Federal Register / Vol. 81, No. 41 / Wednesday, March 2, 2016 / Rules and Regulations 10771 

the decedent; a child, parent, or sibling 

of the decedent, whether biological, 

adopted, or step relation; and any lineal 

or collateral descendant of the decedent; 

(ii) A personal representative, as 

defined in paragraph (b) of this section; 

(iii) A representative of a 

Congressionally-chartered Veterans 

Service Organization; 

(iv) An individual employed by the 

relevant state or local government 

whose official responsibilities include 

serving veterans and families of 

veterans, such as a state or county 

veterans service officer; 

(v) Any individual who is 

responsible, under the laws of the 

relevant state or locality, for the 

disposition of the unclaimed remains of 

the decedent or for other matters 

relating to the interment or 

memorialization of the decedent; or 

(vi) Any individual, if the dates of 

service of the veteran to be 

memorialized, or on whose service the 

eligibility of another individual for 

memorialization is based, ended prior to 

April 6, 1917. 

(2) Applicant defined—memorial 

headstones and markers. An applicant 

for a memorial headstone or marker to 

commemorate an eligible individual 

must be a member of the decedent’s 

family, which includes the decedent’s 

spouse or individual who was in a legal 

union as defined in 38 CFR 

3.1702(b)(1)(ii) with the decedent; a 

child, parent, or sibling of the decedent, 

whether biological, adopted, or step 

relation; and any lineal or collateral 

descendant of the decedent. 

* * * * * 

§ 38.632 [Amended] 

■ 3. Amend § 38.632(b)(1) by removing 

‘‘a Government-furnished headstone or 

marker and, in appropriate instances,’’. 

[FR Doc. 2016–04553 Filed 3–1–16; 8:45 am] 

BILLING CODE P 

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. 

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/textidx?&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. 


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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-observedadverse-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-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides. 

A summary of the toxicological 

endpoints for penoxsulam used for 

human risk assessment is shown in 

Table 1 of this unit. 


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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR PENOXSULAM FOR USE IN HUMAN HEALTH RISK

ASSESSMENT

Exposure/scenario Point of departure and uncertainty/safety factors 

RfD, PAD, LOC for risk 

assessment Study and toxicological effects 

Acute dietary (All Populations, including Infants and Children and 

Females 13–49 years of age). 

No toxicological endpoint attributable to a single exposure was identified in the available toxicology studies on penoxsulam. 

This exposure scenario was therefore not assessed for human health risk. 

Chronic dietary (All populations). NOAEL = 14.7 mg/kg/day ..............

UFA = 10 × 

UFH = 10 × 

FQPA SF = 1x 

Chronic RfD = 0.147 mg/kg/day ....

cPAD = 0.147 mg/kg/day 

1 Year Chronic Feeding Study in Dogs. 

LOAEL = 46.2 mg/kg/day based on multifocal 

hyperplasia of the renal pelvic epithelium. 

Incidental oral short-term (1 to 30 

days). 

NOAEL= 17.8 mg/kg/day ...............

UFA = 10 × 

UFH = 10 × 

FQPA SF = 1x 

LOC for MOE = 100 ...................... 13-Week Feeding Study in Dogs. 

LOAEL = 49.4 mg/kg/day based on multifocal 

hyperplasia of the renal pelvic epithelium and 

crystals in the renal pelvis and collecting ducts. 

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) and Intermediate-Term (1 

to 6 months). 

NOAEL= 17.8 mg/kg/day ...............

UFA = 10 × 

UFH = 10 × 

FQPA SF = 1× 

LOC for MOE = 100 ...................... 13-Week Feeding Study in Dogs. 

LOAEL = 49.4 mg/kg/day based on multifocal 

hyperplasia of the renal pelvic epithelium and 

crystals in the renal pelvis and 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 tolerancelevel 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–OHpenoxsulam; SFA; sulfonamide; and 

5,8-diOH. The Agency used screeninglevel 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-scienceand-assessing-pesticide-risks/aboutwater-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 nonoccupational, 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 shortterm (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). 


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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-andassessing-pesticide-risks/standardoperating-procedures-residentialpesticide. 

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-andassessing-pesticide-risks/cumulativeassessment-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 nondietary exposure. Because EPA’s level of 

concern for penoxsulam is a MOE of 100 

or below, these MOEs are not of 

concern. 


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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 intermediateterm 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). 


asabaliauskas on DSK3SPTVN1PROD with RULES
10776 Federal Register / Vol. 81, No. 41 / Wednesday, March 2, 2016 / Rules and Regulations 

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] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.605, paragraph (a) is 

revised to read as follows: 

§ 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. 

Commodity Parts per 

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 

kiwifruit .................................... 0.01 

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 

* * * * * 

[FR Doc. 2016–04598 Filed 3–1–16; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2015–0485; FRL–9942–48] 

Alpha-[2,4,6-Tris[1- 

(phenyl)ethyl]phenyl]-Omega-hydroxy 

poly(oxyethylene) poly(oxypropylene) 

copolymer; Tolerance Exemption 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of Alpha-[2,4,6- 

Tris[1-(phenyl)ethyl]phenyl]-Omegahydroxy poly(oxyethylene) 

poly(oxypropylene) copolymer, the 

poly(oxypropylene) content averages 2– 

8 moles, the poly(oxyethylene) content 

averages 16–30 moles, when used as an 

inert ingredient in a pesticide 

formulation. Stepan Co. submitted a 

petition to EPA under the Federal Food, 

Drug, and Cosmetic Act (FFDCA), 

requesting an exemption from the 

requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of Alpha-[2,4,6-Tris[1- 

(phenyl)ethyl]phenyl]-Omega-hydroxy 

poly(oxyethylene) poly(oxypropylene) 

copolymer, the poly(oxypropylene) 

content averages 2–8 moles, the 

poly(oxyethylene) content averages 16– 

30 moles, on food or feed commodities. 

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–2015–0485, 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 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at http://

www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/

40tab_02.tpl. 

C. 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–2015–0485 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. 


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