Federal Register / Vol. 77, No. 189 / Friday, September 28, 2012 / Rules and Regulations 59561 

Commodity Parts per 

million 

* * * * * 

Berry and small fruit, group 13–07 0.15 

* * * * * 

Vegetable, soybean, succulent .... 0.15 

* * * * * 

* * * * * 

[FR Doc. 2012–23986 Filed 9–27–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0493; FRL–9361–4] 

Sulfoxaflor; Pesticide Tolerances for 

Emergency Exemptions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

time-limited tolerances for residues of 

sulfoxaflor, N-methyloxido [1-[6- 

(trifluoromethyl)-3-pyridinyl]ethyl] l4- 

sulfanylidene] cyanamide, including its 

metabolites and degradates in or on 

cotton, undelinted seed; cotton, gin 

byproducts; and cotton, hulls. This 

action is in response to EPA’s granting 

of emergency exemptions under section 

18 of the Federal Insecticide, Fungicide, 

and Rodenticide Act (FIFRA) 

authorizing use of the pesticide on 

cotton. This regulation establishes 

maximum permissible levels for 

residues of sulfoxaflor in or on these 

commodities. These time-limited 

tolerances expire on December 31, 2015. 

DATES: This regulation is effective 

September 28, 2012. Objections and 

requests for hearings must be received 

on or before November 27, 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–2012–0493, 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: 

Libby Pemberton, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

703–308–9364; email address: 

pemberton.libby@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: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at http:// 

ecfr.gpoaccess.gov/cgi/t/text/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under section 408(g) of the Federal 

Food, Drug, and Cosmetic Act (FFDCA), 

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–2012–0493 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 27, 2012. 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 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–2012–0493, 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 statue. 

• 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. 

II. Background and Statutory Findings 

EPA, on its own initiative, in 

accordance with FFDCA sections 408(e) 

and 408(l)(6) of, 21 U.S.C. 346a(e) and 

346a(1)(6), is establishing time-limited 

tolerances for combined residues of 

sulfoxaflor, N-methyloxido [1-[6- 

(trifluoromethyl)-3-pyridinyl]ethyl] l4- 

sulfanylidene] cyanamide, including its 

metabolites and degradates in or on 

cotton, undelinted seed at 0.2 parts per 

million (ppm); cotton, gin byproducts at 

6.0 ppm; and cotton, hulls at 0.35 ppm. 

These time-limited tolerances expire on 

December 31, 2015. 

Section 408(l)(6) of FFDCA requires 

EPA to establish a time-limited 

tolerance or exemption from the 

requirement for a tolerance for pesticide 

chemical residues in food that will 

result from the use of a pesticide under 

an emergency exemption granted by 

EPA under section 18 of FIFRA. Such 

tolerances can be established without 

providing notice or period for public 

comment. EPA does not intend for its 

actions on FIFRA section 18 related 

time-limited tolerances to set binding 

precedents for the application of FFDCA 

section 408 and the safety standard to 

other tolerances and exemptions. 

Section 408(e) of FFDCA allows EPA to 

establish a tolerance or an exemption 

from the requirement of a tolerance on 

its own initiative, i.e., without having 

received any petition from an outside 

party. 

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.’’ 

mstockstill on DSK4VPTVN1PROD with RULES

59562 Federal Register / Vol. 77, No. 189 / Friday, September 28, 2012 / Rules and Regulations 

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 * * *.’’ 

Section 18 of FIFRA authorizes EPA 

to exempt any Federal or State agency 

from any provision of FIFRA, if EPA 

determines that ‘‘emergency conditions 

exist which require such exemption.’’ 

EPA has established regulations 

governing such emergency exemptions 

in 40 CFR part 166. 

III. Emergency Exemption for 

Sulfoxaflor for Various Commodities 

and FFDCA Tolerances 

The states of Arkansas, Mississippi, 

Tennessee, and Louisiana submitted 

emergency use requests for the use of 

the unregistered active ingredient, 

sulfoxaflor, on cotton to control the 

tarnished plant bug. The requests are a 

result of the resurgence of tarnished 

plant bug as a primary pest of cotton. 

