Federal Register / Vol. 80, No. 239 / Monday, December 14, 2015 / Rules and Regulations 77255 

EPA APPROVED REGULATIONS IN THE TEXAS SIP—Continued 

State citation Title/subject 

State 

approval/ 

submittal 

date 

EPA approval date Explanation 

*******

Division 4: Materials Handling, Construction, Roads, Streets, Alleys, and Parking Lots 

*******

Section 111.147 ........................... Roads, Streets, and Alleys .......... 1/25/2012 12/14/2015 [Insert FEDERAL REGISTER citation].

* * * * * * * 

* * * * * (e) * * * 

EPA APPROVED NONREGULATORY PROVISIONS AND QUASI-REGULATORY MEASURES IN THE TEXAS SIP 

Name of SIP provision Applicable geographic or 

nonattainment area 

State 

submittal/ 

effective 

date 

EPA approval date Comments 

*******

Revision to El Paso PM10 Attainment Demonstration SIP (dust 

control contingency measures).

El Paso, TX ................................. 3/7/2012 12/14/2015 [Insert FEDERAL REGISTER citation].

[FR Doc. 2015–31310 Filed 12–11–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0769; FRL–9937–22] 

Naphthalene Acetates; Pesticide 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of the 

naphthalene acetate group in or on 

pomegranate. Interregional Research 

Project Number 4 (IR–4) requested the 

tolerance under the Federal Food, Drug, 

and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

December 14, 2015. Objections and 

requests for hearings must be received 

on or before February 12, 2016, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2014–0769, 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–2014–0769 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

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77256 Federal Register / Vol. 80, No. 239 / Monday, December 14, 2015 / Rules and Regulations 

must be in writing, and must be 

received by the Hearing Clerk on or 

before February 12, 2016. 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– 

2014–0769, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

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

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http://

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

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at http:// 

www.epa.gov/dockets. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of February 

11, 2015 (80 FR 7559) (FRL–9921–94), 

EPA issued a document pursuant to 

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

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

pesticide petition (PP 4E8310) by IR–4, 

IR–4 Project Headquarters, 500 College 

Road East, Suite 201 W, Princeton, NJ. 

The petition requested that 40 CFR 

180.155 be amended by establishing 

tolerances for residues of a family of 

plant growth regulators, the 

naphthalene acetates, in or on 

pomegranate at 0.05 parts per million 

(ppm). That document referenced a 

summary of the petition prepared by 

AMVAC Chemical 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. 

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 the naphthalene 

acetates including exposure resulting 

from the tolerances established by this 

action. EPA’s assessment of exposures 

and risks associated with the 

naphthalene acetates follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered their 

validity, completeness, and reliability as 

well as the relationship of the results of 

the studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. 

In this regulatory action, 1- 

naphthaleneacetic acid is a species of 

chemical that includes several similar 

compounds: Naphthaleneacetamide 

(NAA acetamide), naphthaleneacetic 

acid, potassium naphthaleneacetate 

(NAA potassium salt), ammonium 

naphthaleneacetate (ammonium NAA), 

sodium naphthaleneacetate (NAA 

sodium salt), and ethyl 

naphthaleneacetate (NAA ethyl ester). 

These chemicals are assessed as a single 

group and are collectively referred to as 

the naphthalene acetates (NAA). 

Hereafter, NAA will be used to refer to 

the entire naphthalene acetate group. 

These chemical compounds are 

structurally related, metabolized to the 

acid form (by both plants and animals), 

and are eliminated from the body as 

glycine and glucuronic acid conjugates 

within 36 to 48 hours after exposure. 

EPA has concluded that toxicity testing 

on any of these compounds should 

serve for all members of this group of 

chemicals. 

In general, NAA sodium salt was the 

most toxic form in sub-chronic and 

chronic studies. Repeated exposure in 

oral toxicity studies resulted in 

decreased body weights and body 

weight gains accompanied by decreased 

food consumption. The major target 

organs of sub-chronic and chronic oral 

exposure were the liver, stomach, and 

lung. Others symptoms of toxicity from 

oral exposure included decreased 

hematocrit and hemoglobin, reduced 

red blood cell (RBC) count in rats and 

dogs, and hypocellularity of the bone 

marrow in dogs. In contrast to oral 

exposures, NAA ethyl ester was the 

most toxic chemical species when 

administered dermally, inducing 

epidermal hyperplasia and 

hyperkeratosis, sebaceous gland 

hyperplasia, and dermal inflammation. 

