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[Federal Register Volume 74, Number 154 (Wednesday, August 12, 2009)]
[Rules and Regulations]
[Pages 40513-40518]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-19200]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0373; FRL-8428-3]

1-Naphthaleneacetic Acid Ethyl Ester; Pesticide Tolerance for 
Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for 
residues of 1-naphthaleneacetic acid ethyl ester in or on avocados. 
This action is in response to EPA's granting of an emergency exemption 
under section 18 of the Federal Insecticide, Fungicide, and Rodenticide 
Act (FIFRA) authorizing use of the pesticide on avocado trees. This 
regulation establishes a maximum permissible level for residues of 1-
naphthaleneacetic acid ethyl ester in this food commodity. The time-
limited tolerance expires and is revoked on December 31, 2012.

DATES: This regulation is effective August 12, 2009. Objections and 
requests for hearings must be received on or before October 13, 2009, 
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-2009-0373. All documents in the 
docket are listed in the docket index available in 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: Andrew Ertman, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9367; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     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 provides 
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

[[Page 40514]]

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 Access Electronic Copies of this Document?

    In addition to accessing electronically available documents at 
http://www.regulations.gov, you may access this Federal Register 
document electronically through the EPA Internet under the ``Federal 
Register'' listings at http://www.epa.gov/fedrgstr. You may also access 
a frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's e-CFR cite at http://www.gpoaccess.gov/ecfr

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 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. 
The EPA procedural regulations which govern the submission of 
objections and requests for hearings appear in 40 CFR part 178. 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-
2009-0373 in the subject line on the first page of your submission. All 
requests must be in writing, and must be mailed or delivered to the 
Hearing Clerk on or before October 13, 2009.
    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 that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
number EPA-HQ-OPP-2009-0373, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line 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. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408(e) and 
408(l)(6) of FFDCA, 21 U.S.C. 346a(e) and 346a(1)(6), is establishing a 
time-limited tolerance for residues of the plant growth regulator 1-
naphthaleneacetic acid ethyl ester in or on avocados at 0.05 parts per 
million (ppm). This time-limited tolerance expires and is revoked on 
December 31, 2012. EPA will publish a document in the Federal Register 
to remove the revoked tolerances from the CFR.
    Section 408(l)(6) of FFDCA requires EPA to establish a time-limited 
tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
section 18 related time-limited tolerances to set binding precedents 
for the application of section 408 of FFDCA and the new safety standard 
to other tolerances and exemptions. Section 408(e) of FFDCA allows EPA 
to establish a tolerance or an exemption from the requirement of a 
tolerance on its own initiative, i.e., without having received any 
petition from an outside party.
    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. . . 
.''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' EPA has established 
regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for 1-Naphthaleneacetic Acid Ethyl Ester on 
Avocados and FFDCA Tolerances

    Avocado growers in Southern California are dealing with emergency 
conditions in their orchards caused by unique environmental factors 
including a hard freeze, strong Santa Ana winds, drought, and fires 
that burned through orchards damaging or killing trees. Trees adversely 
affected by these conditions need to be ``stumped'' to be brought back 
into production. The processing of ``stumping'' entails cutting the 
primary scaffolding limbs of the tree back to stumps and painting them 
with white latex paint to protect them from sunburn and disease. The 
treatment of the pruned branches and cut stumps with naphthalene acetic 
acid ethyl ester slows the re-growth of vegetative sprouts by about 
70%. This growth inhibition results in several lateral sprouts instead 
of literally hundreds of sprouts growing at and below the pruning cuts. 
This shortens the pruning time per tree or stump and the management of 
the re-growth can be accomplished with only one pruning per season. 
After having reviewed the submission, EPA determined that emergency 
conditions exist for this State, and that the criteria for an emergency 
exemption are met. EPA has authorized under FIFRA section 18 the use of 
1-naphthaleneacetic acid ethyl ester on avocado trees limbs that have 
been pruned or cut back to a stump for control of excess sprout growth 
in California. As part of its evaluation of the emergency exemption 
application, EPA assessed the potential risks presented by residues of 
1-naphthaleneacetic acid ethyl ester in or on avocados. In doing so, 
EPA considered the safety standard in section 408(b)(2) of FFDCA, and 
EPA decided that the necessary tolerance under section 408(l)(6) of 
FFDCA would be consistent with the safety standard and with FIFRA 
section 18. Consistent with the need to move quickly on the emergency 
exemption in order to address an urgent non-routine situation

