81_FR_38718 81 FR 38604 - Clofentezine; Pesticide Tolerances

81 FR 38604 - Clofentezine; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 81, Issue 114 (June 14, 2016)

Page Range38604-38609
FR Document2016-13911

This regulation establishes tolerances for residues of clofentezine in or on multiple commodities which are identified and discussed later in this document. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

Federal Register, Volume 81 Issue 114 (Tuesday, June 14, 2016)
[Federal Register Volume 81, Number 114 (Tuesday, June 14, 2016)]
[Rules and Regulations]
[Pages 38604-38609]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-13911]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0749; FRL-9942-23]


Clofentezine; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
clofentezine in or on multiple commodities which are identified and 
discussed later in this document. Interregional Research Project Number 
4 (IR-4) requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective June 14, 2016. Objections and 
requests for hearings must be received on or before August 15, 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-2014-0749, 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

[[Page 38605]]

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 
Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2014-0749 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 
August 15, 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-2014-0749, 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 February 11, 2015 (80 FR 7559) (FRL-
9921-94), 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 
4E8312) by IR-4, IR-4 Project Headquarters, Rutgers, The State 
University of New Jersey, 500 College Road East, Suite 201 W, 
Princeton, NJ 08540. The petition requested that 40 CFR 180.446 be 
amended by establishing tolerances for residues of the acaricide 
clofentezine in or on avocado at 0.3 parts per million (ppm); papaya at 
0.3 ppm; fruit, pome, group 11-10 at 0.5 ppm; cherry, subgroup 12-12A 
at 1.0 ppm; peach, subgroup 12-12B at 1.0 ppm; and fruit, small, vine 
climbing, except fuzzy kiwifruit, subgroup 13-07F at 1.0 ppm. Upon the 
approval of the aforementioned tolerances, IR-4 proposed that the 
existing tolerances for apple at 0.5 ppm; pear at 0.5 ppm; cherry at 
1.0 ppm; nectarine at 1.0 ppm; peach at 1.0 ppm; and grape at 1.0 ppm 
be removed as unnecessary. That document referenced a summary of the 
petition prepared by Makhteshim Agan of North America, the registrant, 
which is available in the docket, http://www.regulations.gov. One 
comment was received in response to the notice of filing, however it 
related to a different chemical.

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 clofentezine including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with clofentezine 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.
    Subchronic and chronic studies indicate the liver is the primary 
target organ for clofentezine with secondary effects on the thyroid. 
Body weight and body weight gain were decreased whereas liver weights 
were increased and hepatocellular enlargement was reported along with 
other observations (increases in plasma cholesterol and triglyceride 
levels). The induction of the liver enzyme, uridine diphosphate 
glucuronyltransferase (UDPGT) and the subsequent increase in the 
metabolism and the excretion of the thyroid

[[Page 38606]]

hormone T4 reduced the availability of T4 required for the general 
metabolism and the maintenance of homeostasis. The decreased levels of 
plasma T4 resulted in the stimulation of the thyroid by the pituitary 
gland to raise the plasma T4 levels. Thyroid changes in the form of 
colloid depletion, thyroid follicular cell hypertrophy and hyperplasia 
were observed as a means to regain the homeostasis.
    Two pre-natal developmental toxicity studies are available, one in 
the rat and one in the rabbit. No evidence (quantitative or 
qualitative) of increased susceptibility was seen in either study 
(developmental NOAELs were set at or above the limit dose for both 
studies). There was no evidence (quantitative or qualitative) of 
increased susceptibility seen following pre-and/or post-natal exposure 
in rats for 2-generations in the reproduction study (NOAEL set at the 
highest dose tested).
    Clofentezine does cause thyroid tumors in male rats after long-term 
high exposure resulting in progressive effects on the thyroid that 
leads to hyperplasia and eventual tumor formation. No mechanism or mode 
of action has been submitted to the Agency at this time for 
clofentezine. As a result, clofentezine has been classified as a 
possible human carcinogen based on male rat thyroid follicular cell 
adenoma and/or carcinoma combined tumor rates. The Q1* value 
for use in clofentezine risk assessment using the \3/4\ inter species 
scaling factor is 3.76 x 10-\2\ (mg/kg/day)-\1\. 
Clofentezine is not considered to be a mutagen.
    Specific information on the studies received and the nature of the 
adverse effects caused by clofentezine as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document titled ``Clofentezine.'' Human-
Health Risk Assessment to Support a Section 3 Registration Request to 
Add New Uses on Avocado and Papaya, and New Uses for Pome Fruit Group 
11-10, Cherry sub-group 12-12A, Peach sub-group 12-12B, and Small Fruit 
Vine Climbing except Fuzzy Kiwifruit Subgroup 13-07F based on Existing 
Tolerances on Representative Commodities'' on page 38 in docket ID 
number EPA-HQ-OPP-2014-0749.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for clofentezine used for 
human risk assessment is shown in Table 1 of this Unit.

 Table 1--Summary of Toxicological Doses and Endpoints for Clofentezine for Use in Human Health Risk Assessment
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                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk  assessment
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Acute dietary (All populations)..     No appropriate endpoint was identified including developmental toxicity
                                                            studies in rats and rabbits.
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Chronic dietary (All populations)  NOAEL= 1.25 mg/kg/    Chronic RfD = 0.013  1-year chronic dog study--LOAEL =
                                    day.                  mg/kg/day.           25 mg/kg based on increased liver
                                   UFA = 10x...........  cPAD = 0.013 mg/kg/   weights, hepatocellular
                                   UFH = 10x...........   day.                 enlargement, and increased serum
                                   FQPA SF = 1x........                        cholesterol, triglycerides and
                                                                               alkaline phosphatase levels.
                                  ------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Classification: Possible human carcinogen (classification of C), Q* using the
                                           \3/4\ interspecies scaling factor is 3.76 x 10-2 (mg/kg/day)-1.
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. NOAEL = no-observed-adverse-effect-level. PAD = population
  adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation
  from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human
  population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to clofentezine, EPA considered exposure under the petitioned-
for tolerances as well as all existing clofentezine tolerances in 40 
CFR 180.446. EPA assessed dietary exposures from clofentezine 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 clofentezine; therefore, a 
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the 2003-2008 food consumption data from the U.S. 
Department of Agriculture's (USDA) National Health and Nutrition 
Examination Survey, What We Eat in America, (NHANES/WWEIA). As to 
residue levels in food, a partially refined chronic dietary exposure 
and risk assessment was performed that directly

[[Page 38607]]

