80 FR 77255 - Naphthalene Acetates; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 239 (December 14, 2015)

Page Range		77255-77260
FR Document		2015-31309

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).

Federal Register, Volume 80 Issue 239 (Monday, December 14, 2015)

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

-----------------------------------------------------------------------

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/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
----------------------------------------------------------------------------------------------------------------
Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
----------------------------------------------------------------------------------------------------------------
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:
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

[[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

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

EPA APPROVED REGULATIONS IN THE TEXAS SIP—Continued
State
approval/
State citation Title/subject EPA approval date Explanation
submittal
date

* * * * * * *

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 REG-
ISTER citation].

* * * * * * *

* * * * * (e) * * *

EPA APPROVED NONREGULATORY PROVISIONS AND QUASI-REGULATORY MEASURES IN THE TEXAS SIP
State
Applicable geographic or submittal/
Name of SIP provision EPA approval date Comments
nonattainment area effective
date

* * * * * * *
Revision to El Paso PM10 Attain- El Paso, TX ................................. 3/7/2012 12/14/2015 [Insert FEDERAL REG-
ment Demonstration SIP (dust ISTER citation].
control contingency measures).

[FR Doc. 2015–31310 Filed 12–11–15; 8:45 am] or at the Office of Pesticide Programs provides a guide to help readers
BILLING CODE 6560–50–P Regulatory Public Docket (OPP Docket) determine whether this document
in the Environmental Protection Agency applies to them. Potentially affected
Docket Center (EPA/DC), West William entities may include:
ENVIRONMENTAL PROTECTION Jefferson Clinton Bldg., Rm. 3334, 1301 • Crop production (NAICS code 111).
AGENCY Constitution Ave. NW., Washington, DC • Animal production (NAICS code
20460–0001. The Public Reading Room 112).
40 CFR Part 180 is open from 8:30 a.m. to 4:30 p.m., • Food manufacturing (NAICS code
Monday through Friday, excluding legal 311).
[EPA–HQ–OPP–2014–0769; FRL–9937–22]
holidays. The telephone number for the • Pesticide manufacturing (NAICS
Naphthalene Acetates; Pesticide Public Reading Room is (202) 566–1744, code 32532).
Tolerances and the telephone number for the OPP B. How can I get electronic access to
Docket is (703) 305–5805. Please review other related information?
AGENCY: Environmental Protection the visitor instructions and additional
Agency (EPA). You may access a frequently updated
information about the docket available electronic version of EPA’s tolerance
ACTION: Final rule. at http://www.epa.gov/dockets. regulations at 40 CFR part 180 through
SUMMARY: This regulation establishes a FOR FURTHER INFORMATION CONTACT: the Government Printing Office’s e-CFR
tolerance for residues of the Susan Lewis, Registration Division site at http://www.ecfr.gov/cgi-bin/text-
naphthalene acetate group in or on (7505P), Office of Pesticide Programs, idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
pomegranate. Interregional Research Environmental Protection Agency, 1200 40tab_02.tpl.
Project Number 4 (IR–4) requested the Pennsylvania Ave. NW., Washington,
C. How can I file an objection or hearing
tolerance under the Federal Food, Drug, DC 20460–0001; main telephone
request?
and Cosmetic Act (FFDCA). number: (703) 305–7090; email address:
RDFRNotices@epa.gov. Under FFDCA section 408(g), 21
DATES: This regulation is effective
U.S.C. 346a, any person may file an
December 14, 2015. Objections and SUPPLEMENTARY INFORMATION:
objection to any aspect of this regulation
requests for hearings must be received I. General Information and may also request a hearing on those
on or before February 12, 2016, and objections. You must file your objection
must be filed in accordance with the A. Does this action apply to me?
or request a hearing on this regulation
mstockstill on DSK4VPTVN1PROD with RULES

instructions provided in 40 CFR part You may be potentially affected by in accordance with the instructions
178 (see also Unit I.C. of the this action if you are an agricultural provided in 40 CFR part 178. To ensure
SUPPLEMENTARY INFORMATION).
producer, food manufacturer, or proper receipt by EPA, you must
ADDRESSES: The docket for this action, pesticide manufacturer. The following identify docket ID number EPA–HQ–
identified by docket identification (ID) list of North American Industrial OPP–2014–0769 in the subject line on
number EPA–HQ–OPP–2014–0769, is Classification System (NAICS) codes is the first page of your submission. All
available at http://www.regulations.gov not intended to be exhaustive, but rather objections and requests for a hearing

VerDate Sep<11>2014 16:45 Dec 11, 2015 Jkt 238001 PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 E:\FR\FM\14DER1.SGM 14DER1

Document Created: 2015-12-14 13:47:09
Document Modified: 2015-12-14 13:47:09

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule.
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).
Contact		Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
FR Citation		80 FR 77255
CFR Associated		Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements