73214 Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Rules and Regulations 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0774; FRL–9919–69] 

Hexythiazox; Pesticide Tolerance for 

Emergency Exemptions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

time-limited tolerance for residues of 

hexythiazox in or on sugar beet root. 

This action is associated with the 

utilization of a crisis exemption under 

the Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA) authorizing 

use of the pesticide on sugar beets. This 

regulation establishes a maximum 

permissible level for residues of 

hexythiazox in or on sugar beet root. 

The time-limited tolerance expires on 

December 31, 2019. 

DATES: This regulation is effective 

December 10, 2014. Objections and 

requests for hearings must be received 

on or before February 9, 2015, 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–2014–0774, 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: 

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 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 section 408(g) of the Federal 

Food, Drug, and Cosmetic Act (FFDCA), 

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–2014–0774 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 February 9, 2015. 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– 

2014–0774, 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. Background and Statutory Findings 

EPA, on its own initiative, in 

accordance with FFDCA sections 408(e) 

and 408(l)(6), 21 U.S.C. 346a(e) and 

346a(1)(6), is establishing a time-limited 

tolerance for residues of hexythiazox 

and its metabolites containing the (4- 

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

thiazolidine moiety, calculated as the 

stoichiometric equivalent of 

hexythiazox, in or on sugar beet root at 

0.15 parts per million (ppm). This timelimited tolerance expires on December 

31, 2019. 

Section 408(l)(6) of FFDCA requires 

EPA to establish a time-limited 

tolerance or exemption from the 

requirement for a tolerance for pesticide 

chemical residues in food that will 

result from the use of a pesticide under 

an emergency exemption granted by 

EPA under FIFRA section 18. Such 

tolerances can be established without 

providing notice or period for public 

comment. EPA does not intend for its 

actions on FIFRA section 18 related 

time-limited tolerances to set binding 

precedents for the application of FFDCA 

section 408 and the safety standard to 

other tolerances and exemptions. 

Section 408(e) of FFDCA allows EPA to 

establish a tolerance or an exemption 

from the requirement of a tolerance on 

its own initiative, i.e., without having 

received any petition from an outside 

party. 

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 


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Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Rules and Regulations 73215 

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. . . .’’ 

Section 18 of FIFRA authorizes EPA 

to exempt any Federal or State agency 

from any provision of FIFRA, if EPA 

determines that ‘‘emergency conditions 

exist which require such exemption.’’ 

EPA has established regulations 

governing such emergency exemptions 

in 40 CFR part 166. 

III. Emergency Exemption for 

Hexythiazox on Sugar Beet Root and 

FFDCA Tolerances 

The Idaho and Oregon State 

Departments of Agriculture (the States) 

reported that two-spotted spider mite 

infestations at above-normal levels have 

caused severe losses in the past several 

years in sugar beet fields. Based upon 

activity observed in the early spring of 

2014, they projected similar mite 

population levels for the 2014 season as 

well. The States claimed that alternative 

controls and practices would not 

provide adequate control with high 

infestations and would not prevent 

significant economic losses from 

occurring. The States also noted concern 

that some of the alternative pesticides 

may be harmful to beneficial insects 

which help control mites, and to bees 

pollinating crops in the area. The 

applicants asserted that an emergency 

condition existed in accordance with 

the criteria for approval of an emergency 

exemption, and utilized crisis 

exemptions under FIFRA section 18 

which allowed the use of hexythiazox 

on sugar beet root for control of twospotted spider mites in the Idaho and 

Oregon. After having reviewed the 

submissions, EPA concurred that an 

emergency condition existed. 

