
[Federal Register Volume 77, Number 89 (Tuesday, May 8, 2012)]
[Rules and Regulations]
[Pages 26954-26959]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-11117]



[[Page 26954]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2004-0144; FRL-9346-9]
RIN 2070-ZA16


1-Naphthaleneacetic acid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 1-
naphthaleneacetic acid, potassium and sodium salts in or on potatoes. 
Stehekin, LLC petitioned EPA for clearance of use of this pesticide 
under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 8, 2012. Objections and 
requests for hearings must be received on or before July 9, 2012, 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: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2004-0144. All documents in the 
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Rose Mary Kearns, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number: (703)-305-5611; email address: 
kearns.rosemary@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. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

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://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the 
harmonized test guidelines referenced in this document electronically, 
please go to http://www.epa.gov/ocspp and select ``Test Methods and 
Guidelines.''

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-2004-0144 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 9, 2012. 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 that does not contain any 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 a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2004-0144, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave. 
NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Summary of Petitioned-for Tolerance

    In the Federal Register of September 8, 2010 (75 FR 54629) (FRL-
8843-3), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a (d)(3), announcing the filing of a pesticide petition (PP 
0F7687) by Stehekin, LLC, 1012 Good Lander Drive, Selah, Washington 
98942. The petition requested that a tolerance exemption be established 
for residues of the fungicide 1-naphthaleneacetic acid (1-
naphthaleneacetamide), on potatoes. That notice referenced a summary of 
the petition prepared by Stehekin, LLC, 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 a revised petition which requested a tolerance and 
review of the data supporting the petition, EPA has determined that it 
is appropriate to establish a tolerance in association with the use of 
1-naphthaleneacetic acid (1-naphthaleneacetamide) on potatoes.

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.''

[[Page 26955]]

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 section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, 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-naphthalneactic acid, 
its salts, ester, and acetamide which are collectively referred to as 
naphthalene acetates (NAA) including exposure resulting from the 
tolerances established by this action. EPA's assessment of exposures 
and risks associated with NAA 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 are 
expected to exhibit similar toxicological effects. Therefore the Agency 
concluded that required toxicity testing on any form should serve for 
all members of this group of chemicals.
    Naphthalene acetates have low acute toxicity via the oral, 
inhalation and dermal routes of exposure. 1-Naphthaleneacetic acid is 
not a skin irritant or a dermal sensitizer. The 1-naphthaleneacetic 
acid and its sodium salt were found to be irritating to the eye. 
Repeated exposure oral toxicity studies in rats and dogs resulted in 
decreased body weights and body weight gains accompanied by decreased 
food consumption.
    The major target organs of subchronic and chronic oral exposure 
were the liver, stomach and lung. Repeated oral exposure also resulted 
in decreased hematocrit and hemoglobin along with reduced RBC count in 
rats and dogs and hypocellularity of the bone marrow in dogs.
    There was no developmental toxicity at the highest dose of 1-
naphthaleneacetic acid tested in the rat or in the rabbit, but 
developmental toxicity (decreased fetal weight and minor skeletal 
changes) were seen in rats orally gavaged with the sodium salt.
    Reproductive effects of naphthaleneacetic acid sodium salt were 
limited to reduced litter survival and pup weight throughout lactation 
in both generations of offspring in a 2-generation reproduction study.
    Naphthaleneacetic acid and it's 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 
mutagenic. Additionally 1-naphthaleneacetic acid was tested for mitotic 
gene conversion and dominant lethality in rats and found to be 
negative.
    Carcinogenicity studies of NAA in mice and in rats for the 1-
naphthaleneacetic acid group showed no evidence of carcinogenicity. 
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 the document ``Naphthalene Acetates HED Risk 
Assessment for Section 3 Proposed New Use on Potato Seed Pieces'' at 
pages 10 through 14 in docket ID number EPA-HQ-OPP-2004-0144.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for 1-naphthaleneaetic 
acid used for human risk assessment is shown in Table 1 of this unit.

