Federal Register / Vol. 78, No. 191 / Wednesday, October 2, 2013 / Rules and Regulations 60715 

Commodity Parts per 

million 

* * * * * 

Custard apple ............................... 0 .60 

Date .............................................. 8 .0 

* * * * * 

Fruit, pome, group 11–10 ............. 2 .0 

Fruit, small, vine climbing, except 

fuzzy kiwifruit, subgroup 13– 

07F ............................................ 1 .0 

* * * * * 

Grain, aspirated grain fractions .... 120 

* * * * * 

Herb subgroup 19A, except chive 400 

* * * * * 

Ilama ............................................. 0 .60 

* * * * * 

Pea and bean, dried shelled, except soybean, subgroup 6C, except pea, blackeyed, seed and 

pea, southern, seed .................. 0 .50 

* * * * * 

Sorghum, grain, forage ................. 15 

Sorghum, grain, grain ................... 6 .0 

Sorghum, grain, stover ................. 20 

Sorghum, sweet, forage ............... 15 

Sorghum, sweet, grain ................. 6 .0 

Sorghum, sweet, stalk .................. 15 

Sorghum, sweet, stover ................ 20 

Soursop ........................................ 0 .60 

* * * * * 

Sugar apple .................................. 0 .60 

* * * * * 

Vegetable, fruiting, group 8–10 .... 2 .0 

* * * * * 

* * * * * 

(b) Section 18 emergency exemptions. 

[Reserved] 

* * * * * 

(d) * * * 

(2) * * * 

Commodity Parts per 

million 

* * * * * 

Chive ............................................. 4 .5 

* * * * * 

Rapeseed subgroup 20A .............. 1 .0 

Spice subgroup 19B ..................... 4 .5 

Sunflower subgroup 20B .............. 1 .0 

[FR Doc. 2013–24127 Filed 10–1–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0885; FRL–9397–8] 

Sedaxane; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of sedaxane in or 

on potato and potato, wet peel. 

Syngenta Crop Protection, LLC 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

October 2, 2013. Objections and 

requests for hearings must be received 

on or before December 2, 2013, 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–2012–0885, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

a.m. to 4:30 p.m., Monday through 

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: Lois 

Rossi, Registration Division, Office of 

Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW., Washington, DC 20460–0001; 

telephone number: (703) 305–7090; 

email address: RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2012–0885 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 December 2, 2013. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2012–0885, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, EPA/DC, 

(28221T), 1200 Pennsylvania Ave. NW., 

Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http://


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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 December 

19, 2012 (77 FR 75082) (FRL–9372–6), 

EPA issued a document pursuant to 

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

346a(d)(3), announcing the filing of a 

pesticide petition (PP 2F8113) by 

Syngenta Crop Protection, Inc., 

Regulatory Affairs, P.O. Box 18300, 

Greensboro, NC 27419–8300. The 

petition requested that 40 CFR 180.665 

be amended by establishing tolerances 

for residues of the fungicide sedaxane, 

in or on potato at 0.02 parts per million 

(ppm) and potato, wet peel at 0.06 ppm. 

That document 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 

recommended that a different tolerance 

be set for potato, wet peel. 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 subchronic neurotoxicity (SCN) studies, 

sedaxane caused decreased activity, 

decreased muscle tone, decreased 

rearing and decreased grip strength. 

There are indications of reproductive 

toxicity in rats at the high dose, 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 quantitative 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 are discussed in the 

final rule published in the Federal 

Register of June 20, 2012 (77; FR 36920) 

(FRL–9345–8). 

B. Toxicological Points of Departure/

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which the NOAEL and LOEAL 

are identified. Uncertainty/safety factors 

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 discussed in Unit B 

of the final rule published in the 

Federal Register of June 20, 2012 (77 FR 

36920) (FRL–9345–8). 

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 as well as all existing 

sedaxane tolerances in 40 CFR 180.665. 

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 2003–2008 food 

consumption information from the U.S. 

