9772 Federal Register / Vol. 81, No. 38 / Friday, February 26, 2016 / Rules and Regulations 

■ a. Adding entries (110) and (111) in 

numerical order to table (d); and 

■ b. Adding new entry (42) in numerical 

order to table (e) to read as follows: 

§ 52.820 Identification of plan. 

* * * * * 

(d) * * * 

EPA-APPROVED IOWA SOURCE-SPECIFIC ORDERS/PERMITS

Name of source Order/Permit No. State effective 

date EPA Approval date Explanation 

*******

(110) Griffin Pipe Products 

Co., LLC.

Administrative Consent Order No. 2015–AQ–02 ....... 1/29/15 2/26/16 [Insert Federal 

Register citation].

(111) Alter Metal Recycling.Permit No. 14–A–521 ................................................. 9/2/14 2/26/16 [Insert Federal 

Register citation].

(e) * * * 

EPA-APPROVED IOWA NONREGULATORY PROVISIONS

Name of nonregulatory 

SIP provision Applicable geographic or nonattainment area State submittal date EPA Approval date Explanation 

*******

(42) Lead attainment SIP Portions of Pottawattamie County .............................. 1/30/15 2/26/16 [Insert Federal 

Register citation].

[EPA–R07– 

OAR–2015– 

0582; FRL– 

9942–79– 

Region 7]. 

[FR Doc. 2016–04082 Filed 2–25–16; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0709; FRL–9941–92] 

Trifloxystrobin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of trifloxystrobin 

in or on multiple commodities which 

are identified and discussed later in this 

document. Bayer CropScience requested 

these tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

February 26, 2016. Objections and 

requests for hearings must be received 

on or before April 26, 2016, 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–2014–0709, 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: 

Susan Lewis, 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–2014–0709 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 April 26, 2016. Addresses for 

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Federal Register / Vol. 81, No. 38 / Friday, February 26, 2016 / Rules and Regulations 9773 

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– 

2014–0709, 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 February 

11, 2015 (80 FR 7559) (FRL–9921–94), 

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 4F8288) 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 CGA321113, (E,E)-methoxyimino-[2-[1-(3- 

trifluoromethyl-phenyl)- 

ethylideneaminooxymethyl]- 

phenyl]acetic acid, calculated as the 

stoichiometric equivalent of 

trifloxystrobin, in or on leafy greens 

(crop subgroup 4A) at 30 parts per 

million (ppm); herb (crop subgroup 

19A) at 200 ppm; spice (crop subgroup 

19B), except black pepper) at 30 ppm; 

head and stem brassica (crop subgroup 

5A) at 2 ppm; leafy brassica greens (crop 

subgroup 5B) at 30 ppm; tuberous and 

corm vegetables (crop subgroup 1C) at 

0.04 ppm; small fruit vine climbing 

(except fuzzy kiwifruit) (crop subgroup 

13–07F) at 2.0 ppm; and low growing 

berry (crop subgroup 13–07G) at 1.5 

ppm. Bayer CropScience, also requested 

that the existing tolerance for leafy 

petioles (subgroup 4B) be amended from 

3.5 ppm to 9 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 

modified the commodity terms for 

several tolerances to reflect the correct 

commodity definition. The reason 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 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 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 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 both 

the negative results in the battery of 

mutagenicity tests (except at a cytoxic 

dose in one in vitro test), and from 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-adverseeffect-level (NOAEL) and the lowestobserved-adverse-effect-level (LOAEL) 

from the toxicity studies are discussed 

in the document ‘‘Trifloxystrobin. 

Aggregate Human Health Risk 

Assessment for the Proposed New Uses 

on Leafy Greens (Crop Subgroup 4A), 

Head and Stem Brassica Vegetables 

(Crop Subgroup 5A), Leafy Brassica 

Greens (Crop Subgroup 5B), Herbs (Crop 

Group 19A), and Spices, Except Black 

Pepper (Crop Subgroup 19B); to Amend 

the Current Tolerance on Leafy Petioles 

(Crop Subgroup 4B); and to Convert the 

Potato Tolerance to the Tuberous and 

Corm Vegetables Subgroup (Crop 

Subgroup 1C), Convert the Grape 

Tolerance to the Small Fruit Vine 

Climbing (Subgroup 13–07F), and 

Convert the Strawberry Tolerance to the 

Low Growing Berries (Subgroup 13– 

07G).,’’ dated December 1, 2015. 