The states assert growers are facing a 

longer control season for tarnished plant 

bug. In addition, tarnished plant bug has 

developed resistance to registered 

alternatives. After having reviewed the 

submissions, EPA determined that 

emergency conditions exist for these 

States, and that the criteria for 

emergency exemptions are met. EPA has 

authorized specific exemptions under 

FIFRA section 18 for the use of 

sulfoxaflor on cotton for control of 

tarnished plant bug in Arkansas, 

Mississippi, Tennessee, and Louisiana. 

As part of its evaluation of the 

emergency exemption application, EPA 

assessed the potential risks presented by 

residues of sulfoxaflor in or on cotton. 

In doing so, EPA considered the safety 

standard in FFDCA section 408(b)(2), 

and EPA decided that the necessary 

tolerance under FFDCA section 408(l)(6) 

would be consistent with the safety 

standard and with FIFRA section 18. 

Consistent with the need to move 

quickly on the emergency exemption in 

order to address an urgent non-routine 

situation and to ensure that the resulting 

food is safe and lawful, EPA is issuing 

this tolerance without notice and 

opportunity for public comment as 

provided in FFDCA section 408(l)(6). 

Although these time-limited tolerances 

expire on December 31, 2015, under 

FFDCA section 408(l)(5), residues of the 

pesticide not in excess of the amounts 

specified in the tolerance remaining in 

or on cotton, undelinted seed; cotton, 

ginbyproducts; and cotton, hulls after 

that date will not be unlawful, provided 

the pesticide was applied in a manner 

that was lawful under FIFRA, and the 

residues do not exceed a level that was 

authorized by these time-limited 

tolerances at the time of that 

application. EPA will take action to 

revoke these time-limited tolerances 

earlier if any experience with, scientific 

data on, or other relevant information 

on this pesticide indicate that the 

residues are not safe. 

Because these time-limited tolerances 

are being approved under emergency 

conditions, EPA has not made any 

decisions about whether sulfoxaflor 

meets FIFRA’s registration requirements 

for use on cotton or whether permanent 

tolerances for this use would be 

appropriate. Under these circumstances, 

EPA does not believe that these timelimited tolerances decision serves as a 

basis for registration of sulfoxaflor by a 

State for special local needs under 

FIFRA section 24(c). Nor does this 

tolerance by itself serve as the authority 

for persons in any State other than 

Arkansas, Mississippi, Tennessee, and 

Louisiana to use this pesticide on the 

applicable crops under FIFRA section 

18 absent the issuance of an emergency 

exemption applicable within that State. 

For additional information regarding the 

emergency exemption for sulfoxaflor, 

contact the Agency’s Registration 

Division at the address provided under 

FOR FURTHER INFORMATION CONTACT. 

IV. 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 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 expected as a result 

of these emergency exemption requests 

and the time-limited tolerances for 

combined residues of sulfoxaflor in or 

on cotton, undelinted seed at 0.2 parts 

per million (ppm); cotton, gin 

byproducts at 6.0 ppm; and cotton, hulls 

at 0.35 ppm. Use of cotton commodities 

conforming to these temporary 

tolerances as animal feed is not 

expected to produce sulfoxaflor residues 

in livestock commodities. EPA’s 

assessment of exposures and risks 

associated with establishing these timelimited tolerances follows. 

A. 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 

during 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 sulfoxaflor used for 

human risk assessment is shown in the 

Table of this unit. 

mstockstill on DSK4VPTVN1PROD with RULES

Federal Register / Vol. 77, No. 189 / Friday, September 28, 2012 / Rules and Regulations 59563 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR SULFOXAFLOR 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 13–50 

years of age).

NOAEL = 1.8 mg/kg/ 

day.

UFA = 3x 

≤UFH = 10x 

≤FQPA SF = 1x 

Acute RfD = 0.06 g/ 

kg/day.

aPAD = 0.06 mg/kg/ 

day 

Developmental Neurotoxicity Study. LOAEL = 7.1 mg/kg/day 

based on decreased neonatal survival on postnatal day 0 

through 4. 

Acute dietary (General population including infants and 

children).