incorporated average field trial residues and used percent crop treated 
information.
    iii. Cancer. EPA determines whether quantitative cancer exposure 
and risk assessments are appropriate for a food-use pesticide based on 
the weight of the evidence from cancer studies and other relevant data. 
If quantitative cancer risk assessment is appropriate, cancer risk may 
be quantified using a linear or nonlinear approach. If sufficient 
information on the carcinogenic mode of action is available, a 
threshold or nonlinear approach is used and a cancer RfD is calculated 
based on an earlier non cancer key event. If carcinogenic mode of 
action data are not available, or if the mode of action data determines 
a mutagenic mode of action, a default linear cancer slope factor 
approach is utilized. Based on the data summarized in Unit III.A., EPA 
has concluded that clofentezine should be classified as possible human 
carcinogen and a linear approach has been used to quantify cancer risk. 
Cancer risk was quantified using the same estimates as discussed in 
Unit III.C.1.ii.
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and 
information on the anticipated residue levels of pesticide residues in 
food and the actual levels of pesticide residues that have been 
measured in food. If EPA relies on such information, EPA must require 
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after 
the tolerance is established, modified, or left in effect, 
demonstrating that the levels in food are not above the levels 
anticipated. For the present action, EPA will issue such data call-ins 
as are required by FFDCA section 408(b)(2)(E) and authorized under 
FFDCA section 408(f)(1). Data will be required to be submitted no later 
than 5 years from the date of issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if:
     Condition a: The data used are reliable and provide a 
valid basis to show what percentage of the food derived from such crop 
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area. In addition, the 
Agency must provide for periodic evaluation of any estimates used. To 
provide for the periodic evaluation of the estimate of PCT as required 
by FFDCA section 408(b)(2)(F), EPA may require registrants to submit 
data on PCT.
    Average percent crop treated estimates were used in the chronic and 
cancer dietary risk assessments for the following crops that are 
currently registered for clofentezine: Almonds: 5%; apples: 2.5%; 
apricots: 2.5%; cherries: 5%; grapes: 1%; nectarines: 5%; peaches: 5%; 
pears: 5%; and walnuts: 5%.
    In most cases, EPA uses available data from United States 
Department of Agriculture/National Agricultural Statistics Service 
(USDA/NASS), proprietary market surveys, and the National Pesticide Use 
Database for the chemical/crop combination for the most recent 6-7 
years. EPA uses an average PCT for chronic dietary risk analysis. The 
average PCT figure for each existing use is derived by combining 
available public and private market survey data for that use, averaging 
across all observations, and rounding to the nearest 5%, except for 
those situations in which the average PCT is less than one. In those 
cases, 1% is used as the average PCT and 2.5% is used as the maximum 
PCT. EPA uses a maximum PCT for acute dietary risk analysis. The 
maximum PCT figure is the highest observed maximum value reported 
within the recent 6 years of available public and private market survey 
data for the existing use and rounded up to the nearest multiple of 5%.
    The Agency believes that the three conditions discussed in Unit 
III.C.1.iv. have been met. With respect to Condition a, PCT estimates 
are derived from Federal and private market survey data, which are 
reliable and have a valid basis. The Agency is reasonably certain that 
the percentage of the food treated is not likely to be an 
underestimation. As to Conditions b and c, regional consumption 
information and consumption information for significant subpopulations 
is taken into account through EPA's computer-based model for evaluating 
the exposure of significant subpopulations including several regional 
groups. Use of this consumption information in EPA's risk assessment 
process ensures that EPA's exposure estimate does not understate 
exposure for any significant subpopulation group and allows the Agency 
to be reasonably certain that no regional population is exposed to 
residue levels higher than those estimated by the Agency. Other than 
the data available through national food consumption surveys, EPA does 
not have available reliable information on the regional consumption of 
food to which clofentezine may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for clofentezine in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of clofentezine. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the First Index Reservoir Screening Tool (FIRST) and 
Screening Concentration in Ground Water (SCI-GROW) models, the 
estimated drinking water concentrations (EDWCs) of clofentezine for 
chronic exposures for non-cancer and cancer assessments are estimated 
to be 0.062 parts per billion (ppb) for surface water and 0.041 ppb for 
ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic and cancer dietary 
risk assessment, the water concentration of value 0.062 ppb was used to 
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Clofentezine is not registered for any specific use patterns that 
would result in residential exposure.
    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 clofentezine to share a common mechanism of 
toxicity with any other substances, and clofentezine does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
clofentezine 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

[[Page 38608]]

the cumulative effects of such chemicals, see EPA's Web site at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

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. Two pre-natal developmental 
toxicity studies were available, one in the rat and one in the rabbit. 
No evidence (quantitative or qualitative) of increased susceptibility 
was seen in either study (developmental NOAELs were set at or above the 
limit dose for both studies). There was no evidence (quantitative or 
qualitative) of increased susceptibility seen following pre-and/or 
post-natal exposure in rats for 2-generations in the reproduction study 
(NOAEL set at the highest dose tested).
    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 clofentezine is complete.
    ii. There is no indication that clofentezine 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 clofentezine 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 chronic and cancer analyses incorporated anticipated 
residues (average residues from available field trial data) for all 
registered and proposed commodities and the latest PCT data available. 
The highest estimated drinking water concentrations of clofentezine 
were incorporated directly into the chronic and cancer assessments. 
These assessments will not underestimate the exposure and risks posed 
by clofentezine.

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, 
clofentezine 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 
clofentezine from food and water will utilize <1% of the cPAD for all 
population groups. There are no residential uses for clofentezine.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account short-term residential exposure 
plus chronic exposure to food and water (considered to be a background 
exposure level).
    A short- and intermediate-term adverse effect was identified; 
however, clofentezine is not registered for any use patterns that would 
result in short- or intermediate-term residential exposure. Short- and 
intermediate-term risk is assessed based on short- and intermediate-
term residential exposure plus chronic dietary exposure. Because there 
is no short- or intermediate-term residential exposure and chronic 
dietary exposure has already been assessed under the appropriately 
protective cPAD (which is at least as protective as the POD used to 
assess short- or intermediate-term risk), no further assessment of 
short- or intermediate-term risk is necessary, and EPA relies on the 
chronic dietary risk assessment for evaluating short- and intermediate-
term risk for clofentezine.
    4. Aggregate cancer risk for U.S. population. Using the exposure 
assumptions described in this unit for cancer exposure, EPA has 
concluded that by applying the Q1* of 3.76 x 
10-\2\ mg/kg/day to the exposure value results in a cancer 
risk estimate of 3.8 x 10-\7\ to the general U.S. 
population. EPA generally considers cancer risks (expressed as the 
probability of an increased cancer case) in the range of 1 in 1 million 
(or 1 x 10-\6\) or less to be negligible.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to clofentezine residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high performance liquid 
chromatography (HPLC)) 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.
    There are no Codex MRLs for residues on avocado and papaya.
    The U.S. pome fruit tolerance of 0.5 ppm is harmonized with the 
Codex MRL.
    The U.S. tolerance is 1.0 ppm in/on stone fruit (12-12A and 12-
12B). The Codex MRL for stone fruit is 0.5 ppm. The clofentezine 
residues in/on representative stone fruit crops, cherry and peach, from 
the submitted U.S. field trial data are greater than 0.5 ppm and

[[Page 38609]]

setting the tolerances for 12-12A and 12-12B at 0.5 ppm to harmonize 
with Codex could result a tolerance exceedance for U.S. growers. 
Therefore, the U.S. tolerance cannot be harmonized with Codex MRL for 
stone fruit at this time.
    The U.S. tolerance of 1.0 ppm for the crop subgroup fruit, small, 
vine climbing, except fuzzy kiwifruit, 13-07F does not harmonize with 
the Codex MRL of 2.0 ppm. The petitioner requested a 13-07F subgroup 
tolerance at 1.0 ppm, which would maintain the existing tolerance on 
grapes at 1.0 ppm consistent with the MRL at 1.0 ppm maintained by 
several countries including Japan and Korea. EPA is not harmonizing 
with Codex in order to maintain MRL harmony with several other 
countries to avoid potential export issues.

V. Conclusion

    Therefore, tolerances are established for residues of clofentezine 
in or on avocado at 0.30 ppm; papaya at 0.30 ppm; fruit, pome, group 
11-10 at 0.50 ppm; cherry, subgroup 12-12A at 1.0 ppm; peach, subgroup 
12-12B at 1.0 ppm; and fruit, small, vine climbing, except fuzzy 
kiwifruit, subgroup 13-07F at 1.0 ppm. In addition, the existing 
tolerances for apple at 0.5 ppm; pear at 0.5 ppm; cherry at 1.0 ppm; 
nectarine at 1.0 ppm; peach at 1.0 ppm; and grape at 1.0 ppm are 
removed as unnecessary.

