[Federal Register Volume 78, Number 99 (Wednesday, May 22, 2013)]
[Rules and Regulations]
[Pages 30213-30218]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-12207]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0203; FRL-9386-1]


1-Naphthaleneacetic acid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 1-
naphthaleneacetic acid in or on avocado; fruit, pome, group 11-10; 
mango; sapote, mamey; and rambutan. This regulation additionally 
deletes certain tolerances, identified and discussed later in this 
document. Interregional Research Project Number 4 (IR-4) requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective May 22, 2013. Objections and 
requests for hearings must be received on or before July 22, 2013, 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-2012-0203, 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), EPA West 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: Laura Nollen, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200

[[Page 30214]]

Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 
(703) 305-7390; email address: nollen.laura@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-2012-0203 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
July 22, 2013. 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-2012-0203, 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.htm.

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 May 2, 2012 (77 FR 25954) (FRL-9346-1), 
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 2E7991) 
by IR-4, 500 College Road East, Suite 201W, Princeton, NJ 08540. The 
petition requested that 40 CFR 180.155 be amended by establishing 
tolerances for residues of the plant growth regulator 1-
naphthaleneacetic acid and its conjugates in or on rambutan at 3 parts 
per million (ppm); avocado, mango, and sapote, mamey at 0.05 ppm; and 
fruit, pome, group 11-10 at 0.15 ppm. The petition additionally 
requested to amend the tolerances in 40 CFR 180.155 by removing the 
tolerance for fruit, pome, group 11 at 0.15 ppm, as it will be 
superseded by the tolerance on fruit, pome, group 11-10 at 0.15 ppm. 
That document referenced a summary of the petition prepared on behalf 
of IR-4 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.
    Based upon review of the data supporting the petition, EPA has 
revised the proposed tolerance on rambutan from 3.0 ppm to 2.0 ppm. The 
Agency has also revised the tolerance expression for all established 
commodities to be consistent with current Agency policy. The reason for 
these changes is explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in that section, 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 1-naphthaleneacetic acid, including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with 1-naphthaleneacetic 
acid follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    Based on structural activity relationship and metabolism data, all 
forms of 1-naphthaleneacetic acid, its salts, ester, and acetamide 
which are collectively referred to as naphthalene acetates (NAA), are 
expected to exhibit similar toxicological effects. In selecting 
endpoints of toxicity for risk assessment to exposures to the various 
NAA forms, the most conservative endpoint was selected from the studies 
that showed the lowest NOAELs for assessing a particular exposure. In 
addition, all forms degrade to the acid fairly quickly in the field and 
in biological systems.

[[Page 30215]]

Therefore, EPA has concluded that required toxicity testing on any form 
should serve for all members of this group of chemicals.
    Repeated oral exposures to NAA in rats and dogs resulted in 
decreased body weights, and body weight gains accompanied by decreased 
food consumption. The major target organs from subchronic and chronic 
oral exposures were the liver, stomach, and lung. Repeated oral 
exposures also resulted in decreased hematocrit and hemoglobin, along 
with reduced red blood cell count in rats and dogs and hypocellularity 
of the bone marrow in dogs.
    There was no developmental toxicity at the highest dose of NAA (the 
acid) tested in the rat or in the rabbit (orally gavaged), but 
developmental toxicity (decreased fetal weight and minor skeletal 
changes) were seen in rats orally gavaged with the sodium salt. 
Reproductive effects of NAA sodium salts were limited to reduced litter 
survival and pup weight throughout lactation in both generations of 
offspring in a 2-generation reproduction study.
    NAA and its acetamide and the ethyl ester were tested for mutagenic 
effects in a gene mutation bacterial assay, mouse lymphoma assay, and 
mouse erythrocyte micronucleus assay, mouse lymphoma assay, and mouse 
erythrocyte micronucleus assay and were not found to be mutagenic. 
Additionally, NAA was tested for mitotic gene conversion and dominant 
lethality in rats and found to be negative. In a published 
carcinogenicity study of NAA acetamide in mice and a guideline chronic/
oncogenicity study of NAA sodium salt in rats and mice, NAA 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 Acetates Human Health 
Risk Assessment for a Proposed Use on Avocado, Mango, Mamey Sapote, 
Rambutan, and Updating Crop Group Fruit, Pome, Group 11-10.'' at pages 
42-50 in docket ID number EPA-HQ-OPP-2012-0203.

