54242 Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Rules and Regulations 

beyond those imposed by state law. For 

that reason, this action: 

• Is not a significant regulatory action 

subject to review by the Office of 

Management and Budget under 

Executive Orders 12866 (58 FR 51735, 

October 4, 1993) and 13563 (76 FR 3821, 

January 21, 2011); 

• does not impose an information 

collection burden under the provisions 

of the Paperwork Reduction Act (44 

U.S.C. 3501 et se.); 

• is certified as not having a 

significant economic impact on a 

substantial number of small entities 

under the Regulatory Flexibility Act (5 

U.S.C. 601 et se.); 

• does not contain any unfunded 

mandate or significantly or uniquely 

affect small governments, as described 

in the Unfunded Mandates Reform Act 

of 1995 (Public Law 104–4); 

• does not have Federalism 

implications as specified in Executive 

Order 13132 (64 FR 43255, August 10, 

1999); 

• is not an economically significant 

regulatory action based on health or 

safety risks subject to Executive Order 

13045 (62 FR 19885, April 23, 1997); 

• is not a significant regulatory action 

subject to Executive Order 13211 (66 FR 

28355, May 22, 2001); 

• is not subject to requirements of 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) because 

application of those requirements would 

be inconsistent with the Clean Air Act; 

and 

• does not provide EPA with the 

discretionary authority to address, as 

appropriate, disproportionate human 

health or environmental effects, using 

practicable and legally permissible 

methods, under Executive Order 12898 

(59 FR 7629, February 16, 1994). 

The SIP is not approved to apply on 

any Indian reservation land or in any 

other area where EPA or an Indian tribe 

has demonstrated that a tribe has 

jurisdiction. In those areas of Indian 

country, the rule does not have tribal 

implications and will not impose 

substantial direct costs on tribal 

governments or preempt tribal law as 

specified by Executive Order 13175 (65 

FR 67249, November 9, 2000). 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this action 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. A major rule 

cannot take effect until 60 days after it 

is published in the Federal Register. 

This action is not a ‘‘major rule’’ as 

defined by 5 U.S.C. 804(2). 

Under section 307(b)(1) of the Clean 

Air Act, petitions for judicial review of 

this action must be filed in the United 

States Court of Appeals for the 

appropriate circuit by November 9, 

2015. Filing a petition for 

reconsideration by the Administrator of 

this final rule does not affect the finality 

of this action for the purposes of judicial 

review nor does it extend the time 

within which a petition for judicial 

review may be filed, and shall not 

postpone the effectiveness of such rule 

or action. This action may not be 

challenged later in proceedings to 

enforce its requirements. (See CAA 

section 307(b)(2).) 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Carbon monoxide, 

Incorporation by reference, 

Intergovernmental relations, Nitrogen 

dioxide, Ozone, Particulate matter, 

Reporting and recordkeeping 

requirements, and Volatile organic 

compounds. 

Authority: 42 U.S.C. 7401 et seq. 

Dated: July 1, 2015. 

Shaun L. McGrath, 

Regional Administrator, Region 8. 

40 CFR part 52 is amended as follows: 

PART 52 [AMENDED] 

■ 1. The authority citation for Part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart TT—Utah 

■ 2. Section 52.2320 is amended by 

adding paragraph (c)(80) to read as 

follows: 

§ 52.2320 Identification of plan. 

* * * * * 

(c) * * * 

(80) Revisions to the Utah State 

Implementation Plan involving Section 

X, Vehicle Inspection and Maintenance 

Program, Part A, General Requirements 

and Applicability, and Utah Rules 

R307–110–1 and R307–110–31. The 

Utah Air Quality Board (UAQB) adopted 

these SIP revisions on December 5, 

2012, they became state effective on 

December 6, 2012, and were submitted 

by the Governor to EPA by a letter dated 

January 10, 2013. In addition, revisions 

to the Utah State Implementation Plan 

involving; Section X, Vehicle Inspection 

and Maintenance Program, Part F, 

Cache County and Utah Rule R307–110– 

36 were submitted for Agency action. 