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 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: May 31, 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.  180.446, in the table in paragraph (a)(1):
0
a. Remove the entries for ``Apple'', ``Cherry'', ``Grape'', 
``Nectarine'', ``Peach'', and ``Pear''; and
0
b. Add alphabetically the entries for ``Avocado'', ``Cherry, subgroup 
12-12A'', ``Fruit, pome, group 11-10'', ``Fruit, small, vine climbing, 
except fuzzy kiwifruit, Subgroup 13-07F'', ``Papaya'', and ``Peach, 
subgroup 12-12B''.
    The additions read as follows:


Sec.  180.446  Clofentezine; tolerances for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Avocado....................................................         0.30
Cherry, subgroup 12-12A....................................          1.0
Fruit, pome, group 11-10...................................         0.50
Fruit, small, vine climbing, except fuzzy kiwifruit,                 1.0
 Subgroup 13-07F...........................................
 
                                * * * * *
Papaya.....................................................         0.30
Peach, subgroup 12-12B.....................................          1.0
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2016-13911 Filed 6-13-16; 8:45 am]
 BILLING CODE 6560-50-P



                                              38604              Federal Register / Vol. 81, No. 114 / Tuesday, June 14, 2016 / Rules and Regulations

                                              Children from Environmental Health                      Register. This action is not a ‘‘major                                                                   Parts per
                                                                                                                                                                         Commodity
                                              Risks and Safety Risks’’ (62 FR 19885,                  rule’’ as defined by 5 U.S.C. 804(2).                                                                     million
                                              April 23, 1997). This action does not
                                                                                                      List of Subjects in 40 CFR Part 180                    Hop, dried cones ..................                           40
                                              contain any information collections
                                              subject to OMB approval under the                         Environmental protection,
                                              Paperwork Reduction Act (PRA) (44                       Administrative practice and procedure,
                                                                                                                                                                 *           *               *             *          *
                                              U.S.C. 3501 et seq.), nor does it require               Agricultural commodities, Pesticides
                                              any special considerations under                        and pests, Reporting and recordkeeping                 Nut, tree, group     14 1
                                                                                                                                                                                  .............                       0.04
                                              Executive Order 12898, entitled                         requirements.                                          Nut, tree, group 14–12 .........                         0.02
                                              ‘‘Federal Actions to Address                              Dated: May 31, 2016.
                                              Environmental Justice in Minority                       Susan Lewis,
                                              Populations and Low-Income                                                                                         *           *               *             *          *
                                                                                                      Director, Registration Division, Office of
                                              Populations’’ (59 FR 7629, February 16,                 Pesticide Programs.                                    Pistachio 1   .............................              0.04
                                              1994).
                                                 Since tolerances and exemptions that                   Therefore, 40 CFR chapter I is
                                              are established on the basis of a petition              amended as follows:                                        *           *               *             *          *
                                              under FFDCA section 408(d), such as
                                              the tolerances in this final rule, do not               PART 180—[AMENDED]                                       1 This tolerance expires on December 14,
                                                                                                                                                             2016.
                                              require the issuance of a proposed rule,                ■ 1. The authority citation for part 180
                                              the requirements of the Regulatory                                                                             *       *      *          *         *
                                                                                                      continues to read as follows:                          [FR Doc. 2016–13910 Filed 6–13–16; 8:45 am]
                                              Flexibility Act (RFA) (5 U.S.C. 601 et
                                              seq.), do not apply.                                        Authority: 21 U.S.C. 321(q), 346a and 371.         BILLING CODE 6560–50–P
                                                 This action directly regulates growers,              ■ 2. In § 180.628, in the table in
                                              food processors, food handlers, and food                paragraph (a):
                                              retailers, not States or tribes, nor does               ■ a. Remove the entries for ‘‘Cherry,
                                                                                                                                                             ENVIRONMENTAL PROTECTION
                                              this action alter the relationships or                  sweet,’’ ‘‘Cherry, tart,’’ ‘‘Plum,                     AGENCY
                                              distribution of power and                               chickasaw,’’ and ‘‘Plum, damson;’’
                                              responsibilities established by Congress                                                                       40 CFR Part 180
                                                                                                      ■ b. Revise the entry for ‘‘Egg;’’
                                              in the preemption provisions of FFDCA                   ■ c. Amend the existing entries by                     [EPA–HQ–OPP–2014–0749; FRL–9942–23]
                                              section 408(n)(4). As such, the Agency                  adding a footnote for ‘‘Artichoke,
                                              has determined that this action will not                globe,’’ ‘‘Fruit, stone, group 12–12,                  Clofentezine; Pesticide Tolerances
                                              have a substantial direct effect on States              except cherry, chickasaw plum, and                     AGENCY:  Environmental Protection
                                              or tribal governments, on the                           damson plum,’’ ‘‘Hop, dried cones,’’                   Agency (EPA).
                                              relationship between the national                       ‘‘Nut, tree, group 14,’’ and ‘‘Pistachio;’’            ACTION: Final rule.
                                              government and the States or tribal                     and
                                              governments, or on the distribution of                  ■ d. Add alphabetically the entries for                SUMMARY:         This regulation establishes
                                              power and responsibilities among the                    ‘‘Artichoke, globe,’’ ‘‘Fruit, stone, group                  tolerances for residues of clofentezine in
                                              various levels of government or between                 12–12,’’ ‘‘Hop, dried cones,’’ and ‘‘Nut,                    or on multiple commodities which are
                                              the Federal Government and Indian                       tree, group 14–12.’’                                         identified and discussed later in this
                                              tribes. Thus, the Agency has determined                    The additions and revisions read as                       document. Interregional Research
                                              that Executive Order 13132, entitled                    follows:                                                     Project Number 4 (IR–4) requested these
                                              ‘‘Federalism’’ (64 FR 43255, August 10,                                                                              tolerances under the Federal Food,
                                              1999) and Executive Order 13175,                        § 180.628 Chlorantraniliprole; tolerances                    Drug, and Cosmetic Act (FFDCA).
                                              entitled ‘‘Consultation and Coordination                for residues.
                                                                                                                                                                   DATES: This regulation is effective June
                                              with Indian Tribal Governments’’ (65 FR                    (a) * * *                                                 14, 2016. Objections and requests for
                                              67249, November 9, 2000) do not apply                                                                                hearings must be received on or before
                                              to this action. In addition, this action                                                              Parts  per
                                                                                                                Commodity                                          August 15, 2016, and must be filed in
                                                                                                                                                     million
                                              does not impose any enforceable duty or                                                                              accordance with the instructions
                                              contain any unfunded mandate as                                                                                      provided in 40 CFR part 178 (see also
                                              described under Title II of the Unfunded                    *            *              *           *          *     Unit I.C. of the SUPPLEMENTARY
                                              Mandates Reform Act (UMRA) (2 U.S.C.                                                                                 INFORMATION).
                                              1501 et seq.).                                          Artichoke, globe 1 ..................                    4.0
                                                 This action does not involve any                     Artichoke, globe ....................                    2.0 ADDRESSES: The docket for this action,
                                              technical standards that would require                                                                               identified by docket identification (ID)
                                              Agency consideration of voluntary                                                                                    number EPA–HQ–OPP–2014–0749, is
                                                                                                          *            *              *           *          *     available at http://www.regulations.gov
                                              consensus standards pursuant to section
                                              12(d) of the National Technology                                                                                     or at the Office of Pesticide Programs
                                                                                                      Egg .......................................              1.0
                                              Transfer and Advancement Act                                                                                         Regulatory Public Docket (OPP Docket)
                                              (NTTAA) (15 U.S.C. 272 note).                                                                                        in the Environmental Protection Agency
                                                                                                          *            *              *           *          *     Docket Center (EPA/DC), West William
                                              VII. Congressional Review Act                                                                                        Jefferson Clinton Bldg., Rm. 3334, 1301
                                                Pursuant to the Congressional Review                  Fruit, stone, group 12–12 .....                          2.5 Constitution Ave. NW., Washington, DC
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                                              Act (5 U.S.C. 801 et seq.), EPA will                    Fruit, stone, group 12–12,                                   20460–0001. The Public Reading Room
                                              submit a report containing this rule and                   except cherry, chickasaw                                  is open from 8:30 a.m. to 4:30 p.m.,
                                                                                                         plum, and damson plum 1                               4.0 Monday through Friday, excluding legal
                                              other required information to the U.S.
                                              Senate, the U.S. House of                                                                                            holidays. The telephone number for the
                                              Representatives, and the Comptroller                        *            *              *           *          *     Public Reading Room is (202) 566–1744,
                                              General of the United States prior to                                                                                and the telephone number for the OPP
                                              publication of the rule in the Federal                  Hop, dried cones 1 ................                      90 Docket is (703) 305–5805. Please review



