Document ID: EPA-HQ-OPP-2014-0879-0004
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Penoxsulam
Posted Date: 2016-03-02T05:00Z

[Federal Register Volume 81, Number 41 (Wednesday, March 2, 2016)]
[Rules and Regulations]
[Pages 10771-10776]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04598]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0879; FRL-9940-36]

Penoxsulam; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
penoxsulam in or on multiple commodities which are identified and 
discussed later in this document. Interregional Research Project Number 
4 (IR-4) requested these tolerances associated with pesticide petition 
number (PP#) 4E8330, under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective March 2, 2016. Objections and 
requests for hearings must be received on or before May 2, 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-2014-0879, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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-2014-0879 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 
May 2, 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-2014-0879, 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 March 4, 2015 (80 FR 11611) (FRL-9922-
68), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C.

[[Page 10772]]

346a(d)(3), announcing the filing of a pesticide petition (PP#) 4E8330 
by Interregional Research Project Number 4 (IR-4), 500 College Road 
East, Princeton, NJ 08540. The petition requested that 40 CFR 180.605 
be amended by establishing tolerances for residues of the herbicide 
penoxsulam, (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4] 
triazolo[1,5-c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide), 
in or on fruit, pome, group 11-10 at 0.01 parts per million (ppm); 
fruit, stone, group 12-12 at 0.01 ppm; fruit, small, vine climbing, 
subgroup 13-07F, except fuzzy kiwifruit at 0.01 ppm; nut, tree, group 
14-12 at 0.01 ppm; olive at 0.01 ppm; and pomegranate at 0.01 ppm. In 
addition, the petitioner proposed removal of existing tolerances on 
grape; nut, tree, group 14; and pistachio as they are superseded by 
this rule. That document referenced a summary of the petition prepared 
on behalf of IR-4 by Dow AgroSciences LLC, the registrant, which is 
available in the docket EPA-HQ-OPP-2014-0879 at http://www.regulations.gov. There were no comments received in response to the 
notice of filing.

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 penoxsulam including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with penoxsulam follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their 
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 subchronic and chronic feeding studies in rats and dogs, the 
kidney was the most sensitive target organ. Hyperplasia of the renal 
pelvic epithelium was observed in both species, and in the rat, effects 
on renal function and increased severity of chronic 
glomerulonephropathy were also observed following chronic exposure. 
Effects on the liver, hematological parameters, and body weight were 
observed sporadically in some studies. In subchronic and chronic 
feeding studies in mice, no effects of toxicological significance were 
observed.
    There was no evidence of increased quantitative or qualitative 
susceptibility of fetuses or offspring, as compared to adults. In 
developmental toxicity studies in rats and rabbits, no developmental 
toxicity was observed at maternally toxic dose levels. In a 2-
generation reproduction study in rats, delays in preputial separation 
were noted in the presence of parental toxicity. No treatment-related 
neurotoxicity or immunotoxicity were observed in any of the available 
studies on penoxsulam. No systemic or dermal toxicity was noted in a 
28-day dermal toxicity study in rats.
    Although an increased incidence of mononuclear cell leukemia (MNCL) 
was observed in a chronic toxicity/carcinogenicity study in Fisher 344 
rats, EPA determined that human cancer risk is likely to be minimal and 
is not conducting a separate quantitative cancer assessment for the 
following reasons: (1) Lack of a dose-response, suggesting that the 
tumor may not be treatment-related; (2) the tumors were found in only 
one gender and one species (they were not found in female rats or 
mice); (3) the tumors are of questionable relevance to humans since 
there is no similar tumor occurring in humans; (4) penoxsulam is 
negative for mutagenicity; and (5) MNCL is not associated with exposure 
to other triazolopyrimidines, which is the chemical class of herbicides 
to which penoxsulam belongs. Therefore, based on the current (2005) 
Agency guidelines for cancer assessment, EPA has determined that the 
chronic assessment will be protective of any potential cancer risks.
    Specific information on the studies received and the nature of the 
adverse effects caused by penoxsulam 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 document, ``Penoxsulam. Human Health New Use 
Risk Assessment to Support the Registration of Proposed Use on Pome 
Fruit, Stone Fruit, Olive, Pomegranate, and Fruit, Small, Vine Climbing 
(Subgroup 13-07F, Except Fuzzy Kiwifruit); and Crop Group Conversion 
for Tree Nuts'' on pages 10-16 in docket ID number EPA-HQ-OPP-2014-
0879.

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 penoxsulam used for 
human risk assessment is shown in Table 1 of this unit.