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 (LOC) to use in evaluating the risk posed by human exposure to 
the pesticide. For hazards that have a threshold below which there is 
no appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors (U/SF) are used in conjunction 
with the POD to calculate a safe exposure level--generally referred to 
as a population-adjusted dose (PAD) or a reference dose (RfD)--and a 
safe margin of exposure (MOE). For non-threshold risks, the Agency 
assumes that any amount of exposure will lead to some degree of risk. 
Thus, the Agency estimates risk in terms of the probability of an 
occurrence of the adverse effect expected in a lifetime. For more 
information on the general principles EPA uses in risk characterization 
and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for 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 and
          Exposure/scenario               uncertainty/safety     RfD, PAD, LOC for risk  Study and toxicological
                                               factors                 assessment                effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population       An acute RfD for the general population or any population subgroups was
 including infants and children and       not selected because no effect attributable to a single exposure was
 females 13-49 years of age)                                   observed in animal studies.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)....  NOAEL = 15 mg/kg/day...  Chronic RfD = 0.15 mg/   Chronic Toxicity--Dog
                                       UFA = 10x..............   kg/day.                  LOAEL = 75 mg/kg/day
                                       UFH = 10x..............  cPAD = 0.15 mg/kg/day..   based on stomach
                                       FQPA SF = 1x...........                            lesions in 75% of the
                                                                                          males and by slight
                                                                                          sinusoidal
                                                                                          histiocytosis in the
                                                                                          liver of 50% of the
                                                                                          males.
Dermal short-term (1 to 30 days).....  Dermal study...........  LOC for MOE = 100......  21-Day dermal: NAA Na
                                       NOAEL = 300 mg/kg/day..                            salt LOAEL = 1,000 mg/
                                       UFA = 10x..............                            kg/day based on
                                       UFH = 10x..............                            reduced body weight
                                       FQPA SF = 1x...........                            gain and food
                                                                                          efficiency.
Inhalation short-term (1 to 30 days).  Oral study.............  LOC for MOE = 1,000....  Developmental Rat: NAA
                                       NOAEL = 50 mg/kg/day...                            LOAEL = 150 mg/kg/day
                                       UFA = 10x..............                            based on decreased
                                       UFH = 10x..............                            body weight gain
                                       FQPA SF = 10x..........                            during gestation
                                                                                          period.
��������������������������������������
Cancer (Oral, dermal, inhalation)....                   Not likely to be carcinogenic to humans.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligrams/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).


[[Page 30216]]

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to NAA, EPA considered exposure under the petitioned-for 
tolerances as well as all existing NAA tolerances in 40 CFR 180.155. 
EPA assessed dietary exposures from 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 Dietary Exposure Evaluation Model software with the 
Food Commodity Intake Database (DEEM-FCID) Version 3.16, which uses 
food consumption data from the U.S. Department of Agriculture's 
National Health and Nutrition Examination Survey, What We Eat in 
America, (NHANES/WWEIA), conducted from 2003-2008. As to residue levels 
in food, EPA assumed 100 percent crop treated (PCT) and tolerance-level 
residues for all commodities. In addition, DEEM version 7.81 default 
processing factors were used, when appropriate.
    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 PCT information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for NAA. Tolerance level residues and/or 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://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST) and 
Concentration in Ground Water (SCI-GROW) models, the estimated drinking 
water concentrations (EDWCs) of NAA for chronic exposures for non-
cancer assessments are estimated to be 2.99 parts per billion (ppb) for 
surface water and 0.0226 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 of value 3.0 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 dermal and inhalation exposures to residential 
handlers, resulting from loading and applying NAA. There are no 
residential uses for NAA that result in exposure to children via 
incidental oral activities. 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 postapplication exposure to NAA for adults or children 
based on the residential use pattern; therefore, residential 
postapplication exposure is not expected, nor is intermediate- or long-
term exposure scenarios 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://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    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://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA 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 NAA group of chemicals. The available data provided no 
indication of increased quantitative or qualitative susceptibility of 
rats or rabbits to in utero exposure to NAA or to prenatal and 
postnatal exposure in rat reproduction studies. In the developmental 
toxicity study conducted with NAA sodium salt in rats, fetal toxicity 
(mainly decreased fetal weights and minor skeletal changes) was 
observed at a dose lower than the maternally toxic dose.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF was reduced to 1X for the oral and dermal routes of exposure 
and retained at 10X for the inhalation route of exposure. That decision 
is based on the following findings:
    i. The toxicity database for NAA is not complete. EPA concluded 
that a 28-day inhalation toxicity study is required for NAA, based on a 
weight-of-evidence approach. A 10X SF was retained for the inhalation 
route of exposure due to the lack of the required 28-day inhalation 
study and given that the endpoint for subchronic inhalation is based on 
a developmental study (NOAEL = 50 mg/kg/day) that noted decreased body 
weight gains during gestation.
    Additionally, recent changes to 40 CFR part 158 imposed new data 
requirements for immunotoxicity testing

[[Page 30217]]