The NAA sodium salt required a 10-fold 

higher dose to elicit similar dermal 

effects and no dermal effects were noted 

in the NAA acetamide exposure. 

Systemic toxicity was not a 

consequence of dermal exposure to any 

of the tested naphthalene acetates. 

Developmental and offspring toxicity 

was linked to NAA sodium salt 

exposure but was not a common 

observation for the entire naphthalene 

acetate group. Developing rats exhibited 

decreased fetal weight and minor 

skeletal changes and were more 

susceptible to NAA sodium salt toxicity 

than the maternal rats. Skeletal defects 

and variants were observed in rabbit 

fetuses after exposure to NAA sodium 

salt in the developmental rabbit study; 

however these effects only occurred at 

doses that also compromised maternal 

health. Offspring toxicity from NAA 

sodium salt manifested as reduced litter 

survival and pup weight throughout 

lactation in two generations. These 

effects coincided with reduced body 

weight in both parental generations 

indicating the adults and their young 

were equally susceptible to NAA 

sodium salt. 

Carcinogenicity studies of NAA 

acetamide in mice and NAA sodium salt 

in rats and mice are considered 

adequate for the evaluation of the 

oncogenicity of the NAA group. In these 

three studies the tested NAA 

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compounds were not carcinogenic in 

mice or rats. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by NAA 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, 

‘‘Naphthalene Acetate. Human Health 

Risk Assessment for a Proposed New 

Use on Pomegranate’’ at pp. 31 in 

docket ID number EPA–HQ–OPP–2014– 

0769. 

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 the NOAEL and the 

LOAEL are identified. Uncertainty/

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http://

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

A summary of the toxicological 

endpoints for NAA used for human risk 

assessment is shown in Table 1 of this 

unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR NAA 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 (General population including infants and 

children).

An acute RfD for the general population or any population subgroups was not selected because no effect attributable to a single exposure was observed in animal studies. 

Chronic dietary (All populations) NOAEL = 25 mg/kg/

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.25 

mg/kg/day.

cPAD = 0.25 mg/kg/

day 

Co-critical Dog Studies with NAA Na salt: Subchronic Toxicity. 

Chronic Toxicity. 

Subchronic.1

LOAEL = 150 mg/kg/day based on GI tract lesions and 

hypocellularity of the bone marrow. 

Subchronic NOAEL = 25 mg/kg/day. 

Chronic LOAEL = 75 mg/kg/day based on stomach lesions in 

75% of the males and slight sinusoidal histiocytosis in the 

liver of 50% of the males. 

Adult Oral Short-term (1–30 

Days).

NOAEL = 25 mg/kg/

day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC = 100 ............... Co-critical Dog Studies with NAA Na salt: Subchronic Toxicity. 

Chronic Toxicity. 

Subchronic LOAEL = 150 mg/kg/day based on GI tract lesions 

and hypocellularity of the bone marrow. 

Subchronic NOAEL = 25 mg/kg/day. 

Chronic LOAEL = 75 mg/kg/day based on stomach lesions in 

75% of the males and slight sinusoidal histiocytosis in the 

liver of 50% of the males. 

Chronic NOAEL = 15 mg/kg/day. 

Inhalation Short-Term (1–30 

days).

NOAEL = 25 mg/kg/

day 2

UFA = 10x 

UFH = 10x 

FQPA SF = 10x 3

LOC = 1000 ............. Co-critical Dog Studies with NAA Na salt: 

Subchronic Toxicity. 

Chronic Toxicity. 

Subchronic LOAEL = 150 mg/kg/day based on GI tract lesions 

and hypocellularity of the bone marrow. 

Subchronic NOAEL = 25 mg/kg/day. 

Chronic LOAEL = 75 mg/kg/day based on stomach lesions in 

75% of the males and slight sinusoidal histiocytosis in the 

liver of 50% of the males. 

Chronic NOAEL = 15 mg/kg/day. 

Cancer ....................................... Not carcinogenic based on rats and mice bioassays. Not mutagenic. 

LOC = level of concern. 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. Mg/kg/day = milligram/kilogram/day. 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). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (c = chronic). RfD = reference dose. 1The NOAEL/LOAEL used to set endpoints for the co-critical dog studies are in bold. 

