
[Federal Register Volume 81, Number 34 (Monday, February 22, 2016)]
[Rules and Regulations]
[Pages 8658-8663]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03608]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-1012; FRL-9941-38]


Pyriproxyfen; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation increases the currently established tolerance 
for residues of pyriproxyfen in or on tea from 0.02 parts per million 
(ppm) to 15 ppm. Sumitomo Chemical Company, Ltd., c/o Valent U.S.A. 
Corporation, requested these tolerances under the Federal Food, Drug, 
and Cosmetic Act (FFDCA).

DATES: This regulation is effective February 22, 2016. Objections and 
requests for hearings must be received on or before April 22, 2016, 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), West William Jefferson Clinton 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: Susan Lewis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: RDFRNotices@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. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather 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://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

[[Page 8659]]

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 
April 22, 2016. 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.html.

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 December 2, 2015 (80 FR 75449) (FRL-
9939-55), 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 
#4E8326) by Sumitomo Chemical Company, Ltd., c/o Valent U.S.A. 
Corporation, 1600 Riviera Avenue, Suite 200, Walnut Creek, CA 94596. 
The petition requested that 40 CFR 180.510 be amended to increase the 
currently established tolerance for residues of pyriproxyfen in/on tea 
from 0.02 ppm to 15.0 parts per million (ppm). That document referenced 
a summary of the petition prepared by Sumitomo Chemical Company, Ltd., 
c/o Valent U.S.A. Corporation, the registrant, which is available in 
the docket, http://www.regulations.gov. There were no substantive 
comments received in response to the notice of filing.
    Based upon review of the data supporting the petition, the 
petitioned-for tolerance for residues of pyriproxyfen in/on tea (15.0 
ppm) must be corrected to 15 ppm, consistent with current practices for 
setting tolerances. The reason for this change is explained in Unit 
IV.D.

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 elicits 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, 
kidney, and hematopoietic system are the primary targets of 
pyriproxyfen. Neurotoxicity, in the form of reduced motor activity, 
occurred only at a doses well above those required to elicit toxicity 
in the liver, kidney, and hematopoietic system indicating the nervous 
system is not a principle target. There was no evidence of prenatal or 
postnatal sensitivity or increased susceptibility in developmental 
toxicity studies in rats and rabbits, and in a 2-generation 
reproduction toxicity study in rats. An immunotoxicity study showed no 
adverse effects on the immune system. No significant systemic toxicity 
was observed in the 21-day dermal toxicity study in rats. In a 28-day 
inhalation study, salivation in females and sporadic decreased body 
weight gains in males was observed at 1 milligram/Liter (mg/L); 
however, these effects were not considered biologically relevant. There 
is 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 LOAEL 
from the toxicity studies can be found at http://www.regulations.gov on 
pp. 10-18 in the document titled ``Pyriproxyfen. Human Health Risk 
Assessment for the Petition to Increase the Established Tolerance in/on 
Tea with a U.S. Registration for Imported Pyriproxyfen-treated Tea.'' 
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.

[[Page 8660]]

