Federal Register / Vol. 77, No. 119 / Wednesday, June 20, 2012 / Rules and Regulations 36919 

(b) Business Training and Travel 

Expenses. The engaging organization 

(recipient of the ITEP pilot participant) 

may pay for any business training and 

travel expenses incurred by the 

employee while participating in the 

ITEP pilot. 

(c) Prohibition. A private sector 

organization may not charge the DoD or 

any agency of the Federal Government, 

as direct or indirect costs under a 

Federal contract, for the costs of pay or 

benefits paid by that organization to an 

employee assigned to a DoD 

Component. 

§ 241.10 Small business consideration. 

The DoD CIO on behalf of the 

Secretary of Defense shall: 

(a) Ensure that, of the assignments 

made each year, at least 20 percent are 

from small business concerns (as 

defined by 5 U.S.C. 3703(e)(2)(A)). 

(b) Take into consideration the 

questions of how assignments might be 

used to help meet the needs of the DoD 

with respect to the training of 

employees in IT. 

§ 241.11 Numerical limitation. 

The ITEP Pilot is an opportunity for 

the exchange of knowledge, experience 

and skills between DoD and the private 

sector. The DoD has the flexibility to 

send their employees to the private 

sector or receive private sector 

employees, or participate in a one-forone exchange. In no event may more 

than 10 employees participate in 

assignments under this section at any 

given time. 

§ 241.12 Reporting requirements. 

(a) For each of fiscal years 2010 

through 2015, the Secretary of Defense 

shall submit annual reports to the 

congressional defense committees, not 

later than 1 month after the end of the 

fiscal year involved, a report on any 

activities carried out during such fiscal 

year, including the following 

information: 

(1) Respective organizations to and 

from which an employee is assigned; 

(2) Positions those employees held 

while they were so assigned; 

(3) Description of the tasks they 

performed while they were so assigned; 

and 

(4) Discussion of any actions that 

might be taken to improve the 

effectiveness of the Pilot program, 

including any proposed changes in the 

law. 

(b) These reports will be prepared and 

submitted by DoD CIO in coordination 

with DoD Components participating in 

the Pilot, to the appropriate 

congressional committees. 

§ 241.13 Implementation. 

The DoD CIO is responsible for 

administering, coordinating and 

implementing the Pilot Program for the 

Temporary Exchange of Information 

Personnel, referred to as the Information 

Technology Exchange Program (ITEP) 

pilot. The DoD CIO will coordinate with 

DoD Components. 

Dated: June 15, 2012. 

Patricia L. Toppings, 

OSD Federal Register Liaison Officer, 

Department of Defense. 

[FR Doc. 2012–15007 Filed 6–19–12; 8:45 am] 

BILLING CODE 5001–06–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0615; FRL–9345–8] 

Sedaxane; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of sedaxane in or 

on multiple food commodities which 

are identified and discussed later in this 

document. Syngenta Crop Protection, 

Inc. requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: This regulation is effective June 

20, 2012. Objections and requests for 

hearings must be received on or before 

August 20, 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–2010–0615, 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: 

Heather Garvie, Registration Division, 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–0034; email address: 

garvie.heather@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–2010–0615 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before August 20, 2012. Addresses for 

mail and hand delivery of objections 


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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–2010–0615, by one of 

the following methods: 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2010–0615 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 August 11, 

2010 (75 FR 48667) (FRL–8840–6), 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 #0F7721) by Syngenta Crop 

Protection, Inc., Regulatory Affairs, P.O. 

Box 18300, Greensboro, NC 27419– 

8300. The petition requested that 40 

CFR part 180 be amended by 

establishing tolerances for residues of 

the fungicide sedaxane, in or on barley, 

grain, seed at 0.01 parts per million 

(ppm); barley, hay, seed at 0.05 ppm; 

barley, straw, seed at 0.01 ppm; canola, 

seed at 0.01 ppm; oat, grain, seed at 0.01 

ppm; rye, seed at 0.01 ppm; soybean, 

forage, seed at 0.06 ppm; soybean, hay, 

seed at 0.4 ppm; soybean, seed at 0.01 

ppm; triticale, seed at 0.01 ppm; wheat, 

forage, seed at 0.02 ppm; wheat, grain, 

seed at 0.01 ppm; wheat, hay, seed at 

0.07 ppm; and wheat, straw, seed at 0.01 

ppm. That notice referenced a summary 

of the petition prepared by Syngenta 

Crop Protection, Inc., the registrant, 

which is available in the docket, http://

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

Based upon review of the data 

supporting the petition, EPA has 

modified the tolerances to correct 

commodity definitions and to 

recommend tolerances other than the 

proposed tolerances. The reasons for 

these changes are explained in Unit 

IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue * * *.’’ 

