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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ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2013–0714, 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. To access the OCSPP test 

guidelines referenced in this document 

electronically, please go to http://

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2013–0714 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– 

2013–0714, 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 

21, 2014 (79 FR 9870) (FRL–9904–98), 

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 3E8162) by 

Technology Sciences Group on behalf of 

Isagro S.p.A., 1150 18th Street NW., 

Suite 1000, Washington, DC 20036. The 

petition requested that 40 CFR part 180 

be amended by establishing import 

tolerances for residues of the fungicide 

benalaxyl-M in or on grape at 1.1 parts 

per million (ppm); grape juice at 1.1 

ppm; grape wine at 1.1 ppm; grape 

raisin at 2.2 ppm; tomato at 0.25 ppm; 

and tomato processed at 0.25 ppm. That 

document referenced a summary of the 

petition prepared by Technology 

Sciences Group on behalf of Isagro 

S.p.A., the registrant, which is available 

in the docket, http://

www.regulations.gov. No tolerancerelated comments were submitted. 

Based upon review of the data 

supporting the petition, EPA is 

establishing tolerances as follows: 3.0 

ppm for grapes and 0.20 ppm for 

tomato. 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 benalaxyl-M 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with benalaxyl-M 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 


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concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. 

Benalaxyl-M has no significant acute 

toxicity via oral, dermal or inhalation 

route of exposure. It is not a skin irritant 

and does not cause skin sensitization. 

The liver and thyroid are the primary 

target organs for benalaxyl-M. In rats, 

increased liver weights, clinical 

chemistry changes indicative of liver 

toxicity, hepatocellular hypertrophy, 

and thyroid follicular cell hypertrophy 

were seen following subchronic and 

chronic exposure. In mice, increased 

liver weight and microscopic lesions in 

the liver (hepatocellular hypertrophy, 

necrosis, eosinophilic foci) were 

observed following subchronic and 

chronic exposure. Additionally, chronic 

exposure in rats and mice led to 

increases in the incidence of liver (rat, 

mouse) and thyroid (rat) tumors. In 

dogs, increased liver weight, changes in 

clinical chemistry indicative of liver 

toxicity, and hepatocellular hypertrophy 

were observed following subchronic 

exposure via the diet, whereas clinical 

chemistry changes indicative of liver 

toxicity, fat vacuolation in the liver, and 

thyroid follicular cell hypertrophy were 

observed following chronic exposure via 

capsules. 

No evidence of increased quantitative 

or qualitative susceptibility was seen in 

the benalaxyl-M hazard database 

following in utero exposure with rats or 

rabbits in the prenatal developmental 

studies or in young rats in the 2– 

generation reproduction study. No 

evidence of maternal toxicity or 

developmental effects was observed in 

the developmental toxicity studies in 

rabbits or rats. There is no reproductive 

concern. No neurotoxic effects were 

observed in the acute and subchronic 

neurotoxicity studies in rats, and no 

immunotoxic effects were observed in 

the immunotoxicity study in rats. 

Benalaxyl-M was classified as ‘‘Likely 

to be Carcinogenic to Humans’’. This 

determination was based on the 

treatment-related liver tumors observed 

in male mice, liver tumors observed in 

male and female rats; and thyroid 

follicular cell tumors observed in female 

rats. No treatment-related tumors were 

observed in female mice. A linear lowdose extrapolation model (Q*1) was 

used to estimate cancer risk, based on 

the male mouse liver tumor rates. There 

is no mutagenicity concern from the in 

vivo or in vitro genetic toxicity assays. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by benalaxyl-M as well as 

the no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

‘‘Benalaxyl-M. Human-Health Risk 

Assessment for Tolerances in/on 

Imported Grape and Tomato’’ on pages 

10 through 20 in docket ID number 

EPA–HQ–OPP–2013–0714. 

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 benalaxyl-M used for 

human risk assessment is shown in the 

Table of this unit. 

Table—Summary of Toxicological Doses 

and Endpoints for Benalaxyl-M for Use 

in Human Health Risk Assessment 

TABLE 4.5.4.—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR BENALAXYL-M FOR USE IN DIETARY HUMAN

HEALTH RISK ASSESSMENTS

Exposure/Scenario Point of departure 

Uncertainty/ 

FQPA safety factors 

RfD, PAD, Level 

of concern for 

risk assessment 

Study and toxicological effects 

Acute Dietary (General Population, including Infants, 

Children, and females 

13+).

No appropriate 

acute endpoint 

was identified.

Chronic Dietary ...................

(All Popyulations) ................

NOAEL= 20 mg/

kg/day.

UFA= 10x ...........

UFH= 10x ...........

FQPA UFDB = 

10x.