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                                                                 Federal Register / Vol. 81, No. 114 / Tuesday, June 14, 2016 / Rules and Regulations                                           38605

                                              the visitor instructions and additional                 submit a copy of the filing (excluding                 filing, however it related to a different
                                              information about the docket available                  any Confidential Business Information                  chemical.
                                              at http://www.epa.gov/dockets.                          (CBI)) for inclusion in the public docket.
                                                                                                                                                             III. Aggregate Risk Assessment and
                                              FOR FURTHER INFORMATION CONTACT:                        Information not marked confidential
                                                                                                                                                             Determination of Safety
                                              Susan Lewis, Registration Division                      pursuant to 40 CFR part 2 may be
                                              (7505P), Office of Pesticide Programs,                  disclosed publicly by EPA without prior                   Section 408(b)(2)(A)(i) of FFDCA
                                              Environmental Protection Agency, 1200                   notice. Submit the non-CBI copy of your                allows EPA to establish a tolerance (the
                                              Pennsylvania Ave. NW., Washington,                      objection or hearing request, identified               legal limit for a pesticide chemical
                                              DC 20460–0001; main telephone                           by docket ID number EPA–HQ–OPP–                        residue in or on a food) only if EPA
                                              number: (703) 305–7090; email address:                  2014–0749, by one of the following                     determines that the tolerance is ‘‘safe.’’
                                              RDFRNotices@epa.gov.                                    methods:                                               Section 408(b)(2)(A)(ii) of FFDCA
                                                                                                        • Federal eRulemaking Portal: http://                defines ‘‘safe’’ to mean that ‘‘there is a
                                              SUPPLEMENTARY INFORMATION:
                                                                                                      www.regulations.gov. Follow the online                 reasonable certainty that no harm will
                                              I. General Information                                  instructions for submitting comments.                  result from aggregate exposure to the
                                                                                                      Do not submit electronically any                       pesticide chemical residue, including
                                              A. Does this action apply to me?                                                                               all anticipated dietary exposures and all
                                                                                                      information you consider to be CBI or
                                                 You may be potentially affected by                   other information whose disclosure is                  other exposures for which there is
                                              this action if you are an agricultural                  restricted by statute.                                 reliable information.’’ This includes
                                              producer, food manufacturer, or                                                                                exposure through drinking water and in
                                                                                                        • Mail: OPP Docket, Environmental
                                              pesticide manufacturer. The following                                                                          residential settings, but does not include
                                                                                                      Protection Agency Docket Center (EPA/
                                              list of North American Industrial                                                                              occupational exposure. Section
                                                                                                      DC), (28221T), 1200 Pennsylvania Ave.
                                              Classification System (NAICS) codes is                                                                         408(b)(2)(C) of FFDCA requires EPA to
                                                                                                      NW., Washington, DC 20460–0001.                        give special consideration to exposure
                                              not intended to be exhaustive, but rather
                                                                                                        • Hand Delivery: To make special                     of infants and children to the pesticide
                                              provides a guide to help readers
                                                                                                      arrangements for hand delivery or                      chemical residue in establishing a
                                              determine whether this document
                                                                                                      delivery of boxed information, please                  tolerance and to ‘‘ensure that there is a
                                              applies to them. Potentially affected
                                                                                                      follow the instructions at http://                     reasonable certainty that no harm will
                                              entities may include:
                                                 • Crop production (NAICS code 111).                  www.epa.gov/dockets/contacts.html.                     result to infants and children from
                                                 • Animal production (NAICS code                      Additional instructions on commenting                  aggregate exposure to the pesticide
                                              112).                                                   or visiting the docket, along with more                chemical residue. . . .’’
                                                 • Food manufacturing (NAICS code                     information about dockets generally, is                   Consistent with FFDCA section
                                              311).                                                   available at http://www.epa.gov/                       408(b)(2)(D), and the factors specified in
                                                 • Pesticide manufacturing (NAICS                     dockets.                                               FFDCA section 408(b)(2)(D), EPA has
                                              code 32532).                                            II. Summary of Petitioned-For                          reviewed the available scientific data
                                                                                                      Tolerance                                              and other relevant information in
                                              B. How can I get electronic access to                                                                          support of this action. EPA has
                                              other related information?                                 In the Federal Register of February                 sufficient data to assess the hazards of
                                                You may access a frequently updated                   11, 2015 (80 FR 7559) (FRL–9921–94),                   and to make a determination on
                                              electronic version of EPA’s tolerance                   EPA issued a document pursuant to                      aggregate exposure for clofentezine
                                              regulations at 40 CFR part 180 through                  FFDCA section 408(d)(3), 21 U.S.C.                     including exposure resulting from the
                                              the Government Publishing Office’s e-                   346a(d)(3), announcing the filing of a                 tolerances established by this action.
                                              CFR site at http://www.ecfr.gov/cgi-bin/                pesticide petition (PP 4E8312) by IR–4,                EPA’s assessment of exposures and risks
                                              text-idx?&c=ecfr&tpl=/ecfrbrowse/                       IR–4 Project Headquarters, Rutgers, The                associated with clofentezine follows.
                                              Title40/40tab_02.tpl.                                   State University of New Jersey, 500
                                                                                                      College Road East, Suite 201 W,                        A. Toxicological Profile
                                              C. How can I file an objection or hearing               Princeton, NJ 08540. The petition                         EPA has evaluated the available
                                              request?                                                requested that 40 CFR 180.446 be                       toxicity data and considered its validity,
                                                Under FFDCA section 408(g), 21                        amended by establishing tolerances for                 completeness, and reliability as well as
                                              U.S.C. 346a, any person may file an                     residues of the acaricide clofentezine in              the relationship of the results of the
                                              objection to any aspect of this regulation              or on avocado at 0.3 parts per million                 studies to human risk. EPA has also
                                              and may also request a hearing on those                 (ppm); papaya at 0.3 ppm; fruit, pome,                 considered available information
                                              objections. You must file your objection                group 11–10 at 0.5 ppm; cherry,                        concerning the variability of the
                                              or request a hearing on this regulation                 subgroup 12–12A at 1.0 ppm; peach,                     sensitivities of major identifiable
                                              in accordance with the instructions                     subgroup 12–12B at 1.0 ppm; and fruit,                 subgroups of consumers, including
                                              provided in 40 CFR part 178. To ensure                  small, vine climbing, except fuzzy                     infants and children.
                                              proper receipt by EPA, you must                         kiwifruit, subgroup 13–07F at 1.0 ppm.                    Subchronic and chronic studies
                                              identify docket ID number EPA–HQ–                       Upon the approval of the                               indicate the liver is the primary target
                                              OPP–2014–0749 in the subject line on                    aforementioned tolerances, IR–4                        organ for clofentezine with secondary
                                              the first page of your submission. All                  proposed that the existing tolerances for              effects on the thyroid. Body weight and
                                              objections and requests for a hearing                   apple at 0.5 ppm; pear at 0.5 ppm;                     body weight gain were decreased
                                              must be in writing, and must be                         cherry at 1.0 ppm; nectarine at 1.0 ppm;               whereas liver weights were increased
                                              received by the Hearing Clerk on or                     peach at 1.0 ppm; and grape at 1.0 ppm                 and hepatocellular enlargement was
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                                              before August 15, 2016. Addresses for                   be removed as unnecessary. That                        reported along with other observations
                                              mail and hand delivery of objections                    document referenced a summary of the                   (increases in plasma cholesterol and
                                              and hearing requests are provided in 40                 petition prepared by Makhteshim Agan                   triglyceride levels). The induction of the
                                              CFR 178.25(b).                                          of North America, the registrant, which                liver enzyme, uridine diphosphate
                                                In addition to filing an objection or                 is available in the docket, http://                    glucuronyltransferase (UDPGT) and the
                                              hearing request with the Hearing Clerk                  www.regulations.gov. One comment was                   subsequent increase in the metabolism
                                              as described in 40 CFR part 178, please                 received in response to the notice of                  and the excretion of the thyroid