These SIP revisions were adopted by the 

UAQB November 6, 2013, they became 

State effective on November 7, 2013, 

and were submitted by the Governor to 

EPA by a letter dated January 28, 2014. 

(i) Incorporation by reference. 

(A)(1) Utah Rules R307, 

Environmental Quality, Air Quality, 

R307–110, General Requirements: State 

Implementation Plan, R307–110–1, 

Incorporation by Reference, and R307– 

110–31, Section X, Vehicle Inspection 

and Maintenance Program, Part A, 

General Requirements and 

Applicability; effective December 6, 

2012, as proposed in the Utah State 

Bulletin on October 1, 2012, and 

published as adopted in the Utah State 

Bulletin on January 1, 2013. 

(2) Section X, Vehicle Inspection and 

Maintenance Program, Part A, General 

Requirements and Applicability, 

adopted by the Utah Air Quality Board 

on December 5, 2012. (B)(1) Utah Rule 

R307, Environmental Quality, Air 

Quality, R307–110, General 

Requirements: State Implementation 

Plan, R307–110–36, Section X, Vehicle 

Inspection and Maintenance Program, 

Part F, Cache County; effective 

November 7, 2013, as proposed in the 

Utah State Bulletin on September 1, 

2013, and published as adopted in the 

Utah State Bulletin on December 1, 

2013. 

(2) Section X, Vehicle Inspection and 

Maintenance Program Part F, Cache 

County, adopted by the Utah Air Quality 

Board on November 6, 2013. 

* * * * * 

[FR Doc. 2015–22594 Filed 9–8–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0506; FRL–9930–04] 

Cyprodinil; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of cyprodinil in 

or on multiple commodities that are 

identified and discussed later in this 

document, and removes the established 

tolerance on fruit, stone, group 12. 

Interregional Research Project Number 4 


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Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Rules and Regulations 54243 

(IR–4) requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: This regulation is effective 

September 9, 2015. Objections and 

requests for hearings must be received 

on or before November 9, 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–2014–0506, 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–2014–0506 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before November 9, 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– 

2014–0506, 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 September 

5, 2014 (79 FR 53009) (FRL–9914–98), 

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 4E8293) by IR–4, 

500 College Road East, Suite 201W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR part 180 be 

amended by establishing tolerances for 

residues of the fungicide cyprodinil, 4- 

cyclopropyl-6-methyl-N-phenyl-2- 

pyrimidinamine, in or on acerola at 1.5 

parts per million (ppm); artichoke, globe 

at 4.0 ppm; feijoa at 1.5 ppm; fruit, stone 

group 12–12 at 2.0 ppm; guava at 1.5 

ppm; jaboticaba at 1.5 ppm; passionfruit 

at 1.5 ppm; pomegranate at 7.0 ppm; 

starfruit at 1.5 ppm; and wax jambu at 

1.5 ppm. This petition additionally 

requested to remove the tolerance in 40 

CFR 180.532 for residues of cyprodinil 

in or on fruit, stone, group 12 at 2.0 

ppm. That document referenced a 

summary of the petition prepared on 

behalf of IR–4 by Syngenta Crop 

Protection, the registrant, which is 

available in the docket, http://

www.regulations.gov. Comments were 

received on the notice of filing. EPA’s 

response to these comments is 

discussed in Unit IV.C. 

Based upon review of the data 

supporting the petition, EPA has revised 

the proposed tolerance on pomegranate, 

and has revised the commodity 

definition for artichoke to artichoke, 

globe. The reasons for these changes are 

explained in Unit IV.D. 

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 


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54244 Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Rules and Regulations 

aggregate exposure for cyprodinil 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with cyprodinil 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 major target organs of cyprodinil 

are the liver and the kidney. Liver 

effects were consistent among rats and 

mice in both subchronic and chronic 

studies and typically included increased 

liver weights and increases in serum 

clinical chemistry parameters, 

associated with adverse effects on liver 

function (i.e., increased cholesterol and 

phospholipid levels). Microscopic 

lesions in rats and mice included 

hepatocyte hypertrophy and 

hepatocellular necrosis. In the kidneys, 

chronic tubular lesions and chronic 

kidney inflammation following 

subchronic exposure and increased 

kidney weights and progressive 

nephropathy following chronic 

exposures in male rats. Chronic effects 

in dogs were limited to decreased bodyweight gain, decreased food 

consumption and decreased food 

efficiency. The hematopoietic system 

also appeared to be a target of 

cyprodinil, as mild anemia was seen 

following subchronic rat exposure 

(reductions in hematocrit and 

hemoglobin and microcytosis). 

