69648 Federal Register / Vol. 76, No. 217 / Wednesday, November 9, 2011 / Rules and Regulations 

(a), by adding a new footnote 1, and by 

revising paragraph (d) to read as 

follows: 

§ 180.629 Flutriafol; tolerances for 

residues. 

(a) * * * 

Commodity Parts per million 

*******

Banana1 ............................................................................................................................................................................... 0.30 

Beet, sugar .......................................................................................................................................................................... 0.08 

*******

Fruit, pome, group 11–09 .................................................................................................................................................... 0.40 

Fruit, stone, group 12–10 .................................................................................................................................................... 1.5 

*******

Grape ................................................................................................................................................................................... 1.5 

Grape, raisin ........................................................................................................................................................................ 2.4 

*******

Peanut .................................................................................................................................................................................. 0.09 

*******

1There are no U.S. registrations as of October 26, 2011. 

* * * * * 

(d) Indirect or inadvertent residues. 

Tolerances are established for the 

indirect or inadvertent residues of the 

fungicide flutriafol, including its 

metabolites and degradates, in or on the 

commodities in the table below when 

present therein as a result of the 

application of flutriafol to the growing 

crops listed in the table to paragraph (a) 

of this section. Compliance with the 

following tolerance levels specified 

below is to be determined by measuring 

only flutriafol ((±)-a-(2-fluorophenyl)-a- 

(4-fluorophenyl)-1H-1,2,4-triazole-1- 

ethanol) in or on the following 

commodities: 

Commodity Parts per million 

Corn, field, forage ................................................................................................................................................................ 0.09 

Corn, field, grain .................................................................................................................................................................. 0.01 

Corn, field, refined oil .......................................................................................................................................................... 0.02 

Corn, field, stover ................................................................................................................................................................ 0.07 

Corn, pop ............................................................................................................................................................................. 0.01 

Corn, pop, stover ................................................................................................................................................................. 0.07 

Corn, sweet, forage ............................................................................................................................................................. 0.09 

Corn, sweet, kernel plus cob with husk removed ............................................................................................................... 0.01 

Corn, sweet, stover .............................................................................................................................................................. 0.07 

Cotton, gin byproducts ......................................................................................................................................................... 0.02 

Cotton, undelinted seed ....................................................................................................................................................... 0.01 

[FR Doc. 2011–28947 Filed 11–8–11; 8:45 am] 

BILLING CODE P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0456; FRL–8890–1] 

Trifloxystrobin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of trifloxystrobin 

in or on alfalfa, forage and alfalfa, hay. 

Bayer CropScience requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

November 9, 2011. Objections and 

requests for hearings must be received 

on or before January 9, 2012, 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–2011–0456. 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; email address: 

Maignan.Tawanda@epa.gov. 

SUPPLEMENTARY INFORMATION: 


jlentini on DSK4TPTVN1PROD with RULES
Federal Register / Vol. 76, No. 217 / Wednesday, November 9, 2011 / Rules and Regulations 69649 

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://ecfr.gpoaccess.gov/cgi/t/ 

text/text-idx?&c=ecfr&tpl=/ecfrbrowse/ 

Title40/40tab_02.tpl. 

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–2011–0456 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 January 9, 2012. 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–2011–0456, 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 

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 July 20, 

2011 (76 FR 43231) (FRL–8880–1), 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 0F7713) 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 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 alfalfa, forage at 

0.01 parts per million (ppm) and alfalfa, 

hay at 0.01 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. 

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. There is no evidence of 

increased susceptibility following 

prenatal exposure to rats and rabbits 

and postnatal 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 are discussed in the 

final rule published in the Federal 


jlentini on DSK4TPTVN1PROD with RULES
69650 Federal Register / Vol. 76, No. 217 / Wednesday, November 9, 2011 / Rules and Regulations 

Register of June 11, 2010 (75 FR 33190) 

(FRL–8829–2). 

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 discussed in 

Unit III.B. of the final rule published in 

the Federal Register of June 11, 2010 

(75 FR 33190). 

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. 

Such effects were identified for 

trifloxystrobin. In estimating acute 

dietary exposure for females 13–49 

years old, EPA conducted an analysis 

using the Dietary Exposure Evaluation 

Model (DEEMTM 7.81), which used food 

consumption information from the 

United States 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 from field residue trials. 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 

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 (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of 

trifloxystrobin plus its major 

degradation product, CGA–321113 for 

the proposed alfalfa use are less than 

those previously estimated in the 

revised EDWCs for turf use. 

Acute and chronic exposures are 

estimated to be 47.99 parts per billion 

(ppb) and 47.31 ppb for surface water, 

respectively. 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 under the following exposure 

scenarios: Adult post-application 

dermal exposure; and children’s postapplication dermal and/or hand to 

mouth exposure. 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 Web site at 

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

cumulative. 


