66138 Federal Register / Vol. 83, No. 246 / Wednesday, December 26, 2018 / Rules and Regulations 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. The EPA will 

submit a report containing this action 

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. A major rule cannot take effect 

until 60 days after it is published in the 

Federal Register. This action is not a 

‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

Under section 307(b)(1) of the Clean 

Air Act, petitions for judicial review of 

this action must be filed in the United 

States Court of Appeals for the 

appropriate circuit by February 25, 

2019. Filing a petition for 

reconsideration by the Administrator of 

this final rule does not affect the finality 

of this action for the purposes of judicial 

review nor does it extend the time 

within which a petition for judicial 

review may be filed, and shall not 

postpone the effectiveness of such rule 

or action. This action may not be 

challenged later in proceedings to 

enforce its requirements. (See section 

307(b)(2).) 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Intergovernmental relations, 

Ozone, Reporting and recordkeeping 

requirements, Volatile organic 

compounds. 

Dated: November 30, 2018. 

Deborah Jordan, 

Acting Regional Administrator, Region IX. 

Part 52, chapter I, title 40 of the Code 

of Federal Regulations is amended as 

follows: 

PART 52—APPROVAL AND 

PROMULGATION OF 

IMPLEMENTATION PLANS 

■ 1. The authority citation for part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart F—California 

■ 2. Section 52.220 is amended by 

adding paragraph (c)(509)(i)(B) to read 

as follows: 

§ 52.220 Identification of plan-in part. 

* * * * * 

(c) * * * 

(509) * * * 

(i) * * * 

(B) Feather River Air Quality 

Management District. 

(1) Rule 3.23, ‘‘Natural Gas-Fired 

Water Heaters, Small Boilers, and 

Process Heaters’’ adopted on October 3, 

2016. 

* * * * * 

[FR Doc. 2018–27756 Filed 12–21–18; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2017–0063; FRL–9986–85] 

Chlorate; Pesticide Exemptions From 

Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of chlorate in or 

on cantaloupe and tomato under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

December 26, 2018. Objections and 

requests for hearings must be received 

on or before February 25, 2019 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–2017–0063, 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: 

Anita Pease, Antimicrobials Division 

(7510P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW, Washington, DC 

20460–0001; main telephone number: 

(703) 305–7090; email address: 

ADFRNotices@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–2017–0063 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 25, 2019. 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– 

2017–0063, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 


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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 

Exemptions 

In the Federal Register of December 

15, 2017 (82 FR 59604) (FRL–9970–50), 

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 4F8325) by ICA 

Trinova, Inc., 1 Beavers Street, Suite B, 

Newnan, GA 30263. The petition 

requested that EPA (1) establish a 

tolerance for residues of chlorate in or 

on cantaloupes at 1.5 parts per million 

(ppm), and (2) establish an exemption 

from the requirement of a tolerance for 

residues of chlorate in or on tomatoes. 

Chlorate is a by-product of chlorine 

dioxide, which is generated from the 

active ingredient, sodium chlorite, when 

it is applied via fumigation to tomatoes 

and cantaloupes post- harvest, during 

storage and shipment. The Agency 

reviewed submitted residue chemistry 

data for chlorine dioxide and chlorate. 

Given that residues for chlorine dioxide 

were not detected and only residues of 

chlorate were quantified, EPA has 

determined that tolerance exemptions 

are appropriate for chlorate on both 

tomatoes and cantaloupes. 

A summary of the petition prepared 

by ICA Trinova Inc., the petitioner and 

registrant is available in the docket, 

http://www.regulations.gov. Comments 

were received on the notice of filing; the 

Agency’s response to these comments is 

located in Unit IV.B. of this document. 

For reasons explained in Unit IV.C., 

EPA is establishing an exemption from 

the requirement of a tolerance for 

residues of chlorate in or on cantaloupe 

and tomato. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish an exemption 

from the requirement of 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(c)(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. In making this 

safety determination, EPA must take 

into consideration the factors laid out in 

section 408(b)(2)(C) and (D). 

Specifically, 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 

therein, 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 chlorate 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with chlorate 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. 

