Federal Register / Vol. 77, No. 134 / Thursday, July 12, 2012 / Rules and Regulations 41081 

DELEGATION STATUS FOR PART 63 STANDARDS—ARIZONA—Continued 

Subpart Description ADEQ 1 MCAQD 2 PDEQ 3 PCAQCD 4 GRIC 5

TTTTTT ............ Secondary Nonferrous Metals Processing Area 

Sources.

.................... X X .................... ....................

VVVVVV ........... Chemical Manufacturing Industry—Area Sources .... .................... X .................... .................... ....................

WWWWWW ..... Area Source Standards for Plating and Polishing 

Operations.

.................... X .................... .................... ....................

XXXXXX ........... Area Source Standards for Nine Metal Fabrication 

and Finishing Source Categories.

.................... X .................... .................... ....................

YYYYYY ........... Area Sources: Ferroalloys Production Facilities ....... .................... X .................... .................... ....................

ZZZZZZ ............ Area Source Standards for Aluminum, Copper, and 

Other Nonferrous Foundries.

.................... X .................... .................... ....................

AAAAAAA ......... Asphalt Processing and Asphalt Roofing Manufacturing—Area Sources..................... X .................... .................... ....................

BBBBBBB ......... Chemical Preparations Industry—Area Sources ...... .................... X .................... .................... ....................

CCCCCCC ....... Paint and Allied Products Manufacturing—Area 

Sources.

.................... X .................... .................... ....................

DDDDDDD ....... Prepared Feeds Manufacturing—Area Sources ....... .................... X .................... .................... ....................

1Arizona Department of Environmental Quality 

2 Maricopa County Air Quality Department 

3Pima County Department of Environmental Quality 

4Pinal County Air Quality Control District 

5Gila River Indian Community Department of Environmental Quality. This table includes the GRIC DEQ only for purposes of identifying all 

state, local, and tribal agencies responsible for implementing part 63 standards within the geographical boundaries of the State of Arizona and 

does not establish any state regulatory authority in Indian country. 

* * * * * 

[FR Doc. 2012–17031 Filed 7–11–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0758; FRL–9353–8] 

Sulfentrazone; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of sulfentrazone 

in or on multiple commodities which 

are identified and discussed later in this 

document. Interregional Research 

Project Number 4 (IR–4) and FMC 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective July 

12, 2012. Objections and requests for 

hearings must be received on or before 

September 10, 2012, 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–2011–0758 is 

available at http://www.regulations.gov 

or at the OPP Docket in the 

Environmental Protection Agency 

Docket Center (EPA/DC), located in EPA 

West, 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: 

Andrew Ertman, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9367; email address: 

ertman.andrew@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. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

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://ecfr.gpoaccess.gov/cgi/t/ 

text/text-idx?&c=ecfr&tpl=/ecfrbrowse/ 

Title40/40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 

21 U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2011–0758 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 September 10, 2012. Addresses 

for mail and hand delivery of objections 


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41082 Federal Register / Vol. 77, No. 134 / Thursday, July 12, 2012 / Rules and Regulations 

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 that does not 

contain any 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 a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2011–0758, 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 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), Mail Code: 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.htm. 

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 5, 

2011 (76 FR 61647) (FRL–8890–5), EPA 

issued a notice pursuant to FFDCA 

section 408(d)(3), 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide 

petition (PP 1E7890) by (IR–4), Rutgers, 

The State University of New Jersey, 500 

College Road East, Suite 201–W., 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.498 be 

amended by establishing tolerances for 

residues of the herbicide sulfentrazone 

(N-[2,4-dichloro-5-[4-(difluoromethyl)- 

4,5-dihydro-3-methyl-5-oxo-1H-1,2,4- 

triazol-1- 

yl]phenyl]methanesulfonamide) and its 

metabolites 3- 

hydroxymethylsulfentrazone (N-[2,4- 

dichloro-5-[4-(difluoromethyl)-4,5- 

dihydro-3-hydroxymethyl-5-oxo-1H1,2,4-triazol-1- 

yl]phenyl]methanesulfonamide) and 3- 

desmethyl sulfentrazone (N-[2,4- 

dichloro-5-[4-(difluoromethyl)-4,5- 

dihydro-5-oxo-1H-1,2,4-triazol-1- 

yl]phenyl]methanesulfonamide), in or 

on rhubarb at 0.2 parts per million 

(ppm); turnip, roots at 0.2 ppm; turnip, 

tops at 0.7 ppm; and sunflower 

subgroup 20B at 0.2 ppm; ‘‘Tolerances 

with regional registrations’’ in or on 

wheat, forage at 0.45 ppm (Pacific 

Northwest only); wheat, hay at 0.20 

ppm (Pacific Northwest only); wheat, 

grain at 0.20 ppm (Pacific Northwest 

only); wheat, straw at 1.4 ppm (Pacific 

Northwest only); and cowpea, succulent 

at 0.15 ppm (Tennessee only). In 

addition, the petition requested to 

amend the current tolerances in 40 CFR 

180.498 in or on bean, lima, succulent 

at 0.15 ppm by removing the tolerance 

from the table in Section (a)(2) and 

adding the tolerance to Section (c) 