As part of its evaluation of the 

emergency exemption applications, EPA 

assessed the potential risks presented by 

residues of hexythiazox in or on sugar 

beet root. In doing so, EPA considered 

the safety standard in FFDCA section 

408(b)(2), and EPA decided that the 

necessary tolerance under FFDCA 

section 408(l)(6) would be consistent 

with the safety standard and with 

FIFRA section 18. Consistent with the 

need to move quickly on the emergency 

exemptions in order to address an 

urgent non-routine situation and to 

ensure that the resulting food is safe and 

lawful, EPA is issuing this tolerance 

without notice and opportunity for 

public comment as provided in FFDCA 

section 408(l)(6). Although this timelimited tolerance expires on December 

31, 2019, under FFDCA section 

408(l)(5), residues of the pesticide not in 

excess of the amount specified in the 

tolerance remaining in or on sugar beet 

root after that date will not be unlawful, 

provided the pesticide was applied in a 

manner that was lawful under FIFRA, 

and the residues do not exceed a level 

that was authorized by this time-limited 

tolerance at the time of that application. 

EPA will take action to revoke this timelimited tolerance earlier if any 

experience with, scientific data on, or 

other relevant information on this 

pesticide indicate that the residues are 

not safe. 

Because this time-limited tolerance is 

being approved under emergency 

conditions, EPA has not made any 

decisions about whether hexythiazox 

meets FIFRA’s registration requirements 

for use on sugar beets or whether 

permanent tolerances for this use would 

be appropriate. Under these 

circumstances, EPA does not believe 

that this time-limited tolerance decision 

serves as a basis for registration of 

hexythiazox by a State for special local 

needs under FIFRA section 24(c). Nor 

does this tolerance by itself serve as the 

authority for persons in any State other 

than Idaho and Oregon to use this 

pesticide on sugar beets under FIFRA 

section 18 absent the issuance of an 

emergency exemption applicable within 

that State. For additional information 

regarding the emergency exemption for 

hexythiazox, contact the Agency’s 

Registration Division at the address 

provided under FOR FURTHER

INFORMATION CONTACT. 

IV. 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 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 expected as a result 

of these emergency exemption requests 

and the time-limited tolerance for 

residues of hexythiazox in or on sugar 

beet root at 0.15 ppm. EPA’s assessment 

of exposures and risks associated with 

establishing the time-limited tolerance 

follows. 

A. 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). 


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B. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to hexythiazox, EPA 

considered exposure under the timelimited tolerance established by this 

action 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. No adverse acute 

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 default 

processing factors from EPA’s Dietary 

Exposure Evaluation Model 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 toxicological endpoints 

for hexythiazox used for human risk 

assessment discussed in Unit III.B. of 

the February 8, 2013 Federal Register 

final rule, EPA has concluded that 

hexythiazox should be classified as 

‘‘Likely to be Carcinogenic to Humans’’ 

and that a nonlinear RfD approach is 

appropriate for assessing cancer risk. 

Cancer risk was therefore assessed using 

the chronic RfD and the chronic 

exposure estimates as discussed in Unit 

IV.B.1.ii. of this document. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for hexythiazox. Tolerance level 

residues and 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 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 concentration (EDWC) 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 residue values greatly exceed 

groundwater EDWCs, surface water 

residues were used in the dietary risk 

assessments. 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 exposure. Since no 

dermal hazards were identified 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 

for hexythiazox because no dermal 

hazards were identified, and inhalation 

exposures are typically negligible in 

outdoor settings. The post-application 

exposures were assessed for children 

from incidental oral exposure resulting 

from transfer of residues from the hands 

or objects to the mouth, and from the 

incidental ingestion of soil. Postapplication hand-to-mouth and objectto-mouth exposures are expected to be 

short-term (1 to 30 days) in duration due 

to the intermittent nature of 

applications in residential settings. 

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/science/

USEPA-OPP-HED_

Residential%20SOPs_Oct2012.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. 

C. 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 SF when reliable data 

available to EPA support the choice of 

a different factor. 

2. Prenatal and postnatal sensitivity. 

The prenatal and postnatal toxicology 

database 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 that 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: 


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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 uncertainty factors (UFs) to 

account for neurotoxicity. 

iii. There is no evidence that 

hexythiazox results in increased 

susceptibility of 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 PCT and 

tolerance-level residues. 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. 

