Carfentrazone-ethyl; Pesticide Tolerances, 26135-26141 [2016-10235]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 81, Number 84 (Monday, May 2, 2016)]
[Rules and Regulations]
[Pages 26135-26141]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10235]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0030; FRL-9942-47]


Carfentrazone-ethyl; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
Carfentrazone-ethyl 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 May 2, 2016. Objections and 
requests for hearings must be received on or before July 1, 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-2015-0030, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at https://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

[[Page 26136]]

number: (703) 305-7090; email address: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at https://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-2015-0030 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 
July 1, 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-2015-0030, by one of 
the following methods:
     Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets/contacts.html.

Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of May 20, 2015 (80 FR 28925) (FRL-9927-
39), 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 
4E8337) by Interregional Research Project Number 4 (IR-4), 500 College 
Road East, Suite 201 W, Princeton, NJ 08540. The petition requested 
that 40 CFR part 180 be amended by establishing tolerances for residues 
of the herbicide carfentrazone-ethyl, (ethyl-alpha-2-dichloro-5-[4-
(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-,2,4-triazol-1-yl]-4-
fluorobenzenepropanoate) and the metabolite carfentrazone-ethyl 
chloropropionic acid (a, 2-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-
3-methyl-5-oxo-1H-1,2,4-triazol-1-yl]-4-fluorobenzenepropanoic acid), 
in or on the raw agricultural commodity artichoke at 0.10 parts per 
million (ppm); asparagus at 0.25 ppm; peppermint, tops at 0.25 ppm; 
spearmint, tops at 0.25 ppm; teff, grain at 0.25 ppm; teff, forage at 
1.00 ppm; teff, hay at 0.30 ppm; teff, straw at 0.10 ppm; vegetable, 
bulb, group 3-07 at 0.10 ppm; vegetable, fruiting, group 8-10 at 0.10 
ppm; fruit, citrus, group 10-10 at 0.10 ppm; fruit, pome, group 11-10 
at 0.10 ppm; fruit, stone, group 12-12 at 0.10 ppm; caneberry subgroup 
13-07A at 0.10 ppm; bushberry subgroup 13-07B at 0.10 ppm; fruit, small 
vine climbing, subgroup 13-07F, except fuzzy kiwi fruit at 0.10 ppm; 
berry, low growing, subgroup 13-07G at 0.10 ppm; nut, tree, group 14-12 
at 0.10 ppm; oilseed group 20 at 0.20 ppm; grain, cereal forage group 
16 at 1.0 ppm; grain, cereal, hay, group 16 at 0.30 ppm; grain cereal, 
stover, group 16 at 0.80 ppm; and grain, cereal, straw, group 16 at 3.0 
ppm.
    The petitioner also proposed to amend the tolerance for banana from 
0.20 ppm to 0.10 ppm and to remove the following established 
tolerances: Vegetable, bulb group 3 at 0.10 ppm; vegetable, fruiting, 
group 8 at 0.10 ppm; fruit, citrus, group 10 at 0.10 ppm; fruit, pome, 
group 11 at 0.10 ppm; fruit, stone, group 12 at 0.10 ppm; berry group 
13 at 0.10 ppm; borage at 0.10 ppm; grape at 0.10 ppm; caneberry 
subgroup 13A at 0.10 ppm; nut, tree group 14 at 0.10 ppm; pistachio at 
0.10 ppm; pummelo at 0.10 ppm; kiwi fruit at 0.10 ppm; canola at 0.10 
ppm; cotton, undelinted seed at 0.20 ppm; crambe, seed at 0.10 ppm; 
flax, seed at 0.10 ppm; rapeseed, seed at 0.10 ppm; okra at 0.10 ppm; 
safflower seed at 0.10 ppm; salal at 0.10 ppm; sunflower seed at 0.10 
ppm; strawberry at 0.10 ppm; juneberry at 0.10 ppm; lingonberry at 0.10 
ppm; mustard, seed at 0.10 ppm; barley bran at 0.80 ppm; barley, flour 
at 0.80 ppm; corn, field, forage at 0.20 ppm; corn, sweet, forage at 
0.20 ppm, corn, sweet, kernel plus cob with husk removed at 0.10 ppm; 
grain, cereal, forage, fodder and straw group 16, except corn and 
sorghum; forage at 1.0 ppm; grain, cereal, forage, fodder and straw, 
group 16, hay at 0.30 ppm; grain, cereal, forage, fodder and straw, 
group 16, stover at 0.30 ppm; grain, cereal, forage, fodder and straw, 
group 16, except rice; straw at 0.10 ppm; grain, cereal, group 15 at 
0.10 ppm; grain, cereal, stover at 0.80 ppm; grain, cereal, straw at 
3.0 ppm; millet, flour at 0.80 ppm; oat, flour at 0.80 ppm; rice, straw 
at 1.0 ppm; rye, bran at 0.80 ppm; rye, flour at 0.80 ppm; sorghum, 
forage at 0.20 ppm; sorghum, sweet at 0.10 ppm; wheat, bran at 0.80 
ppm; wheat, flour at 0.80 ppm; wheat, germ at 0.80 ppm; wheat, 
middlings at 0.80 ppm; and wheat, shorts at 0.80 ppm.
    In the Federal Register of October 21, 2015 (80 FR 63731) (FRL-
9935-29), EPA amended the initial notice of filing for pesticide 
petition (PP 4E8337) to include a proposal to also establish a 
tolerance in or on the raw agricultural commodity quinoa, grain at 0.10 
ppm and psyllium, seed at 0.10 ppm. That document referenced a summary 
of the petition prepared by FMC Corporation, the registrant, which is 
available in the docket, https://www.regulations.gov. EPA received two 
comments on the notice of filing that supported the establishment of 
these tolerances.
    Based upon review of the data supporting the petition, EPA has 
changed some of the levels proposed.

[[Page 26137]]

The reasons for these changes are explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for carfentrazone-ethyl including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with carfentrazone-
ethyl 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.
    In mammals, protoporphyrinogen oxidase, (PPO) is an important 
enzyme in heme biosynthesis and its inhibition can lead to toxic 
effects where heme is utilized (e.g., red blood cells). The mammalian 
toxicity database for carfentrazone-ethyl indicates that effects 
observed following repeated oral exposures are consistent with those 
expected from PPO inhibition, toxicity of the hematopoietic system and 
liver.
    Subchronic oral toxicity studies in rats, mice, and dogs 
demonstrated that the primary effects were on hematopoietic system 
(decreased mean corpuscular hemoglobin and mean corpuscular volume). 
There was also increased urinary porphyrin excretion, increased liver 
weights, and alterations in liver histopathology consisting of: Hepatic 
pigment deposition, hepatocytomegaly, single cell necrosis, and cell 
mitosis. Similarly, chronic toxicity studies in rats and dogs 
demonstrated increased urinary porphyrin excretion. Chronic studies in 
rats and mice found liver histopathology (pigment deposits) and 
fluorescence microscopy of liver sections revealed red fluorescent 
granules consistent with porphyrin deposits. There were no indicators 
of targeted effects on the immune system. The results of the acute 
neurotoxicity study indicated clinical signs (i.e., salivation) and 
mild decreases in motor activity but only at the limit dose and only on 
the treatment day. However, there were no other signs of neurotoxicity 
in the rest of the database.
    There was no evidence of increased susceptibility in prenatal 
developmental toxicity studies (rats and rabbits) or the 
multigenerational reproductive toxicity study in rats. Fetal effects in 
the rat developmental study (increase in litter incidence of wavy and 
thickened ribs) and offspring effects in the rat reproduction toxicity 
study (decreased pup body weights) were seen at or above doses 
eliciting blood and liver effects in maternal/parental animals, effects 
that are consistent with those observed in the hazard database. No 
developmental effects were seen in the rabbits.
    Carfentrazone-ethyl has been classified as ``not likely to be 
carcinogenic'' based on the lack of evidence for carcinogenicity in 
mice and rats; therefore, a quantitative cancer risk assessment was not 
conducted.
    Specific information on the studies received and the nature of the 
adverse effects caused by carfentrazone-ethyl 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 https://www.regulations.gov in document ``Carfentrazone-ethyl. Human Health 
Risk Assessment in Support of Application to Globe Artichoke, 
Asparagus, Mint, Psyllium, Quinoa, and Teff and Updates to Several Crop 
Group (CG) or Subgroup (CSG) Designations'' on pages 31-35 in docket ID 
number EPA-HQ-OPP-2015-0030.