Department of Agriculture’s (USDA’s) 

National Health and Nutrition 

Examination Survey, What We Eat in 

America (NHANES/WWEIA). As to 

residue levels in food, EPA conducted a 

highly conservative acute dietary risk 


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assessment which used tolerance level 

residues and assumed that 100% of all 

commodities were treated. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, EPA used the food 

consumption data from the USDA’s 

2003–2008 NHANES/WWEIA. As to 

residue levels in food, EPA conducted a 

partially refined chronic dietary risk 

assessment which used anticipated 

residues and assumed 100 percent crop 

treated (PCT) for all commodities except 

for soybean, wheat, and potato, where 

average PCT estimates of 51, 32, and 67, 

respectively, were used, and modeled 

drinking water estimates were included. 

iii. Cancer. EPA assessed exposure for 

the purpose of estimating cancer risk 

assuming anticipated residues and 100 

PCT for all commodities except for 

soybean, wheat, and potato, where 

average percent crop treated estimates of 

51, 32, and 67, respectively, were used, 

and modeled drinking water estimates 

were included. 

iv. Anticipated residue PCT 

information. Section 408(b)(2)(E) of 

FFDCA authorizes EPA to use available 

data and information on the anticipated 

residue levels of pesticide residues in 

food and the actual levels of pesticide 

residues that have been measured in 

food. If EPA relies on such information, 

EPA must require pursuant to FFDCA 

section 408(f)(1) that data be provided 5 

years after the tolerance is established, 

modified, or left in effect, demonstrating 

that the levels in food are not above the 

levels anticipated. For the present 

action, EPA will issue such data call-ins 

as are required by FFDCA section 

408(b)(2)(E) and authorized under 

FFDCA section 408(f)(1). Data will be 

required to be submitted no later than 

5 years from the date of issuance of 

these tolerances. Section 408(b)(2)(F) of 

FFDCA states that the Agency may use 

data on the actual percent of food 

treated for assessing chronic dietary risk 

only if: 

• Condition A: The data used are 

reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain the pesticide residue. 

• Condition B: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• Condition C: Data are available on 

pesticide use and food consumption in 

a particular area, the exposure estimate 

does not understate exposure for the 

population in such area. In addition, the 

Agency must provide for periodic 

evaluation of any estimates used. To 

provide for the periodic evaluation of 

the estimate of PCT as required by 

FFDCA section 408(b)(2)(F), EPA may 

require registrants to submit data on 

PCT. 

The Agency estimated the PCT for 

existing uses as follows: 

For chronic and cancer dietary 

exposure assessment, 100% was 

assumed for all commodities except for 

soybeans (51%) and wheat (32%), 

which incorporated average PCT 

estimates. Average PCT estimates were 

also used for the proposed use on potato 

(67%). 

In most cases, EPA uses available data 

from United States Department of 

Agriculture/National Agricultural 

Statistics Service (USDA/NASS), 

proprietary market surveys, and the 

National Pesticide Use Database for the 

chemical/crop combination for the most 

recent 6–7 years. EPA uses an average 

PCT for chronic dietary risk analysis. 

The average PCT figure for each existing 

use is derived by combining available 

public and private market survey data 

for that use, averaging across all 

observations, and rounding to the 

nearest 5%, except for those situations 

in which the average PCT is less than 

one. In those cases, 1% is used as the 

average PCT and 2.5% is used as the 

maximum PCT. EPA uses a maximum 

PCT for acute dietary risk analysis. The 

maximum PCT figure is the highest 

observed maximum value reported 

within the recent 6 years of available 

public and private market survey data 

for the existing use and rounded up to 

the nearest multiple of 5%. 

The Agency believes that the three 

conditions discussed in Unit III.C.1.iv. 

have been met. With respect to 

Condition A, PCT estimates are derived 

from Federal and private market survey 

data, which are reliable and have a valid 

basis. The Agency is reasonably certain 

that the percentage of the food treated 

is not likely to be an underestimation. 

As to Conditions B and C, regional 

consumption information and 

consumption information for significant 

subpopulations is taken into account 

through EPA’s computer-based model 

for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available reliable information on 

the regional consumption of food to 

which sedaxane may be applied in a 

particular area. 

