52210 Federal Register / Vol. 79, No. 170 / Wednesday, September 3, 2014 / Rules and Regulations 

[FR Doc. 2014–20920 Filed 9–2–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0504; FRL–9915–46] 

Trifloxystrobin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of trifloxystrobin 

in or on pea, dry, seed; pea, field, hay; 

and pea, field, vines. Bayer CropScience 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

September 3, 2014. Objections and 

requests for hearings must be received 

on or before November 3, 2014, 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: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2013–0504, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., Rm. 3334, 1301 

Constitution Ave. NW., Washington, DC 

20460–0001. The Public Reading Room 

is open from 8:30 a.m. to 4:30 p.m., 

Monday through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main telephone 

number: (703) 305–7090; email address: 

RDFRNotices@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. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

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.ecfr.gov/cgi-bin/textidx?&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–2013–0504 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 November 3, 2014. 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 (excluding 

any Confidential Business Information 

(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 the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2013–0504, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http://

www.epa.gov/dockets/contacts.html. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at http:// 

www.epa.gov/dockets. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of October 25, 

2013 (78 FR 63938) (FRL–9901–96), 

EPA issued a document pursuant to 

FFDCA section 408(d)(3), 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide petition (PP 3F8180) 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 

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, 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 pea, dry, seed 

at 0.06 parts per million (ppm); pea, 

field, hay at 15 ppm; pea, field, vines at 

4.0 ppm; chickpea, seed at 0.06 ppm; 

and lentil, seed at 0.06 ppm. That 

document 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 review of the data 

supporting the petition, EPA has 

corrected proposed commodity 

definitions and eliminated certain 

proposed crop tolerances. 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 


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Federal Register / Vol. 79, No. 170 / Wednesday, September 3, 2014 / Rules and Regulations 52211 

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 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 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 their 

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 and a mild dermal and 

eye irritant. 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. Liver effects characterized by 

an increase in liver weights and an 

increased incidence of hepatocellular 

hypertrophy and/or hepatocellular 

necrosis were seen in rats, mice, and 

dogs. 

There is no concern for neurotoxicity 

or immunotoxicity in the database. In 

the rabbit developmental toxicity study, 

an increase in the incidence of fused 

sternabrae was seen at a dose 10 times 

higher than the maternal lowest 

observed adverse effect level (LOAEL). 

In the rat reproduction study, both 

parents and offspring showed decreases 

in body weight during lactation. The rat 

and rabbit developmental and the rat 

reproduction toxicity data do not 

demonstrate an increase in 

susceptibility in the fetus or other 

offspring. 

Trifloxystrobin is classified as: ‘‘Not 

likely to be Carcinogenic to Humans’’ 

based on negative results in: 

1. The battery of mutagenicicty tests 

(except at a cytoxic dose in one in vitro 

test), and 

2. The long-term carcinogenicity 

studies in rats and mice. 

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 

Register of June 11, 2010 (75 FR 33190) 

(FRL–8829–2) and in the document 

‘‘Trifloxystrobin. Aggregate Human 

Health Risk Assessment for the 

Proposed New Uses on Chickpea, Dry 

Peas, and Lentils with Updated 

Residential Risk Estimates of All 

Existing Residential Uses (Lawns/Turf; 

Gardens and Trees),’’ dated June 10, 

2014, Appendix A, pp. 27–31 in docket 

ID number EPA–HQ–OPP–2013–0504. 

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 was discussed in 

Unit III B. of the final rule published in 

the Federal Register of June 11, 2010. 

However, subsequent to that Federal 

Register publication, EPA reassessed the 

liver effects seen in the 28-day dermal 

toxicity study according to current 

policy, and determined that since these 

effects should not be considered 

adverse, no toxicity endpoint was 

identified. The NOAEL for the 28-day 

dermal study was set at 1,000 mg/kg/

day and the LOAEL was not established. 

Therefore, the endpoints assessed as 

part of this action exclude the endpoint 

for dermal exposure identified in the 

table published in the above-referenced 

Federal Register on June 11, 2010. 

