[Federal Register Volume 73, Number 64 (Wednesday, April 2, 2008)]
[Rules and Regulations]
[Pages 17906-17910]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-6699]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0678; FRL-8356-6]


Acequinocyl; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues 
of acequinocyl and its metabolite, 2-dodecyl-3-hydroxy-1, 4-
naphthoquinone (acequinocyl-OH) expressed as acequinocyl equivalents in 
or on nut, tree, group 14 and grape and removes the separate tolerances 
established for almond. Arysta LifeScience North America Corporation 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective April 2, 2008. Objections and 
requests for hearings must be received on or before June 2, 2008, 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-2006-0678. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 
Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov website to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in 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: Marilyn Mautz, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-6785; 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 those 
engaged in the following activities:
     Crop production (NAICS code 111), e.g., agricultural 
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers 
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g., 
agricultural workers; commercial applicators; farmers; greenhouse, 
nursery, and floriculture workers; residential users.
    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 Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket 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 EPA's tolerance regulations at 
40 CFR part 180 through the Government Printing Office's pilot e-CFR 
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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-2006-0678 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 as required by 40 CFR part 178 on or 
before June 2, 2008.
    In addition to filing an objection or hearing request with the 
Hearing Clerk

[[Page 17907]]

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 this copy, identified by docket ID number EPA-HQ-OPP-2006-0678, 
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'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. Petition for Tolerance

    In the Federal Register of August 11, 2006 (71 FR 46223) (FRL-8085-
8), 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 
6F7040) by Arysta LifeScience North America Corporation, 15401 Weston 
Pkwy., Suite 150, Cary, NC 27513. The petition requested that 40 CFR 
180.599 be amended by establishing a tolerance for combined residues of 
the insecticide acequinocyl and its metabolite 2-dodecyl-3-hydroxy-1,4-
naphthoquinone (acequinocyl-OH) expressed as acequinocyl equivalents in 
or on tree nuts (crop group 14) at 0.02 parts per million (ppm). That 
notice referenced a summary of the petition prepared by Arysta 
LifeScience North America Corporation, the registrant, which is 
available to the public in the docket, http://www.regulations.gov. A 
comment was received on the notice of filing. EPA's response to the 
comment is discussed in Unit IV.C. below. In the Federal Register of 
January 23, 2008 (73 FR 3964) (FRL-8345-7), 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 7F7176) by Arysta 
LifeScience North America Corporation. The petition requested that 40 
CFR 180.599 be amended by establishing a tolerance for acequinocyl and 
its metabolite acequinocyl-OH expressed as acequinocyl equivalents in 
or on grapes at 7.0 parts per million (ppm), grape juice at 0.05 ppm 
and raisins at 0.1 ppm. The proposed grape tolerance of 7.0 ppm was 
subsequently amended by the petitioner to 1.0 ppm.
    Based upon review of the data supporting the petition, EPA has 
revised the tolerances proposed for grape, grape juice and raisin; and 
changed the commodity definition for tree nuts (crop group 14). The 
appropriate tolerance for grape was calculated to be 1.6 ppm. The grape 
processing data provided for grape juice and raisins showed the 
combined residues of acequinocyl and acequinocyl-OH did not concentrate 
in either of these commodities and, thus separate tolerances are not 
required for grape juice or raisins. The recommended tolerance level 
for grape was determined considering Agency guidance (Guidance for 
Setting Pesticide Tolerances Based on Field Trial Data). The commodity 
definition for tree nuts (crop group 14) has been changed to nut, tree, 
group 14.

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. . . 
.'' These provisions were added to FFDCA by the Food Quality Protection 
Act (FQPA) of 1996.
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for the petitioned-for tolerance 
for combined residues of acequinocyl and its metabolite acequinocyl-OH 
expressed as aceqinocyl equivalents on nut, tree, group 14 and grape at 
0.02 ppm and 1.6 ppm, respectively. EPA's assessment of exposures and 
risks associated with establishing the tolerance 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. Specific information on the studies received and the nature 
of the adverse effects caused by acequinocyl as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies are discussed in the 
acequinocyl final rule published in the Federal Register of July 21, 
2004 (69 FR 43525) (FRL-7364-1).