EPA did not use anticipated residue 

or PCT information in the acute dietary 

assessment for sedaxane. However, for 

the chronic and cancer dietary 

assessments, anticipated residues were 

used along with 100 PCT for all food 

commodities except for soybean, wheat, 

and potato, where average PCT 

estimates of 51, 32, and 67, respectively, 

were used, and modeled drinking water 

estimates were included. 

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 Tier I Food Quality 

Protection Act (FQPA) Index Reservoir 

Screening Tool (FIRST) and Tier II 

pesticide root zone model PRZMGroundwater (PRZM–GW Version 1.0, 

12/11/2012), the estimated drinking 

water concentrations (EDWCs) of 

sedaxane for acute exposures are 

estimated to be 4.1 parts per billion 

(ppb) for surface water and 15.1 ppb for 

ground water. The water exposures for 

the chronic dietary and cancer 

assessments are estimated to be 1.2 ppb 

for surface water and 13 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 15.1 ppb was 

used to assess the contribution to 

drinking water. For chronic and cancer 

dietary risk assessment, the water 

concentration value of 13 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 


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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. 

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. 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). 

In addition, there is no evidence of 

neuropathology or abnormalities in the 

development of the fetal nervous system 

from the available toxicity studies 

conducted with sedaxane. 

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. 

ii. The sedaxane toxicology database 

did not demonstrate evidence of 

neurotoxicity. Although sedaxane 

caused changes in endpoints such as 

decreased activity, decreased muscle 

tone, decreased rearing and decreased 

grip strength in the ACN study and 

reduced locomotor activity in the SCN 

study, EPA believes these effects do not 

support a finding that sedaxane is a 

neurotoxicant. The observed effects in 

the ACN and SCN studies were likely 

secondary to inhibition of 

mitochondrial energy production, 

which is the pesticidal mode of action 

for sedaxane. Furthermore, there was no 

corroborative neuro-histopathology 

demonstrated in any study, even at the 

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

day). Therefore, based on its chemical 

structure, its pesticidal mode of action, 

and lack of evidence of neurohistopathology in any acute and 

repeated-dose toxicity study, sedaxane 

does not demonstrate potential for 

neurotoxicity. Since sedaxane did not 

demonstrate increased 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 as screening-level 

(acute) or partially-refined (chronic) 

assessments. 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 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. 

Sedaxane is a member of the pyrazole 

carboxamide fungicides. Metabolic 

processes involving cleavage of the 

linkage between the pyrazole and 

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- and intermediate-term risk. 

Short- and intermediate-term aggregate 

exposure takes into account short- and 

intermediate-term residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). Short- and 

intermediate-term adverse effects were 

identified; however, sedaxane is not 

registered for any use patterns that 

would result in short- or intermediateterm residential exposures. Because 

there is no short- or intermediate-term 

residential exposure and chronic dietary 

exposure has already been assessed 

under the appropriately protective 

cPAD (which is at least as protective as 

the POD used to assess short-term risk), 

no further assessment of short- or 

intermediate-term risk is necessary, and 

EPA relies on the chronic dietary risk 

assessment for evaluating short- and 

intermediate-term risk for sedaxane. 

4. 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 

1 × 10¥6 for the U.S. population. EPA 

considers risks in the range of 1 × 10¥6

to be negligible. 

5. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 


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Federal Register / Vol. 78, No. 191 / Wednesday, October 2, 2013 / Rules and Regulations 60719 

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 

June 30, 2014, 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 Agency determined that the 

tolerance level for potato, wet peel 

should be changed from the petitionedfor 0.06 ppm to 0.075 ppm based upon 

EPA’s examination of the level of 

residues that may remain on potatoes 

following application of sedaxane at the 

maximum label rate and the average 

degree of sedaxane residue 

concentration in wet potato peel. 

V. Conclusion 

Therefore, tolerances are established 

for residues of sedaxane, including its 

metabolites and degradates in or on 

potato; and potato, wet peel at 0.02 and 

0.075 ppm respectively. 

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) (2 U.S.C. 1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

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

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

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

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 17, 2013. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. In § 180.665, add alphabetically the 

following commodities to the table in 

paragraph (a) to read as follows: 

§ 180.665 Sedaxane; tolerances for 

residues. 

