Federal Register / Vol. 81, No. 66 / Wednesday, April 6, 2016 / Rules and Regulations 19891 

control number and adding, in its place, 

‘‘2900–0219’’. 

The addition reads as follows: 

§ 17.903 Payme. 

(a)(1) * * * For those services or 

benefits covered by §§ 17.900 through 

17.905 but not covered by CHAMPVA 

we will use payment methodologies the 

same or similar to those used for 

equivalent services or benefits provided 

to veterans. 

* * * * * 

§ 17.904 [Amended] 

■ 5. Amend § 17.904 by, at the end of 

the section, removing ‘‘2900–0578’’ 

from the notice of the Office of 

Management and Budget control 

number and adding, in its place, ‘‘2900– 

0219’’. 

[FR Doc. 2016–07897 Filed 4–5–16; 8:45 am] 

BILLING CODE 8320–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2015–0338 and EPA–HQ– 

OPP–2015–0339; FRL–9942–32] 

Hexythiazox; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends 

tolerances for residues of hexythiazox in 

or on citrus and cotton. Gowan 

Company requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective April 

6, 2016. Objections and requests for 

hearings must be received on or before 

June 6, 2016, 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 dockets for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2015–0338 and 

EPA–HQ–OPP–2015–0339, are 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: 

Susan Lewis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main telephone 

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

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2015–0338 and EPA–HQ–OPP– 

2015–0339 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 June 6, 2016. 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– 

2015–0338 and EPA–HQ–OPP–2015– 

0339, 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 July 17, 

2015 (80 FR 42462) (FRL–9929–13), 

EPA issued a document pursuant to 

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

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

pesticide petitions (PP 5F8346 and PP 

5F8356) by Gowan Company, P.O. Box 

5569, Yuma, AZ 85366–5569. The 

petitions requested that tolerances 

currently listed in 40 CFR 180.448 be 

amended for residues of the insecticide 

hexythiazox and its metabolites 

containing the (4-chlorophenyl)-4- 

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

or on citrus, dried pulp at 0.6 parts per 

million (ppm); citrus, oil at 26 ppm; 

fruit, citrus, group 10 at 0.6 ppm; cotton 

gin byproducts at 15 ppm; and cotton, 

undelinted seed at 0.5 ppm. That 

document referenced a summary of the 

petitions prepared by Gowan Company, 

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 

revoked citrus, dried pulp tolerance as 

it is covered by the recommended fruit, 

citrus, group 10–10 tolerance. For citrus 

oil, EPA revised the tolerance to 25 ppm 

and for cotton undelinted seed to 0.4 


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ppm. The reasons for these changes are 

explained in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

Consistent with FFDCA section 

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

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for 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. Hexythiazox has 

low acute toxicity by oral, dermal and 

inhalation routes of exposure. It is not 

a dermal irritant, is negative for dermal 

sensitization and produces only mild 

eye irritation. 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 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 weight of evidence 

indicates that assessing chronic risk 

using the chronic population adjusted 

dose will be protective for any potential 

carcinogenic effects. Since the effects 

seen in the study that serves as the basis 

for the chronic PAD occurred at doses 

substantially below the lowest dose that 

induced tumors, the chronic PAD is 

considered protective of all chronic 

effects including potential 

carcinogenicity. 

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 the document: 

Hexythiazox. Human Health Risk 

Assessment to Support Amended Uses 

on Cotton and Citrus in docket ID 

number EPA–HQ–OPP–2015–0338 or 

EPA–HQ–OPP–2015–0339. 

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 

shown in Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR HEXYTHIAZOX FOR USE IN HUMAN HEALTH RISK

ASSESSMENT

Exposure/scenario 

Point of departure 

and 

uncertainty/safety 

factors 

RfD, PAD, LOC for 

risk 

assessment 

Study and toxicological effects 

Acute dietary (All populations) .. No risk is expected from this exposure scenario as no hazard was identified in any toxicity study for this duration of exposure. 

Chronic dietary (All populations) NOAEL = 2.5 mg/kg/

day UFA = 10x.

