Federal Register / Vol. 79, No. 185 / Wednesday, September 24, 2014 / Rules and Regulations 56963 

(‘‘NAAQS’’ or ‘‘standards’’) for lead 

(Pb). We are making several corrections 

to the table entitled ‘‘Arizona—2008 

Lead NAAQS.’’ In the Gila County 

portion of the boundary description, we 

are adding township T4S, R14E. 

Although most of this township lies in 

Pinal County and is listed in that 

portion of the table, a small area in the 

northeast corner of T4S, R14E lies 

within Gila County. Also in the Gila 

County portion of the boundary 

description, we are removing the 

phrase, ‘‘except those portions in the 

San Carlos Indian Reservation’’ because 

there are no tribal lands within the Gila 

County portions of T4S, R16E and T5S, 

R16E. Finally, in the Pinal County 

portion of the boundary description, we 

are adding T4S, R15E. This township, 

which was part of the area that was 

initially designated as unclassifiable for 

the 2008 Pb NAAQS, was inadvertently 

omitted from the boundary description 

when the area was redesignated to 

nonattainment. 

DATES: This rule is effective on October 

3, 2014. 

FOR FURTHER INFORMATION CONTACT: 

Ginger Vagenas, Air Planning Office 

(AIR–2), U.S. Environmental Protection 

Agency, Region IX, (415) 972–3964, 

vagenas.ginger@epa.gov. 

SUPPLEMENTARY INFORMATION: In FR Doc. 

2014–20920 appearing on page 52205 in 

the Federal Register of Wednesday, 

September 3, 2014, the following 

correction is made: 

§ 81.303 [Corrected] 

■ 1. On page 52209, in § 81.303, the 

table entitled ‘‘Arizona—2008 Lead 

NAAQS’’ is corrected to read as follows: 

ARIZONA—2008 LEAD NAAQS 

Designated area 

Designation for the 2008 

NAAQSa

Date 1 Type 

Hayden, AZ: 

Gila County (part) The portions of Gila County that are bounded by T4S, R14E; T4S, R15E; T4S, 

R16E; T5S, R15E; T5S, R16E.

10–3–14 Nonattainment. 

Pinal County (part) The portions of Pinal County that are bounded by: T4S, R14E; T4S, R15E; T4S, 

R16E (except those portions in the San Carlos Indian Reservation);T5S, R14E; T5S, R15E; T5S, 

R16E (except those portions in the San Carlos Indian Reservation); T6S, R14E; T6S, R15E; T6S, 

R16E (except those portions in the San Carlos Indian Reservation).

10–3–14 Nonattainment. 

*******

a Includes Indian Country located in each county or area, except as otherwise specified. 

1 December 31, 2011 unless otherwise noted. 

Dated: September 15, 2014. 

Alexis Strauss, 

Acting Regional Administrator, Region 9. 

[FR Doc. 2014–22738 Filed 9–23–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0593; FRL–9914–35] 

Fluensulfone; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of fluensulfone 

in or on cucurbit vegetables and fruiting 

vegetables. Makhteshim Agan of North 

American Inc. (MANA), doing business 

as (dba) ADAMA, requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

September 24, 2014. Objections and 

requests for hearings must be received 

on or before November 24, 2014, 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–2012–0593, 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: Lois 

Rossi, 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. To access the OCSPP test 

guidelines referenced in this document 

electronically, please go to http://


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56964 Federal Register / Vol. 79, No. 185 / Wednesday, September 24, 2014 / Rules and Regulations 

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ 

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–2012–0593 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 November 24, 2014. 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– 

2012–0593, 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 September 

28, 2012 (77 FR 59578) (FRL–9364–6), 

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 2F8019) by 

Makhteshim Agan of North America, 

Inc. (MANA), dba ADAMA, 3120 

Highwoods Blvd., Suite 100, Raleigh, 

NC 27604. The petition requested that 

40 CFR 180 be amended by establishing 

tolerances for residues of the nematicide 

fluensulfone, {5-Chloro-2-[(3,4,4- 

trifluoro-3-buten-1-yl)sulfonyl]thiazole}, 

in or on cucurbit vegetables at 1.0 parts 

per million (ppm) and fruiting 

vegetables at 0.6 ppm. That document 

referenced a summary of the petition 

prepared by MANA, the registrant, 

which is available in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

Based upon review of the data 

supporting the petition, EPA has revised 

the proposed tolerance levels of 1.0 and 

0.6 ppm for cucurbits and fruiting 

vegetables to 0.50 and 0.50 ppm, 

respectively. The reasons for these 

changes are explained in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

Consistent with FFDCA section 

408(b)(2)(D), and the factors specified in 

FFDCA section 408(b)(2)(D), EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for 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. Fluensulfone has 