(a) * * * 

Commodity Parts 

per million 

* * * * * 

Potato ................................. 0 .02 

Potato, wet peel .................. 0 .075 

* * * * * 


sroberts on DSK5SPTVN1PROD with RULES
60720 Federal Register / Vol. 78, No. 191 / Wednesday, October 2, 2013 / Rules and Regulations 

* * * * * 

[FR Doc. 2013–23941 Filed 10–1–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0332; FRL–9401–3] 

Methyl Parathion; Removal of Expired 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: EPA is removing listings in 

the Code of Federal Regulations (CFR) 

for already expired tolerances for 

methyl parathion, for the purpose of 

clarity and in accordance with current 

EPA practice. 

DATES: This regulation is effective 

October 2, 2013. 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2009–0332, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

a.m. to 4:30 p.m., Monday through 

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Joseph Nevola, Pesticide Re-Evaluation 

Division (7508P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW., 

Washington, DC 20460–0001; telephone 

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

nevola.joseph@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at http://

www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/

40tab_02.tpl. 

II. Background 

A. What action is the agency taking? 

In this final rule, EPA is removing 

listings in the CFR for already expired 

tolerances for methyl parathion in 

§ 180.121(e). In the Federal Register of 

January 5, 2001 (66 FR 1242) (FRL– 

6752–6), EPA promulgated a final rule 

revoking methyl parathion uses in 

commodities for which methyl 

parathion use was unlawful after 

December 31, 1999. The final rule listed 

these expired tolerances in § 180.121(e). 

However, some people have 

inaccurately read § 180.121(e) to mean 

that there are active methyl parathion 

tolerances for these commodities. In 

order to eliminate confusion, EPA is 

removing paragraph (e) in its entirety. 

EPA is not making any change in the 

status of these expired tolerances, just 

removing an informational listing that 

the Agency believes is no longer needed 

and that may be misleading if not read 

correctly. 

EPA is issuing a final rule for this 

purpose without notice and opportunity 

to comment. Section 553(b)(3)(B) of the 

Administrative Procedure Act provides 

that notice and comment is not 

necessary ‘‘when the agency for good 

cause finds (and incorporates the 

finding and a brief statement of reasons 

therefore in the rules issued) that notice 

and public procedure thereon are 

impracticable, unnecessary, or contrary 

to the public interest.’’ EPA finds good 

cause here because removing the listings 

does not affect the legal status of the 

already expired tolerances. 

B. What is the agency’s authority for 

taking this action? 

EPA is not taking any action that 

substantively changes a tolerance. EPA 

is only taking administrative action to 

remove the informational listing in 

§ 180.121(e). 

C. When do these actions become 

effective? 

As stated in the DATES section, this 

final rule is effective October 2, 2013. 

The methyl parathion tolerances 

expired more than 13 years ago and the 

Agency believes that the informational 

listing in § 180.121(e) is no longer 

needed. 

III. Statutory and Executive Order 

Reviews 

In this final rule, EPA is removing a 

listing of already expired tolerances. 

The Office of Management and Budget 

(OMB) has exempted this type of action 

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 due to its lack of 

significance, 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). 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.), or impose any 

enforceable duty or contain any 

unfunded mandate as described under 

Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (2 U.S.C. 

1501 et seq.). Nor does it require any 

special considerations as required by 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994); or OMB review or any other 

Agency action under Executive Order 

13045, entitled ‘‘Protection of Children 

from Environmental Health Risks and 

Safety Risks’’ (62 FR 19885, April 23, 

1997). This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

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

to the Regulatory Flexibility Act (RFA) 

(5 U.S.C. 601 et seq.), the Agency hereby 

certifies that this final rule will not have 

a significant economic impact on a 

substantial number of small entities. 

Furthermore, for the pesticide named in 

this final rule, the Agency knows of no 

extraordinary circumstances that exist 

as to the present removal of listings for 

already expired tolerances that would 

change EPA’s analysis. In addition, the 

Agency has determined that this action 

will not have a substantial direct effect 


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