 Table 1--Summary of Toxicological Doses and Endpoints for 1-Naphthaleneacetic Acid 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 subgroups was not selected because no
 including infants and children).   effect attributable to a single (or few) day(s) oral exposure was observed
                                    in animal studies.
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[[Page 26956]]

 
Chronic dietary (All populations)  NOAEL = 15 mg/kg/day  Chronic RfD = 0.15   Chronic Toxicity--Dog.
                                   UFA = 10x...........   mg/kg/day.          LOAEL = 75 mg/kg/day based on
                                   UFH = 10x...........  cPAD = 0.15 mg/kg/    stomach lesions in 75% of the
                                                          day.                 males and by slight sinusoidal
                                                                               histocytosis in the liver of 50%
                                                                               of the males.
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Dermal short-term (1 to 30 days).  Dermal (or oral)      LOC for MOE = 100..  Dermal Toxicity Study-Rat.
                                    study NOAEL = 300                         LOAEL = 1000 mg/kg/day based on
                                    mg/kg/day.                                 reduced body weight gain and food
                                   UFA = 10x...........                        efficiency.
                                   UFH = 10x...........
----------------------------------------------------------------------------------------------------------------
Dermal intermediate-term (1 to 6   Dermal (or oral)      LOC for MOE = 100..  Dermal Toxicity Study--Rat.
 months).                           study NOAEL = 300                         LOAEL = 1000 mg/kg/day based on
                                    mg/kg/day.                                 reduced body weight gain and food
                                   UFA = 10x...........                        efficiency.
                                   UFH = 10x...........
----------------------------------------------------------------------------------------------------------------
Inhalation short-term (1 to 30     Inhalation (or oral)  LOC for MOE = 100..  Developmental Toxicity Study--Rat.
 days).                             study NOAEL= 50 mg/                       LOAEL = 250 mg/kg/day based on
                                    kg/day (inhalation                         decreased body weight gain during
                                    absorption rate =                          the gestation period.
                                    100%).
                                   UFA = 10x...........
                                   UFH = 10x...........
----------------------------------------------------------------------------------------------------------------
Inhalation (1 to 6 months).......  Inhalation (or oral)  LOC for MOE = 100..  Subchronic Study--Dog.
                                    study NOAEL = 25 mg/                      LOAEL = for systemic toxicity =
                                    kg/day (inhalation                         150 mg/kg/day based on lesions of
                                    absorption rate =                          the GI tract and hypocellularity
                                    100%).                                     of the bone marrow.
                                   UFA = 10x...........
                                   UFH = 10x...........
----------------------------------------------------------------------------------------------------------------
Cancer (all routes)..............                        A ``not likely'' human carcinogen.
----------------------------------------------------------------------------------------------------------------
LOAEL = lowest observed adverse effect level. LOC = level of concern. MOE = margin of exposure. N/A = not
  applicable. NOAEL = no observed adverse effect level. PAD = population adjusted dose (a = acute, c = chronic).
  POD = Point of Departure = A data 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. 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).

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 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 the food consumption data from the USDA 1994-1996 
and 1998 CSFII. As to residue levels in food, EPA assumed tolerance 
level residues for all registered uses, 100% crop treated for all 
commodities with existing tolerances, and default processing factors.
    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 1-naphthaleneacetic. Tolerance level residues 
and/or 100% CT 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 1-naphthaleneacetic acid. 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 
Screening Concentration in Ground Water (SCI-GROW) models, estimated 
drinking water concentrations (EDWCs) of naphthaleneacetic acetates for 
peak and average concentrations of naphthalene acetates in surface 
water are 0.02 ppm and 0.003 ppm respectively. The modeled peak and 
average EDWCs for ground water is 0.00002 ppm.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model.
    For chronic dietary risk assessment, the water concentration of 
value .003

