51492 Federal Register / Vol. 79, No. 168 / Friday, August 29, 2014 / Rules and Regulations 

11. Indian Tribal Governments 

This proposed rule does not have 

tribal implications under Executive 

Order 13175, Consultation and 

Coordination with Indian Tribal 

Governments, because it would not have 

a substantial direct effect on one or 

more Indian tribes, on the relationship 

between the Federal Government and 

Indian tribes, or on the distribution of 

power and responsibilities between the 

Federal Government and Indian tribes. 

12. Energy Effects 

This proposed rule is not a 

‘‘significant energy action’’ under 

Executive Order 13211, Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use. 

13. Technical Standards 

This proposed rule does not use 

technical standards. Therefore, we did 

not consider the use of voluntary 

consensus standards. 

14. Environment 

We have analyzed this proposed rule 

under Department of Homeland 

Security Management Directive 023–01 

and Commandant Instruction 

M16475.lD, which guide the Coast 

Guard in complying with the National 

Environmental Policy Act of 1969 

(NEPA) (42 U.S.C. 4321–4370f), and 

have made a preliminary determination 

that this action is one of a category of 

actions that do not individually or 

cumulatively have a significant effect on 

the human environment. This proposed 

rule establishes a temporary safety zone 

to protect the public from fireworks 

fallout. This rule is categorically 

excluded from further review under 

paragraph 34(g) of Figure 2–1 of the 

Commandant Instruction. A preliminary 

environmental analysis checklist 

supporting this determination and a 

Categorical Exclusion Determination are 

available in the docket where indicated 

under ADDRESSES. We seek any 

comments or information that may lead 

to the discovery of a significant 

environmental impact from this 

proposed rule. 

List of Subjects in 33 CFR Part 165 

Harbors, Marine safety, Navigation 

(water), Reporting and recordkeeping 

requirements, Security measures, and 

Waterways. 

For the reasons discussed in the 

preamble, the Coast Guard proposes to 

amend 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, 160.5; Pub. L. 

107–295, 116 Stat. 2064; Department of 

Homeland Security Delegation No. 0170.1. 

■ 2. Add temporary § 165.T05–0723 to 

read as follows: 

§ 165.T05–0723 Safety Zone, Shallowbag 

Bay; Manteo, NC. 

(a) Definitions. For the purposes of 

this section, Captain of the Port means 

the Commander, Sector North Carolina. 

Representative means any Coast Guard 

commissioned, warrant, or petty officer 

who has been authorized to act on the 

behalf of the Captain of the Port. 

(b) Location. The following area is a 

safety zone: This safety zone will 

encompass all waters on Shallowbag 

Bay within a 200 yard radius of a barge 

anchor in position 35°54′31′′ N, 

longitude 075°39′42′′ W. All geographic 

coordinates are North American Datum 

1983 (NAD 83). 

(c) Regulations. (1) The general 

regulations contained in § 165.23 of this 

part apply to the area described in 

paragraph (b) of this section. 

(2) Persons or vessels requiring entry 

into or passage through any portion of 

the safety zone must first request 

authorization from the Captain of the 

Port, or a designated representative, 

unless the Captain of the Port 

previously announced via Marine Safety 

Radio Broadcast on VHF Marine Band 

Radio channel 22 (157.1 MHz) that this 

regulation will not be enforced in that 

portion of the safety zone. The Captain 

of the Port can be contacted at telephone 

number (910) 343–3882 or by radio on 

VHF Marine Band Radio, channels 13 

and 16. 

(d) Enforcement. The U.S. Coast 

Guard may be assisted in the patrol and 

enforcement of the zone by Federal, 

State, and local agencies. 

(e) Enforcement period. This section 

will be enforced from 8 p.m. to 10 p.m. 

on September 26, 2014 unless cancelled 

earlier by the Captain of the Port. 

Dated: August 14, 2014. 

S. R. Murtagh, 

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

Port North Carolina. 

[FR Doc. 2014–20675 Filed 8–28–14; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0297; FRL–9911–57] 

Kasugamycin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of kasugamycin in 

or on fruit, pome. Arysta LifeScience 

North America, LLC (Arysta 

LifeScience), requested a number of 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA) which 

are addressed in this document. 

