57450 Federal Register / Vol. 79, No. 186 / Thursday, September 25, 2014 / Rules and Regulations 

adopted, EPA-approved water quality 

standards. 

E. Executive Order 13132 (Federalism) 

This action does not have federalism 

implications. It will not have substantial 

direct effects on the states, on the 

relationship between the national 

government and the states, or on the 

distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132. This rule 

removes federally-promulgated water 

quality standards addressing nutrient 

pollution in Florida in order to allow 

Florida to implement its state-adopted, 

EPA-approved water quality standards. 

Thus, Executive Order 13132 does not 

apply to this action. 

F. Executive Order 13175 (Consultation 

and Coordination With Indian Tribal 

Governments) 

This action does not have tribal 

implications, as specified in Executive 

Order 13175 (65 FR 67249, November 9, 

2000). This rule imposes no regulatory 

requirements or costs on any tribal 

government. It does not have substantial 

direct effects on tribal governments, the 

relationship between the Federal 

government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

government and Indian tribes. Thus, 

Executive Order 13175 does not apply 

to this action. 

G. Executive Order 13045 (Protection of 

Children From Environmental Health 

and Safety Risks) 

This rule is not subject to Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997), because it is not 

economically significant as defined in 

Executive Order 12866 and because the 

environmental health or safety risks 

addressed by this action do not present 

a disproportionate risk to children. 

H. Executive Order 13211 (Actions That 

Significantly Affect Energy Supply, 

Distribution, or Use) 

This action is not subject to Executive 

Order 13211 (66 FR 28355 (May 22, 

2001)), because it is not a significant 

regulatory action under Executive Order 

12866. 

I. National Technology Transfer and 

Advancement Act of 1995 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (‘‘NTTAA’’), Public Law 

104–113, 12(d) (15 U.S.C. 272 note) 

directs EPA to use voluntary consensus 

standards in its regulatory activities, 

unless to do so would be inconsistent 

with applicable law or otherwise 

impractical. Voluntary consensus 

standards are technical standards (e.g., 

materials specifications, test methods, 

sampling procedures, and business 

practices) that are developed or adopted 

by voluntary consensus standards 

bodies. The NTTAA directs EPA to 

provide Congress, through OMB, 

explanations when the Agency decides 

not to use available and applicable 

voluntary consensus standards. 

This rulemaking does not involve 

technical standards. Therefore, EPA is 

not considering the use of any voluntary 

consensus standards. 

J. Executive Order 12898—Federal 

Actions To Address Environmental 

Justice in Minority Populations and 

Low-Income Populations 

Executive Order 12898 (59 FR 7629, 

February 16, 1994) establishes federal 

executive policy on environmental 

justice. Its main provision directs 

federal agencies, to the greatest extent 

practicable and permitted by law, to 

make environmental justice part of their 

mission by identifying and addressing, 

as appropriate, disproportionately high 

and adverse human health or 

environmental effects of their programs, 

policies, and activities on minority 

populations and low-income 

populations in the United States. 

EPA has determined that this rule will 

not have disproportionately high and 

adverse human health or environmental 

effects on minority or low-income 

populations because: (1) Florida’s WQS 

apply to waters across the state, and 

thus this action will not 

disproportionately affect any one group 

over another, and (2) EPA has 

previously determined, based on the 

most current science, that Florida’s 

adopted and EPA-approved criteria are 

protective of human health and aquatic 

life. 

K. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

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 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. 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). This rule will be effective on 

October 27, 2014. 

List of Subjects in 40 CFR Part 131 

Environmental protection, Florida, 

Nitrogen and phosphorus pollution, 

Numeric nutrient criteria, Nutrients, 

Water quality standards. 

Dated: September 17, 2014. 

Gina McCarthy, 

Administrator. 

For the reasons set out in the 

preamble, 40 CFR part 131 is amended 

as follows: 

PART 131—WATER QUALITY 

STANDARDS 

■ 1. The authority citation for part 131 

continues to read as follows: 

Authority: 33 U.S.C. 1251 et seq. 

Subpart D—Federally Promulgated 

Water Quality Standards 

§ 131.43 [Removed] 

■ 2. Remove § 131.43. 

[FR Doc. 2014–22835 Filed 9–24–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0268; FRL–9915–78] 

Thiabendazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of thiabendazole 

in or on multiple commodities which 

are identified and discussed later in this 

document. Syngenta Crop Protection, 

LLC., requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: This regulation is effective 

September 25, 2014. Objections and 

requests for hearings must be received 

on or before November 24, 2014, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2013–0268, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 79, No. 186 / Thursday, September 25, 2014 / Rules and Regulations 57451 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., Rm. 3334, 1301 

Constitution Ave. NW., Washington, DC 

20460–0001. The Public Reading Room 

is open from 8:30 a.m. to 4:30 p.m., 

Monday through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; 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–2013–0268 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 November 24, 2014. Addresses 

for mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2013–0268, 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 August 1, 

2014 (79 FR 44729) (FRL–9911–67), 

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 3F8166) by 

Syngenta Crop Protection, LLC, P.O. 

