Federal Register / Vol. 78, No. 137 / Wednesday, July 17, 2013 / Rules and Regulations 42693 

414–747–7148, email 

Joseph.P.Mccollum@uscg.mil. 

SUPPLEMENTARY INFORMATION: The Coast 

Guard will enforce the Safety Zone; 

Chicago Harbor, Navy Pier Southeast, 

Chicago, IL listed in 33 CFR 165.931 for 

the following events: 

(1) Navy Pier Fireworks with times 

and dates as follows: 

July 17, 2013 from 9:15 p.m. through 

9:45 p.m.; 

July 20, 2013 from 10:00 p.m. through 

10:30 p.m.; 

July 24, 2013 from 9:15 p.m. through 

9:45 p.m.; 

July 27, 2013 from 10:00 p.m. through 

10:30 p.m.; 

July 31, 2013 from 9:15 p.m. through 

9:45 p.m.; 

August 3, 2013 from 10:00 p.m. 

through 10:30 p.m.; 

August 7, 2013 from 9:15 p.m. 

through 9:45 p.m.; 

August 8, 2013 from 9:15 p.m. 

through 9:45 p.m.; 

August 9, 2013 from 10:00 p.m. 

through 10:30 p.m.; 

August 10, 2013 from 10:00 p.m. 

through 10:30 p.m.; 

August 14, 2013 from 9:15 p.m. 

through 9:45 p.m.; 

August 17, 2013 from 10:00 p.m. 

through 10:30 p.m.; 

August 21, 2013 from 9:15 p.m. 

through 9:45 p.m.; 

August 24, 2013 from 10:00 p.m. 

through 10:30 p.m.; 

August 28, 2013 from 9:15 p.m. 

through 9:45 p.m.; 

August 31, 2013 from 10:00 p.m. 

through 10:30 p.m. 

This safety zone encompasses the 

waters of Lake Michigan within Chicago 

Harbor between the east end of the 

Chicago Lock guide wall and the 

Chicago Harbor breakwater beginning at 

41°53′24′′ N, 087°35′26′′ W; then south 

to 41°53′09′′ N, 087°35′26′′ W; then west 

to 41°53′09′′ N, 087°36′09′′ W; then 

north to 41°53′24′′ N, 087°36′09′′ W; 

then back to the point of origin. All 

vessels must obtain permission from the 

Captain of the Port, Lake Michigan, or 

his or her on-scene representative to 

enter, move within or exit the safety 

zone. Vessels and persons granted 

permission to enter the safety zone shall 

obey all lawful orders or directions of 

the Captain of the Port, Lake Michigan, 

or his or her on-scene representative. 

This notice is issued under authority 

of 33 CFR 165.931 and 5 U.S.C. 552(a). 

In addition to this notice in the Federal 

Register, the Coast Guard will provide 

the maritime community with advance 

notification of these enforcement 

periods via broadcast Notice to Mariners 

or Local Notice to Mariners. If the 

Captain of the Port, Lake Michigan, 

determines that the safety zone need not 

be enforced for the full duration stated 

in this notice, he or she may use a 

Broadcast Notice to Mariners to grant 

general permission to enter the safety 

zone. The Captain of the Port, Lake 

Michigan, or his or her on-scene 

representative may be contacted via 

VHF Channel 16. 

Dated: July 1, 2013. 

M.W. Sibley, 

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

Port, Lake Michigan. 

[FR Doc. 2013–17104 Filed 7–16–13; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket No. USCG–2013–0140] 

Safety Zone; USA Triathlon; Milwaukee 

Harbor, Milwaukee, Wisconsin. 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of enforcement of 

regulation. 

SUMMARY: The Coast Guard will enforce 

the safety zone on Lake Michigan within 

Milwaukee Harbor, Wisconsin for the 

2013 Olympic and Sprint Distance 

National Championships. This action is 

necessary and intended to ensure safety 

of life on the navigable waters during 

the 2013 Olympic and Sprint Distance 

National Championships. During the 

aforementioned periods, the Coast 

Guard will enforce restrictions upon, 

and control movement of, vessels in a 

specified safety zone. During the 

enforcement periods, no person or 

vessel may enter the safety zone without 

permission of the Captain of the Port, 

Lake Michigan. 

