Federal Register / Vol. 79, No. 117 / Wednesday, June 18, 2014 / Rules and Regulations 34629 

were also considered in arriving at this 

conclusion. This rule is categorically 

excluded, under figure 2–1, paragraphs 

(34)(g) and (34)(h) of the Instruction 

since it involves establishment of safety 

zones for annually recurring marine 

events, including marine related 

fireworks events and special local 

regulations for regattas. An 

environmental analysis checklist and a 

categorical exclusion determination are 

available in the docket where indicated 

under ADDRESSES. 

List of Subjects in 33 CFR Part 165 

Harbors, Marine safety, Navigation 

(water), Reporting and recordkeeping 

requirements, Security measures, 

Waterways. 

For the reasons discussed in the 

preamble, the Coast Guard amends 33 

CFR part 165 as follows: 

PART 165—REGULATED NAVIGATION 

AREAS AND LIMITED ACCESS AREAS 

■ 1. The authority citation for part 165 

continues to read as follows: 

Authority: 33 U.S.C. 1231; 46 U.S.C. 

Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 

33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; 

Pub. L. 107–295, 116 Stat. 2064; Department 

of Homeland Security Delegation No. 0170.1. 

§ 165.173 [Amended] 

■ 2. Amend the table in § 165.173 as 

follows: 

■ a. Add a new category entitled ‘‘5.0 

MAY’’ below the category ‘‘1.0 365 DAY 

JANUARY–DECEMBER’’ and above the 

category ‘‘6.0 JUNE’’; 

■ b. Redesignate item 6.2, ‘‘RI National 

Guard Air Show’’ as item 5.1, and locate 

it beneath the category ‘‘5.0 MAY’’; 

■ c. Redesignate item 7.12 ‘‘Swim 

Buzzards Bay’’ as item 6.2, and locate it 

below item 6.1 ‘‘Oak Bluffs Summer 

Solstice’’, and reserve item 7.12; 

■ d. Revise the entry for ‘‘Date’’ in 

newly redesignated item 5.1, ‘‘RI Air 

National Guard Air Show’’ to read 

‘‘Date: One weekend (Friday, Saturday, 

and Sunday) in May, June, or July, as 

announced in the local Notice to 

Mariners.’’; and 

■ e. Revise the entry for ‘‘Date’’ in newly 

redesignated item 6.2 ‘‘Swim Buzzards 

Bay’’ to read ‘‘Date: One Saturday or 

Sunday in June, July, or August, as 

announced in the local Notice to 

Mariners.’’ 

Dated: May 21, 2014. 

J.T. Kondratowicz, 

Captain, U.S. Coast Guard, Captain of the 

Port Southeastern New England. 

[FR Doc. 2014–14238 Filed 6–17–14; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0673; FRL–9911–08] 

Pyroxasulfone; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends 

tolerances for residues of pyroxasulfone 

in or on corn, field, forage and corn, 

field, grain. K–I Chemical U.S.A. Inc. 

c/o Landis International, Inc. requested 

these amended tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective June 

18, 2014. Objections and requests for 

hearings must be received on or before 

August 18, 2014, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2013–0673, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., Rm. 3334, 1301 

Constitution Ave. NW., Washington, DC 

20460–0001. The Public Reading Room 

is open from 8:30 a.m. to 4:30 p.m., 

Monday through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main telephone 

number: (703) 305–7090; email address: 

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

40tab_02.tpl. 

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–2013–0673 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 18, 2014. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2013–0673, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

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

NW., Washington, DC 20460–0001. 


ehiers on DSK2VPTVN1PROD with RULES
34630 Federal Register / Vol. 79, No. 117 / Wednesday, June 18, 2014 / Rules and Regulations 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http:// 

www.epa.gov/dockets/contacts.html. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at 