Sodium chlorite is the active 

ingredient that is applied to the 

tomatoes and cantaloupe. Once applied, 

it is activated by a weak acid, creating 

gaseous chlorine dioxide. As chlorine 

dioxide is released, it also produces the 

byproduct, chlorate. Based on submitted 

residue data, the only residues of the 

pesticide with the potential for being 

present on food commodities are 

chlorate ions; therefore, the Agency 

assessed the safety of aggregate exposure 

to chlorate in support of this tolerance 

action. 

Inorganic chlorates (also known as 

chlorate salts) encompass all chlorates 

including the most abundant salt, 

sodium chlorate. Toxicology data 

relevant to the human health risk 

assessment are summarized here and 

more information about the toxicology 

data and references can be found in the 

Risk Assessment of Tomato and 

Cantaloupe Fumigation with Sodium 

Chlorite 3.2% (chlorine dioxide gas) and 

Inorganic Chlorates Human Health 

Assessment Scoping Document in 

Support of Registration Review (Docket 

ID No. EPA–HQ–OPP–2016–0080–0008) 

both of which can be found in the 

docket for this action at http://

www.regulations.gov. 

The hazard database indicates that the 

thyroid is the primary target organ of 

chlorate. Effects observed in subchronic 

and chronic toxicity studies show 

increased thyroid gland weights, colloid 

depletion, decreases in triiodothyronine 

(T3) and thyroxine (T4) accompanied by 

increases in thyroid stimulating 

hormone (TSH), increased incidence of 

thyroid follicular cell hypertrophy, 

thyroid cell mineralization, follicular 

cell hyperplasia, and adenomas or 

carcinomas in rat studies. Other effects 

include hematological changes 

(hemoglobin concentration, hematocrit, 

decreased red blood counts (RBC), and 

increased reticulocyte counts in 

females), methemoglobin concentration 

changes, and pituitary vacuolization in 

subchronic studies starting at doses 10- 

fold higher than where thyroid effects 

are observed. 

In a 2-year drinking water study, there 

was some evidence of thyroid gland 

follicular cell tumors in male rats; 

however, because chlorate is not 

mutagenic and these tumors were only 

seen at high doses, chlorate is not likely 

to be carcinogenic since the chronic 

reference dose is below the dose at 

which alteration of thyroid hormone 

homeostasis occurs. Moreover, although 

there was equivocal and marginal 

evidence of increased pancreatic islet 

carcinoma in female mice, the Agency 

has concluded that the selected chronic 

reference dose is protective of these 

potential cancer effects. 

No increased qualitative or 

quantitative susceptibility in rats or 

rabbits was seen in reproduction and 

developmental studies with chlorate. 

Chlorate did not cause developmental 

effects in rats at doses up to the limit 

dose (1,000 mg/kg/day) or in rabbits up 

to half the limit dose. Although chlorate 

has not been evaluated for neurotoxic 

effects, acute and subchronic toxicity 

studies do not indicate any neurotoxic 

potential. In a 2-generation reproduction 

toxicity study, increased absolute and 

relative thyroid weight and increased 

incidence of slight to moderate 

hyperactivity of the thyroid glands were 

reported in parental and adult F1 males 

and females at doses 14x higher than the 


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thyroid effects identified in the adult rat 

subchronic and chronic studies. 

The chronic oral toxicity of chlorate 

was examined in a study conducted by 

the National Toxicology Program (NTP). 

In this study, Fischer 344 rats (50/sex/ 

group) were exposed to drinking water 

containing 0, 125, 1,000, or 2,000 mg/L 

chlorate for 2 years (equivalent to 5/5, 

35/45, and 75/95 mg/kg/day (males/ 

females)). T4 and T3 levels were 

significantly reduced at 35 and 75 mg/ 

kg/day on day 4, and in 75 mg/kg/day 

males and females at week 3. TSH was 

significantly increased in 35 and 75 mg/ 

kg/day males on day 4 and at week 3, 

in 35 and 75 mg/kg/day females on day 

4, in 75 mg/kg/day females at week 3, 

and in 75 mg/kg/day males and females 

at week 13. At the high dose, increased 

incidences of thyroid gland follicular 

cell carcinoma were seen in male rats 

(incidence: 4/47) compared to none in 

controls, and of thyroid gland follicular 

cell adenoma or carcinoma (combined) 

in males (incidence: 6/47) and females 

(incidence: 4/46) compared to one 

animal in controls of both sexes. The 

incidences of thyroid gland follicular 

cell hypertrophy were significantly 

increased in mid- and high-dose groups 

of males (33/43 and 40/47 vs. 4/47 in 

control) and females (3/47, 7/47, 27/43, 

42/46 vs. 3/47 in control). 

