Document ID: EPA-HQ-OPP-2008-0362-0003
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Quinoxyfen
Posted Date: 2009-04-01T04:00Z

[Federal Register: April 1, 2009 (Volume 74, Number 61)]
[Rules and Regulations]               
[Page 14738-14743]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01ap09-13]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0362; FRL-8405-2]

 
Quinoxyfen; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
quinoxyfen in or on artichoke, globe; fruit, stone, group 12; squash, 
winter; pumpkin; and gourd, edible. This regulation also deletes the 
established cherry, sweet;

[[Page 14739]]

and cherry, tart tolerances, as they will be superseded by inclusion in 
the stone fruit crop group. This regulation additionally deletes the 
time-limited tolerances for pumpkin; winter squash; and melon subgroup 
9A, as the tolerances expired on December 31, 2007. Interregional 
Research Project Number 4 (IR-4) requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective April 1, 2009. Objections and 
requests for hearings must be received on or before June 1, 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-2008-0362. 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: Laura Nollen, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7390; e-mail address: nollen.laura@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
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 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 EPA's tolerance regulations 
at 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 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. 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-2008-0362 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 1, 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 this copy, identified by docket ID number 
EPA-HQ-OPP-2008-0362, 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. Petition for Tolerance

    In the Federal Register of June 4, 2008 (73 FR 31862) (FRL-8365-3), 
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 8E7325) 
by Interregional Research Project Number 4 (IR-4), 500 College Rd. 
East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 
CFR 180.588 be amended by establishing tolerances for residues of the 
fungicide quinoxyfen, 5,7-dichloro-4-(4-fluorophenoxy)quinoline, in or 
on artichoke, globe at 1.4 parts per million (ppm); fruit, stone, group 
12 at 0.70 ppm; squash, winter at 0.20 ppm; pumpkin at 0.20 ppm; and 
gourd, edible at 0.20 ppm. IR-4 additionally proposed to remove the 
established tolerances for the residues of quinoxyfen in or on the food 
commodities cherry, sweet; and cherry, tart at 0.30 ppm. That notice 
referenced a summary of the petition prepared on behalf of IR-4 by Dow 
AgroSciences LLC, the registrant, which is available to the public in 
the docket, http://www.regulations.gov There were no comments received 
in response to the notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes

[[Page 14740]]

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 the petitioned-for 
tolerances for residues of quinoxyfen on artichoke, globe at 1.4 ppm; 
fruit, stone, group 12 at 0.70 ppm; squash, winter at 0.20 ppm; pumpkin 
at 0.20 ppm; and gourd, edible at 0.20 ppm. EPA's assessment of 
exposures and risks associated with establishing tolerances 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.
    The existing quinoxyfen data indicate that it possesses low acute 
toxicity via the oral, dermal and inhalation routes. It is a mild eye 
irritant and dermal sensitizer, but it is not a dermal irritant.
    The primary target organs affected by quinoxyfen are the liver and 
kidney. Subchronic effects in rats and mice included increased liver 
weights, hepatocellular hypertrophy and individual cell hepatocellular 
necrosis, and chronic effects in the dog included increased liver 
weights, increased alkaline phosphatase levels and increased incidences 
of slight microscopic hepatic lesions. Kidney effects were noted only 
in the rat combined chronic/carcinogenicity study, resulting in an 
increased severity of chronic progressive glomerulonephropathy in 
males. Rabbits were much more susceptible to the effects of quinoxyfen 
than any other species. Systemic effects observed in the rabbit 
developmental study included inanition, loss of body weight, perineal 
soiling, blood in the cage pan associated with urine, and abortions.
    Long-term dietary administration of quinoxyfen did not result in an 
overall treatment-related increase in incidence of tumor formation in 
rats or mice. As a result, EPA classified quinoxyfen as ``not likely to 
be carcinogenic to humans.'' Quinoxyfen did not show evidence of 
mutagenicity in in vitro or in vivo studies. No evidence of 
neurotoxicity or neuropathology was seen in any of the submitted 
studies, including the acute and subchronic neurotoxicity studies.
    The toxicology data for quinoxyfen provides no indication of 
increased susceptibility, as compared to adults, of rat and rabbit 
fetuses to in utero exposure in developmental studies. No maternal or 
developmental toxicity was observed in the rat developmental toxicity 
study. The rabbit developmental toxicity study included maternal toxic 
effects (inanition, decreased body weight and weight gain, decreased 
fecal output, perineal soiling, blood in the cage pan associated with 
urine, and abortions) at the same dose as developmental effects 
(increased abortions). In the 2-generation reproduction study conducted 
with rats, increased quantitative susceptibility of offspring 
(minimally reduced pup weights) was noted in the absence of maternal 
toxicity at the high dose. There was no evidence of immunotoxicity in 
the database.
    Specific information on the studies received and the nature of the 
adverse effects caused by quinoxyfen as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://
www.regulations.gov in document ``Quinoxyfen. Human Health Risk 
Assessment for the Proposed Food Use of Quinoxyfen on Stone Fruits Crop 
Group 12 (excluding Cherry), Artichoke, Winter Squash, (Pumpkin and 
Edible Gourds),'' at pages 45-48 in docket ID number EPA-HQ-OPP-2008-
0362.