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

II. Summary of Petitioned-for Tolerance 

In the Federal Register of October 25, 

2013 (78 FR 63938) (FRL–9901–96), 

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 3F8196) by K–I 

Chemical U.S.A. Inc. c/o Landis 

International, Inc., P.O. Box 5126, 

Valdosta, GA 31603–5126. The petition 

requested that 40 CFR 180.659 be 

amended by increasing the tolerance for 

residues of the herbicide, 

pyroxasulfone, [3-[[[5- 

(difluoromethoxy)-1-methyl-3- 

(trifluoromethyl)-1H-pyrazol-4- 

yl]methyl]sulfonyl]-4,5-dihydro-5,5- 

dimethylisoxazole] and its metabolite 5- 

difluoromethoxy-1-methyl-3- 

trifluoromethyl-1 H-pyrazol-4- 

carboxylic acid (M3) calculated as the 

stoichiometric equivalent of 

pyroxasulfone, in or on corn, field, grain 

from 0.015 to 0.02 parts per million 

(ppm); and also increasing the tolerance 

for residues of pyroxasulfone, [3-[[[5- 

(difluoromethoxy)-1-methyl-3- 

(trifluoromethyl)-1H-pyrazol-4- 

yl]methyl]sulfonyl]-4,5-dihydro-5,5- 

dimethylisoxazole] and its metabolites 

5-difluoromethoxy-1-methyl-3- 

trifluoromethyl-1 H-pyrazol-4- 

ylmethanesulfonic acid (M1), 5- 

difluoromethoxy-1-methyl-3- 

trifluoromethyl-1 H-pyrazol-4- 

carboxylic acid (M3), and 5- 

difluoromethoxy-3-trifluoromethyl-1 Hpyrazol-4-yl) methanesulfonic acid 

(M25) calculated as the stoichiometric 

equivalent of pyroxasulfone in or on 

corn, field, forage from 0.06 to 0.09 

ppm. The amended tolerances were 

sought to cover residues that may be 

found on corn following use of 

pyroxasulfone with an adjuvant. That 

document referenced a summary of the 

petition prepared by K–I Chemical 

U.S.A. Inc. c/o Landis International, 

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. 

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 pyroxasulfone, 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with pyroxasulfone follows. 

A. Toxicological Profile 

In the Federal Register of July 31, 

2013 (78 FR 46274) (FRL–9393–6), EPA 

published a final rule (2013 rulemaking) 

establishing certain tolerances for 

residues of the herbicide pyroxasulfone 

and its metabolites based on EPA’s 

conclusion that aggregate exposure to 

pyroxasulfone is safe for the general 

population, including infants and 

children. Since the 2013 rulemaking, 

there have been no additional tolerance 

actions for pyroxasulfone, nor has the 

toxicity profile for pyroxasulfone 

changed. Specific information on the 

studies reviewed for that rulemaking 

and the nature of the adverse effects 

caused by pyroxasulfone, 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 

2013 rulemaking which can be found in 

docket ID number EPA–HQ–OPP–2012– 

0439. 

B. Toxicological Points of Departure/

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http://

www.epa.gov/pesticides/factsheets/

riskassess.htm. A summary of the 

toxicological endpoints for 

pyroxasulfone used for human risk 

assessment is also discussed in Unit 

III.B of the final rule published in the 

Federal Register of February 29, 2012 

(77 FR 12207) (FRL–9334–2). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to pyroxasulfone, EPA 

conducted a new dietary exposure and 

risk assessment that considered 

exposure under the petitioned-for 

tolerances as well as all existing 

pyroxasulfone tolerances in 40 CFR 

180.659. EPA assessed dietary 

exposures from pyroxasulfone 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 pyroxasulfone. In estimating acute 

dietary exposure, EPA used food 

consumption information from the 

United States Department of 

Agriculture’s (USDA) National Health 

and Nutrition Examination Survey, 

What We Eat in America, (NHANES/

WWEIA). As to residue levels in food, 

EPA assumed 100 percent crop treated 

(PCT) at tolerance-level residues 

adjusted upward to account for 

metabolites which are not in the 


ehiers on DSK2VPTVN1PROD with RULES
Federal Register / Vol. 79, No. 117 / Wednesday, June 18, 2014 / Rules and Regulations 34631 

tolerance expression from specific use 

patterns. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA/NHANES/WWEIA. As 

to residue levels in food, EPA made the 

same assumptions (adjusted tolerancelevel residues and 100 PCT) as in the 

acute dietary exposure assessment. 

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. Cancer risk is 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. EPA has 

concluded that a nonlinear RfD 

approach is appropriate for assessing 

cancer risk to pyroxasulfone. Cancer 

risk was assessed using the same 

exposure estimates as discussed in Unit 

III.C.1.ii. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for pyroxasulfone. Adjusted tolerance 

level residues and/or 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 pyroxasulfone in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

pyroxasulfone. 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 Pesticide 

Root Zone Model Ground Water (PRZM 

GW), the estimated drinking water 

concentrations (EDWCs) of 

pyroxasulfone for acute exposures are 

estimated to be 17 parts per billion 

(ppb) for surface water and 210 ppb for 

ground water. EDWCs of pyroxasulfone 

for chronic exposures for non-cancer 

assessments are estimated to be 3.2 ppb 

for surface water and 174 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 210 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 174 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). 