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the toxicological level of concern (LOC) is derived 
from the highest dose at which the NOAEL are observed in the toxicology 
study identified as appropriate for use in risk assessment. However, if 
a NOAEL cannot be determined, the lowest dose at which the LOAEL of 
concern are identified is sometimes used for risk assessment. 
Uncertainty/safety factors (UFs) are used in conjunction with the level 
of concern (LOC) 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 risks by 
comparing aggregate exposure to the pesticide to the acute population 
adjusted (aPAD) dose and chronic population adjusted dose (cPAD). The 
aPAD and cPAD are calculated by dividing the LOC by all applicable UFs. 
Short-term, intermediate-term, and long-term risks are evaluated by 
comparing aggregate exposure to the LOC to ensure that the margin of 
exposure (MOE) called for by the product of all applicable UFs is not 
exceeded.
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk and estimates risk in terms 
of the probability of occurrence of additional adverse cases. 
Generally, cancer risks are

[[Page 17908]]

considered non-threshold. 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/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
    A summary of the toxicological endpoints for acequinocyl used for 
human risk assessment can be found at http://www.regulations.gov in the 
document ``Human Health Risk Assessment for Use of Acequinocyl on 
Grapes, the Tree Nut Crop Group, and Residential Sites (Ornamentals)'' 
on pages 13 and 14 in docket ID number EPA-HQ-OPP-2006-0678-0006.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to acequinocyl, EPA considered exposure under the petitioned-
for tolerances as well as all existing acequinocyl tolerances in 40 CFR 
180.599. EPA assessed dietary exposures from acequinocyl 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 
acequinocyl; 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 United States 
Department of Agriculture (USDA) 1994-1996 and 1998; CSFII. As to 
residue levels in food, EPA assumed all foods for which there are 
tolerances were treated and contain tolerance-level residues. 
Anticipated residues were not used.
    iii. Cancer. The Agency classified acequinocyl as a ``not likely 
carcinogen''. Therefore, an exposure assessment for the purpose of 
estimating cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. The Agency did not use 
anticipated residue estimates or PCT information in the acequinocyl 
dietary exposure assessment.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring data to complete a comprehensive dietary exposure 
analysis and risk assessment for acequinocyl in drinking water. Because 
the Agency does not have comprehensive monitoring data, drinking water 
concentration estimates are made by reliance on simulation or modeling 
taking into account data on the environmental fate characteristics of 
acequinocyl. 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 Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) with the index reservoir scenarios model, the 
estimated drinking water concentrations (EDWCs) of acequinocyl only and 
of the combined residues of acequinocyl and its metabolite 
(acequinocyl-OH) for chronic exposures are estimated to be 2.73 and 
0.37 parts per billion (ppb), respectively for surface water. Based on 
the Screening Concentration in Ground Water (SCI-GROW) model, for 
chronic ground water exposure, the EDWC value for the combined residues 
of acequinocyl and its metabolite (acequinocyl-OH) is 0.0036 ppb.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. Acute dietary risk assessments 
were not conducted because an end point of concern attributable to a 
single dose was not identified. For chronic dietary risk assessment, 
the water concentration value of 2.73 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).
     Acequinocyl is currently registered for the following residential 
non-dietary sites: Ornamental plants. EPA assessed residential exposure 
using the following assumptions: Exposure is considered to be short 
term only, due to the infrequent use patterns associated with homeowner 
products; and individuals are wearing shorts, short-sleeved shirts, 
socks, and shoes. The estimates of exposure to residential handlers are 
based on surrogate data available from the Outdoor Residential Exposure 
Task Force (ORETF) and the Pesticide Handlers Exposure Data (PHED) 
(August, 1998). The residential exposure assessed was exposure to 
adults from residential application of acequinocyl. Short-term 
inhalation and dermal exposure estimates were generated for residential 
adult handlers during the mixing, loading and application of 
acequinocyl in residential settings. Based on the use pattern, no 
significant post application exposure in residential settings is 
anticipated.
    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.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to acequinocyl and any other 
substances and acequinocyl does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has not assumed that acequinocyl has 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 website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional (10X) tenfold 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 data base 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. In applying 
this provision, EPA either retains the default value of 10X when 
reliable data do not support the choice of a different factor, or, if 
reliable data are available, EPA uses a different additional FQPA 
safety factor value based on the use of traditional UFs and/or special 
FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There is no evidence of 
increased quantitative susceptibility following in utero exposure to 
acequinocyl in rat or rabbit developmental studies or following 
prenatal and/or postnatal exposure to acequnocyl in a two-generation 
reproduction study in rats. There is an apparent qualitative increase 
in susceptibility in the rat and rabbit developmental studies as 
indicated by increases in resorptions that occurred at the same or 
higher dose that caused maternal toxicity, but the concern is low 
since: (1) The fetal effects were noted in the presence of maternal 
toxicity; and (2) the effects are well-characterized in