Consistent with FFDCA section 

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

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for sedaxane 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with sedaxane follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. 

The toxicological effects reported in 

the submitted animal studies such as 

mitochondrial disintegration and 

glycogen depletion in the liver are 

consistent with the pesticidal mode of 

action also being the mode of toxic 

action in mammals. The rat is the most 

sensitive species tested, and the main 

target tissue for sedaxane is the liver. 

Sedaxane also caused thyroid 

hypertrophy/hyperplasia. In the acute 

neurotoxicity (ACN) and sub-chronic 

neurotoxicity (SCN) studies, sedaxane 

caused decreased activity, decreased 

muscle tone, decreased rearing and 

decreased grip strength. 

There are indications of reproductive 

toxicity in rats, but these effects did not 

result in reduced fertility. In the rat, no 

adverse effects in fetuses were seen in 

developmental toxicity studies at 

maternally toxic doses. However, in the 

rabbit, fetal toxicity was observed at the 

same doses as the dams. Offspring 

effects in the reproduction study 

occurred at the same doses causing 

parental effects, thus there was no 

qualitative increase in sensitivity in rat 

pups. Sedaxane is tumorigenic in the 

liver in the rat and mouse, and led to 

tumors in the thyroid and uterus in the 

rat and was classified as ‘‘likely to be 

carcinogenic to humans.’’ Sedaxane was 

negative in the mutagenicity studies. 

The 28-day dermal study did not show 

systemic toxicity at the limit dose of 

1,000 milligrams/kilogram/day (mg/kg/ 

day). Sedaxane has low acute toxicity by 

the oral, dermal, and inhalation routes. 

It is not a dermal sensitizer, causes no 

skin irritation and only slight eye 

irritation. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by sedaxane as well as 

the no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in document 

‘‘Sedaxane. Human Health Risk 

Assessment to Support New Seed 

Treatment Uses on Canola, Cereal 

Grains (Barley, Oat, Rye, Triticale, and 

Wheat), and Soybean’’, dated February 

16, 2012, pages 37–77 in docket ID 

number EPA–HQ–OPP–2010–0615. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 


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analysis of the doses in each 

toxicological study to determine the 

dose at which the NOAEL and the 

LOAEL of concern are identified. 

Uncertainty/safety factors (USFs) are 

used in conjunction with the POD to 

calculate a safe exposure level— 

generally referred to as a populationadjusted 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 sedaxane used for human 

risk assessment is shown in the 

following Table. 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR SEDAXANE 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 (general populations, including infants and children).NOAEL = 30 mg/ 

kg/day. 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 0.30 

mg/kg/day.

aPAD = 0.30 mg/ 

kg/day. 

Rat ACN Study. 

NOAEL = 30 mg/kg. 

LOAEL = 250 mg/kg based on reduced activity, decreased 

rearing, initial inactivity, piloerection, ruffled fur and recumbency, decreased BW, decreased BWG and food 

consumption (males). In females, weakened condition, 

swaying gait, decreased activity, reduced muscle tone, 

and decreased locomotor activity and rearing. The 

weakened condition, swaying gait and decreased activity were observed on days 2–7, while the other effects 

were on day 1. 

Chronic dietary (All populations) ............ NOAEL = 11 mg/ 

kg/day. 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.11 

mg/kg/day.

cPAD = 0.11 mg/ 

kg/day. 

Chronic Rat Study. 

NOAEL = 11/14 mg/kg bw/day male/female. 

LOAEL = 67/86 mg/kg bw/day male/female in males 

based on decreased hind limb grip strength, increased 

liver weight, increased incidences of hepatocyte hypertrophy and eosinophilic foci, and thyroid follicular cell 

hypertrophy, basophilic colloid, epithelial desquamation 

and increased phosphate levels (male). In females, it 

was based on decreased body weight and body weight 

gain, increased liver weight and the same thyroid 

histopathology noted above for males. 

Cancer (Oral, dermal, inhalation) ........... Classification: ‘‘Likely to be Carcinogenic to Humans’’ based on significant tumor increases in two 

adequate rodent carcinogenicity studies. Q1* = 4.64 × 10¥3 (mg/kg/day)¥1. 