[[Page 26957]]

ppm 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). There is a potential 
for short-term residential exposure to NAA from ornamental uses.
    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 naphthalene acetates 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 Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. There is low concern (and no 
residual uncertainty) for prenatal and/or postnasal toxicity resulting 
from exposure to the NAA group of chemicals. The available data 
provided no indication of increased susceptibility (quantitative or 
qualitative) to rats or rabbits to in utero exposure to naphthalene 
acetates or to prenatal and postnatal exposure in rat reproduction 
studies.
    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. That decision is based on the following 
findings:
    i. Acceptable developmental toxicity studies in the rat and rabbit, 
and an acceptable reproduction study in the rat are available. Recent 
changes to 40 CFR part 158 require acute and subchronic neurotoxicity 
and immunotoxicity studies. An immunotoxicity study is not available. 
However, the toxicology data base for NAA 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. The toxicity database does not show any indications of 
neurotoxicity or neuropathology (the liver, stomach, lung, and 
hematological parameters are the target organs based on repeat toxicity 
studies in rats, mice and dogs).
    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.
    iv. There are no residual uncertainties identified in the exposure 
databases. EPA made conservative (protective) assumptions in dietary 
assessment and in the ground and surface water modeling used to assess 
exposure to NAA in drinking water. EPA made conservative (protective) 
assumptions in the residential handler assessment. Post-application 
exposure to residents is not expected.

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% of the cPAD for children 1-2 
years old, the population group receiving the greatest exposure.
    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).
    There is potential for short-term residential exposure to NAA from 
ornamental uses. Oral, dermal and inhalation exposures cannot be 
combined for short-term aggregate risk assessment, however, because 
oral exposure endpoints are not based on common toxicological effects 
with either dermal or inhalation endpoints. Estimated dermal and 
inhalation MOEs for residential exposure to naphthalene acetates are 
3,800 and 58,000 respectively. These estimated exposures are greater 
than the target MOE of 100 and therefore not of concern. Although a POD 
from an oral study was used to assess residential handler inhalation 
risks for NAA, the Agency does not believe this assessment is under-
protective of adult handlers. Inhalation MOEs calculated for 
residential handlers were all >58,000, thus providing an ample margin 
of safety to account for any uncertainties in route-to-route 
extrapolation.
    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).
    Intermediate-term exposure to NAA is not expected based on 
residential use patterns. Therefore, 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,

[[Page 26958]]

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 methodology (HPLC methods (Method NAA-AM 
001 and Method NAA-AM-002) for determination of NAA in plant 
commodities have been submitted and reviewed. These methods have been 
subjected to successful independent laboratory validations. Acceptable 
recoveries were obtained from apples, olives and olive oil fortified 
with NAA at the method limit of quantitation (LOQ; 0.01 ppm) and at 1.0 
ppm.
    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 U.N. 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.
    No Codex, Canadian, or Mexican maximum residue limits (MRLs) have 
been established for residues of naphthalene acetates. Therefore, there 
are no trade issues with this action.

C. Revisions to Petitioned-for Tolerances

    The applicant's petition requested an exemption from the 
requirement of a tolerance for this seed potato application but upon 
review of submitted information, the Agency determined that a potato 
tolerance is needed. In lieu of providing field trial data, a 
theoretical calculation was provided, to show that residues of 1-
naphthaleneacetic acid on potatoes will be less than the analytical 
method's level of quantitation (0.01 ppm) when using the label 
application rates on potato seed pieces. The Agency determined that a 
tolerance at the level of quantitation is appropriate and that an 
exemption is not appropriate because some residues below the level of 
quantitation may be present and there is toxicological concern for NAA.

V. Conclusion

    Therefore, tolerances are established for residues of 1-
naphthaleneacetic acid and its conjugates calculated as 1-
naphthaleneacetic acid from the application of 1-naphthaleneacetic 
acid, its ammonium, sodium, or potassium salts, ethyl ester, and 
acetamide in or on food commodities as follows: in or on potato at 0.01 
ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA 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 section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. 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) (Pub. L. 104-4).
    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), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. 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 this final rule in the Federal 
Register. This final rule 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: April 27, 2012.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

[[Page 26959]]

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 amended by alphabetically adding the following 
commodity to the table in paragraph (a) to read as follows:


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

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Potato......................................................        0.01
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2012-11117 Filed 5-7-12; 8:45 am]
BILLING CODE 6560-50-P


