystrobin does not show any 

evidence of treatment-related effects on 

the immune system. There was a 

decrease in the incidence of 

hemosiderosis in the spleen of F0 and 

F1 parental males and females in the 2- 

generation reproduction study. The 

effect was not seen in any other toxicity 

studies, and it was not a primary effect 

on the spleen. This decrease may 

indicate a decrease of red blood cell 

turnover; but it is not an effect on the 

immune system. Further, there was no 

evidence of neurotoxicity at the limit 

dose in an unacceptable acute 

neurotoxicity study or in the other 

subchronic and chronic studies in the 

database. The EPA does not believe that 

conducting neurotoxicity or 

immunotoxicity studies will result in a 

dose less than the PODs already used in 

this risk assessment and an additional 

database uncertainty factor for potential 

neurotoxicity and/or immunotoxicity 

does not need to be applied. 

ii. There is no indication that 

trifloxystrobin is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional uncertainty factors (UFs) to 

account for neurotoxicity. 

iii. There is no evidence that 

trifloxystrobin results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the two-generation 

reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The acute and chronic dietary food 

exposure assessments utilize existing 

and proposed tolerance level residues 

and 100% crop treated information for 

all commodities, except for apples, 

oranges, and grapes which utilized 

anticipated residue levels for the 

chronic dietary. By using these 

screening-level assessments with minor 

refinement, actual exposures/risks from 

residues in food will not be 

underestimated. EPA made conservative 

(protective) assumptions in the ground 

and surface water modeling used to 

assess exposure to trifloxystrobin in 

drinking water. EPA used similarly 

conservative assumptions to assess 

postapplication exposure of 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 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

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PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, 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 females 13 to 49 years old. 

2. Chronic-term risk. Using the 

exposure assumptions described in this 

unit for chronic exposure, EPA has 

concluded that chronic exposure to 

trifloxystrobin from food and water will 

utilize 15% of the cPAD for the general 

U.S. population and 43% of the cPAD 

for children 1 to 2 years old, the 

population group receiving the greatest 

exposure. Based on the explanation in 

Unit III.C.3., regarding residential use 

patterns, chronic residential exposure to 

residues of trifloxystrobin is not 

expected. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term 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 

residential exposure, and the Agency 

has determined that it is appropriate to 

aggregate chronic exposure through food 

and water with short-term residential 

exposures to trifloxystrobin. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of 1,200 for adults (dermal 

residential + dietary food and drinking 

water exposures); 680 for children 1 to 

2 years old (dermal residential + dietary 

food and drinking water exposures); and 

170 for children 1 to 2 years old 

(incidental oral + dietary food and 

drinking water exposures). Because 

EPA’s level of concern for 

trifloxystrobin is a MOE of 100 or 

below, these MOEs are not of concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Trifloxystrobin is not expected to pose 

an intermediate-term risk based on a 

short soil half-life (approximately 2 

days). 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

trifloxystrobin is not expected to pose a 

cancer risk to humans. 

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 nitrogen 

phosphorus detection (GC/NPD)), 

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; email address: residuemethods@epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint U.N. 

Food and Agriculture Organization/ 

World Health Organization food 

standards program, and it is recognized 

as an international food safety 

standards-setting organization in trade 

agreements to which the United States 

is a party. EPA may establish a tolerance 

that is different from a Codex MRL; 

however, FFDCA section 408(b)(4) 

requires that EPA explain the reasons 

for departing from the Codex level. 

The Codex has established a MRL for 

trifloxystrobin in or on maize fodder 

(dry) at 10 ppm. Canada has a proposed 

(not yet established) MRL of 0.02 for 

corn grain, sweet corn, popcorn grain 

for parent and metabolite. Since the 

Codex MRL is for a commodity that is 

not recognized domestically and would 

normally not be transported across 

international borders, there is no 

concern for international 

harmonization. Also, since the Canadian 

MRL has not been established, there is 

no concern for international 

harmonization. 

C. Revisions to Petitioned-For 

Tolerances 

Trifloxystrobin tolerances for crop 

commodities listed in 40 CFR 

180.555(a)(1) are expressed in terms of 

the residues of the fungicide 

trifloxystrobin, benzeneacetic acid, 

(E,E)-a-(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-trifluoromethyl-phenyl)- 

ethylideneaminooxymethyl]- 

phenyl]acetic acid. EPA has revised the 

trifloxystrobin tolerance expression to 

clarify the chemical moieties that are 

covered by the tolerances and specify 

how compliance with the tolerances is 

to be measured. 