Although increases in thyroid weight or 

hypertrophy of thyroid follicular cells 

were observed at higher doses in the 28- 

day and 90-day oral toxicity study in 

rats, treatment-related changes in 

thyroid weights or gross/microscopic 

observations were not observed in the 

chronic rat study or in other studies. 

A 28-day dietary immunotoxicity 

study in mice resulted in no apparent 

suppression of the humoral component 

of the immune system. The only effect 

attributed to cyprodinil treatment was 

higher liver weights at the highest dose 

tested. There were no treatment-related 

effects on spleen or thymus weights; no 

effects on specific activity or total 

activity of splenic immunoglobulin M 

(IgM) antibody-forming cells to the T 

cell-dependent antigen sheep red blood 

cells (sRBC). 

An acute neurotoxicity study 

indicated systemic toxicity with signs of 

induced hunched posture, pilorection, 

and reduced responsiveness to sensory 

stimuli and reduced motor activity. 

Clinical signs, hypothermia, and 

changes in motor activity were found to 

be reversible by day 8 and 15 

investigations. A subchronic 

neurotoxicity study showed no 

treatment related effects on mortality, 

clinical signs, or gross or histological 

neuropathology. Functional 

observational battery (FOB) and motor 

activity testing revealed no treatment 

related effects up to the highest dose 

tested. 

There was no evidence of increased 

susceptibility in the developmental rat 

or rabbit study following in utero 

exposure or in the two-generation 

reproduction study following pre- and 

post-natal exposure. Fetal toxicity, 

manifested as significantly lower fetal 

weights and an increased incidence of 

delayed ossification in the rat and a 

slight increase in litters showing extra 

ribs in the rabbit, was reported in 

developmental toxicity studies. In a rat 

two-generation reproduction study, 

significantly lower pup weights for F1

and F2 offspring were observed. Each of 

these fetal or neonatal effects occurred 

at the same dose levels at which 

maternal toxicity (decreased body 

weight gain) was observed and were 

considered to be secondary to maternal 

toxicity. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by cyprodinil 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:// 

www.regulations.gov in document: 

Cyprodinil. Human Health Risk 

Assessment for the Expansion of 

Existing Crop Group/Representative 

Commodity Uses to Stone Fruit Group 

12–12, and Adding New Uses on the 

Artichoke, Guava, Pomegranate, 

Passionfruit, Feijoa, Jaboticaba, Wax 

Jambu, Starfruit, and Acerola and 

Amended Uses on Greenhouse 

Cucumbers and Small Tomatoes at 

pages 36–40 in docket ID number EPA– 

HQ–OPP–2014–0506. 

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 cyprodinil used for 

human risk assessment is discussed in 

Unit III.B. of the final rule published in 

the Federal Register of October 16, 2012 

(77 FR 49732) (FRL–9359–7). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to cyprodinil, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

cyprodinil tolerances in 40 CFR 

180.532. EPA assessed dietary 

exposures from cyprodinil 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 cyprodinil. In estimating acute 

dietary exposure, EPA used food 

consumption information from the 

United States Department of Agriculture 

(USDA) National Health and Nutrition 

Examination Survey, What We Eat in 

America, (NHANES/WWEIA), from 

2003 to 2008. As to residue levels in 

food, EPA utilized tolerance-level 

residues and 100 percent crop treated 

(PCT) for all commodities. The acute 

assessment also incorporated Dietary 

Exposure Evaluation Model software 

with the Food Commodity Intake 

Database (DEEM–FCID) Version 3.18 

default processing factors; and empirical 

processing factors for tomato paste/

tomato puree and lemon/lime juice, 

where 1X empirical processing factors 

were used to modify the tolerance 

values. 