low acute toxicity via the oral, dermal, 

and inhalation routes of exposure. It is 

not an eye or skin irritant but is a skin 

sensitizer. Acute oral toxicity studies 

were also conducted with the 

metabolites thiazole sulfonic acid 

(TSA), butene sulfonic acid (BSA), and 

methyl sulfone (MeS). The results 

indicated TSA and BSA were of low 

toxicity (Toxicity Category III), while 

MeS was of moderate toxicity (Toxicity 

Category II) by the oral route of 

exposure. The acute oral toxicity studies 

indicated that BSA and TSA were 

comparably less toxic than fluensulfone. 

Twenty-eight-day oral toxicity studies 

conducted with BSA and TSA were 

submitted and also indicated that both 

metabolites are of much lower toxicity 

than the parent compound. 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. 

Dietary and inhalation studies in rats 

showed evidence of portal-of-entry 

effects in the forestomach, pharynx, 

epiglottis, and nasal cavity. The most 

sensitive endpoints for assessing human 

health risk are the increased pup-loss 

effects for acute dietary exposure; body 

weight, hematological and clinical 

chemistry changes for chronic dietary as 

well as short/intermediate term dermal 

exposures; and clotting time, decreased 

thymus weight, and portal-of-entry 

effects (histopathology of the epiglottis 

and nasal cavity) for inhalation 

exposures (short/intermediate term). 

Decreased locomotor activity in 

females, and decreased spontaneous 

activity, decreased rearing, and 

impaired righting response in both sexes 

were observed in the acute 


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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 document 

Fluensulfone: New Active Ingredient 

Human Health Risk Assessment of 

Proposed Uses on Cucurbit Vegetables 

and Fruiting Vegetables on pages 32–46 

in docket ID number EPA–HQ–OPP– 

2012–0593. 

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://

www.epa.gov/pesticides/factsheets/

riskassess.htm. A summary of the 

toxicological endpoints for fluensulfone 

used for human risk assessment is 

shown in the Table of this unit. 

TABLE—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 = 16.2/23 

mg/kg/day (M/F).

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 = 122.0/169.1 

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= 3.1 mg/kg/

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.03 

mg/kg/day.

cPAD = 0.03 mg/kg/

day 

Co-critical 90-day dog and chronic dog 

Chronic: 

LOAEL = 16 mg/kg/day based on decreased body weight, increased mean hemoglobin concentration distribution width, 

and increased relative and absolute reticulocyte counts in 

both sexes, decreased prothrombin time in males and increased platelets in females. 

Subchronic: 

NOAEL = 1.6 mg/kg/day 

LOAEL = 17.1 mg/kg/day based on decreased body weight in 

females and increased relative and absolute reticulocyte 

counts, decreased bilirubin, decreased albumin, decreased 

A/G ratio, increased TSH, and pigmented Kupffer cells in 

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. 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 in 40 CFR part 

180. 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. In estimating acute dietary 

exposure, EPA used food consumption 

information from the United States 

Department of Agriculture’s (USDA) 

National Health and Nutrition 

Examination Survey, What We Eat In 


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America (NHANES/WWEIA) conducted 

from 2003–2008. As described in Units 

IV and V, tolerances for fluensulfone are 

in terms of the BSA metabolite. 

However, as previously noted, the BSA 

metabolite is not of toxicological 

concern. Therefore, as to residue levels 

in food, EPA assumed 100 percent crop 

treated (PCT); limit-of-quantitation 

residues of fluensulfone, as reflected in 

crop field trials (equivalent to a 

fluensulfone-based tolerance); and 

empirically derived processing factors. 

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) which used food 

consumption data from the USDA 

NHANES.WWEIA 2003–2008. As 

described in Units IV and V, tolerances 

for fluensulfone are in terms of the BSA 

metabolite. However, as previously 

noted, the BSA metabolite is not of 

toxicological concern. Therefore, as to 

residue levels in food, EPA assumed 100 

PCT; limit-of-quantitation residues of 

fluensulfone, as reflected in crop field 

trials (equivalent to a fluensulfonebased tolerance); and empirically 

derived processing factors. 

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., 

chronic exposure. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for fluensulfone. Residues equivalent to 

a fluensulfone-based tolerance 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://www.epa.gov/

oppefed1/models/water/index.htm. 

