45438 Federal Register / Vol. 80, No. 146 / Thursday, July 30, 2015 / Rules and Regulations 

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: July 22, 2015. 

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 § 180.418, revise the entries for 

‘‘corn, field, forage,’’ ‘‘corn, field, 

stover,’’ and ‘‘corn, pop, stover’’ in the 

table in paragraph (a)(2) to read as 

follows: 

§ 180.418 Cypermethrin and isomers 

alpha-cypermethrin and zeta-cypermethrin; 

tolerances for residues. 

(a) * * * 

(2) * * * 

Commodity Parts per 

million 

*****

Corn, field, forage ................. 9.0 

*****

Corn, field, stover ................. 30 

*****

Corn, pop, stover .................. 30 

*****

* * * * * 

[FR Doc. 2015–18737 Filed 7–29–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0138; FRL–9923–86] 

Isofetamid; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of isofetamid in 

or on multiple commodities that are 

identified and discussed later in this 

document. ISK Biosciences Corporation 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective July 

30, 2015. Objections and requests for 

hearings must be received on or before 

September 28, 2015, 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–2013–0138, 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; 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 


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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–2013–0138 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 September 28, 2015. 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– 

2013–0138, 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 June 5, 2013 

(78 FR 33785) (FRL–9386–2), 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 3F8142) by ISK Biosciences 

Corporation, 7470 Auburn Road, Suite 

A, Concord, Ohio 44077. The petition 

requested that 40 CFR part 180 be 

amended by establishing tolerances for 

residues of the fungicide isofetamid, N- 

[1,1-dimethyl-2-[2-methyl-4-(1- 

methylethoxy)phenyl]-2-oxoethyl]-3- 

methyl-2-thiophenecarboxamide in or 

on almond at 0.02 parts per million 

(ppm); almond, hulls at 0.2 ppm; 

lettuce, head at 6.0 ppm; lettuce, leaf at 

7.0 ppm; low growing berry crop 

subgroup 13–07G at 4.0 ppm; rapeseed, 

crop subgroup 20A at 0.04 ppm; and 

small fruit vine climbing crop subgroup 

13–07F at 3.0 ppm. That document 

referenced a summary of the petition 

prepared by ISK Biosciences 

Corporation, 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 

determined that additional tolerances 

are necessary; revised some of the 

proposed tolerances; and corrected 

some commodity definitions for the 

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 

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 isofetamid 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with isofetamid 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. The toxicology 

database is complete for isofetamid. In 

repeated dose studies, the liver was the 

primary target organ in the rat, mouse, 

and dog, as indicated by increased liver 

weights, changes in the clinical 

chemistry values, and liver 

hypertrophy. A second target organ was 

the thyroid in the rat and dog, as 

indicated by changes in thyroid weights 

and histopathology. Adrenal weight 

changes were observed in the 

subchronic rat and dog studies. In the 

rat and dog, the dose levels where 

toxicity was observed were similar or 

higher in the chronic studies compared 

with the respective subchronic studies, 

showing an absence of progression of 

liver toxicity with time. There was no 

evidence of carcinogenicity in the rat or 

mouse cancer studies; the mutagenicity 

battery was negative. There are no 

genotoxicity, neurotoxicity, or 

immunotoxicity concerns observed in 

the available toxicity studies. 

Developmental toxicity was not 

observed in the rat or rabbit, and 

offspring effects such as decreased body 

weight were seen only in the presence 

of parental toxicity in the multigeneration rat study. Isofetamid is 

classified as ‘‘Not Likely to be 

Carcinogenic to Humans’’ based on the 

absence of increased tumor incidence in 

acceptable/guideline carcinogenicity 

studies in rats and mice. Isofetamid is 

not acutely toxic; it is classified as 

Toxicity Category III for acute oral and 

dermal exposure, and Toxicity Category 

IV for inhalation exposure. Furthermore, 

it is not irritating to the eye or skin, and 

it is not a dermal sensitizer. Specific 

information on the studies received and 

the nature of the adverse effects caused 

by isofetamid as well as the noobserved-adverse-effect-level (NOAEL) 

and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies 

can be found at http://

www.regulations.gov in document 

Isofetamid. Aggregate Human Health 

Risk Assessment for the Proposed New 

Uses of the New Active Fungicide, 


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including Agricultural Uses on 

Almonds, Lettuce, Small Vine Climbing 

Fruits (Crop Subgroup 13–07F), Low 

Growing Berries (Crop Subgroup 13– 

07G), and Rapeseed (Crop Subgroup 

20A); and Uses on Turfgrass (including 

Golf Courses, Sod Farms, Seed Farms, 

Recreational Fields, and Commercial/

Residential Lawns) at pages 12–18 in 

docket ID number EPA–HQ–OPP–2013– 

0138. 

