[Federal Register Volume 80, Number 239 (Monday, December 14, 2015)]
[Rules and Regulations]
[Pages 77255-77260]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31309]


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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.

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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: [email protected].

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/text-idx?&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

[[Page 77256]]

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

[[Page 77257]]

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 no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level 
(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-and-assessing-pesticide-risks/assessing-human-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
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                                    Point of departure
        Exposure/scenario            and  uncertainty/    RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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Acute dietary (General population  An acute RfD for the general population or any population subgroups was not
 including infants and children).   selected because no effect attributable to a single exposure was observed in
                                    animal studies.
                                  ------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL = 25 mg/kg/day  Chronic RfD = 0.25   Co-critical Dog Studies with NAA
                                   UFA = 10x...........   mg/kg/day.           Na salt: Subchronic Toxicity.
                                   UFH = 10x...........  cPAD = 0.25 mg/kg/   Chronic Toxicity.
                                   FQPA SF = 1x........   day.                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  LOC = 100..........  Co-critical Dog Studies with NAA
                                   UFA = 10x...........                        Na salt: Subchronic Toxicity.
                                   UFH = 10x...........                       Chronic Toxicity.
                                   FQPA SF = 1x........                       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  LOC = 1000.........  Co-critical Dog Studies with NAA
                                    \2\                                        Na salt:
                                   UFA = 10x...........                       Subchronic Toxicity.
                                   UFH = 10x...........                       Chronic Toxicity.
                                   FQPA SF = 10x \3\...                       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.
\1\ The 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.
\3\ FQPA SF for inhalation accounts for the lack of an inhalation study.


[[Page 77258]]

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-science-and-assessing-pesticide-risks/about-water-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 non-cancer 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 non-occupational, 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/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-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-and-assessing-pesticide-risks/culmative-assessment-risk-pesticides.

 D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the 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

[[Page 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 post-
application 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: 
[email protected].

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

[[Page 77260]]

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]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.


0
2. In Sec.  180.155, add to the table in alphabetical order an entry 
for ``pomegranate'' to read as follows:


Sec.  180.155  1-Naphthaleneacetic acid; tolerance for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Pomegranate................................................        0.05
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2015-31309 Filed 12-11-15; 8:45 am]
BILLING CODE 6560-50-P