DATES: This zone will be enforced from 

10:15 a.m. until 1:15 p.m. on August 9, 

from 6:30 a.m. until 11:30 a.m. on 

August 10, and from 6:30 a.m. until 

10:30 a.m. on August 11, 2013. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this notice, call 

or email MST1 Joseph McCollum, 

Prevention Department, Coast Guard 

Sector Lake Michigan, Milwaukee, WI at 

(414) 747–7148, email 

Joseph.P.McCollum@uscg.mil. 

SUPPLEMENTARY INFORMATION: The Coast 

Guard will enforce the safety zone listed 

in 33 CFR 165.T09–0140 Safety Zone; 

USA Triathlon, Milwaukee Harbor, 

Milwaukee, Wisconsin for the 2013 

Olympic and Sprint Distance National 

Championships from 10:15 a.m. until 

1:15 p.m. on August 9, from 6:30 a.m. 

until 11:30 a.m. on August 10, and from 

6:30 a.m. until 10:30 a.m. on August 11, 

2013. This zone encompasses all waters 

of Milwaukee Harbor, including 

Lakeshore inlet and Discovery World 

Marina, west of a line across the 

entrance to the Discovery World Marina 

connecting 43°02′15.1′′ N, 087°53′37.4′′ 

W and 43°01′44.2′′ N, 087°53′44.6′′ W 

(NAD 83). 

All vessels must obtain permission 

from the Captain of the Port, Lake 

Michigan, or his or her on-scene 

representative to enter, move within, or 

exit a safety zone. Vessels and persons 

granted permission to enter the safety 

zone shall obey all lawful orders or 

directions of the Captain of the Port, 

Lake Michigan, or a designated 

representative. 

This notice is issued under authority 

of 33 CFR 165.T09–0140 and 5 U.S.C. 

552(a). In addition to this notice in the 

Federal Register, the Coast Guard will 

provide the maritime community with 

advance notification of this event via 

Broadcast Notice to Mariners or Local 

Notice to Mariners. The Captain of the 

Port, Lake Michigan, or his or her onscene representative may be contacted 

via VHF Channel 16. 

Dated: July 1, 2013. 

M.W. Sibley, 

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

Port, Lake Michigan. 

[FR Doc. 2013–17107 Filed 7–16–13; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0412; FRL–9391–1] 

Hexythiazox; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

new tolerances and revises existing 

tolerances for residues of hexythiazox in 

or on multiple commodities which are 

identified and discussed later in this 

document. Gowan Company and the 

Interregional Research Project Number 4 

(IR–4) requested the tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: This regulation is effective July 

17, 2013. Objections and requests for 

hearings must be received on or before 

September 16, 2013, and must be filed 

in accordance with the instructions 


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42694 Federal Register / Vol. 78, No. 137 / Wednesday, July 17, 2013 / Rules and Regulations 

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–2013–0412, 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: Olga 

Odiott, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9369; email address: 

odiott.olga@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–2013–0412 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before September 16, 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– 

2013–0412, 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. 

