81_FR_8692 81 FR 8658 - Pyriproxyfen; Pesticide Tolerances

81 FR 8658 - Pyriproxyfen; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 81, Issue 34 (February 22, 2016)

Page Range8658-8663
FR Document2016-03608

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).

Federal Register, Volume 81 Issue 34 (Monday, February 22, 2016)
[Federal Register Volume 81, Number 34 (Monday, February 22, 2016)]
[Rules and Regulations]
[Pages 8658-8663]
From the Federal Register Online  [www.thefederalregister.org]
[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: [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 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: 
[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.
    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



                                                8658                  Federal Register / Vol. 81, No. 34 / Monday, February 22, 2016 / Rules and Regulations

                                                    Authority: 42 U.S.C. 7401 et seq.                               ■ b. Removing ‘‘Chapter 10 Nitrogen                             The revision and addition read as
                                                                                                                    Oxides Emissions Budget Program                               follows:
                                                Subpart J—District of Columbia                                      (Sections 1000–1099).’’
                                                                                                                                                                                  § 52.470   Identification of plan.
                                                ■ 2. In § 52.470, the table in paragraph                            ■ c. Adding a new Chapter 10 entitled
                                                (c) is amended by:                                                  ‘‘Air Quality—Non-EGU Limits on                               *       *    *        *      *
                                                ■ a. Revising the entry for ‘‘Section                               Nitrogen Oxides Emissions.’’                                      (c) * * *
                                                199.’’

                                                                                 EPA-APPROVED REGULATIONS AND STATUTES IN THE DISTRICT OF COLUMBIA SIP
                                                                                                                                                     State effective
                                                                State citation                                   Title/Subject                                               EPA Approval date              Additional explanation
                                                                                                                                                          date

                                                                                             District of Columbia Municipal Regulations (DCMR), Title 20—Environment
                                                                                                                                        Chapter 1 General

                                                         *                              *                        *                                   *                      *                     *                       *
                                                Section 199 ..................................    Definitions and Abbreviations ......                       03/08/15    02/22/16, [insert Federal      Amended definition of
                                                                                                                                                                           Register citation].           ‘‘Fossil fuel-fired’’

                                                            *                            *                              *                            *                       *                      *                     *
                                                                                                 Chapter 10 Air Quality—Non-EGU Limits on Nitrogen Oxides Emissions
                                                Section 1000 ................................     Applicability ..................................           03/08/15    02/22/16, [insert Federal
                                                                                                                                                                           Register citation].
                                                Section 1001 ................................     NOX Emissions Budget and NOX                               03/08/15    02/22/16, [insert Federal
                                                                                                   Limit Per Source.                                                       Register citation].
                                                Section 1002 ................................     Emissions Monitoring ..................                    03/08/15    02/22/16, [insert Federal
                                                                                                                                                                           Register citation].
                                                Section 1003 ................................     Record-Keeping and Reporting ...                           03/08/15    02/22/16, [insert Federal
                                                                                                                                                                           Register citation].
                                                Section 1004 ................................     Excess Emissions ........................                  03/08/15    02/22/16, [insert Federal
                                                                                                                                                                           Register citation].

                                                            *                            *                              *                            *                       *                      *                     *



                                                *       *         *       *       *                                 ADDRESSES:    The docket for this action,                     I. General Information
                                                [FR Doc. 2016–03489 Filed 2–19–16; 8:45 am]                         identified by docket identification (ID)
                                                                                                                                                                                  A. Does this action apply to me?
                                                BILLING CODE 6560–50–P                                              number EPA–HQ–OPP–2011–1012, is
                                                                                                                    available at http://www.regulations.gov                          You may be potentially affected by
                                                                                                                    or at the Office of Pesticide Programs                        this action if you are an agricultural
                                                ENVIRONMENTAL PROTECTION                                            Regulatory Public Docket (OPP Docket)
                                                AGENCY                                                                                                                            producer, food manufacturer, or
                                                                                                                    in the Environmental Protection Agency                        pesticide manufacturer. The following
                                                40 CFR Part 180                                                     Docket Center (EPA/DC), West William                          list of North American Industrial
                                                                                                                    Jefferson Clinton Bldg., Rm. 3334, 1301                       Classification System (NAICS) codes is
                                                [EPA–HQ–OPP–2011–1012; FRL–9941–38]                                 Constitution Ave. NW., Washington, DC                         not intended to be exhaustive, but rather
                                                                                                                    20460–0001. The Public Reading Room                           provides a guide to help readers
                                                Pyriproxyfen; Pesticide Tolerances
                                                                                                                    is open from 8:30 a.m. to 4:30 p.m.,                          determine whether this document
                                                AGENCY:  Environmental Protection                                   Monday through Friday, excluding legal                        applies to them. Potentially affected
                                                Agency (EPA).                                                       holidays. The telephone number for the                        entities may include:
                                                ACTION: Final rule.                                                 Public Reading Room is (202) 566–1744,                           • Crop production (NAICS code 111).
                                                                                                                    and the telephone number for the OPP
                                                SUMMARY:   This regulation increases the                            Docket is (703) 305–5805. Please review                          • Animal production (NAICS code
                                                currently established tolerance for                                                                                               112).
                                                                                                                    the visitor instructions and additional
                                                residues of pyriproxyfen in or on tea
                                                                                                                    information about the docket available                           • Food manufacturing (NAICS code
                                                from 0.02 parts per million (ppm) to 15
                                                                                                                    at http://www.epa.gov/dockets.                                311).
                                                ppm. Sumitomo Chemical Company,
                                                Ltd., c/o Valent U.S.A. Corporation,                                FOR FURTHER INFORMATION CONTACT:                                 • Pesticide manufacturing (NAICS
                                                requested these tolerances under the                                Susan Lewis, Registration Division                            code 32532).
                                                Federal Food, Drug, and Cosmetic Act                                (7505P), Office of Pesticide Programs,                        B. How can I get electronic access to
                                                (FFDCA).                                                            Environmental Protection Agency, 1200                         other related information?
                                                DATES: This regulation is effective                                 Pennsylvania Ave. NW., Washington,
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                                                February 22, 2016. Objections and                                   DC 20460–0001; main telephone                                    You may access a frequently updated
                                                requests for hearings must be received                              number: (703) 305–7090; email address:                        electronic version of EPA’s tolerance
                                                on or before April 22, 2016, and must                               RDFRNotices@epa.gov.                                          regulations at 40 CFR part 180 through
                                                be filed in accordance with the                                                                                                   the Government Printing Office’s e-CFR
                                                                                                                    SUPPLEMENTARY INFORMATION:
                                                instructions provided in 40 CFR part                                                                                              site at http://www.ecfr.gov/cgi-bin/text-
                                                178 (see also Unit I.C. of the                                                                                                    idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
                                                SUPPLEMENTARY INFORMATION).                                                                                                       40tab_02.tpl.