DATES: This regulation is effective 

August 29, 2014. Objections and 

requests for hearings must be received 

on or before October 28, 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–2010–0297, 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; 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 


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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://ecfr.gpoaccess.gov/cgi/t/

text/text-idx?&c=ecfr&tpl=/ecfrbrowse/

Title40/40tab_02.tpl. To access the 

OCSPP test guidelines referenced in this 

document electronically, please go to 

http://www.epa.gov/ocspp and select 

‘‘Test Methods and Guidelines.’’ 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2010–0297 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 October 28, 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– 

2010–0297, 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.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 May 19, 

2010 (75 FR 28009) (FRL–8823–2), 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 0F7689) by Arysta 

LifeScience North America, LLC, 15401 

Weston Parkway, Cary, NC 27513. The 

petition requested that 40 CFR 180.614 

be amended by establishing tolerances 

for residues of the fungicide 

kasugamycin, in or on fruiting 

vegetables (crop group 8) at 0.15 parts 

per million (ppm), pome fruit (crop 

group 11) at 0.25 ppm, and walnuts at 

0.04 ppm. That document referenced a 

summary of the petition prepared by 

Arysta LifeScience, the registrant, which 

is available in the docket, http://

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

Based upon review of the data 

supporting the petition, EPA has 

modified the proposed tolerance levels 

and the crops for which tolerances will 

be established. The reasons for these 

changes are explained in Unit IV.C. The 

tolerance in imported fruiting 

vegetables, crop group 8 is not being 

removed or revised at this time. This 

regulation additionally deletes the timelimited tolerance for apple, as the 

tolerance will be superseded by 

permanent tolerances in the various 

pome fruits. 

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 kasugamycin on 

pome commodities, including exposure 

resulting from the tolerances established 

by this action. EPA’s assessment of 

exposures and risks associated with 

kasugamycin 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. 

Kasugamycin is a member of the 

aminoglycoside family of antibiotics, 

which also includes streptomycin and 

gentamicin. These agents inhibit 

bacterial protein synthesis by binding to 

the 30S subunit of the bacterial 

ribosome. Their penetration through the 

cell membrane of the bacterium 

depends partly on oxygen-dependent 

active transport by a polyamine carrier 

system that seems to be absent in 

mammalian systems. 

Kasugamycin exhibits low acute 

toxicity, being only a mild dermal and 

ocular irritant. The major effects 

observed across species in multipledose studies were decreased body 

weights and body weight gains. The 

primary target organs identified for 

kasugamycin were the testes and kidney 

in the rat and mouse. However, these 

effects were only seen at higher dose 

levels, generally at the highest dose 

tested (HDT). In the combined chronic 

toxicity/carcinogenicity study in rats, 

the basis for the lowest-observedadverse-effect level (LOAEL) was an 

increased incidence and severity of 

testicular tubular atrophy, observed 

during the histopathologic examinations 

at the end of the 2-year dosing period, 

as well as at 6 months, and 1 year. 

Testicular degeneration and atrophy 


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were observed in adult F1 males in the 

rat reproductive toxicity study at the 

highest dose. Testicular tubular 

dilatation and degeneration were 

observed in the mouse subchronic 

study, but at a dose that exceeded the 

limit dose; the mouse carcinogenicity 

study tested at much lower doses, and 

these effects were not observed. In the 

dog chronic toxicity study, testicular 

inflammation was reported at the high 

dose, but was not accompanied by 

atrophic or degenerative changes, and 

was not considered a treatment-related 

adverse effect. 

Kidney toxicity is often associated 

with exposure to aminoglycoside 

antibiotics, and the metabolism study 

indicated higher levels of radioactivity 

in the kidneys than other tissues. In 

male F1 rats in the reproductive toxicity 

study, dilatation of the kidney, and an 

increased incidence of chronic 

progressive nephropathy were observed. 

In the subchronic rat study, an 

increased incidence of eosinophilic 

bodies (graded slight for severity) in the 

renal proximal tubular cells was 

reported in males at several dose levels. 

These effects were considered treatment 

related, but not adverse due to their low 

severity grade, and lack of associated 

findings. However, in female rats, 

increased epithelial cells in the urinary 

sediment, along with decreased urine 

pH (decreased pH was also seen in 

males), were observed at the high dose, 

and considered evidence of possible 

kidney toxicity. Lipofuscin deposition 

(slight) was observed in the rat 

combined chronic toxicity/

carcinogenicity study, but was not 

considered adverse due to the lack of 

other related findings; this study tested 

up to the no-observed-adverse-effect 

level (NOAEL) of the subchronic study. 