Box 18300, Greensboro, NC 27419– 

8300. The petition requested that 40 

CFR 180.242 be amended by 

establishing tolerances for residues of 

the fungicide thiabendazole (2-(4- 

thiazolyl)benzimidazole) and its 

metabolite benzimidazole, in or on 

vegetable, root (except sugar beet), 

subgroup 1B at 0.02 ppm; radish, tops 

at 0.02 ppm; onion, bulb, subgroup 3– 

07A at 0.02 ppm; Brassica, head and 

stem, subgroup 5–A at 0.02 ppm; 

vegetable, cucurbit group 9 at 0.02 ppm; 

barley, grain at 0.05 ppm; barley, hay at 

0.30 ppm; barley, straw at 0.30 ppm; 

wheat, grain at 0.05 ppm; wheat, straw 

at 0.30 ppm; wheat, hay at 0.30 ppm; 

wheat, forage 0.30 ppm; oats, grain at 

0.05 ppm; oats, hay at 0.30 ppm; oats, 

straw at 0.30 ppm; oats, forage at 0.30 

ppm; rye, grain at 0.05 ppm; rye, straw 

at 0.30 ppm; rye, forage at 0.30 ppm; 

triticale, grain at 0.05 ppm; triticale, hay 

at 0.30 ppm; triticale, straw at 0.30 ppm; 

triticale, forage at 0.30 ppm; alfalfa, 

forage at 0.02 ppm; alfalfa, hay at 0.02 

ppm; and spinach at 0.02 ppm. That 

document referenced a summary of the 

petition prepared by Syngenta Crop 

Protection, the registrant, which is 

available in the docket, http://

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

The Notice of Filing (NOF) published 

on August 1, 2014 (79 FR 44729) 

supersedes an earlier NOF for the same 

petition for thiabendazole that was 

issued in the Federal Register of June 5, 

2013 (78 FR 33785) (FRL–9386–2). 

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 thiabendazole 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with thiabendazole follows. 


tkelley on DSK3SPTVN1PROD with RULES
57452 Federal Register / Vol. 79, No. 186 / Thursday, September 25, 2014 / Rules and Regulations 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. 

The thyroid and liver (centrilobular 

hypertrophy) are the primary target 

organs of thiabendazole toxicity. 

Thiabendazole produced a treatmentrelated increase in absolute and relative 

liver weights in both sexes in a chronic 

dog study. Other treatment related 

effects reported were histopathological 

changes in kidneys (hyperplasia of 

transitional epithelium, tubular 

degeneration) and spleen (congested 

and pigmented) in rats. Additional toxic 

effects observed in these studies 

included decreases in body weight and/ 

or food consumption. The available 

database indicates that thiabendazole is 

not neurotoxic. In an acute 

neurotoxicity rat study (ACN), decreases 

in the Functional Observation Battery 

(FOB) (reduced body temperature in 

males, reduced rearing in females, and 

reduced locomotor activity in males and 

females at time of peak effect 

(approximately 3 hours post-dose) were 

seen without morphological or 

histopathological effects on the brain. 

Thiabendazole was not neurotoxic in 

rats in a subchronic neurotoxicity study. 

In a 21-day dermal toxicity study in rats, 

no systemic or dermal effects were seen 

at the limit dose (1,000 milligram/

kilogram/day (mg/kg/day)). In prenatal 

developmental toxicity studies in rats, 

rabbits, and mice and in the 2- 

generation reproduction study in rats, 

effects in the fetuses or neonates 

occurred at or above doses that caused 

maternal or parental toxicity. 

In the adult animal, effects on the 

thyroid following thiabendazole 

exposure were observed at a dose lower 

than the neurotoxicity dose observed in 

the ACN. There are no thiabendazole 

data with which to determine whether 

this is also the case in the fetus/

postnatal animal. Based on a weight of 

evidence (WOE) approach considering 

all the available hazard and exposure 

information for thiabendazole, the 

Agency concluded that a developmental 

thyroid toxicity study is required since 

there is clear evidence of thyroid 

toxicity in adult animals and thus a 

concern for potential toxicity during 

pregnancy, infancy and childhood. The 

developmental thyroid toxicity study 

will better address this concern than a 

developmental neurotoxicity study. 

In an immunotoxicity study, 

thiabendazole produced significant 

decreased spleen activity at the highest 

dose tested (5,000 ppm equivalent to 

1,027 mg/kg/day) which also produced 

significant increased liver weight. 

The genetic toxicology studies on 

thiabendazole indicate that it is not 

genotoxic in in vivo and in vitro assays. 