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                                                                 Federal Register / Vol. 81, No. 34 / Monday, February 22, 2016 / Rules and Regulations                                          8659

                                                C. How can I file an objection or hearing               that 40 CFR 180.510 be amended to                     considered available information
                                                request?                                                increase the currently established                    concerning the variability of the
                                                  Under FFDCA section 408(g), 21                        tolerance for residues of pyriproxyfen                sensitivities of major identifiable
                                                U.S.C. 346a, any person may file an                     in/on tea from 0.02 ppm to 15.0 parts                 subgroups of consumers, including
                                                objection to any aspect of this regulation              per million (ppm). That document                      infants and children.
                                                                                                        referenced a summary of the petition                     Pyriproxyfen elicits low acute toxicity
                                                and may also request a hearing on those
                                                                                                        prepared by Sumitomo Chemical                         by oral, dermal, inhalation, and ocular
                                                objections. You must file your objection
                                                                                                        Company, Ltd., c/o Valent U.S.A.                      routes of exposure. Pyriproxyfen is not
                                                or request a hearing on this regulation
                                                                                                        Corporation, the registrant, which is                 a skin irritant and was negative in the
                                                in accordance with the instructions
                                                                                                        available in the docket, http://                      dermal sensitization study in guinea
                                                provided in 40 CFR part 178. To ensure
                                                                                                        www.regulations.gov. There were no                    pigs. Based on repeated dose studies in
                                                proper receipt by EPA, you must
                                                                                                        substantive comments received in                      mice, rats, and dogs the liver, kidney,
                                                identify docket ID number EPA–HQ–
                                                                                                        response to the notice of filing.                     and hematopoietic system are the
                                                OPP–2011–1012 in the subject line on                      Based upon review of the data                       primary targets of pyriproxyfen.
                                                the first page of your submission. All                  supporting the petition, the petitioned-              Neurotoxicity, in the form of reduced
                                                objections and requests for a hearing                   for tolerance for residues of                         motor activity, occurred only at a doses
                                                must be in writing, and must be                         pyriproxyfen in/on tea (15.0 ppm) must                well above those required to elicit
                                                received by the Hearing Clerk on or                     be corrected to 15 ppm, consistent with               toxicity in the liver, kidney, and
                                                before April 22, 2016. Addresses for                    current practices for setting tolerances.             hematopoietic system indicating the
                                                mail and hand delivery of objections                    The reason for this change is explained               nervous system is not a principle target.
                                                and hearing requests are provided in 40                 in Unit IV.D.                                         There was no evidence of prenatal or
                                                CFR 178.25(b).                                                                                                postnatal sensitivity or increased
                                                  In addition to filing an objection or                 III. Aggregate Risk Assessment and
                                                                                                                                                              susceptibility in developmental toxicity
                                                hearing request with the Hearing Clerk                  Determination of Safety
                                                                                                                                                              studies in rats and rabbits, and in a 2-
                                                as described in 40 CFR part 178, please                    Section 408(b)(2)(A)(i) of FFDCA                   generation reproduction toxicity study
                                                submit a copy of the filing (excluding                  allows EPA to establish a tolerance (the              in rats. An immunotoxicity study
                                                any Confidential Business Information                   legal limit for a pesticide chemical                  showed no adverse effects on the
                                                (CBI)) for inclusion in the public docket.              residue in or on a food) only if EPA                  immune system. No significant systemic
                                                Information not marked confidential                     determines that the tolerance is ‘‘safe.’’            toxicity was observed in the 21-day
                                                pursuant to 40 CFR part 2 may be                        Section 408(b)(2)(A)(ii) of FFDCA                     dermal toxicity study in rats. In a 28-day
                                                disclosed publicly by EPA without prior                 defines ‘‘safe’’ to mean that ‘‘there is a            inhalation study, salivation in females
                                                notice. Submit the non-CBI copy of your                 reasonable certainty that no harm will                and sporadic decreased body weight
                                                objection or hearing request, identified                result from aggregate exposure to the                 gains in males was observed at 1
                                                by docket ID number EPA–HQ–OPP–                         pesticide chemical residue, including                 milligram/Liter (mg/L); however, these
                                                2011–1012, by one of the following                      all anticipated dietary exposures and all             effects were not considered biologically
                                                methods:                                                other exposures for which there is                    relevant. There is no evidence for
                                                  • Federal eRulemaking Portal: http://                 reliable information.’’ This includes                 carcinogenicity to humans based on the
                                                www.regulations.gov. Follow the online                  exposure through drinking water and in                absence of carcinogenicity in mice and
                                                instructions for submitting comments.                   residential settings, but does not include            rats. Pyriproxyfen is negative for
                                                Do not submit electronically any                        occupational exposure. Section                        mutagenic activity in a battery of