Tolerances with regional registrations. 

Upon approval of the aforementioned 

tolerance on the sunflower subgroup 

20B, the petition additionally proposed 

to remove the established tolerance in or 

on the raw agricultural commodity 

sunflower, seed at 0.2 ppm. That notice 

referenced a summary of the petition 

prepared by FMC, the registrant, which 

is available in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

In the Federal Register of July 6, 2011 

(76 FR 39358) (FRL–8875–6), EPA 

issued a notice pursuant to FFDCA 

section 408(d)(3), 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide 

petition (PP 1F7838) by FMC 

Corporation, 1735 Market St., 

Philadelphia, PA 19103. The petition 

requested that 40 CFR 180.498 be 

amended by establishing tolerances for 

residues of the herbicide sulfentrazone 

(N-[2,4-dichloro-5-[4-(difluoromethyl)- 

4,5-dihydro-3-methyl-5-oxo-1H-1,2,4- 

triazol-1- 

yl]phenyl]methanesulfonamide) and its 

metabolites 3- 

hydroxymethylsulfentrazone (N-[2,4- 

dichloro-5-[4-(difluoromethyl)-4,5- 

dihydro-3-hydroxymethyl-5-oxo-1H1,2,4-triazol-1- 

yl]phenyl]methanesulfonamide) and 3- 

desmethyl sulfentrazone (N-[2,4- 

dichloro-5-[4-(difluoromethyl)-4,5- 

dihydro-5-oxo-1H-1,2,4-triazol-1- 

yl]phenyl]methanesulfonamide), in or 

on crop group 10–10 citrus fruit at 0.15 

ppm; crop group 13–07 berry and small 

fruit at 0.15 ppm; crop group 14 tree nut 

and pistachio at 0.15 ppm; and crop 

group 18 non-grass animal feed (forage, 

fodder, straw, and hay): Alfalfa, forage 

at 5 ppm; alfalfa, hay at 20 ppm; alfalfa, 

seed at 3 ppm; clover, forage at 5 ppm; 

clover, hay at 20 ppm; and clover, seed 

at 3 ppm. That notice referenced a 

summary of the petition prepared by 

FMC, the registrant, which is available 

in the docket, http:// 

www.regulations.gov. A comment was 

received on the notice of filing. EPA’s 

response to this comment is discussed 

in Unit IV.C. 

Based upon review of the data 

supporting the petition, EPA has 

modified the tolerance levels for some 

commodities and is not establishing 

tolerances on alfalfa forage, hay, and 

seed and clover forage, hay, and seed. 

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 sulfentrazone 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with sulfentrazone 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. 

Based on the results of acute toxicity 

studies in rats, sulfentrazone was 

classified as having low acute toxicity 

via the oral, dermal, and inhalation 

routes of exposure. It is a mild eye 


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irritant, but not a dermal irritant or 

sensitizer. Subchronic and chronic 

toxicity studies in rats, mice and dogs 

identified the hematopoietic system as 

the target of sulfentrazone. 

Protoporphyrinogen oxidase inhibition 

in the mammalian species may result in 

disruption of heme synthesis. In these 

studies, disruption of heme synthesis 

was observed at about the same dose 

levels across species, except in the case 

of mice, where the effects were seen at 

a slightly higher dose. The 

hematotoxicity occurred around the 

same dose level for short- through longterm exposure without increasing in 

severity. 

In the oral and dermal rat 

developmental toxicity studies, 

decreased fetal body weights and 

reduced/delayed skeletal ossifications 

were noted at doses that were not 

maternally toxic. In rabbits, 

developmental effects such as decreased 

pup viability were observed at a 

maternally toxic dose (clinical signs, 

abortions and decreased body weight 

gains). In the 2-generation reproduction 

study in rats, offspring effects such as 

decreased body weights and decreased 

litter survival were observed at a 

maternally toxic dose (slightly 

decreased body weight gain). 

