Document ID: EPA-HQ-OPP-2006-0167-0003
Agency: epa
Document Type: Rule
Title: Quinoxyfen; Pesticide Tolerance
Posted Date: 2006-08-25T21:07:31Z

[Federal Register: August 25, 2006 (Volume 71, Number 165)]
[Rules and Regulations]               
[Page 50350-50354]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25au06-13]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0167; FRL-8088-8]

 
Quinoxyfen; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
quinoxyfen in or on commodities: lettuce, head and lettuce, leaf; 
melon, subgroup 9A; pepper, bell and pepper, nonbell; and strawberry. 
The Interregional Research Project Number 4 (IR-4) requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as 
amended by the Food Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective August 25, 2006. Objections and 
requests for hearings must be received on or before October 24, 2006, 
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-2006-0167. All documents in the 
docket are listed in the index for the docket. 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 Building), 2777 S. Crystal Drive, 
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The Docket telephone 
number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Sidney Jackson, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7610; e-mail address: jackson.sidney@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:
     Crop production (NAICS 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 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 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 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 40 CFR part 180 through the 
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr.
 To access the OPPTS Harmonized Guidelines 

referenced in this document, go directly

[[Page 50351]]

to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, 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-2006-0167 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 24, 2006.
    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-2006-0167, 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 
Building), 2777 S. Crystal Drive, 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 telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of April 21, 2006 (71 FR 20667) (FRL-8056-
4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 
3E6755; 5E6969; and 5E6970) by the Interregional Research Project 
4 (IR-4), 681 U.S. Highway 1 South, North Brunswick, 
NJ 08902-3390. The petitions 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 the raw 
agricultural commodities: eggplant at 1.0 parts per million (ppm) (PP 
3E6755); peppers (bell and non-bell) at 1.0 ppm (PP 3E6755); melon 
subgroup 9A at 0.1 ppm (PP 5E6969); lettuce, head and leaf at 17.0 ppm 
(PP 5E6970); and strawberry at 0.8 ppm (PP 5E6970). That notice 
included a summary of the petition prepared by Dow AgroSciences, the 
registrant. There were no comments received in response to the notice 
of filing.
    Upon completing review of the current quinoxyfen database, the 
Agency concluded that the appropriate tolerance levels for quinoxyfen 
residues in or on pending crops should be established as follow: 
Lettuce, head at 7.0 ppm; lettuce, leaf at 19 ppm; melon, subgroup 9A 
at 0.08 ppm; pepper, bell at 0.35 ppm; pepper, non-bell at 1.7 ppm; and 
strawberry at 0.90 ppm. The Agency concluded that there are 
insufficient data to establish a tolerance for quinoxyfen residues in 
or on eggplant, at this time.
    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....''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of the FFDCA and a complete 
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with 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, consistent with section 
408(b)(2) of FFDCA, for a tolerance for residues of quinoxyfen on 
lettuce, head at 7.0 ppm; lettuce, leaf at 19 ppm; melon (subgroup 9A) 
at 0.08 ppm; pepper, bell at 0.35 ppm; pepper, non-bell at 1.7 ppm; and 
strawberry at 0.90 ppm. 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 their 
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 toxic 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 in the Federal 
Register of September 29, 2003 (68 FR 55858) (FRL-7318-2), under docket 
ID number EPA-HQ-OPP-2003-0218, to which the reader may refer for 
additional information.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the dose at which no adverse effects are observed 
(the NOAEL) from the toxicology study identified as appropriate for use 
in risk assessment is used to estimate the toxicological level of 
concern (LOC). However, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) is sometimes used for risk 
assessment if no NOAEL was achieved in the toxicology study selected. 
An uncertainty factor (UF) is applied to reflect 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.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify non-threshold hazards such as 
cancer. The

[[Page 50352]]

Q* approach assumes that any amount of exposure will lead to some 
degree of cancer risk, estimates risk in terms of the probability of 
occurrence of additional cancer cases. More information can be found on 
the general principles EPA uses in risk characterization at http://www.epa.gov/pesticides/health/human.htm
.