                                                information you consider to be CBI or                   408(b)(2)(C) of FFDCA requires EPA to                 mutagenicity studies conducted with
                                                other information whose disclosure is                   give special consideration to exposure                both the parent and/or metabolites.
                                                restricted by statute.                                  of infants and children to the pesticide              Specific information on the studies
                                                  • Mail: OPP Docket, Environmental                     chemical residue in establishing a                    received and the nature of the adverse
                                                Protection Agency Docket Center (EPA/                   tolerance and to ‘‘ensure that there is a             effects caused by pyriproxyfen as well
                                                DC), (28221T), 1200 Pennsylvania Ave.                   reasonable certainty that no harm will                as the no-observed-adverse-effect-level
                                                NW., Washington, DC 20460–0001.                         result to infants and children from                   (NOAEL) and the LOAEL from the
                                                  • Hand Delivery: To make special                      aggregate exposure to the pesticide                   toxicity studies can be found at http://
                                                arrangements for hand delivery or                       chemical residue. . . .’’                             www.regulations.gov on pp. 10–18 in
                                                delivery of boxed information, please                      Consistent with FFDCA section                      the document titled ‘‘Pyriproxyfen.
                                                follow the instructions at http://www.                  408(b)(2)(D), and the factors specified in            Human Health Risk Assessment for the
                                                epa.gov/dockets/contacts.html.                          FFDCA section 408(b)(2)(D), EPA has                   Petition to Increase the Established
                                                Additional instructions on commenting                   reviewed the available scientific data                Tolerance in/on Tea with a U.S.
                                                or visiting the docket, along with more                 and other relevant information in                     Registration for Imported Pyriproxyfen-
                                                information about dockets generally, is                 support of this action. EPA has                       treated Tea.’’ in docket ID number EPA–
                                                available at http://www.epa.gov/                        sufficient data to assess the hazards of              HQ–OPP–2011–1012.
                                                dockets.                                                and to make a determination on
                                                                                                                                                              B. Toxicological Points of Departure/
                                                II. Summary of Petitioned-for Tolerance                 aggregate exposure for pyriproxyfen
                                                                                                                                                              Levels of Concern
                                                                                                        including exposure resulting from the
                                                  In the Federal Register of December 2,                tolerances established by this action.                   Once a pesticide’s toxicological
                                                2015 (80 FR 75449) (FRL–9939–55),                       EPA’s assessment of exposures and risks               profile is determined, EPA identifies
                                                EPA issued a document pursuant to                       associated with pyriproxyfen follows.                 toxicological points of departure (POD)
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                                                FFDCA section 408(d)(3), 21 U.S.C.                                                                            and levels of concern to use in
                                                346a(d)(3), announcing the filing of a                  A. Toxicological Profile                              evaluating the risk posed by human
                                                pesticide petition (PP #4E8326) by                        EPA has evaluated the available                     exposure to the pesticide. For hazards
                                                Sumitomo Chemical Company, Ltd.,                        toxicity data and considered its validity,            that have a threshold below which there
                                                c/o Valent U.S.A. Corporation, 1600                     completeness, and reliability as well as              is no appreciable risk, the toxicological
                                                Riviera Avenue, Suite 200, Walnut                       the relationship of the results of the                POD is used as the basis for derivation
                                                Creek, CA 94596. The petition requested                 studies to human risk. EPA has also                   of reference values for risk assessment.


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                                                8660             Federal Register / Vol. 81, No. 34 / Monday, February 22, 2016 / Rules and Regulations

                                                PODs are developed based on a careful                   a population-adjusted dose (PAD) or a                  EPA uses in risk characterization and a
                                                analysis of the doses in each                           reference dose (RfD)—and a safe margin                 complete description of the risk
                                                toxicological study to determine the                    of exposure (MOE). For non-threshold                   assessment process, see http://www.epa.
                                                dose at which no adverse effects are                    risks, the Agency assumes that any                     gov/pesticides/factsheets/
                                                observed (the NOAEL) and the lowest                     amount of exposure will lead to some                   riskassess.htm.
                                                dose at which adverse effects of concern                degree of risk. Thus, the Agency
                                                                                                                                                                  A summary of the toxicological
                                                are identified (the LOAEL). Uncertainty/                estimates risk in terms of the probability
                                                safety factors are used in conjunction                  of an occurrence of the adverse effect                 endpoints for pyriproxyfen used for
                                                with the POD to calculate a safe                        expected in a lifetime. For more                       human risk assessment is shown in
                                                exposure level—generally referred to as                 information on the general principles                  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                   RfD, PAD, LOC for risk
                                                       Exposure/Scenario                                                                                                  Study and toxicological effects
                                                                                           uncertainty/safety factors                     assessment

                                                Acute dietary (All populations) ..      An appropriate endpoint attributable to a single oral dose was not identified in the toxicology database, includ-
                                                                                                                   ing the developmental and reproduction toxicity studies.

