34896 Federal Register / Vol. 81, No. 105 / Wednesday, June 1, 2016 / Rules and Regulations 

from the operating regulations is 

authorized under 33 CFR 117.35. 

Dated: May 25, 2016. 

C.J. Bisignano 

Supervisory Bridge Management Specialist, 

First Coast Guard District. 

[FR Doc. 2016–12740 Filed 5–31–16; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2015–0569; FRL–9946–07] 

Fluensulfone; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of fluensulfone 

in or on multiple commodities which 

are identified and discussed later in this 

document. Interregional Research 

Project Number 4 (IR–4) and 

Makhteshim Agan of North America, Inc 

(d/b/a ADAMA) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is June 1, 2016. 

Objections and requests for hearings 

must be received on or before August 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–2015–0569, 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–2015–0569 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 

August 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– 

2015–0569, 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 October 21, 

2015 (80 FR 63731) (FRL–9935–29), 

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 5E8384) by IR–4, 

500 College Road East, Suite 201 W., 

Princeton, NJ 08540. The petition 

requested that 40 CFR part 180 be 

amended by establishing a tolerance for 

residues of fluensulfone equivalents 

(i.e., the sum of thiazole sulfonic acid 

(TSA) and butene sulfonic acid (BSA) 

expressed as total fluensulfone 

equivalents) in or on the raw 

agricultural commodity vegetable, 

tuberous and corm, subgroup 1C at 0.6 

ppm. That document referenced a 

summary of the petition prepared by 

Makhteshim Agan of North America, 

Inc., the registrant, which is available in 

the docket, http://www.regulations.gov. 

A comment was received on the notice 

of filing, however it related to the 

chemical propenicol, not fluensulfone. 

In the Federal Register of March 16, 

2016 (81 FR 14030) (FRL–9942–86), 

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 5F8351) by 

Makhteshim Agan of North America, 

Inc. (d/b/a ADAMA), 3120 Highwoods 

Blvd., Suite 100, Raleigh, NC 27604. 

The petition requested that 40 CFR part 

180 be amended by establishing a 

tolerance for residues of nematicide 

fluensulfone, including its metabolites 

and degradates, in or on berry, low 

growing, subgroup 13–07G at 0.30 ppm; 

head and stem Brassica subgroup 5A at 

1.3 ppm; leafy Brassica greens subgroup 

5B at 13 ppm; leafy vegetables, group 4, 

except Brassica vegetables at 2.6 ppm; 

leaves of root and tuber vegetables, 

group 2 at 20 ppm; radish, oriental at 

0.50 ppm; and root vegetables, subgroup 


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1B, except sugar beet and oriental radish 

at 3.3 ppm. In addition, the petition 

requested to amend 40 CFR 180.680 to 

revise the existing tolerance expression 

in the introductory paragraph (a) to read 

‘‘Tolerances are established for residues 

of the nematicide fluensulfone, 

including its metabolites and 

degradates, in or on the commodities in 

the table below. Compliance with the 

tolerance levels specified below is to be 

determined by measuring only 3,4,4- 

trifluoro-but-3-ene-1-sulfonic acid.’’ 

That document referenced a summary of 

the petition prepared by Makhteshim 

Agan of North America, Inc., the 

registrant, which is available in the 

docket, EPA–HQ–OPP–2015–0478 at 

http://www.regulations.gov. Comments 

were received on the notice of filing. 

EPA’s response to these comments is 

discussed in Unit IV.C. 

Based upon review of the data 

supporting the petition, EPA has 

modified the levels at which tolerances 

are being established for most 

commodities. The reasons for these 

changes are explained in Unit IV.D. 

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 fluensulfone 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with fluensulfone 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. 

The residue of concern for dietary 

assessment is the parent compound, 

fluensulfone. Residues of the 

metabolites butene sulfonic acid (BSA) 

and thiazole sulfonic acid (TSA) occur 

at levels significantly greater than 

fluensulfone; however, these 

metabolites are considered non-toxic at 

levels that may occur from the use of 

fluensulfone. Based on the available 

data addressing toxicity of the BSA and 

TSA metabolites, the Agency has 

determined that they are not of 

toxicological concern. 