[[Page 10773]]

                      Table 1--Summary of Toxicological Doses and Endpoints for Penoxsulam for Use in Human Health Risk Assessment
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                                        Point of departure and
          Exposure/scenario               uncertainty/safety     RfD, PAD, LOC for risk                  Study and toxicological effects
                                               factors                 assessment
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Acute dietary (All Populations,        No toxicological endpoint attributable to a single exposure was identified in the available toxicology studies on
 including Infants and Children and                   penoxsulam. This exposure scenario was therefore not assessed for human health risk.
 Females 13-49 years of age).
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Chronic dietary (All populations).     NOAEL = 14.7 mg/kg/day.  Chronic RfD = 0.147 mg/  1 Year Chronic Feeding Study in Dogs.
                                       UFA = 10 x.............   kg/day.                 LOAEL = 46.2 mg/kg/day based on multifocal hyperplasia of the
                                       UFH = 10 x.............  cPAD = 0.147 mg/kg/day.   renal pelvic epithelium.
                                       FQPA SF = 1x...........
Incidental oral short-term (1 to 30    NOAEL= 17.8 mg/kg/day..  LOC for MOE = 100......  13-Week Feeding Study in Dogs.
 days).                                UFA = 10 x.............                           LOAEL = 49.4 mg/kg/day based on multifocal hyperplasia of the
                                       UFH = 10 x.............                            renal pelvic epithelium and crystals in the renal pelvis and
                                       FQPA SF = 1x...........                            collecting ducts.
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Dermal (All Durations).                An endpoint for systemic toxicity was not identified in the rat 28-day dermal study and there were no neurotoxic,
                                        developmental, or immunotoxic effects observed for penoxsulam. This exposure scenario was not assessed for human
                                                                                          health risk.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Inhalation Short-Term (1 to 30 days)   NOAEL= 17.8 mg/kg/day..  LOC for MOE = 100......  13-Week Feeding Study in Dogs.
 and Intermediate-Term (1 to 6         UFA = 10 x.............                           LOAEL = 49.4 mg/kg/day based on multifocal hyperplasia of the
 months).                              UFH = 10 x.............                            renal pelvic epithelium and crystals in the renal pelvis and
                                       FQPA SF = 1x...........                            collecting ducts.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation).     Classification: A separate quantitative cancer assessment is not being conducted as the cRfD is considered
                                        protective of potential carcinogenic effects.
--------------------------------------------------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = milligram/
  kilogram/day. MOE = margin of exposure. 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 penoxsulam, EPA considered exposure under the petitioned-
for tolerances as well as all existing penoxsulam tolerances in 40 CFR 
180.605. EPA assessed dietary exposures from penoxsulam 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 penoxsulam; therefore, a 
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the Dietary Exposure Evaluation Model software with 
the Food Commodity Intake Database (DEEM-FCID) Version 3.16. This 
software uses 2003-2008 food consumption data from the U.S. Department 
of Agriculture's (USDA's) National Health and Nutrition Examination 
Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in 
food, EPA tolerance-level residues, 100 percent crop treated (PCT) for 
all commodities, and DEEM (Version 7.81) default processing factors.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that the chronic assessment for penoxsulam is considered 
protective of potential cancer risks. Therefore, a separate dietary 
exposure assessment for the purpose of assessing cancer risk is 
unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for penoxsulam. Tolerance-level residues and/or 100 
PCT were assumed for all food commodities.
    2. Dietary exposure from drinking water. In drinking water, the 
residues of concern include penoxsulam parent, along with the following 
degradates: BSTCA; 2-amino TCA; 5-OH-penoxsulam; SFA; sulfonamide; and 
5,8-diOH. The Agency used screening-level water exposure models in the 
dietary exposure analysis and risk assessment for penoxsulam in 
drinking water. These simulation models take into account data on the 
physical, chemical, and fate/transport characteristics of penoxsulam. 
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.
    Penoxsulam is registered for control of aquatic weeds. For that use 
pattern, the maximum application rate is 150 parts per billion (ppb) in 
the water column. For chronic dietary risk assessment, the water 
concentration value of 150 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).
    Penoxsulam is currently registered for the following uses that 
could result in residential exposures: Residential and commercial turf 
(lawns and golf courses) and aquatic use sites. EPA assessed 
residential exposure using the following assumptions: For handlers, it 
is assumed that residential use will result in short-term (1 to 30 
days) duration dermal and inhalation exposures. Residential post-
application exposure is also assumed to be short-term (1-30 days) in 
duration, resulting from the following exposure scenarios:
     Physical activities on turf: Adults (dermal) and children 
1-2 years old (dermal and incidental oral);
     mowing turf: Adults (dermal) and children 11 to <16 years 
old (dermal);
     exposure to golf courses during golfing: Adults (dermal), 
children 11 to <16 years old (dermal), and children 6 to <11 years old 
(dermal); and
     exposure during aquatic activities (e.g. swimming): Adults 
(dermal, inhalation, ingestion) and children 3 to <6 years old (dermal, 
inhalation, ingestion).

