[Federal Register Volume 77, Number 239 (Wednesday, December 12, 2012)]
[Rules and Regulations]
[Pages 73951-73956]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-29978]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-1012; FRL-9365-6]


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 multiple commodities which are identified and 
discussed later in this document. Interregional Research Project Number 
4 (IR-4) requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective December 12, 2012. Objections and 
requests for hearings must be received on or before February 11, 2013, 
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: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2011-1012, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution 
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information 
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Andrew Ertman, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9367; email address: [email protected].

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. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather

[[Page 73952]]

provides a guide to help readers determine whether this document 
applies to them. Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How Can I File an Objection or Hearing Request?

    Under FFDCA section 408(g), 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-2011-1012 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
February 11, 2013. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    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 (excluding any (Confidential Business Information CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2011-1012, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of March 14, 2012 (77 FR 15012) (FRL-9335-
9), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
1E7950) 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, 2-[1-methyl-2-(4-phenoxyphenoxy)ethoxypyridine, in or on 
vegetable, bulb, group 3-07 at 0.70 parts per million (ppm); vegetable, 
fruiting, group 8-10 at 0.20 ppm; fruit, citrus, group 10-10 at 0.30 
ppm; fruit, pome, group 11-10 at 0.20 ppm; caneberry subgroup 13-07A at 
1.0 ppm; bushberry subgroup 13-07B at 1.0 ppm; berry, low growing, 
except strawberry, subgroup 13-07H at 1.0 ppm; and herb subgroup 19A at 
50 ppm. Also, due to the establishment of the tolerances for the new 
crop groups listed in this unit, the petition proposed the removal of 
the following commodities as unnecessary: Vegetable, bulb, group 3, 
except onion, bulb; onion, bulb; vegetable, fruiting, group 8; okra; 
fruit, citrus; fruit, pome; caneberry subgroup 13-A; bushberry subgroup 
13-B; cranberry; loganberry; juneberry; lingonberry; and salal. That 
document referenced a summary of the petition prepared by Valent USA 
Corporation, the registrant, which is available in the docket, 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 the levels at which tolerances are being established for 
several commodities. The reason for these changes is explained in Unit 
IV.C.

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 FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA 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 pyriproxyfen including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with pyriproxyfen 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 by oral, dermal, inhalation, 
and ocular routes of exposure. Pyriproxyfen is not a skin irritant and 
was negative in the dermal sensitization study in guinea pigs. Based on 
repeated dose studies in mice, rats, and dogs the liver and kidney are 
the principal target organs, with slight anemia occurring in rodent 
species. The review of the acute and subchronic neurotoxicity studies 
indicates pyriproxyfen is not a neurotoxic chemical. There was no 
evidence of prenatal or postnatal sensitivity or increased 
susceptibility in developmental studies in rats and rabbits, and in 
reproduction studies in rats. In the 2-generation reproduction toxicity 
study, offspring toxicity (decreased body weight on pups during 
lactation days 14 to 21) occurred in the presence of decreased body 
weight in parental animals at the same dose level. An immunotoxicity 
study showed no adverse effects on the immune system. No significant 
systemic toxicity was

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observed in either the 21-day dermal toxicity study in rats. In a 28-
day inhalation study, the Lowest-observed-adverse-effect-level (LOAEL) 
of 1 milligram/Liter (mg/L) based on salivation in females and sporadic 
decreased body weight gains in males was not considered biologically 
relevant. With respect to carcinogenicity pyriproxyfen has been 
classified as a ``Group E'' chemical--no evidence for carcinogenicity 
to humans based on the absence of carcinogenicity in mice and rats. 
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 on pp. 28-33 in the document titled ``Pyriproxyfen. 
Human Health Risk Assessment for the Request to Add Uses on Herb 
Subgroup 19A, and the Expansions of Existing Crop Group Uses to 
Numerous Crop Subgroups'' in docket ID number EPA-HQ-OPP-2011-1012.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). 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 expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for pyriproxyfen used for 
human risk assessment is shown in Table 1 of this unit.

