Document ID: EPA-HQ-OPP-2006-0889-0004
Agency: epa
Document Type: Notice
Title: Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: Pyriproxyfen
Posted Date: 2007-08-22T04:00Z

[Federal Register: August 22, 2007 (Volume 72, Number 162)]
[Rules and Regulations]               
[Page 46914-46919]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22au07-8]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0889; FRL-8142-4]

 
Pyriproxyfen; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
pyriproxyfen in or on animal feed, nongrass, group 18, forage; animal 
feed, nongrass, group 18, hay; animal feed, nongrass, group 18, seed; 
banana; beet, sugar, dried pulp; cacao bean, dried; caneberry, subgroup 
13-A; canola, seed; coffee, instant; coffee, green bean; cranberry; 
date; grain, cereal, group 15; grain, cereal, forage, fodder and straw, 
group 16; pawpaw; peanut; pineapple; pineapple, process residue; 
pomegranate; potato, chips; potato, granules/flakes; potato, wet peel; 
rice, hulls; safflower, seed; sesame, seed; sugarcane; tea; vegetable, 
bulb, group 3, except onion, bulb; and vegetable, root and tuber, group 
1. Interregional Research Project Number 4 (IR-4), 500 College Road 
East, Suite 201 W, Princeton, NJ 08540 requested these tolerances under 
the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective August 22, 2007. Objections and 
requests for hearings must be received on or before October 22, 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-2006-0889. 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.

FOR FURTHER INFORMATION CONTACT: Shaja R. Brothers, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-3194; e-mail address: 
brothers.shaja@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-2006-0889 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 22, 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-2006-0889, 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

[[Page 46915]]

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 November 22, 2006 (71 FR 67571) (FRL-
8102-2), 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 
6E7003) by IR-4, 500 College Road 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, 
2-1-methyl-2-(4-phenoxyphenoxy)ethoxypyridine, in or on vegetable, root 
and tuber, group 1 at 0.15 part per million (ppm); vegetable, leaves of 
root and tuber, group 2 at 2.0 ppm; vegetable, bulb, group 3, except 
onion, dry bulb at 0.70 ppm; vegetable, leafy, except brassica, group 4 
at 2.0 ppm; vegetable, legume, group 6 at 0.2 ppm; vegetable, foliage 
of legume, group 7 at 2.0 ppm; caneberry, subgroup 13A at 1.0 ppm; 
grain, cereal, group 15 at 1.1 ppm; grain, cereal, forage, fodder and 
straw, group 16 at 1.1 ppm; animal feed, nongrass, group 18 at 0.7 ppm 
for forage, 2.0 for seed, and 1.1 for hay; asparagus at 2.0 ppm; banana 
and plantain at 0.2 ppm; cacao bean at 0.02 ppm; canola, seed at 0.20 
ppm; coffee at 0.02 ppm; cranberry at 1.0 ppm; date at 0.3 ppm; grass, 
forage at 0.5 ppm; grass, hay at 1.0 ppm; kiwifruit at 0.1 ppm; pawpaw 
at 1.0 ppm; peanut at 0.2 ppm; pineapple at 0.3 ppm; pomegranate at 
0.20 ppm; safflower, seed at 0.2 ppm; sesame, seed at 0.02 ppm; 
sugarcane at 1.1 ppm; tea at 0.02 ppm; watercress at 2.0 ppm; and 
artichoke, globe at 2.0 ppm. That notice referenced a summary of the 
petition prepared by Valent USA Corporation, the registrant, which is 
available to the public in the docket, http://www.regulations.gov. One 

comment was received on the notice of filing. EPA's response to comment 
is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has 
determined that proposed tolerances for vegetable, leaves of root, and 
tuber, group 2; vegetable, leafy, except, Brassica, group 4; vegetable, 
legume, group 6; vegetable, foliage of legume, group 7; artichoke, 
globe; asparagus; kiwifruit; and watercress will not be established at 
this time. Further, the Agency is establishing the following additional 
tolerances in conjunction with the tolerances that were requested: 
Beet, sugar, dried, pulp; potato, granules/flakes; potato, chips; 
potato, wet peel; rice, hulls; coffee, instant; and pineapple, process 
residue. The reason for these changes is explained in Unit IV.