Pyroxasulfone 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 pyroxasulfone to share a common 

mechanism of toxicity with any other 

substances, and pyroxasulfone does not 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that 

pyroxasulfone does not have a common 

mechanism of toxicity with other 

substances. For information regarding 

EPA’s efforts to determine which 

chemicals have a common mechanism 

of toxicity and to evaluate the 

cumulative effects of such chemicals, 

see EPA’s Web site at http://

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

Food Quality Protection Act (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 prenatal and postnatal toxicity 

database for pyroxasulfone includes 

developmental toxicity studies in rats 

and rabbits, a DNT study in rats, and a 

2-generation reproduction toxicity study 

in rats. As discussed in the 2013 

rulemaking, evidence of increased 

susceptibility of fetuses and offspring 

was seen in the DNT study and 

developmental toxicity study in rabbits 

following in utero or post-natal 

exposure to pyroxasulfone. No 

increased susceptibility was seen in the 

rat developmental or reproduction 

toxicity studies. In rabbits, 

developmental toxicity was only seen at 

the limit dose of 1,000 milligrams/

kilogram/day (mg/kg/day) as reduced 

fetal weight and increased fetal 

resorptions with a NOAEL of 500 mg/

kg/day for these effects, compared to no 

maternal toxicity at these doses. In a 

DNT study in rats, offspring toxicity 

(decreased brain weight and 

morphometric changes on PND 21) was 

seen at 300 mg/kg/day compared to no 

maternal toxicity at 900 mg/kg/day. The 

degree of concern for the increased 

susceptibility seen in these studies is 

low and there are no residual 

uncertainties based on the following 

considerations: 

i. The increased susceptibility is 

occurring at high doses. 

ii. NOAELs and LOAELs have been 

identified for all effects of concern, and 

thus a clear dose response has been well 

defined. 

iii. The PODs selected for risk 

assessment are protective of the fetal/

offspring effects. 

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 

pyroxasulfone is complete. 

ii. Pyroxasulfone is a neurotoxic 

chemical and there is evidence of 

increased susceptibility of offspring 

with regard to neurotoxic effects in the 

rat DNT study. There is also evidence of 

increased susceptibility of fetuses/

offspring with regard to non-neurotoxic 

effects in the rabbit developmental 

toxicity study. However, concern for the 

increased susceptibility is low for the 

reasons stated in Unit III.D.2.; therefore, 

EPA determined that a 10X FQPA SF is 

not necessary to protect infants and 

children. 

iii. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

adjusted tolerance-level residues. EPA 

made conservative (protective) 

assumptions in the ground and surface 


ehiers on DSK2VPTVN1PROD with RULES
34632 Federal Register / Vol. 79, No. 117 / Wednesday, June 18, 2014 / Rules and Regulations 

water modeling used to assess exposure 

to pyroxasulfone in drinking water. 

These assessments will not 

underestimate the exposure and risks 

posed by pyroxasulfone. 

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. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

pyroxasulfone will occupy 3.6% of the 

aPAD for all infants (<1 year old), the 

population group receiving the greatest 

exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to pyroxasulfone 

from food and water will utilize 48% of 

the cPAD for all infants (<1 year old) the 

population group receiving the greatest 

exposure. There are no residential uses 

for pyroxasulfone. 

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, pyroxasulfone is 

not registered for any use patterns that 

would result in short- or intermediateterm residential exposure. 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- and 

intermediate-term risk), no further 

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

the chronic dietary risk assessment for 

evaluating short- and intermediate-term 

risk for pyroxasulfone. 

4. Aggregate cancer risk for U.S. 

population. The Agency has determined 

that the quantification of risk using a 

non-linear (i.e., RfD) approach will 

adequately account for all chronic 

toxicity, including carcinogenicity, that 

could result from exposure to 

pyroxasulfone. Therefore, based on the 

results of the chronic risk assessment 

discussed in Unit III.E.2., pyroxasulfone 

is not expected to pose a cancer risk to 

humans. 

5. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to 

pyroxasulfone residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(a liquid chromatography/mass 

spectrometry/mass spectrometry (LC/

MS/MS) method) is available to enforce 

the tolerance expression. The method 

may be requested from: Chief, 

Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: residuemethods@

epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. The Codex has not 

established a MRL for pyroxasulfone. 

V. Conclusion 

Therefore, tolerances are established 

for residues of pyroxasulfone, [3-[[[5- 

(difluoromethoxy)-1-methyl-3- 

(trifluoromethyl)-1H-pyrazol-4- 

yl]methyl]sulfonyl]-4,5-dihydro-5,5- 

dimethylisoxazole], including its 

metabolites and degradates, as set forth 

in the regulatory text. 

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 


ehiers on DSK2VPTVN1PROD with RULES
Federal Register / Vol. 79, No. 117 / Wednesday, June 18, 2014 / Rules and Regulations 34633 

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: June 12, 2014. 