• 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 September 

28, 2012 (77 FR 59578) (FRL–9364–6), 

January 16, 2013 (78 FR 3377) (FRL– 

9375–4), and August 22, 2012 (77 FR 

50661) (FRL–9358–9), EPA issued 

notices pursuant to FFDCA section 

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

announcing the filing of a pesticide 

petitions (PP 2F8054 and PP 2F8073 by 

Gowan Company, P.O. Box 556, Yuma, 

AZ 85336; and PP 2E8016 by the 

Interregional Research Project Number 4 

(IR–4), 500 College Road East, Suite 201 

W, Princeton, NJ 08540. The petitions 

requested that 40 CFR 180.448 be 

amended by establishing tolerances for 

residues of the insecticide hexythiazox, 

(trans-5-(4-chlorophenyl)-N-cyclohexyl4-methyl-2-oxothiazolidine-3- 

carboxamide) and its metabolites 

containing the (4-chlorophenyl)-4- 

methyl-2-oxo-3-thiazolidine moiety, in 

or on grain, sorghum, grain at 3.0 parts 

per million (ppm); grain, sorghum, 

forage at 5 ppm; grain, sorghum, stover 

at 6 ppm; egg at 0.05 ppm; poultry, meat 

at 0.05 ppm; poultry, meat byproducts 

at 0.05 ppm; by increasing the 

established tolerance for milk from 0.02 

ppm to 0.05 ppm and the established 

tolerances for ruminant meat 

byproducts from 0.05 ppm to 0.5 ppm 

(PP 2F8054); and by amending the 

regional restriction of the tolerances for 

cotton, gin byproducts; and cotton, 

undelinted seed by including Arizona 

(PP 2F8073). Petition 2E8016 requested 

that 40 CFR 180.448 be amended by 

establishing tolerances for residues of 

hexythiazox in or on pepper/eggplant 

subgroup 8–10B at 1.5 ppm; fruit, pome, 

group 11–10 at 0.25 ppm; caneberry 

subgroup 13–07A at 1.0 ppm; fruit, 

small, vine climbing, except fuzzy 

kiwifruit, subgroup 13–07F at 1.0 ppm; 

and berry, low growing, subgroup 13– 

07G at 3.0 ppm. The documents 

referenced summaries of the petitions, 

which are available in the docket, 

http://www.regulations.gov by docket ID 

numbers EPA–HQ–OPP–2012–0624 (PP 

2F8054), EPA–HQ–OPP–2012–0923 (PP 

2F8073), and EPA–HQ–OPP–2012–0357 

(PP 2E8016). There were no comments 

received in response to the notices of 

filing. 

Based on EPA’s review of the data 

supporting the petitions, Gowan 

Company revised their petition PP 

2F8054 by adding a request for an 

increase in the established tolerance for 

grain, aspirated fractions; deleting the 

proposed tolerance for poultry, meat; 

and by deleting the proposed changes to 

the established tolerances for milk; and 

for poultry, meat byproducts. 

The IR–4 revised their petition PP 

2E8016 by increasing the proposed 

tolerances for fruit, pome, group 11–10; 

and for berry, low growing, 

subgroup13–07G. 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 


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Federal Register / Vol. 78, No. 137 / Wednesday, July 17, 2013 / Rules and Regulations 42695 

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 hexythiazox 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with hexythiazox 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 toxicity 

database for hexythiazox is complete. 

Hexythiazox has low acute toxicity by 

the oral, dermal, and inhalation routes 

of exposure. It produces mild eye 

irritation, is not a dermal irritant, and is 

negative for dermal sensitization. 

Hexythiazox is associated with toxicity 

of the liver and adrenals following 

subchronic and chronic exposure to 

dogs, rats, and mice, with the dog being 

the most sensitive species. The prenatal 

developmental studies in rabbits and 

rats and the two-generation 

reproduction study in rats showed no 

indication of increased susceptibility to 

in utero and/or postnatal exposure to 

hexythiazox. Reproductive toxicity was 

not observed. There is no concern for 

immunotoxicity or neurotoxicity 

following exposure to hexythiazox. The 

toxicology database for hexythiazox 

does not show any evidence of 

treatment-related effects on the immune 

system. Hexythiazox is classified as 

‘‘likely to be carcinogenic to humans;’’ 

however, the evidence as a whole is not 

strong enough to warrant a quantitative 

estimation of human risk. Since the 

effects seen in the study that serves as 

the basis for the chronic reference dose 

(RfD) occurred at doses substantially 

below the lowest dose that induced 

tumors, the Agency concluded that 

quantification of risk using a non-linear 

approach; i.e., RfD, for hexythiazox will 

adequately account for all chronic 

toxicity, including carcinogenicity, that 

could result from exposure to 

hexythiazox. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by hexythiazox 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 