Based on the Pesticide Root Zone 

Model Ground Water (PRZMGW), the 

estimated drinking water concentrations 

(EDWCs) of fluensulfone and its 

metabolites of toxic concern for acute 

exposures are estimated to be 11.80 

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 

acute dietary risk assessment, the water 

concentration value of 77.6 ppb was 

used to assess the contribution to 

drinking water. For 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 not registered for any 

specific use patterns that would result 

in residential exposure. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found 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:// 

www.epa.gov/pesticides/cumulative. 

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. 

There was no evidence of quantitative 

or qualitative susceptibility in 

developmental toxicity studies in rats 

and rabbits. Offspring effects in those 

studies occurred in the presence of 

maternal toxicity and were not 

considered more severe than the 

parental effects. However, there was 

evidence of increased qualitative 

susceptibility of pups in the 2- 

generation reproduction study in rats. 

Maternal effects observed in that study 

were decreases in body weight and body 

weight gain; at the same dose, effects in 

offspring were decreased pup weights, 

decreased spleen weight, and increased 

pup death. 

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/or post-natal 

toxicity following in utero exposure to 

rats or rabbits and pre- and/or 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 and endpoints selected for 

risk assessment are equal to or less than 

the NOAEL from that study, the degree 

of concern for the susceptibility 

observed in the 2-generation 

reproduction study is low. The selected 

POD will be protective of these 

developmental effects. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the 10X FQPA 

SF were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for 

fluensulfone is complete. 

ii. 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. 

iii. There is no evidence that 

fluensulfone results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies. 

However, there was evidence of 

increased qualitative susceptibility of 

young rats in the 2-generation 


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reproduction study. For the reasons 

discussed in Unit III.D.2., EPA 

concludes that the 10X FQPA SF is not 

necessary to adequately protect infants 

and children. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The current dietary assessment is based 

on high-end assumptions such as 

maximum residue levels from field 

trials of the parent compound in food, 

100 PCT, and modeled estimates of 

residues in drinking water. EPA made 

conservative (protective) assumptions in 

the groundwater and surface water 

modeling used to assess exposure to 

fluensulfone in drinking water. 

Furthermore, there are no proposed 

residential uses. 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 aPAD and 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 7.4% of the 

aPAD for all infants, the population 

group receiving the greatest exposure. 

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 9.5% of 

the cPAD for all infants, the population 

group receiving the greatest exposure. 

There are no residential uses for 

fluensulfone. 

3. Short- and intermediate-term risk. 

Short-and intermediate-term risk are 

assessed based on short-term residential 

exposure plus chronic dietary exposure. 

A short- and intermediate-term adverse 

effect was identified; however, 

fluensulfone is not registered for any 

use patterns that would result in shortor intermediate-term residential 

exposure. Because there is no short-term 

or intermediate-term residential 

exposure and chronic dietary exposure 

has already been assessed under the 

appropriately protective cPAD (which is 

at least as protective as the POD used to 

assess short-term risk), no further 

assessment of short- or intermediateterm risk is necessary, and EPA relies on 

the chronic dietary risk assessment for 

evaluating short- and intermediate-term 

risk for fluensulfone. 

4. Aggregate cancer risk for U.S. 

population. Based on the data 

summarized in Unit III.C.1.iii., EPA has 

concluded that the cPAD is protective of 

potential cancer effects. Given the 

results of the chronic risk assessment, 

fluensulfone is not expected to pose a 

cancer risk. 

5. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to fluensulfone 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Suitable methods for tolerance 

enforcement have been developed and 

independently validated. For all 

matrices and analytes, the limit of 

quantitation (LOQ), defined as the 

lowest spiking level where acceptable 

precision and accuracy data were 

obtained, was determined to be 0.01 

milligram/kilogram (mg/kg). The limit 

of detection (LOD) was defined to be 

30% of the LOQ (i.e. 0.0003 mg/kg). The 

Food and Drug Administration (FDA) 

multi-residue methods are not suitable 

for detection and enforcement of 

fluensulfone residues (as the sulfonic 

acid metabolite BSA) in non-fatty 

matrices. 

Adequate enforcement methodology 

(reverse-phase high performance liquid 

chromotography-mass spectrometry/

mass 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 MRLs 

for fluensulfone. 

C. Revisions to Petitioned-For 

Tolerances 

The proposed tolerance levels, 1.0 

and 0.6 ppm for cucurbits and fruiting 

vegetables, respectively, differ from 

those being established by EPA. 