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Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Rules and Regulations 54245 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA NHANES/WWEIA. As 

to residue levels in food, EPA utilized 

average field trial residues for pome 

fruit, head lettuce, leaf lettuce, spinach, 

tomato, and grape and tolerance-level 

residues for the remaining commodities. 

The Agency also assumed 100 PCT. The 

chronic assessment also incorporated 

DEEM default processing factors except 

for tomato paste/tomato puree and 

lemon juice/lime juice, where a 1X 

empirical processing factor was used to 

modify the tolerance values. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that cyprodinil 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 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 residues of concern in 

drinking water for risk assessment 

purposes are cyprodinil and the 

degradate CGA 249287. The estimated 

drinking water concentrations (EDWCs) 

for each of these was calculated using a 

molecular weight conversion and then 

combined for each modeled scenario. 

The Agency used screening level water 

exposure models in the dietary exposure 

analysis and risk assessment for 

cyprodinil and CGA 249287 in drinking 

water. These simulation models take 

into account data on the physical, 

chemical, and fate/transport 

characteristics of cyprodinil and CGA 

249287. Further information regarding 

EPA drinking water models used in 

pesticide exposure assessment can be 

found at http://www.epa.gov/oppefed1/

models/water/index.htm. 

Based on the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS), Screening 

Concentration in Ground Water (SCI– 

GROW), and Pesticide Root Zone Model 

for Groundwater (PRZM–GW) models, 

the EDWCs of cyprodinil and CGA 

249287 for acute exposures are 

estimated to be 34.8 parts per billion 

(ppb) for surface water and 2.05 ppb for 

ground water. EDWCs for chronic 

exposures for non-cancer assessments 

are estimated to be 24.7 ppb for surface 

water and 1.80 ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. The 

water concentration values of 34.8 ppb 

and 24.7 ppb were used to assess the 

contribution to drinking water for the 

acute and chronic dietary risk 

assessments, respectively. 

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). 

Cyprodinil is currently registered for 

the following uses that could result in 

residential exposures: Ornamental 

landscapes. EPA assessed residential 

exposure using the following 

assumptions: Short-term inhalation 

exposures to adult residential handlers 

from the application of cyprodinil to 

ornamental landscapes. The residential 

handler exposure scenarios were 

considered to be short-term only, due to 

the infrequent use patterns associated 

with homeowner products. Dermal 

exposures were not assessed since there 

was no dermal endpoint identified for 

cyprodinil. Postapplication exposures to 

adults or children were not expected 

and were not assessed. Further 

information regarding EPA standard 

assumptions and generic inputs for 

residential exposures may be found at 

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

residential-exposure-sop.html. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found cyprodinil to share 

a common mechanism of toxicity with 

any other substances, and cyprodinil 

does not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that cyprodinil 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. 

In a rat developmental toxicity study, 

there were significantly lower mean 

fetal weights in the high dose group 

compared to controls as well as a 

significant increase in skeletal 

anomalies in the high dose group due to 

abnormal ossification. The skeletal 

anomalies or variations were considered 

to be a transient developmental delay 

that occurred secondary to the maternal 

toxicity noted in the high dose group. In 

the rabbit study, the only treatmentrelated developmental effect was the 

indication of an increased incidence of 

a 13th rib at maternally toxic doses. 

Signs of fetal effects in the reproductive 

toxicity study included significantly 

lower F1 and F2 pup weights in the 

high dose group during lactation, which 

continued to be lower than controls 

post-weaning and after the pre-mating 

period in the F1 generation. 

Reproductive effects were seen only at 

doses that also caused parental toxicity. 