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). BW = 

Body weight. BWG = Body weight gain. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to sedaxane, EPA considered 

exposure under the petitioned-for 

tolerances. EPA assessed dietary 

exposures from sedaxane 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 sedaxane. In estimating acute dietary 

exposure, EPA used food consumption 

information from the U.S. Department of 

Agriculture (USDA) 1994–1996 and 

1998 Nationwide Continuing Surveys of 

Food Intake by Individuals (CSFII). As 

to residue levels in food, EPA 

conducted a highly conservative acute 

dietary risk assessment which used 

tolerance level residues 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 conducted a highly 

conservative chronic dietary risk 

assessment which used tolerance level 

residues and assumed 100 PCT for all 

commodities. 

iii. 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. If quantitative cancer risk 

assessment is appropriate, cancer risk 

may be quantified using a linear or 

nonlinear approach. If sufficient 

information on the carcinogenic mode 

of action is available, a threshold or 

nonlinear approach is used and a cancer 

RfD is calculated based on an earlier 

noncancer key event. If carcinogenic 

mode of action data are not available, or 

if the mode of action data determines a 

mutagenic mode of action, a default 

linear cancer slope factor approach is 

utilized. Based on the data summarized 

in Unit III.A., EPA has concluded that 

sedaxane should be classified as ‘‘Likely 

to be Carcinogenic to Humans’’ and a 

linear approach has been used to 

quantify cancer risk. This finding is 

based on significant tumor increases in 

two adequate rodent carcinogenicity 

studies. EPA assessed exposure for the 

purpose of estimating cancer risk 


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assuming tolerance level residues and 

100 PCT for all commodities. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for sedaxane. 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 sedaxane in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of sedaxane. 

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 FQPA Index Reservoir 

Screening Tool (FIRST) and Tier II 

pesticide root zone model (PRZM) (grab 

working-level sampling, ground water 

(GW) (Prerelease Version), the estimated 

drinking water concentrations (EDWCs) 

of sedaxane for acute exposures are 

estimated to be 1.4 parts per billion 

(ppb) for surface water and 8.3 ppb for 

ground water. The water exposures for 

the chronic dietary and cancer 

assessments are estimated to be 0.9 ppb 

for surface water and 6.5 ppb for ground 

water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 8.3 ppb was used 

to assess the contribution to drinking 

water. For chronic and cancer dietary 

risk assessment, the water concentration 

value of 6.5 ppb was used to assess the 

contribution to drinking water. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). Sedaxane 

is not registered for any specific use 

patterns that would result in residential 

exposure. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

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

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ EPA has not 

found sedaxane to share a common 

mechanism of toxicity with any other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that sedaxane 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. 

The toxicological database for sedaxane 

is complete with regard to prenatal and 

postnatal toxicity, and there are no 

residual uncertainties. There is no 

evidence for increased susceptibility 

following prenatal and/or postnatal 

exposures to sedaxane based on effects 

seen in developmental toxicity studies 

in rabbits or rats. There was no evidence 

of increased susceptibility in a 2- 

generation reproduction study in rats 

following prenatal or postnatal exposure 

to sedaxane. There is no evidence of 

neuropathology or abnormalities in the 

development of the fetal nervous system 

from the available toxicity studies 

conducted with sedaxane. Clear 

NOAELs/LOAELs were established for 

the developmental effects seen in rats 

and rabbits as well as for the offspring 

effects seen in the 2-generation 

reproduction study. The dose-response 

relationship for the effects of concern is 

well characterized. The NOAEL used for 

the acute dietary risk assessment (30 

mg/kg/day), based on effects observed in 

the ACN study, is protective of the 

developmental and offspring effects 

seen in rabbits and rats (NOAELs of 

100–200 mg/kg/day). 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1x. That decision is 

based on the following findings: 

i. The toxicity database for sedaxane 

is complete and includes the 

immunotoxicity study and neurotoxicity 

screening battery. 

ii. The sedaxane toxicology database 

did not demonstrate evidence of 

neurotoxicity. There are no specific 

concerns for neurotoxicity as the 

observed effects in the ACN and SCN 

studies were likely secondary to 

inhibition of mitochondrial energy 

production caused by sedaxane. 

Sedaxane caused changes in apical 

endpoints such as decreased activity, 

decreased muscle tone, decreased 

rearing and decreased grip strength in 

the ACN and SCN studies. There was no 

corroborative neuro-histopathology 

demonstrated in any study, even at the 

highest doses tested (i.e., 2,000 mg/kg/ 

day). Based on its chemical structure, its 

pesticidal mode of action and lack of 

evidence of neuro-histopathology in any 

acute and repeated-dose toxicity study, 

sedaxane does not demonstrate 

potential for neurotoxicity. Since 

sedaxane did not demonstrate 

susceptibility to the young or specific 

neurotoxicity, a developmental 

neurotoxicity (DNT) study is not 

required. 

iii. There is no evidence that sedaxane 

results in increased susceptibility in in 

utero rats or rabbits in the prenatal 

developmental studies or in young rats 

in the 2-generation reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to sedaxane in 

drinking water. These assessments will 

not underestimate the exposure and 

risks posed by sedaxane. 