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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://

www2.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides. 

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. 

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 exposure 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 and 

100 percent crop treated (PCT) for all 

commodities. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used 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). As to 

residue levels in food, EPA assumed 

100% crop treated, tolerance level 

residues, anticipated residues for some 

crops, and default processing factors. 

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://www2.epa.gov/

pesticide-science-and-assessingpesticide-risks/about-water-exposuremodels-used-pesticide. 

Based on the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and Pesticide 

Root Zone Model Ground Water (PRZM 

GW) models, the estimated drinking 

water concentrations (EDWCs) 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 non-cancer 

exposure assessments, EDWCs 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 acute (427 ppb) and chronic 

(365 ppb) dietary assessments in the 

Dietary Exposure Evaluation Model— 

Food Commodity Intake Database 

(DEEM–FCID) food categories of ‘‘water, 

direct, all sources’’ and ‘‘water, indirect, 

all sources.’’ 

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: Ornamental 

plants 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. Because 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 

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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 

for infants and children. Intermediateterm incidental oral post-application 

exposures are not expected because 

trifloxystrobin is not persistent in soil or 

water; furthermore, the short-term 

incidental oral risk estimates would be 

protective of the possible intermediateterm 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://www2.epa.gov/pesticidescience-and-assessing-pesticide-risks/

standard-operating-proceduresresidential-pesticide. 

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://www2.epa.gov/pesticide-scienceand-assessing-pesticide-risks/

cumulative-assessment-risk-pesticides. 

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 

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. 

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 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. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

trifloxystrobin will occupy 3.1% of the 

aPAD for females 13–49 years old, the 

population group receiving the greatest 

exposure. 

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 71% of 

the cPAD for 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 of 300 for adults and 120 for 

children 1 to < 2 years old. 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 

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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 with nitrogen 

phosphorus detection (GC/NPD), 

Method AG–659A) is available to 

enforce the tolerance expression for the 

combined residues of trifloxystrobin 

and CGA–321113 in plant and livestock 

commodities. The lowest level of 

method validation (LLMV) is equivalent 

to the limit of quantitation (LOQ) which 

was 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 established MRLs for 

trifloxystrobin in or on lettuce, head at 

15 ppm; celery at 1 ppm; brussel sprouts 

at 0.1 ppm; cabbage at 0.5 ppm; flower 

head Brassicas (includes broccoli; 

broccoli, Chinese; and cauliflower) at 

0.5 ppm; potato at 0.2 ppm; grape at 3 

ppm; and strawberry at 1 ppm. These 

MRLs are different than the tolerances 

established for trifloxystrobin in the 

United States. 

These tolerances, with exception to 

grape and potato, cannot be harmonized 

with the Codex MRLs because the MRLs 

for those commodities are expressed in 

terms of trifloxystrobin (parent only) 

while U.S. tolerances are based on the 

combined residues of trifloxystrobin 

and its acid metabolite CGA–321113, 

expressed in parent equivalents. 

Therefore, harmonization is not possible 

for these commodities as the Codex 

MRLs are too low based on the U.S. 

residue definition for tolerance 

enforcement. For grape and potato, the 

U.S. is establishing MRLs for the 

requested representative crop groups; 

fruit, small vine climbing, except fuzzy 

kiwifruit, subgroup 13–07F and 

vegetable, tuberous and corm, subgroup 

1C. These MRLs will be lower than 

Codex, but identical to Canadian MRLs 

(for grape and potato). This will permit 

harmonization with the existing 

Canadian MRLs as requested by the 

petitioner and facilitate trade with 

Canada. 

