Document ID: EPA-HQ-OPP-2009-0018-0004
Agency: epa
Document Type: Rule
Title: Pyriproxyfen; Pesticide Tolerances
Posted Date: 2009-10-28T04:00Z

[Federal Register: October 28, 2009 (Volume 74, Number 207)]
[Rules and Regulations]               
[Page 55463-55467]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28oc09-11]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0018; FRL-8795-3]

 
Pyriproxyfen; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY:  This regulation establishes tolerances for residues of 
pyriproxyfen in or on artichoke, globe; asparagus; fruit, small, vine 
climbing subgroup, except grape 13-07E; vegetable, foliage of legume, 
group 7; vegetable, leafy, except brassica, group 4; vegetable, leaves 
of root and tuber, group 2; and watercress. It also removes the section 
18 time-limited tolerances on succulent bean, celery and strawberry 
since these tolerances have expired. Interregional Research Project 
Number 4 (IR-4) requested these tolerances under the Federal Food, 
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective October 28, 2009. Objections and 
requests for hearings must be received on or before December 28, 2009, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2009-0018. 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: Barbara Madden, Registration Division, 
Office of Pesticide Programs, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: 
(703) 305-6463; e-mail address: madden.barbara@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. To access the OPPTS Harmonized Test 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gov/oppts and select ``Test Methods & Guidelines'' on 
the left side navigation menu.

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-2009-0018 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 December 28, 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-2009-0018, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.

[[Page 55464]]

     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 April 8, 2009 (74 FR 15971) (FRL-8407-
4), 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 
8E7492) by IR-4, IR-4 Project Headquarters, 500 College Rd. East, Suite 
201 W., Princeton, NJ 08540. The petition requested that 40 CFR 180.510 
be amended by establishing tolerances for residues of the insecticide 
pyriproxyfen in or on artichoke, globe at 2.0 parts per million (ppm); 
asparagus at 2.0 ppm; fruit, small, vine climbing subgroup, except 
grape 13-07E at 0.35 ppm; vegetable, foliage of legume, group 7 at 2.0 
ppm; vegetable, leafy, except brassica, group 4 at 3.0 ppm; vegetable, 
leaves of root and tuber, group 2 at 2.0 ppm; and watercress at 2.0 
ppm. That notice referenced a summary of the petition prepared by 
Valent U.S.A. Corporation, the registrant, on behalf of IR-4 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 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 pyriproxyfen in or on vegetable, leaves of 
root and tuber, group 2 at 2.0 ppm; vegetable, leafy, except brassica, 
group 4 at 3.0 ppm; vegetable, foliage of legume, group 7 at 2.0 ppm; 
artichoke, globe at 2.0 ppm; asparagus at 2.0 ppm; watercress at 2.0 
ppm; and small fruit vine climbing subgroup, except grape 13-07E at 
0.35 ppm 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.
    Pyriproxyfen is of low acute toxicity. Pyriproxyfen is not a dermal 
sensitizer. No significant systemic toxicity was observed in either the 
21-day dermal toxicity study in rats or the 28-day inhalation toxicity 
study in rats. Subchronic and chronic toxicity studies in mice, rats 
and dogs indicate that the liver and kidney are the principal target 
organs with slight anemia occurring in the rodent species. There was no 
evidence of increased susceptibility to rat and rabbit fetuses in 
prenatal developmental toxicity studies or to rat offspring in the 2-
generation rat reproduction study. No evidence of developmental 
toxicity was seen in special studies that evaluated pyriproxyfen 
toxicity following perinatal and prenatal exposure in rats. There was 
no evidence of carcinogenicity in either a 78-week mouse feeding study 
or in the 2-year rat chronic/carcinogenicity study. Pyriproxyfen is 
classified as a ``Group E'' chemical - no evidence of carcinogenicity 
to humans. Pyriproxyfen is negative for mutagenic activity in a battery 
of mutagenicity studies conducted with both the parent and/or 
metabolites. Specific information on the studies received and the 
nature of the adverse effects caused by pyriproxyfen 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 docket ID number EPA-HQ-OPP-2009-0018 on pages 
34-36 of the document titled ``Pyriproxyfen. Human Health Risk 
Assessment for the Proposed Use of Pyriproxyfen in/on Vegetables, 
Leaves of Root and Tuber, Group 2; Vegetables, Leafy, Except Brassica, 
Group 4; Vegetable, Foliage of Legume, Group 7; Fruit, Small, Vine 
Climbing, Except Grape, Subgroup 13-07E; Artichoke, Globe; Asparagus; 
and Watercress Commodities.''