In the acute neurotoxicity study, an 

increased incidence of clinical signs 

(staggered gait, splayed hind limbs, and 

abdominal gripping), changes in 

functional observation battery (FOB) 

parameters, and decreased motor 

activity were observed; however, 

complete recovery was observed within 

14 days and there was no evidence of 

neuropathology. In the subchronic 

neurotoxicity study, clinical signs of 

toxicity, increased motor activity, and/ 

or decreased body weights, body-weight 

gain, and food consumption were 

observed. There was no evidence of 

neuropathology in either study. A 

published, non-guideline 

developmental toxicity study in the rat 

(de Castro, et al., 2007) failed to 

demonstrate conclusively 

developmental neurotoxicity and 

contains several shortcomings that limit 

its use for regulatory purposes. Further, 

the reported offspring effects involving 

measures of physical and reflex 

development are likely secondary 

effects reflective of the poor general 

state of the offspring, as reported in the 

rat 2-generation reproductive toxicity 

study at similar dose levels. 

No systemic toxicity was seen via the 

dermal route up to the limit dose in a 

28-day dermal toxicity study in rabbits. 

Preliminary review of a recently 

submitted 28-day rat immunotoxicity 

study suggests that sulfentrazone does 

not directly target the immune system; 

and, there is no evidence of 

immunotoxicity in the rest of the 

toxicity database for sulfentrazone. 

Carcinogenicity studies in rats and 

mice showed no evidence of increased 

incidence of tumor formation due to 

treatment with sulfentrazone. Therefore, 

the EPA classified sulfentrazone as ‘‘not 

likely to be carcinogenic to humans.’’ 

The available mutagenicity studies 

indicate that sulfentrazone is weakly 

clastogenic in the in vitro mouse 

lymphoma assay in the absence of S9 

activation; however, the response was 

not evident in the presence of S9 

activation. Sulfentrazone is neither 

mutagenic in bacterial cells, nor 

clastogenic in male or female mice in 

vivo. Specific information on the studies 

received and the nature of the adverse 

effects caused by sulfentrazone 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 ‘‘Sulfentrazone: Human-Health 

Risk Assessment for the Establishment 

of Sulfentrazone Tolerances in/on: 

Rhubarb, Turnip Roots and Tops, 

Sunflower Subgroup 20B, Succulent 

Cowpea, Succulent Lima Bean, 

Succulent Vegetable Soybean, Wheat 

(Spring), Citrus Fruit Group 10–10, 

Low-Growing Berry Group 13–07, Tree 

Nut Group 14, Pistachios, and Crop 

Group 18 Nongrass Animal Feeds,’’ 

pp. 45–49 in docket ID number EPA– 

HQ–OPP–2011–0758. 

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 (LOC) 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 sulfentrazone used for 

human risk assessment is shown in the 

following table: 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR SULFENTRAZONE 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 (Females 13–49 years of 

age).

NOAEL = 14 mg/ 

kg/day 

UFA = 10X 

UFH = 10X 

FQPA SF = 1X 

Acute RfD = 0.14 

mg/kg/day 

aPAD = 0.14 mg/ 

kg/day.

2-Generation Reproductive Toxicity Study—Rat Offspring 

Toxicity LOAEL = 33 (M) and 40 (F) mg/kg/day based 

on reduced prenatal viability (fetal & litter), reduced litter 

size, increased number of stillborn pups, reduced pup 

and litter postnatal survival, and decreased pup body 

weights throughout lactation. 

Acute dietary (General population including infants and children).NOAEL = 250 mg/ 

kg/day 

UFA = 10X 

UFH = 10X 

FQPA SF = 1X 

Acute RfD = 2.5 

mg/kg/day 

aPAD = 2.5 mg/kg/ 

day.

Acute Neurotoxicity Study—Rat LOAEL = 750 mg/kg/day 

based on increased incidence of clinical signs and FOB 

parameters and decreased motor activity. 


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

ASSESSMENT—Continued 

Exposure/scenario 

Point of departure 

and uncertainty/ 

safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Chronic dietary (All populations) ............ NOAEL = 14 mg/ 

kg/day 

UFA = 10X 

UFH = 10X 

FQPA SF = 1X 

Chronic RfD = 0.14 

mg/kg/day 

cPAD = 0.14 mg/ 

kg/day.

2-Generation Reproductive Toxicity Study—Rat Offspring 

Toxicity LOAEL = 33 (M) and 40 (F) mg/kg/day based 

on reduced prenatal viability (fetal & litter), reduced litter 

size, increased number of stillborn pups, reduced pup 

and litter postnatal survival, and decreased pup body 

weights throughout lactation. 