    A summary of the toxicological endpoints for quinoxyfen used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of September 29, 2003 (68 FR 55858) 
(FRL-7318-2), under docket ID number EPA-HQ-OPP-2003-0218, to which the 
reader may refer for additional information.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.588) for the residues of quinoxyfen, in or on a 
variety of raw agricultural commodities. Permanent tolerances are 
established for residues of quinoxyfen per se in/on cherry, sweet and 
cherry, tart at 0.30 ppm; grape at 0.60 ppm; and dried hop cones at 3.0 
ppm. In addition, time-limited tolerances are established under Section 
18 emergency exemptions for residues of quinoxyfen per se in/on 
pumpkin; squash, winter; and vegetables, curcubit, subgroup 9A. Risk 
assessments were conducted by EPA to assess 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 one-day or single exposure.
    There were no toxic effects attributable to a single dose. 
Therefore, an endpoint of concern was not identified to quantitate 
acute-dietary risk to the general population or to the subpopulation 
females 13-50 years old. As a result, no acute risk is expected from 
exposure to quinoxyfen.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the Dietary Exposure Evaluation Model software with 
the Food Commodity Intake Database (DEEM-FCID\TM\), Version 2.03, which 
incorporates food consumption data as reported by respondents in the 
USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by 
Individuals (CSFII), and accumulated exposure to the chemical for each 
commodity.
    The following assumptions were made for the chronic exposure 
assessments: An unrefined, Tier 1 chronic dietary (food and water) 
exposure assessment using tolerance-level residues and assuming 100% 
crops treated for all proposed commodities, and default DEEM Version 
7.76 processing factors for all commodities.
    iii. Cancer. Quinoxyfen is classified as ``not likely to be 
carcinogenic to humans,'' based on the lack of evidence of 
carcinogenicity in rat and mice studies. Therefore, an exposure 
assessment for the purpose of evaluating cancer risk is not needed.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for quinoxyfen 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 physical 
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.

    Typically EPA evaluates the potential for human exposure to 
pesticides in drinking water through an assessment of available surface 
water and ground water monitoring data and modeling. For quinoxyfen, no 
monitoring data were available for use in this drinking water 
assessment. Therefore, potential human exposures to quinoxyfen were 
evaluated through modeling.
    The Agency used the FQPA Index Reservoir Screening Tool (FIRST) to 
calculate the surface water Estimated Exposure Concentrations (EECs) 
and the screening model SCI-GROW to calculate the groundwater EECs. The 
Agency considered residues of quinoxyfen per se, plus a metabolite, 3-
OH quinoxyfen, in modeling studies. To do this, aerobic soil metabolism 
and aerobic aquatic metabolism half-lives determined for the parent 
compound in the guideline studies were recalculated using concentration 
data for the parent compound plus 3-OH quinoxyfen when the latter 
compound was present. Additionally, the Agency was restricted to the 
use of soil adsorption coefficients determined only for the parent 
compound; however, other available information from the guideline 
studies indicates that 3-OH quinoxyfen has mobility in soil similar to 
that of the parent compound. Because hydroxylation (the addition of the 
3-OH) could increase its mobility relative to quinoxyfen, this 
metabolite has the potential to reach drinking water sources in 
significant quantities.
    For the surface water and groundwater assessments, EECs were 
determined using a maximum annual application rate for cherries of 0.55 
lb a.i./A (five applications of 0.114 lb a.i./A/application).
    Based on the FIRST and SCI-GROW models, the estimated environmental 
concentrations (EECs) of quinoxyfen for chronic exposures are estimated 
to be 0.84 ppb for surface water and 0.006 ppb for ground water. Model 
estimates of drinking water concentrations were directly entered into 
the dietary exposure model (DEEM-FCID).
    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 use on any sites that would result in residential 
exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the 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 quinoxyfen and 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 not assumed that quinoxyfen 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 
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.