Review of literature studies indicated 

that thiabendazole has weak aneugenic 

activity in both somatic and germinal 

cells. In a chronic rat study, 

thiabendazole induced thyroid tumors 

in males only. Thiabendazole did not 

induce tumors in mice. Thiabendazole 

has been classified by the Agency as 

‘‘likely to be carcinogenic at doses high 

enough to cause a disturbance of the 

thyroid hormonal balance but not likely 

to be carcinogenic at doses lower than 

those which could cause a disturbance 

of this hormonal balance.’’ Taking into 

account all of this information, the 

Agency has determined that 

quantification of risk using a non-linear 

approach (i.e., chronic population 

adjusted dose (cPAD)) will adequately 

account for all chronic toxicity, 

including carcinogenicity that could 

result from exposure to thiabendazole. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by thiabendazole 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 ‘‘Thiabendazole: Human Health 

Risk Assessment for the Requested 

Increase in the Currently Registered 

Seed Treatment Use Rate on Soybeans 

and the New Section 3 Uses of 

Thiabendazole for Seed Treatment on 

Assorted Vegetables and Small Grains 

Including: Vegetable, Root (Except 

Sugar Beet), Subgroup 1B; Radish Tops; 

Onion, Bulb, Subgroup 3–07A; Brassica, 

Head and Stem, Subgroup 5A; 

Vegetable, Cucurbit Group 9; Alfalfa; 

Spinach; and a Number of Small Grains 

(Barley, Oats, Rye, and Triticale)’’ on 

pages 45–53 in docket ID number EPA– 

HQ–OPP–2013–0268. 

B. Toxicological Points of Departure/

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern (LOC) to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which 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 thiabendazole used for 

human risk assessment is shown in the 

following table of this unit. 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 79, No. 186 / Thursday, September 25, 2014 / Rules and Regulations 57453 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR THIABENDAZOLE 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 (general population 

including females 13–49 years of 

age and children).

NOAEL = 50 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = UFDB 10x 

Acute RfD = 0.05 mg/

kg/day.

aPAD = 0.05 mg/kg/day 

Acute neurotoxicity study. 

LOAEL = 200 mg/kg based decreases in the FOB 

(reduced body temperature in males, and reduced 

rearing in females, reduced locomotor activity in 

males and females, at time of peak effect (approximately 3 hours post-dose). Reduced body 

weight gain and food consumption occurred on 

day 1. 

Chronic dietary (all populations) ...... NOAEL= 10 mg/kg/day

UFA = 3x 

UFH = 10x 

FQPA SF = UFDB 10x 

Chronic RfD = 0.033 

mg/kg/day.

cPAD = 0.033 mg/kg/

day 

2-year chronic carcinogenicity in the rat. 

Chronic LOAEL = 30 mg/kg/day based on decreased body weight gains and liver hypertrophy. 

Thiabendazole induced thyroid adenomas in male 

rats at dosages of ≥30 mg/kg/day. Supported by 

subchronic toxicity rat study. 

Subchronic LOAEL = 40 mg/kg/based on reduced 

body weight and body weight gains and 

histopathological changes in the bone marrow 

(erythroid hyperplasia), liver (centrilobular hypertrophy), thyroid (follicular cell hypertrophy) and 

spleen (pigmented). 

Incidental oral short-term (1 to 30 

days) and intermediate-term (1 to 

6 months).

NOAEL= 10 mg/kg/day

UFA = 3x 

UFH = 10x 

FQPA SF = 10x UFDB

LOC for MOE = 300 ..... Subchronic oral toxicity study—rat. 

LOAEL = 40 mg/kg/day based on reduced body 

weight gains and histopathological changes in the 

bone marrow, liver and thyroid. 

Dermal short-term (1 to 30 days) 

and intermediate-term (1 to 6 

months).

Dermal (or oral) study ...

NOAEL = 10 mg/kg/day 

(dermal absorption 

rate = 0.5%.

UFA = 3x 

UFH = 10x 

FQPA SF = 10x UFDB

LOC for MOE = 300 ..... Subchronic oral toxicity study—rat. 

LOAEL = 40 mg/kg/day based on reduced body 

weight gains and histopathological changes in the 

bone marrow, liver and thyroid. 

Inhalation short-term (1 to 30 days) 

and intermediate-term (1 to 6 

months).

NOAEL= 10 mg/kg/day

UFA = 3x 

UFH = 10x 

FQPA SF = 10x UFDB

LOC for MOE = 300 ..... Subchronic oral toxicity study—rat. 

LOAEL = 40 mg/kg/day based on reduced body 

weight gains and histopathological changes in the 

bone marrow, liver and thyroid. 

Cancer (oral, dermal, inhalation) ..... Likely to be carcinogenic at doses high enough to cause a disturbance of the thyroid hormonal balance 

but not likely to be carcinogenic at doses lower that those which could cause a disturbance of this hormonal balance. Quantification of risk using a non-linear approach (i.e., cPAD) will adequately account for 

all chronic toxicity, including carcinogenicity that could result from exposure to thiabendazole. 