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.025 

mg/kg/day.

cPAD = 0.025 mg/

kg/day 

1-year toxicity feeding study—Dog 

LOAEL = 12.5 mg/kg/day based on increased absolute and relative adrenal weights and associated adrenal histopathology. 


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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR HEXYTHIAZOX FOR USE IN HUMAN HEALTH RISK

ASSESSMENT—Continued 

Exposure/scenario 

Point of departure 

and 

uncertainty/safety 

factors 

RfD, PAD, LOC for 

risk 

assessment 

Study and toxicological effects 

Incidental oral short-term (1 to 

30 days) and intermediateterm (1 to 6 months).

NOAEL = 30 mg/kg/

day UFA = 10x.

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 2-generation reproduction study—Rat. 

LOAEL = 180 mg/kg/day based on decreased pup body weight 

during lactation and delayed hair growth and/or eye opening, 

and decreased parental body-weight gain and increased absolute and relative liver, kidney, and adrenal weights. 

Co-critical 

13-Week Oral Toxicity Study—Rat. 

NOAEL = 5.5 mg/kg/day 

LOAEL = 38 mg/kg/day, based on increased absolute and relative liver weights in both sexes, increased relative ovarian 

and kidney weights, and fatty degeneration of the adrenal 

zona fasciculata. 

@397.5/257.6 mg/kg/day, decreased body-weight gain in females, slight swelling of hepatocytes in central zone (both 

sexes), increased incidence of glomerulonephrosis in males, 

increased adrenal weights. 

Inhalation short-term (1 to 30 

days) and 

intermediate-term (1 to 6 

months).

Oral study NOAEL = 

30 mg/kg/day (inhalation absorption 

rate = 100%).

UFA = 10x 

UFH = 10x 

LOC for MOE = 100 2-generation reproduction study—Rat. 

LOAEL = 180 mg/kg/day based on decreased pup body weight 

during lactation and delayed hair growth and/or eye opening, 

and decreased parental body-weight gain and increased absolute and relative liver, kidney, and adrenal weights. 

Co-Critical 

13-Week Feeding Study—Rat. 

LOAEL = 38.1 mg/kg/day, based on increased absolute and 

relative liver weights in both sexes, increased relative ovarian 

and kidney weights, and fatty degeneration of the adrenal 

zona fasciculata. 

Cancer (Oral, dermal, inhalation).Classification: ‘‘Likely to be Carcinogenic to Humans’’. Insufficient evidence to warrant a quantitative estimation 

of human risk using a cancer slope factor based on the common liver tumors (benign and malignant) observed 

only in high dose female mice, and benign mammary gland tumors of no biological significance, observed only 

in high dose male rats in the absence of mutagenic concerns. The chronic RfD is protective of all chronic effects including potential carcinogenicity of hexythiazox. 

FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = 

milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = 

chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in 

sensitivity among members of the human population (intraspecies). 

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 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. Based on the data 

summarized in Unit III.A., 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 

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 Surface Water 

Concentration Calculator, the estimated 

drinking water concentrations (EDWCs) 

of hexythiazox for chronic exposures for 

non-cancer assessments are estimated to 

be 4.3 parts per billion (ppb) for surface 

water. Since groundwater residues are 

not expected to exceed surface water 

residues, surface water residues were 

used in the dietary risk assessment. 

Modeled estimates of drinking water 


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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, lawns, recreational sites such 

as campgrounds and golf courses, 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. Intermediate-term 

exposures are not likely because of the 

intermittent nature of applications by 

residential applicators. Since 

hexythiazox does not pose a significant 

dermal risk, a quantitative dermal risk 

assessment was not performed and 

handler margins of exposure (MOE) 

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. Post-application 

exposures are expected to be short-term 

(1 to 30 days) in duration for most 

exposure scenarios, and intermediateterm (1 to 6 months) in duration for soil 

ingestion only due to the aerobic soil 

metabolism half-life for hexythiazox. 

Adult post-application 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. 

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. 

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 development 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. 

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. 