                                                Chronic dietary (All popu-             NOAEL = 35.1 mg/kg/day ........        Chronic RfD = 0.35 mg/kg/day          Subchronic (41321716) and chronic
                                                  lations).1                           UFA = 10x                              cPAD = 0.35 mg/kg/day                   (43210503)—rat (co-critical). LOAEL =
                                                                                       UFH = 10x                                                                      141.28 mg/kg/day based on decreased
                                                                                       FQPA SF = 1x                                                                   body weight and body weight gain, ane-
                                                                                                                                                                      mia, 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 (44985002).
                                                  days).                               UFA = 10x                                                                      Maternal LOAEL = 300 mg/kg/day
                                                                                       UFH = 10x                                                                      based on decreased body weight, body
                                                                                                                                                                      weight gain, and food consumption, and
                                                                                                                                                                      increased water consumption.
                                                Incidental oral intermediate-          NOAEL = 35.1 mg/kg/day ........        LOC for MOE = 100 .................   Subchronic (41321716) and chronic
                                                  term (1–6 months).1                  UFA = 10x                                                                      (43210503)—rat (co-critical). LOAEL =
                                                                                       UFH = 10x                                                                      141.28 mg/kg/day based on decreased
                                                                                                                                                                      body weight and body weight gain, ane-
                                                                                                                                                                      mia, and increased relative liver weight
                                                                                                                                                                      with    elevated     cholesterol    and
                                                                                                                                                                      phospholipid levels.

                                                Dermal short- and intermediate-        Based on the systemic toxicity NOAEL of 1,000 mg/kg/day (limit dose) in the 21 day dermal toxicity study in
                                                  term (1–30 days and 1–6                 rats, quantification of dermal risks is not required. In addition, no developmental concerns (toxicity) were
                                                  months).                                seen in either rats or rabbits.

                                                Dermal long-term (6 months-            NOAEL = 35.1 mg/kg/day ........        LOC for MOE = 100 .................   Subchronic (41321716) and chronic
                                                  lifetime).1                          DAF = 30% 2                                                                    (43210503)—rat (co-critical). LOAEL =
                                                                                       UFA = 10x                                                                      141.28 mg/kg/day based on decreased
                                                                                       UFH = 10x                                                                      body weight and body weight gain, ane-
                                                                                                                                                                      mia, and increased relative liver weight
                                                                                                                                                                      with    elevated     cholesterol    and
                                                                                                                                                                      phospholipid levels.

                                                Inhalation short- and inter-             Based on the absence of biologically relevant toxicity at 1.0 mg/L, the quantification of inhalation risks is not
                                                  mediate-term (1–30 days and                  required. In addition, no developmental concerns (toxicity) were seen in either rats or rabbits.
                                                  1–6 months).

                                                Inhalation long-term (6 months-        NOAEL = 35.1 mg/kg/day ........        LOC for MOE = 100 .................   Subchronic (41321716) and chronic
                                                  lifetime).1                          UFA = 10x                                                                      (43210503)—rat (co-critical). LOAEL =
                                                                                       UFH = 10x                                                                      141.28 mg/kg/day based on decreased
                                                                                                                                                                      body weight and body weight gain, ane-
                                                                                                                                                                      mia, and increased relative liver weight
                                                                                                                                                                      with    elevated     cholesterol    and
                                                                                                                                                                      phospholipid levels.

                                                Cancer (Oral, dermal, inhala-                                     No evidence of carcinogenicity in mice and rats (TXR 0012966).
                                                  tion).
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                                                   Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and used to mark the begin-
                                                ning 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, respec-
                                                tively. 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%.


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                                                                 Federal Register / Vol. 81, No. 34 / Monday, February 22, 2016 / Rules and Regulations                                           8661