[[Page 40515]]

and to ensure that the resulting food is safe and lawful, EPA is 
issuing this tolerance without notice and opportunity for public 
comment as provided in section 408(l)(6) of FFDCA. Although this time-
limited tolerance expires and is revoked on December 31, 2012, under 
section 408(l)(5) of FFDCA, residues of the pesticide not in excess of 
the amounts specified in the tolerance remaining in or on avocados 
after that date will not be unlawful, provided the pesticide was 
applied in a manner that was lawful under FIFRA, and the residues do 
not exceed a level that was authorized by this time-limited tolerance 
at the time of that application. EPA will take action to revoke this 
time-limited tolerance earlier if any experience with, scientific data 
on, or other relevant information on this pesticide indicate that the 
residues are not safe.
    Because this time-limited tolerance is being approved under 
emergency conditions, EPA has not made any decisions about whether 1-
naphthaleneacetic acid ethyl ester meets FIFRA's registration 
requirements for use on avocados or whether a permanent tolerance for 
this use would be appropriate. Under these circumstances, EPA does not 
believe that this time-limited tolerance decision serves as a basis for 
registration of 1-naphthaleneacetic acid ethyl ester by a State for 
special local needs under FIFRA section 24(c). Nor does this tolerance 
serve as the basis for persons in any State other than California to 
use this pesticide on this crop under FIFRA section 18 absent the 
issuance of an emergency exemption applicable within that State. For 
additional information regarding the emergency exemption for 1-
naphthaleneacetic acid ethyl ester, contact the Agency's Registration 
Division at the address provided under FOR FURTHER INFORMATION CONTACT.

IV. 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 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 expected as a result of this emergency exemption request and 
the time-limited tolerances for residues of 1-naphthalene acetic acid 
ethyl ester on avocado at 0.05 ppm. EPA's assessment of exposures and 
risks associated with establishing time-limited tolerances follows.

A. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as the highest dose at which no 
adverse effects are observed (the NOAEL) in the toxicology study 
identified as appropriate for use in risk assessment. However, if a 
NOAEL cannot be determined, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) or a benchmark dose (BMD) approach 
is sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the POD to take into account uncertainties 
inherent in the extrapolation from laboratory animal data to humans and 
in the variations in sensitivity among members of the human population 
as well as other unknowns. Safety is assessed for acute and chronic 
dietary risks by comparing aggregate food and water exposure to the 
pesticide to the acute population adjusted dose (aPAD) and chronic 
population adjusted dose (cPAD). The aPAD and cPAD are calculated by 
dividing the POD by all applicable UFs. Aggregate short-term, 
intermediate-term, and chronic-term risks are evaluated by comparing 
food, water, and residential exposure to the POD to ensure that the 
margin of exposure (MOE) called for by the product of all applicable 
UFs is not exceeded. This latter value is referred to as the level of 
concern (LOC).
    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 
greater than that 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-naphthaleneacetic 
acid ethyl ester used for human risk assessment can be found at http://www.regulations.gov in document Naphthalene Acetates HED Risk 
Assessment for Section 18 Use of Naphthalene Acetic Acid Ethyl Ester on 
Avocado Trees, page 11 in docket ID number EPA-HQ-OPP-2009-0373.