Exposure to fluensulfone results in 

effects on the hematopoietic system 

(decreased platelets, increased white 

blood cells, hematocrit, and 

reticulocytes), kidneys, and lungs. Body 

weight and clinical chemistry changes 

were observed across multiple studies 

and species. Evidence of qualitative 

increased susceptibility of infants and 

children to the effects of fluensulfone 

was observed in the 2-generation 

reproduction study in rats, wherein pup 

death was observed at a dose that 

resulted in body weight effects in the 

dams. There was no evidence of either 

qualitative or quantitative susceptibility 

in developmental toxicity studies in rats 

or rabbits. 

The most sensitive endpoints for 

assessing safety of aggregate exposures 

to fluensulfone under the FFDCA are 

the increased pup-loss effects for acute 

dietary exposure; and body weight, 

hematological and clinical chemistry 

changes for chronic dietary as well as 

short/intermediate term dermal 

exposures. 

Decreased locomotor activity in 

females, and decreased spontaneous 

activity, decreased rearing, and 

impaired righting response in both sexes 

were observed in the acute 

neurotoxicity study at the lowest dose 

tested. No other evidence for 

neurotoxicity was observed in the other 

studies in the toxicity database, 

including a subchronic neurotoxicity 

study. The doses and endpoints chosen 

for risk assessment are all protective of 

the effects seen in the acute 

neurotoxicity study. A developmental 

neurotoxicity study is not required. 

Although the mouse carcinogenicity 

study showed an association with 

alveolar/bronchiolar adenomas and 

carcinomas in the female, EPA has 

determined that quantification of risk 

using the chronic reference dose (RfD) 

will account for all chronic toxicity, 

including carcinogenicity, that could 

result from exposure to fluensulfone 

and its metabolites. That conclusion is 

based on the following considerations: 

1. The tumors occurred in only one 

sex in one species. 

2. No carcinogenic response was seen 

in either sex in the rat. 

3. The tumors in the mouse study 

were observed at a dose that is almost 

13 times higher than the dose chosen for 

risk assessment. 

4. Fluensulfone and its metabolites 

are not mutagenic. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by fluensulfone 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 the document 

titled ‘‘Fluensulfone—Aggregate Human 

Health Risk Assessment Addressing 

Label Amendments, Changes to the 

Residue Definition, and New Uses on 

Multiple Crops’’ on page 43 in docket ID 

number EPA–HQ–OPP–2015–0569. 

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 


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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 fluensulfone used for 

human risk assessment is shown in 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FLUENSULFONE 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).

NOAEL = 16.2 mg/ 

kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 0.16 

mg/kg/day.

aPAD = 0.16 mg/kg/ 

day 

2-generation reproduction—rat offspring. 

LOAEL = 122.0 mg/kg/day based on an increase in pup loss 

between PND 1 and 4 in the F1 and F2 offspring with the 

majority of deaths occurring on day 2. 

Chronic dietary (All populations) NOAEL= 9.6 mg/kg/ 

day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.10 

mg/kg/day.

cPAD = 0.10 mg/kg/ 

day 

2-year toxicity/carcinogenicity-rat. 

LOAEL = 57.7 mg/kg/day based on decreased body weight in 

males, and hematology changes, clinical chemistry changes 

and histopathological effects in the lung and esophagus of 

both sexes. 

Incidental oral short-term (1 to 

30 days).

NOAEL= 9.6 mg/kg/ 

day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 2-year toxicity/carcinogenicity-rat. 

LOAEL = 57.7 mg/kg/day based on decreased body weight in 

males, and hematology changes, clinical chemistry changes 

and histopathological effects in the lung and esophagus of 

both sexes. 

Dermal short-term (1 to 30 

days).

Oral study NOAEL = 

9.6 mg/kg/day 

(dermal absorption 

factor = 9.5%) 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 2-year toxicity/carcinogenicity-rat. 

LOAEL = 57.7 mg/kg/day based on decreased body weight in 

males, and hematology changes, clinical chemistry changes 

and histopathological effects in the lung and esophagus of 

both sexes. 

Cancer (Oral, dermal, inhalation).EPA has determined that quantification of risk using the chronic RfD will adequately account for all chronic toxicity, including carcinogenicity. 