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 https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for carfentrazone-ethyl 
used for human risk assessment is discussed in Unit III.B., of the 
final rule published in the Federal Register of May 4, 2012 (77 FR 
26456) (FRL-9346-5).
    All of the toxicological endpoints remain the same except the acute 
dietary endpoint has been removed. The Agency reevaluated the points of 
departure and available data. Previously, the acute neurotoxicity study 
in rats was used to evaluate acute dietary exposures; however, effects 
(salivation and decreased motor activity) were only seen at the LOAEL 
of 1000 mg/kg/day which is not considered relevant for human health 
risk assessment. There were no other effects seen in the database 
attributable to a single dose. Therefore, the previous acute dietary 
endpoint is no longer considered valid.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to carfentrazone-ethyl, EPA considered exposure under the 
petitioned-for tolerances as well as all existing carfentrazone-ethyl 
tolerances in 40 CFR 180.515. EPA assessed dietary exposures from 
carfentrazone-ethyl in food as follows:

[[Page 26138]]

    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 carfentrazone-ethyl; 
therefore, a quantitative acute dietary exposure assessment was not 
conducted.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the Dietary Exposure Evaluation Model with the Food 
Commodity Intake Database (DEEM-FCID). This software incorporates 2003-
2008 food consumption data from the U.S. Department of Agriculture's 
National Health and Nutrition Examination Survey, What We Eat in 
America, (NHANES/WWEIA). As to residue levels in food, EPA assumed 
tolerance-level residues or, if necessary, tolerance-level residues 
adjusted to account for the residues of concern for risk assessment and 
100 percent crop treated (PCT). Since adequate processing studies have 
been submitted which indicate that tolerances in/on apple juice, citrus 
juice, grape juice, grape raisin, dried potato, dried prune, prune 
juice, tomato paste, and tomato puree are unnecessary, the 
DEEMTM (ver 7.81) default processing factors for these 
commodities were reduced to 1. The DEEMTM (ver 7.81) default 
processing factors were retained for the remaining relevant 
commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that carfentrazone-ethyl does not pose a cancer risk to 
humans. Therefore, a dietary exposure assessment for the purpose of 
assessing cancer risk was not conducted.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue or PCT information in the dietary 
assessment for carfentrazone-ethyl. Tolerance level residues and 100 
PCT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for carfentrazone-ethyl in drinking water. These simulation 
models take into account data on the physical, chemical, and fate/
transport characteristics of carfentrazone-ethyl. Further information 
regarding EPA drinking water models used in pesticide exposure 
assessment can be found at https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Tier 1 Rice Model and Pesticide Root Zone Model Ground 
Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of 
carfentrazone-ethyl for chronic exposures for non-cancer assessments 
are estimated to be 86 ppb for surface water and 43.9 ppb for ground 
water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the water concentration of value 86 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).
    Carfentrazone-ethyl is currently registered for the following uses 
that could result in residential exposures: Golf courses, residential 
lawns, and aquatic areas. EPA assessed residential exposure using the 
following assumptions: That homeowner handlers wear shorts, short-
sleeved shirts, socks, and shoes, and that they complete all tasks 
associated with the use of a pesticide product including mixing/
loading, if needed, as well as the application. Residential handler 
exposure scenarios for residential lawn applications are considered to 
be short-term only, due to the infrequent use patterns associated with 
homeowner products. Therefore, short-term inhalation risk was assessed 
for residential handlers; however, since no hazard was identified via 
the dermal route of exposure, a dermal risk assessment was not 
conducted for residential handlers. Aquatic applications by homeowners 
are not permitted by the label directions for use, therefore no 
residential handler exposure from the aquatic application scenario is 
anticipated.
    EPA uses the term ``post-application'' to describe exposure to 
individuals that occur as a result of being in an environment that has 
been previously treated with a pesticide. Carfentrazone- ethyl can be 
used in many areas that can be frequented by the general population 
including home lawns, golf courses and aquatic recreational areas such 
as ponds and lakes that have been treated for removal of aquatic 
vegetation. As a result, individuals can be exposed by entering these 
areas if they have been previously treated. Therefore, short-term post-
application exposure and risk are also assessed for carfentrazone-
ethyl.
    The Agency assessed residential handler (adult) exposure for the 
turf application scenario and adult post-application exposure for the 
aquatic exposure scenario. The most conservative exposure scenario for 
adults, the aquatic exposure scenario-swimmer exposure assessment 
(combined incidental oral and inhalation), was used to estimate post-
application risk. Dermal risks assessments were not conducted because 
no hazard was identified via the dermal route of exposure. For 
children, the aquatic exposure scenario-swimmer exposure assessment was 
used. Since the incidental oral and inhalation PODs are based on the 
same study, the exposures from these routes were combined. Further 
information regarding EPA standard assumptions and generic inputs for 
residential exposures may be found at https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    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 carfentrazone-ethyl to share a common mechanism 
of toxicity with any other substances, and carfentrazone-ethyl does not 
appear to produce a toxic metabolite produced by other substances. For 
the purposes of this tolerance action, therefore, EPA has assumed that 
carfentrazone-ethyl does not have a common mechanism of toxicity with 
other substances. For information regarding EPA's efforts to determine 
which chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's Web site at https://
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