‘‘Hexythiazox. Human Health Risk 

Assessment to Support New Uses on 

Grain Sorghum, Pepper/Eggplant 

Subgroup 8–10B, Pome Fruit Group 11– 

10, Caneberry Subgroup 13–07A, Small 

Vine Climbing, Except Fuzzy Kiwifruit 

Subgroup 13–07F, and Low Growing 

Berry Subgroup 13–07G’’ in docket ID 

number EPA–HQ–OPP–2013–0412. 

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 hexythiazox used for 

human risk assessment is discussed in 

Unit III.B. of the final rule published in 

the Federal Register of February 8, 2013 

(78 FR 9322) (FRL–9376–9). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to hexythiazox, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing hexythiazox tolerances in 40 

CFR 180.448. EPA assessed dietary 

exposures from hexythiazox 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. No such effects were 

identified in the toxicological studies 

for hexythiazox; therefore, a quantitative 

acute dietary exposure assessment is 

unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA U.S. Department of 

Agriculture’s 2003–2008 National 

Health and Nutrition Examination 

Survey, What We Eat in America 

(NHANES/WWEIA). As to residue levels 

in food, EPA used tolerance level 

residues, assumed 100 percent crop 

treated (PCT), and incorporated DEEM 

default processing factors when 

processing data were not available. 

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. Based on the 

data summarized in Unit III.A. of the 

Federal Register of March 17, 2010 (75 

FR 12691) (FRL–8813–7), EPA has 

concluded that a nonlinear RfD 

approach is appropriate for assessing 

cancer risk to hexythiazox. 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 hexythiazox. Tolerance level 


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residues and/or 100% CT 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 hexythiazox in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

hexythiazox. 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), the estimated 

drinking water concentrations (EDWCs) 

of hexythiazox for chronic exposures for 

non-cancer and cancer assessments is 

estimated to be 4.31 parts per billion 

(ppb) for surface water. Since surface 

water residues value greatly exceed 

groundwater EDWCs, surface water 

residues were used in the dietary risk 

assessment. Modeled estimates of 

drinking water concentrations were 

directly entered into the dietary 

exposure model. 

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). 

Hexythiazox is currently registered for 

the following uses that could result in 

residential exposures: Ornamental 

plantings, turf, and fruit and nut trees in 

residential settings. EPA assessed 

residential exposure using the following 

assumptions: Residential handler 

exposures are expected to be short-term 

(1 to 30 days) via either the dermal or 

inhalation routes of exposures. Since a 

quantitative dermal risk assessment is 

not needed for hexythiazox; MOEs were 

calculated for the inhalation route of 

exposure only. Both adults and children 

may be exposed to hexythiazox residues 

from contact with treated lawns or 

treated residential plants. Adult 

postapplication exposures were not 

assessed since no quantitative dermal 

risk assessment is needed for 

hexythiazox and inhalation exposures 

are typically negligible in outdoor 

settings. The exposure assessment for 

children included incidental oral 

exposure resulting from transfer of 

residues from the hands or objects to the 

mouth, and from incidental ingestion of 

soil. Post application hand-to-mouth 

and object-to-mouth exposures are 

expected to be short-term (1 to 30 days) 

in duration due to the intermittent 

nature of applications in residential 

environments. Given the long half-life of 

hexythiazox in soil, intermediate-term 

(1 to 6 months) exposure is also possible 

from incidental ingestion of soil. 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

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

trac/science/trac6a05.pdf. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

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

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ EPA has not 

found hexythiazox to share a common 

mechanism of toxicity with any other 

substances, and hexythiazox does not 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that 

hexythiazox 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 prenatal and postnatal toxicology 

data base indicates no increased 

susceptibility of rats or rabbits to in 

utero and/or postnatal exposure to 

hexythiazox. 