Short- (1–30 days) and IntermediateTerm (1–6 months) Incidental Oral.NOAEL = 14 mg/ 

kg/day 

UFA = 10X 

UFH = 10X 

FQPA SF = 1X 

LOC for MOE = 

100 

2-Generation Reproduction Study—Rat Offspring LOAEL 

= 33 mg/kg/day based on decreased pup body weights 

and reduced postnatal survival in both generations. 

Short-Term Dermal (1–30 days) ............ Dermal study 

NOAEL = 100 mg/ 

kg/day (dermal 

absorption rate = 

100%).

UFA = 10X 

UFH = 10X 

FQPA SF = 1X 

LOC for MOE = 

100 

Dermal Developmental Study—Rat LOAEL = 250 mg/kg/ 

day based on decreased fetal body weight; increased 

incidences of fetal skeletal variations: Hypoplastic or 

wavy ribs, incompletely ossified lumbar vertebral arches, and incompletely ossified ischia or pubes; and reduced number of thoracic vertebral and rib ossification 

sites. 

Short-Term Inhalation (1–30 days) ........ Inhalation (or oral) 

study 

NOAEL = 10 mg/ 

kg/day (inhalation absorption 

rate = 100%).

UFA = 10X 

UFH = 10X 

FQPA SF = 10X 

LOC for MOE = 

1000 

Prenatal Developmental Toxicity—Rat Developmental 

LOAEL = 25 mg/kg/day, based upon decreased mean 

fetal weights, and retardation in skeletal development 

evidenced by an increased number of litters with any 

variation and by decreased number of caudal vertebral 

and metacarpal ossification sites. 

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). UFDB = to account for the absence of data or other data deficiency. UFH = potential variation in sensitivity among members of the human population (intraspecies). M = male. 

F = female. FOB = functional observation battery. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to sulfentrazone, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing sulfentrazone tolerances in 40 

CFR 180.498. EPA assessed dietary 

exposures from sulfentrazone 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 sulfentrazone. EPA performed 

separate acute risk assessments for 

females 13 to 49 years old and for the 

general population, including infants 

and children, based on different 

endpoints and aPADs. In estimating 

acute dietary exposure, EPA used food 

consumption information from the 

United States Department of Agriculture 

(USDA) 1994–1996 and 1998 

Nationwide Continuing Surveys of Food 

Intake by Individuals (CSFII). As to 

residue levels in food, EPA used 

tolerance-level residues, dietary 

exposure evaluation model DEEMTM

(ver. 7.81) default processing factors, 

and assumed 100 percent crop treated 

(PCT) for all commodities. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

CSFII. As to residue levels in food, EPA 

used tolerance-level residues, DEEMTM

(ver. 7.81) default processing factors, 

and assumed 100 PCT for all 

commodities. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that sulfentrazone does not 

pose a cancer risk to humans. Therefore, 

a dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue or PCT information 

in the dietary assessment for 

sulfentrazone. Tolerance level residues 

and 100 PCT were assumed for all food 

commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for sulfentrazone in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

sulfentrazone. 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. 

Sulfentrazone and 3-carboxylic acid 

sulfentrazone are the residues of 

concern in drinking water. Therefore, 

the First Index Reservoir Screening Tool 

(FIRST) model was used to estimate 

concentrations of sulfentrazone and 3- 

carboxylic acid sulfentrazone in surface 

water, and the Screening Concentration 

in Ground Water (SCI–GROW) model 

was utilized to estimate concentrations 

in ground water. The estimated drinking 

water concentrations (EDWCs) of 

sulfentrazone and 3-carbyoxylic acid 

sulfentrazone for acute exposures are 

estimated to be 35.8 parts per billion 

(ppb) for surface water and 26.0 ppb for 

ground water. For chronic exposures for 

non-cancer assessments, EDWCs are 


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estimated to be 7.8 ppb for surface water 

and 26.0 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 35.8 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 26.0 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). 

Sulfentrazone is currently registered 

for the following use that could result in 

residential exposures: Residential home 

lawns/turf and recreational turf, such as 

golf courses. EPA assessed residential 

exposure using the following 

assumptions: Adults were assessed for 

potential short-term dermal and 

inhalation handler exposure from 

applying sulfentrazone to residential 

turf/home lawns and for short-term 

post-application dermal exposure from 

contact with treated residential and 

recreational turf home lawns and golf 

courses. For adult handlers, dermal and 

inhalation exposures were aggregated 

for the short-term assessment. Because 

the level of concern for dermal 

exposures (MOEs less than 100) and 

inhalation exposure (MOEs less than 

1,000) are different, a total aggregate risk 

index (ARI) approach was used for adult 

handlers instead of the MOE approach. 