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 (food and water) exposure for 

females 13–49 years old, EPA conducted 

an analysis using the Dietary Exposure 

Evaluation Model (DEEM–FCID) 

Version 3.16. This model uses 2003– 

2008 food consumption data from the 

U.S. Department of Agriculture’s 

(USDA’s) National Health and Nutrition 

Examination Survey, What We Eat in 

America (NHANES/WWEIA). An acute 

dietary assessment was conducted 

assuming tolerance level residues (plus 

the additional metabolite residues as 

noted in this paragraph) and 100 

percent crop treated (PCT) for all 

commodities. For the dietary 

assessment, a value of 0.20 ppm for the 

metabolite L7a was added to the 

tolerance level for meat byproducts of 

cattle, goats, horses, and sheep to 

account for the higher residues in liver; 

therefore, these commodities were 

assessed in the dietary assessments at 

0.3 ppm. Pork was assessed in the 

DEEM at the established tolerance level 

of 0.05 ppm; pork, liver was assessed at 

0.16 ppm to account for the residues of 

the metabolite L7a. DEEM version 7.81 

default processing factors were assumed 

except for where tolerances were 

established for processed commodities. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the Dietary Exposure 


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Evaluation Model (DEEM–FCID) 

Version 3.16. This model uses 2003– 

2008 food consumption data from the 

U.S. Department of Agriculture’s 

(USDA’s) National Health and Nutrition 

Examination Survey, What We Eat in 

America (NHANES/WWEIA). A chronic 

dietary exposure assessment was 

conducted assuming 100 PCT, 

anticipated residues (ARs) for grapes, 

apples, oranges, and pears, and 

tolerance level residues for the rest of 

the commodities, including additional 

metabolite residues as noted in this 

paragraph. A value of 0.20 ppm for the 

metabolite L7a was added to the 

tolerance level for meat byproducts of 

cattle, goats, horses, and sheep to 

account for the higher residues in liver; 

therefore, these commodities were 

assessed in the dietary assessments at 

0.3 ppm. Pork was assessed in the 

DEEM at the established tolerance level 

of 0.05 ppm; pork, liver was assessed at 

0.16 ppm to account for residues of the 

metabolite L7a. DEEM version 7.81 

default processing factors were assumed 

except for where tolerances were 

established for processed commodities. 

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 (AR) and 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. 

EPA used anticipated residue 

information in the chronic dietary 

assessment for trifloxystrobin for grapes, 

apples, oranges, and pears. 

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) and 

PRZMGround Water (PRZM–GW) 

models, the estimated drinking water 

concentrations (EDWCs) of total toxic 

residues of trifloxystrobin and its major 

degradation product for acute exposures 

are estimated to be 29 parts per billion 

(ppb) for surface water and 427 ppb for 

ground water. For chronic exposures for 

non-cancer assessments are estimated to 

be 23 ppb for surface water and 365 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 427 ppb was used to assess the 

contribution to drinking water. 

For chronic dietary risk assessment, 

the water concentration of value 365 

ppb was used to assess the contribution 

to drinking water. 

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 from relevant registered 

trifloxystrobin products using the 

Agency’s 2012 Residential Standard 

Operating Procedures (SOPs) along with 

updates in dermal risk assessment 

hazard and policy regarding body 

weight in addition to the following 

assumptions: 

i. Residential handler exposures. 

Residential handler exposure is 

expected to be short-term only. 

Intermediate-term exposures are not 

likely because of the intermittent nature 

of applications by homeowners. Dermal 

handler exposures were not assessed 

since no adverse systemic dermal 

hazard was identified for trifloxystrobin. 

ii. Residential post-application 

exposures. Since dermal hazard has not 

been identified for trifloxystrobin, a 

quantitative post-application assessment 

for dermal exposure is not necessary 

and the only exposure scenarios 

quantitatively assessed are for children 

1 to <2 years old who may experience 

short-term incidental oral exposure to 

trifloxystrobin from treated turf. 

Incidental oral granule ingestion is not 

applicable because there is no endpoint 

identified for the acute dietary duration. 

Intermediate-term incidental oral postapplication exposures are not expected 

because trifloxystrobin is not persistent 

in soil or water; furthermore, the shortterm incidental oral risk estimates 

would be protective of the possible 

intermediate-term incidental oral 

exposures because the POD for both 

durations is the same. Post-application 

inhalation exposure is expected to be 

negligible for the proposed residential 

uses. 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

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

pesticides/science/residential-exposuresop.html 

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. 

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 


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Federal Register / Vol. 79, No. 170 / Wednesday, September 3, 2014 / Rules and Regulations 52213 

quantitative or qualitative susceptibility 

to trifloxystrobin in rats or rabbits. In 

the prenatal developmental study in 

rats, there was no developmental 

toxicity at and up to the limit dose. In 

the prenatal developmental study in 

rabbits, developmental toxicity was seen 

at a dose that was higher than the dose 

causing maternal toxicity. In the 

multigeneration study, offspring and 

parental LOAELs are at the same dose 

level. 