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 population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). For 

linear cancer risks, EPA calculates the 

lifetime probability of acquiring cancer 

given the estimated aggregate exposure. 

Short-term, intermediate-term, 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. 

Sedaxane is a member of the pyrazole 

carboxamide fungicides. Metabolic 

processes involving cleavage of the 

linkage between the pyrazole and 


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phenyl rings of these compounds have 

the potential to produce common 

pyrazole-metabolites. Indeed, confined 

rotational crops studies for sedaxane 

and isopyrazam demonstrate that low 

levels of three common metabolites 

form. However, due to the low levels of 

these compounds in rotational crops 

(≤0.01 ppm), and low concerns about 

their potential toxicity relative to parent 

molecules, any risks from aggregation of 

exposures to common metabolites 

across chemicals will be insignificant. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

sedaxane will occupy <1% of the aPAD 

for all populations. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to sedaxane from 

food and water will utilize <1% of the 

cPAD for all populations. There are no 

residential uses for sedaxane. 

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, sedaxane 

is not registered for any use patterns 

that would result in short-term 

residential exposure. Short-term risk is 

assessed based on short-term residential 

exposure plus chronic dietary exposure. 

Because there is no short-term 

residential exposure and chronic dietary 

exposure has already been assessed 

under the appropriately protective 

cPAD (which is at least as protective as 

the POD used to assess short-term risk), 

no further assessment of short-term risk 

is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating short-term risk for sedaxane. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). An 

intermediate-term adverse effect was 

identified; however, sedaxane is not 

registered for any use patterns that 

would result in intermediate-term 

residential exposure. Intermediate-term 

risk is assessed based on intermediateterm residential exposure plus chronic 

dietary exposure. Because there is no 

intermediate-term residential exposure 

and chronic dietary exposure has 

already been assessed under the 

appropriately protective cPAD (which is 

at least as protective as the POD used to 

assess intermediate-term risk), no 

further assessment of intermediate-term 

risk is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating intermediate-term risk for 

sedaxane. 

5. Aggregate cancer risk for U.S. 

population. The Agency has classified 

sedaxane as ‘‘Likely to be Carcinogenic 

to Humans’’ based on significant tumor 

increases in two adequate rodent 

carcinogenicity studies. Accordingly, a 

cancer dietary risk assessment was 

conducted, indicating a risk estimate of 

7 × 10¥7 for the US population. This 

assessment assumed tolerance level 

residues, 100 PCT for all commodities, 

and included modeled drinking water 

estimates. 

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 sedaxane 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

is available to enforce the tolerance 

expression. A modification of the Quick, 

Easy, Cheap, Effective, Rugged, and Safe 

(QuEChERS) method was developed for 

the determination of residues of 

sedaxane (as its isomers SYN508210 

and SYN508211) in/on various crops. A 

successful independent laboratory 

validation (ILV) study was also 

conducted on the modified QuEChERS 

method using samples of wheat green 

forage and wheat straw fortified with 

SYN508210 and SYN508211 at 0.005 

and 0.05 ppm. The analytical standard 

for sedaxane, with an expiration date of 

April 2012, is currently available in the 

EPA National Pesticide Standards 

Repository. The method may be 

requested from: Chief, Analytical 

Chemistry Branch, Environmental 

Science Center, 701 Mapes Rd., Ft. 

Meade, MD 20755–5350; telephone 

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

residuemethods@epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. The Codex has not 

established MRLs for sedaxane. 

C. Revisions to Petitioned-For 

Tolerances 

The tolerance levels for feedstuffs for 

soybean, forage; wheat, forage; wheat, 

hay; and barley, hay being established 

by EPA differ from those proposed in 

the tolerance petition submitted by 

Syngenta. The Agency used the 

Organization for Economic Cooperation 

and Development tolerance calculation 

procedures to determine that the 

following tolerance levels are needed: 

0.05 for soybean, forage; 0.015 for 

wheat, forage; 0.06 for wheat, hay; and 

0.04 for barley, hay. The petitioner did 

not propose separate tolerances for 

feedstuffs derived from oat and rye, 

however, the Agency is establishing 

them as follows: Oat, forage at 0.015; 

oat, hay at 0.06; oat, straw at 0.01; rye, 

forage at 0.015; and rye, straw at 0.01. 