ARIs of less than 1 indicate risks are not 

of concern. Children, ages 11 < 16 years 

old and 6 < 11 years old, were assessed 

for post-application dermal exposure 

from contact with treated residential 

and recreational turf (home lawns and 

golf courses). Children, ages 1 < 2 years 

old, were assessed for post-application 

dermal and incidental oral (hand-tomouth, object-to-mouth, soil ingestion 

and episodic ingestion of granules) 

exposure to residential turf/home lawns. 

For the short-term exposure duration, 

the post-application exposure scenarios 

that were combined for children 1 < 2 

years old are the dermal and hand-tomouth scenarios. This combination 

should be considered a protective 

estimate of children’s exposure to 

pesticides used on turf. For the 

intermediate-term exposure duration, 

the only potential post-application 

exposure scenario is soil ingestion. 

Chronic exposures are not expected and 

were not assessed. 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

found at http://www.epa.gov/pesticides/ 

trac/science/trac6a05.pdf. 

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 sulfentrazone to 

share a common mechanism of toxicity 

with any other substances, and 

sulfentrazone does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that sulfentrazone 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 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

There is evidence of increased 

quantitative susceptibility following in 

utero exposure in the oral and dermal 

rat developmental toxicity studies. 

Developmental effects, including 

decreased fetal body weights and 

reduced/delayed skeletal ossifications 

were observed at doses that were not 

maternally toxic. In the 2-generation 

reproduction study in rats, offspring 

effects such as decreased body weights 

and decreased litter survival were 

observed at a slightly maternally toxic 

dose (slightly decreased body weight 

gain), indicating possible slightly 

increased qualitative susceptibility. 

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 for all scenarios 

except for inhalation exposure, where a 

10X FQPA SF factor has been retained 

due to the lack of an appropriate 

inhalation study. That decision is based 

on the following findings: 

i. The toxicity database for 

sulfentrazone is complete with the 

exception of a 28-day inhalation study 

in rats. A 10X FQPA SF has been 

retained for inhalation exposure 

scenarios due to this data gap. 

ii. There is no indication that 

sulfentrazone is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional safety factors to account for 

neurotoxicity. 

iii. There is evidence of increased 

quantitative susceptibility following in 

utero exposure in the oral and dermal 

developmental toxicity studies in rat 

and possible evidence of slightly 

increased qualitative susceptibility of 

offspring in the 2-generation rat 

reproduction study. However, concern 

is low because clear NOAELs have been 

identified for the effects noted in these 

studies and both of the developmental 

toxicity studies have been chosen for 

endpoint selection, thereby protecting 

the relevant human subpopulations 

from the noted effects. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to sulfentrazone 

in drinking water. EPA used similarly 

conservative assumptions to assess 

postapplication exposure of children as 

well as incidental oral exposure of 

toddlers. These assessments will not 

underestimate the exposure and risks 

posed by sulfentrazone. 

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. 


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1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

sulfentrazone will occupy 3.2% of the 

aPAD for females 13–49 years old, 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 sulfentrazone 

from food and water will utilize 4.2% of 

the cPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. Based on the explanation in 

Unit III.C.3., regarding residential use 

patterns, chronic residential exposure to 

residues of sulfentrazone 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). 

Sulfentrazone 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 sulfentrazone. 

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 an 

aggregate MOE of 280 for children 1–2 

years old, and an ARI of 3.9 for the 

general U.S. population and adult 

males. Because EPA’s level of concern 

for sulfentrazone is an MOE of 100 or 

below and/or and ARI of 1 or below, 

this MOE and ARI 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). 

Sulfentrazone is currently registered 

for uses that could result in 

intermediate-term residential exposure, 

and the Agency has determined that it 

is appropriate to aggregate chronic 

exposure through food and water with 

intermediate-term residential exposures 

to sulfentrazone. 

Using the exposure assumptions 

described in this unit for intermediateterm exposures, EPA has concluded that 

the combined intermediate-term food, 

water, and residential exposures result 

in an aggregate MOE of 2,400 for 

children 1–2 years old, the only 

population subgroup of concern. 

