Document ID: EPA-HQ-OPP-2006-0075-0003
Agency: epa
Document Type: Rule
Title: Fenazaquin, 4-tert-butylphenethyl Quinazolin-4-yl Ether; Pesticide Import Tolerance
Posted Date: 2007-08-08T04:00Z

[Federal Register: August 8, 2007 (Volume 72, Number 152)]
[Rules and Regulations]               
[Page 44388-44393]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08au07-10]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0075; FRL-8141-3]

 
Fenazaquin, 4-tert-butylphenethyl Quinazolin-4-yl Ether; 
Pesticide Import Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes import tolerances for residues of 
fenazaquin, 4-tert-butylphenethyl quinazolin-4-yl ether, in or on apple 
at 0.2 parts per million (ppm); in or on pear at 0.2 ppm; in or on 
citrus fruit group 10, except grapefruit, at 0.5 ppm; and in or on 
citrus oil at 10 ppm. Gowan Company requested these tolerances under 
the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective August 8, 2007. Objections and 
requests for hearings must be received on or before October 9, 2007, 
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-2006-0075. 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 web site 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.

[[Page 44389]]

FOR FURTHER INFORMATION CONTACT: Dan Peacock, Registration Division, 
Office of Pesticide Programs, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: 
(703) 305-5407; e-mail address: peacock.dan@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), 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 the 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-2006-0075 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 October 9, 2007.
    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-2006-0075, 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 April 12, 2006 (71 FR 18736) (FRL-7775-
5), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of an import pesticide 
petition (PP 9E5059) by Gowan Company, 370 S. Main Street, Yuma, AZ 
85364. The petition requested that 40 CFR part 180 be amended by 
establishing import tolerances for residues of the insecticide, 
fenazaquin, in or on apple at 0.2 ppm; in or on pear at 0.2 ppm, and in 
or on citrus fruits at 0.5 ppm. That notice referenced a summary of the 
petition prepared by Gowan Company, the registrant, which is available 
to the public in the docket, under docket identification (ID) number 
EPA-HQ-OPP-2006-0075-0002 at http://www.regulations.gov. There were no 

comments received in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has 
modified Gowan Company's request for tolerances as follows. This 
regulation establishes import tolerances for residues of fenazaquin in 
or on apple at 0.2 ppm; in or on pear at 0.2 ppm; in or on citrus fruit 
group 10, except grapefruit, at 0.5 ppm; and in or on citrus oil at 10 
ppm. The reason for the addition of a tolerance for citrus oil at 10 
ppm is explained in Unit V. (Conclusions).

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of the 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 the 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 the 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 the FFDCA by the Food Quality 
Protection Act (FQPA) of 1996.
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in 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 import 
tolerances for residues of Fenazaquin in or on apple at 0.2 ppm; in or 
on pear at 0.2 ppm; in or on citrus fruit group 10, except grapefruit, 
at 0.5 ppm; and in or on citrus oil at 10 ppm. EPA's assessment of 
exposures and risks associated with establishing the tolerance follows.

[[Page 44390]]

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 Fenazaquin 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.
 The referenced document (Fenazaquin: PP 

9E5059. Tolerances on apples, pears and citrus fruits exported to the 
U.S. HED Risk Assessment) is available in the docket established by 
this action, which is described under ADDRESSES, and is identified as 
docket ID No. EPA-HQ-OPP-2006-0075-0004 in that docket.

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 no adverse effects are observed (the 
NOAEL) in the toxicology study identified as appropriate for use in 
risk assessment. However, if a NOAEL cannot be determined, the lowest 
dose at which adverse effects of concern are identified (the LOAEL) is 
sometimes used for risk assessment. Uncertainty/safety factors (UF) are 
used in conjunction with the 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 dose (aPAD) and chronic population adjusted dose 
(cPAD). The aPAD and cPAD are calculated by dividing the LOC by all 
applicable uncertainty/safety factors. 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 uncertainty/safety factors 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 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 Fenazaquin used for 
human risk assessment is shown in Table 1 below of this unit and in 
docket ID number EPA-HQ-OPP-2007-0075-0004 in an alternate format.