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. The Agency 

has waived requirements for a 

subchronic neurotoxicity study because: 

a. Trifloxystrobin was not neurotoxic 

in the acute neurotoxicity study, nor in 

any of the repeated dose studies in the 

available data, 

b. There is no evidence of 

neurotoxicity in the existing 

trifloxystrobin database or that of other 

strobilurin pesticides, and 

c. Because endpoints and PODs used 

for risk assessment are likely to be 

protective of neurotoxicity concerns. 

EPA has also waived requirements for 

subchronic inhalation testing. 

Trifloxystrobin exhibits low toxicity 

(Category IV) via inhalation route of 

exposure. 

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. Adverse effects were not 

seen up to the limit dose in an acute 

neurotoxicity study. There is no 

evidence of neurotoxicity in subchronic 

and chronic toxicity studies (rats, dogs, 

mice), in developmental toxicity studies 

(rats, rabbits), or in a reproductive 

toxicity study (rats). There is no concern 

for neurotoxicity of trifloxystrobin based 

on the available database. 

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 exposure databases are complete or 

are estimated based on data that 

reasonably account for potential 

exposures. The exposure assessments 

will not underestimate the potential 

dietary (food and drinking water) or 

non-dietary exposures for infants and 

children from the use of trifloxystrobin. 

The acute and chronic dietary food 

exposure assessment was conservatively 

based on 100 PCT assumptions and 

conservative ground water drinking 

water modeling estimates. The dietary 

drinking water assessment utilizes water 

concentration values generated by 

models and associated modeling 

parameters which are designed to 

provide conservative, health protective, 

high-end estimates of water 

concentrations, and are not likely to be 

exceeded. In addition, the residential 

post-application assessment is based 

upon the residential SOPs employing 

surrogate study data and reasonable 

‘‘worst-case’’ assumptions. These data 

and assessments are reliable and are not 

expected to underestimate exposure and 

risk posed by trifloxystrobin to adults or 

children as well as incidental oral 

exposure of young children (1–2 years 

old). 

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 group, females 13 to 49 

years old, 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 1.3% 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 32% of 

the cPAD for the general U.S. 

population and 78% for all infants <1 

year 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 for adults of 300 (from food, 

water and residential inhalation 

exposures) and for children 120 (from 

food, water and residential incidental/

hand-to-mouth oral exposure). 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). 

Although the Agency identified an 

intermediate-term endpoint, the Agency 

does not expect trifloxystrobin to result 

in intermediate-term residential 

exposure, due to the intermittent nature 

of homeowner applications and its short 

soil half-life (about 2 days). Therefore, 

the Agency relies on the chronic risk 

assessment to account for intermediateterm risk and concludes that 

trifloxystrobin does not pose an 

intermediate-term aggregate risk. 

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 method with 

nitrogen phosphorus detection (GC/

NPD), Method AG–659A) is available to 

enforce the tolerances for the combined 

residues of trifloxystrobin and CGA– 

321113 in plant and livestock 

commodities. Subject crops under this 


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52214 Federal Register / Vol. 79, No. 170 / Wednesday, September 3, 2014 / Rules and Regulations 

action were analyzed for residues of 

trifloxystrobin and CGA–321113 using a 

high performance liquid 

chromatography method with tandem 

mass spectrometry detection (LC/MS/

MS). The lowest level of method 

validation (LLMV) is equivalent to the 

limit of quantitation (LOQ) which is 

0.010 ppm for each analyte in/on all 

matrices. 

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 

United Nations 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 MRLs 

for trifloxystrobin on the crops subject 

to this action. 

C. Revisions to Petitioned-For 

Tolerances 

EPA determined that the proposed 

tolerances for chickpea hay and vines 

are not needed since both commodities 

are not significant livestock feed items. 

In addition, the proposed tolerances on 

chickpea seed and lentil seed are not 

needed since pea, dry, seed under the 

definition in 40 CFR 180.1 includes 

these commodities. 

To reflect the correct commodity 

definitions, EPA revised the proposed 

commodity listings for ‘‘pea, dry, hay’’ 

and ‘‘pea, dry, vines’’ to read: ‘‘pea, 

field, hay’’ and ‘‘pea, field, vines’’, 

respectively. 