B. 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 NOAEL in the toxicology study 
identified as appropriate for use in risk assessment. However, if a 
NOAEL cannot be determined, 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 quinoxyfen used for 
human risk assessment can be found at http://www.regulations.gov in 
document ``Quinoxyfen. Human Health Risk Assessment for the Proposed 
Food Use of Quinoxyfen on Stone Fruits Crop Group 12 (excluding 
Cherry), Artichoke, Winter Squash, (Pumpkin and Edible Gourds),'' at 
pages 25-26 in docket ID number EPA-HQ-OPP-2008-0362.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to quinoxyfen, EPA considered exposure under the petitioned-
for tolerances as well as all existing quinoxyfen tolerances in 40 CFR 
180.588. EPA assessed dietary exposures from quinoxyfen 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 
quinoxyfen; 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

[[Page 14741]]

Continuing Survey of Food Intake by Individuals (CSFII). As to residue 
levels in food, EPA used tolerance-level residues, Dietary Exposure 
Evaluation Model (DEEM) default processing factors, and assumed 100 
percent crop treated (PCT) for all proposed commodities.
    iii. Cancer. Based upon lack of evidence of carcinogenicity in rats 
and mice by all routes of exposure, EPA has classified quinoxyfen as 
``not likely to be carcinogenic to humans;'' therefore, a quantitative 
exposure assessment to evaluate cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for quinoxyfen. 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 quinoxyfen in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of quinoxyfen. 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) model for 
surface water, and the Screening Concentration in Ground Water (SCI-
GROW) model for ground water, the estimated drinking water 
concentrations (EDWCs) of quinoxyfen for surface water are estimated to 
be 9.9 parts per billion (ppb) for acute exposures, and 0.66 ppb for 
chronic exposures. For ground water, the estimated drinking water 
concentration is 0.0034 ppb.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the water concentration of value 0.66 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). Quinoxyfen is not 
registered for any specific use patterns that would result in 
residential exposure.
    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 quinoxyfen to share a common mechanism of 
toxicity with any other substances, and quinoxyfen does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
quinoxyfen 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 website 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. The toxicology data for 
quinoxyfen provides no indication of increased susceptibility, as 
compared to adults, of rat and rabbit fetuses to in utero exposure in 
developmental studies up to the limit dose of 1,000 milligrams/
kilogram/day (mg/kg/day). In the multi-generation rat reproduction 
study, offspring effects were noted at the high dose of 100 mg/kg/day 
tested (minimally reduced F1a pup weights) in the absence of 
maternal toxicity at the same level; thereby showing quantitative 
evidence of increased susceptibility in rat offspring. However, concern 
is low since:
    i. The effects in pups are well-characterized with a clear NOAEL of 
20 mg/kg/day.
    ii. The pup effects are minimal at the LOAEL and only noted in the 
first generation offspring.
    iii. The doses and endpoints selected for regulatory purposes would 
address the concerns of the pup effects noted in the rat reproduction 
study.
    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. The toxicity database for quinoxyfen is complete except for 
immunotoxicity testing. Recent changes to 40 CFR part 158 make 
immunotoxicity testing (OPPTS Guideline 870.7800) required for 
pesticide registration; however, the existing data are sufficient for 
endpoint selection for exposure/risk assessment scenarios, and for 
evaluation of the requirements under the FQPA. The available data for 
quinoxyfen do not show potential for immunotoxic effects. Therefore, 
EPA does not believe that conducting the immunotoxicity study will 
result in a NOAEL lower than the NOAEL of 20 mg/kg/day already set for 
quinoxyfen. Consequently, an additional database uncertainty factor 
does not need to be applied.
    ii. There is no indication that quinoxyfen is a neurotoxic chemical 
and there is no need for a developmental neurotoxicity study or 
additional UFs to account for neurotoxicity.
    iii. Although there is quantitative evidence of increased 
susceptibility of offspring (minimally reduced pup weights) in the 
absence of maternal effects in the rat multi-generation reproduction 
study, the Agency did not identify any residual uncertainties after 
establishing toxicity endpoints and traditional UFs to be used in the 
risk assessment. Therefore, there are no residual concerns regarding 
developmental effects in the young.
    iv. There are no residual uncertainties identified in the exposure 
databases. Dietary food exposure assessments were performed based on 
100% crop treated and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground water and surface water modeling 
used to assess exposure to quinoxyfen in drinking water. These 
assessments will not underestimate the exposure and risks posed by 
quinoxyfen.