NOAEL = 25 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 0.25 

mg/kg/day.

aPAD = 0.25 mg/kg/ 

day 

Acute Neurotoxicity Study. LOAEL = 75 mg/kg/day based on 

decreased motor activity. 

Chronic dietary (All populations) NOAEL = 5.13 mg/ 

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.05 

mg/kg/day.

cPAD = 0.05 mg/kg/ 

day 

Chronic/Carcinogenicity Study in the Rat. LOAEL = 21.3 mg/kg/ 

day based on liver effects including increased blood cholesterol, liver weight, hypertrophy, fatty change, single cell necrosis and macrophages observed in the males and females. 

Cancer (Oral, dermal, inhalation).Sulfoxaflor is classified as ‘‘Suggestive Evidence of Carcinogenic Potential.’’ Quantification of risk using a nonlinear approach (i.e., RfD) will adequately account for all chronic toxicity, including carcinogenicity. 

UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population 

(intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference 

dose. LOAEL = lowest observed adverse effect level. NOAEL = no observed adverse effect level. 

B. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to sulfoxaflor, EPA considered 

exposure under the time-limited 

tolerances established by this action. 

EPA assessed dietary exposures from 

sulfoxaflor in food as follows: 

i. Acute and Chronic exposure. Acute 

and chronic effects were identified for 

sulfoxaflor. In estimating acute and 

chronic 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). EPA’s 

dietary exposure assessment assumed 

that all cotton in the U.S. is treated with 

sulfoxaflor (i.e., 100% crop treated); an 

empirical factor of 0.1X to account for 

the reduction in sulfoxaflor residues 

during the processing of cottonseed into 

oil (which is the only human food 

associated with cotton); and used 

health-protective models to estimate 

residues in drinking water. 

ii. Cancer. EPA determines whether 

quantitative cancer exposure and risk 

assessments are appropriate for a fooduse pesticide based on the weight of the 

evidence from cancer studies and other 

relevant data. Cancer risk may be 

quantified using a linear or nonlinear 

approach. If sufficient information is 

available to determine the carcinogenic 

mode of action, and that mode of action 

has a threshold, then EPA will use a 

threshold or nonlinear approach and 

calculate a cancer RfD based on an 

earlier noncancer key event. If the mode 

of carcinogenic action is unknown, or if 

the mode of action appears to be 

mutagenic, a default linear cancer slope 

factor approach is utilized. Based on 

studies demonstrating key events of a 

hypothesized mode of action leading to 

the observed tumors and no 

mutagenicity concerns, EPA has 

concluded that a nonlinear RfD 

approach is appropriate for assessing 

cancer risk to sulfoxaflor. Cancer risk 

was assessed using the same exposure 

estimates as discussed in Unit IV.B.1.i., 

acute and chronic exposure. 

iii. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for sulfoxaflor. For this risk assessment, 

EPA assumed that all cottonseed oil 

contains tolerance level residues 

(modified by an empirical processing 

factor) and that 100% of cotton is 

treated with sulfoxaflor. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for sulfoxaflor in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of sulfoxaflor. 

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/Exposure Analysis Modeling 

System (PRZM/EXAMS) and Screening 

Concentration in Ground Water (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of 

sulfoxaflor for acute exposures are 

estimated to be 2.76 parts per billion 

(ppb) for surface water and 45.1 ppb for 

ground water; for chronic exposures for 

non-cancer assessments are estimated to 

be 0.865 ppb for surface water and 45.1 

ppb for ground water. Environmental 

fate data indicate that the predominant 

residue in surface water will be the 

parent compound and the predominant 

residue in groundwater will be the 

X11719474 metabolite (88% of the total 

residue) and X11519450 (12% of the 

total residue). For convenience, EPA’s 

exposure assessment multiplies the 

relative toxicity of each metabolite by its 

proportion to express the residue 

concentration in terms of parent 

sulfoxaflor-equivalents. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 0.045 ppm 

(0.0397 ppm X11719474 + 0.0054 ppm 

X11519450) was used to assess the 

contribution of drinking water to dietary 

exposure for the general population, 

except women of child-bearing age (13– 

49 years). For females 13–49 years old, 

the acute surface water EDWC (0.0028 

ppm) was used to assess the 

contribution of drinking water. For 

mstockstill on DSK4VPTVN1PROD with RULES

59564 Federal Register / Vol. 77, No. 189 / Friday, September 28, 2012 / Rules and Regulations 

chronic dietary risk assessment for the 

general population, including females 

13–49 years old, the ground water 

concentration of value 0.066 ppm was 

used to assess the contribution of 

drinking water. The groundwater value 

of 0.066 ppm reflects individual 

concentrations of X11719474 and 

X11519540, adjusted for their relative 

potencies of 0.3X and 10X, respectively. 