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                                              38606              Federal Register / Vol. 81, No. 114 / Tuesday, June 14, 2016 / Rules and Regulations

                                              hormone T4 reduced the availability of                  carcinoma combined tumor rates. The                    that have a threshold below which there
                                              T4 required for the general metabolism                  Q1* value for use in clofentezine risk                 is no appreciable risk, the toxicological
                                              and the maintenance of homeostasis.                     assessment using the 3⁄4 inter species                 POD is used as the basis for derivation
                                              The decreased levels of plasma T4                       scaling factor is 3.76 × 10¥2 (mg/kg/                  of reference values for risk assessment.
                                              resulted in the stimulation of the                      day)¥1. Clofentezine is not considered                 PODs are developed based on a careful
                                              thyroid by the pituitary gland to raise                 to be a mutagen.                                       analysis of the doses in each
                                              the plasma T4 levels. Thyroid changes                      Specific information on the studies                 toxicological study to determine the
                                              in the form of colloid depletion, thyroid               received and the nature of the adverse                 dose at which no adverse effects are
                                              follicular cell hypertrophy and                         effects caused by clofentezine as well as              observed (the NOAEL) and the lowest
                                              hyperplasia were observed as a means to                 the no-observed-adverse-effect-level                   dose at which adverse effects of concern
                                              regain the homeostasis.                                 (NOAEL) and the lowest-observed-                       are identified (the LOAEL). Uncertainty/
                                                Two pre-natal developmental toxicity                  adverse-effect-level (LOAEL) from the                  safety factors are used in conjunction
                                              studies are available, one in the rat and               toxicity studies can be found at http://               with the POD to calculate a safe
                                              one in the rabbit. No evidence                          www.regulations.gov in the document                    exposure level—generally referred to as
                                              (quantitative or qualitative) of increased              titled ‘‘Clofentezine.’’ Human-Health                  a population-adjusted dose (PAD) or a
                                              susceptibility was seen in either study                 Risk Assessment to Support a Section 3                 reference dose (RfD)—and a safe margin
                                              (developmental NOAELs were set at or                    Registration Request to Add New Uses                   of exposure (MOE). For non-threshold
                                              above the limit dose for both studies).                 on Avocado and Papaya, and New Uses                    risks, the Agency assumes that any
                                              There was no evidence (quantitative or                  for Pome Fruit Group 11–10, Cherry                     amount of exposure will lead to some
                                              qualitative) of increased susceptibility                sub-group 12–12A, Peach sub-group 12–                  degree of risk. Thus, the Agency
                                              seen following pre-and/or post-natal                    12B, and Small Fruit Vine Climbing                     estimates risk in terms of the probability
                                              exposure in rats for 2-generations in the               except Fuzzy Kiwifruit Subgroup 13–                    of an occurrence of the adverse effect
                                              reproduction study (NOAEL set at the                    07F based on Existing Tolerances on                    expected in a lifetime. For more
                                              highest dose tested).                                   Representative Commodities’’ on page
                                                Clofentezine does cause thyroid                                                                              information on the general principles
                                                                                                      38 in docket ID number EPA–HQ–OPP–                     EPA uses in risk characterization and a
                                              tumors in male rats after long-term high                2014–0749.
                                              exposure resulting in progressive effects                                                                      complete description of the risk
                                              on the thyroid that leads to hyperplasia                B. Toxicological Points of Departure/                  assessment process, see http://
                                              and eventual tumor formation. No                        Levels of Concern                                      www2.epa.gov/pesticide-science-and-
                                              mechanism or mode of action has been                      Once a pesticide’s toxicological                     assessing-pesticide-risks/assessing-
                                              submitted to the Agency at this time for                profile is determined, EPA identifies                  human-health-risk-pesticides.
                                              clofentezine. As a result, clofentezine                 toxicological points of departure (POD)                   A summary of the toxicological
                                              has been classified as a possible human                 and levels of concern to use in                        endpoints for clofentezine used for
                                              carcinogen based on male rat thyroid                    evaluating the risk posed by human                     human risk assessment is shown in
                                              follicular cell adenoma and/or                          exposure to the pesticide. For hazards                 Table 1 of this Unit.

                                                TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR CLOFENTEZINE FOR USE IN HUMAN HEALTH RISK
                                                                                          ASSESSMENT
                                                                                       Point of departure        RfD, PAD, LOC for
                                                     Exposure/scenario                  and uncertainty/                risk                                Study and toxicological effects
                                                                                         safety factors             assessment

                                              Acute dietary (All populations) ..             No appropriate endpoint was identified including developmental toxicity studies in rats and rabbits.

                                              Chronic dietary (All populations)      NOAEL= 1.25 mg/            Chronic RfD = 0.013        1-year chronic dog study—LOAEL = 25 mg/kg based on in-
                                                                                      kg/day.                     mg/kg/day.                 creased liver weights, hepatocellular enlargement, and in-
                                                                                     UFA = 10x                  cPAD = 0.013 mg/             creased serum cholesterol, triglycerides and alkaline phos-
                                                                                     UFH = 10x                    kg/day                     phatase levels.
                                                                                     FQPA SF = 1x

                                              Cancer (Oral, dermal, inhala-            Classification: Possible human carcinogen (classification of C), Q* using the 3⁄4 interspecies scaling factor is
                                                tion).                                                                        3.76 × 10¥2 (mg/kg/day)¥1.
                                                FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day =
                                              milligram/kilogram/day. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference
                                              dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
                                              of the human population (intraspecies).