Because EPA’s level of concern for 

sulfentrazone is an MOE of 100 or 

below, this MOE is not of concern. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

sulfentrazone is not expected to pose a 

cancer risk to humans. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population or to infants and children 

from aggregate exposure to 

sulfentrazone residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(gas chromatography (GC)) is available 

to enforce the tolerance expression. The 

method has been forwarded for 

inclusion in the Pesticides Analytical 

Manual, Volume II. The method may be 

requested from: Chief, Analytical 

Chemistry Branch, Environmental 

Science Center, 701 Mapes Rd., Ft. 

Meade, MD 20755–5350; telephone 

number: (410) 305–2905; email address: 

residuemethods@epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

There are no Codex MRLs established 

for sulfentrazone on the subject crops in 

this rule. 

C. Response to Comments 

A comment was received objecting 

generally to the use of this chemical 

stating that the ‘‘* * * product should 

[sic] not be approved to be 

manufactured or sold anywhere on earth 

* * *’’ The Agency understands the 

commenter’s 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 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. This comment appears to be 

directed at the underlying statute and 

not EPA’s implementation of it; the 

commenter has made no contention that 

EPA has acted in violation of the 

statutory framework. 

D. Revisions to Petitioned-For 

Tolerances 

The tolerances proposed in the 

petitions have been revised as follows: 

the rhubarb tolerance is being set at 0.15 

ppm instead of 0.2 ppm; the turnip root 

tolerance is being set at 0.15 ppm 

instead of 0.2 ppm; the turnip top 

tolerance is being set at 0.60 ppm 

instead of 0.7 ppm; the wheat forage 

tolerance is being set at 0.50 ppm 

instead of 0.45 ppm; the wheat hay 

tolerance is being set at 0.30 instead of 

0.20 ppm; the wheat grain tolerance is 

being set at 0.15 ppm instead of 0.20 

ppm; the wheat straw tolerance is being 

set at 1.5 ppm instead of 1.4 ppm. EPA 

revised the tolerance levels based on 

analysis of the residue field trial data 

and by using the organization for 

economic cooperation and development 

(OECD) tolerance calculation 

procedures. 

Tolerances are not being established 

at this time for alfalfa forage, hay, and 

seed and clover forage, hay, and seed 

due to the need for additional residue 

data and a ruminant feeding study. 

V. Conclusion 

Therefore, tolerances are established 

for residues of sulfentrazone, (N-[2,4- 

dichloro-5-[4-(difluoromethyl)-4,5- 

dihydro-3-methyl-5-oxo-1H-1,2,4- 

triazol-1- 

yl]phenyl]methanesulfonamide) and its 

metabolites 3- 

hydroxymethylsulfentrazone (N-[2,4- 

dichloro-5-[4-(difluoromethyl)-4,5- 

dihydro-3-hydroxymethyl-5-oxo-1H1,2,4-triazol-1- 

yl]phenyl]methanesulfonamide) and 3- 

desmethyl sulfentrazone (N-[2,4- 

dichloro-5-[4-(difluoromethyl)-4,5- 

dihydro-5-oxo-1H-1,2,4-triazol-1- 

yl]phenyl]methanesulfonamide), in 

section 180.498(a)(2) in or on rhubarb at 

0.15 ppm; turnip roots at 0.15 ppm; 

turnip tops at 0.60 ppm; sunflower 

subgroup 20B at 0.20 ppm; citrus fruit 

group 10–10 at 0.15 ppm; low growing 

berry group 13–07 at 0.15 ppm; tree nut 

group 14 at 0.15 ppm; pistachio at 0.15 

ppm; and section 180.498 (c) tolerances 


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Federal Register / Vol. 77, No. 134 / Thursday, July 12, 2012 / Rules and Regulations 41087 

with regional registrations for wheat 

forage at 0.50 ppm; wheat hay at 0.30 

ppm; wheat grain at 0.15 ppm; wheat 

straw at 1.5 ppm; and cowpea, 

succulent at 0.15 ppm. 

In addition, the following tolerances 

are being removed as unnecessary in 

section 180.498(a)(2), sunflower seed, 

and strawberry, and in section 

180.498(b), flax seed and strawberry. 

Lastly, the tolerance for ‘‘bean, lima, 

succulent’’ is being moved from section 

180.498(a)(2) to section 180.498(c). 

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 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 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) (Pub. L. 104–4). 

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), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. 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 this final rule in the 

Federal Register. This final rule 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: July 3, 2012. 

Lois Rossi, 

Director, Registration Division, Office 

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 180.498 is amended by: 

■ i. In the table to paragraph (a)(2), 

remove the entries for ‘‘bean, lima, 

succulent,’’ ‘‘sunflower, seed,’’ and 

‘‘strawberry’’, and add alphabetically 

new entries as shown below. 