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 

hexythiazox is complete. 

ii. There is no indication that 

hexythiazox is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that 

hexythiazox 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% CT and 

tolerance-level residues. The dietary 

risk assessment is highly conservative 

and not expected to underestimate risk. 

EPA made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to hexythiazox in drinking water. EPA 

used similarly conservative assumptions 

to assess postapplication exposure of 

children as well as incidental oral 

exposure of toddlers. These assessments 

will not underestimate the exposure and 

risks posed by hexythiazox. 

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. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, hexythiazox is not 

expected to pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to hexythiazox 

from food and water will utilize 82% of 

the cPAD for children 1–2 years of age 

the population group receiving the 

greatest exposure. Based on the 

explanation in Unit III.C.3., regarding 

residential use patterns, chronic 

residential exposure to residues of 

hexythiazox is not expected. 


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Federal Register / Vol. 78, No. 137 / Wednesday, July 17, 2013 / Rules and Regulations 42697 

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). Hexythiazox is 

currently registered for uses that could 

result in short-term residential 

exposure, and the Agency has 

determined that it is appropriate to 

aggregate chronic exposure through food 

and water with short-term residential 

exposures to hexythiazox. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of 9,100 for adults and 1,300 for 

children. Because EPA’s level of 

concern for hexythiazox is a MOE of 100 

or below, these MOEs are not of 

concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Hexythiazox is currently registered for 

uses that could result in intermediateterm residential exposure, and the 

Agency has determined that it is 

appropriate to aggregate chronic 

exposure through food and water with 

intermediate-term residential exposures 

to hexythiazox. 

Using the exposure assumptions 

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

the combined intermediate-term food, 

water, and residential exposures result 

in aggregate MOEs of 9,300 for adults 

and 1,500 for children. Because EPA’s 

level of concern for hexythiazox is a 

MOE of 100 or below, these MOEs are 

not of concern. 

5. Aggregate cancer risk for U.S. 

population. As discussed in Unit III. 

C.1.iii., EPA concluded that regulation 

based on the chronic reference dose will 

be protective for both chronic and 

carcinogenic risks. As noted in this unit 

there are no chronic risks of concern. 

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 hexythiazox 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(high performance liquid 

chromatography method with UV 

detection (HPLC/UV)) is available for 

the enforcement of tolerances for 

residues of hexythiazox and its 

metabolites containing the PT–1–3 

moiety in crop and livestock 

commodities. This method is listed in 

the U.S. EPA Index of Residue 

Analytical Methods under hexythiazox 

as method AMR–985–87. 

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. 

Codex MRLs for plant commodities 

are established for eggplant at 0.1 ppm, 

pome fruit at 0.4 ppm, grapes at 1.0 

ppm, and strawberry at 6 ppm 

(proposed) for residues of hexythiazox 

and its metabolites containing the PT– 

1–3-moiety, expressed as hexythiazox. 

The U.S. is currently harmonized with 

Codex with respect to residue definition 

in plants, and is recommending 

tolerances for CG 11–10 (pome fruit), 

CSG 13–07F (small, vine climbing fruit, 

except kiwifruit), and CSG 13–07G (low 

growing berry) that are harmonized with 

the current Codex MRLs for pome fruit, 

grapes (representative commodity of 

CSG 13–07F), and strawberry 

(representative commodity of CSG 13– 

07G). The current Codex MRL of 0.1 

ppm for eggplant is based on a use in 

the Netherlands at a significantly lower 

application rate than the use currently 

proposed in the U.S. The Codex MRL 

would not cover residues seen in the 

U.S. field trial data; therefore 

harmonization with codex with respect 

to eggplants is not possible at this time. 

The Agency is currently harmonized 

with Codex with respect to the residue 

definition in livestock commodities. 

The current milk tolerance of 0.05 ppm 

is harmonized with the Codex MRL for 

milk. The Agency is recommending an 

increase in the ruminant meat 

byproduct tolerances to 0.5 ppm and an 

increase in the current egg tolerance to 

0.05 ppm to harmonize with Codex. 