                                              C. Exposure Assessment                                     i. Acute exposure. Quantitative acute                 ii. Chronic exposure. In conducting
                                                                                                      dietary exposure and risk assessments                  the chronic dietary exposure assessment
                                                1. Dietary exposure from food and                     are performed for a food-use pesticide,                EPA used the 2003–2008 food
                                              feed uses. In evaluating dietary                        if a toxicological study has indicated the             consumption data from the U.S.
                                              exposure to clofentezine, EPA                           possibility of an effect of concern                    Department of Agriculture’s (USDA)
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                                              considered exposure under the                           occurring as a result of a 1-day or single             National Health and Nutrition
                                              petitioned-for tolerances as well as all                exposure. No such effects were                         Examination Survey, What We Eat in
                                              existing clofentezine tolerances in 40                  identified in the toxicological studies                America, (NHANES/WWEIA). As to
                                              CFR 180.446. EPA assessed dietary                       for clofentezine; therefore, a quantitative            residue levels in food, a partially refined
                                              exposures from clofentezine in food as                  acute dietary exposure assessment is                   chronic dietary exposure and risk
                                              follows:                                                unnecessary.                                           assessment was performed that directly



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                                                                 Federal Register / Vol. 81, No. 114 / Tuesday, June 14, 2016 / Rules and Regulations                                         38607

                                              incorporated average field trial residues               provide for the periodic evaluation of                 the regional consumption of food to
                                              and used percent crop treated                           the estimate of PCT as required by                     which clofentezine may be applied in a
                                              information.                                            FFDCA section 408(b)(2)(F), EPA may                    particular area.
                                                 iii. Cancer. EPA determines whether                  require registrants to submit data on                     2. Dietary exposure from drinking
                                              quantitative cancer exposure and risk                   PCT.                                                   water. The Agency used screening level
                                              assessments are appropriate for a food-                    Average percent crop treated                        water exposure models in the dietary
                                              use pesticide based on the weight of the                estimates were used in the chronic and                 exposure analysis and risk assessment
                                              evidence from cancer studies and other                  cancer dietary risk assessments for the                for clofentezine in drinking water.
                                              relevant data. If quantitative cancer risk              following crops that are currently                     These simulation models take into
                                              assessment is appropriate, cancer risk                  registered for clofentezine: Almonds:                  account data on the physical, chemical,
                                              may be quantified using a linear or                     5%; apples: 2.5%; apricots: 2.5%;                      and fate/transport characteristics of
                                              nonlinear approach. If sufficient                       cherries: 5%; grapes: 1%; nectarines:                  clofentezine. Further information
                                              information on the carcinogenic mode                    5%; peaches: 5%; pears: 5%; and                        regarding EPA drinking water models
                                              of action is available, a threshold or                  walnuts: 5%.                                           used in pesticide exposure assessment
                                              nonlinear approach is used and a cancer                    In most cases, EPA uses available data              can be found at http://www2.epa.gov/
                                              RfD is calculated based on an earlier                   from United States Department of                       pesticide-science-and-assessing-
                                              non cancer key event. If carcinogenic                   Agriculture/National Agricultural                      pesticide-risks/about-water-exposure-
                                              mode of action data are not available, or               Statistics Service (USDA/NASS),                        models-used-pesticide.
                                              if the mode of action data determines a                 proprietary market surveys, and the                       Based on the First Index Reservoir
                                              mutagenic mode of action, a default                     National Pesticide Use Database for the                Screening Tool (FIRST) and Screening
                                              linear cancer slope factor approach is                  chemical/crop combination for the most                 Concentration in Ground Water (SCI–
                                              utilized. Based on the data summarized                  recent 6–7 years. EPA uses an average                  GROW) models, the estimated drinking
                                              in Unit III.A., EPA has concluded that                  PCT for chronic dietary risk analysis.                 water concentrations (EDWCs) of
                                              clofentezine should be classified as                    The average PCT figure for each existing               clofentezine for chronic exposures for
                                              possible human carcinogen and a linear                  use is derived by combining available                  non-cancer and cancer assessments are
                                              approach has been used to quantify                      public and private market survey data                  estimated to be 0.062 parts per billion
                                              cancer risk. Cancer risk was quantified                 for that use, averaging across all                     (ppb) for surface water and 0.041 ppb
                                              using the same estimates as discussed in                observations, and rounding to the                      for ground water.
                                              Unit III.C.1.ii.                                        nearest 5%, except for those situations                   Modeled estimates of drinking water
                                                 iv. Anticipated residue and percent                  in which the average PCT is less than                  concentrations were directly entered
                                              crop treated (PCT) information. Section                 one. In those cases, 1% is used as the                 into the dietary exposure model. For
                                              408(b)(2)(E) of FFDCA authorizes EPA                    average PCT and 2.5% is used as the                    chronic and cancer dietary risk
                                              to use available data and information on                maximum PCT. EPA uses a maximum                        assessment, the water concentration of
                                              the anticipated residue levels of                       PCT for acute dietary risk analysis. The               value 0.062 ppb was used to assess the
                                              pesticide residues in food and the actual               maximum PCT figure is the highest                      contribution to drinking water.
                                              levels of pesticide residues that have                  observed maximum value reported                           3. From non-dietary exposure. The
                                              been measured in food. If EPA relies on                 within the recent 6 years of available                 term ‘‘residential exposure’’ is used in
                                              such information, EPA must require                      public and private market survey data                  this document to refer to non-
                                              pursuant to FFDCA section 408(f)(1)                     for the existing use and rounded up to                 occupational, non-dietary exposure
                                              that data be provided 5 years after the                 the nearest multiple of 5%.                            (e.g., for lawn and garden pest control,
                                              tolerance is established, modified, or                     The Agency believes that the three                  indoor pest control, termiticides, and
                                              left in effect, demonstrating that the                  conditions discussed in Unit III.C.1.iv.               flea and tick control on pets).
                                              levels in food are not above the levels                 have been met. With respect to                            Clofentezine is not registered for any
                                              anticipated. For the present action, EPA                Condition a, PCT estimates are derived                 specific use patterns that would result
                                              will issue such data call-ins as are                    from Federal and private market survey                 in residential exposure.
                                              required by FFDCA section 408(b)(2)(E)                  data, which are reliable and have a valid                 4. Cumulative effects from substances
                                              and authorized under FFDCA section                      basis. The Agency is reasonably certain                with a common mechanism of toxicity.
                                              408(f)(1). Data will be required to be                  that the percentage of the food treated                Section 408(b)(2)(D)(v) of FFDCA
                                              submitted no later than 5 years from the                is not likely to be an underestimation.                requires that, when considering whether
                                              date of issuance of these tolerances.                   As to Conditions b and c, regional                     to establish, modify, or revoke a
                                                 Section 408(b)(2)(F) of FFDCA states                 consumption information and                            tolerance, the Agency consider
                                              that the Agency may use data on the                     consumption information for significant                ‘‘available information’’ concerning the
                                              actual percent of food treated for                      subpopulations is taken into account                   cumulative effects of a particular
                                              assessing chronic dietary risk only if:                 through EPA’s computer-based model                     pesticide’s residues and ‘‘other
                                                 • Condition a: The data used are                     for evaluating the exposure of                         substances that have a common
                                              reliable and provide a valid basis to                   significant subpopulations including                   mechanism of toxicity.’’
                                              show what percentage of the food                        several regional groups. Use of this                      EPA has not found clofentezine to
                                              derived from such crop is likely to                     consumption information in EPA’s risk                  share a common mechanism of toxicity
                                              contain the pesticide residue.                          assessment process ensures that EPA’s                  with any other substances, and
                                                 • Condition b: The exposure estimate                 exposure estimate does not understate                  clofentezine does not appear to produce
                                              does not underestimate exposure for any                 exposure for any significant                           a toxic metabolite produced by other
                                              significant subpopulation group.                        subpopulation group and allows the                     substances. For the purposes of this
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                                                 • Condition c: Data are available on                 Agency to be reasonably certain that no                tolerance action, therefore, EPA has
                                              pesticide use and food consumption in                   regional population is exposed to                      assumed that clofentezine does not have
                                              a particular area, the exposure estimate                residue levels higher than those                       a common mechanism of toxicity with
                                              does not understate exposure for the                    estimated by the Agency. Other than the                other substances. For information
                                              population in such area. In addition, the               data available through national food                   regarding EPA’s efforts to determine
                                              Agency must provide for periodic                        consumption surveys, EPA does not                      which chemicals have a common
                                              evaluation of any estimates used. To                    have available reliable information on                 mechanism of toxicity and to evaluate