                                                C. Exposure Assessment                                  into the dietary exposure model. For                  this tolerance action; therefore, EPA has
                                                   1. Dietary exposure from food and                    chronic dietary risk assessment, the                  assumed that pyriproxyfen does not
                                                feed uses. In evaluating dietary                        water concentration of value 2.98 ppb                 have a common mechanism of toxicity
                                                exposure to pyriproxyfen, EPA                           was used to assess the contribution to                with other substances. For information
                                                considered exposure under the                           drinking water.                                       regarding EPA’s efforts to determine
                                                petitioned-for tolerances as well as all                   3. From non-dietary exposure. The                  which chemicals have a common
                                                existing pyriproxyfen tolerances in 40                  term ‘‘residential exposure’’ is used in              mechanism of toxicity and to evaluate
                                                CFR 180.510. EPA assessed dietary                       this document to refer to                             the cumulative effects of such
                                                exposures from pyriproxyfen in food as                  nonoccupational, non-dietary exposure                 chemicals, see EPA’s Web site at http://
                                                follows:                                                (e.g., for lawn and garden pest control,              www.epa.gov/pesticides/cumulative.
                                                   i. Acute exposure. Quantitative acute                indoor pest control, termiticides, and
                                                                                                        flea and tick control on pets).                       D. Safety Factor for Infants and
                                                dietary exposure and risk assessments                                                                         Children
                                                are performed for a food-use pesticide,                    Pyriproxyfen is currently registered
                                                if a toxicological study has indicated the              for flea and tick control (home                         1. In general. Section 408(b)(2)(C) of
                                                possibility of an effect of concern                     environment and pet treatments) as well               FFDCA provides that EPA shall apply
                                                occurring as a result of a 1-day or single              as products for ant and roach control                 an additional tenfold (10X) margin of
                                                exposure.                                               (indoor and outdoor applications).                    safety for infants and children in the
                                                   No such effects were identified in the               Formulations include carpet powders,                  case of threshold effects to account for
                                                toxicological studies for pyriproxyfen;                 foggers, aerosol sprays, liquids                      prenatal and postnatal toxicity and the
                                                therefore, a quantitative acute dietary                 (shampoos, sprays, and pipettes for pet               completeness of the database on toxicity
                                                exposure assessment is unnecessary.                     treatments), granules, bait (indoor and               and exposure unless EPA determines
                                                   ii. Chronic exposure. In conducting                  outdoor), and impregnated materials                   based on reliable data that a different
                                                the chronic dietary exposure assessment                 (pet collars). EPA assessed residential               margin of safety will be safe for infants
                                                EPA used the food consumption data                      exposure using the following                          and children. This additional margin of
                                                from the USDA 2003–2008 National                        assumptions: Although there is the                    safety is commonly referred to as the
                                                Health and Nutrition Examination                        potential for short-term residential                  FQPA Safety Factor (SF). In applying
                                                Survey, What We Eat in America                          handler dermal and inhalation exposure                this provision, EPA either retains the
                                                (NHANES/WWEIA). As to residue levels                    as well as short or intermediate-term                 default value of 10X, or uses a different
                                                in food, EPA assumed 100 percent crop                   post-application exposure from the                    additional safety factor when reliable
                                                treated (PCT) and tolerance-level                       registered uses of pyriproxyfen, there                data available to EPA support the choice
                                                residues.                                               are no short or intermediate-term                     of a different factor.
                                                   iii. Cancer. Based on the data                       dermal or inhalation PODs and                           2. Prenatal and postnatal sensitivity.
                                                summarized in Unit III.A., EPA has                      quantitative assessments were not                     Based on the available data, there is no
                                                concluded that pyriproxyfen does not                    conducted.                                            quantitative and qualitative evidence of
                                                pose a cancer risk to humans. Therefore,                   Based on the registered use patterns,              increased susceptibility observed
                                                a dietary exposure assessment for the                   the following post-application scenarios              following in utero pyriproxyfen
                                                purpose of assessing cancer risk is                     were assessed: Short- and intermediate-               exposure to rats and rabbits or following
                                                unnecessary.                                            term hand-to-mouth exposures for 1 to                 prenatal/postnatal exposure in the 2-
                                                   iv. Anticipated residue and percent                  <2 year olds from treated carpets and                 generation reproduction study.
                                                crop treated (PCT) information. EPA did                 flooring and petting treated animals                    3. Conclusion. EPA has determined
                                                not use anticipated residue and/or PCT                  (shampoos, sprays, spot-on treatments                 that reliable data show the safety of
                                                information in the dietary assessment                   and collars); long-term hand-to-mouth                 infants and children would be
                                                for pyriproxyfen. Tolerance-level                       exposures for 1 to <2 year olds from                  adequately protected if the FQPA SF
                                                residues and/or 100 PCT were assumed                    treated carpets and flooring and petting              were reduced to 1X. That decision is
                                                for all food commodities.                               treated animals; and long-term dermal                 based on the following findings:
                                                   2. Dietary exposure from drinking                    exposures from treated carpets, flooring,               i. The toxicity database for
                                                water. The Agency used screening-level                  and pets.                                             pyriproxyfen is complete.
                                                water exposure models in the dietary                       Further information regarding EPA                    ii. There is no indication that
                                                exposure analysis and risk assessment                   standard assumptions and generic                      pyriproxyfen is a neurotoxic chemical
                                                for pyriproxyfen in drinking water.                     inputs for residential exposures may be               and there is no need for a
                                                These simulation models take into                       found at http://www.epa.gov/pesticides/               developmental neurotoxicity study or
                                                account data on the physical, chemical,                 trac/science/trac6a05.pdf.                            additional UFs to account for
                                                and fate/transport characteristics of                      4. Cumulative effects from substances              neurotoxicity.
                                                pyriproxyfen. Further information                       with a common mechanism of toxicity.                    iii. There is no evidence that
                                                regarding EPA drinking water models                     Section 408(b)(2)(D)(v) of FFDCA                      pyriproxyfen results in increased
                                                used in pesticide exposure assessment                   requires that, when considering whether               susceptibility in in utero rats or rabbits
                                                can be found at http://www.epa.gov/                     to establish, modify, or revoke a                     in the prenatal developmental studies or
                                                oppefed1/models/water/index.htm.                        tolerance, the Agency consider                        in young rats in the 2-generation
                                                   Based on the Tier 1 Rice Model and                   ‘‘available information’’ concerning the              reproduction study.
                                                the Generic Estimated Exposure                          cumulative effects of a particular                      iv. There are no residual uncertainties
                                                Concentration (GENEEC) model the                        pesticide’s residues and ‘‘other                      identified in the exposure databases.
                                                estimated drinking water concentrations                 substances that have a common                         The dietary food exposure assessments
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                                                (EDWCs) of pyriproxyfen for chronic                     mechanism of toxicity.’’                              were performed based on 100 PCT and
                                                exposure assessments are estimated to                      EPA has not found pyriproxyfen to                  tolerance-level residues. EPA made
                                                be 2.98 parts per billion (ppb) for                     share a common mechanism of toxicity                  conservative (protective) assumptions in
                                                surface water and 0.006 ppb for ground                  with any other substances, and                        the ground and surface water modeling
                                                water.                                                  pyriproxyfen does not appear to                       used to assess exposure to pyriproxyfen
                                                   Modeled estimates of drinking water                  produce a toxic metabolite produced by                in drinking water. EPA used similarly
                                                concentrations were directly entered                    other substances. For the purposes of                 conservative assumptions to assess post-