D. 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. 

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 to 2 years of 

age, the population group receiving the 

greatest exposure. Based on the 

explanation in this document in the unit 

regarding residential use patterns, 

chronic residential exposure to residues 

of hexythiazox is not expected. Because 

the cPAD utilized for the most 

vulnerable population group is below 

100%, aggregate exposure to 

hexythiazox is not expected to cause 

chronic risks of concern. 

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 9,600 (adult females), 9,100 

(adult males), and 1,300 for children. 

Because EPA’s level of concern for 

hexythiazox is an MOE of 100 or below, 

these MOEs are not of concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

non-dietary, non-occupational 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 9,800 (adult 

females), 9,300 (adult males), and 1,500 

for children. Because EPA’s level of 

concern for hexythiazox is an MOE of 

100 or below, these MOEs are not of 

concern. 

5. Aggregate cancer risk for U.S. 

population. EPA’s classification of 

hexythiazox as ‘‘Likely to be 

Carcinogenic to Humans’’ is based upon 

increased benign and malignant liver 

tumors in high-dose female mice, and 

benign mammary tumors in high-dose 

male rats. EPA determined that a 

nonlinear RfD quantitative estimation of 

human cancer risk is appropriate, based 

on the following: The liver tumors 

observed are very common in that 

species of mice and were only seen in 

high dose female mice; the mammary 

tumors observed were benign and only 

occurred in the high-dose male rats; no 

mutagenic effects were observed in 

mammalian somatic and germ cell 

studies; and the chronic NOAEL used 

for determining the RfD is 65 times 

lower than the lowest dose at which 

tumors were observed. Therefore, the 

nonlinear chronic RfD approach is 

protective of all chronic effects 

including potential carcinogenicity of 

hexythiazox. As a result, the expected 

aggregate exposure to hexythiazox does 

not present cancer 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. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(high performance liquid 

chromatography method with 

ultraviolet detection (HPLC/UV)) is 

available for 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 ‘‘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 not established an 

MRL for hexythiazox in or on sugar beet 

root. 

VI. Conclusion 

Therefore, a time-limited tolerance is 

established for residues of hexythiazox 

and its metabolites containing the (4- 

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

thiazolidine moiety, calculated as the 

stoichiometric equivalent of 


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hexythiazox, in or on beet, sugar, root at 

0.15 ppm. This tolerance expires on 

December 31, 2019. 

VII. Statutory and Executive Order 

Reviews 

This action establishes tolerances 

under FFDCA sections 408(e) and 

408(l)(6). 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 in accordance with 

FFDCA sections 408(e) and 408(l)(6), 

such as the tolerances 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 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act 

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

VIII. 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: December 3, 2014. 

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, revise paragraph (b) to 

read as follows: 

§ 180.448 Hexythiazox; tolerance for 

residues. 

* * * * * 

(b) Section 18 emergency exemptions. 

A time-limited tolerance specified in the 

following table is established for 

residues of hexythiazox and its 

metabolites containing the (4- 

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

thiazolidine moiety, calculated as the 

stoichiometric equivalent of 

hexythiazox, in or on the specified 

agricultural commodity, resulting from 

use of the pesticide pursuant to FIFRA 

section 18 emergency exemptions. The 

tolerance expires on the date specified 

in the table. 

Commodity Parts per 

million 

Expiration 

date 

Beet, sugar, root ... 0.15 12/31/19 

* * * * * 

[FR Doc. 2014–28935 Filed 12–9–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0695; FRL–9919–34] 

Diisopropanolamine; Exemption From 

the Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of 

diisopropanolamine when used as an 

inert ingredient (neutralizer or 

stabilizer) at no more than 10% in 

pesticide formulations applied to 

growing crops or to raw agricultural 

commodities after harvest. United 

Phosphorus, Inc. submitted a petition to 

EPA under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), requesting 

establishment of an exemption from the 

requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of diisopropanolamine. 

DATES: This regulation is effective 

December 10, 2014. Objections and 

requests for hearings must be received 

on or before February 9, 2015, and must 

be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2013–0695, 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: 

Susan T. Lewis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main telephone 


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