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 post-application 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 81% of 

the cPAD for children 1 to 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. 

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 1,300 for children and 9,900 

for adults. 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 


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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 1,500 for children 

and 9,900 for adults. 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 

ultraviolet detection (HPLC/UV)) is 

available to enforce the tolerance 

expression. 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. 

The Codex has established MRLs for 

residues of hexythiazox on citrus, fruits 

but not for cotton. The Codex plant 

residue definition is for hexythiazox as 

opposed to the U.S. definition which 

includes hexythiazox plus metabolites 

containing the (4-chlorophenyl)-4- 

methyl-2-oxo-3-thiazolidine moiety. The 

differences in U.S. and Codex residue 

definitions prohibits harmonization. 

C. Revisions to Petitioned-for Tolerances 

Although the petitioner requested an 

amended tolerance for citrus, dried pulp 

at 0.6, the Agency has determined that 

no such tolerance is necessary because 

that commodity is covered by the 

established citrus group 10–10 

tolerance. The Agency is revising the 

tolerance for citrus oil to 25 ppm based 

on the following: By multiplying the 

citrus oil processing factor (104X) from 

the 2006 processing study (D334889, 07/ 

03/2006, T. Bloem) by the highest 

average field trial (HAFT) residue for 

lemons (0.243 ppm) from the submitted 

citrus study since lemons are the citrus 

crop that produced the highest residues. 

As noted in its most recent crop group 

rulemaking in the Federal Register of 

August 22, 2012 (77 FR 50617) (FRL– 

9354–3), EPA generally does not 

establish new tolerances under preexisting crop groups that have been 

updated. EPA updated crop group 10 in 

2010, making the new group 10–10. 

Therefore, EPA is establishing citrus 

fruit group tolerances for group 10–10, 

rather than crop group 10 as requested. 

The Agency is amending the tolerance 

for cotton, undelinted seed at 0.4 ppm 

based on the available cotton data that 

reflect a national use at the label 

specified 35 day pre-harvest internal 

(PHI) to calculate the 0.4 ppm tolerance. 

V. Conclusion 

Therefore, tolerances are amended for 

residues of hexythiazox and its 

metabolites containing the (4- 

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

thiazolidine moiety, in or on citrus, oil 

at 25 ppm; fruit, citrus, group 10–10 at 

0.6 ppm; cotton, gin byproducts at 15 

ppm; cotton, undelinted seed at 0.4 

ppm. The current citrus, dried pulp 

tolerance is revoked because it is 

unnecessary due to the establishment of 

the fruit, citrus, group 10–10 tolerance. 

VI. Statutory and Executive Order 

Reviews 

This action amends 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 action 

has been exempted from review under 

Executive Order 12866, this action 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 action 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 action 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 action. In addition, this action 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

Mandates Reform Act (UMRA) (2 U.S.C. 

1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 


asabaliauskas on DSK3SPTVN1PROD with RULES
19896 Federal Register / Vol. 81, No. 66 / Wednesday, April 6, 2016 / Rules and Regulations 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act 

(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: March 22, 2016. 

Susan Lewis, 

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: 

■ i. Add alphabetically the entries for 

‘‘Cotton, gin byproducts’’ and ‘‘Cotton, 

undelinted seed’’ to the table in 

paragraph (a). 

■ ii. Remove the entry for ‘‘Citrus, dried 

pulp’’ from the table in paragraph (a). 

■ iii. Revise the entry for ‘‘Citrus, oil’’ in 

the table in paragraph (a). 

■ iv. Remove the entries for ‘‘Cotton, gin 

byproducts, CA and AZ only’’, and 

‘‘Cotton, undelinted seed, CA and AZ 

only’’ from the table in paragraph (c). 

■ v. Revise the entry for ‘‘Fruit, citrus 

group 10 (CA, AZ, TX only)’’ in the 

table in paragraph (c). 

The additions and revisions read as 

follows: 

§ 180.448 Hexythiazox; tolerances for 

residues. 