[[Page 26139]]

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. There is no evidence of 
increased pre- and/or postnatal susceptibility following carfentrazone-
ethyl exposure.
    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 carfentrazone-ethyl is complete. Since 
the last risk assessment, an immunotoxicity study has been submitted 
and the results of the study incorporated into the current assessment.
    ii. Although effects were seen in the acute neurotoxicity study 
(clinical signs and mild decreases in motor activity), concern is low 
since: (a) The effects are minimal; (b) the effects were seen at the 
highest doses tested (>=1000 mg/kg); and (c) there is no evidence of 
neurotoxicity in the rest of the carfentrazone-ethyl database, 
including the subchronic neurotoxicity study.
    iii. There is no evidence that carfentrazone-ethyl results in 
increased susceptibility in rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to carfentrazone-ethyl in drinking water. EPA used 
similarly conservative assumptions to assess postapplication exposure 
of children as well as incidental oral exposure of toddlers. These 
assessments will not underestimate the exposure and risks posed by 
carfentrazone-ethyl.

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, 
carfentrazone-ethyl 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 
carfentrazone-ethyl from food and water will utilize 78% of the cPAD 
for children 1-2 years old the population group receiving the greatest 
exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
carfentrazone-ethyl is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Carfentrazone-ethyl is currently registered for uses that could 
result in short-term residential exposure, and the Agency has 
determined that it is appropriate to aggregate chronic exposure through 
food and water with short-term residential exposures to carfentrazone-
ethyl.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 7,500 for adults 
(residential handlers) and 2,100 for children (1-2 years old) (hand-to-
mouth exposures). Because EPA's level of concern for carfentrazone-
ethyl is a MOE of 100 or below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). An intermediate-term adverse effect was identified; however 
carfentrazone-ethyl is not registered for any use patterns that would 
result in intermediate-term residential exposure. Intermediate-term 
risk is assessed based on intermediate-term residential exposure plus 
chronic dietary exposure. Because there is no 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 intermediate-term risk), EPA 
relies on the chronic dietary risk assessment for evaluating 
intermediate-term risks for carfentrazone-ethyl.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, carfentrazone-ethyl is not expected to pose a cancer risk to 
humans.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to carfentrazone-ethyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology is available to enforce the 
tolerance expression. This analytical enforcement method involves 
separate analyses for parent and the metabolite. The parent is analyzed 
by evaporation and reconstitution of the sample prior to analysis by 
liquid chromatography/mass spectrometry/gas chromatography/electron 
capture detection (LC/MS/MS GC/ECD). The metabolite is refluxed in the 
presence of acid and cleaned up with solid phase extraction prior to 
analysis by LC/MS/MS.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established a MRL for carfentrazone-ethyl for 
these crops.