In the mouse, following subchronic 

exposure, minimal to severe basophilia/ 

hyperplasia in the renal pars recta in 

females was observed. No renal effects 

were reported in the mouse 

carcinogenicity study at lower doses, or 

in the dog subchronic or chronic 

studies. 

There was no evidence that exposure 

to kasugamycin results in neurotoxicity, 

and a developmental neurotoxicity 

(DNT) study is not required. Also, there 

was no evidence of immune system 

effects based on the review of a 

submitted immunotoxicity study. 

Although a 28-day rat inhalation 

toxicity study was not submitted, EPA 

has determined that it is not required 

based on available hazard and exposure 

information. 

The database is complete with respect 

to pre- and postnatal toxicity, and 

shows no evidence of increased 

qualitative or quantitative susceptibility 

in the offspring, or in the developing 

fetus. There was no evidence of 

carcinogenicity in male and female 

mice, nor in male and female rats at 

doses that were adequate to assess the 

carcinogenic potential of kasugamycin. 

There was no evidence of mutagenicity. 

Based on the overall weight of the 

evidence, kasugamycin is classified as 

‘‘not likely to be carcinogenic to 

humans.’’ 

Although antimicrobial drug residues 

present in or on food may cause adverse 

effects on the ecology of the intestinal 

microflora of consumers, the Agency 

does not believe this is a concern for 

kasugamycin because of the use pattern 

(application occurring prior to fruit 

development) and low residue detection 

in field trials. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by kasugamycin as well 

as the NOAEL and the LOAEL from the 

toxicity studies can be found at http:// 

www.regulations.gov in document 

‘‘Kasugamycin. Human Health Risk 

Assessment for the Proposed Use of the 

Fungicide on Fruiting Vegetables, Pome 

Fruits, and Walnuts’’ at pp. 15–21 in 

docket ID number EPA–HQ–OPP–2010– 

0297. 

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 (LOC) 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 NOAEL and the LOAEL 

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 kasugamycin used for human risk 

assessment is shown in Table 1 of this 

unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR KASUGAMYCIN RELEVANT TO FFDCA ANALYSIS

Exposure scenario Point of departure Uncertainty and 

FQPA SF 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Acute dietary (all populations) ..... An appropriate dose and endpoint for this risk assessment scenario was not identified, based on a lack of 

single-dose effects in the database. 

Chronic dietary (all populations 

including infants and children, 

and females age 13 to 49).

NOAEL = 11 mg/kg/

day.

UFA = 10X 

UFH = 10X 

FQPA SF = 1X 

Chronic RfD = 0.11 

mg/kg/day.

cPAD = 0.11 mg/kg/

day.

Combined chronic toxicity/carcinogenicity study in the rat. 

LOAEL = 116 mg/kg/day, based 

on testicular atrophy and softening. 

Cancer (oral, dermal, inhalation) Classification: ‘‘Not likely to be carcinogenic to humans.’’ 

Point of Departure = a data point or estimated point derived from observed dose-response data, which is used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. UF = uncertainty factor. UFA = extrapolation from 

animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). FQPA SF = Food 

Quality Protection Act Safety Factor. NOAEL = no-observed-adverse-effect level. LOAEL = lowest-observed-adverse-effect level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. LOC = level of concern. 


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C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to kasugamycin, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing kasugamycin tolerances in 40 

CFR 180.614. EPA assessed dietary 

exposures from kasugamycin 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 kasugamycin; 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 United 

States Department of Agriculture 

(USDA) 1994–1996 and the 1998 

Nationwide Continuing Surveys of Food 

Intake by Individuals (CSFII). An 

unrefined chronic aggregate dietary 

(food and drinking water) exposure and 

risk assessment was conducted using 

the Dietary Exposure Evaluation Model 

software with the Food Commodity 

Intake Database (DEEM–FCIDTM), 

Version 2.03. The residue inputs into 

the dietary model were the 

recommended tolerance level residues 

and default processing factors were 

used, with the exception of the apple 

juice processing factor, for which the 

1.5X data-derived processing factor was 

used. EPA assumed 100% crop treated 

(PCT) for all proposed uses. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that kasugamycin does not 

pose a cancer risk to humans. Therefore, 

a quantitative dietary exposure 

assessment for the purpose of assessing 

cancer risk is unnecessary. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for kasugamycin. 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 kasugamycin in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

kasugamycin. 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 kasugamycin for chronic exposures 

for non-cancer assessments are 

estimated to be 0.001178 ppm for 

surface water. EDWCs of kasugamycin 

for ground water were estimated to be 

0.000116 ppm via the Screening 

Concentration in Ground Water (SCI– 

GROW) system. Modeled estimates of 

drinking water concentrations were 

directly entered into the dietary 

exposure model. For chronic dietary 

risk assessment, the water concentration 

of value 0.001178 ppm 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). 