(a) General. * * * 

Commodity Parts per 

million 

*****

Citrus, oil ..................................... 25 

*****

Cotton, gin byproducts ............... 15 

Commodity Parts per 

million 

Cotton, undelinted seed ............. 0.4 

*****

(c) Tolerances with regional 

registrations. * * * 

Commodity Parts per 

million 

*****

Fruit, citrus group 10–10 (CA, 

AZ, TX only) ............................ 0.6 

*****

* * * * * 

[FR Doc. 2016–07661 Filed 4–5–16; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 15 

[ET Docket No. 13–49; FCC 16–24] 

Unlicensed—National Information 

Infrastructure, Order on 

Reconsideration 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule. 

SUMMARY: This document responds to 

seven petitions for reconsideration of 

certain rules adopted in the First Report 

and Order (First R&O) in this 

proceeding, the Commission amends its 

Part 15 rules governing the operation of 

unlicensed National Information 

Infrastructure (U–NII) devices in the 5 

GHz band. These rule changes are 

intended to make broadband 

technologies more widely available for 

consumers and businesses by 

temporarily increasing the in-band 

power limits and permanently 

increasing the out-of- band power limits 

for certain U–NII–3 band devices. The 

Commission also takes steps to maintain 

certain levels of interference protection 

for other authorized operations within 

the 5 GHz band. 

DATES: Effective May 6, 2016. 

FOR FURTHER INFORMATION CONTACT: Aole 

Wilkins, Office of Engineering and 

Technology, (202) 418–2406, email: 

Aole.Wilkins@fcc.gov, TTY (202) 418– 

2989. 

SUPPLEMENTARY INFORMATION: This is a 

summary of the Commission’s 

Memorandum Opinion & Order 

(MO&O), ET Docket No. 13–49, FCC 16– 

24, adopted March 1, 2015, and released 

March 2, 2016. The full text of this 

document is available for inspection 

and copying during normal business 

hours in the FCC Reference Center 

(Room CY–A257), 445 12th Street SW., 

Washington, DC 20554. The full text 

may also be downloaded at: 

www.fcc.gov. People with Disabilities: 

To request materials in accessible 

formats for people with disabilities 

(braille, large print, electronic files, 

audio format), send an email to fcc504@

fcc.gov or call the Consumer & 

Governmental Affairs Bureau at 202– 

418–0530 (voice), 202–418–0432 (tty). 

Summary of Memorandum Opinion 

and Order 

A. U–NII–3 Band Proposals for Changes 

to the First R&O 

1. Prior to adoption of the First R&O, 

the FCC’s rules permitted the 

certification of devices that operate in 

the 5.725–5.85 GHz (U–NII–3) band 

under two different rule sections (i.e. 

Sections 15.247 and 15.407). In some 

instances, and especially for devices 

that operate in point-to-point 

configurations with high gain antennas, 

the old Section 15.247 out-of-band 

emission (OOBE) limits were as much as 

47 dB more permissive than the Section 

15.407 OOBE limits and, therefore 

devices certified under the old limits 

were significantly more likely to create 

harmful interference to other operations. 

In the First R&O, the Commission 

adopted a consolidated set of rules for 

the 5.725–5.85 GHz band devices under 

the Section 15.407 U–NII rules to 

resolve interference issues to Terminal 

Doppler Weather Radar (TDWR) and 

other radar facilities in the adjacent 

band. In the First R&O, the Commission 

recognized that point-to-point systems 

utilizing high gain transmit antennas 

certified under the old Section 15.247 

requirement may have to be modified to 

comply with the lower OOBE limit 

required for operation under Section 

15.407. The Commission stated that 

manufacturers had the flexibility to 

determine how they should meet the 

lower OOBE limits, whether by 

reducing output power, decreasing the 

transmit antenna gain, or utilizing 

improved bandpass filters. 

2. In response to the First R&O, the 

Commission received several petitions 

for reconsideration of its decision. 

Petitioners, mainly manufacturers and 

operators of high gain point-to-point 

communication systems, ask that the 

Commission’s decision to impose more 

restrictive OOBE limits for devices in 


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