2 Inhalation absorption is assumed to be equivalent to oral absorption. 

3FQPA SF for inhalation accounts for the lack of an inhalation study. 

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77258 Federal Register / Vol. 80, No. 239 / Monday, December 14, 2015 / Rules and Regulations 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to NAA, EPA considered 

exposure under the petitioned-for 

tolerance as well as all existing NAA 

tolerances in 40 CFR 180.155. EPA 

assessed dietary exposure to NAA 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 NAA; therefore, a quantitative acute 

dietary exposure assessment is 

unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the Dietary Exposure 

Evaluation Model software with the 

Food Commodity Intake Database 

(DEEM–FCID), Version 3.16, which 

incorporates 2003–2008 food 

consumption data from the U.S. 

Department of Agriculture’s (USDA’s) 

National Health and Nutrition 

Examination Survey, What We Eat in 

America, (NHANES/WWEIA). DEEM 

default processing factors were used to 

modify the tolerance values. As to NAA 

residues levels in food, tolerance-level 

residues and 100 percent crop treated 

(PCT) assumptions were applied for all 

affected crops. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that NAA 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 anticipated residue and/or PCT 

information in the dietary assessment 

for NAA. Tolerance level residues and 

100 PCT were assumed for all food 

commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening-level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for NAA in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of NAA. 

Further information regarding EPA 

drinking water models used in pesticide 

exposure assessment can be found at 

http://www2.epa.gov/pesticide-scienceand-assessing-pesticide-risks/aboutwater-exposure-models-used-pesticide. 

Tier 1 (Rice Model) Estimated 

Drinking Water Concentrations (EDWCs) 

in surface and groundwater for NAA 

were used in the dietary exposure 

assessment. The EDWCs were calculated 

using the Tier 1 surface water aquatic 

model First Index Reservoir Screening 

tool (FIRST) and the Tier I/II 

groundwater model Pesticide Root Zone 

Model Ground Water (PRZM GW), in 

Tier I mode. Accordingly, the EDWCs of 

NAA for chronic exposures for noncancer assessments are estimated to be 

65.1 parts per billion (ppb) for surface 

water and 646 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 646 ppb 

was used to assess the contribution to 

drinking water. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). 

NAA is currently registered for root 

dip and sprout inhibition applications 

to ornamentals, which could result in 

residential exposures. There is a 

potential for short-term oral and 

inhalation exposures to residential 

handlers, resulting from loading and 

applying NAA. Though there is 

potential for dermal exposures for 

residential handlers, no dermal 

endpoint was selected due to the lack of 

systemic toxicity up to the limit dose 

(1,000 milligram/kilogram/day (mg/kg/

day)). There are no residential uses for 

NAA that result in incidental dermal or 

oral exposure to children. The rooting 

compounds are applied by holding the 

plant and dipping the roots into 

solution. Very little exposure is 

expected from this use. Sprout 

inhibitors are applied by spray or paint 

brush/roller after pruning trees, or by 

spraying near the base of the tree after 

pruning root suckers. There is very little 

potential for post-application exposure 

to NAA for adults or children based on 

the residential use pattern; therefore, 

residential post-application exposure is 

not expected, nor is intermediate- or 

long-term exposure based on the 

intermittent nature of applications by 

homeowners. 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

found at http://www2.epa.gov/pesticidescience-and-assessing-pesticide-risks/

standard-operating-proceduresresidential-pesticide. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

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

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found NAA to share a 

common mechanism of toxicity with 

any other substances, and NAA does not 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that NAA 

does not have a common mechanism of 

toxicity with other substances. For 

information regarding EPA’s efforts to 

determine which chemicals have a 

common mechanism of toxicity and to 

evaluate the cumulative effects of such 

chemicals, see EPA’s Web site at http:// 

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

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

Food Quality Protection Act Safety 

Factor (FQPA 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 low concern and no residual 

uncertainty for pre- and/or postnatal 

toxicity resulting from exposure to the 

naphthalene acetates. Clear NOAELs 

and LOAELs were established for the 

developmental and offspring effects and 

the points of departure selected for all 

exposure scenarios are protective of 

these effects. 