The Agency classified the use on 

poultry meat at § 180.6(a)(3), no 

reasonable expectation of finite 

residues; therefore the U.S. will not 

need to set a tolerance for this 

commodity. The relevant Codex MRL 

has been set at 0.05 ppm with a footnote 

that states ‘‘absent at the limit of 

quantitation’’. Effectively, the Codex 

MRL acknowledges the absence of 

residues and the U.S. determination that 

no tolerance is required results in a 

harmonized approach to residues in 

poultry meat. There are no Canadian or 

Mexican MRLs currently established for 

hexythiazox. 

C. Revisions to Petitioned-For 

Tolerances 

Based on EPA’s review of the data 

supporting the petitions, Gowan 

Company revised their petition PP 

2F8054 as follows: 

• By adding a request for an increase 

in the established tolerance for grain, 

aspirated fractions from 0.5 ppm to 5 

ppm. The submitted residue chemistry 

data show that sorghum residues 

concentrate in aspirated grain fractions 

(AGF), and that an increased tolerance 

of 5 ppm is needed to cover residues in 

sorghum AGF. 

• By deleting the proposed tolerance 

for poultry, meat; and the proposed 

changes to the established tolerances for 

milk; and poultry, meat byproducts. 

Poultry metabolism and feeding studies 

demonstrate that there are not likely to 

be residues in poultry meat; therefore a 

tolerance on poultry meat is not 

required. The data also shows that the 

current tolerances for milk; and poultry, 

meat byproducts; are adequate and no 

changes are required at this time. 

The IR–4 revised their petition PP 

2E8016 as follows: 

• By increasing the proposed 

tolerances for fruit, pome, group,11–10 

from 0.25 ppm to 0.4 ppm; and for 

berry, low growing, subgroup13–07G 

from 3 ppm to 6 ppm. The Agency is 

recommending these changes to 

harmonize with Codex MRLs. 

The Agency is also removing the 

established tolerances for fruit, pome, 

group 11; caneberry subgroup 13A; 

grape; and strawberry from 40 CFR. 

These tolerances are being replaced by 

the fruit, pome, group 11–10; caneberry 

subgroup 13–07A; fruit, small, vine 

climbing, subgroup 13–07F, except 

fuzzy kiwifruit; and berry, low growing, 

subgroup 13–07G, respectively. The 

Agency concluded that based on the 

residue data, these changes are required 

to support the new uses. 


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42698 Federal Register / Vol. 78, No. 137 / Wednesday, July 17, 2013 / Rules and Regulations 

V. Conclusion 

Therefore, tolerances are established 

for residues of hexythiazox and its 

metabolites containing the (4- 

chlorophenyl)-4-methyl-2-oxo-3- 

thiazolidine moiety, as requested in the 

petitions. 

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: July 2, 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 § 180.448: 

■ a. Remove the following commodities 

in the table in paragraph (a) ‘‘Caneberry 

subgroup 13A;’’ ‘‘Fruit, pome, group 

11;’’ ‘‘Grape;’’ and ‘‘Strawberry.’’ 

■ b. Revise the following commodities 

in the table in paragraph (a) ‘‘Cattle, 

meat byproducts;’’ ‘‘Egg;’’ ‘‘Goat, meat 

byproducts;’’ ‘‘Grain, aspirated 

fractions;’’ ‘‘Horse, meat byproducts;’’ 

and ‘‘Sheep, meat byproducts.’’ 

■ c. Add alphabetically the 

commodities to the table in paragraph 

(a). 

■ d. Revise the following commodities 

in the table in paragraph (c) ‘‘Cotton, gin 

byproducts, CA only;’’ and ‘‘Cotton, 

undelinted seed, CA only.’’ 

■ e. Add alphabetically the 

commodities to the table in paragraph 

(c). 

The revisions and additions read as 

follows: 

§ 180.448 Hexythiazox; tolerance for 

residues. 