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 highest dose at which no 
adverse effects are observed (the NOAEL) in the toxicology study 
identified as appropriate for use in risk assessment. However, if a 
NOAEL cannot be determined, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach 
is sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the POD to take into account uncertainties 
inherent in the extrapolation from laboratory animal data to humans and 
in the variations in sensitivity among members of the human population 
as well as other unknowns. Safety is assessed for acute and chronic 
dietary risks by comparing aggregate food and water exposure to the 
pesticide to the acute population adjusted dose (aPAD) and chronic 
population adjusted dose (cPAD). The aPAD and cPAD are calculated by 
dividing the POD by all applicable UFs. Aggregate short-term, 
intermediate-term, and chronic-term risks are evaluated by comparing 
food, water, and residential exposure to the POD to ensure that the 
margin of exposure (MOE) called for by the product of all applicable 
UFs is not exceeded. This latter value is referred to as the Level of 
Concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk. Thus, the Agency estimates 
risk in terms of the probability of an occurrence of the adverse effect 
greater than that expected in a lifetime. For more information on

[[Page 55465]]

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 pyriproxyfen used for 
human risk assessment can be found at http://www.regulations.gov in 
docket ID number EPA-HQ-OPP-2009-0018 on pages 16-18 of the document 
titled ``Pyriproxyfen. Human Health Risk Assessment for the Proposed 
Use of Pyriproxyfen in/on Vegetables, Leaves of Root and Tuber, Group 
2; Vegetables, Leafy, Except Brassica, Group 4; Vegetable, Foliage of 
Legume, Group 7; Fruit, Small, Vine Climbing, Except Grape, Subgroup 
13-07E; Artichoke, Globe; Asparagus; and Watercress Commodities.''

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to pyriproxyfen, EPA considered exposure under the petitioned-
for tolerances as well as all existing pyriproxyfen tolerances in 40 
CFR 180.510. EPA assessed dietary exposures from pyriproxyfen 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 pyriproxyfen; 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 U.S. Department 
of Agriculture (USDA) 1994-1996 and 1998 Continuing Survey of Food 
Intake by Individuals (CSFII). As to residue levels in food, EPA 
performed an unrefined chronic analysis which assumed 100% crop treated 
(CT), default processing factors, and tolerance level residues for all 
commodities.
    iii. Cancer. Based on the absence of evidence of carcinogenicity in 
two adequate rodent carcinogenicity studies, EPA has classified 
pyriproxyfen as ``not likely to be carcinogenic to humans.'' Therefore, 
a quantitative exposure assessment to evaluate cancer risk is 
unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
As noted above in Unit III.C.1.ii., EPA did not use anticipated residue 
and/or PCT information in the dietary assessment for pyriproxyfen. 
Tolerance level residues and/or 100% CT 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 pyriproxyfen in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of pyriproxyfen. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of 
pyriproxyfen for chronic exposures for non-cancer assessments are 
estimated to be 0.52 parts per billion (ppb) for surface water and 
0.0022 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the water concentration of value 0.52 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).
    Pyriproxyfen is the active ingredient in many registered 
residential products for flea and tick control (home environment and 
pet treatments) as well as products for ant and roach control (indoor 
and outdoor applications). Formulations include carpet powders, 
foggers, aerosol sprays, liquids (shampoos, sprays and pipettes for pet 
treatments), granules, bait (indoor and outdoor), and impregnated 
materials (pet collars). Only a post-application residential assessment 
was conducted as the Agency did not select any short-term dermal or 
inhalation endpoints. Toddlers are anticipated to have the highest 
exposures from treated home environments and pets due to typical hand-
to-mouth behavior. EPA assessed residential exposure using the 
following assumptions:
     Short-term, intermediate-term, and long-term toddler hand-
to-mouth exposures (consisting of petting treated animals and touching 
treated carpets/flooring).
     Long-term dermal exposures for products with anticipated 
efficacy more than 6 months (carpet powders and pet collars).
     Combined treatment toddler exposure scenarios as a result 
of treatments to the home environment and the pet in the same period 
(such as carpet powder and pet shampoo treatments). Episodic ingestion 
of granules by toddlers is anticipated, but an assessment for this 
scenario is not included, since an acute dietary endpoint was not 
selected.
    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 pyriproxyfen to share a common mechanism of 
toxicity with any other substances, and pyriproxyfen does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
pyriproxyfen 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 Food Quality 
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA 
either retains the default value of 10X, or uses a different additional 
SF when reliable data available to EPA support the choice of a 
different factor.
    2. Prenatal and postnatal sensitivity. Based on the available data, 
there is no quantitative and qualitative evidence of increased 
susceptibility observed following in utero pyriproxyfen exposure to 
rats and rabbits or following prenatal/postnatal exposure in the 2-
generation reproduction study.