C. Revisions to Petitioned-For 

Tolerances 

The Agency is revising the 

commodity terms for the requested 

tolerances to reflect the common 

commodity vocabulary currently used 

by the Agency. Specifically, head and 

stem Brassica subgroup 5A was changed 

to Brassica, head and stem, subgroup 

5A; leafy Brassica subgroup 5B was 

changed to Brassica, leafy greens, 

subgroup 5B; tuberous and corm 

vegetable subgroup 1C was changed to 

vegetable, tuberous and corm, subgroup 

1C. small fruit vine climbing subgroup 

(except fuzzy kiwifruit), subgroup 13– 

07F was changed to fruit, small vine 

climbing, except fuzzy kiwifruit, 

subgroup 13–07F and low growing 

berry, subgroup 13–07G was changed to 

berry, low growing, subgroup 13–07G. 

Bayer requested a tolerance for spice 

(crop subgroup 19B), except black 

pepper. As black pepper is the 

representative commodity for spice 

subgroup 19B, it may not be excepted 

from a tolerance. 40 CFR 180.40(h). 

Without sufficient data to establish the 

subgroup tolerance, the Agency is 

establishing an individual tolerance for 

the crop for which data was submitted— 

dill, seed. 

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 Brassica, head 

and stem, subgroup 5A at 2 ppm; 

Brassica, leafy greens, subgroup 5B at 30 

ppm; herb subgroup 19A at 200 ppm; 

dill, seed at 30 ppm; vegetable, tuberous 

and corm, subgroup 1C at 0.04 ppm; 

fruit, small vine climbing, except fuzzy 

kiwifruit, subgroup 13–07F at 2.0 ppm; 

berry, low growing, subgroup 13–07G at 

1.5 ppm; and leaf petioles, subgroup 4A 

at 30 ppm. 

The existing tolerance for leaf petioles 

subgroup 4B, is amended from 3.5 ppm 

to 9 ppm based on new celery residue 

data at zero day (pre-harvest interval) 

PHI. The existing tolerance for potato at 

0.04 ppm is being removed because it is 

included with the new tolerance being 

established for tuberous and corm 

vegetables (crop subgroup 1C) at 0.04 

ppm. Similarly, the current tolerances 

for grape at 2.0 ppm and strawberry at 

1.1 ppm are being removed as they are 

included in the new tolerances for the 

small fruit vine climbing (subgroup 13– 

07F) at 2.0 ppm, and low growing 

berries (subgroup 13–07G) at 1.5 ppm, 

respectively. 

VI. Statutory and Executive Order 

Reviews 

This action 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 action 

has been exempted from review under 

Executive Order 12866, this action 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 

mstockstill on DSK4VPTVN1PROD with RULES

Federal Register / Vol. 81, No. 38 / Friday, February 26, 2016 / Rules and Regulations 9777 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This action 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 action 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 action. In addition, this action 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

Mandates Reform Act (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 

(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: February 11, 2016. 

Susan Lewis, 

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, is amended: 

■ a. By alphabetically adding the 

commodities to the table in paragraph 

(a); 

■ b. By removing ‘‘Grape’’, ‘‘Potato’’, 

and ‘‘Strawberry’’ from the table in 

paragraph (a); 

■ c. By revising ‘‘Leaf petioles subgroup 

4B’’ in the table in paragraph (a). 

The additions and revision read as 

follows: 

§ 180.555 Trifloxystrobin; tolerances for 

residues. 

(a) General. * * * 

Commodity Parts per 

million 

*******

Berry, low growing subgroup 13–07G ..................................................................................................................................................... 1.5 

Brassica, head and stem, subgroup 5A .................................................................................................................................................. 2.0 

Brassica, leafy greens, subgroup 5B ...................................................................................................................................................... 30 

* * * * * * * 

Dill, seed .................................................................................................................................................................................................. 30 

* * * * * * * 

Fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13–07F ....................................................................................................... 2.0 

* * * * * * * 

Herbs, subgroup 19A ............................................................................................................................................................................... 200 

* * * * * * * 

Leaf petioles subgroup 4B ....................................................................................................................................................................... 9.0 

Leafy greens, subgroup 4A ..................................................................................................................................................................... 30 

* * * * * * * 

Vegetable, tuberous and corm, subgroup 1C ......................................................................................................................................... 0.04 

* * * * * * * 

* * * * * 

[FR Doc. 2016–04070 Filed 2–25–16; 8:45 am] 

BILLING CODE 6560–50–P 

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