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 fluensulfone, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing fluensulfone tolerances in 40 

CFR 180.680. Parent fluensulfone occurs 

at residue levels well below those of the 

BSA metabolite, the residue defined for 

the enforcement of tolerances. As 

previously noted, the BSA metabolite is 

not of toxicological concern. Since 

tolerances do not include fluensulfone 

itself, EPA has used the Organization for 

Economic Cooperation and 

Development (OECD) maximum residue 

limit (MRL) calculation procedures to 

derive tolerance-equivalent residue 

levels for fluensulfone. For foods where 

the level of fluensulfone is expected to 

be below the limit of quantification 

(LOQ), 0.01 ppm, the Agency has 

assumed that residues occur at the LOQ. 

For foods with quantifiable levels of 

fluensulfone, EPA has assumed that 

residues occur at the toleranceequivalent level. EPA assessed dietary 

exposures from fluensulfone 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. 

Such effects were identified for 

fluensulfone. In estimating acute dietary 

exposure, EPA used 2003–2008 food 

consumption information from the 

United States 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, 

the acute dietary risk assumed 

tolerance-equivalent residues and 100 

percent crop treated (PCT). 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used 2003–2008 food consumption 

information from the USDA’s NHANES/ 

WWEIA. As to residue levels in food, 

the chronic dietary risk assumed 

tolerance-equivalent residues and 100 

PCT. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that a nonlinear RfD 

approach is appropriate for assessing 

cancer risk to fluensulfone. Cancer risk 

was assessed using the same exposure 

estimates as discussed in Unit III.C.1.ii. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue or PCT information 

in the dietary assessment for 

fluensulfone. Tolerance-equivalent 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 fluensulfone in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

fluensulfone. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

can be found at http://www2.epa.gov/

pesticide-science-and-assessingpesticide-risks/about-water-exposuremodels-used-pesticide. 


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Based on the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and Pesticide 

Root Zone Model Ground Water (PRZM 

GW) models, the estimated drinking 

water concentrations (EDWCs) for acute 

exposures are estimated to be 11.8 parts 

per billion (ppb) for surface water and 

77.6 ppb for ground water and for 

chronic exposures are estimated to be 

0.173 ppb for surface water and 52.5 

ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For the 

acute dietary risk assessment, the water 

concentration value of 77.6 ppb was 

used to assess the contribution to 

drinking water. For the chronic dietary 

risk assessment, the water concentration 

of value 52.5 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). 

Fluensulfone is currently registered for 

the following uses that could result in 

residential exposures: Turf/lawns. EPA 

assessed residential exposure using the 

following assumptions: For residential 

handlers, a quantitative exposure/risk 

assessment was not developed because 

the product is not intended to be 

applied by homeowners. For adult 

residential post-application exposure, 

the Agency evaluated dermal postapplication exposure only to outdoor 

turf/lawn applications (high contact 

activities). The Agency also evaluated 

residential post-application exposure for 

children via dermal and hand-to-mouth 

routes of exposure, resulting from 

treated outdoor turf/lawn applications 

(high contact activities). 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

found at http://www2.epa.gov/pesticidescience-and-assessing-pesticide-risks/

standard-operating-proceduresresidential-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 fluensulfone to 

share a common mechanism of toxicity 

with any other substances, and 

fluensulfone does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that fluensulfone 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 

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. 

No evidence of quantitative or 

qualitative susceptibility was seen in 

developmental toxicity studies in rats 

and rabbits. Fetal effects in those studies 

occurred in the presence of maternal 

toxicity and were not considered more 

severe than the maternal effects. 

However, there was evidence of 

increased qualitative, but not 

quantitative, susceptibility of pups in 

the 2-generation reproduction study in 

rats. Maternal effects observed in that 

study were decreased body weight and 

body weight gain; at the same dose, 

effects in offspring were decreased pup 

weights, decreased spleen weight, and 

increased pup loss (PND 1–4). 

Although there is evidence of 

increased qualitative susceptibility in 

the 2-generation reproduction study in 

rats, there are no residual uncertainties 

with regard to pre- and post-natal 

toxicity following in utero exposure to 

rats or rabbits and pre- and post-natal 

exposures to rats. Considering the 

overall toxicity profile, the clear NOAEL 

for the pup effects observed in the 2- 

generation reproduction study, and that 

the doses selected for risk assessment 

are protective of all effects in the 

toxicity database including the offspring 

effects, the degree of concern for the 

susceptibility is low. 