 Table 1--Summary of Toxicological Doses and Endpoints for Pyriproxyfen for Use in Human Health Risk Assessment
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                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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Acute dietary (Females 13-50        An appropriate endpoint attributable to a single oral dose was not available
 years of age and general              in the data base, including the developmental and reproduction toxicity
 population).                                                         studies.
                                  ------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL = 35.1 mg/kg/   Chronic RfD = 0.35   Subchronic and chronic rat (co-
                                    day.                  mg/kg/day.           critical)
                                   UFA = 10X...........  cPAD = 0.35 mg/kg/   LOAEL = 141.28 mg/kg/day based on
                                   UFH = 10X...........   day.                 decreased body weight and
                                   FQPA SF = 1X........                        alterations in clinical pathology
                                                                               parameters.
Incidental oral short-term (1 to   NOAEL = 100 mg/kg/    LOC for MOE = 100..  Rat developmental toxicity
 30 days).                          day.                                       Maternal LOAEL = 300 mg/kg/day
                                   UFA = 10X...........                        based on decreased body weight,
                                   UFH = 10X...........                        body weight gain, and food
                                   FQPA SF = 1X........                        consumption, and increased water
                                                                               consumption.
Incidental oral intermediate-term  NOAEL = 35.1 mg/kg/   LOC for MOE = 100..  Subchronic and chronic rat (co-
 (1 to 6 months).                   day.                                       critical)
                                   UFA= 10X............                       LOAEL = 141.28 mg/kg/day based on
                                   UFH= 10X............                        decreased body weight and
                                   FQPA SF = 1X........                        alterations in clinical pathology
                                                                               parameters.
Dermal long-term (6 months--       Oral study NOAEL =    LOC for MOE = 100..  Subchronic and chronic rat (co-
 lifetime).                         35.1 mg/kg/day                             critical)
                                    (dermal absorption                        LOAEL = 141.28 mg/kg/day based
                                    rate = 30%.                                decreased body weight and
                                   UFA = 10X...........                        alterations in clinical pathology
                                   UFH = 10X...........                        parameters.
                                   FQPA SF = 1X........
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (c = chronic). RfD = reference dose. UF = uncertainty factor. UFA =
  extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of
  the human population (intraspecies).

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;

[[Page 73954]]

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 
assumed 100 percent crop treated (PCT) and tolerance level residues.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that pyriproxyfen does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for pyriproxyfen. Tolerance level residues and/or 
100 PCT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for 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 Tier 1 Rice Model and the Generic Estimated Exposure 
Concentration (GENEEC) model the estimated drinking water 
concentrations (EDWCs) of pyriproxyfen for chronic exposure assessments 
are estimated to be 2.98 parts per billion (ppb) for surface water and 
0.006 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 2.98 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 currently registered 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). EPA assessed residential exposure 
using the following assumptions: Although there is the potential for 
short-term residential handler dermal and inhalation exposure as well 
as short or intermediate post-application exposure from the registered 
uses of pyriproxyfen, there are no short-term dermal or inhalation PODs 
and quantitative assessments were not conducted.
    Based on the registered use patterns, the following post-
application scenarios were assessed: Short- and intermediate-term hand-
to-mouth exposures for 1 to <2 year olds from treated carpets and 
flooring and petting treated animals (shampoos, sprays, spot-on 
treatments and collars); long-term hand-to-mouth exposures for 1 to <2 
year olds from treated carpets and flooring and petting treated 
animals; and long-term dermal exposures from treated carpets, flooring, 
and pets.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    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 Web site 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 
safety factors (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.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for pyriproxfen 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 (UFs) 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 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to pyriproxyfen in drinking water. EPA used 
similarly conservative assumptions to assess post-application exposure 
of 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 dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and

[[Page 73955]]

residential exposure to the appropriate PODs to ensure that an adequate 
MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from 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 12% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. A long-term post-application residential assessment was 
performed for toddlers only since they 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 MOE is 220 for children 1-2 years old. As this MOE is greater 
than 100, the chronic aggregate risk does not exceed EPA's level of 
concern.
    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 result in an aggregate MOE of 2,000 for 
children 1-2 years old, the population subgroup receiving the greatest 
exposure. Because EPA's level of concern (LOC) for pyriproxyfen is a 
MOE of 100 or below, this MOE is not of 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 through food and 
water with intermediate-term residential exposures to 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 result in an 
aggregate MOE of 720 for children 1-2 years old, the population 
subgroup receiving the greatest exposure. Because EPA's LOC for 
pyriproxyfen is a MOE of 100 or below, this MOE is not of concern.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, pyriproxyfen is not expected to pose a cancer risk to humans.
    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 with Nitrogen 
Phosphorous Detection; 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; email address: 
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has established MRLs for pyriproxyfen in or on citrus 
fruit at 0.50 ppm. This MRL is the same as the tolerance being 
established for pyriproxyfen on the citrus group 10-10 in the United 
States. There are no Codex MRLs for the other commodities addressed by 
this final rule.