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 pyriproxyfen 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 pyriproxyfen 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 pyriproxyfen 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 
pyriproxyfen 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 tolerances 
for residues of pyriproxyfen on animal feed, nongrass, group 18, forage 
at 0.70 ppm; animal feed, nongrass, group 18, hay at 1.1 ppm; animal 
feed, nongrass, group 18, seed at 2.0 ppm; banana at 0.20 ppm; beet, 
sugar, dried pulp at 3.0 ppm; cacao bean, dried at 0.02 ppm; caneberry, 
subgroup 13-A at 1.0 ppm; canola, seed at 0.20 ppm; coffee, instant at 
0.10 ppm; coffee, green bean at 0.02 ppm; cranberry at 1.0 ppm; date at 
0.30 ppm; grain, cereal, group 15 at 1.1 ppm; grain, cereal, forage, 
fodder and straw, group 16 at 1.1 ppm; pawpaw at 1.0 ppm; peanut at 
0.20 ppm; pineapple at 0.30 ppm; pineapple, process residue at 1.1 ppm; 
pomegranate at 0.20 ppm; potato, chips at 0.75 ppm; potato, granules/
flakes at 0.75 ppm; potato, wet peel at 0.75 ppm; rice, hulls at 5.5 
ppm; safflower, seed at 0.20 ppm; sesame, seed at 0.02 ppm; sugarcane 
at 1.1 ppm; tea at 0.02 ppm; vegetable, bulb, group 3, except onion, 
bulb at 0.70 ppm; and vegetable, root and tuber, group 1 at 0.15 ppm. 
EPA's assessment of exposures and risks associated with establishing 
the tolerances follow.

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 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.epa.gov/fedrgstr/EPA-PEST/2003/May/Day-14/p12022.htm
 in Federal 

Register of May 14, 2003 (68 FR 25831) (FRL-7305-9).

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-, 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.
    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

[[Page 46916]]

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 pyriproxyfen used for 
human risk assessment can be found at http://www.regulations.gov in document 

title Pyriproxyfen Human Health Risk Assessment Use on Numerous Crops. 
IR-4 Tolerance Plan (Reduced Data Set Translations) on pages 9-10 in 
Docket ID EPA-HQ-OPP-2006-0889.

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 one-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 1994-1996 and 
1998 Nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII). As to residue levels in food, EPA performed a Tier 1 chronic 
analysis which assumed 100% crop treated (CT), default processing 
factors, and tolerance level residues for all commodities.
    iii. Cancer. A cancer dietary risk assessment was not performed 
because no evidence of carcinogenicity has been found for pyriproxyfen.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring data to complete a comprehensive dietary exposure 
analysis and risk assessment for pyriproxyfen in drinking water. 
Because the Agency does not have comprehensive monitoring data, 
drinking water concentration estimates are made by reliance on 
simulation or modeling taking into account data on the environmental 
fate characteristics of 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 EPA's Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Groundwater (SCI-
GROW) models, the estimated environmental concentrations (EECs) of 
pyriproxyfen for acute and chronic exposures for surface water are 
estimated to be 2.15 parts per billion (ppb), and 0.40 ppb, 
respectively. The EEC for chronic exposure is estimated to be 0.006 ppb 
for groundwater. Both models assumed a maximum seasonal application 
rate of 0.11 lb ai/A, 3 times per year (citrus and stone fruit).
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the water concentration of value 0.40 ppb was used to 
access 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 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 pyriproxyfen and 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 not assumed that pyriproxyfen 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. 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.
    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:

[[Page 46917]]

    i. The toxicity database for pyriproxyfen is complete.
    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 to account for neurotoxicity.
    iii. There is no evidence that pyriproxyfen results in increased 
susceptibility in in utero 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

    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-term, and long-term risks are evaluated by comparing 
aggregate exposure to the LOC to ensure that the MOE called for by the 
product of all applicable uncertainty/safety factors is not exceeded.
    1. Acute risk. No such effects were identified in the toxicological 
studies for pyriproxyfen; therefore, a quantitative acute risk 
assessment is unnecessary.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
pyriproxyfen from food and water will utilize 10% of the cPAD for the 
population group children 1-2 years old. A long-term post-application 
residential assessment was performed for toddlers only since they are 
anticipated to have the 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 570 to 4,700.
    3. Short-term and intermediate-term risk. Short and intermediate-
term aggregate exposures take into account residential exposure plus 
chronic exposure to food and water (considered to be a background 
exposure level). Pyriproxyfen is currently registered for use that 
could result in short-term and intermediate-term residential exposures 
and the Agency has determined that it is appropriate to aggregate 
chronic food and water for short-term and intermediate-term exposures 
for pyriproxyfen.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food, water, and residential 
exposures aggregated result in aggregate MOEs range from 1,200 to 
14,000 for children 1-2 years old, and females 13-49 years old, 
respectively.
    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that food, water, and 
residential exposures aggregated result in aggregate MOEs range from 
430 to 4,700 for children 1-2 years old, and females 13-49 years old, 
respectively.
    4. Aggregate cancer risk for U.S. population. Pyriproxyfen is 
classified as a ``Group E'' chemical (negative for carcinogenicity to 
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.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to 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 
(MRLs) for pyriproxyfen.

C. Response to Comments

    One comment was received by the Agency from a private citizen. The 
comment applies to the use of ``available data'' concerning the 
cumulative effects of the pesticide's residues and ``other substances 
that have a common mechanism of toxicity.'' In this case, EPA did not 
assume that this chemical has a common mechanism of toxicity with other 
substances as the chemical does not generate metabolites produced also 
by other chemicals. For specific information regarding EPA's approach 
to the use of common mechanism of toxicity to evaluate the cumulative 
effects of chemicals, please refer to EPA's website at http://www.epa.gov/pesticides/cumulative/
 to see policy statements.