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). UFDB = to account for the absence of data or other data deficiency. 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 thiabendazole, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing thiabendazole tolerances in 40 

CFR 180.242. EPA assessed dietary 

exposures from thiabendazole 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. 

Such effects were identified for 

thiabendazole. In estimating acute 

dietary exposure, EPA used food 

consumption data from the U.S. 

Department of Agriculture’s (USDA’s) 

National Health and Nutrition 

Examination Survey, What We Eat in 

America, (NHANES/WWEIA). As to 

residue levels in food, EPA used a 

refined acute probabilistic dietary 

exposure assessment for thiabendazole 

using both anticipated residue estimates 

based on USDA Pesticide Data Program 

(PDP) monitoring data and percent crop 

treated (PCT) information for soybean 

and wheat and assumed 100 PCT for all 

other commodities. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used food consumption data from 

the USDA NHANES/WWEIA. As to 

residue levels in food, EPA used a 

refined chronic probabilistic dietary 

exposure assessment for thiabendazole 

using both anticipated residue estimates 

based on USDA PDP monitoring data 

and PCT information for soybean and 

wheat and assumed 100 PCT for all 

other commodities. 

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 


tkelley on DSK3SPTVN1PROD with RULES
57454 Federal Register / Vol. 79, No. 186 / Thursday, September 25, 2014 / Rules and Regulations 

data determines a mutagenic mode of 

action, a default linear cancer slope 

factor approach is utilized. Based on the 

data summarized in Unit III.A., EPA has 

concluded that a nonlinear RfD 

approach is appropriate for assessing 

cancer risk to thiabendazole. Cancer risk 

was assessed using the same exposure 

estimates as discussed in Unit III.C.1.ii. 

iv. Anticipated residue and PCT 

information. 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 if: 

• 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, 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 as follows: 

Acute dietary risk assessment: 

soybeans 2.5%; wheat 2.5%. 

Chronic dietary risk assessment: 

soybeans 1%; wheat 1%. 

In most cases, EPA uses available data 

from United States Department of 

Agriculture/National Agricultural 

Statistics Service (USDA/NASS), 

proprietary market surveys, and the 

National Pesticide Use Database for the 

chemical/crop combination for the most 

recent 6–7 years. EPA uses an average 

PCT for chronic dietary risk analysis. 

The average PCT figure for each existing 

use is derived by combining available 

public and private market survey data 

for that use, averaging across all 

observations, and rounding to the 

nearest 5%, except for those situations 

in which the average PCT is less than 

one. In those cases, 1% is used as the 

average PCT and 2.5% is used as the 

maximum PCT. EPA uses a maximum 

PCT for acute dietary risk analysis. The 

maximum PCT figure is the highest 

observed maximum value reported 

within the recent 6 years of available 

public and private market survey data 

for the existing use and rounded up to 

the nearest multiple of 5%. 

The Agency believes that the three 

conditions discussed in Unit III.C.1.iv. 

have been met. With respect to 

Condition a, PCT estimates are derived 

from Federal and private market survey 

data, which are reliable and have a valid 

basis. The Agency is reasonably certain 

that the percentage of the food treated 

is not likely to be an underestimation. 

As to Conditions b and c, regional 

consumption information and 

consumption information for significant 

subpopulations is taken into account 

through EPA’s computer-based model 

for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available reliable information on 

the regional consumption of food to 

which thiabendazole may be applied in 

a particular area. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for thiabendazole in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

thiabendazole. 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 FQPA Index Reservoir 

Screening Tool (FIRST) and Pesticide 

Root Zone Model Ground Water (PRZM 

GW), the estimated drinking water 

concentrations (EDWCs) of 

thiabendazole for acute exposures are 

estimated to be 3.80 parts per billion 

(ppb) for surface water and 0.62 ppb for 

ground water and for chronic exposures 

are estimated to be 0.47 ppb for surface 

water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 3.80 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 0.47 ppb was used to assess the 

contribution to drinking water. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). 

Thiabendazole is currently registered for 

use as antimicrobial ingredient in paint, 

sponges, carpet backing, canvas textiles, 

wallboard and ceiling tiles, 

polyurethane foam, plastics and rubber, 

paper, and coatings and filters used in 

HVAC systems. There are two 

antimicrobial exposure scenarios that 

were assessed for residential exposures: 

Treated paint and impregnated sponges. 

The other antimicrobial uses of 

thiabendazole (carpet backing, canvas 

textiles, wallboard and ceiling tiles, 

polyurethane foam, plastics and rubber, 

paper, and coatings and filters used in 

HVAC systems) are not expected to 

cause exposure in residential settings 

because there is no direct contact to the 

treated articles, the vapor pressure of 

thiabendazole is very low, and the 

unlikelihood that the treated plastics 

and rubbers would be used in toys. 