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). 

Sulfoxaflor is currently not registered 

for any use that will result in residential 

exposure. 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 sulfoxaflor to 

share a common mechanism of toxicity 

with any other substances, and 

sulfoxaflor does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that sulfoxaflor 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. 

C. 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 SF when reliable data 

available to EPA support the choice of 

a different factor. 

2. Prenatal and postnatal sensitivity. 

The prenatal and postnatal toxicity 

databases for sulfoxaflor are complete. 

Although adverse developmental effects 

were observed in rats, the mode of 

action is understood and does not 

appear relevant to humans. Data 

indicate that juvenile rats are uniquely 

sensitive to perturbation of the muscular 

nicotinic receptor by sulfoxaflor, 

leading to sustained muscle contraction 

and increased neonatal deaths. 

Supporting studies indicate that 

sulfoxaflor does not interact with 

nicotinic receptors in the adult rat, fetal 

human, or adult human. Furthermore, 

the observation that no neonatal deaths 

or neuromuscular/skeletal effects were 

noted in the rabbit developmental 

toxicity study supports the conclusion 

that rats are uniquely sensitive to 

developmental toxicity due to 

sulfoxaflor exposure. These differences 

suggest that to the extent that neonatal 

death in rats occurs as a result of 

sulfoxaflor binding to the fetal receptor, 

these effects would not be observed in 

humans. 

3. Conclusion. EPA has determined 

that reliable data show that the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: the 

level of concern for neurotoxicity is low 

because the effects are well 

characterized and clear NOAELs are 

established. Similarly, although there is 

increased quantitative susceptibility in 

the developmental neurotoxicity (DNT) 

study, the level of concern for the 

increased susceptibility is low because 

the effects are well characterized and 

the endpoints chosen for risk 

assessment are protective of potential in 

utero developmental effects. In addition, 

the exposure assessments are highly 

conservative and unlikely to 

underestimate exposure/risk. 

D. 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). 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 

sulfoxaflor will occupy 4% of the aPAD 

for infants (<1 year), 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 sulfoxaflor 

from food and water will utilize 9% of 

the cPAD for infants (<1 year)the 

population group receiving the greatest 

exposure. There are no residential uses 

for sulfoxaflor. 

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). A short-term adverse 

effect was identified; however, 

sulfoxaflor is not registered for any use 

patterns that would result in short-term 

residential exposure. Because there is 

no short-term residential exposure, 

sulfoxaflor poses no short-term risk. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

non-dietary, non-occupational exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). 

An intermediate-term adverse effect 

was identified; however, sulfoxaflor is 

not registered for any use patterns that 

would result in intermediate-term 

residential exposure. Intermediate-term 

risk is assessed based on intermediateterm residential exposure plus chronic 

dietary exposure. Because there is no 

intermediate-term residential exposure, 

sulfoxaflor poses no intermediate-term 

risk. 

5. Aggregate cancer risk for U.S. 

population. EPA determined that there 

is a ‘‘Suggestive Evidence of 

Carcinogenic Potential’’ for sulfoxaflor 

based on the preputial gland tumor 

response seen in rats. When there is 

suggestive evidence, the Agency does 

not attempt a dose-response assessment 

as the nature of the data generally 

would not support one. Rather, the 

Agency has determined that 

quantification of risk using a non-linear 

approach (i.e., reference dose (RfD) will 

adequately account for all chronic 

toxicity, including carcinogenicity, that 

could result from exposure to 

sulfoxaflor. 