Chronic RfD = ....

cPAD = 0.02 mg/

kg/day.

Chronic Toxicity/Carcinogenicity Study—rat 

(49040634) 

LOAEL = 135 mg/kg/day based on based on an increase in g-glutamyl transferase (GGT) in males, 

slight increases liver weight in both sexes, increased incidence of hepatocellular hypertrophy in 

both sexes, increased incidence of thyroid follicular 

cell hypertrophy in both sexes, increased incidence 

of thyroid cell hyperplasia in females, increased incidence of thyroid follicular ectasia in females, and 

an increased incidence of ovarian stromal cell 

hyperplasia in females. 


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TABLE 4.5.4.—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR BENALAXYL-M FOR USE IN DIETARY HUMAN

HEALTH RISK ASSESSMENTS—Continued 

Exposure/Scenario Point of departure 

Uncertainty/ 

FQPA safety factors 

RfD, PAD, Level 

of concern for 

risk assessment 

Study and toxicological effects 

Cancer (oral) ....................... Classification: 

‘‘Likely to be 

Carcinogenic to 

Humans’’. 

Based on male 

mouse liver tumors, Q1*= 

5.90 × 10 3

(mg/kg/

day) 1.

Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no observed adverse effect 

level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = 

potential variation in sensitivity among members of the human population (intraspecies). UFDB = to account for the absence of a comparative thyroid study. FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (c = chronic). RfD = reference dose. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to benalaxyl-M, EPA assessed 

dietary exposures from benalaxyl-M in 

food as follows: 

i. Acute exposure. No such effects 

were identified in the toxicological 

studies for benalaxyl-M; therefore, a 

quantitative acute dietary exposure 

assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 2003–2008 CSFII. As to 

residue levels in food, EPA used 

tolerance-level residues and 100% crop 

treated. 

iii. Cancer. EPA determines whether 

quantitative cancer exposure and risk 

assessments are appropriate for a fooduse pesticide based on the weight of the 

evidence from cancer studies and other 

relevant data. If quantitative cancer risk 

assessment is appropriate, cancer risk 

may be quantified using a linear or 

nonlinear approach. If sufficient 

information on the carcinogenic mode 

of action is available, a threshold or 

nonlinear approach is used and a cancer 

RfD is calculated based on an earlier 

noncancer key event. If carcinogenic 

mode of action data are not available, or 

if the mode of action data determines a 

mutagenic mode of action, a default 

linear cancer slope factor approach is 

utilized. Based on the data summarized 

in Unit III.A., EPA has concluded that 

benalaxyl-M should be classified as 

‘‘Likely to be Carcinogenic to Humans’’ 

and a linear approach has been used to 

quantify cancer risk. Cancer risk was 

quantified using the same estimates as 

discussed in Unit III.C.1.ii., chronic 

exposure. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for benalaxyl-M. Tolerance level 

residues and/or 100% CT were assumed 

for all food commodities. 

2. Dietary exposure from drinking 

water. An assessment of residues in 

drinking water is not required for this 

assessment because there is no drinking 

water exposure in the U.S. associated 

with the establishment of an import 

tolerance. 

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). BenalaxylM is not registered for any specific use 

patterns that would result in residential 

exposure. 

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 benalaxyl-M to 

share a common mechanism of toxicity 

with any other substances, and 

benalaxyl-M does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that benalaxyl-M 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. 

No evidence of increased quantitative or 

qualitative susceptibility was seen 

following in utero exposure to 

benalaxyl-M with rats or rabbits in the 

prenatal developmental toxicity studies 

or in young rats in the 2-generation 

reproduction study. The 2-generation 

reproduction study resulted in no 

effects on reproductive function or 

fertility. The offspring effects occurred 

at the same dose that caused parental 

effects. No evidence of developmental 

delay or developmental toxicity was 

observed in developmental toxicity 

studies in rabbits or in rats. 

The rabbit was tested at the limit dose 

(1000 mg/kg/day), and no maternal or 

developmental toxicity was observed. 

No significant developmental or 

maternal toxicity occurred at the highest 

dose level tested in the rat study, but the 


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limit dose was not tested. It is not 

necessary to require the submission of 

an additional rat study since a study at 

higher dose levels would not result in 

a lower NOAEL and the point of 

departure is already 10-fold lower than 

the NOAEL in the rat study. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were retained at 10×. That decision is 

based on the following findings: 

i. The toxicity database for benalaxylM is complete for purposes of assessing 

the exposures from the use of benalaxylM on imported grapes and tomatoes. 

However, there remains some 

uncertainty regarding the potential for 

benalaxyl-M effects on thyroid. Thyroid 

toxicity was seen following subchronic 

and chronic exposures to adult rats. 