EPA assessed residential exposure to 

treated paint and impregnated sponges 

using the following assumptions: For 

treated paint, residential short-term 

dermal and inhalation exposure to 

residential handlers using brush/roller 

application and airless sprayer 

application; for the impregnated sponge 

use, short- and intermediate-term 

incidental oral exposure. Thiabendazole 

treated sponges are limited to 600 ppm 

thiabendazole on a sponge. Various 

residue amounts may be transferred 

from the sponge to food contact 

surfaces, such as countertops and 

utensils/glassware, and then to food and 

subsequently ingested. An assessment 

was conducted for incidental oral 

exposure assuming that 100% of the 

thiabendazole on a treated sponge is 

transferred to surfaces over 20 days and 

that each 20 days the user would use a 

new sponge (5% released per day). This 

assumption is considered conservative 

because (1) sponges will generally be 

used much longer than 20 days; (2) it is 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 79, No. 186 / Thursday, September 25, 2014 / Rules and Regulations 57455 

unlikely that 100% of the thiabendazole 

would be released from the sponge in 

such a short period; and (3) it is very 

unlikely that 100% of any released 

thiabendazole would be transferred to 

countertops because this assumption 

does not account any thiabendazole that 

is washed down the sink or that 

normally degrades. 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 thiabendazole to 

share a common mechanism of toxicity 

with any other substances, and 

thiabendazole does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that thiabendazole 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. 

No evidence of increased quantitative or 

qualitative susceptibility was seen 

following in utero exposure to 

thiabendazole with rats or rabbits in the 

prenatal developmental studies or in 

young rats in the 2-generation 

reproduction study. There is no 

evidence for neurotoxicity following 

oral exposures to thiabendazole. 

Thyroid toxicity was seen following 

subchronic and chronic exposures to 

adult rats in multiple studies. There is, 

however, no data regarding the potential 

effects of thiabendazole on thyroid 

homeostasis in the young animals. This 

lack of characterization creates 

uncertainty with regards to potential life 

stage sensitivities due to exposure to 

thiabendazole. Therefore, the Agency is 

requiring a developmental thyroid assay 

in rats with thiabendazole. This study 

will better address the concern for 

potential thyroid toxicity in the young. 

Although the Agency is asking for the 

developmental thyroid study, EPA does 

not expect it to result in a lower point 

of departure than what the Agency is 

regulating from and therefore the 10X is 

protective. There are no residual 

uncertainties in the thiabendazole 

residue database with regards to dietary 

or occupational exposure. Therefore, the 

FQPA SF is retained at 10X in the form 

of a database uncertainty factor (UFDB). 

For the acute dietary endpoint the total 

UF is 1,000 (an interspecies scaling 

factor of 10X, an intraspecies variability 

factor of 10X, a FQPA database 

uncertainty factor of 10X for lack of a 

developmental thyroid study). For the 

remaining endpoints, the combined 

total UF is 300 (an interspecies scaling 

factor of 3X, lowered from 10X for 

toxicodynamic reasons (rats eliminate 

thyroxine (a thyroid hormone) at a 

higher rate than humans), an 

intraspecies variability factor of 10X, an 

FQPA database uncertainty factor of 

10X for lack of a developmental thyroid 

study was applied). 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF is 

retained at 10X in the form of a database 

uncertainty factor (UFDB). That decision 

is based on the following findings: 

i. The toxicology database for 

thiabendazole is complete with the 

exception of a developmental thyroid 

toxicity study. Based on a WOE 

approach considering all the available 

hazard and exposure information for 

thiabendazole, the Agency concluded 

that a developmental thyroid toxicity 

study is required since there is clear 

evidence of thyroid toxicity in adult 

animals and thus a concern for potential 

toxicity during pregnancy, infancy and 

childhood. The developmental thyroid 

toxicity study will better address this 

concern than a developmental 

neurotoxicity study. Acceptable studies 

are available for developmental, 

reproduction, chronic, subchronic, 

subchronic neurotoxicity and 

immunotoxicity. 

ii. There is no indication that 

thiabendazole is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. The data submitted to the Agency, 

as well as those from published 

literature, demonstrate no increased 

susceptibility in rats, rabbits, or mice to 

in utero and/or early postnatal exposure 

to thiabendazole. In the prenatal 

developmental toxicity studies in rats, 

rabbits, and mice and in the 2- 

generations reproduction study in rats, 

developmental effects in the fetuses or 

neonates occurred at or above doses that 

caused maternal or parental toxicity. A 

developmental neurotoxicity study with 

thiabendazole was deemed not required 

by the Agency. 