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 

fluensulfone is complete. 

ii. Evidence of potential neurotoxicity 

was only seen following acute exposure 

to fluensulfone and the current PODs 

chosen for risk assessment are 

protective of the effects observed. There 

is no need for a developmental 

neurotoxicity study or additional UFs to 

account for neurotoxicity. 

iii. There is no indication of 

quantitative susceptibility in the 

developmental and reproductive 

toxicity studies, and there are no 

residual uncertainties concerning preor post-natal toxicity. In addition, the 

endpoints and doses chosen for risk 

assessment are protective of the 

qualitative susceptibility observed 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 equivalent-level residues. EPA 

made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to fluensulfone in drinking water. EPA 

used similarly conservative assumptions 

to assess post-application exposure of 

children as well as incidental oral 

exposure of toddlers. These assessments 

will not underestimate the exposure and 

risks posed by fluensulfone. 

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. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

fluensulfone will occupy 9.3% of the 

aPAD for all infants less than 1 year old, 

the population group receiving the 

greatest exposure. 


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2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to fluensulfone 

from food and water will utilize 3.9% of 

the cPAD for all infants less than 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 

fluensulfone 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). 

Fluensulfone 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 fluensulfone. 

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 5,700 for adults and 3,000 for 

children 1–2 years old. Because EPA’s 

level of concern for fluensulfone 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, fluensulfone 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 

fluensulfone. 

5. Aggregate cancer risk for U.S. 

population. EPA assessed cancer risk 

using a non-linear approach (i.e., RfD) 

since it adequately accounts for all 

chronic toxicity, including 

carcinogenicity, that could result from 

exposure to fluensulfone. As the chronic 

dietary endpoint and dose are protective 

of potential cancer effects, fluensulfone 

is not expected to pose an aggregate 

cancer risk. 

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 fluensulfone 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(acetonitrile/water (1:1, v/v) extraction 

and analysis by reverse-phase highperformance liquid chromatographymass spectrometry (HPLC–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. 

The Codex has not established any 

MRLs for fluensulfone for the 

commodities covered by this document. 

C. Response to Comments 

Three comments were submitted in 

response to the March 16, 2016 Notice 

of Filing. Two of them opposed the 

petition generally due to there being too 

many toxic chemicals being used in 

America without citing any specific 

human health concerns about 

fluensulfone itself. The Agency 

understands the commenters’ concerns 

and recognizes that some individuals 

believe that pesticides should be banned 

on agricultural crops. However, the 

existing legal framework provided by 

section 408 of the Federal Food, Drug 

and Cosmetic Act (FFDCA) states that 

tolerances may be set when persons 

seeking such tolerances or exemptions 

have demonstrated that the pesticide 

meets the safety standard imposed by 

that statute. The comment appears to be 

directed at the underlying statute and 

not EPA’s implementation of it; the 

citizen has made no contention that 

EPA has acted in violation of the 

statutory framework. 

The second comment was from the 

Center for Food Safety and primarily 

concerned about Agency compliance 

with any relevant obligations under the 

Endangered Species Act. This comment 

is not relevant to the Agency’s 

evaluation of safety of the fluensulfone 

tolerances; section 408 of the FFDCA 

focuses on potential harms to human 

health and does not permit 

consideration of effects on the 

environment. 

D. Revisions to Petitioned-For 

Tolerances 

Most of the petitioned-for tolerance 

levels differ from those being 

established by the Agency. In the cases 

of the tolerances proposed by ADAMA, 

it is not clear to the Agency how the 

tolerance levels proposed in the March 

16, 2016 Notice of Filing (Federal 

Register 2016–05952) were derived. 

EPA’s tolerance levels are based on 

residues of BSA only, without any 

conversion to fluensulfone equivalents. 