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, 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 pea, dry, seed 

at 0.06 ppm; pea, field, hay at 15 ppm; 

and pea, field, vines at 4 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) 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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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) (2 U.S.C. 1501 et seq.). 

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) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), 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 the rule in the Federal 

Register. This action 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: August 25, 2014. 

Lois Rossi, 

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. In § 180.555, add alphabetically the 

following entries to the table in 

paragraph (a) to read as follows: 

§ 180.555 Trifloxystrobin; tolerance for 

residues. 

(a) * * * 


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Federal Register / Vol. 79, No. 170 / Wednesday, September 3, 2014 / Rules and Regulations 52215 

Commodity Parts per 

million 

*****

Pea, dry, seed ...................... 0.06 

Pea, field, hay ....................... 15 

Pea, field, vines .................... 4 

*****

* * * * * 

[FR Doc. 2014–20928 Filed 9–2–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0622 and EPA–HQ– 

OPP–2014–0124; FRL–9912–91] 

Saflufenacil; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

and revises tolerances for residues of 

saflufenacil in or on multiple 

commodities which are identified and 

discussed later in this document. BASF 

Corporation requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

September 3, 2014. Objections and 

requests for hearings must be received 

on or before November 3, 2014, 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: The dockets for this action, 

identified by docket identification (ID) 

numbers EPA–HQ–OPP–2013–0622 and 

EPA–HQ–OPP–2014–0124, are available 

at http://www.regulations.gov or at the 

Office of Pesticide Programs Regulatory 

Public Docket (OPP Docket) in the 

Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., Rm. 3334, 1301 

Constitution Ave. NW., Washington, DC 

20460–0001. The Public Reading Room 

is open from 8:30 a.m. to 4:30 p.m., 

Monday through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main telephone 

number: (703) 305–7090; email address: 

RDFRNotices@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. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

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.ecfr.gov/cgi-bin/textidx?&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 numbers EPA–HQ– 

OPP–2013–0622 and EPA–HQ–OPP– 

2014–0124 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 November 3, 2014. 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 (excluding 

any Confidential Business Information 

(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 the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2013–0622 and EPA–HQ–OPP–2014– 

0124, by one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center 

(EPA/DC), (28221T), 1200 Pennsylvania 

Ave. NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http://

www.epa.gov/dockets/contacts.html. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at 

http://www.epa.gov/dockets. 

II. Summary of Petitioned-for Tolerance 

In the Federal Register of October 25, 

2013 (78 FR 63938) (FRL–9901–96), 

EPA issued a document pursuant to 

FFDCA section 408(d)(3), 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide petition (PP 3F8192) by BASF 

Corporation, 26 Davis Dr., P.O. Box 

13528, Research Triangle Park, NC 

27709–3528. The petition requested that 

40 CFR 180.649 be amended by 

establishing tolerances for residues of 

the herbicide saflufenacil, 2-chloro-5- 

[3,6-dihydro-3-methyl-2,6-dioxo-4-

(trifluoromethyl)-1(2H)-pyrimidinyl]-4- 

fluoro-N-[[methyl(1-methylethyl)amino]

sulfonyl]benzamide, and its metabolites, 

N-[2-chloro-5-(2,6-dioxo-4- 

(trifluoromethyl)-3,6-dihydro-1(2H)- 

pyrimidinyl)-4-fluorobenzoyl]-N′- 

isopropylsulfamide and N-[4-chloro-2- 

fluoro-5-({[(isopropylamino)sulfonyl

]amino}carbonyl)phenyl]urea, 

calculated as the stoichiometric 

equivalent of saflufenacil, in or on grass, 

forage at 15 parts per million (ppm); 

grass, hay at 20 ppm; grass, seed 

screenings at 0.9 ppm; and grass, straw 

at 1.5 ppm and revising the livestock 

commodity tolerances for (cattle, goat, 

horse, and sheep): Fat from 0.01 ppm to 

0.05 ppm; liver from 2.5 ppm to 45 

ppm; and meat byproducts, except liver 

from 0.05 ppm to 0.5 ppm; hog, fat from 

0.01 ppm to 0.05 ppm; hog, liver from 

0.80 ppm to 45 ppm; and hog, meat 

byproducts, except liver from 0.02 ppm 

to 0.5 ppm. 

The same Federal Register document 

of October 25, 2013, also announced 


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