[[Page 10774]]

    Due to the lack of a dermal endpoint, EPA did not quantify exposure 
and risk estimates from dermal exposure scenarios. EPA did not combine 
exposure resulting from adult handler and post-application exposure 
resulting from treated gardens, lawns, golfing, and/or aquatic areas in 
residential settings because of the conservative assumptions and inputs 
within each estimated exposure scenario. The Agency believes that 
combining exposures resulting from handler and post-application 
activities would result in an overestimate of adult exposure. EPA 
selected the most conservative adult residential scenario (adult 
handler inhalation exposure from backpack sprayer applications to 
lawns/turf) as the contributing source of residential exposure to be 
combined with the dietary exposure for the aggregate assessment. The 
children's 3 to <6 oral exposure is based on post-application ingestion 
exposures during aquatic activities. The children's 1 to <2 oral 
exposure is based on post-application hand-to-mouth exposures from 
applications to lawns/turf. To include exposure from object-to-mouth 
and soil ingestion in addition to hand-to-mouth would overestimate the 
potential for oral exposure. Further information regarding EPA standard 
assumptions and generic inputs for residential exposures may be found 
at http://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 penoxsulam to share a common mechanism of 
toxicity with any other substances, and penoxsulam does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
penoxsulam does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's Web site at http://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 Food Quality 
Protection Act Safety Factor (FQPA 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. No evidence of quantitative 
or qualitative increased susceptibility, as compared to adults, of rat 
fetuses to in utero or postnatal exposure was observed in developmental 
toxicity studies in rats or rabbits or a reproduction study in rats. 
Developmental toxicity was not observed in the rat or rabbit up to 
doses resulting in maternal toxicity. In the rat reproductive toxicity 
study, slightly increased time to preputial separation in F1 males and 
decreased pup weight gain were observed in the presence of parental 
toxicity (kidney lesions in females).
    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 penoxsulam is complete.
    ii. There is no indication that penoxsulam 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 penoxsulam results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to penoxsulam 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 penoxsulam.

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, 
penoxsulam 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 
penoxsulam from food and water will utilize 6% of the cPAD for all 
infants <1 year 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 
penoxsulam 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). Penoxsulam 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 penoxsulam.
    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 5,400 for adults 
and 2,100 for children 1-2 years old, the two population subgroups 
receiving the greatest combined dietary and non-dietary exposure. 
Because EPA's level of concern for penoxsulam is a MOE of 100 or below, 
these MOEs are not of concern.

[[Page 10775]]

    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, 
penoxsulam 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), no further assessment 
of intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating intermediate-term risk for 
penoxsulam.
    5. Aggregate cancer risk for U.S. population. As discussed in Unit 
III.A., EPA determined that the chronic assessment is protective of the 
potential cancer risks. Based on the chronic assessment, there is no 
concern for an aggregate cancer risk from exposure to penoxsulam.
    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 penoxsulam residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology, high performance liquid 
chromatography (HPLC) methods with positive-ion electro spray interface 
(ESI) and tandem mass spectroscopy-mass spectroscopy detector (LC/MS/
MS), is available to enforce the tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level. There are currently no 
established Codex MRLs for the residues of penoxsulam.

C. Revisions to Petitioned-For Tolerances

    EPA has revised the tolerance expression to clarify first, that, as 
provided in FFDCA section 408(a)(3), the tolerance covers metabolites 
and degradates of penoxsulam not specifically mentioned; and second, 
that compliance with the specified tolerance levels is to be determined 
by measuring only the specific compounds mentioned in the tolerance 
expression.

V. Conclusion

    Therefore, tolerances are established for residues of penoxsulam, 
(2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4] triazolo[1,5-
c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide), in or on 
fruit, pome, group 11-10 at 0.01 ppm; fruit, small, vine climbing 
subgroup 13-07F, except fuzzy kiwifruit at 0.01 ppm; fruit, stone, 
group 12-12 at 0.01 ppm; nut, tree, group 14-12 at 0.01 ppm; olive at 
0.01 ppm; and pomegranate at 0.01 ppm. Additionally, the existing 
tolerances for grape; nut, tree, group 14; and pistachio are removed.

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).

[[Page 10776]]

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: February 23, 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.  180.605, paragraph (a) is revised to read as follows:

Sec.  180.605  Penoxsulam; tolerances for residues.

    (a) General. Tolerances are established for residues of penoxsulam, 
including its metabolites and degradates, in or on the commodities 
listed in the table below. Compliance with the tolerance levels 
specified below is to be determined by measuring only penoxsulam 2-
(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c] pyrimidin-
2-yl)-6-(trifluoromethyl) benzenesulfonamide, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond, hulls...............................................        0.01
Fish........................................................        0.01
Fish, shellfish, crustacean.................................        0.01
Fish, shellfish, mollusc....................................        0.02
Fruit, pome, group 11-10....................................        0.01
Fruit, small, vine climbing, subgroup 13-07F, except fuzzy          0.01
 kiwifruit..................................................
Fruit, stone, group 12-12...................................        0.01
Nut, tree, group 14-12......................................        0.01
Olive.......................................................        0.01
Pomegranate.................................................        0.01
Rice, grain.................................................        0.02
Rice, straw.................................................        0.50
------------------------------------------------------------------------

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[FR Doc. 2016-04598 Filed 3-1-16; 8:45 am]
BILLING CODE 6560-50-P