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 the oral and 

dermal routes of exposure but retained 

a 10X for the inhalation route of 

exposure. That decision is based on the 

following findings: 

i. The toxicity database for NAA is 

complete, except for a subchronic 

inhalation toxicity study. EPA is 

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Federal Register / Vol. 80, No. 239 / Monday, December 14, 2015 / Rules and Regulations 77259 

retaining a 10X FQPA SF for the 

inhalation route of exposure however, 

as discussed in Unit III.C.3, the EPA 

only expects short-term inhalation 

exposures to residential handlers, 

resulting from loading and applying 

NAA. Therefore, there is no concern for 

increased susceptibility in infants and 

children via the inhalation route. EPA 

waived the requirements for the acute 

and subchronic neurotoxicity studies. 

ii. There is no indication that NAA is 

a neurotoxic chemical based on the 

available studies in the database, and 

EPA determined that there is no need 

for acute and subchronic developmental 

neurotoxicity studies or additional UFs 

to account for neurotoxicity. 

iii. The endpoints selected from the 

co-critical dog studies are protective of 

the effects observed in the rat 

developmental, rabbit developmental, 

and rat reproduction studies. Therefore, 

the potential for increased susceptibility 

in infants and children is low. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The chronic dietary food exposure 

assessment was performed based on 100 

PCT and tolerance-level residues. EPA 

made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to NAA in drinking water. Based on the 

discussion in Unit III.C.3., regarding 

limited residential use patterns, 

exposure to residential handlers is very 

low and EPA does not anticipate postapplication exposure to children or 

incidental dermal or oral exposures to 

toddlers resulting from use of NAA in 

residential settings. These assessments 

will not underestimate the exposure and 

risks posed by NAA. 

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, NAA 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 NAA from food 

and water will utilize 15% of the cPAD 

for infants <1 year old the population 

group receiving the greatest exposure. 

Based on the explanation in Unit 

III.C.3., regarding residential use 

patterns, chronic residential exposure to 

residues of NAA 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). Using the exposure 

assumptions described in this unit for 

short-term exposures, short-term 

aggregate risk was estimated for 

combined oral and inhalation exposure 

in adults applying naphthalene acetate 

products with a paint-airless sprayer. 

This is considered the worst case 

scenario for the aggregate risk 

assessment. Endpoints selected for the 

short-term adult oral exposure and 

inhalation exposure were based on 

common effects and could therefore be 

combined in the aggregate assessment. 

The EPA calculated an aggregated risk 

indices (ARI) to combine inhalation and 

oral exposures to adults. This resulted 

in an ARI greater than 1. An ARI value 

greater than 1 is not of concern to EPA, 

therefore, aggregate exposure to 

residential handlers is acceptable. 

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). 

Because no intermediate-term adverse 

effect was identified, NAA is not 

expected to pose an intermediate-term 

risk. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

NAA 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 NAA 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology, 

a high performance liquid 

chromatography (HPLC) method using 

fluorescence detection (Method NAA– 

AM–001) and a similar method (Method 

NAA–AM–002), is available to enforce 

the tolerance expression for NAA in 

plant commodities. 

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. 

There is no established Codex MRL 

for NAA use on pomegranate. 

V. Conclusion 

Therefore, a tolerance is established 

for residues of NAA in or on 

pomegranate at 0.05 ppm. 

VI. Statutory and Executive Order 

Reviews 

This action establishes a tolerance 

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 

mstockstill on DSK4VPTVN1PROD with RULES

77260 Federal Register / Vol. 80, No. 239 / Monday, December 14, 2015 / Rules and Regulations 

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: December 3, 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 § 180.155, add to the table in 

alphabetical order an entry for 

‘‘pomegranate’’ to read as follows: 

§ 180.155 1-Naphthaleneacetic acid; 

tolerance for residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Pomegranate .............................. 0.05 

* * * * * 

* * * * * 

[FR Doc. 2015–31309 Filed 12–11–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2015–0451; FRL–9939–28] 

Polyamide Ester Polymers; Tolerance 

Exemption 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of several 

polyamide ester polymers as listed in 

this final rule. Spring Trading Co. on 

behalf of Croda, Inc. submitted a 

petition to EPA under the Federal Food, 

Drug, and Cosmetic Act (FFDCA), 

requesting an exemption from the 

requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of the listed chemicals on 

food or feed commodities. 

DATES: This regulation is effective 

December 14, 2015. Objections and 

requests for hearings must be received 

on or before February 12, 2016, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2015–0451, 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. 

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