[[Page 17909]]

that a clear NOAEL was identified. An increase in mortality in the 
offsprings of F1 and/or F2 generation was identified in the two-
generation reproduction study; however, EPA does not consider this as 
evidence for increased susceptibility because the mortality occurred 
after weaning (day 21) during days 22 to 55 when food intake by the 
pups substantially increases, substantially increasing the administered 
dose of pesticide. In any event these effects occurred in the presence 
of maternal toxicity and a clear NOAEL was identified. There are no 
residual uncertainties and low concern for prenatal and/or postnatal 
toxicity following exposure to acequinocyl.
    3. Conclusion. EPA has determined that reliable data show that it 
would be safe for infants and children to reduce the FQPA safety factor 
to 1X. That decision is based on the following findings:
    i. The toxicity database for acequinocyl is complete.
    ii. Though two studies showed effects that could be indicative of 
neurotoxicity, EPA concluded that exposure to acequinocyl does not pose 
a neurotoxicity concern and there is no need for a developmental 
neurotoxicity study or additional UFs to account for neurotoxicity. 
First, acequinocyl is a known Vitamin K antagonist; neurotoxic 
compounds of similar structure were not identified. Second, the study 
effects are considered as secondary because they were observed at very 
high doses (58.9/69.2 milligrams/kilogram/day (mg/kg/day) and 111.2/
133.5 mg/kg/day in the rat reproduction study and 252.7/286.0 mg/kg/day 
in the rat subchronic study.) In the two-generation reproduction study, 
significant reduction in startle response in F2 pups was observed in 
the high dose groups. However, other functional development studies 
(such as a papillary reflex test at 21 days post partum, an open field 
exploration test at 35 to 48 days post partum) that were performed on 
pups did not show significant differences as compared to control values 
even at the highest dosage rate.
    iii. There is no evidence that acequinocyl results in increased 
quantitative susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the two-generation 
reproduction study. As discussed above, there is low concern for any 
potential qualitative sensitivity observed in these studies.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100% crop treated (CT) and tolerance-level residues. Conservative 
ground water and surface water modeling estimates were used. No 
significant post application exposure to children is anticipated from 
the registered use of acequinocyl on ornamental plants. These 
assessments will not underestimate the exposure and risks posed by 
acequinocyl.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing 
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and 
cPAD are calculated by dividing the LOC by all applicable UFs. For 
linear cancer risks, EPA calculates the probability of additional 
cancer cases given aggregate exposure. Short-term, intermediate-term, 
and long-term risks are evaluated by comparing aggregate exposure to 
the LOC to ensure that the MOE called for by the product of all 
applicable UFs is not exceeded.
    1. Acute risk. No acute risk is expected because an endpoint of 
concern attributable to a single dose was not identified.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
acequinocyl from food and water will utilize 41% of the cPAD for the 
population group children 1 to 2 years old, the most highly exposed 
population subgroup. Based on the use pattern, chronic residential 
exposure to residues of Acequinocyl is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Acequinocyl is currently registered for use that could result in 
short-term residential exposure and the Agency has determined that it 
is appropriate to aggregate chronic food and water and short-term 
exposures for acequinocyl.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food, water, and residential 
exposures aggregated result in aggregate MOEs of 2,700 for adult 
residential handlers 50+ years old mixing, loading and applying 
acequinocyl in residential settings. The adult 50+ years old population 
is the highest exposed population group and the MOE of 2,700 is 
considered protective of the other adult population groups. Based on 
the use pattern, no significant post application exposure is 
anticipated, therefore, no residential post application assessment was 
conducted.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Acequinocyl is not registered for use on any sites that would 
result in intermediate-term residential exposure. Therefore, the 
aggregate risk is the sum of the risk from food and water, which do not 
exceed the Agency's level of concern.
    5. Aggregate cancer risk for U.S. population. Acequinocyl is not 
considered to be a carcinogen and thus is not expected to pose a cancer 
risk.
    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 acequinocyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Analytical enforcement methods include liquid chromatography with 
tandem mass spectrometric detection (LC/MS/MS). The limit of 
quantitation (LOQ) is 0.01 ppm for each analyte in plant and livestock 
commodities and the reported limit of detection (LOD) is 0.003 ppm for 
each analyte in plant commodities.
    Adequate enforcement methodology (two liquid chromatography with 
tandem mass spectrometric detection LC/MS/MS) methods (Morse Methods 
Meth-133 revision 4 and Meth-135, revision 2 for 
grape and tree nuts, respectively) are available to enforce the 
tolerance expression. The methods 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 established or proposed CODEX, Canadian, or Mexican 
maximum residue limits (MRLs) for acequinocyl.