There are, however, no data regarding 

the potential effects of benalaxyl-M on 

thyroid homeostasis in the young 

animals. This lack of characterization 

creates uncertainty with regards to 

potential life stage sensitivities due to 

exposure to benalaxyl-M. For future 

uses with higher exposure potential, the 

Agency will require a comparative 

thyroid assay in rats to assess the 

potential impact of benalaxyl-M 

exposure on thyroid function in the 

young given the pivotal role of thyroid 

hormones in brain development. 

ii. There is no indication that 

benalaxyl-M 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 

benalaxyl-M 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. 

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. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, benalaxyl-M 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 benalaxyl-M 

from food will utilize 1.4% of the cPAD 

for the general U.S. population and all 

population sub-groups. The most highly 

exposed population subgroup was 

children 1–2 years old with an 

estimated risk of 7.1% cPAD. 

3. Aggregate cancer risk for U.S. 

population. The cancer dietary 

assessment made use of the same input 

assumptions as the chronic analysis. 

Benalaxyl-M has been classified as 

‘‘Likely to be Carcinogenic to Humans’’. 

A linear low-dose extrapolation model 

(Q1*) was used to estimate cancer risk, 

with a Q1* = 5.90 × 10¥3 (mg/kg/

day) ¥1. The cancer risk estimate to the 

U.S. population is 1.7 × 10¥6. EPA 

generally considers cancer risks in the 

range of 10¥6 or less to be negligible. 

The precision which can be assumed for 

cancer risk estimates is best described 

by rounding to the nearest integral order 

of magnitude on the log scale; for 

example, risks falling between 3 × 10¥7

and 3 × 10¥6 are expressed as risks in 

the range of 10¥6. Considering the 

precision with which cancer hazard can 

be estimated, the conservativeness of 

low-dose linear extrapolation, and the 

rounding procedure described above in 

this unit, cancer risk should generally 

not be assumed to exceed the 

benchmark level of concern of the range 

of 10¥6 until the calculated risk exceeds 

approximately 3 × 10¥6. This is 

particularly the case where some 

conservatism is maintained in the 

exposure assessment. 

4. Determination of safety. There are 

no existing or proposed US registrations 

of benalaxyl-M and the only route of 

exposure is via dietary ingestion from 

imported grape and tomato 

commodities. Therefore, aggregate 

exposure and risk estimates are 

equivalent to the dietary exposures and 

risk estimates. 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 benalaxyl-M residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(RA.09.01, a high-performance liquid 

chromatography method with tandem 

mass spectrometry detection (HPLC/

MS/MS) is available to enforce the 

tolerance expression. 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: residuemethods@

epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint 

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 

benalaxyl-M at 0.3 and 0.2 ppm in or on 

grape and tomato, respectively. As a 

result, the EPA recommendations will 

result in harmonization of the U.S. 

tolerance with the Codex MRL for 

tomato, but not for grape since 

benalaxyl-M residues from the grape 

trials in Argentina were significantly 

higher than the Codex MRL. 

C. Revisions to Petitioned-for Tolerances 

The requested tolerance levels differ 

from those being established by EPA. 

The petitioner used the NAFTA 

calculator to propose tolerance levels 

while EPA used OECD MRL calculation 

procedures. Additionally, for 

determination of the grape and tomato 

tolerance levels, the petitioner included 

the results from all trials. In contrast, 

EPA included only those data that 

matched the critical Good Agricultural 

Practice (cGAP). The tolerance for grape, 

raisin was not recommended because it 

is covered by the grape tolerance. No 

separate tolerances are needed for grape 

juice, grape wine, or processed tomato 

products as processing studies showed 

that residues of benalaxyl-M do not 

concentrate in these processed 

commodities. 


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45448 Federal Register / Vol. 80, No. 146 / Thursday, July 30, 2015 / Rules and Regulations 

V. Conclusion 

Therefore, tolerances are established 

for residues of benalaxyl-M, in or on 

grape and tomato at 3.0 and 0.20 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 

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 24, 2015. 

Marty Monell, 

Acting 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 § 180.684 to subpart C to read 

as follows: 

§ 180.684 Benalaxyl-M; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the fungicide 

benalaxyl-M, 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 benalaxyl [methyl N- 

(2,6-dimethylphenyl)-N-(phenylacetyl)- 

DL-alaninate] in or on the commodity. 

Commodity Parts per million 

Grape 1 ................................ 3 .0 

Tomato 1 ............................. 0 .20 

1There is no U.S. registration for use on 

this commodity as of July 30, 2015. 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 2015–18741 Filed 7–29–15; 8:45 am] 

BILLING CODE 6560–50–P 


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