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to 1-naphthaleneacetic acid ethyl ester, EPA considered 
exposure under the time-limited tolerances established by this action 
as well as all existing naphthalene acetic acid tolerances in 40 CFR 
180.155(a), naphthalene acetic acid ethyl ester tolerances in 40 CFR 
180.155(b), and [alpha]-naphthaleneacetamide and its metabolite 
[alpha]-naphthalene acetic acid (calculated as [alpha]-naphthalene 
acetic acid) tolerances in 40 CFR 180.309. For commodities having 
tolerances for both naphthalene acetic acid and the acetamide of 
naphthalene acetic acid, the total amount of residues calculated as 
naphthalene acetic acid shall not exceed the higher of the two 
tolerances (40 CFR 180.3(d)(7)). Collectively, these chemicals are 
referred to as the naphthalene acetates. For the purpose of the human 
health risk assessment, all forms of the naphthalene acetates are 
combined (1-Naphthaleneacetic acid (NAA), its salts, ester, and 
acetamide) because they are structurally related and are metabolized to 
the acid form and eliminated from the body as glycine and glucuronic 
acid conjugates within 48 hours after exposure EPA assessed dietary 
exposures from the naphthalene acetates in food as follows:
    i. Acute exposure. In estimating acute dietary exposure, EPA used 
food consumption information from the United States Department of 
Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of 
Food Intake by Individuals (CSFII). As to residue levels in food, the 
acute dietary exposure/risk analyses for all supported naphthalene 
acetates food uses were conducted using conservative, Tier 1 exposure 
assessments. The Tier I analyses assume tolerance level residues for 
all registered uses, 100 PCT for all commodities with existing 
tolerances, and default processing factors.

[[Page 40516]]

    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, the chronic dietary 
exposure/risk analyses for all supported food uses for the naphthalene 
acetates were conducted using conservative, Tier 1 exposure 
assessments. The Tier I analyses assume tolerance level residues for 
all registered uses, 100 PCT for all commodities with existing 
tolerances, and default processing factors.
    iii. Cancer. Based on the results of carcinogenicity studies in 
rats and mice, EPA has classified the naphthalene acetates as ``not 
likely to be carcinogenic to humans'' therefore, a quantitative cancer 
exposure assessment is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for the naphthalene acetates. 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 the naphthalene acetates in drinking water. These 
simulation models take into account data on the physical, chemical, and 
fate/transport characteristics of the naphthalene acetates. 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, the 
estimated drinking water concentrations (EDWCs) of naphthalene acetates 
for acute exposures are estimated to be 12.9 parts per billion (ppb) 
for surface water and 0.0008 ppb for ground water and for chronic 
exposures for non-cancer assessments are estimated to be 0.71 ppb for 
surface water and 0.0008 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model for acute dietary risk 
assessment, the water concentration value of 12.9 ppb was used to 
assess the contribution to drinking water, and for chronic dietary risk 
assessment, the water concentration of value 0.71 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).
    Although there are residential uses for the naphthalene acetates, 
the uses are for ornamentals only (i.e., not turf) and post-application 
residential exposure is expected to be negligible. Therefore, a 
quantitative assessment is not required.
    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 the naphthalene acetates to share a common 
mechanism of toxicity with any other substances, and the naphthalene 
acetates do not appear to produce a toxic metabolite produced by other 
substances. For the purposes of this tolerance action, therefore, EPA 
has assumed that the naphthalene acetates do 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 
the policy statements released by EPA's Office of Pesticide Programs 
concerning common mechanism determinations and procedures for 
cumulating effects from substances found to have a common mechanism on 
EPA's website at http://www.epa.gov/pesticides/cumulative.