Kasugamycin 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 kasugamycin to share a common 

mechanism of toxicity with any other 

substances, and kasugamycin does not 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that 

kasugamycin 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 Safety 

Factor (FQPA 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 was no evidence of increased 

quantitative or qualitative susceptibility 

in rat or rabbit developmental toxicity 

studies, or in the rat reproductive study. 

No developmental effects were seen in 

the rat developmental study, whereas 

maternal toxicity (decreased body 

weight gain, food consumption, and 

feed efficiency) was observed at the 

highest dose. Although no maternal or 

developmental toxicity was observed in 

the main rabbit developmental toxicity 

study, in the dose range-finding study, 

maternal weight loss, reduced food 

consumption during dosing, and 

abortions (occurring at GD 18 or later) 

were observed at higher doses. Fetal 

weight was decreased at the maternally 

toxic dose but, due to abortions or 

maternal death, was not evaluated at the 

higher doses. In the rat reproductive 

toxicity study, parental toxicity 

included decreased parental body 

weight/weight gain at the mid and high 

doses. No offspring toxicity was 

observed. Reproductive toxicity was 

observed only at the highest dose tested 

(above the parental LOAEL), with 

testicular atrophy, decreased fertility 

and fecundity in the F1 parents for both 

litters, and an increased pre-coital 

interval during the mating period for the 

F2b litter. 

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 for the following 

reasons: 

i. The toxicity database for 

kasugamycin is complete, including rat 

acute and subchronic neurotoxicity 

screening studies and a mouse 

immunotoxicity study. Based on the 

lack of observed neurotoxicity, a DNT 

study is not required. Furthermore, a 28- 

day inhalation study is not required 

based on the available hazard and 

exposure information and proposed and 

existing uses for kasugamycin. 

ii. There is no evidence of increased 

quantitative or qualitative pre- and/or 

postnatal susceptibility observed in 

developmental toxicity studies in the rat 

and rabbit, or in a 2-generation 

reproduction study in the rat. 


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iii. The exposure assessment for food 

and drinking water will not 

underestimate potential dietary 

exposure to kasugamycin. There are no 

proposed or existing residential uses for 

kasugamycin. 

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, kasugamycin 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 kasugamycin 

from food and water are below HED’s 

LOC of 100% of the cPAD for all 

population subgroups. The most highly 

exposed population subgroup, children 

1–2 years old, had a risk estimate of 

1.7% cPAD. There are no residential 

uses for kasugamycin to aggregate with 

chronic exposure to kasugamycin from 

food and water. 

3. Short- and intermediate-term risk. 

Short- and intermediate-term aggregate 

exposures take into account short- and 

intermediate-term residential exposures 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). Because there are no 

residential uses for kasugamycin, 

kasugamycin is not expected to pose a 

short- or intermediate-term risk. 

4. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

kasugamycin 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 kasugamycin 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

high-performance liquid 

chromatography with ultraviolet 

detection (HPLC/UV) 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 kasugamycin. 

C. Revisions to Petitioned-For 

Tolerances 

As EPA explained in its latest crop 

group rulemaking published in the 

Federal Register of August 22, 2012 (77 

FR 50617) (FRL–9354–3), EPA will 

attempt to conform petitions seeking 

tolerances for crop groups to the newer 

established crop groups, rather than 

establish new tolerances under the preexisting crop groups, as part of its effort 

to eventually convert tolerances for any 

pre-existing crop group to tolerances 

with coverage under the revised crop 

group. Therefore, although the 

petitioner requested tolerances for crop 

group 11 (pome fruit), EPA evaluated 

tolerances for crop group 11–10 (pome 

fruit). 

Based on the available residue data 

and using the Organization for 

Economic Co-operation and 

Development (OECD) tolerance 

calculation procedure, EPA is 

establishing a tolerance of 0.20 ppm for 

residues of kasugamycin in or on fruit, 

pome (crop group 11–10). 

EPA also is not establishing tolerances 

for walnuts and fruiting vegetables 

because the petitioner withdrew its 

tolerance requests for those 

commodities. 