There is evidence of thyroid toxicity 

following subchronic and chronic 

exposures to rats characterized as 

histopathological changes in the thyroid 

in multiple studies in rats. Disruption of 

thyroid homeostasis is the initial, 

critical effect that may lead to adverse 

effects on the developing nervous 

system. Thus, as noted above, a 

developmental thyroid study is 

required. 

iv. There are no residual uncertainties 

in the exposure database. The dietary 

risk assessment is conservative and will 

not underestimate dietary and/or nondietary occupational exposure to 

thiabendazole. The acute and chronic 

dietary assessments conducted with the 

Dietary Exposure Evaluation Model 

software with the Food Commodity 

Intake Database (DEEM–FCID) were 

refined analyses. The assessments 

utilized anticipated residues, default 

processing factors, and available percent 

crop treated data. The DEEM analysis 

also used Tier 1 drinking water 

estimates. For these reasons it can be 

concluded that the DEEM–FCID analysis 

does not underestimate risk from acute 

or chronic exposure to thiabendazole. 

Similarly, EPA does not believe that the 

non-dietary occupational exposures are 

underestimated because they are also 

based on conservative assumptions, 

including maximum application rates, 

and standard values for unit exposures 

and acreage treated/amount handled. 

These assessments will not 

underestimate the exposure and risks 

posed by thiabendazole. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 


tkelley on DSK3SPTVN1PROD with RULES
57456 Federal Register / Vol. 79, No. 186 / Thursday, September 25, 2014 / Rules and Regulations 

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. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

thiabendazole will occupy 69% of the 

aPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to thiabendazole 

from food and water will utilize 4.7% of 

the cPAD for children 1–2 years old, 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 thiabendazole is not 

expected. 

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). 

Thiabendazole is currently registered 

for uses that could result in short- and 

intermediate-term residential exposure, 

and the Agency has determined that it 

is appropriate to aggregate chronic 

exposure through food and water with 

short- and intermediate-term residential 

exposures to thiabendazole. 

Using the exposure assumptions 

described in this unit for short- and 

intermediate-term exposures, EPA has 

concluded the combined short- and 

intermediate-term food, water, and 

residential exposures result in aggregate 

MOEs from the paint use of 2,000 for all 

population subgroups and aggregate 

MOEs from the sponge use of 1,400 for 

children 1–2 years old and 7,300 for the 

general population. Because EPA’s level 

of concern for thiabendazole is a MOE 

of 300 or below, these MOEs are not of 

concern. 

4. Aggregate cancer risk for U.S. 

population. Since thiabendazole is 

classified as likely to be carcinogenic at 

doses high enough to cause a 

disturbance of the thyroid hormonal 

balance but not likely to be carcinogenic 

at doses lower than those which could 

cause a disturbance of this hormonal 

balance, a cancer dietary exposure 

assessment is not required. EPA is 

currently regulating chronic dietary risk 

with a chronic RfD that reflects a dose 

level below dose levels at which thyroid 

hormone balance is impacted and 

consequently is also being protective of 

potential carcinogenic effects. 

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 

thiabendazole residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Acceptable enforcement analytical 

methods are available for thiabendazole 

and benzimidazole in plant 

commodities. Four 

spectrophotofluorometric methods for 

the determination of thiabendazole are 

published in the Pesticide Analytical 

Manual (PAM) Vol. II, and a high 

performance liquid chromatography 

(HPLC) method with fluorescence 

detection (FLD) for the determination of 

benzimidazole (free and conjugated) is 

identified in the U.S. EPA Index of 

Residue Analytical Methods under 

thiabendazole as Study No. 93020. 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: residuemethods@

epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has not established a MRL 

for thiabendazole on any of the 

commodities cited in this document. 

C. Revisions to Petitioned-For 

Tolerances 

Finally, EPA has revised the tolerance 

expression to clarify (1) that, as 

provided in FFDCA section 408(a)(3), 

the tolerance covers metabolites and 

degradates of thiabendazole not 

specifically mentioned; and (2) that 

compliance with the specified tolerance 

levels is to be determined by measuring 

only the specific compounds mentioned 

in the tolerance expression. 

V. Conclusion 

Therefore, tolerances are established 

for residues of thiabendazole, [2-(4- 

thiazolyl) benzimidazole] and its 

metabolite benzimidazole (free and 

conjugated), in or on alfalfa, forage at 

0.02 ppm; alfalfa, hay at 0.02 ppm; 

barley, grain at 0.05 ppm; barley, hay at 

0.30 ppm; barley, straw at 0.30 ppm; 

Brassica, head and stem, subgroup 5A at 

0.02 ppm; oat, forage at 0.30 ppm; oat, 

grain at 0.05 ppm; oat, hay at 0.30 ppm; 

oat, straw at 0.30 ppm; onion, bulb, 

subgroup 3–07A at 0.02 ppm; radish, 

tops at 0.02 ppm; rye, forage at 0.30 

ppm; rye, grain at 0.05 ppm; rye, straw 

at 0.30 ppm; spinach at 0.02 ppm; 

triticale, forage at 0.30 ppm; triticale, 

grain at 0.05 ppm; triticale, hay at 0.30 

ppm; triticale, straw at 0.30 ppm; 

vegetable, cucurbit, group 9 at 0.02 

ppm; vegetable, root (except sugarbeet), 

subgroup 1B at 0.02 ppm; wheat, forage 

at 0.30 ppm; and wheat, hay at 0.30 

ppm. In addition, the following existing 

tolerances are modified: wheat, grain 

from 1.0 ppm to 0.05 ppm; and wheat 

straw from 1.0 ppm to 0.30 ppm. 