■ ii. Revise paragraphs (b) and (c). 

The added and revised text read as 

follows: 

§ 180.498 Sulfentrazone; tolerances for 

residues. 

(a) * * * 

(2) * * * 

Commodity Parts per 

million 

* * * * * 

Berry, low growing, group 13– 

07 ........................................ 0.15 

* * * * * 

Fruit, citrus, group 10–10 ....... 0.15 

* * * * * 

Nut, tree, group 14 ................. 0.15 

* * * * * 

Pistachio ................................. 0.15 

Rhubarb .................................. 0.15 

* * * * * 

Sunflower subgroup 20B ........ 0.20 

Turnip, roots ........................... 0.15 

Turnip, tops ............................. 0.60 

* * * * * 

(b) Section 18 emergency exemptions. 

[Reserved]. 

(c) Tolerances with regional 

registrations. Tolerances with regional 

registration are established for the 

combined residues of the free and 

conjugated forms of sulfentrazone, 

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 the sum 

of sulfentrazone (N-[2,4-dichloro-5-[4- 

(difluoromethyl)-4,5-dihydro-3-methyl5-oxo-1H-1,2,4-triazol-1- 

yl]phenyl]methanesulfonamide) and its 

metabolites HMS (N-(2,4-dichloro-5-(4- 

(difluoromethyl)-4,5-dihydro-3- 

hydroxymethyl-5-oxo-1H-1,2,4-triazol-1- 

yl)phenyl)methanesulfonamide) and 

DMS (N-(2,4-dichloro-5-(4- 

(difluoromethyl)-4,5-dihydro-5-oxo-1H1,2,4-triazol-1- 

yl)phenyl)methanesulfonamide, 

calculated as the stoichiometric 

equivalent of sulfentrazone in or on the 

following commodities. 

Commodity Parts per 

million 

Bean, lima, succulent ........... 0 .15 

Cowpea, succulent ............... 0 .15 

Wheat, forage ....................... 0 .50 

Wheat, grain ......................... 0 .15 

Wheat, hay ........................... 0 .30 

Wheat, straw ......................... 1 .5 


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41088 Federal Register / Vol. 77, No. 134 / Thursday, July 12, 2012 / Rules and Regulations 

* * * * * 

[FR Doc. 2012–17020 Filed 7–11–12; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF THE INTERIOR 

Fish and Wildlife Service 

50 CFR Part 17 

[Docket No. FWS–R2–ES–2011–0042; 

4500030113] 

RIN 1018–AV86 

Endangered and Threatened Wildlife 

and Plants; Determination of 

Endangered Status for the Chupadera 

Springsnail and Designation of Critical 

Habitat 

AGENCY: Fish and Wildlife Service, 

Interior. 

ACTION: Final rule. 

SUMMARY: We, the U.S. Fish and 

Wildlife Service, determine endangered 

status for the Chupadera springsnail and 

designate critical habitat for the species 

under the Endangered Species Act of 

1973, as amended. The effect of this rule 

is to conserve the Chupadera springsnail 

and its habitat under the Endangered 

Species Act. 

DATES: This rule becomes effective on 

August 13, 2012. 

ADDRESSES: This final rule and 

associated final economic analysis and 

final environmental assessment are 

available on the Internet at http:// 

www.regulations.gov or http:// 

www.fws.gov/southwest/es/NewMexico/. 

Comments and materials received, as 

well as supporting documentation used 

in preparing this final rule, are available 

for public inspection, by appointment, 

during normal business hours, at the 

U.S. Fish and Wildlife Service, New 

Mexico Ecological Services Field Office, 

2105 Osuna Rd. NE., Albuquerque, NM 

87113; telephone 505–346–2525; 

facsimile 505–346–2542. 

FOR FURTHER INFORMATION CONTACT: 

Wally ‘‘J’’ Murphy, Field Supervisor, 

U.S. Fish and Wildlife Service, New 

Mexico Ecological Services Field Office, 

2105 Osuna Rd. NE., Albuquerque, NM 

87113; telephone 505–346–2525; 

facsimile 505–346–2542. If you use a 

telecommunications device for the deaf 

(TDD), call the Federal Information 

Relay Service (FIRS) at 800–877–8339. 

SUPPLEMENTARY INFORMATION: This 

document consists of: (1) A final rule to 

list the Chupadera springsnail as 

endangered and (2) a final critical 

habitat designation for the Chupadera 

springsnail. 