[[Page 26140]]

C. Revisions to Petitioned-For Tolerances

    The Agency is revising the petitioned-for tolerance requests for 
asparagus, peppermint, and spearmint from the proposed 0.25 ppm to 0.10 
ppm. The residue field trials for these commodities resulted in 
residues that are less than 0.05 ppm, the limit of quantitation (LOQ). 
Using the Organization for Economic Co-operation and Development (OECD) 
tolerance-calculation procedures, the Agency modified the requested 
tolerance levels from 0.25 ppm to 0.10 ppm. In an effort to not create 
a potential trade irritant, the Agency also determined that the 
requested tolerance amendment in or on oilseed subgroup 20 at 0.20 ppm 
should be established on the separate subgroups for rapeseed subgroup 
20A and sunflower subgroup 20B at 0.10 ppm to align with the MRLs for 
rapeseed and sunflower at 0.10 ppm in Canada and establish a cottonseed 
subgroup 20C at 0.20 ppm. Coconut will be removed and superseded by 
nut, tree, group 14-12. EPA also determined that the tolerance for teff 
straw should be 3.0 ppm based on available residue data.
    Further, on November 20, 2015, the Federal Register published a 
final rule (80 FR 72599) that removed the entries in paragraph (a) in 
180.515, for caneberry subgroup 13A; cotton, hulls; cotton, meal; 
cotton, refined oil and rice, straw, effective on May 18, 2016. 
Therefore, these commodities will not be removed under this action.

V. Conclusion

    Therefore, tolerances are established for residues of 
carfentrazone-ethyl, (ethyl-alpha-2-dichloro-5-[4-(difluoromethyl)-4,5-
dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-yl]-4-
fluorobenzenepropanoate) and the metabolite carfentrazone-ethyl 
chloropropionic acid (a, 2-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-
3-methyl-5-oxo-1H-1,2 ,4-triazol-1-yl]-4-fluorobenzenepropanoic acid), 
in or on the raw agricultural commodity artichoke, globe 0.10 ppm; 
asparagus at 0.10 ppm; banana at 0.10 ppm; berry, low growing, subgroup 
13-07G at 0.10 ppm; bushberry, subgroup 13-07B at 0.10 ppm; caneberry 
subgroup 13-07A at 0.10 ppm; cottonseed subgroup 20C at 0.20 ppm; 
fruit, citrus, group 10-10 at 0.10 ppm; fruit, pome, group 11-10 at 
0.10 ppm; fruit, small, vine climbing, subgroup 13-07F, except Fuzzy 
kiwifruit at 0.10 ppm; fruit, stone, group 12-12 at 0.10 ppm; grain, 
cereal, group 16, forage at 1.0 ppm; grain, cereal, group 16, hay at 
0.30 ppm; grain, cereal, group 16, stover at 0.80 ppm; grain, cereal, 
group 16, straw at 3.0 ppm; nut, tree, group 14-12 at 0.10 ppm; 
peppermint, tops at 0.10 ppm; psyllium, seed at 0.10 ppm; quinoa, grain 
at 0.10 ppm; rapeseed subgroup 20A at 0.10 ppm; spearmint, tops at 0.10 
ppm; sunflower subgroup 20B at 0.10 ppm; teff, forage at 1.0 ppm; teff, 
grain at 0.25 ppm; teff, hay at 0.30 ppm; teff, straw at 3.0 ppm; 
vegetable, bulb, group 3-07 at 0.10 ppm; and vegetable, fruiting, group 
8-10 at 0.10 ppm.
    Additionally, tolerances are removed, for barley, bran at .80 ppm; 
barley, flour at 0.80 ppm; berry group 13 at 0.10 ppm; borage at 0.10 
ppm; canola at 0.10 ppm; coconut at 0.10 ppm; corn, field, forage at 
0.20 ppm; corn, sweet, forage at 0.20 ppm; corn, sweet, kernel plus cob 
with husk removed at 0.10 ppm; cotton, undelinted seed at 0.20 ppm; 
crambe, seed at 0.10 ppm; flax, seed at 0.10 ppm; fruit, citrus, group 
10 at 0.10 ppm; fruit, pome, group 11 at 0.10 ppm; fruit, stone, group 
12 at 0.10 ppm; grain, cereal, forage, fodder and straw group 16, 
except corn and sorghum, forage at 1.0 ppm; grain, cereal, forage, 
fodder and straw group 16, hay at 0.30 ppm; grain, cereal, forage, 
fodder and straw group 16, stover at 0.30 ppm; grain, cereal, forage, 
fodder and straw, group 16 except rice, straw at 0.10 ppm; grain, 
cereal, group 15 at 0.10 ppm; grain, cereal, stover at 0.80 ppm; grain, 
cereal, straw at 3.0 ppm; grape at 0.10 ppm; juneberry at 0.10 ppm; 
lingonberry at 0.10 ppm; millet, flour at .80 ppm; mustard, seed at 
0.10 ppm; nut, tree, group 14 at 0.10 ppm; oat, flour at 0.80 ppm; okra 
at 0.10; pistachio at 0.10 ppm; pummelo at 0.10 ppm; rapeseed, seed at 
0.10 ppm; rice, hulls at 3.5 ppm; rye, bran at 0.80 ppm; rye, flour at 
0.80 ppm; safflower, seed at 0.10 ppm; salal at 0.10 ppm; sorghum, 
forage at 0.20 ppm; sorghum, sweet at 0.10 ppm; strawberry at 0.10 ppm; 
sunflower, seed at 0.10 ppm; vegetable, bulb, group 3 at 0.10 ppm; 
vegetable, fruiting, group 8 at 0.10 ppm; wheat, bran at 0.80 ppm; 
wheat, flour at 0.80 ppm; wheat, germ at 0.80 ppm; wheat middlings at 
0.80 ppm; and wheat, shorts at 0.80 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition 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