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                                              38608              Federal Register / Vol. 81, No. 114 / Tuesday, June 14, 2016 / Rules and Regulations

                                              the cumulative effects of such                          of clofentezine were incorporated                      cancer exposure, EPA has concluded
                                              chemicals, see EPA’s Web site at http://                directly into the chronic and cancer                   that by applying the Q1* of 3.76 × 10¥2
                                              www2.epa.gov/pesticide-science-and-                     assessments. These assessments will not                mg/kg/day to the exposure value results
                                              assessing-pesticide-risks/cumulative-                   underestimate the exposure and risks                   in a cancer risk estimate of 3.8 × 10¥7
                                              assessment-risk-pesticides.                             posed by clofentezine.                                 to the general U.S. population. EPA
                                              D. Safety Factor for Infants and                        E. Aggregate Risks and Determination of                generally considers cancer risks
                                              Children                                                Safety                                                 (expressed as the probability of an
                                                                                                                                                             increased cancer case) in the range of 1
                                                 1. In general. Section 408(b)(2)(C) of                  EPA determines whether acute and                    in 1 million (or 1 × 10¥6) or less to be
                                              FFDCA provides that EPA shall apply                     chronic dietary pesticide exposures are                negligible.
                                              an additional tenfold (10X) margin of                   safe by comparing aggregate exposure                      5. Determination of safety. Based on
                                              safety for infants and children in the                  estimates to the acute PAD (aPAD) and                  these risk assessments, EPA concludes
                                              case of threshold effects to account for                chronic PAD (cPAD). For linear cancer                  that there is a reasonable certainty that
                                              prenatal and postnatal toxicity and the                 risks, EPA calculates the lifetime                     no harm will result to the general
                                              completeness of the database on toxicity                probability of acquiring cancer given the              population, or to infants and children
                                              and exposure unless EPA determines                      estimated aggregate exposure. Short-,                  from aggregate exposure to clofentezine
                                              based on reliable data that a different                 intermediate-, and chronic-term risks                  residues.
                                              margin of safety will be safe for infants               are evaluated by comparing the
                                              and children. This additional margin of                 estimated aggregate food, water, and                   IV. Other Considerations
                                              safety is commonly referred to as the                   residential exposure to the appropriate                A. Analytical Enforcement Methodology
                                              FQPA Safety Factor (SF). In applying                    PODs to ensure that an adequate MOE
                                              this provision, EPA either retains the                  exists.                                                   Adequate enforcement methodology
                                              default value of 10X, or uses a different                  1. Acute risk. An acute aggregate risk              (high performance liquid
                                              additional safety factor when reliable                  assessment takes into account acute                    chromatography (HPLC)) is available to
                                              data available to EPA support the choice                exposure estimates from dietary                        enforce the tolerance expression.
                                              of a different factor.                                  consumption of food and drinking                          The method may be requested from:
                                                 2. Prenatal and postnatal sensitivity.               water. No adverse effect resulting from                Chief, Analytical Chemistry Branch,
                                              Two pre-natal developmental toxicity                    a single oral exposure was identified                  Environmental Science Center, 701
                                              studies were available, one in the rat                  and no acute dietary endpoint was                      Mapes Rd., Ft. Meade, MD 20755–5350;
                                              and one in the rabbit. No evidence                      selected. Therefore, clofentezine is not               telephone number: (410) 305–2905;
                                              (quantitative or qualitative) of increased              expected to pose an acute risk.                        email address: residuemethods@
                                              susceptibility was seen in either study                    2. Chronic risk. Using the exposure                 epa.gov.
                                              (developmental NOAELs were set at or                    assumptions described in this unit for                 B. International Residue Limits
                                              above the limit dose for both studies).                 chronic exposure, EPA has concluded
                                              There was no evidence (quantitative or                  that chronic exposure to clofentezine                     In making its tolerance decisions, EPA
                                              qualitative) of increased susceptibility                from food and water will utilize <1% of                seeks to harmonize U.S. tolerances with
                                              seen following pre-and/or post-natal                    the cPAD for all population groups.                    international standards whenever
                                              exposure in rats for 2-generations in the               There are no residential uses for                      possible, consistent with U.S. food
                                              reproduction study (NOAEL set at the                    clofentezine.                                          safety standards and agricultural
                                              highest dose tested).                                      3. Short- and intermediate-term risk.               practices. EPA considers the
                                                 3. Conclusion. EPA has determined                    Short- and intermediate-term aggregate                 international maximum residue limits
                                              that reliable data show the safety of                   exposure takes into account short-term                 (MRLs) established by the Codex
                                              infants and children would be                           residential exposure plus chronic                      Alimentarius Commission (Codex), as
                                              adequately protected if the FQPA SF                     exposure to food and water (considered                 required by FFDCA section 408(b)(4).
                                              were reduced to 1X. That decision is                    to be a background exposure level).                    The Codex Alimentarius is a joint
                                              based on the following findings:                           A short- and intermediate-term                      United Nations Food and Agriculture
                                                 i. The toxicity database for                         adverse effect was identified; however,                Organization/World Health
                                              clofentezine is complete.                               clofentezine is not registered for any use             Organization food standards program,
                                                 ii. There is no indication that                      patterns that would result in short- or                and it is recognized as an international
                                              clofentezine is a neurotoxic chemical                   intermediate-term residential exposure.                food safety standards-setting
                                              and there is no need for a                              Short- and intermediate-term risk is                   organization in trade agreements to
                                              developmental neurotoxicity study or                    assessed based on short- and                           which the United States is a party. EPA
                                              additional UFs to account for                           intermediate-term residential exposure                 may establish a tolerance that is
                                              neurotoxicity.                                          plus chronic dietary exposure. Because                 different from a Codex MRL; however,
                                                 iii. There is no evidence that                       there is no short- or intermediate-term                FFDCA section 408(b)(4) requires that
                                              clofentezine results in increased                       residential exposure and chronic dietary               EPA explain the reasons for departing
                                              susceptibility in in utero rats or rabbits              exposure has already been assessed                     from the Codex level.
                                              in the prenatal developmental studies or                under the appropriately protective                        There are no Codex MRLs for residues
                                              in young rats in the 2-generation                       cPAD (which is at least as protective as               on avocado and papaya.
                                              reproduction study.                                     the POD used to assess short- or                          The U.S. pome fruit tolerance of 0.5
                                                 iv. There are no residual uncertainties              intermediate-term risk), no further                    ppm is harmonized with the Codex
                                              identified in the exposure databases.                   assessment of short- or intermediate-                  MRL.
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                                              The chronic and cancer analyses                         term risk is necessary, and EPA relies on                 The U.S. tolerance is 1.0 ppm in/on
                                              incorporated anticipated residues                       the chronic dietary risk assessment for                stone fruit (12–12A and 12–12B). The
                                              (average residues from available field                  evaluating short- and intermediate-term                Codex MRL for stone fruit is 0.5 ppm.
                                              trial data) for all registered and                      risk for clofentezine.                                 The clofentezine residues in/on
                                              proposed commodities and the latest                        4. Aggregate cancer risk for U.S.                   representative stone fruit crops, cherry
                                              PCT data available. The highest                         population. Using the exposure                         and peach, from the submitted U.S. field
                                              estimated drinking water concentrations                 assumptions described in this unit for                 trial data are greater than 0.5 ppm and