C. 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 SF 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-natal and postnatal toxicity resulting 
from exposure to the naphthalene acetates. The available data provided 
no indication of increased susceptibility (quantitative or qualitative) 
in rats or rabbits to in utero exposure to naphthalene acetates or to 
pre-natal and post-natal exposure in rat reproduction studies.
    3. Conclusion. Therefore, the FQPA safety factor is reduced to 1x 
for risk assessment for this chemical. A developmental neurotoxicity 
study is not required since there was no evidence of neurotoxicity or 
neuropathology from the available studies and there is no concern or 
residual uncertainty for pre-natal or post-natal toxicity.
    EPA has determined that reliable data show that 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. The toxicity database for the naphthalene acetates is complete.
    ii. There is no indication that the naphthalene acetates are 
neurotoxic chemicals and there is no need for a developmental 
neurotoxicity study or additional UFs to account for neurotoxicity.
    iii. There is no evidence that the naphthalene acetates result 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. The dietary food exposure assessments were 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 the naphthalene acetates in drinking water. EPA 
used similarly conservative assumptions to assess postapplication 
exposure of children as well as incidental oral exposure of toddlers. 
These assessments will not underestimate the exposure and risks posed 
by the naphthalene acetates.

D. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases given the 
estimated aggregate exposure. Short-tern, intermediate-term, and 
chronic-term risks are evaluated by comparing the estimated aggregate 
food, water, and

[[Page 40517]]

residential exposure to the POD to ensure that the MOE called for by 
the product of all applicable UFs is not exceeded.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to the naphthalene acetates will occupy 10% of the aPAD for children 1-
2 years old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
the naphthalene acetates from food and water will utilize 8% of the 
cPAD for children 1-2 years old, the population group receiving the 
greatest exposure.
    3. Short-term and intermediate-term risk. Short-term and 
intermediate-term aggregate exposure takes into account short-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Although the naphthalene acetates are registered for residential 
use, the uses are for ornamentals only (i.e., not turf) and post-
application residential exposure is expected to be negligible. 
Therefore, the short-term and intermediate-term aggregate risks consist 
of the sum of the risk from exposure to the naphthalene acetates 
through food and water and will not be greater than the chronic 
aggregate risk.
    4. Aggregate cancer risk for U.S. population. EPA has classified 
the naphthalene acetates as ``not likely to be carcinogenic to 
humans.'' The naphthalene acetates are not expected to pose a cancer 
risk
    5. 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 naphthalene acetic acid residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    An adequate enforcement methodology is available to enforce the 
tolerance expression of [alpha]-naphthalene acetic acid and 1-
naphthaleneacetamide in or on 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; e-mail address: [email protected].

B. International Residue Limits

    There are no CODEX MRLs for residues of 1-naphthaleneacetic acid 
ethyl ester on avocados.

VI. Conclusion

    Therefore, a time-limited tolerance is established for residues of 
1-naphthaleneacetic acid ethyl ester in or on avocado at 0.05 ppm. This 
tolerance expires and is revoked on December 31, 2012.

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under sections 408(e) and 
408(l)(6) 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 in accordance 
with sections 408(e) and 408(l)(6) of FFDCA, such as the tolerances 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) (Public Law 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).

VIII. 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: July 31, 2009.
Lois Rossi,
Director, Registration Division,Office of Pesticide Programs.

0
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 amended by redesignating paragraphs (a) and (b) 
as paragraphs (a)(1) and (a)(2) and adding a heading to paragraph (a); 
by adding a new paragraph (b); and by adding and reserving paragraphs 
(c) and (d)to read as follows:

[[Page 40518]]

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

    (a) General. (1) * * *
     (2) * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances 
specified in the following table are established for residues of the 
ethyl ester of 1-naphthaleneacetic acid in or on the following raw 
agricultural commodities resulting from use of the pesticide pursuant 
to FIFRA section 18 emergency exemptions. The tolerances expire and are 
revoked on the date specified in the following table.

----------------------------------------------------------------------------------------------------------------
             Commodity               Parts per million                 Expiration/revocation date
----------------------------------------------------------------------------------------------------------------
avocado                                           0.05                                         December 31, 2012
----------------------------------------------------------------------------------------------------------------

    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]
* * * * *
[FR Doc. E9-19200 Filed 8-11-09; 8:45 am]
BILLING CODE 6560-50-S
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