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 sulfoxaflor 

residues. 

mstockstill on DSK4VPTVN1PROD with RULES

Federal Register / Vol. 77, No. 189 / Friday, September 28, 2012 / Rules and Regulations 59565 

V. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate analytical methods have 

been submitted for both data collection 

and for enforcement purposes. In the 

submitted field trial and processing 

studies, residues of sulfoxaflor and its 

metabolites in crops were determined 

using 2 different Dow analytical 

methods (designated as 091031 or 

091116). The proposed method for 

tolerance enforcement in plant 

commodities is method 091116: 

Enforcement Method for the 

Determination of Sulfoxaflor (XDE–208) 

and its Main Metabolites in Agricultural 

Commodities using Offline Solid-Phase 

Extraction and Liquid Chromatography 

with Tandem Mass Spectrometry 

Detection. Method 091116 extracts 

residues with acetonitrile/water and 

includes use of a deuterated internal 

standard, hydrolysis with NaOH to 

release base-labile conjugates, and clean 

up via solid-phase extraction. This 

method is applicable for the quantitative 

determination of residues of sulfoxaflor 

and its metabolites in agricultural 

commodities and processed products. 

The method was adequately validated, 

with a limit of quantitation (LOQ) of 

0.010 mg/kg for all matrices. 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 a MRL 

for sulfoxaflor. 

VI. Conclusion 

Therefore, time-limited tolerances are 

established for residues of, sulfoxaflor, 

N-methyloxido [1-[6-(trifluoromethyl)-3- 

pyridinyl]ethyl] l4-sulfanylidene] 

cyanamide including its metabolites and 

degradates, in or on cotton, undelinted 

seed at 0.2 parts per million (ppm); 

cotton, ginbyproducts at 6.0 ppm; and 

cotton, hulls at 0.35 ppm. These 

tolerances expire on December 31, 2015. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA sections 408(e) and 

408(l)(6). 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 in accordance with 

FFDCA sections 408(e) and 408(l)(6), 

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) (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). 

VIII. 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: September 20, 2012. 

Steven Bradbury, 

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 180.668 is added to subpart 

C to read as follows: 

§ 180.668 Sulfoxaflor; tolerances for 

residues. 

(a) General. [Reserved] 

(b) Section 18 emergency exemptions. 

Time-limited tolerances specified in the 

following table are established for 

residues of the insecticide, sulfoxaflor, 

mstockstill on DSK4VPTVN1PROD with RULES

59566 Federal Register / Vol. 77, No. 189 / Friday, September 28, 2012 / Rules and Regulations 

N-methyloxido [1-[6-(trifluoromethyl)-3- 

pyridinyl]ethyl] l4-sulfanylidene] 

cyanamide, including its metabolites 

and degradates, in or on the 

commodities in the following table 

resulting from use of the pesticide 

pursuant to FIFRA section 18 

emergency exemptions. Compliance 

with the tolerance levels specified in the 

following table is to be determined by 

measuring only sulfoxaflor in or on the 

commodity. The tolerances expire on 

the date specified in the table. 

Commodity Parts per 

million 

Expiration 

date 

Cotton, undelinted 

seed .................... 0 .2 12/31/15 

Cotton, gin byproducts ...................... 6 .0 12/31/15 

Cotton, hulls ............ 0 .35 12/31/15 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 2012–23818 Filed 9–27–12; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF TRANSPORTATION 

National Highway Traffic Safety 

Administration 

49 CFR Part 563 

[Docket No. NHTSA–2012–0099] 

RIN 2127–AL14 

Event Data Recorders 

Correction 

In rule document 2012–19580, 

appearing on pages 47552–47557 in the 

issue of Thursday, August 9, 2012, make 

the following correction: 

§ 563.8 Data format [Corrected] 

On page 47557 in the table titled 

‘‘Table III—Reported Data Element 

Format’’, in the ‘‘Accuracy 1’’ column, in 

the twenty-fifth row, ‘‘ ±ms’’ should 

read ‘‘ ±2ms’’. 

[FR Doc. C1–2012–19580 Filed 9–27–12; 8:45 am] 

BILLING CODE 1505–01–D 

mstockstill on DSK4VPTVN1PROD with RULES