      Table 1.--Summary of Toxicological Dose and Endpoints for Fenazaquin for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose used in risk
                                             assessment,          Special FQPA SF and
          Exposure/Scenario                interspecies and       level of concern for   Study and toxicological
                                         intraspecies and any      risk assessment UF            effects
                                         traditional FQPA, SF
----------------------------------------------------------------------------------------------------------------
Acute dietary (general population      NOAEL = 10 mg/kg/day SF  Special FQPA SF = 1 x    Rat developmental
 including infants and children)        = 100                   aPAD = acute...........   toxicity
                                       Acute RfD = 0.1 mg/kg/   RfD = 0.1 mg/kg/day....  LOAEL = 40 mg/kg/day
                                        day.                                              based on findings (as
                                                                                          early as GD 6-9) of
                                                                                          decreased body weight
                                                                                          gain, food intake, and
                                                                                          food efficiency.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (all populations)      NOAEL= 5 mg/kg/day       Special FQPA             Rat two-generation
                                       SF = 100...............  SF = 1 x...............   toxicity study
                                       Chronic RfD = 0.05 mg/   cPAD = chronic.........  LOAEL = 25 mg/kg/day
                                        kg/day.                 RfD = 0.05 mg/kg/day...   based on excessive
                                                                                          salivation and
                                                                                          decreased body weight/
                                                                                          weight gain and food
                                                                                          intake.
----------------------------------------------------------------------------------------------------------------
Short-term, intermediate-term, and     These exposure
 long-term incidential oral (1-30       scenarios do not apply
 days; 1-6 months) (Residential)        to this risk
                                        assessment because
                                        there are no proposed
                                        registered residential
                                        uses of fenazaquin.
----------------------------------------------------------------------------------------------------------------
Short-term, intermediate-term, and     These exposure
 long-term dermal (1-30 days; 1-6       scenarios do not apply
 months) (Residential)                  to this risk
                                        assessment because
                                        there are no proposed
                                        registered residential
                                        or occupational uses
                                        of fenazaquin.
----------------------------------------------------------------------------------------------------------------
Short-term, intermediate-term, long-   These exposure
 term inhalation (1-30 days; 1-6        scenarios do not apply
 months) (Residential)                  to this risk
                                        assessment because
                                        there are no proposed
                                        registered residential
                                        or occupational uses
                                        of fenazaquin.
----------------------------------------------------------------------------------------------------------------

[[Page 44391]]

Cancer (oral, dermal, inhalation)      A quantitative exposure
                                        assessment for cancer
                                        risk was not performed
                                        because fenazaquin has
                                        been classified as
                                        ``Not likely to be
                                        Carcinogenic to
                                        Humans'' and is not
                                        expected to pose a
                                        cancer risk.
----------------------------------------------------------------------------------------------------------------

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to fenazaquin, EPA considered exposure under the petitioned-
for tolerances as well as a tolerance in or on citrus oil. EPA assessed 
dietary exposures from Fenazaquin 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. In estimating acute 
dietary exposure, EPA used food consumption information from the United 
States Department of Agriculture (USDA) 1998 Nationwide Continuing 
Surveys of Food Intake by Individuals (CSFII). As to residue levels in 
food, EPA assumed all foods for which there are tolerances were treated 
and contain tolerance-level residues. Percent Crop Treated (PCT) and 
anticipated residues were not used.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1998 CSFII. 
As to residue levels in food, EPA assumed all foods for which there are 
tolerances were treated and contain tolerance-level residues. Percent 
Crop Treated (PCT) and anticipated residues were not used.
    iii. Cancer. A quantitative exposure assessment for cancer risk was 
not performed because fenazaquin has been classified as ``Not likely to 
be Carcinogenic to Humans'' and is not expected to pose a cancer risk.
    iv. Anticipated residue and PCT information.PCT and anticipated 
residues were not used.
    2. Dietary exposure from drinking water. Because the import 
tolerances in this Final Rule do not involve current or proposed 
registered uses of Fenazaquin in the United States, EPA does not 
anticipate dietary exposure from drinking water. Therefore, EPA has not 
assessed such exposure in this document.
    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).
     Fenazaquin 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 fenazaquin and any other 
substances and fenazaquin 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 fenazaquin 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 uncertainty/safety 
factors and/or special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There are no qualitative or 
quantitative prenatal or postnatal susceptibility issues based on 
available data from two developmental toxicity studies and a two-
generation reproduction toxicity study.
    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 fenazaquin is complete.
    ii. There is no need for a developmental neurotoxicity study or 
additional uncertainty factors to account for neurotoxicity.
    iii. There is no evidence that fenazaquin results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the two-generation 
reproduction study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100% CT and tolerance-level residues.
    v. There is no potential for dietary drinking water exposure and 
there are no residential uses.