The Agency used the OECD MRL 

procedures to derive the levels being 

established in today’s action. For crop 

groups, and per EPA’s current policy, 

tolerance levels for each representative 

commodity were calculated separately, 

and then the maximum value within 

each crop group was selected as the 

tolerance level. For root vegetables 

except sugar beet (Subgroup 1B), the 

tolerance level is based on data from 

radish root (including Oriental radish 

root). Although a separate listing for 

Oriental radish was requested, EPA is 

not establishing a separate tolerance 

level since that crop is a member of crop 

subgroup 1B. For leaves of root and 

tuber vegetables (Crop Group 2), EPA is 

establishing a tolerance for residues in/ 

on the leaves of root and tuber 

vegetable, except sugar beet because the 

petitioned-for uses do not include a use 

on sugar beet; the tolerance is based on 

data from radish tops (including 

Oriental radish tops). The tolerance for 

residues in/on leafy vegetables except 

Brassica vegetables (Group 4) is based 

on data from leaf lettuce and spinach, 

assessed separately. For head and stem 

Brassica (Subgroup 5A), the tolerance is 


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Federal Register / Vol. 81, No. 105 / Wednesday, June 1, 2016 / Rules and Regulations 34901 

based on data from cabbage. For 

Brassica leafy greens (Subgroup 5B), 

data from mustard greens, komatsuna 

(Japanese mustard spinach), and mizuna 

(Japanese mustard) were combined to 

derive the tolerance level. All of EPA’s 

tolerance levels are expressed to provide 

sufficient precision for enforcement 

purposes, and this may include the 

addition of trailing zeros (e.g., 0.30 ppm 

rather than 0.3 ppm). 

In the case of the tolerance proposed 

by IR–4, the petitioned-for tolerance is 

based on the sum of residues of BSA 

and TSA, expressed as fluensulfone, 

rather than on residues of BSA only, 

which is how the tolerance expression 

currently describes measurement of 

residues for compliance purposes. 

Basing enforcement on BSA alone 

provides a suitable marker of use, 

simplifies residue analysis, and avoids 

enforcement complications that may 

result from the potential for TSA to 

carry over in treated soil from one year 

to the next. Furthermore, IR–4 did not 

propose tolerances for residues of 

fluensulfone in processed potato 

commodities. The submitted potato 

processing study indicates that during 

processing, residues of BSA in chips 

and in granules/flakes are likely to 

concentrate to levels greater than in 

tubers. Therefore, EPA is establishing 

separate tolerances to cover residues in 

those commodities. 

V. Conclusion 

Therefore, tolerances are established 

for residues of fluensulfone in or on 

berry, low growing, subgroup 13–07G at 

0.30 ppm; Brassica, head and stem, 

subgroup 5A at 1.50 ppm; Brassica, 

leafy greens, subgroup 5B at 9.0 ppm; 

potato, chips at 0.60 ppm; potato, 

granules/flakes at 0.80 ppm; vegetables, 

leafy, except Brassica, group 4 at 2.0 

ppm; vegetable, leaves of root and tuber, 

group 2, except sugar beet at 30 ppm; 

vegetables, root, except sugar beet, 

subgroup 1B at 3.0 ppm; and vegetables, 

tuberous and corm, subgroup 1C at 0.50 

ppm. Also, the time-limited Section 18 

tolerance for ‘‘carrot’’ is removed since 

it is now covered by the permanent 

tolerance for ‘‘vegetables, root, except 

sugar beet, subgroup 1B.’’ And lastly, 

the tolerance expression is changed as 

requested by the petitioner. 

VI. Statutory and Executive Order 

Reviews 

This action establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this action 

has been exempted from review under 

Executive Order 12866, this action is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This action does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

U.S.C. 3501 et seq.), nor does it require 

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.), do not apply. 

This action directly regulates growers, 

food processors, food handlers, and food 

retailers, not States or tribes, nor does 

this action alter the relationships or 

distribution of power and 

responsibilities established by Congress 

in the preemption provisions of FFDCA 

section 408(n)(4). As such, the Agency 

has determined that this action will not 

have a substantial direct effect on States 

or tribal governments, on the 

relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this action. In addition, this action 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

Mandates Reform Act (UMRA) (2 U.S.C. 

1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act 

(NTTAA) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: May 19, 2016. 