Also, the time-limited tolerances for 

beet, sugar, dried pulp; beet, sugar, 

roots; and beet, sugar, tops, are removed 

because they expired on 12/25/10. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 79, No. 186 / Thursday, September 25, 2014 / Rules and Regulations 57457 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

U.S.C. 3501 et seq.), nor does it require 

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of FFDCA section 408(n)(4). As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

Tribes. Thus, the Agency has 

determined that Executive Order 13132, 

entitled ‘‘Federalism’’ (64 FR 43255, 

August 10, 1999) and Executive Order 

13175, entitled ‘‘Consultation and 

Coordination with Indian Tribal 

Governments’’ (65 FR 67249, November 

9, 2000) do not apply to this final rule. 

In addition, this final rule does not 

impose any enforceable duty or contain 

any unfunded mandate as described 

under Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (2 U.S.C. 

1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 18, 2014. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.242, revise paragraph (a)(1) 

and the introductory text of paragraph 

(a)(2) to read as follows: 

§ 180.242 Thiabendazole; tolerances for 

residues. 

(a) General. (1) Tolerances are 

established for residues of 

thiabendazole, including its metabolites 

and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only the sum of 

thiabendazole (2-(4- 

thiazolyl)benzimidazole) and its 

metabolite benzimidazole (free and 

conjugated), calculated as the 

stoichiometric equivalent of 

thiabendazole, in or on the commodity. 

Commodity Parts per 

million 

Alfalfa, forage ....................................................................................................................................................................................... 0.02 

Alfalfa, hay ........................................................................................................................................................................................... 0.02 

Apple, wet pomace .............................................................................................................................................................................. 12.0 

Avocado 1 ............................................................................................................................................................................................. 10.0 

Banana, postharvest ............................................................................................................................................................................ 3.0 

Barley, grain ......................................................................................................................................................................................... 0.05 

Barley, hay ........................................................................................................................................................................................... 0.30 

Barley, straw ........................................................................................................................................................................................ 0.30 

Bean, dry, seed ................................................................................................................................................................................... 0.1 

Brassica, head and stem, subgroup 5A .............................................................................................................................................. 0.02 

Cantaloupe 1 ........................................................................................................................................................................................ 15.0 

Carrot, roots, postharvest .................................................................................................................................................................... 10.0 

Citrus, oil .............................................................................................................................................................................................. 15.0 

Corn, field, forage ................................................................................................................................................................................ 0.01 

Corn, field, grain .................................................................................................................................................................................. 0.01 

Corn, field, stover ................................................................................................................................................................................ 0.01 

Corn, pop, forage ................................................................................................................................................................................. 0.01 

Corn, pop, grain ................................................................................................................................................................................... 0.01 

Corn, pop, stover ................................................................................................................................................................................. 0.01 

Corn, sweet, forage ............................................................................................................................................................................. 0.01 

Corn, sweet, kernels plus cop with husks removed ............................................................................................................................ 0.01 

Corn, sweet, stover .............................................................................................................................................................................. 0.01 

Fruit, citrus, group 10, postharvest ...................................................................................................................................................... 10.0 

Fruit, pome, group 11, postharvest ..................................................................................................................................................... 5.0 

Mango .................................................................................................................................................................................................. 10.0 

Mushroom ............................................................................................................................................................................................ 40.0 

Oats, forage ......................................................................................................................................................................................... 0.30 

Oats, grain ........................................................................................................................................................................................... 0.05 

Oats, hay ............................................................................................................................................................................................. 0.30 

Oats, straw ........................................................................................................................................................................................... 0.30 

Onion, bulb, subgroup 3–07A .............................................................................................................................................................. 0.02 

Papaya, postharvest ............................................................................................................................................................................ 5.0 


tkelley on DSK3SPTVN1PROD with RULES
57458 Federal Register / Vol. 79, No. 186 / Thursday, September 25, 2014 / Rules and Regulations 

Commodity Parts per 

million 

Potato, postharvest .............................................................................................................................................................................. 10.0 

Radish, tops ......................................................................................................................................................................................... 0.02 

Rye, forage .......................................................................................................................................................................................... 0.30 

Rye, grain ............................................................................................................................................................................................ 0.05 

Rye, straw ............................................................................................................................................................................................ 0.30 

Soybean ............................................................................................................................................................................................... 0.1 

Spinach ................................................................................................................................................................................................ 0.02 

Strawberry 1 ......................................................................................................................................................................................... 5.0 

Sweet potato (postharvest to sweet potato intended only for use as seed) ...................................................................................... 0.05 

Triticale, forage .................................................................................................................................................................................... 0.30 

Triticale, grain ...................................................................................................................................................................................... 0.05 

Triticale, hay ........................................................................................................................................................................................ 0.30 

Triticale, straw ...................................................................................................................................................................................... 0.30 

Vegetable, cucurbit, group 9 ............................................................................................................................................................... 0.02 

Vegetable, root (except sugarbeet), subgroup 1B .............................................................................................................................. 0.02 

Wheat, forage ...................................................................................................................................................................................... 0.30 

Wheat, grain ........................................................................................................................................................................................ 0.05 

Wheat, hay ........................................................................................................................................................................................... 0.30 

Wheat, straw ........................................................................................................................................................................................ 0.30 

1There are no U.S. registrations on the indicated commodity. 

