[Federal Register Volume 81, Number 114 (Tuesday, June 14, 2016)]
[Rules and Regulations]
[Pages 38604-38609]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13911]



40 CFR Part 180

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

Clofentezine; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.


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].


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 
     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 
    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
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk  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/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.
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 
    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 
    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 
    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 
    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 
    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:


1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

2. In Sec.  180.446, in the table in paragraph (a)(1):
a. Remove the entries for ``Apple'', ``Cherry'', ``Grape'', 
``Nectarine'', ``Peach'', and ``Pear''; and
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]