(a) General. * * * 

Commodity Parts per 

million 

*****

Berry, low growing, subgroup 

13–07G ................................. 6 

Caneberry subgroup 13–07A ... 1 

*****

Cattle, meat byproducts ........... 0 .5 

*****

Egg ........................................... 0 .05 

Fruit, pome, group 11–10 ......... 0 .4 

Fruit, small, vine climbing, subgroup 13–07F, except fuzzy 

kiwifruit .................................. 1 

*****

Goat, meat byproducts ............. 0 .5 

Grain, aspirated fractions ......... 5 

*****

Horse, meat byproducts ........... 0 .5 

*****

Pepper/eggplant subgroup 8– 

10B ........................................ 1 .5 

*****

Sheep, meat byproducts .......... 0 .5 

*****

* * * * * 

(c) Tolerances with regional 

registrations. * * * 

Commodity Parts per 

million 

*****

Cotton, gin byproducts, CA and 

AZ only .................................. 3 .0 

Cotton, undelinted seed, CA 

and AZ only ........................... 0 .20 

*****

Sorghum, grain, forage (EPA 

Regions 6–8 only) ................. 5 

Sorghum, grain, grain (EPA Regions 6–8 only) ..................... 3 

Sorghum, grain, stover (EPA 

Regions 6–8 only) ................. 6 


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Federal Register / Vol. 78, No. 137 / Wednesday, July 17, 2013 / Rules and Regulations 42699 

Commodity Parts per 

million 

*****

* * * * * 

[FR Doc. 2013–16911 Filed 7–16–13; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Parts 1 and 54 

[CC Docket No. 02–6; FCC 13–81] 

Application for Review of a Decision of 

the Wireline Competition Bureau by 

Dooly County School System; Schools 

and Libraries Universal Service 

Support Mechanism 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule. 

SUMMARY: In this document, the Federal 

Communications Commission 

(Commission), denies in part and 

dismisses in part an Application for 

Review filed by the Dooly County 

School System and rescinds the 

remaining interim filing procedures 

established by the Commission in the 

2001 Interim Filing Procedures Order. 

These actions are needed to provide 

clarity and certainty as to the filing 

deadline for applications for review 

arising from Universal Service 

Administrative Company-related 

proceedings. 

DATES: Effective August 16, 2013. 

FOR FURTHER INFORMATION CONTACT: 

Regina Brown, Attorney, Wireline 

Competition Bureau, (202) 418–0792 or 

TTY: (202) 418–0484. 

SUPPLEMENTARY INFORMATION: This is a 

summary of that portion of the 

Commission’s Order which rescinds the 

remaining interim filing procedure 

established by the Commission in the 

2001 Interim Filing Procedures Order in 

CC Docket No. 02–6; FCC 13–81, 

released on June 10, 2013. The full text 

of this document is available for public 

inspection during regular business 

hours in the FCC Reference Center, 

Room CY–A257, 445 12th Street SW., 

Washington, DC 20554 or at the 

following Internet address: http:// 

transition.fcc.gov/Daily_Releases/ 

Daily_Business/2012/db0425/DA–12– 

646A1.pdf. 

1. As codified in the Code of Federal 

Regulations, the Commission’s rules 

state that ‘‘the application for review 

and any [supplement] thereto shall be 

filed within 30 days of public notice of 

such action.’’ Dooly County’s 

Application for Review was filed on 

January 10, 2012, which was more than 

30 days after public notice of the 

Bureau’s Al-Ihsan Academy Order, 

which was released on December 5, 

2011. Therefore, in its Application for 

Review, Dooly County also seeks a 

waiver of the application for review 

filing deadline, if needed. As an initial 

matter, however, Dooly County argues 

that a waiver of the deadline for filing 

an application for review is unnecessary 

because the current deadline for filing 

an application for review arising from 

USAC-related proceedings is 60 days 

from public notice of such action as 

established in the Commission’s 

December 2001 Interim Filing 

Procedures Order, 67 FR 3441, January 

24, 2002, and not 30 days as provided 

in the Code of Federal Regulations. 