Although both the petitioner and EPA 

have used the OECD calculation 

procedures to obtain tolerance levels, 

the residue definitions being used are 

different. The petitioner’s proposed 

levels are based on residues of BSA and 

TSA, combined and expressed as parent 

fluensulfone whereas the EPAcalculated tolerances are based on 

residues of only the BSA metabolite, 

expressed as parent fluensulfone. 

Furthermore, the petitioner combined 

residue data from the representative 

commodities to obtain their proposed 

tolerances. In accordance with policy, 

EPA calculated separate tolerance levels 

for each representative commodity and 

then selected the maximum tolerance 

estimate within each group, resulting in 

tolerance levels of 0.80 ppm and 0.70 

ppm for cucurbits and fruiting 

vegetables, respectively. 

However, in order to mitigate 

estimated worker risks associated with 

chemigation operations, Makhteshim 

has reduced the proposed application 

rate from 3.5 lb. fluensulfone per acre to 

2.5 lb. per acre. For purposes of 

establishing a tolerance that is reflective 

of the revised application rate, the 

residue data were re-evaluated. The 

resulting tolerance level for both 

cucurbit vegetables and fruiting 

vegetables is 0.50 ppm. 

V. Conclusion 

Therefore, tolerances are established 

for residues of the nematicide 

fluensulfone, including its metabolites 

and degradates, in or on vegetables, 

cucurbit, group 9 at 0.50 ppm and 

vegetables, fruiting, group 8–10 at 0.50 

ppm. Compliance with the tolerance 

levels specified below is to be 

determined by measuring only 3,4,4- 

trifluoro-but-3-ene-1-sulfonic acid, 

calculated as the stoichiometric 

equivalent of fluensulfone. 


tkelley on DSK3SPTVN1PROD with RULES
56968 Federal Register / Vol. 79, No. 185 / Wednesday, September 24, 2014 / Rules and Regulations 

VI. Statutory and Executive Order 

Reviews 

This final rule 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 final rule 

has been exempted from review under 

Executive Order 12866, this final rule 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 final rule 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 tolerances 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 final rule 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 final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(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 of 1995 

(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: September 11, 2014. 

Jack Housenger, 

Director, 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 added to to 

subpart C 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, calculated as the 

stoichiometric equivalent of 

fluensulfone. 

Commodity Parts per 

million 

Vegetables, cucurbits, group 9 ... 0.50 

Vegetables, fruiting, group 8–10 0.50 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertant residues. 

[Reserved] 

[FR Doc. 2014–22466 Filed 9–23–14; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Parts 0, 1, and 17 

[WT Docket No. 10–88; RM 11349; FCC 14– 

117] 

Amendments To Modernize and Clarify 

the Commission’s Rules Concerning 

Construction, Marking and Lighting of 

Antenna Structures 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule. 

SUMMARY: In this document, the Federal 

Communications Commission (FCC) 

streamlines and eliminates outdated 

provisions of the Commission’s rules 

governing the construction, marking, 

and lighting of antenna structures. 

DATES: Effective October 24, 2014 except 

for the amendments to 47 CFR 17.4, 

17.48, and 17.49, which contain 

information collection requirements that 

have not been approved by the Office of 

Management and Budget (OMB). The 

Commission will publish a document in 

the Federal Register announcing the 

effective date of these amendments. 

FOR FURTHER INFORMATION CONTACT: 

Michael Smith of the Spectrum and 

Competition Policy Division, Wireless 

Telecommunications Bureau, (202) 418– 

0584, MichaelC.Smith@fcc.gov. 

SUPPLEMENTARY INFORMATION: This is a 

summary of the part 17 Report and 

Order, RM 11349, WT Docket No. 10– 

88, FCC 14–117, adopted and released 

August 8, 2014. The full text of the part 

17 Report and Order is available for 

inspection and copying during business 

hours in the FCC Reference Information 

Center, Portals II, 445 12th Street SW., 

Room CY–A257, Washington, DC 20554. 

Also, it may be purchased from the 

Commission’s duplicating contractor at 

Portals II, 445 12th Street SW., Room 

CY–B402, Washington, DC 20554; the 

contractor’s Web site, http://

www.bcpiweb.com; or by calling (800) 

378–3160, facsimile (202) 488–5563, or 

email FCC@BCPIWEB.com. Copies of 

the part 17 Report and Order also may 

be obtained via the Commission’s 

Electronic Comment Filing System 

(ECFS) by entering the docket number 

WT Docket No. 10–88. Additionally, the 

complete item is available on the 

Federal Communications Commission’s 

Web site at http://www.fcc.gov. 


tkelley on DSK3SPTVN1PROD with RULES