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 isofetamid used for 

human risk assessment is shown in 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ISOFETAMID FOR USE IN HUMAN HEALTH RISK

ASSESSMENT

Exposure/scenario 

Point of departure 

and 

uncertainty/safety 

factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Acute Dietary (All Populations) A toxicity endpoint was not identified. 

Toxicological effects attributable to a single exposure (dose) were not observed in oral toxicity studies. 

Chronic dietary (All populations) NOAEL = 76.6 mg/

kg/day 

UFA = 10X 

UFH = 10X 

FQPA SF = 1X 

Chronic RfD = 0.77 

mg/kg/day 

cPAD = 0.77 mg/kg/

day 

Reproduction and fertility effects (rat) 

LOAEL = 679/775 mg/kg/day based on hepatocellular hypertrophy in the liver and follicular cell hypertrophy in the thyroid 

in both sexes and generations, decreased spleen weights 

and cytoplasmic eosinophilic inclusion bodies in the liver of 

F1 males, and decreased pup body weight in both sexes and 

generations. 

Incidental oral short-term (1 to 

30 days) and Incidental oral 

intermediate-term (1 to 6 

months) 

NOAEL = 76.6 mg/

kg/day 

UFA = 10X 

UFH = 10X 

FQPA SF = 1X 

Residential LOC for 

MOE = 100. 

Reproduction and fertility effects (rat) 

LOAEL = 679/775 mg/kg/day based on hepatocellular hypertrophy in the liver and follicular cell hypertrophy in the thyroid 

in both sexes and generations, decreased spleen weights 

and cytoplasmic eosinophilic inclusion bodies in the liver of 

F1 males, and decreased pup body weight in both sexes and 

generations 

Dermal Short-Term (1–30 days) A toxicity endpoint was not identified. 

Systemic toxicity was not seen in 28-day dermal toxicity in rats up to the limit dose (1,000 mg/kg/day). There 

are no concerns for developmental or reproductive toxicity or neurotoxicity in rat and rabbit studies. 

Inhalation short-term (1 to 30 

days) 

NOAEL = 76.6 mg/

kg/day 

UFA = 10X 

UFH = 10X 

FQPA SF = 1X 

Residential LOC for 

MOE = 100 

Reproduction and fertility effects (rat) 

LOAEL = 679/775 mg/kg/day based on hepatocellular hypertrophy in the liver and follicular cell hypertrophy in the thyroid 

in both sexes and generations, decreased spleen weights 

and cytoplasmic eosinophilic inclusion bodies in the liver of 

F1 males, and decreased pup body weight in both sexes and 

generations. 

Cancer (Oral, dermal, inhalation) Classification: ‘‘Not likely to be Carcinogenic to Humans’’ based on the absence of significant tumor increases 

in two adequate rodent carcinogenicity studies. 

FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = 

milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = 

chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFDB = to account for the absence of data or other data deficiency. UFH = potential variation in sensitivity among members of the human population (intraspecies). UFL = use 

of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term risk assessment. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. EPA assessed dietary 

exposures from isofetamid 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. No such effects were 

identified in the toxicological studies 

for isofetamid; therefore, a quantitative 

acute dietary exposure assessment is 

unnecessary. 


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Federal Register / Vol. 80, No. 146 / Thursday, July 30, 2015 / Rules and Regulations 45441 

1Available: http://www.epa.gov/pesticides/

science/residential-exposure-sop.html. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, EPA used the 2003–2008 

food consumption data from the USDA’s 

National Health and Nutrition 

Examination Survey, What We Eat in 

America (NHANES/WWEIA). A 

partially refined chronic (food and 

drinking water) dietary assessment was 

conducted assuming mean field trial 

residues of the combined residues of 

parent and GPTC for all proposed crops 

and 100% CT. Empirical and default 

processing factors were used as 

available. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that isofetamid 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. EPA did 

not use PCT information in the dietary 

assessment for isofetamid. Mean field 

trial residues of the combined residues 

of parent and GPTC were used. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for isofetamid in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of isofetamid. 