The Agency has revised the tolerance 

expression in 40 CFR 180.614(a) to 

clarify: 

1. That, as provided in FFDCA section 

408(a)(3), the tolerance covers 

metabolites and degradates of 

kasugamycin not specifically 

mentioned. 

2. That compliance with the specified 

tolerance levels is to be determined by 

measuring only the specific compounds 

mentioned in the tolerance expression. 

V. Conclusion 

Therefore, tolerances are established 

for residues of kasugamycin, in or on 

pome fruits (crop group 11–10) at 0.20 

ppm. This regulation additionally 

deletes the time-limited tolerance for 

apple, as the tolerance will be 

superseded by permanent tolerances in 

the various pome fruits. 

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. 


wreier-aviles on DSK5TPTVN1PROD with RULES
Federal Register / Vol. 79, No. 168 / Friday, August 29, 2014 / Rules and Regulations 51497 

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: August 20, 2014. 

Marty Monell, 

Acting Director, Office of Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Revise § 180.614 to read as follows: 

§ 180.614 Kasugamycin; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of kasugamycin, 

including its metabolites and 

degradates, in or on the commodities 

listed in the following table. 

Compliance with the tolerance levels 

specified is to be determined by 

measuring only kasugamycin (3-O-[2- 

amino-4-[(carboxyimino-methyl)amino]- 

2,3,4,6-tetradeoxy-a-D-arabinohexopyranosyl]-D-chiro-inositol) in or 

on the commodity. 

Commodity Parts per 

million 

Fruit, pome, group 11–10 ......... 0.20 

Vegetable, fruiting, group 8 1 .... 0.04 

1There is no U.S. registration as of September 1, 2005. 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 2014–20502 Filed 8–28–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 271 

[FRL–9915–97–Region–6; EPA–R06–RCRA– 

2013–0785] 

Oklahoma: Final Authorization of State 

Hazardous Waste Management 

Program Revision 

AGENCY: Environmental Protection 

Agency. 

ACTION: Direct final rule. 

SUMMARY: Oklahoma Department of 

Environmental Quality (ODEQ) has 

applied to the Environmental Protection 

Agency (EPA) for Final authorization of 

the changes to its hazardous waste 

program under the Resource 

Conservation and Recovery Act (RCRA). 

EPA has determined that these changes 

satisfy all requirements needed to 

qualify for Final authorization, and is 

authorizing the State’s changes through 

this immediate final action. The EPA is 

publishing this rule to authorize the 

changes without a prior proposal 

because we believe this action is not 

controversial and do not expect 

comments that oppose it. Unless we 

receive written comments which oppose 

this authorization during the comment 

period, the decision to authorize 

Oklahoma’s changes to its hazardous 

waste program will take effect. If we 

receive comments that oppose this 

action, we will publish a document in 

the Federal Register withdrawing this 

rule before it takes effect, and a separate 

document in the proposed rules section 

of this Federal Register will serve as a 

proposal to authorize the changes. 

DATES: This final authorization will 

become effective on October 28, 2014 

unless the EPA receives adverse written 

comment by September 29, 2014. If the 

EPA receives such comment, it will 

publish a timely withdrawal of this 

immediate final rule in the Federal 

Register and inform the public that this 

authorization will not take effect. 

ADDRESSES: Submit your comments by 

one of the following methods: 

1. Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

2. Email: patterson.alima@epa.gov. 

3. Mail: Alima Patterson, Region 6, 

Regional Authorization Coordinator, 

State/Tribal Oversight Section (6PD–O), 

Multimedia Planning and Permitting 

Division, EPA Region 6, 1445 Ross 

Avenue, Dallas, Texas 75202–2733. 

4. Hand Delivery or Courier. Deliver 

your comments to Alima Patterson, 

Region 6, Regional Authorization 

Coordinator, State/Tribal Oversight 

Section (6PD–O), Multimedia Planning 

and Permitting Division, EPA Region 6, 

1445 Ross Avenue, Dallas, Texas 75202– 

2733. 

Instructions: Do not submit 

information that you consider to be CBI 

or otherwise protected through 

regulations.gov, or email. The Federal 

regulations.gov Web site is an 

‘‘anonymous access’’ system, which 

means the 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 the EPA without 

going through 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, the 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 the EPA cannot read your 

comment due to technical difficulties 

and cannot contact you for clarification, 

the 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. 

You can view and copy Oklahoma’s 

application and associated publicly 


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