[[Page 26141]]

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: April 25, 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.  180.515, the table in paragraph (a) is revised to read as 
follows:


Sec.  180.515  Carfentrazone-ethyl; tolerance for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Acerola.....................................................        0.10
Almond, hulls...............................................        0.20
Animal feed, nongrass, crop group 18, forage................         2.0
Animal feed, nongrass, crop group 18, hay...................         5.0
Animal feed, nongrass, crop group 18, seed..................        15.0
Artichoke, globe............................................        0.10
Asparagus...................................................        0.10
Atemoya.....................................................        0.10
Avocado.....................................................        0.10
Banana......................................................        0.10
Berry, low growing, subgroup 13-07G.........................        0.10
Birida......................................................        0.10
Bushberry subgroup 13-07B...................................        0.10
Cacao bean, bean............................................        0.10
Cactus......................................................        0.10
Caneberry subgroup 13A \1\..................................         0.1
Caneberry subgroup 13-07A...................................        0.10
Canistel....................................................        0.10
Cattle, fat.................................................        0.10
Cattle, meat................................................        0.10
Cattle, meat byproducts.....................................        0.10
Cherimoya...................................................        0.10
Coffee, bean, green.........................................        0.10
Cotton, gin byproducts......................................          10
Cotton, hulls \1\...........................................        0.60
Cotton, meal \1\............................................        0.35
Cotton, refined oil \1\.....................................         1.0
Cottonseed subgroup 20C.....................................        0.20
Custard apple...............................................        0.10
Date, dried fruit...........................................        0.10
Feijoa......................................................        0.10
Fig.........................................................        0.10
Fish........................................................        0.30
Fruit, citrus, group 10-10..................................        0.10
Fruit, pome, group 11-10....................................        0.10
Fruit, small vine climbing, subgroup 13-07F, except Fuzzy           0.10
 kiwifruit..................................................
Fruit, stone, group 12-12...................................        0.10
Goat, fat...................................................        0.10
Goat, meat..................................................        0.10
Goat, meat byproducts.......................................        0.10
Grain, aspirated grain fractions............................         1.8
Grain, cereal, group 15 (except rice grain and sorghum              0.10
 grain).....................................................
Grain, cereal, group 16, forage.............................         1.0
Grain, cereal, group 16, hay................................        0.30
Grain, cereal, group 16, stover.............................        0.80
Grain, cereal, group 16, straw..............................         3.0
Grass, forage...............................................         5.0
Grass, hay..................................................         8.0
Guava.......................................................        0.10
Herbs and spices group 19...................................         2.0
Hog, fat....................................................        0.10
Hog, meat...................................................        0.10
Hog, meat byproducts........................................        0.10
Hop, dried cones............................................        0.10
Horse, fat..................................................        0.10
Horse, meat.................................................        0.10
Horse, meat byproducts......................................        0.10
Horseradish.................................................        0.10
Ilama.......................................................        0.10
Jaboticaba..................................................        0.10
Kava, roots.................................................        0.10