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 Flooded 

Application Model and the Pesticide 

Root Zone Model Ground Water (PRZM 

GW) the estimated drinking water 

concentrations (EDWCs) of isofetamid 

for chronic exposures for non-cancer 

assessments are estimated to be 110 ppb 

for surface water and 43 ppb for ground 

water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

chronic dietary risk assessment, the 

water concentration value of 110 ppb 

was used to assess the contribution from 

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). 

Isofetamid is currently under review 

for registering the following uses that 

could result in residential exposures: 

Foliar and systemic fungicide for 

control in turfgrass including golf 

courses, residential lawns, and 

recreational turfgrass. Since there may 

be residential use sites, residential 

handler exposure and risk estimates 

were calculated for all possible 

residential exposure scenarios. 

Including all possible residential 

exposure scenarios provides a 

conservative and health protective 

assessment for the potential for 

homeowners to use the professionally 

labeled products on residential use 

sites. Since there is no dermal toxicity 

endpoint, the residential handler 

assessment only includes the inhalation 

route of exposure. Residential handler 

exposure is expected to be short-term in 

duration as a maximum of eight 

applications are allowed per year. Thus, 

intermediate-term exposures are not 

likely because of the intermittent nature 

of applications by homeowners. Unit 

exposure values and estimates for area 

treated or amount handled were taken 

from the Agency’s 2012 Residential 

SOPs 1 (Lawns/Turf). The algorithms 

used to estimate exposure and dose for 

residential handlers can be found in the 

2012 Residential SOPs 2 (Lawns/Turf). 

Risk estimates of all possible scenarios 

are not of concern. Short-term 

inhalation MOEs range from 850,000 to 

18,000,000. 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 isofetamid to share 

a common mechanism of toxicity with 

any other substances, and isofetamid 

does not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that isofetamid 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 evidence of developmental 

toxicity or reproductive susceptibility, 

and there are no residual uncertainties 

concerning pre- or post-natal toxicity or 

exposure. 

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 isofetamid 

is complete. 

ii. There is no indication that 

isofetamid 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 

isofetamid 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 dietary food exposure assessments 

were performed based on 100 PCT and 

average (mean) field trial residues. EPA 

made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to isofetamid in drinking water. EPA 

used similarly conservative assumptions 

to assess post application exposure of 

children as well as incidental oral 

exposure of toddlers. These assessments 

will not underestimate the exposure and 

risks posed by isofetamid. 

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 


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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. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, isofetamid is not 

expected to pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to isofetamid 

from food and water will utilize <1% 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 

isofetamid 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). Isofetamid 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 

isofetamid. 

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 24,000 and 3,900 for adults 

and children (1–2 years old) 

respectively. Because EPA’s level of 

concern for isofetamid 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). An 

intermediate-term adverse effect was 

identified; however, isofetamid is not 

registered for any use patterns that 

would result in intermediate-term 

residential exposure. Intermediate-term 

risk is assessed based on intermediateterm residential exposure plus chronic 

dietary exposure. Because there is no 

intermediate-term residential exposure 

and chronic dietary exposure has 

already been assessed under the 

appropriately protective cPAD (which is 

at least as protective as the POD used to 

assess intermediate-term risk), no 

further assessment of intermediate-term 

risk is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating intermediate-term risk for 

isofetamid. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

isofetamid 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 isofetamid 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

liquid chromatography with tandem 

mass spectrometry (LC–MS/MS) method 

(Document Number JSM0119; MRID 

49011967) is available to enforce the 

tolerance expression. 

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 any 

MRLs for isofetamid. Canada is 

concurrently establishing tolerances for 

all of the same commodities identified 

in this document except almond hulls 

because Canada does not set tolerances 

on livestock feed commodities. Canada’s 

recommended tolerance levels for these 

commodities are the same as the U.S. 

established tolerance levels. The 

tolerance expression for the U.S. and 

Canada is the same, with isofetamid as 

the residue of concern for primary 

crops. 

C. Revisions to Petitioned-For 

Tolerances 

The Agency has made revisions to 

some of the petitioned-for tolerance 

levels based on the following reasons: 

1. Organization for Economic 

Cooperation and Development (OECD) 

tolerance calculation procedures; 

2. The parent only is the residue of 

concern for primary crop tolerances 

rather than parent and the metabolite 

GPTC; and 

3. The concentration of residues in 

two processed commodities. 

Since all residues of isofetamid 

(parent) were nondetectable (<0.01 

ppm) in almond nutmeat and hulls, the 

proposed tolerances of 0.02 ppm for 

almond (nutmeat) and 0.2 ppm for 

almond hulls will both be reduced to 

0.01 ppm, the limit of quantitation of 

the analytical method. 