E. 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

[[Page 14742]]

all applicable UFs. For linear cancer risks, EPA calculates the 
probability of additional cancer cases given the estimated aggregate 
exposure. Short-term, intermediate-term, and chronic-term risks are 
evaluated by comparing the estimated aggregate food, water, and 
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. An acute aggregate risk assessment takes into 
account exposure estimates from acute dietary consumption of food and 
drinking water. No acute dietary endpoint was identified for any 
segment of the United States (U.S.) population. Therefore, quinoxyfen 
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 
quinoxyfen from food and water will utilize 2% of the cPAD for children 
1 to 2 years old, the population group receiving the greatest exposure. 
There are no residential uses for quinoxyfen to consider.
    3. Short-term and intermediate-term risk. Short-term and 
intermediate-term aggregate exposure takes into account short-term and 
intermediate-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Quinoxyfen is not registered for any use patterns that would result 
in residential exposure. Therefore, the short-term and intermediate-
term aggregate risk is the sum of the risk from exposure to quinoxyfen 
through food and water and will not be greater than the chronic 
aggregate risk.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in mice and rats at doses that were judged 
to be adequate to assess the carcinogenic potential, quinoxyfen was 
classified as ``not likely to be carcinogenic to humans.'' Therefore, 
quinoxyfen is not expected to pose a cancer risk to humans.
    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 quinoxyfen residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography with mass-
selective detection (GC-MSD)) is available to enforce the tolerance 
expression. 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: 
residuemethods@epa.gov.

B. International Residue Limits

    There are no Mexican maximum residue limits (MRLs) established for 
residues of quinoxyfen in crops associated with this review. Codex MRLs 
exist for quinoxyfen on cherry, sweet and tart at 0.4 ppm; and Canadian 
MRLs exist for cherry, sweet and tart at 0.3 ppm. However, the proposed 
tolerance for fruit, stone, group 12 (0.70 ppm), of which cherry is a 
part, cannot be harmonized with the Codex or Canadian MRLs on these 
commodities because field trial data supporting the stone fruit group 
tolerance shows residue levels that are higher than 0.4 ppm.

V. Conclusion

    Therefore, tolerances are established for residues of quinoxyfen, 
5,7-dichloro-4-(4-fluorophenoxy)quinoline, in or on artichoke, globe at 
1.4 ppm; fruit, stone, group 12 at 0.70 ppm; squash, winter at 0.20 
ppm; pumpkin at 0.20 ppm; and gourd, edible at 0.20 ppm. This 
regulation also deletes the established tolerances in or on cherry, 
sweet; and cherry, tart, as they are superseded by inclusion in fruit, 
stone, group 12. This regulation additionally deletes the time-limited 
tolerances for pumpkin; winter squash; and melon subgroup 9A, as the 
tolerances expired on December 31, 2007.

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) (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

[[Page 14743]]

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 19, 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 180.588 is amended in paragraph (a), by removing the 
commodities ``Cherry, sweet'' and ``Cherry, tart''; and by 
alphabetically adding the following commodities to the table; and in 
paragraph (b), by removing all of the commodities and reserving the 
paragraph designation and heading to read as follows:

Sec.  180.588  Quinoxyfen; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Artichoke, globe.....................................                1.4
Fruit, stone, group 12...............................               0.70
                                * * * * *
Gourd, edible........................................               0.20
                                * * * * *
Pumpkin..............................................               0.20
Squash, winter.......................................               0.20
                                * * * * *
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
* * * * *

[FR Doc. E9-7046 Filed 3-31-09; 8:45 am]

BILLING CODE 6560-50-S