Kiwifruit...................................................        0.10
Longan......................................................        0.10
Lychee......................................................        0.10
Mango.......................................................        0.10
Milk........................................................        0.05
Noni........................................................        0.10
Nut, tree, group 14-12......................................        0.10
Olive.......................................................        0.10
Palm heart..................................................        0.10
Palm heart, leaves..........................................        0.10
Papaya......................................................        0.10
Passionfruit................................................        0.10
Pawpaw......................................................        0.10
Peanut......................................................        0.10
Peanut, hay.................................................        0.10
Peppermint, tops............................................        0.10
Persimmon...................................................        0.10
Pomegranate.................................................        0.10
Poultry, meat byproducts....................................        0.10
Psyllium, seed..............................................        0.10
Pulasan.....................................................        0.10
Quinoa, grain...............................................        0.10
Rambutan....................................................        0.10
Rapeseed, forage............................................        0.10
Rapeseed subgroup 20A.......................................        0.10
Rice, grain.................................................         1.3
Rice, straw \1\.............................................         1.0
Sapodilla...................................................        0.10
Sapote, black...............................................        0.10
Sapote, mamey...............................................        0.10
Sheep, fat..................................................        0.10
Sheep, meat.................................................        0.10
Sheep, meat byproducts......................................        0.10
Shellfish...................................................        0.30
Sorghum, grain..............................................        0.25
Soursop.....................................................        0.10
Soybean, seed...............................................        0.10
Spanish lime................................................        0.10
Spearmint, tops.............................................        0.10
Star apple..................................................        0.10
Starfruit...................................................        0.10
Stevia......................................................        0.10
Strawberrypear..............................................        0.10
Sugar apple.................................................        0.10
Sugarcane...................................................        0.15
Sunflower, subgroup 20B.....................................        0.10
Tea, dried..................................................        0.10
Teff, forage................................................         1.0
Teff, grain.................................................        0.25
Teff, hay...................................................        0.30
Teff, straw.................................................         3.0
Ti, leaves..................................................        0.10
Ti, roots...................................................        0.10
Vanilla.....................................................        0.10
Vegetable, brassica, leafy, group 5.........................        0.10
Vegetable, bulb, group 3-07.................................        0.10
Vegetable, cucurbit, group 9................................        0.10
Vegetable, foliage of legume, except soybean, subgroup 7A...        0.10
Vegetable, fruiting, group 8-10.............................        0.10
Vegetable, leafy, except brassica, group 4..................        0.10
Vegetable, leaves of root and tuber, group 2................        0.10
Vegetable, legume, group 6..................................        0.10
Vegetable, root and tuber, group 1..........................        0.10
Wasaba, roots...............................................        0.10
Wax jambu...................................................        0.10
------------------------------------------------------------------------
\1\ Effective Date to be removed: May 18, 2016.

* * * * *
[FR Doc. 2016-10235 Filed 4-29-16; 8:45 am]
 BILLING CODE 6560-50-P