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 for non-inhalation 

exposure scenarios. For inhalation 

exposure scenarios for all population 

groups, EPA is retaining a 10X FQPA 

SF. That decision is based on the 

following findings: 

i. The toxicity database for cyprodinil 

is complete, except for a 90-day 

inhalation toxicity study. In the absence 

of a route-specific inhalation study, EPA 

is relying on the 28-day feeding/rangeVerDate Sep<11>2014 14:17 Sep 08, 2015 Jkt 235001 PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 E:\FR\FM\09SER1.SGM 09SER1

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54246 Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Rules and Regulations 

finding rat oral study to estimate risk 

from inhalation exposures. EPA has 

determined that the use of this study to 

extrapolate an inhalation endpoint may 

understate risk. Accordingly, to address 

this uncertainty, EPA has concluded 

that the 10X FQPA SF should be 

retained for risk assessments involving 

inhalation exposure. 

ii. As to evidence of neurotoxicity, in 

an acute neurotoxicity study in rats 

clinical signs, hypothermia, and 

changes in motor activity were all found 

to be reversible and no longer seen at 

day 8 and 15 investigations. There were 

no treatment-related effects on mortality 

or gross or histological neuropathology. 

Reduced motor activity, induced 

hunched posture, piloerection and 

reduced responsiveness to sensory 

stimuli were observed and disappeared 

in all animals by day three to four. For 

the subchronic neurotoxicity study in 

rats, there was no indication that 

cyprodinil is a neurotoxic chemical. 

Based on this evidence, there is no need 

for a developmental neurotoxicity study 

or additional UFs to account for 

neurotoxicity. 

iii. When toxicity was observed in the 

prenatal developmental toxicity studies 

in rats and rabbits and the twogeneration reproduction study in rats, 

toxicity to the fetuses or offspring 

occurred at the same doses at which 

effects were observed in maternal/

parental animals. Additionally, the 

skeletal anomalies or variations were 

considered to be a transient 

developmental delay that occurred 

secondary to the maternal toxicity noted 

in the high dose group. Therefore, there 

is no evidence that cyprodinil results in 

increased susceptibility in in utero rats 

or rabbits in the prenatal developmental 

studies or in young rats in the twogeneration reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The acute dietary assessment was 

conservative and based upon 100 PCT 

and tolerance-level residues, as well as 

DEEM default and empirical processing 

factors. The chronic dietary assessment 

was partially refined with average field 

trial residues for some commodities and 

tolerance-level residues for the 

remaining commodities. DEEM default 

and empirical processing factors were 

also incorporated into the chronic 

dietary assessment. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to cyprodinil in 

drinking water. Based on the discussion 

in Unit III.C.3, postapplication exposure 

of children as well as incidental oral 

exposure of toddlers is not expected. 

These assessments will not 

underestimate the exposure and risks 

posed by cyprodinil. 

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 

cyprodinil will occupy 8.6% of the 

aPAD for children one to two 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 cyprodinil 

from food and water will utilize 85% of 

the cPAD for children one to two 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 

cyprodinil 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). Cyprodinil 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 

cyprodinil. 

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 an 

aggregate MOE of 7,900. Because EPA’s 

level of concern for cyprodinil is a MOE 

of 1,000 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, cyprodinil 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 

cyprodinil. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

cyprodinil 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 cyprodinil 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate high performance liquid 

chromatography, using ultra-violet 

detection (HPLC/UV) methods (Methods 

AG–631 and AG–631B) are available to 

enforce the tolerance expression of 

cyprodinil in/on plant commodities. 

The methods 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, 


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Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Rules and Regulations 54247 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has established MRLs for 

cyprodinil in or on stone fruit at 2.0 

ppm. This MRL is the same as the 

tolerance established for cyprodinil in 

the United States for fruit, stone, group 

12–12. The Codex has not established a 

MRL for cyprodinil in or on the other 

commodities associated with this 

action. 

C. Response to Comments 

Several comments were received in 

response to the notice of filing. All but 

one were concerned with potential 

environmental impacts, and were not 

specifically related to the cyprodinil 

action. EPA notes that these comments 

address potential environmental 

concerns; however, the safety standard 

for approving tolerances under section 

408 of the FFDCA focuses on potential 

harms to human health and does not 

permit consideration of effects on the 

environment. 