Daniel J. Rosenblatt, 

Acting 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. Section 180.680 is revised to read 

as follows: 

§ 180.680 Fluensulfone; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the 

nematicide fluensulfone, including its 

metabolites and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only 3,4,4-trifluoro-but-3- 

ene-1-sulfonic acid. 

Commodity Parts per 

million 

Berry, low growing, subgroup 

13–07G ................................... 0.30 

Brassica, head and stem, subgroup 5A ................................. 1.50 

Brassica, leafy greens, subgroup 

5B ............................................ 9.0 

Potato, chips ............................... 0.60 

Potato, granules/flakes ............... 0.80 

Tomato, paste ............................. 1.0 

Vegetables, cucurbits, group 9 ... 0.50 

Vegetables, fruiting, group 8–10 0.50 

Vegetables, leafy, except Brassica, group 4 ........................... 2.0 

Vegetables, leaves of root and 

tuber, group 2, except sugar 

beet ......................................... 30 

Vegetables, root, except sugar 

beet, subgroup 1B .................. 3.0 

Vegetables, tuberous and corm, 

subgroup 1C ........................... 0.50 


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34902 Federal Register / Vol. 81, No. 105 / Wednesday, June 1, 2016 / Rules and Regulations 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertant residues. 

[Reserved] 

[FR Doc. 2016–12722 Filed 5–31–16; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2015–0212; FRL–9943–73] 

Aldicarb, Alternaria destruens, 

Ampelomyces quisqualis, Azinphosmethyl, Etridiazole, Fenarimol, et al.; 

Tolerance and Tolerance Exemption 

Actions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: EPA is revoking certain 

tolerances in follow-up to canceled 

product registrations or uses for 

acephate, aldicarb, azinphos-methyl, 

etridiazole, fenarimol, imazamethabenzmethyl, tepraloxydim, thiazopyr, and 

tralkoxydim, and is revoking tolerance 

exemptions for certain pesticide active 

ingredients. However, EPA will not 

revoke the thiacloprid tolerances at this 

time that had been previously proposed 

for revocation. Also, EPA is making 

minor revisions to the section heading 

and introductory text for Pythium 

oligandrum DV 74. In addition, in 

accordance with current Agency 

practice, EPA is making revisions to the 

tolerance expression for 

imazamethabenz-methyl, and removing 

expired tolerances and tolerance 

exemptions for certain pesticide active 

ingredients. 

DATES: This regulation is effective 

November 28, 2016. Objections and 

requests for hearings must be received 

on or before August 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–2015–0212, 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: 

Joseph Nevola, Pesticide Re-Evaluation 

Division (7508P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW., 

Washington, DC 20460–0001; telephone 

number: (703) 308–8037; email address: 

nevola.joseph@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. How can I file an objection or hearing 

request? 

Under the Federal Food, Drug, and 

Cosmetic Act (FFDCA) section 408(g), 

21 U.S.C. 346a(g), 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–2015–0212 in the subject 

line on the first page of your 

submission. All objections and requests 

for a hearing must be in writing, and 

must be received by the Hearing Clerk 

on or before August 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– 

2015–0212, 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. Background 

A. What action is the Agency taking? 

In the Federal Register of July 22, 

2015 (80 FR 43373) (FRL–9929–12), 

EPA issued a proposed rule to revoke 

certain tolerances for acephate, aldicarb, 

azinphos-methyl, etridiazole, fenarimol, 

imazamethabenz-methyl, tepraloxydim, 

thiacloprid, thiazopyr, and tralkoxydim, 

and tolerance exemptions for certain 

pesticide active ingredients, in followup to canceled product registrations or 

uses. Also, EPA proposed to make 

minor revisions to the section heading 

and introductory text for Pythium 

oligandrum DV 74. In addition, in 

accordance with current Agency 

practice, EPA proposed to make minor 

revisions to the tolerance expression for 

imazamethabenz-methyl, and remove 

expired tolerances and tolerance 

exemptions for certain pesticide active 

ingredients. The proposal provided a 

60-day comment period. 

Since the proposed rule of July 22, 

2015, amendments for the last two 

acephate labels with succulent bean use 

(revising succulent bean to a non-food 

use) were approved by EPA, as 

anticipated and discussed in the 


sradovich on DSK3TPTVN1PROD with RULES