[[Page 44392]]

    By using these screening-level assessments, acute and chronic 
exposures/risks will not be underestimated.

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 uncertainty/
safety factors. For linear cancer risks, EPA calculates the probability 
of additional cancer cases given aggregate exposure. Short-term, 
intermediate, 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 uncertainty/safety factors is not 
exceeded.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food to 
fenazaquin will occupy 48% of the aPAD for the population group 
(children, 1-2 years old) receiving the greatest exposure. There is no 
acute dietary exposure from water.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
fenazaquin from food will utilize 25% of the cPAD for the population 
group (children, 1-2 years old) receiving the greatest exposure. 
Because the tolerances being established in this Final Rule are for 
uses outside of the United States, there is no acute dietary exposure 
from water. There are no residential uses for Fenazaquin that result in 
chronic residential exposure to Fenazaquin.
    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).
    Fenazaquin is not registered for use on any sites that would result 
in residential exposure. Also, because the tolerances being established 
in this Final Rule are for uses outside of the United States, there is 
no acute dietary exposure from water. Therefore, the aggregate risk is 
the sum of the risk from food, which does 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).
    Fenazaquin is not registered for use on any sites that would result 
in residential exposure. Also, because the tolerances being established 
in this final rule are for uses outside of the United States, there is 
no chronic dietary exposure from water. Therefore, the aggregate risk 
is the sum of the risk from food, which does not exceed the Agency's 
level of concern.
    5. Aggregate cancer risk for U.S. population. Fenazaquin is not 
expected to pose a cancer risk based on negative cancer findings in two 
adequate rodent carcinogenicity studies.
    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 fenazaquin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography) is available 
to enforce the tolerance expression, using the existing Food and Drug 
Administration (FDA) Multiresidue Methods in the Pesticide Analytical 
Manual (PAM), Vol I, available from http://www.cfsan.fda.gov/~lrd/pestadd.html
.

B. International Residue Limits

    There are no established or proposed Canadian, Mexican or Codex 
MRLs for residues of fenazaquin in plant commodities.

C. Response to Comments

    The Agency did not receive any comments to this request for import 
tolerances for fenazaquin.

V. Conclusion

    Therefore, the Agency is establishing import tolerances for 
residues of Fenazaquin in or on apple at 0.2 parts per million (ppm); 
in or on pear at 0.2 ppm; in or on citrus fruit group 10, except 
grapefruit, at 0.5 ppm; and in or on citrus oil at 10 ppm. The original 
petition did not request the establishment of a tolerance in or on 
citrus oil at 10 ppm. However, the Agency added this tolerance for the 
following reason. Separate tolerances are not required for apple and 
orange juice as residues do not concentrate in these commodities. 
However, the citrus processing studies indicate that fenazaquin 
residues concentrate on average by 25x in citrus oil and thus residues 
in citrus oil could exceed the tolerance for citrus fruits. Based on 
the 25x processing factor and residue data on fenazaquin levels in or 
on oranges, a tolerance of 10 ppm would be appropriate for citrus oil.

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

[[Page 44393]]

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: July 26, 2007.
Debra Edwards,
Director, 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 180.632 is added to read as follows:

Sec.  180.632  Fenazaquin; import tolerances for residues.

    (a) General. Import tolerances are established for residues of the 
insecticide and miticide, fenazaquin, 4-tert-butylphenethyl quinazolin-
4-yl ether, in or on raw agricultural commodities as follows:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Apple................................................                0.2
Citrus Oil...........................................                 10
Fruit, Citrus, Group 10, except Grapefruit...........                0.5
Pear.................................................                0.2
------------------------------------------------------------------------

    (b) Section is emergency exempotions. [Reserved]
    (c) Tolerances with regional registration. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]
[FR Doc. E7-15334 Filed 8-7-07; 8:45 am]

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