C. Revisions to Petitioned-for Tolerances

    Based on calculations using the Organization for Economic Co-
operation and Development (OECD) MRL calculator, the Agency is 
establishing the tolerance for the herb subgroup 19A at 100 ppm instead 
of the proposed level of 50 ppm. In addition, the tolerance for the 
citrus fruit group 10-10 is being revised to 0.5 ppm to harmonize with 
Codex and the tolerance for the fruiting vegetable group 8-10 is being 
revised to 0.8 ppm to harmonize with the Canadian MRL for bell peppers.
    Lastly, EPA has revised the tolerance expression to clarify:
    1. That, as provided in FFDCA section 408(a)(3), the tolerance 
covers metabolites and degradates of pyriproxyfen not specifically 
mentioned.
    2. That compliance with the specified tolerance levels is to be 
determined by measuring only the specific compounds mentioned in the 
tolerance expression.

V. Conclusion

    Therefore, tolerances are established for residues of pyriproxyfen, 
2-[1-methyl-2-(4-phenoxyphenoxy) ethoxypyridine, in or on vegetable, 
bulb, group 3-07 at 0.70 ppm; vegetable, fruiting, group 8-10 at 0.80 
ppm; fruit, citrus, group 10-10 at 0.50 ppm; fruit, pome, group 11-10 
at 0.20 ppm; caneberry subgroup 13-07A at 1.0 ppm; bushberry subgroup 
13-07B at 1.0 ppm; berry, low growing, except strawberry, subgroup 13-
07H at 1.0 ppm; and the herb subgroup 19A at 100 ppm. Also, due to the 
establishment of the tolerances for the new crop groups listed in this 
unit, the following are being removed as unnecessary: Vegetable, bulb, 
group 3, except onion, bulb; onion, bulb; vegetable, fruiting, group 8; 
okra; fruit, citrus; fruit, pome; caneberry subgroup 13-A; bushberry 
subgroup 13-B; cranberry; loganberry; juneberry; lingonberry; salal; 
and citrus hybrids.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d) 
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

[[Page 73956]]

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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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) (2 U.S.C. 1501 et seq.).
    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) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
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 
the rule in the Federal Register. This action 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: December 4, 2012.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
    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. In Sec.  180.510:
0
a. Revise the introductory text of paragraph (a)(1).
0
b. Remove from the table in paragraph (a)(1) the commodities: 
``Bushberry subgroup 13-B''; ``Caneberry subgroup 13-A''; ``Citrus 
hybrids'', ``Cranberry''; ``Fruit, citrus''; ``Fruit, pome''; 
``Juneberry''; ``Lingonberry''; ``Loganberry''; ``Okra''; ``Onion, 
bulb''; ``Salal''; and ``Vegetable, bulb, group 3, except onion, 
bulb''; and ``Vegetable, fruiting, group 8''.
0
c. Add alphabetically the following commodities to the table in 
paragraph (a)(1).
    The amendments read as follows:


Sec.  180.510  Pyriproxyfen; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of 
pyriproxyfen, including its metabolites and degradates, in or on the 
commodities in the following table. Compliance with the tolerance 
levels specified is determined by measuring only pyriproxyfen, 2-[1-
methyl-2-(4-phenoxyphenoxy) ethoxy]pyridine, in or on the commodity.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Berry, low growing, except strawberry, subgroup 13-07H....          1.0
 
                                * * * * *
Bushberry subgroup 13-07B.................................          1.0
 
                                * * * * *
Caneberry subgroup 13-07A.................................          1.0
 
                                * * * * *
Fruit, citrus, group 10-10................................          0.50
Fruit, pome, group 11-10..................................          0.20
 
                                * * * * *
Herb subgroup 19A.........................................        100
 
                                * * * * *
Vegetable, bulb, group 3-07...............................          0.70
 
                                * * * * *
Vegetable, fruiting, group 8-10...........................          0.80
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2012-29978 Filed 12-11-12; 8:45 am]
BILLING CODE 6560-50-P