Because we dismiss in part Dooly 

County’s Application for Review on the 

basis that Dooly County did not afford 

the Bureau an opportunity to address 

the arguments raised in its Application 

for Review, and deny it in part with 

respect to its argument previously raised 

with and denied by the Bureau, and 

because Dooly County did not 

demonstrate good cause exists 

warranting a waiver of the 

Commission’s rules, we need not 

address the question of whether Dooly 

County’s filing was timely. 

2. However, to provide clarity and 

certainty as to the filing deadline for 

applications for review arising from 

USAC-related proceedings, we take this 

opportunity to rescind the interim 

emergency filing procedures for 

applications for review arising from 

USAC-related proceedings established 

by the Commission the Interim Filing 

Procedures Order. In the Interim Filing 

Procedures Order, due to emergency 

events in Washington, DC arising from 

the September 11, 2001 terrorist attacks, 

the Commission amended its procedural 

rules ‘‘on an emergency, interim basis 

. . . to extend the period of filing a 

request for review, or applications for 

review arising from [USAC-related] 

proceedings, from the current 30 day 

period to 60 days, to provide applicants 

with the option of electronic filing (via 

either electronic mail or facsimile) for 

requests for review and petitions for 

reconsideration or applications for 

review that arise from such pleadings.’’ 

until further notice. Subsequently, in 

April 2003, the Commission released 

the Schools and Libraries Second Report 

and Order, 68 FR 36931, June 20, 2003, 

which permanently extended the 

deadline for filing initial appeals with 

USAC or the Commission to 60 days. 

The Schools and Libraries Second 

Report and Order did not, however, 

address the extended filing period for 

applications for review. Subsequently, 

the Commission rescinded all other 

emergency filing procedures adopted in 

late 2001 with the exception of the 

emergency filing procedures established 

in the Interim Filing Procedures Order. 

By this Order, we therefore rescind the 

interim filing procedures established by 

the Commission in the Interim Filing 

Procedures Order. As stated by the 

Commission in the Interim Filing 

Procedures Rescission Order, mail 

delivery in the Washington, DC area has 

greatly improved since 2001 and the 

United States Postal Service has greatly 

reduced the delay in processing mail. 

Also, the Commission has since 2001 

expanded it electronic filing 

capabilities, and implemented its own 

processes to combat the threat of 

contamination of incoming mail. Given 

these circumstances, we conclude that 

the interim electronic filing procedures 

adopted by the Commission in 2001 are 

no longer necessary. Accordingly, we 

rescind those procedures, effective 30 

days after publication of this Order in 

the Federal Register. Thereafter, filings 

of applications for review arising from 

USAC-related proceedings will no 

longer be accepted by facsimile or email 

and will be due within 30 days from 

public notice of such action, as 

provided in the Commission’s rules. 

Once these clarifications take effect, the 

Bureau will issue a Public Notice 

announcing their effectiveness and 

explaining the correct procedures. 

3. This document does not contain 

new or modified information collection 

requirements subject to the Paperwork 

Reduction Act of 1995 (PRA), Public 

Law 104–13. In addition, therefore, it 

does not contain any new or modified 

information collection burden for small 

business concerns with fewer than 25 

employees, pursuant to the Small 

Business Paperwork Relief Act of 2002, 

Public Law 107–198, see 44 U.S.C. 

3506(c)(4). 

4. Accordingly, it is ordered that, 

pursuant to the authority of section 4(i) 

of the Communications Act of 1934, as 

amended, 47 U.S.C. 154(i), the interim 

electronic filing procedures adopted in 

the Interim Filing Procedures Order, 

FCC 01–376, are rescinded. 

5. It is further ordered that the 

rescission of the interim electronic filing 

procedures adopted in the Interim Filing 

Procedures Order shall become effective 

August 16, 2013. 


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