(2) Tolerances are established for 

residues of thiabendazole, including its 

metabolites and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only the sum of 

thiabendazole (2-(4- 

thiazolyl)benzimidazole) and its 

metabolites 5-hydroxythiabendazole 

(free and conjugated) and benzimidazole 

(free and conjugated), calculated as the 

stoichiometric equivalent of 

thiabendazole, in or on the commodity. 

* * * * * 

[FR Doc. 2014–22833 Filed 9–24–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 300 

[EPA–HQ–SFUND–1990–0011; FRL–9916– 

83–Region 6] 

Withdrawal of Direct Final Rule; 

National Oil and Hazardous 

Substances Pollution Contingency 

Plan; National Priorities List: Direct 

Deletion of the Monroe Auto 

Equipment (Paragould Pit) Superfund 

Site 

AGENCY: Environmental Protection 

Agency. 

ACTION: Withdrawal of direct final rule. 

SUMMARY: On August 14, 2014, 

Environmental Protection Agency (EPA) 

published a direct final rule (79 FR 

47586) and a proposed rule; notice of 

intent to delete (79 FR 47610) that 

deleted the Monroe Auto Equipment 

Company (Paragould Pit) site from the 

Superfund National Priorities List 

(NPL). EPA stated in the direct final rule 

that if EPA received adverse comments 

by September 15, 2014, EPA would 

publish a timely notice of withdrawal in 

the Federal Register. Subsequently, EPA 

discovered scribal errors in the 

supporting documentation of the final 

direct rule. EPA will correct those errors 

in a subsequent final action based on 

the parallel proposal which published 

on August 14, 2014. EPA will not 

institute a second comment period on 

this final action. Unless adverse 

comments are received by September 

15, 2014, the effective date of the final 

rule will be September 29, 2014. 

DATES: Effective: The direct final rule 

published at 79 FR 47586 on August 14, 

2014, is withdrawn effective September 

25, 2014. 

FOR FURTHER INFORMATION CONTACT: 

Brian Mueller, Remedial Project 

Manager; U.S. Environmental Protection 

Agency, Region 6; Superfund Division 

(6SF–RL); 1445 Ross Avenue, Suite 

1200, Dallas, Texas 75202–2733, 

telephone (214) 665–7167; email 

address: mueller.brian@epa.gov, 

SUPPLEMENTARY INFORMATION: The EPA 

Region 6 published a direct final Notice 

of Deletion of the Monroe Auto 

Equipment (Paragould Pit) Superfund 

Site located in Paragould, Greene 

County, Arkansas, from the National 

Priorities List (NPL) on August 14, 2014. 

The NPL, promulgated pursuant to 

section 105 of the Comprehensive 

Environmental Response, 

Compensation, and Liability Act 

(CERCLA) of 1980, as amended, is an 

appendix of the National Oil and 

Hazardous Substances Pollution 

Contingency Plan (NCP). The NPL 

constitutes Appendix B of 40 CFR Part 

300 as amended. EPA maintains the 

NPL as the list of sites that appear to 

present a significant risk to public 

health, welfare, or the environment. 

Sites on the NPL may be the subject of 

remedial actions financed by the 

Hazardous Substance Superfund (Fund). 

As described in 300.425(e)(3) of the 

NCP, sites deleted from the NPL 

remains eligible for Fund-financed 

remedial action if future conditions 

warrant such actions. The direct final 

deletion was published by EPA with the 

concurrence of the State of Arkansas, 

through the Arkansas Department of 

Environmental Quality (ADEQ), because 

EPA has determined that all appropriate 

response actions under CERCLA have 

been completed. EPA subsequently 

discovered scribal errors in the 

supporting documentation of the final 

direct rule. EPA will correct those errors 

in a subsequent final action based on 

the parallel proposal which published 

on August 14, 2014. We will not 

institute a second comment period on 

this final action unless adverse 

comments are received by September 

15, 2014. If no adverse comments are 

received the effective date of the 

subsequent action will be September 29, 

2014. 

Dated: September 9, 2014. 

Ron Curry, 

Regional Administrator, Region 6. 

[FR Doc. 2014–22639 Filed 9–24–14; 8:45 am] 

BILLING CODE 6560–50–P 


tkelley on DSK3SPTVN1PROD with RULES