(OCSPP Guideline 870.7800) for pesticide registration. While an 
immunotoxicity study is not available for NAA, the toxicology database 
does not show any evidence of treatment-related effects on the immune 
system and the overall weight-of-evidence suggests that this chemical 
does not directly target the immune system. Consequently, the Agency 
does not believe that conducting a functional immunotoxicity study will 
result in a lower POD than that currently used for overall risk 
assessment, and therefore, an additional safety factor is not needed to 
account for lack of this study.
    Acute and subchronic neurotoxicity studies are also required as a 
part of new data requirements in 40 CFR part 158; however, EPA has 
waived the requirement for these studies at the present time. This 
decision is based on: (1) The lack of neurotoxicity and neuropathology 
in the available toxicology studies for NAA; and (2) liver, stomach, 
and lung were identified as the target organs, with dogs being the most 
sensitive species. Therefore, neurotoxicity studies conducted in rats 
would not provide a more sensitive endpoint for risk assessment, and 
studies would be unlikely to yield PODs lower than the current PODs 
used for overall risk assessment.
    ii. There is no indication that NAA is a neurotoxic chemical and 
there is no need for a developmental neurotoxicity study or additional 
UFs to account for neurotoxicity.
    iii. There is no evidence that NAA results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study. In the developmental toxicity study conducted with NAA sodium 
salt in rats, fetal toxicity was observed at a dose lower than the 
maternally toxic dose. However, there were clear NOAELs in this 
developmental study and the PODs used in the chronic dietary assessment 
(15 mg/kg/day) are protective of the fetal effects observed in the 
study.
    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 water 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 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 2.0% of the cPAD for children 1-2 
years old, the population group receiving the greatest exposure. Based 
on the explanation in Unit III.C.3., regarding residential use 
patterns, chronic residential exposure to residues of 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). Though there 
is potential for short-term dermal and inhalation exposures to adult 
handlers resulting from residential applications of NAA to ornamentals, 
aggregate risk was not estimated for NAA because the toxicity endpoints 
selected for the chronic dietary route of exposure and those selected 
for inhalation and dermal routes of exposure are not based on common 
effects i.e., the chronic dietary endpoint is based on systemic effects 
and the dermal and inhalation endpoints are based on decreased body 
weight gain. Exposure pathways and routes are only aggregated when they 
share a common toxic effect.
    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

    An adequate enforcement method, 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.
    The Codex has not established a MRL for NAA.

C. Revisions to Petitioned-For Tolerances

    Based on the data supporting the petition, EPA revised the proposed 
tolerance on rambutan from 3.0 ppm to

[[Page 30218]]

2.0 ppm. The Agency revised this tolerance level based on analysis of 
the residue field trial data using the Organization for Economic 
Cooperation and Development (OECD) tolerance calculation procedures.
    Finally, the Agency has revised the tolerance expression to 
clarify: (1) That, as provided in FFDCA section 408(a)(3), the 
tolerance covers metabolites and degradates of NAA not specifically 
mentioned; and (2) that compliance with the specified tolerance levels 
is to be determined by measuring only the specific compounds mentioned 
in the tolerance expression.

 V. Conclusion

    Therefore, tolerances are established for residues of NAA, 1-
naphthaleneacetic acid, in or on avocado at 0.05 ppm; fruit, pome, 
group 11-10 at 0.15 ppm; sapote, mamey at 0.05 ppm; mango at 0.05 ppm; 
and rambutan at 2.0 ppm. This regulation additionally removes the 
tolerance in or on fruit, pome, group 11 at 0.15 ppm and the time-
limited tolerance in or on avocado at 0.05 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this final rule has 
been exempted from review under Executive Order 12866, this final rule 
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 final rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This final rule 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 final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (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 of 1995 (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: May 14, 2013.
Daniel J. Rosenblatt,
Acting 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. Section 180.155 is revised to read as follows:


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

    (a) General. Tolerances are established for the residues of 1-
naphthaleneacetic acid, including its metabolites and degradates in or 
on the commodities in the following table. Compliance with the 
tolerance levels specified is to be determined by measuring only 1-
naphthaleneacetic acid and its conjugates, calculated as the 
Stoichiometric equivalent of 1-naphthaleneacetic acid, in or on the 
commodity.

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Avocado..................................................           0.05
Cherry, sweet............................................           0.1
Fruit, pome, group 11-10.................................           0.15
Mango....................................................           0.05
Olive....................................................           0.7
Orange...................................................           0.1
Pineapple\1\.............................................           0.05
Potato...................................................           0.01
Rambutan.................................................           2.0
Sapote, mamey............................................           0.05
Tangerine................................................           0.1
------------------------------------------------------------------------
\1\ There are no U.S. registrations since 1988.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 2013-12207 Filed 5-21-13; 8:45 am]
BILLING CODE 6560-50-P