Based on the OECD tolerance 

calculation procedures, the proposed 

tolerance for head lettuce of 6.0 ppm 

will be reduced to 5.0 ppm. Based on 

the OECD tolerance calculation 

procedures, the proposed tolerance for 

the rapeseed subgroup 20A of 0.04 ppm 

will be reduced to 0.015 ppm. 

The petitioner did not propose 

tolerances for the processed 

commodities, canola oil and raisins. 

Since residues concentrate significantly 

in canola oil and raisins, tolerances will 

be established at 0.03 ppm for canola, 

refined oil, and 5.0 ppm for grape, 

raisin. These Agency recommendations 

are based on the highest average field 

trial (HAFT) residues for canola seed 

and grape and the processing factors for 

canola oil and raisins. The petitioner 

did not propose tolerances for flaxseed 

oil, mustard seed oil, or sesame oil. 

However, flaxseed, mustard seed, and 

sesame are members of the rapeseed 

subgroup 20A, with canola as the 

representative crop, and treated 

commodities could be processed to 

produce sesame oil, mustard seed oil 

and flaxseed oil. Therefore, the Agency 

is also establishing tolerances for 

residues in flaxseed oil, mustard seed 

oil, and sesame oil. Tolerances are being 

established at 0.03 ppm, the same level 

as for refined canola oil. 

Additionally, some of the requested 

tolerances have been corrected. Almond 

has been revised from 0.02 ppm to 0.01 

ppm; almond, hulls from 0.2 ppm to 

0.01 ppm; lettuce, head from 6.0 ppm to 

5.0 ppm; and rapeseed, subgroup 20A 

from 0.04 ppm to 0.015 ppm. The 

Agency is setting tolerances on some 

processed commodities that were not 


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Federal Register / Vol. 80, No. 146 / Thursday, July 30, 2015 / Rules and Regulations 45443 

proposed by the petitioner including 

canola, refined oil at 0.03 ppm; flax, 

seed, oil at 0.03 ppm; grape, raisin at 5.0 

ppm; mustard, seed, oil at 0.03 ppm and 

sesame, oil at 0.03 ppm. 

V. Conclusion 

Therefore, tolerances are established 

for residues of isofetamid, in or on 

almond at 0.01 ppm; almond, hulls at 

0.01 ppm; canola, refined oil at 0.03 

ppm; flax, seed, oil at 0.03 ppm; grape, 

raisin at 5.0 ppm; lettuce, head at 5.0 

ppm; lettuce, leaf at 7.0 ppm; berry, low 

growing, subgroup 13–07G at 4.0 ppm; 

mustard, seed, oil at 0.03 ppm; rapeseed 

subgroup 20A at 0.015 ppm; sesame, oil 

at 0.03 ppm; and fruit, small vine 

climbing, except fuzzy kiwifruit, 

subgroup 13–07F at 3.0 ppm. 

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 

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: July 21, 2015. 

Jack Housenger, 

Director, 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. Add § 180.681 to subpart C to read 

as follows: 

§ 180.681 Isofetamid; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the fungicide 

isofetamid, including its metabolites 

and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only isofetamid, N-[1,1- 

dimethyl-2-[2-methyl-4-(1- 

methylethoxy)phenyl]-2-oxoethyl]-3- 

methyl-2-thiophenecarboxamide, in or 

on the following commodities: 

Commodity Parts per 

million 

Almond .................................. 0.01 

Almond, hulls ........................ 0.01 

Berry, low growing, subgroup 

13–07G ............................. 4.0 

Canola, refined oil ................ 0.03 

Flax, seed, oil ....................... 0.03 

Fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13–07F .................... 3.0 

Grape, raisin ......................... 5.0 

Lettuce, head ........................ 5.0 

Lettuce, leaf .......................... 7.0 

Mustard, seed, oil ................. 0.03 

Rapeseed subgroup 20A ...... 0.015 

Sesame, oil ........................... 0.03 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 2015–18738 Filed 7–29–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0714; FRL–9927–63] 

Benalaxyl-M; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of benalaxyl-M 

in or on grape and tomato. Since there 

are currently no U.S. registrations of 

benalaxyl-M for use on grape and 

tomato, this tolerance will allow the 

import of grape and tomato containing 

residues of benalaxyl-M. Technology 

Sciences Group, on behalf of Isagro 

S.p.A, requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: This regulation is effective July 

30, 2015. Objections and requests for 

hearings must be received on or before 

September 28, 2015, and must be filed 

in accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 


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