D. Safety Factor for Infants and Children

    1.In general. Section 408 of FFDCA provides that EPA shall apply an 
additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal

[[Page 50353]]

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. 
Margins of safety are incorporated into EPA risk assessments either 
directly through use of a MOE analysis or through using uncertainty 
(safety) factors in calculating a dose level that poses no appreciable 
risk to humans. 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 safety factor value based on the use of 
traditional uncertainty factors and/or special FQPA safety factors, as 
appropriate.
    2. Prenatal and postnatal sensitivity. There is no quantitative or 
qualitative evidence of increased susceptibility of rat and rabbit 
fetuses to in utero exposure in developmental studies. There is 
evidence of increased quantitative susceptibility (minimal decrease in 
F1a pup weights) in the rat multi-generation reproduction study, but 
the concern is low since: (1) The effects in pups are well-
characterized with a clear NOAEL; (2) the pup effects are minimal at 
the LOAEL and only noted in the first-generation offspring; and (3) the 
doses and endpoints selected for regulatory purposes would address the 
concerns of the pup effects noted in the rat reproduction study. 
Therefore, there are no residual uncertainties for prenatal/postnatal 
toxicity in this study.
    3. Conclusion. There is a complete toxicity data base for 
quinoxyfen and exposure data are complete or are estimated based on 
data that reasonably account for potential exposures. There are no 
residual uncertainties for prenatal/postnatal toxicity. No additional 
safety factor is needed for data base uncertainties. No clinical sign 
of neurotoxicity or neuropathology was seen in the data base, including 
acute and subchronic neurotoxicity studies. A developmental 
neurotoxicity study is not required. Therefore, EPA determined that the 
10X SF to protect infants and children should be reduced to 1X.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. An endpoint of concern was not identified to 
quantitate acute-dietary risk to the general population or to the 
subpopulation females 13-50 years old. As a result, no acute risk is 
expected from exposure to quinoxyfen.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
quinoxyfen from (food + water) will utilize 1.3% of the cPAD for the 
U.S. population, < 1% of the cPAD for infants < 1 year old), and 2.0% of 
the cPAD for children (1 to 2 years old) the subpopulation at greatest 
exposure. There are no residential uses for quinoxyfen that result in 
chronic residential exposure to quinoxyfen.
    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). Quinoxyfen is not 
registered for use on any sites that would result in 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.
    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). Quinoxyfen is 
not registered for use on any sites that would result in 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. Quinoxyfen has been 
classified as ``not likely to be carcinogenic to humans.'' Therefore, 
quinoxyfen 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, and to infants and children from aggregate 
exposure to quinoxyfen residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    A practical analytical method is available to monitor and enforce 
the tolerances of quinoxyfen residues in crops. The analytical method 
uses capillary gas chromatography and mass spectrometry detector (GC-
MSD) with limits of quantitation (LOQ) of approximately 0.01 ppm. The 
method is adequate for collecting data and enforcing tolerances for 
quinoxyfen residues in/on the subject crops. There are no livestock 
feed items associated with these petitions, therefore, data collection 
and tolerance enforcement methods for livestock commodities are not 
required.

B. International Residue Limits

    There are no Mexican, Canadian or Codex maximum residue limits 
(MRLs) established for quinoxyfen in/on crops considered in this 
action. Therefore, no compatibility issues exist for these tolerances.

V. Conclusion

    Therefore, the tolerance is established for residues of quinoxyfen, 
5,7-dichloro-4-(4-fluorophenoxy) quinoline in or on lettuce, head at 
7.0 ppm and lettuce, leaf at 19 ppm; melon, subgroup 9A at 0.08 ppm; 
pepper, bell at 0.35 ppm; pepper, nonbell at 1.7 ppm; and strawberry at 
0.90 ppm.

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 due to its lack of 
significance, 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). 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., or 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). 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); or OMB review or any Agency action under Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997). 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). 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. In addition, the

[[Page 50354]]

Agency has determined that this action will not have a substantial 
direct effect on States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government, as specified 
in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 
1999). Executive Order 13132 requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by State and local 
officials in the development of regulatory policies that have 
federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications'' as 
described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
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: August 16, 2006.
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 by alphabetically adding commodities to 
the table in paragraph (a) to read as follows:

Sec.  180.588  Quinoxyfen; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
 Lettuce, head.......................................                7.0
Lettuce, leaf........................................                 19
Melon, subgroup 9A...................................               0.08
Pepper, bell.........................................               0.35
Pepper, nonbell......................................                1.7
Strawberry...........................................               0.90
------------------------------------------------------------------------

[FR Doc. E6-14065 Filed 8-24-06; 8:45 am]

BILLING CODE 6560-50-S