In the Agency’s 2006 risk assessment 

for inorganic chlorates, Revised 

Inorganic Chlorates. HED Chapter of the 

Reregistration Eligibility Decision 

Document (RED) (Docket ID No. EPA– 

HQ–OPP–2005–0507–0004) a lower 

95% confidence limit of the benchmark 

dose (BMDL) of 0.9 mg/kg/day was 

derived, based on thyroid gland 

follicular cell hypertrophy at the 5 mg/ 

kg/day dose from the rat chronic cancer 

study (NTP, 2005). EPA has reconsidered the data and determined that 

the original benchmark dose derived 

from the study was not sufficiently 

supported as an effect level at 5 mg/kg/ 

day, and that the 5 mg/kg/day dose can 

be supported as a NOAEL for the study. 

The point of departure (POD) for 

chronic dietary (all populations) 

exposures is thus the 5 mg/kg/day dose, 

based on changes in thyroid hormones 

(decreased T3, decreased T4, and 

increased TSH), and increased 

incidence of thyroid follicular cell 

hypertrophy in male and female rats at 

the next highest dose of 35/45 mg/kg/ 

day (males and females respectively). 

Mineralization of the thyroid at the 5 

mg/kg/day dose level was not 

considered to be adverse. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by chlorate 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 

titled ‘‘Risk Assessment of Tomato and 

Cantaloupe Fumigation with Sodium 

Chlorite 3.2% (chlorine dioxide gas) in 

docket ID number EPA–HQ–OPP–2017– 

0063. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological 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 NOAEL and 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 nonthreshold 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://

www2.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides. 

A summary of the toxicological 

endpoints from the documents 

referenced in section III, A, for chlorate 

used for human risk assessment is 

shown in Table 1. 

TABLE 1—TOXICOLOGY ENDPOINTS FOR USE IN CHLORATE HUMAN HEALTH RISK ASSESSMENTS

Exposure/scenario Point of 

departure 

Uncertainty/ 

FQPA safety 

factors 

RfD, PAD, 

level of 

concern for risk 

assessment 

Study and toxicological effects 

Acute dietary (All populations, including infants and children, and 

females 13—49 years of age).

N/A ................... N/A ................... N/A .................... None of the available studies provided an endpoint of toxicity attributable to a single exposure. 

Chronic dietary (All populations) .... RfD = cPAD = 

0.17 mg/kg/ 

day.

UF = 30x (10x 

intraspecies, 

3x interspecies) FQPA 

SF = 1x.

NOAEL = 5 mg/ 

kg/day.

2 year NTP Study (2005)—rat. 

MRID 49683134. 

LOAEL = 35/45 mg/kg/day (male/female) based 

on changes in thyroid hormones after 3 weeks 

(decreased T4, T3, & increased TSH), increased incidence of thyroid gland follicular cell 

hypertrophy in males and females (after 3 

weeks and 2 years). 

Cancer (Oral, dermal, inhalation) .. The chronic reference dose will be protective of potential carcinogenicity. 

UF = uncertainty factor, FQPA SF = Special FQPA 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, MOE = margin of exposure, LOC = level of 

concern, N/A = not applicable 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to chlorate, EPA considered 

exposure under the petitioned-for 

tolerance and exemption as well as 

existing exposures to chlorate. EPA 

assessed dietary exposures from 

chlorate 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 


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occurring as a result of a 1-day or single 

exposure. 