[[Page 55466]]

    3. Conclusion. EPA has determined that reliable data show that it 
would be safe for infants and children to reduce the FQPA SF to 1X. 
That decision is based on the following findings:
    i. The toxicity database for pyriproxyfen is complete except for 
acute and subchronic neurotoxicity studies and immunotoxicity testing. 
Recent changes to 40 CFR part 158 make these studies (OPPTS Guideline 
870.7800) required for pesticide registration; however, the available 
data for pyriproxyfen do not show potential for neurotoxicity or 
immunotoxicity. Although neurotoxicity studies have not yet been 
submitted, there is no evidence of neurotoxicity in any study in the 
toxicity database for pyriproxyfen. Similarly, although the database 
contains no specific immunotoxicity studies, no evidence of 
immunotoxicity was found in existing studies. EPA does not believe that 
conducting immunotoxicity testing will result in a NOAEL less than the 
chronic Referenced Dose (cRfD) NOAEL of 35.1 milligrams/kilogram body 
weight/day (mg/kg bw/day) already established for pyriproxyfen or that 
acute or subchronic neurotoxicity studies would affect selection of the 
acute Referenced Dose (aRfD) or cRfD. Accordingly, EPA concludes that 
an additional factor for database uncertainties is not needed to 
account for potential immunotoxicity or neurotoxicity.
    ii. There is no indication that pyriproxyfen is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional uncertainty factors (UF) to account for neurotoxicity.
    iii. There is no evidence that pyriproxyfen results in increased 
susceptibility in utero in rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100% CT and tolerance-level residues. Conservative ground water and 
surface water modeling estimates were used. Similarly, conservative 
Residential Standard Operating Procedues (SOPs) were used to assess 
post-application exposure to children as well as incidental oral 
exposure of toddlers. These assessments will not underestimate the 
exposure and risks posed by pyriproxyfen.

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 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 adverse effect resulting from a single-oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
pyriproxyfen 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 
pyriproxyfen from food and water will utilize 10% of the cPAD for 
children 1 to 2 years old, the population group receiving the greatest 
exposure. A long-term post-application residential assessment was 
performed. Toddlers are anticipated to have higher exposures than 
adults from treated home environments and pets due to their behavior 
patterns. The total chronic dietary and residential aggregate MOEs 
range from 580 to 4,500. For pyriproxifen, EPA would be concerned if 
the MOE was below 100.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Pyriproxyfen is currently registered for uses that could result in 
short-term residential exposure and the Agency has determined that it 
is appropriate to aggregate chronic exposure through food and water 
with short-term residential exposures to pyriproxyfen.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures aggregated result in aggregate MOEs of 1,200 
for children 1 to 2 years old, the population group receiving the 
greatest exposure, and therefore is not a concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    Pyriproxyfen is currently registered for uses that could result in 
intermediate-term residential exposure and the Agency has determined 
that it is appropriate to aggregate chronic exposure to pyriproxyfen 
through food and water with intermediate-term exposures for 
pyriproxyfen.
    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that the combined 
intermediate-term food, water, and residential exposures aggregated 
result in aggregate MOEs of 430 for children 1 to 2 years old, the 
population group receiving the greatest exposure, and therefore is not 
a concern.
    5. Aggregate cancer risk for U.S. population. Pyriproxyfen is 
classified as a ``Group E'' chemical (negative for carcinogenicity in 
humans). This classification is based on the lack of evidence of 
carcinogenicity in mice and rats. EPA does not expect pyriproxyfen to 
pose a cancer risk.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to pyriproxyfen residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography/nitrogen-
phosphorous detector; GC/NPD) 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 currently no established Codex maximum residue limits for 
pyriproxyfen.

V. Conclusion

    Therefore, tolerances are established for residues of pyriproxyfen 
in or on artichoke, globe at 2.0 ppm; asparagus at 2.0 ppm; fruit, 
small, vine climbing subgroup, except grape 13-07E at 0.35 ppm; 
vegetable, foliage of legume, group 7 at 2.0 ppm; vegetable, leafy, 
except brassica, group 4 at 3.0 ppm; vegetable, leaves of root and 
tuber, group 2 at 2.0 ppm; and watercress at 2.0 ppm.

[[Page 55467]]

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 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: October 16, 2009.
Daniel J. Rosenblatt,
Acting 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 180.510 is amended by alphabetically adding the following 
commodities to the table in paragraph (a)(1) and by revising paragraph 
(b) to read as follows:

Sec.  180.510  Pyriproxyfen; tolerances for residues

    (a) * * *(1) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Artichoke, globe.....................................                2.0
Asparagus............................................                2.0
                                * * * * *
Fruit, small, vine climbing, except grape, subgroup                 0.35
 13-07E..............................................
                                * * * * *
Vegetable, foliage of legume, group 7................                2.0
                                * * * * *
Vegetable, leafy, except Brassica, group 4...........                3.0
Vegetable, leaves of root and tuber, group 2.........                2.0
                                * * * * *
Watercress...........................................                2.0
                                * * * * *
------------------------------------------------------------------------

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

[FR Doc. E9-25689 Filed 10-27-09; 8:45 am]

BILLING CODE 6560-50-S