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
----------------------------------------------------------------------------------------------------------------
                                     Point of departure and
         Exposure/Scenario             uncertainty/safety    RfD, PAD, LOC for risk    Study and toxicological
                                             factors               assessment                  effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (All populations)....       An appropriate endpoint attributable to a single oral dose was not
                                        identified in the toxicology database, including the developmental and
                                                            reproduction toxicity studies.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All                 NOAEL = 35.1 mg/kg/day  Chronic RfD = 0.35 mg/  Subchronic (41321716) and
 populations).\1\                    UFA = 10x.............   kg/day.                 chronic (43210503)--rat
                                     UFH = 10x.............  cPAD = 0.35 mg/kg/day.   (co-critical). LOAEL =
                                     FQPA SF = 1x..........                           141.28 mg/kg/day based on
                                                                                      decreased body weight and
                                                                                      body weight gain, anemia,
                                                                                      and increased relative
                                                                                      liver weight with elevated
                                                                                      cholesterol and
                                                                                      phospholipid levels.
Incidental oral short-term (1-30     NOAEL = 100 mg/kg/day.  LOC for MOE = 100.....  Rat developmental toxicity
 days).                              UFA = 10x.............                           (44985002). Maternal LOAEL
                                     UFH = 10x.............                           = 300 mg/kg/day based on
                                                                                      decreased body weight,
                                                                                      body weight gain, and food
                                                                                      consumption, and increased
                                                                                      water consumption.
Incidental oral intermediate-term    NOAEL = 35.1 mg/kg/day  LOC for MOE = 100.....  Subchronic (41321716) and
 (1-6 months).\1\                    UFA = 10x.............                           chronic (43210503)--rat
                                     UFH = 10x.............                           (co-critical). LOAEL =
                                                                                      141.28 mg/kg/day based on
                                                                                      decreased body weight and
                                                                                      body weight gain, anemia,
                                                                                      and increased relative
                                                                                      liver weight with elevated
                                                                                      cholesterol and
                                                                                      phospholipid levels.
----------------------------------------------------------------------------------------------------------------
Dermal short- and intermediate-term  Based on the systemic toxicity NOAEL of 1,000 mg/kg/day (limit dose) in the
 (1-30 days and 1-6 months).            21 day dermal toxicity study in rats, quantification of dermal risks is
                                       not required. In addition, no developmental concerns (toxicity) were seen
                                                              in either rats or rabbits.
----------------------------------------------------------------------------------------------------------------
Dermal long-term (6 months-          NOAEL = 35.1 mg/kg/day  LOC for MOE = 100.....  Subchronic (41321716) and
 lifetime).\1\                       DAF = 30% \2\.........                           chronic (43210503)--rat
                                     UFA = 10x.............                           (co-critical). LOAEL =
                                     UFH = 10x.............                           141.28 mg/kg/day based on
                                                                                      decreased body weight and
                                                                                      body weight gain, anemia,
                                                                                      and increased relative
                                                                                      liver weight with elevated
                                                                                      cholesterol and
                                                                                      phospholipid levels.
----------------------------------------------------------------------------------------------------------------
Inhalation short- and intermediate-    Based on the absence of biologically relevant toxicity at 1.0 mg/L, the
 term (1-30 days and 1-6 months).         quantification of inhalation risks is not required. In addition, no
                                        developmental concerns (toxicity) were seen in either rats or rabbits.
----------------------------------------------------------------------------------------------------------------
Inhalation long-term (6 months-      NOAEL = 35.1 mg/kg/day  LOC for MOE = 100.....  Subchronic (41321716) and
 lifetime).\1\                       UFA = 10x.............                           chronic (43210503)--rat
                                     UFH = 10x.............                           (co-critical). LOAEL =
                                                                                      141.28 mg/kg/day based on
                                                                                      decreased body weight and
                                                                                      body weight gain, anemia,
                                                                                      and increased relative
                                                                                      liver weight with elevated
                                                                                      cholesterol and
                                                                                      phospholipid levels.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)..         No evidence of carcinogenicity in mice and rats (TXR 0012966).
----------------------------------------------------------------------------------------------------------------
Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data
  and used to mark the beginning of extrapolation to determine risk associated with lower environmentally
  relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect
  level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential
  variation in sensitivity among members of the human population (intraspecies). DAF = dermal absorption factor.
\1\ The NOAEL and LOAEL for the co-critical studies were based on the female endpoints from the chronic and sub-
  chronic rat studies, respectively. Females demonstrated greater or equivalent sensitivity to oral pyriproxyfen
  exposure relative to males; therefore, selection of two female endpoints accounted for effects observed in the
  males and preserved consistency between the NOAEL and LOAEL.
\2\ DAF estimated by comparing the rat developmental LOAEL of 300 mg/kg/day to the 21-day rat dermal study NOAEL
  of 1,000 mg/kg/day (No NOAEL) = 300/1,000 = 30%.


[[Page 8661]]

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 USDA 2003-2008 
National Health and Nutrition Examination Survey, What We Eat in 
America (NHANES/WWEIA). 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 nonoccupational, 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-term post-application exposure from the 
registered uses of pyriproxyfen, there are no short or intermediate-
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 FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor 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 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 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-

[[Page 8662]]

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 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 230 for children 1 to <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 2,200 for 
children 1 to <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 760 for children 1 to <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: 
residuemethods@epa.gov.

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.
    No Codex MRL for residues of pyriproxyfen is established in/on tea 
commodities.

C. Revisions to Petitioned-for Tolerances

    Although the petitioner requested a tolerance for 15.0 ppm, the 
Agency is establishing a tolerance at 15 ppm, consistent with the 
current practices regarding significant figures for tolerance setting.

V. Conclusion

    Therefore, 40 CFR 180.510 is being amended to increase the 
currently established tolerance for residues of pyriproxyfen in/on tea 
from 0.02 ppm to 15 ppm.

VI. Statutory and Executive Order Reviews

    This action 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 action has been 
exempted from review under Executive Order 12866, this action 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 action 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

[[Page 8663]]

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 action 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 action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(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 (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: February 4, 2016.
Susan Lewis,
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, revise the entry for tea in the table in paragraph 
(a)(1) to read as follows:


Sec.  180.510  Pyriproxyfen; tolerances for residues.

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

------------------------------------------------------------------------
                                                            Parts per
                       Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Tea....................................................              15
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2016-03608 Filed 2-19-16; 8:45 am]
 BILLING CODE 6560-50-P