Executive Summary 

Why we need to publish a rule. Under 

the Endangered Species Act, a species 

may warrant protection through listing 

if it is endangered or threatened 

throughout all or a significant portion of 

its range. The Chupadera springsnail 

(Pyrgulopsis chupaderae) qualifies for 

listing as endangered based on threats to 

its habitat and its very limited range, 

which makes it more susceptible to 

extinction. 

This rule designates the Chupadera 

springsnail as endangered with critical 

habitat. We are listing the Chupadera 

springsnail as endangered. In addition, 

we are designating critical habitat for 

the species in two units on private 

property totaling 0.7 hectares (1.9 acres) 

in Socorro County, New Mexico. 

The Endangered Species Act provides 

the basis for our action. Under the 

Endangered Species Act, we can 

determine that a species is endangered 

or threatened based on any of the 

following five factors: (A) The present or 

threatened destruction, modification, or 

curtailment of its habitat or range; 

(B) overutilization for commercial, 

recreational, scientific, or educational 

purposes; (C) disease or predation; (D) 

the inadequacy of existing regulatory 

mechanisms; or (E) other natural or 

manmade factors affecting its continued 

existence. 

We have determined that the 

Chupadera springsnail is endangered by 

habitat loss and degradation of aquatic 

resources, particularly decreases in 

spring flow due to drought and ongoing 

and future groundwater pumping in the 

surrounding area, habitat degradation 

from livestock grazing, and springhead 

modification. 

We prepared an economic analysis. 

To ensure that we consider the 

economic impacts, we prepared an 

economic analysis of the designation of 

critical habitat. We published an 

announcement and solicited public 

comments on the draft economic 

analysis. The analysis found no 

economic impact of the designation of 

critical habitat beyond an unquantified 

‘‘stigma effect’’ to land values. 

We requested peer review of the 

methods used in our designation. We 

specifically requested that three 

knowledgeable individuals with 

scientific expertise in desert spring 

ecosystems or related fields review the 

scientific information and methods that 

we used when we proposed the species 

as endangered. The peer reviewers 

generally concurred with our methods 

and conclusions and provided 

additional information, clarifications, 

and suggestions to improve the final 

listing and critical habitat rule. 

We sought public comment on the 

designation. During the first comment 

period, we received five comment 

letters directly addressing the proposed 

listing and critical habitat designation. 

During the second comment period, we 

received two comment letters 

addressing the proposed listing and 

critical habitat designation. We received 

no comments during the third comment 

period, nor any comments regarding the 

draft economic analysis or draft 

environmental assessment. 

Background 

It is our intent to discuss below only 

those topics directly relevant to the 

listing of the Chupadera springsnail as 

endangered in this section of the final 

rule. 

Previous Federal Actions 

We identified the Chupadera 

springsnail as a candidate for listing in 

the May 22, 1984, Notice of Review of 

Invertebrate Wildlife for Listing as 

Endangered or Threatened Species 

(49 FR 21664). Candidates are those 

fish, wildlife, and plants for which we 

have on file sufficient information on 

biological vulnerability and threats to 

support preparation of a listing 

proposal, but for which development of 

a listing regulation is precluded by other 

higher priority listing activities. The 

Chupadera springsnail was petitioned 

for listing on November 20, 1985, and 

was found to be warranted for listing 

but precluded by higher priority 

activities on October 4, 1988 (53 FR 

38969). The Chupadera springsnail has 

been included in all of our subsequent 

annual Candidate Notices of Review 

(54 FR 554, January 6, 1989; 56 FR 

58804, November 21, 1991; 59 FR 

58982, November 15, 1994; 61 FR 7595, 

February 28, 1996; 62 FR 49397, 

September 19, 1997; 64 FR 57533, 

October 25, 1999; 66 FR 54807, October 

30, 2001; 67 FR 40657, June 13, 2002; 

69 FR 24875, May 4, 2004; 70 FR 24869, 

May 11, 2005; 71 FR 53755, September 

12, 2006; 72 FR 69033, December 6, 

2007; 73 FR 75175, December 10, 2008; 

74 FR 57803, November 9, 2009; 75 FR 

69221, November 10, 2010; and 76 FR 

66370, October 26, 2011). In 2002, the 

listing priority number was increased 

from 8 to 2 in accordance with our 

priority guidance published on 

September 21, 1983 (48 FR 43098). A 

listing priority of 2 reflects a species 

with threats that are both imminent and 

high in magnitude. On August 2, 2011, 

we published a proposed rule to list the 

Chupadera springsnail as endangered 

with critical habitat (76 FR 46218), and 


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