No such effects were identified in the 

toxicological studies for chlorate; 

therefore, a quantitative acute dietary 

exposure assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, EPA separately assessed the 

components of chronic dietary exposure 

and then aggregated them for assessing 

chronic risk. For existing food crop 

uses, EPA relied on the assessment of 

food crop exposures contained in the 

2006 Inorganic Chlorates Reregistration 

Eligibility Document. For the 

petitioned-for use on cantaloupe, EPA 

based its assessment on the current 

version of Dietary Exposure Evaluation 

Model—Food Consumption Intake 

Database—DEEM–FCIDTM (version 

3.16), the food consumption data from 

the 2003–2008 U.S. Department of 

Agriculture’s National Health and 

Nutrition Examination Survey, What We 

Eat in America, (NHANES/WWEIA), 

and assumed 100 percent of the 

cantaloupe crop treated. For the dietary 

exposure resulting from use in paper 

mills, EPA based its exposure 

assessment on standard operating 

procedure screening-level analyses 

reported in the registration review 

human health scoping document, 

Inorganic Chlorates Human Health 

Assessment Scoping Document in 

Support of Registration Review. 

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 chlorate. 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 

used anticipated residue information 

and PCT estimates in the dietary food 

assessment. 

Section 408(b)(2)(E) of FFDCA 

authorizes EPA to use available data and 

information on the anticipated residue 

levels of pesticide residues in food and 

the actual levels of pesticide residues 

that have been measured in food. If EPA 

relies on such information, EPA must 

require pursuant to FFDCA section 

408(f)(1) that data be provided 5 years 

after the tolerance is established, 

modified, or left in effect, demonstrating 

that the levels in food are not above the 

levels anticipated. For the present 

action, EPA will issue such data call-ins 

as are required by FFDCA section 

408(b)(2)(E) and authorized under 

FFDCA section 408(f)(1). Data will be 

required to be submitted no later than 

5 years from the date of issuance of 

these tolerances. 

Section 408(b)(2)(F) of FFDCA states 

that the Agency may use data on the 

actual percent of food treated for 

assessing chronic dietary risk only 

under the following conditions: 

• Condition a: The data used are 

reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain the pesticide residue. 

• Condition b: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• Condition c: Data are available on 

pesticide use and food consumption in 

a particular area and the exposure 

estimate does not understate exposure 

for the population in such area. In 

addition, the Agency must provide for 

periodic evaluation of any estimates 

used. To provide for the periodic 

evaluation of the estimate of PCT as 

required by FFDCA section 408(b)(2)(F), 

EPA may require registrants to submit 

data on PCT. 

The Agency estimated the PCT for 

existing uses for the chronic dietary 

exposure assessment as follows: corn: 

<1%; cotton (seed treatment): 5%; dry 

beans/peas: <1%; flaxseed: <1%; 

peppers (chili peppers): <1%; potatoes; 

<1%; rice: 1%; safflower (seed 

treatment): 2%; sorghum: <1%; 

soybeans: 5%; soybeans (seed 

treatment): <1%; sunflower (seed 

treatment): <1%; sweet corn: <1%; 

wheat: 1%; and wheat seed (seed 

treatment): <1%. For crops not 

specified, 100% PCT was used. 

In most cases, EPA uses available data 

from United States Department of 

Agriculture/National Agricultural 

Statistics Service (USDA/NASS), 

proprietary market surveys, and 

California Department of Pesticide 

Regulation (CalDPR) Pesticide Use 

Reporting (PUR) for the chemical/crop 

combination for the most recent 10 

years. EPA uses an average PCT for 

chronic dietary risk analysis and a 

maximum PCT for acute dietary risk 

analysis. The average PCT figures for 

each existing use are derived by 

combining available public and private 

market survey data for that use, 

averaging across all observations, and 

rounding up to the nearest 5%, except 

for those situations in which the average 

PCT is less than 1% or less than 2.5%. 

In those cases, the Agency would use 

less than 1% or less than 2.5% as the 

average PCT value, respectively. The 

maximum PCT figure is the highest 

observed maximum value reported 

within the most recent 10 years of 

available public and private market 

survey data for the existing use and 

rounded up to the nearest multiple of 

5%, except where the maximum PCT is 

less than 2.5%, in which case, the 

Agency uses less than 2.5% as the 

maximum PCT. 

2. Dietary exposure from drinking 

water. The estimated drinking water 

concentration (EDWC) was obtained 

from monitoring data gathered between 

2013–2015 and are contained in the SixYear Review Technical Report for 

Chlorate. For purposes of this 

assessment, EPA used the median 

concentration of 120 micrograms/liter. 