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. Section 180.659 is amended by: 

■ a. Revising the commodity ‘‘Corn, 

field, grain’’ in the table in paragraph 

(a)(1) and; 

■ b. Revising the commodity ‘‘Corn 

field, forage’’ in the table in paragraph 

(a)(2) to read as follows: 

§ 180.659 Pyroxasulfone; tolerances for 

residues. 

(a) General. (1) * * * 

Commodity Parts per 

million 

Corn, field, grain ................... 0.02 

* * * * * 

(2) * * * 

Commodity Parts per 

million 

Corn, field, forage ................. 0.09 

* * * * * 

* * * * * 

[FR Doc. 2014–14251 Filed 6–17–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 300 

[EPA–HQ–SFUND–1999–0013; FRL–9912– 

53–Region 2] 

National Oil and Hazardous 

Substances Pollution Contingency 

Plan; National Priorities List: Deletion 

of the Federal Creosote Superfund Site 

AGENCY: Environmental Protection 

Agency. 

ACTION: Final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) Region 2 announces the 

deletion of the Federal Creosote 

Superfund Site (Site) located in the 

Borough of Manville, New Jersey, from 

the National Priorities List (NPL). The 

NPL, promulgated pursuant to section 

105 of the Comprehensive 

Environmental Response, 

Compensation, and Liability Act 

(CERCLA) of 1980, as amended, is an 

appendix of the National Oil and 

Hazardous Substances Pollution 

Contingency Plan (NCP). The EPA and 

the State of New Jersey, through the 

New Jersey Department of 

Environmental Protection, have 

determined that all appropriate 

response actions under CERCLA, other 

than long-term groundwater monitoring, 

and five-year reviews, have been 

completed. However, this deletion does 

not preclude future actions under 

Superfund. 

DATES: This action is effective June 18, 

2014. 

ADDRESSES: Submit your comments, 

identified by Docket ID no. EPA–HQ– 

SFUND–1999–0013, by one of the 

following methods: 

• http://www.regulations.gov. Follow 

on-line instructions for submitting 

comments. 

• Email: puvogel.rich@epa.gov: Rich 

Puvogel, Remedial Project Manager; 

seppi.pat@epa.gov: Pat Seppi, 

Community Involvement Coordinator. 

• Fax: (212) 637–4429. 

• Mail: 

Rich Puvogel, Remedial Project 

Manager, U.S. Environmental 

Protection Agency, Emergency & 

Remedial Response Division, 290 

Broadway, 19th Floor, New York, NY 

10007–1866; 

or 

Pat Seppi, Community Involvement 

Coordinator, U.S. Environmental 

Protection Agency, Public Affairs 

Division, 290 Broadway, 26th Floor, 

New York, NY 10007–1866. 

• Hand delivery: U.S. Environmental 

Protection Agency, Emergency & 

Remedial Response Division, 290 

Broadway, 19th Floor, New York, NY 

10007–1866. 

Such deliveries are only accepted 

during the Docket’s normal hours of 

operation, and special arrangements 

should be made for deliveries of boxed 

information. 

Instructions: Direct your comments to 

Docket ID no. EPA–HQ–SFUND–1999– 

0013. EPA’s policy is that all comments 

received will be included in the public 

docket without change and may be 

made available online at http:// 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through http:// 

www.regulations.gov or email. The 

http://www.regulations.gov Web site is 

an ‘‘anonymous access’’ system, which 

means EPA will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an email comment directly 

to EPA without going through http:// 

www.regulations.gov, your email 

address will be automatically captured 

and included as part of the comment 

that is placed in the public docket and 

made available on the Internet. If you 

submit an electronic comment, EPA 

recommends that you include your 

name and other contact information in 

the body of your comment and with any 

disk or CD–ROM you submit. If EPA 

cannot read your comment due to 

technical difficulties and cannot contact 

you for clarification, EPA may not be 

able to consider your comment. 

Electronic files should avoid the use of 

special characters, any form of 

encryption, and be free of any defects or 

viruses. 

Docket: EPA has established a docket 

for this action under Docket 

Identification No. EPA–HQ–SFUND– 

1999–0013. All documents in the docket 

are listed on the http:// 

www.regulations.gov Web site. Although 

listed in the index, some information is 

not publicly available, i.e., Confidential 

Business Information or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

is not placed on the Internet and will be 

publicly available only in hard copy 

form. Publicly available docket 

materials are available either 

electronically through http:// 

www.regulations.gov or in hard copy at 

the site information repositories. 


ehiers on DSK2VPTVN1PROD with RULES