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                                                8662             Federal Register / Vol. 81, No. 34 / Monday, February 22, 2016 / Rules and Regulations

                                                application exposure of children as well                <2 years old, the population subgroup                 Alimentarius Commission (Codex), as
                                                as incidental oral exposure of toddlers.                receiving the greatest exposure. Because              required by FFDCA section 408(b)(4).
                                                These assessments will not                              EPA’s level of concern (LOC) for                      The Codex Alimentarius is a joint
                                                underestimate the exposure and risks                    pyriproxyfen is a MOE of 100 or below,                United Nations Food and Agriculture
                                                posed by pyriproxyfen.                                  this MOE is not of concern.                           Organization/World Health
                                                                                                           4. Intermediate-term risk.                         Organization food standards program,
                                                E. Aggregate Risks and Determination of
                                                                                                        Intermediate-term aggregate exposure                  and it is recognized as an international
                                                Safety
                                                                                                        takes into account intermediate-term                  food safety standards-setting
                                                   EPA determines whether acute and                     residential exposure plus chronic                     organization in trade agreements to
                                                chronic dietary pesticide exposures are                 exposure to food and water (considered                which the United States is a party. EPA
                                                safe by comparing aggregate exposure                    to be a background exposure level).                   may establish a tolerance that is
                                                estimates to the acute PAD (aPAD) and                      Pyriproxyfen is currently registered               different from a Codex MRL; however,
                                                chronic PAD (cPAD). For linear cancer                   for uses that could result in                         FFDCA section 408(b)(4) requires that
                                                risks, EPA calculates the lifetime                      intermediate-term residential exposure,               EPA explain the reasons for departing
                                                probability of acquiring cancer given the               and the Agency has determined that it                 from the Codex level.
                                                estimated aggregate exposure. Short-,                   is appropriate to aggregate chronic                      No Codex MRL for residues of
                                                intermediate-, and chronic-term risks                   exposure through food and water with                  pyriproxyfen is established in/on tea
                                                are evaluated by comparing the                          intermediate-term residential exposures               commodities.
                                                estimated aggregate food, water, and                    to pyriproxyfen.
                                                residential exposure to the appropriate                                                                       C. Revisions to Petitioned-for Tolerances
                                                                                                           Using the exposure assumptions
                                                PODs to ensure that an adequate MOE                     described in this unit for intermediate-                Although the petitioner requested a
                                                exists.                                                 term exposures, EPA has concluded that                tolerance for 15.0 ppm, the Agency is
                                                   1. Acute risk. An acute aggregate risk               the combined intermediate-term food,                  establishing a tolerance at 15 ppm,
                                                assessment takes into account acute                     water, and residential exposures result               consistent with the current practices
                                                exposure estimates from dietary                         in an aggregate MOE of 760 for children               regarding significant figures for
                                                consumption of food and drinking                        1 to <2 years old, the population                     tolerance setting.
                                                water. No adverse effect resulting from                 subgroup receiving the greatest
                                                a single oral exposure was identified                                                                         V. Conclusion
                                                                                                        exposure. Because EPA’s LOC for
                                                and no acute dietary endpoint was                                                                               Therefore, 40 CFR 180.510 is being
                                                                                                        pyriproxyfen is a MOE of 100 or below,
                                                selected. Therefore, pyriproxyfen is not                                                                      amended to increase the currently
                                                                                                        this MOE is not of concern.
                                                expected to pose an acute risk.                                                                               established tolerance for residues of
                                                   2. Chronic risk. Using the exposure                     5. Aggregate cancer risk for U.S.
                                                                                                                                                              pyriproxyfen in/on tea from 0.02 ppm to
                                                assumptions described in this unit for                  population. Based on the lack of
                                                                                                                                                              15 ppm.
                                                chronic exposure, EPA has concluded                     evidence of carcinogenicity in two
                                                that chronic exposure to pyriproxyfen                   adequate rodent carcinogenicity studies,              VI. Statutory and Executive Order
                                                from food and water will utilize 12% of                 pyriproxyfen is not expected to pose a                Reviews
                                                the cPAD for children 1–2 years old, the                cancer risk to humans.                                   This action establishes tolerances
                                                population group receiving the greatest                    6. Determination of safety. Based on               under FFDCA section 408(d) in
                                                exposure. A long-term post-application                  these risk assessments, EPA concludes                 response to a petition submitted to the
                                                residential assessment was performed                    that there is a reasonable certainty that             Agency. The Office of Management and
                                                for toddlers only since they are                        no harm will result to the general                    Budget (OMB) has exempted these types
                                                anticipated to have higher exposures                    population, or to infants and children                of actions from review under Executive
                                                than adults from treated home                           from aggregate exposure to pyriproxyfen               Order 12866, entitled ‘‘Regulatory
                                                environments and pets due to their                      residues.                                             Planning and Review’’ (58 FR 51735,
                                                behavior patterns. The total chronic                    IV. Other Considerations                              October 4, 1993). Because this action
                                                dietary and residential aggregate MOE is                                                                      has been exempted from review under
                                                230 for children 1 to <2 years old. As                  A. Analytical Enforcement Methodology                 Executive Order 12866, this action is
                                                this MOE is greater than 100, the                          Adequate enforcement methodology                   not subject to Executive Order 13211,
                                                chronic aggregate risk does not exceed                  (Gas Chromatography with Nitrogen-                    entitled ‘‘Actions Concerning
                                                EPA’s level of concern.                                 Phosphorous Detection; GC/NPD) is                     Regulations That Significantly Affect
                                                   3. Short-term risk. Short-term                       available to enforce the tolerance                    Energy Supply, Distribution, or Use’’ (66
                                                aggregate exposure takes into account                   expression.                                           FR 28355, May 22, 2001) or Executive
                                                short-term residential exposure plus                       The method may be requested from:                  Order 13045, entitled ‘‘Protection of
                                                chronic exposure to food and water                      Chief, Analytical Chemistry Branch,                   Children from Environmental Health
                                                (considered to be a background                          Environmental Science Center, 701                     Risks and Safety Risks’’ (62 FR 19885,
                                                exposure level). Pyriproxyfen is                        Mapes Rd., Ft. Meade, MD 20755–5350;                  April 23, 1997). This action does not
                                                currently registered for uses that could                telephone number: (410) 305–2905;                     contain any information collections
                                                result in short-term residential                        email address: residuemethods@                        subject to OMB approval under the
                                                exposure, and the Agency has                            epa.gov.                                              Paperwork Reduction Act (PRA) (44
                                                determined that it is appropriate to                                                                          U.S.C. 3501 et seq.), nor does it require
                                                                                                        B. International Residue Limits
                                                aggregate chronic exposure through food                                                                       any special considerations under
                                                and water with short-term residential                     In making its tolerance decisions, EPA              Executive Order 12898, entitled
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                                                exposures to pyriproxyfen.                              seeks to harmonize U.S. tolerances with               ‘‘Federal Actions to Address
                                                   Using the exposure assumptions                       international standards whenever                      Environmental Justice in Minority
                                                described in this unit for short-term                   possible, consistent with U.S. food                   Populations and Low-Income
                                                exposures, EPA has concluded the                        safety standards and agricultural                     Populations’’ (59 FR 7629, February 16,
                                                combined short-term food, water, and                    practices. EPA considers the                          1994).
                                                residential exposures result in an                      international maximum residue limits                     Since tolerances and exemptions that
                                                aggregate MOE of 2,200 for children 1 to                (MRLs) established by the Codex                       are established on the basis of a petition