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). At this 

time, there are no longer any registered 

uses of chlorate that result in nonoccupational, residential exposures. 

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 inorganic chlorates 

to share a common mechanism of 

toxicity with any other substances, and 

chlorate does not appear to produce a 

toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that chlorate 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 website at http:// 

www2.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides. 

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 


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additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

No increased qualitative or quantitative 

susceptibility in rats or rabbits was seen 

in reproduction and developmental 

studies with chlorate. Chlorate did not 

cause developmental effects in rats at 

doses up to 1,000 mg/kg/day or in 

rabbits at doses up to 500 mg/kg/day. 

No pre- or postnatal susceptibility was 

observed in a reproduction study in rats. 

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 chlorate is 

adequate to characterize the potential 

for prenatal or postnatal risk for infants 

and children. 

ii. There is no indication in the 

available database that chlorate is a 

neurotoxicant. 

iii. There was no pre- or postnatal 

sensitivity or susceptibility observed in 

the submitted developmental studies in 

rats and rabbits and the 2-generation 

reproduction study in rats. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary assessment is based on a 

conservative estimate of dietary 

exposures and drinking water 

monitoring data. These assessments will 

not underestimate the exposure and 

risks posed by chlorate. 

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, chlorate 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 chlorate from 

food and water will utilize 8.4% of the 

cPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. There are no residential 

pesticide uses for chlorate. 

3. Short- and Intermediate-term risk. 

Short- and intermediate-term aggregate 

exposure takes into account short- and 

intermediate-term residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). 

Short- and intermediate-term adverse 

effects were identified; however, 

chlorate is not registered for any use 

patterns that would result in either 

short- or intermediate-term residential 

exposure. Short- and intermediate-term 

risk is assessed based on short- and 

intermediate-term residential exposure 

plus chronic dietary exposure. Because 

there is no short- or intermediate-term 

residential exposure and chronic dietary 

exposure has already been assessed 

under the appropriately protective 

cPAD (which is at least as protective as 

the POD used to assess short- and 

intermediate-term risk), no further 

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

the chronic dietary risk assessment for 

evaluating short- and intermediate-term 

risk for chlorate. 

4. Aggregate cancer risk for U.S. 

population. A cancer aggregate 

assessment was not conducted 

separately, as the chronic aggregate 

assessment is protective of cancer for 

the general U.S. population. Based on 

the results of the assessment of chronic 

risk, the Agency concludes that 

exposure to chlorate will not result in a 

cancer risk of concern. 

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 chlorate 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes since the 

Agency is establishing an exemption 

from the requirement of a tolerance 

without any numerical limitation. 

B. Response to Comments 

Two comments were received in 

response to the Notice of Filing, neither 

of which raised issues related to the 

safety of the tolerances in this action. 

Because they raise issues outside the 

scope of this rulemaking, the Agency is 

not addressing them here. 

C. Revisions to Petitioned-For 

Tolerances 

The residue data indicate that 

following use of the pesticide, there 

were detectable chlorate residues on the 

cantaloupe rind, although none were 

detected in the edible portions of the 

cantaloupe, and that chlorate residues 

on tomato were indistinguishable from 

background levels of chlorate on tomato. 

Because EPA does not anticipate use on 

either commodity to contribute to 

dietary exposure, EPA is issuing an 

exemption from the requirement of 

tolerance residues on cantaloupe and 

tomato. This tolerance exemption covers 

potential residues in or on these 

commodities as a result of direct 

application and allows for the shipment 

of these commodities in interstate 

commerce. 

V. Conclusion 

An exemption from the requirement 

of a tolerance is established for residues 

of chlorate in or on tomato and 

cantaloupe. 

VI. Statutory and Executive Order 

Reviews 

This action establishes an exemption 

from the requirement of a tolerance 

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), nor is it considered a 

regulatory action under Executive Order 

13771, entitled ‘‘Reducing Regulations 

and Controlling Regulatory Costs’’ (82 

FR 9339, February 3, 2017). 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 


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Federal Register / Vol. 83, No. 246 / Wednesday, December 26, 2018 / Rules and Regulations 66143 

under FFDCA section 408(d) 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). 

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: November 30, 2018. 