The wheat trials depict low but finite 

residues in forage, straw, and hay. 

Syngenta proposed, and EPA agrees, 

that tolerances are needed on these 

wheat feedstuffs. Because EPA is relying 

on magnitude of the residue data from 

wheat and barley to establish oat and 

rye tolerances, due to the crop 

similarities and identical use patterns, 

tolerances on oat and rye feedstuffs are 

needed as well. A separate tolerance for 

triticale is not required as wheat 

tolerances cover triticale by definition 

40 CFR 180.1(g). 

V. Conclusion 

Therefore, the following tolerances 

are established for residues of sedaxane, 

in or on wheat, grain at 0.01 ppm; 

barley, grain at 0.01 ppm; soybean, seed 

at 0.01 ppm; canola, seed at 0.01 ppm; 

oat, grain at 0.01 ppm; rye, grain at 0.01 

ppm; soybean, forage at 0.05 ppm; 

soybean, hay at 0.04 ppm; wheat, forage 

at 0.015 ppm; wheat, hay at 0.06 ppm; 

wheat, straw at 0.01 ppm; barley, hay at 

0.04 ppm; barley, straw at 0.01 ppm; 

oat, forage at 0.015 ppm; oat, hay at 0.06 

ppm; oat, straw at 0.01 ppm; rye, forage 

at 0.015 ppm and rye, straw at 0.01 

ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 


pmangrum on DSK3VPTVN1PROD with RULES
36924 Federal Register / Vol. 77, No. 119 / Wednesday, June 20, 2012 / Rules and Regulations 

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: June 8, 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 180.665 is added to read as 

follows: 

§ 180.665 Sedaxane; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the fungicide 

sedaxane, including its metabolites and 

degradates, in or on the commodities in 

the following table. Compliance with 

the tolerance levels specified in the 

following table is to be determined by 

measuring only sedaxane, N-[2-[1,1′- 

bicyclopropyl]-2-ylphenyl]-3- 

(difluoromethyl)-1-methyl-1H-pyrazole4-carboxamide, as the sum of its cis- and 

trans-isomers in or on the commodity. 

Commodity Parts per 

million 

Barley, grain ............................. 0 .01 

Barley, hay ................................ 0 .04 

Barley, straw ............................. 0 .01 

Canola, seed ............................ 0 .01 

Commodity Parts per 

million 

Oat, forage ................................ 0 .015 

Oat, grain .................................. 0 .01 

Oat, hay .................................... 0 .06 

Oat, straw ................................. 0 .01 

Rye, forage ............................... 0 .015 

Rye, grain ................................. 0 .01 

Rye, straw ................................. 0 .01 

Soybean, forage ....................... 0 .05 

Soybean, hay ............................ 0 .04 

Soybean, seed .......................... 0 .01 

Wheat, forage ........................... 0 .015 

Wheat, grain ............................. 0 .01 

Wheat, hay ............................... 0 .06 

Wheat, straw ............................. 0 .01 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect inadvertent residues. 

[Reserved] 

[FR Doc. 2012–14957 Filed 6–19–12; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF TRANSPORTATION 

Office of the Secretary 

49 CFR Part 23 

[Docket No. OST–2011–0101] 

RIN 2105–AE10 

Airport Concessions Disadvantaged 

Business Enterprise: Program 

Improvements 

AGENCY: Office of the Secretary (OST), 

DOT. 

ACTION: Final rule. 

SUMMARY: This final rule amends the 

Department of Transportation’s Airport 

Concessions Disadvantaged Business 

Enterprise (ACDBE) regulation to 

conform it in several respects to the 

disadvantaged business enterprise (DBE) 

rule for highway, transit, and airport 

financial assistance programs. This rule 

also amends small business size limits 

to ensure that the opportunity for small 

businesses to participate in the ACDBE 

program remains unchanged after taking 

inflation into account. This final rule 

also provides an inflationary adjustment 

in the personal net worth (PNW) cap for 

owners of businesses seeking to 

participate in DOT’s ACDBE program 

and suspends, until further notice, 

future use of the exemption of up to $3 

million in an owner’s assets used as 

collateral for financing a concession. 

DATES: This rule’s amendments to 49 

CFR 23.3 and 23.35 are effective June 

20, 2012. This rule’s amendments to 49 

CFR 23.29, 23.33, 23.45, and 23.57 are 

effective July 20, 2012. 


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