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                                                                 Federal Register / Vol. 81, No. 34 / Monday, February 22, 2016 / Rules and Regulations                                                    8663

                                                under FFDCA section 408(d), such as                     PART 180—[AMENDED]                                              FOR FURTHER INFORMATION CONTACT:     Gary
                                                the tolerance in this final rule, do not                                                                                Frazer, Assistant Director for Ecological
                                                require the issuance of a proposed rule,                ■ 1. The authority citation for part 180                        Services, U.S. Fish and Wildlife Service,
                                                the requirements of the Regulatory                      continues to read as follows:                                   18th and C Streets NW., Washington,
                                                Flexibility Act (RFA) (5 U.S.C. 601 et                      Authority: 21 U.S.C. 321(q), 346a and 371.                  DC 20240; telephone 202/208–4646;
                                                seq.), do not apply.                                                                                                    facsimile 703/358–5618, or Angela
                                                   This action directly regulates growers,              ■ 2. In § 180.510, revise the entry for tea
                                                                                                                                                                        Somma, Chief, Endangered Species
                                                food processors, food handlers, and food                in the table in paragraph (a)(1) to read
                                                                                                                                                                        Division, National Marine Fisheries
                                                retailers, not States or tribes, nor does               as follows:
                                                                                                                                                                        Service, 1355 East-West Highway, Silver
                                                this action alter the relationships or                  § 180.510 Pyriproxyfen; tolerances for                          Spring, Maryland 20910; telephone 301/
                                                distribution of power and                               residues.                                                       427–8403; facsimile 301/713–0376. If
                                                responsibilities established by Congress                    (a) * * *                                                   you use a telecommunications device
                                                in the preemption provisions of FFDCA                       (1) * * *                                                   for the deaf (TDD), call the Federal
                                                section 408(n)(4). As such, the Agency                                                                                  Information Relay Service (FIRS) at
                                                has determined that this action will not                                                                   Parts per    800–877–8339.
                                                have a substantial direct effect on States                             Commodity                            million
                                                or tribal governments, on the                                                                                           SUPPLEMENTARY INFORMATION:
                                                relationship between the national
                                                                                                           *              *              *             *           *    Background
                                                government and the States or tribal
                                                governments, or on the distribution of                  Tea ........................................          15
                                                                                                                                                                           Congress enacted the Endangered
                                                power and responsibilities among the                          *            *              *            *           *    Species Act of 1973, as amended (16
                                                various levels of government or between                                                                                 U.S.C. 1531 et seq.) (ESA or Act), to
                                                the Federal Government and Indian                       *          *      *         *         *                         establish a program for the conservation
                                                tribes. Thus, the Agency has determined                 [FR Doc. 2016–03608 Filed 2–19–16; 8:45 am]                     of endangered and threatened species
                                                that Executive Order 13132, entitled                    BILLING CODE 6560–50–P                                          and the ecosystems on which they
                                                ‘‘Federalism’’ (64 FR 43255, August 10,                                                                                 depend. The Secretaries of the Interior
                                                1999) and Executive Order 13175,                                                                                        and Commerce (hereafter referred to as
                                                entitled ‘‘Consultation and Coordination                                                                                ‘‘the Secretaries’’) have the
                                                                                                        DEPARTMENT OF THE INTERIOR
                                                with Indian Tribal Governments’’ (65 FR                                                                                 responsibility for administering the
                                                67249, November 9, 2000) do not apply                   Fish and Wildlife Service                                       ESA. The Secretaries have delegated
                                                to this action. In addition, this action                                                                                this responsibility to the U.S. Fish and
                                                does not impose any enforceable duty or                 50 CFR Chapter IV                                               Wildlife Service of the Department of
                                                contain any unfunded mandate as                                                                                         the Interior and the National Marine
                                                described under Title II of the Unfunded                DEPARTMENT OF COMMERCE                                          Fisheries Service of the Department of