One additional comment was received 

that did not specifically address the 

cyprodinil action, but that raised 

concerns about the toxicity of pesticides 

and requested that no tolerance be 

established. The Agency understands 

the commenter’s concerns and 

recognizes that some individuals believe 

that pesticides should be banned on 

agricultural crops. However, the existing 

legal framework provided by section 

408 of the FFDCA states that tolerances 

may be set when persons seeking such 

tolerances or exemptions have 

demonstrated that the pesticide meets 

the safety standard imposed by that 

statute. This citizen’s comment appears 

to be directed at the underlying statute 

and not EPA’s implementation of it; the 

citizen has made no contention that 

EPA has acted in violation of the 

statutory framework. EPA has found 

that there is a reasonable certainty of no 

harm to humans after considering the 

toxicological studies and the exposure 

levels of humans to cyprodinil. 

D. Revisions to Petitioned-For 

Tolerances 

Based on the data submitted with the 

petition, EPA has determined that the 

proposed tolerance in or on 

pomegranate at 7.0 ppm should be 

established at 10 ppm. This tolerance 

level was determined by the 

Organization for Economic Cooperation 

and Development tolerance calculation 

procedures. Additionally, the Agency is 

establishing a tolerance in or on 

artichoke, globe, rather than the 

petitioned-for commodity artichoke in 

order to provide the correct commodity 

definition. 

V. Conclusion 

Therefore, tolerances are established 

for residues of cyprodinil, 4- 

cyclopropyl-6-methyl-N-phenyl-2- 

pyrimidinamine, in or on acerola at 1.5 

ppm; artichoke, globe at 4.0 ppm; feijoa 

at 1.5 ppm; fruit, stone, group 12–12 at 

2.0 ppm; guava at 1.5 ppm; jaboticaba at 

1.5 ppm; passionfruit at 1.5 ppm; 

pomegranate at 10 ppm; starfruit at 1.5 

ppm; and wax jambu at 1.5 ppm. 

Additionally, this action removes the 

tolerance established in or on fruit, 

stone, group 12 at 2.0 ppm as that crop 

group tolerance is superseded by the 

tolerance being established in this 

action for crop group 12–12. 

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 tolerances 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: August 13, 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 § 180.532, remove the entry, 

‘‘Fruit, stone, group 12’’ and 

alphabetically add the following 

commodities to the table in paragraph 

(a) to read as follows: 


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54248 Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Rules and Regulations 

§ 180.532 Cyprodinil; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

Acerola ........................................ 1.5 

* * * * * 

Artichoke, globe .......................... 4.0 

* * * * * 

Feijoa .......................................... 1.5 

* * * * * 

Fruit, stone, group 12–12 ........... 2.0 

* * * * * 

Guava ......................................... 1.5 

* * * * * 

Jaboticaba .................................. 1.5 

* * * * * 

Passionfruit ................................. 1.5 

* * * * * 

Pomegranate .............................. 10 

* * * * * 

Starfruit ....................................... 1.5 

* * * * * 

Wax jambu .................................. 1.5 

* * * * * 

[FR Doc. 2015–22031 Filed 9–8–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2015–0143; FRL–9932–06] 

Propylene Glycol Monomethyl Ether; 

Exemption from the Requirement of a 

Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of propylene 

glycol monomethyl ether (PGME; CAS 

No. 107–98–2) when used as an inert 

ingredient under 40 CFR 180.910 as a 

solvent in pesticide formulations which 

include pre-and post–harvest use on 

crops. Syngenta Crop Protection 

submitted a petition to EPA under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), requesting establishment of an 

exemption from the requirement of a 

tolerance. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of PGME. 

DATES: This regulation is effective 

September 9, 2015. Objections and 

requests for hearings must be received 

on or before November 9, 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–2015–0143, 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 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–2015–0143 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before November 9, 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– 

2015–0143, 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. Petition for Exemption 

In the Federal Register of April 6, 

2015 (80 FR 18327) (FRL–9924–00), 

EPA issued a document pursuant to 

FFDCA section 408, 21 U.S.C. 346a, 

announcing the filing of a pesticide 

petition inert ingredient (PP IN–10775) 

by Syngenta Crop Protection, P.O. Box 

18300, Greensboro, NC 27409, The 

petition requested that 40 CFR 180.910 

be amended by establishing an 


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