Anita Pease, 

Acting Director, Antimicrobial 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. Add § 180.1364 to subpart D to read 

as follows: 

§ 180.1364 Chlorate; exemption from the 

requirement of a tolerance. 

Residues of chlorate in or on tomato 

and cantaloupe are exempt from the 

requirement of a tolerance when 

resulting from the application of 

gaseous chlorine dioxide as a fungicide, 

bactericide, and antimicrobial pesticide. 

[FR Doc. 2018–27908 Filed 12–21–18; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 271 

[EPA–R06–RCRA–2018–0395; FRL–9987– 

30–Region 6] 

Louisiana: Final Authorization of State 

Hazardous Waste Management 

Program Revision 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: On September 5, 2018, the 

Environmental Protection Agency (EPA) 

published a notice of proposed 

rulemaking to approve a revision to the 

State of Louisiana hazardous waste 

program under the Resource 

Conservation and Recovery Act (RCRA) 

and provided for a thirty-day public 

comment period. The public comment 

period closed on October 5, 2018, and 

EPA received fifteen comments. The 

EPA has reviewed and analyzed all 

submitted comments, and now issues 

this final rule. After consideration of all 

comments, EPA confirms that the 

program revisions to the State of 

Louisiana hazardous waste program 

satisfy all requirements needed to 

qualify for final authorization. 

DATES: This final authorization is 

effective December 26, 2018. 

ADDRESSES: EPA has established a 

docket for this action under Docket ID 

No. EPA–R06–RCRA–2018–0395. All 

documents in the docket are listed in 

www.regulation.gov index. Although 

listed in the index, some of the 

information is not publicly available. 

e.g., Confidential Business Information 

or other information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

will be publicly available only in hard 

copy. Publicly available docket 

materials are available either 

electronically through 

www.regulation.gov or in hard copy. 

You can view and copy Louisiana’s 

application and associated publicly 

available materials from 8:30 a.m. to 

4:00 p.m., Monday through Friday, at 

the following locations: Louisiana 

Department of Environmental Quality, 

602 N Fifth Street, Baton Rouge, 

Louisiana 70884–2178, phone number 

(225) 219–3559 and EPA, Region 6, 1445 

Ross Avenue, Suite 1200, Dallas, Texas 

75202–2733, phone number (214) 665– 

8533. 

FOR FURTHER INFORMATION CONTACT: 

Alima Patterson, Region 6, Regional 

Authorization/Codification Coordinator, 

Permit Section (6MM–RP), Multimedia 

Division, (214) 665–8533, EPA Region 6, 

1445 Ross Avenue, Suite 1200, Dallas, 

Texas 75202–2733, and Email address 

patterson.alima@epa.gov. 

SUPPLEMENTARY INFORMATION: 

A. What revisions is EPA authorizing 

with this action? 

On March 13, 2018, LDEQ submitted 

a final complete program revision 

application seeking authorization of its 

program revision in accordance with 40 

CFR 271.21. EPA now makes a final 

decision that LDEQ’s hazardous waste 

program revisions satisfy all the 

requirements necessary to qualify for 

final authorization. EPA will continue 

to implement and enforce Hazardous 

and Solid Waste Amendments of 1984 

(HSWA) provisions for which the State 

is not authorized. For a list of rules that 

become effective with this Final Rule, 

please see the Proposed Rulemaking 

published in the September 5, 2018, 

Federal Register at 83 FR 45061. 

B. What were the comments and 

responses to EPA’s proposal? 

EPA received fifteen comments. 

Twelve comments were supportive of 

EPA to grant the State of Louisiana 

portions of the Subtitle C Hazardous 

Waste Management Program and two 

were irrelevant to the proposed 

rulemaking. EPA received a written 

adverse comment from TD*X Associates 

LP, Beaumont Texas, (TD*X) requesting 

that EPA not authorize the State of 

Louisiana to implement the regulatory 

provisions commonly known as the 

‘‘Verified Recycler Exemption,’’ or 

‘‘VRE.’’ EPA received only one adverse 

comment, from TD*X, opposing EPA’s 

proposal to authorize revisions to 

Louisiana’s hazardous waste 

regulations. The full set of comments 

can be found in the docket for this 

action. The commenter asserts that the 


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