                                                Mandates Reform Act (UMRA) (2 U.S.C.                                                                                    Commerce (hereafter referred to as ‘‘the
                                                1501 et seq.).                                          National Oceanic and Atmospheric                                Services’’).
                                                   This action does not involve any                     Administration
                                                technical standards that would require                                                                                     The Services recognize that, in the
                                                Agency consideration of voluntary                                                                                       exercise of their general governmental
                                                                                                        50 CFR Chapter IV                                               powers, States possess broad trustee and
                                                consensus standards pursuant to section
                                                12(d) of the National Technology                        [FWS–HQ–ES–2016–N017; FF09E00000 167                            police powers over fish, wildlife, and
                                                Transfer and Advancement Act                            FXES11130900000]                                                plants and their habitats within their
                                                (NTTAA) (15 U.S.C. 272 note).                                                                                           borders. Unless preempted by Federal
                                                                                                        Revised Interagency Cooperative                                 authority, States possess primary
                                                VII. Congressional Review Act                           Policy Regarding the Role of State                              authority and responsibility for
                                                  Pursuant to the Congressional Review                  Agencies in Endangered Species Act                              protection and management of fish,
                                                Act (5 U.S.C. 801 et seq.), EPA will                    Activities                                                      wildlife, and plants and their habitats.
                                                submit a report containing this rule and                AGENCY:   Fish and Wildlife Service,                               State agencies often possess scientific
                                                other required information to the U.S.                  Interior, and National Marine Fisheries                         data and valuable expertise on the status
                                                Senate, the U.S. House of                               Service, National Oceanic and                                   and distribution of endangered,
                                                Representatives, and the Comptroller                    Atmospheric Administration (NOAA),                              threatened, and candidate species of
                                                General of the United States prior to                   Commerce.                                                       wildlife and plants. State agencies,
                                                publication of the rule in the Federal                                                                                  because of their authorities and their
                                                                                                        ACTION: Notice of policy revision.
                                                Register. This action is not a ‘‘major                                                                                  close working relationships with local
                                                rule’’ as defined by 5 U.S.C. 804(2).                   SUMMARY:   The Fish and Wildlife Service                        governments and landowners, are in a
                                                List of Subjects in 40 CFR Part 180                     and National Marine Fisheries Service                           unique position to assist the Services in
                                                                                                        announce an interagency policy to                               implementing all aspects of the Act. In
                                                  Environmental protection,
                                                                                                        clarify the role of State agencies in                           this regard, section 6 of the Act provides
                                                Administrative practice and procedure,
                                                                                                        activities undertaken by the Services                           that the Services shall cooperate to the
                                                Agricultural commodities, Pesticides
                                                                                                        under authority of the Endangered                               maximum extent practicable with the
                                                and pests, Reporting and recordkeeping
                                                                                                        Species Act of 1973, as amended, and                            States in carrying out programs
                                                requirements.
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                                                                                                        associated regulations. The policy,                             authorized by the Act. The term State
                                                  Dated: February 4, 2016.                              which is a revision of a policy issued in                       agency means any State agency,
                                                Susan Lewis,                                            1994, reflects a renewed commitment by                          department, board, commission, or
                                                Director, Registration Division, Office of              the Services and State fish and wildlife                        other governmental entity that is
                                                Pesticide Programs.                                     agencies to work together in conserving                         responsible for the management and
                                                  Therefore, 40 CFR chapter I is                        America’s imperiled wildlife.                                   conservation of fish, plant, or wildlife
                                                amended as follows:                                     DATES: February 22, 2016.                                       resources within a State.


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Document Created: 2016-02-19 23:56:42
Document Modified: 2016-02-19 23:56:42
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis 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).
ContactSusan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
FR Citation81 FR 8658 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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