C. Response to Comments

    One comment was received from a private citizen opposing the 
``manufacturing, selling or use'' of acequinocyl. The commenter further 
stated that it was their wish that no exemptions be issued and that no 
tolerances should be approved. The Agency understands the commenter's 
concerns and recognizes that some individuals believe that pesticides

[[Page 17910]]

should be banned completely. However, under the existing framework 
provided by section 408 of the FFDCA, EPA is required to establish 
pesticide tolerances or exemptions where persons seeking such 
tolerances have demonstrated that the pesticide meets the safety 
standard imposed by that statue. The commenter has not provided the 
Agency with specific rationale nor additional information pertaining to 
the legal standards in FFDCA section 408 for opposing the establishment 
of a tolerance for acequinocyl. In the absence of any additional 
information of a factual nature, the Agency can not effectively respond 
to the commenter's disagreement with the Agency's decision.

V. Conclusion

    Therefore, the tolerances are established for combined residues of 
acequinocyl and its metabolite, 2-dodecyl-3-hydroxy-1,4-naphthoquinone 
expressed as acequinocyl equivalents, in or on grape and nut, tree, 
group 14 at 1.6 ppm and 0.02 ppm, respectively.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance 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 rule has been 
exempted from review under Executive Order 12866, this rule is not 
subject to Executive Order 13211, 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 6, 2000) do not apply to this rule. In addition, This 
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).

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: March 20, 2008.
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. 599 is amended by removing from the table in paragraph 
(a) the entry for almond, and adding new commodities to the table to 
read as follows:


Sec.  180.599  Acequinocyl; Tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Grape................................................                1.6
                                * * * * *
Nut, tree, group 14..................................               0.02
                                * * * * *
------------------------------------------------------------------------

* * * * *
 [FR Doc. E8-6699 Filed 4-1-08; 8:45 am]
BILLING CODE 6560-50-S