EPA’s analysis of the adequacy of the 

existing tolerances for meat, fat and 

meat byproduct of cattle, goats, horses, 

and sheep tolerances based on the 

proposed tolerances as well as existing 

tolerances indicates they need to be 

increased to 0.1 ppm from 0.05 ppm. 

Also, EPA is removing from paragraph 

(b), tolerances for soybean, forage; 

soybean, hay; and soybean, seed which 

expired and were revoked on December 

31, 2009. 

V. Conclusion 

Therefore, existing tolerances in 40 

CFR 180.555(a) are increased for 

residues of trifloxystrobin, 

benzeneacetic acid, (E,E)-a- 

(methoxyimino)-2-[[[[1-[3- 

(trifluoromethyl) 

phenyl]ethylidene]amino]oxy]methyl]- 

methyl ester, in or on corn, field, forage 

at 6.0 ppm; corn, sweet, forage at 7.0 

ppm; and corn, sweet, stover at 4.0 ppm. 

EPA is also removing paragraph (b) 

tolerances for soybean, forage; soybean, 

hay; and soybean, seed which expired 

December 31, 2009. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

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 final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled 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 

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Federal Register / Vol. 75, No. 112 / Friday, June 11, 2010 / Rules and Regulations 33195 

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 FFDCA, such as 

the tolerances 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 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 9, 2000) do not apply 

to this final rule. In addition, this final 

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 

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: May 27, 2010. 

Daniel J. Rosenblatt, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Amend § 180.555 as follows: 

■ a. Revise the introductory text of 

paragraph (a). 

■ b. Revise the following entries in the 

table in paragraph (a): cattle, fat; cattle, 

meat; cattle, meat byproducts; corn, 

field, forage; corn, sweet, forage; corn, 

sweet, stover; goat, fat; goat, meat; goat, 

meat byproducts; horse, fat; horse, meat; 

horse, meat byproducts; and sheep, fat; 

sheep, meat; and sheep, meat 

byproducts. 

■ c. Revise paragraph (b). 

The revisions read as follows: 

§ 180.555 Trifloxystrobin; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of 

trifloxystrobin, including its metabolites 

and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only the sum of 

trifloxystrobin, benzeneacetic acid, 

(E,E)-a-(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-trifluoromethyl-phenyl)- 

ethylideneaminooxymethyl]- 

phenyl]acetic acid, calculated as the 

stoichiometric equivalent of 

trifloxystrobin, in or on the commodity. 

Commodity Parts per 

million 

* * * * * 

Cattle, fat .................................. 0.1 

Cattle, meat .............................. 0.1 

Cattle, meat byproducts ........... 0.1 

* * * * * 

Corn, field, forage ..................... 6.0 

* * * * * 

Corn, sweet, forage .................. 7.0 

* * * * * 

Corn, sweet, stover .................. 4.0 

* * * * * 

Goat, fat .................................... 0.1 

Goat, meat ................................ 0.1 

Goat, meat byproducts ............. 0.1 

* * * * * 

Horse, fat .................................. 0.1 

Horse, meat .............................. 0.1 

Horse, meat byproducts ........... 0.1 

* * * * * 

Sheep, fat ................................. 0.1 

Sheep, meat ............................. 0.1 

Sheep, meat byproducts .......... 0.1 

* * * * * 

(b) Section 18 emergency exemptions. 

[Reserved] 

* * * * * 

[FR Doc. 2010–13938 Filed 6–10–10; 8:45 am] 

BILLING CODE 6560–50–S 

DEPARTMENT OF DEFENSE 

Defense Acquisition Regulations 

System 

48 CFR Part 252 

Defense Federal Acquisition 

Regulation Supplement; New 

Designated Country—Taiwan—DFARS 

Case 2009–D010) 

AGENCY: Defense Acquisition 

Regulations System; Department of 

Defense (DoD). 

ACTION: Final rule. 

SUMMARY: DoD is adopting, as final, an 

interim rule amending the Defense 

Federal Acquisition Regulation 

Supplement (DFARS) to add Taiwan as 

a designated country, due to the 

accession of Taiwan to membership in 

the World Trade Organization 

Government Procurement Agreement. 

DATES: Effective date: June 11, 2010. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Amy Williams, Defense Acquisition 

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