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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 

Food Quality Protection Act Safety 

Factor (FQPA 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 2-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. EPA does not believe that 

conducting neurotoxicity or 

immunotoxicity studies will result in a 

dose less than the points of departure 

already used in this risk assessment and 

an additional database uncertainty 

factor (UF) 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 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 2-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 PCT information for all 

commodities, except for apples, oranges, 

and grapes which utilized anticipated 

residues for the chronic dietary 

assessment. By using these screeninglevel assessments with minor 

refinement, actual exposures/risks from 

residues in food will not be 

underestimated. EPA made conservative 

(protective) assumptions in the ground 

water 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 

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. With the exception of the subpopulation females 13–49 years, 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 <2% of the 

aPAD for females 13–49 years old. 

2. Chronic 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 34% of 

the cPAD for the general U.S. 

population and 64% of the cPAD for 

children 1–2 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 1,100 for adults (dermal 

residential + dietary food and drinking 

water exposures); 650 for children 1–2 

years (dermal residential + dietary food 

and drinking water exposures); and 120 

for children 1–2 years (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). 


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69652 Federal Register / Vol. 76, No. 217 / Wednesday, November 9, 2011 / Rules and Regulations 

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 methodologies 

(gas chromatography with nitrogen 

phosphorus detection (GC/NPD), 

Method AG–659A and liquid 

chromatography with tandem mass 

spectrometry detection (LC/MS/MS), 

Method No. 200177) are 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 not established a MRL 

for trifloxystrobin in or on alfalfa forage 

or alfalfa hay. Also, since Canada does 

not establish tolerances for livestock 

feed items, no Canadian MRLs have 

been established for these commodities. 

V. Conclusion 

Therefore, tolerances are established 

for residues of trifloxystrobin, 

benzeneacetic acid, (E,E)-a- 

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

(trifluoromethyl) 

phenyl]ethylidene]amino]oxy]methyl]- 

methyl ester), in or on alfalfa, forage at 

0.01 ppm and alfalfa, hay at 0.01 ppm. 

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 

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 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 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) (Pub. L. 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: October 4, 2011. 

Daniel J. Rosenblatt, 

Acting 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. Section 180.555 is amended by 

alphabetically adding the following 

commodities to the table in paragraph 

(a) to read as follows: 

§ 180.555 Trifloxystrobin; tolerance of 

residues. 

(a) * * * 

Commodity Parts per 

million 

Alfalfa, forage ......................... 0.01 

Alfalfa, hay .............................. 0.01 

*****


jlentini on DSK4TPTVN1PROD with RULES
Federal Register / Vol. 76, No. 217 / Wednesday, November 9, 2011 / Rules and Regulations 69653 

* * * * * 

[FR Doc. 2011–28945 Filed 11–8–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0619; FRL–8890–2] 

Abamectin (avermectin); Pesticide 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of abamectin 

(avermectin) in or on onion, bulb, 

subgroup 3–07A; chive, fresh leaves; 

chive, dried leaves; and bean, dry, seed. 

This regulation additionally removes 

time-limited tolerances on bean, lima, 

seed; and onion, bulb, as the tolerances 

will be superseded by permanent 

tolerance. Interregional Research Project 

Number 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

November 9, 2011. Objections and 

requests for hearings must be received 

on or before January 9, 2012, 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–2010–0619. 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: 

Laura Nollen, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7390; email address: 

nollen.laura@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://ecfr.gpoaccess.gov/cgi/t/ 

text/text-idx?&c=ecfr&tpl=/ecfrbrowse/ 

Title40/40tab_02.tpl. 

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–2010–0619 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 January 9, 2012. 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–2010–0619, 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 

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 11, 

2010 (75 FR 48667) (FRL–8840–6), 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 0E7738) by IR–4, 

500 College Rd. East, Suite 201W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.449 be 

amended by establishing tolerances for 

residues of the insecticide abamectin 

(avermectin B1), a mixture of 

avermectins containing greater than or 

equal to 80% avermectin B1a (5-Odemethyl avermectin A1) and less than 

or equal to 20% avermectin B1b (5-Odemethyl 25-de(1-methylpropyl)-25-(1- 

methylethyl) avermectin A1) and its 

delta-8,9-isomer, in or on bean, dry, 

seed at 0.01 parts per million (ppm); 

chive, dried leaves at 0.07 ppm; chive, 

fresh leaves at 0.01 ppm; and onion, 

bulb, subgroup 3–07A at 0.01 ppm. That 

notice referenced a summary of the 

petition prepared on behalf of IR–4 by 

Syngenta Crop Protection, Inc., the 

registrant, which is available in the 

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

There were no comments received in 

response to the notice of filing. 


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