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                                                                 Federal Register / Vol. 81, No. 114 / Tuesday, June 14, 2016 / Rules and Regulations                                                            38609

                                              setting the tolerances for 12–12A and                   Paperwork Reduction Act (PRA) (44                      General of the United States prior to
                                              12–12B at 0.5 ppm to harmonize with                     U.S.C. 3501 et seq.), nor does it require              publication of the rule in the Federal
                                              Codex could result a tolerance                          any special considerations under                       Register. This action is not a ‘‘major
                                              exceedance for U.S. growers. Therefore,                 Executive Order 12898, entitled                        rule’’ as defined by 5 U.S.C. 804(2).
                                              the U.S. tolerance cannot be harmonized                 ‘‘Federal Actions to Address
                                                                                                                                                             List of Subjects in 40 CFR Part 180
                                              with Codex MRL for stone fruit at this                  Environmental Justice in Minority
                                              time.                                                   Populations and Low-Income                               Environmental protection,
                                                 The U.S. tolerance of 1.0 ppm for the                Populations’’ (59 FR 7629, February 16,                Administrative practice and procedure,
                                              crop subgroup fruit, small, vine                        1994).                                                 Agricultural commodities, Pesticides
                                              climbing, except fuzzy kiwifruit, 13–07F                   Since tolerances and exemptions that                and pests, Reporting and recordkeeping
                                              does not harmonize with the Codex                       are established on the basis of a petition             requirements.
                                              MRL of 2.0 ppm. The petitioner                          under FFDCA section 408(d), such as                      Dated: May 31, 2016.
                                              requested a 13–07F subgroup tolerance                   the tolerance in this final rule, do not
                                                                                                                                                             Susan Lewis,
                                              at 1.0 ppm, which would maintain the                    require the issuance of a proposed rule,
                                              existing tolerance on grapes at 1.0 ppm                 the requirements of the Regulatory                     Director, Registration Division, Office of
                                                                                                                                                             Pesticide Programs.
                                              consistent with the MRL at 1.0 ppm                      Flexibility Act (RFA) (5 U.S.C. 601 et
                                              maintained by several countries                         seq.), do not apply.                                     Therefore, 40 CFR chapter I is
                                              including Japan and Korea. EPA is not                      This action directly regulates growers,             amended as follows:
                                              harmonizing with Codex in order to                      food processors, food handlers, and food
                                              maintain MRL harmony with several                       retailers, not States or tribes, nor does              PART 180—[AMENDED]
                                              other countries to avoid potential export               this action alter the relationships or
                                              issues.                                                 distribution of power and                              ■ 1. The authority citation for part 180
                                                                                                      responsibilities established by Congress               continues to read as follows:
                                              V. Conclusion                                           in the preemption provisions of FFDCA                      Authority: 21 U.S.C. 321(q), 346a and 371.
                                                 Therefore, tolerances are established                section 408(n)(4). As such, the Agency
                                              for residues of clofentezine in or on                   has determined that this action will not               ■  2. In § 180.446, in the table in
                                              avocado at 0.30 ppm; papaya at 0.30                     have a substantial direct effect on States             paragraph (a)(1):
                                              ppm; fruit, pome, group 11–10 at 0.50                   or tribal governments, on the                          ■ a. Remove the entries for ‘‘Apple’’,
                                              ppm; cherry, subgroup 12–12A at 1.0                     relationship between the national                      ‘‘Cherry’’, ‘‘Grape’’, ‘‘Nectarine’’,
                                              ppm; peach, subgroup 12–12B at 1.0                      government and the States or tribal                    ‘‘Peach’’, and ‘‘Pear’’; and
                                              ppm; and fruit, small, vine climbing,                   governments, or on the distribution of                 ■ b. Add alphabetically the entries for
                                              except fuzzy kiwifruit, subgroup 13–07F                 power and responsibilities among the                   ‘‘Avocado’’, ‘‘Cherry, subgroup 12–
                                              at 1.0 ppm. In addition, the existing                   various levels of government or between                12A’’, ‘‘Fruit, pome, group 11–10’’,
                                              tolerances for apple at 0.5 ppm; pear at                the Federal Government and Indian                      ‘‘Fruit, small, vine climbing, except
                                              0.5 ppm; cherry at 1.0 ppm; nectarine at                tribes. Thus, the Agency has determined                fuzzy kiwifruit, Subgroup 13–07F’’,
                                              1.0 ppm; peach at 1.0 ppm; and grape                    that Executive Order 13132, entitled                   ‘‘Papaya’’, and ‘‘Peach, subgroup 12–
                                              at 1.0 ppm are removed as unnecessary.                  ‘‘Federalism’’ (64 FR 43255, August 10,                12B’’.
                                                                                                      1999) and Executive Order 13175,                          The additions read as follows:
                                              VI. Statutory and Executive Order
                                              Reviews                                                 entitled ‘‘Consultation and Coordination               § 180.446 Clofentezine; tolerances for
                                                                                                      with Indian Tribal Governments’’ (65 FR                residues.
                                                This action establishes tolerances                    67249, November 9, 2000) do not apply
                                              under FFDCA section 408(d) in                           to this action. In addition, this action                   (a) General. (1) * * *
                                              response to a petition submitted to the                 does not impose any enforceable duty or
                                              Agency. The Office of Management and                                                                                                                             Parts per
                                                                                                      contain any unfunded mandate as                                      Commodity                            million
                                              Budget (OMB) has exempted these types                   described under Title II of the Unfunded
                                              of actions from review under Executive                  Mandates Reform Act (UMRA) (2 U.S.C.
                                              Order 12866, entitled ‘‘Regulatory                      1501 et seq.).                                            *           *             *               *          *
                                              Planning and Review’’ (58 FR 51735,                        This action does not involve any                    Avocado ....................................            0.30
                                              October 4, 1993). Because this action                   technical standards that would require                 Cherry, subgroup 12–12A ........                          1.0
                                              has been exempted from review under                     Agency consideration of voluntary                      Fruit, pome, group 11–10 .........                      0.50
                                              Executive Order 12866, this action is                   consensus standards pursuant to section                Fruit, small, vine climbing, ex-
                                              not subject to Executive Order 13211,                                                                            cept fuzzy kiwifruit, Subgroup
                                                                                                      12(d) of the National Technology                         13–07F ..................................                 1.0
                                              entitled ‘‘Actions Concerning                           Transfer and Advancement Act
                                              Regulations That Significantly Affect                   (NTTAA) (15 U.S.C. 272 note).                            *            *              *               *         *
                                              Energy Supply, Distribution, or Use’’ (66                                                                      Papaya ......................................           0.30
                                              FR 28355, May 22, 2001) or Executive                    VII. Congressional Review Act
                                                                                                                                                             Peach, subgroup 12–12B .........                          1.0
                                              Order 13045, entitled ‘‘Protection of                     Pursuant to the Congressional Review
                                              Children from Environmental Health                      Act (5 U.S.C. 801 et seq.), EPA will                        *            *             *            *          *
                                              Risks and Safety Risks’’ (62 FR 19885,                  submit a report containing this rule and
                                              April 23, 1997). This action does not                   other required information to the U.S.                 *        *       *        *         *
                                              contain any information collections                     Senate, the U.S. House of                              [FR Doc. 2016–13911 Filed 6–13–16; 8:45 am]
                                              subject to OMB approval under the                       Representatives, and the Comptroller                   BILLING CODE 6560–50–P
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Document Created: 2016-06-14 02:58:43
Document Modified: 2016-06-14 02:58:43
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 June 14, 2016. Objections and requests for hearings must be received on or before August 15, 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 38604 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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