V. Conclusion

    Following review of the residue data submitted with the petition, 
EPA has made several revisions to the petition's request for the 
establishment of tolerances. First, due to absence of confirmatory 
data, the Agency is not establishing in this regulation the tolerances 
proposed for vegetable, leaves of root, and tuber, group 2; vegetable, 
leafy, except, Brassica, group 4; vegetable, legume, group 6; 
vegetable, foliage of legume, group 7; artichoke, globe; asparagus; 
kiwifruit; and watercress at this time. Second, EPA determined that 
proposed tolerances for various raw agricultural commodities (beets, 
potatoes, rice, coffee, pineapples) did not appropriately address 
residue levels that could occur in foods processed from those raw 
commodities. Accordingly, relying on the theoretical processing factors 
or processing factors from the Agency's pyriproxyfen database, EPA is 
establishing tolerances for the processed commodities of beet, dry 
pulp; potato granules/flakes, chips, and wet peel; rice, hulls; coffee, 
instant; and pineapple processed residue.
    Therefore, tolerances are established for residues of pyriproxyfen, 
2-[1-methyl-2-(4-phenoxyphenoxy)ethoxypyridine, in or on the 
commodities listed in Unit III. paragraph 2.

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,

[[Page 46918]]

entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). This final rule does not 
contain any information collections subject to OMB approval under the 
Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it 
require any special considerations under Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers and food retailers, not States or tribes, nor does this action 
alter the relationships or distribution of power and responsibilities 
established by Congress in the preemption provisions of section 
408(n)(4) of FFDCA. As such, the Agency has determined that this action 
will not have a substantial direct effect on States or tribal 
governments, on the relationship between the national government and 
the States or tribal governments, or on the distribution of power and 
responsibilities among the various levels of government or between the 
Federal Government and Indian tribes. Thus, the Agency has determined 
that Executive Order 13132, entitled Federalism (64 FR 43255, August 
10, 1999) and Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000) do not apply to this rule. In addition, This rule does not impose 
any enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104-4).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of this final rule in the Federal 
Register. This final rule is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: August 9, 2007.
Donald R. Stubbs,
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) to read as follows:

Sec.  180.510  Pyriproxyfen; tolerances for residues.

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

------------------------------------------------------------------------
              Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Animal feed, nongrass, group 18,                                    0.70
 forage
------------------------------------------------------------------------
Animal feed, nongrass, group 18, hay                                 1.1
------------------------------------------------------------------------
Animal feed, nongrass, group 18,                                     2.0
 seed
------------------------------------------------------------------------
                                * * * * *
Banana                                                              0.20
------------------------------------------------------------------------
Beet, sugar, dried pulp                                              3.0
------------------------------------------------------------------------
                                * * * * *
Cacao bean, dried                                                   0.02
------------------------------------------------------------------------
Caneberry, subgroup 13-A                                             1.0
------------------------------------------------------------------------
Canola, seed                                                        0.20
------------------------------------------------------------------------
                                * * * * *
Coffee, instant                                                     0.10
------------------------------------------------------------------------
Coffee, green bean                                                  0.02
------------------------------------------------------------------------
                                * * * * *
Cranberry                                                            1.0
------------------------------------------------------------------------
                                * * * * *
Date                                                                0.30
------------------------------------------------------------------------
                                * * * * *
Grain, cereal, group 15                                              1.1
------------------------------------------------------------------------

[[Page 46919]]

Grain, cereal, forage, fodder and                                    1.1
 straw, group 16
------------------------------------------------------------------------
                                * * * * *
Pawpaw                                                               1.0
------------------------------------------------------------------------
Peanut                                                              0.20
------------------------------------------------------------------------
Pineapple                                                           0.30
------------------------------------------------------------------------
Pineapple, process residue                                           1.1
------------------------------------------------------------------------
                                * * * * *
Pomegranate                                                         0.20
------------------------------------------------------------------------
Potato, chips                                                       0.75
------------------------------------------------------------------------
Potato, granules/flakes                                             0.75
------------------------------------------------------------------------
Potato, wet peel                                                    0.75
------------------------------------------------------------------------
                                * * * * *
Rice, hulls                                                          5.5
------------------------------------------------------------------------
                                * * * * *
Safflower, seed                                                     0.20
------------------------------------------------------------------------
                                * * * * *
Sesame, seed                                                        0.02
------------------------------------------------------------------------
Sugarcane                                                            1.1
------------------------------------------------------------------------
Tea                                                                 0.02
------------------------------------------------------------------------
Vegetable, bulb, group 3, except                                    0.70
 onion, bulb
------------------------------------------------------------------------
Vegetable, root and tuber, group 1..                                0.15
------------------------------------------------------------------------

* * * * *
[FR Doc. E7-16310 Filed 8-21-07; 8:45 am]

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