Federal Register / Vol. 80, No. 246 / Wednesday, December 23, 2015 / Rules and Regulations 79711 

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 2-propenoic acid, homopolymer, 

ester with a-[2,4,6-tris(1- 

phenylethyl)phenyl]-whydroxypoly(oxy-1,2-ethanediyl), 

compd. with 2,2′,2′′-nitrilotris[ethanol]. 

IX. Conclusion 

Accordingly, EPA finds that 

exempting residues of 2-propenoic acid, 

homopolymer, ester with a-[2,4,6-tris(1- 

phenylethyl)phenyl]-whydroxypoly(oxy-1,2-ethanediyl), 

compd. with 2,2′,2′′-nitrilotris[ethanol] 

from the requirement of a tolerance will 

be safe. 

X. Statutory and Executive Order 

Reviews 

This action establishes 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). This action does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

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

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This action directly regulates growers, 

food processors, food handlers, and food 

retailers, not States or tribes, nor does 

this action alter the relationships or 

distribution of power and 

responsibilities established by Congress 

in the preemption provisions of FFDCA 

section 408(n)(4). As such, the Agency 

has determined that this action will not 

have a substantial direct effect on States 

or tribal governments, on the 

relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this action. In addition, this action 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

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

1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act 

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

XI. Congressional Review Act 

Pursuant to the Congressional Review 

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

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

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

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: December 11, 2015. 

Susan Lewis, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.960, add alphabetically the 

following polymer to the table to read as 

follows: 

§ 180.960 Polymers; exemptions from the 

requirement of a tolerance. 

* * * * * 

Polymer CAS No. 

* * * * * 

2-propenoic acid, 

homopolymer, ester with 

a-[2,4,6-tris(1- 

phenylethyl)phenyl]-whydroxypoly(oxy-1,2- 

ethanediyl), compd. with 

2,2′,2′′-nitrilotris[ethanol]), 

minimum number average 

molecular weight (in amu), 

10,000 ............................... 1477613–46–9 

* * * * * 

[FR Doc. 2015–32176 Filed 12–22–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0788; FRL–9939–83] 

Propiconazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of propiconazole 

in or on multiple commodities which 

are identified and discussed later in this 

document. Interregional Research 

Project Number 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

December 23, 2015. Objections and 

requests for hearings must be received 

on or before February 22, 2016, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2014–0788, 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 


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information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: 

Susan Lewis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main telephone 

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

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2014–0788 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 22, 2016. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2014–0788, 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 October 21, 

2015 (80 FR 63731) (FRL–9935–29), 

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 4E8321) by IR–4, 

IR–4 Project Headquarters, Rutgers, The 

State University of New Jersey, 500 

College Road East, Suite 201 W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.434 be 

amended by establishing tolerances for 

residues of the fungicide, 

propiconazole, 1-[[2-(2,4- 

dichlorophenyl)-4-propyl-1,3-dioxolan2-yl] methyl]-1H-1,2,4-triazole and its 

metabolites determined as 2,4,- 

dichlorobenzoic acid (2,4–DCBA), 

expressed as the stoichiometric 

equivalent of propiconazole, in or on 

the following raw agricultural 

commodities: Dill, dried at 80 parts per 

million (ppm); dill, fresh at 30 ppm; 

dill, seed at 15 ppm; fruit, stone, group 

12–12, except plum at 4 ppm and nut, 

tree, group 14–12 at 0.1 ppm; leafy 

Brassica greens, subgroup 5B at 20 ppm; 

quinoa, grain, at 3.0 ppm; radish, roots 

at 0.04 ppm; radish, tops at 0.2 ppm; ti 

palm, leaves at 10 ppm; ti palm, roots 

at 0.3 ppm, and watercress at 6 ppm. 

IR–4 also requested that upon 

establishment of the above tolerances, 

that the existing tolerances for ‘‘fruit, 

stone, group 12, except plum’’ and ‘‘nut, 

tree, group 14’’ be removed. That 

document referenced a summary of the 

petition prepared by Syngenta, the 

registrant, which is available in the 

docket, http://www.regulations.gov. The 

October 21, 2015 notice supersedes a 

notice of filing published in the Federal 

Register on February 11, 2015 (80 FR 

7559) (FRL–9921–94). The October 21, 

2015 notice includes the commodity 

‘‘quinoa, grain’’ as well as the other 

commodities that were originally 

requested in the February 11, 2015 

notice. Two comments were received in 

response to the October 21, 2015 notice 

of filing. EPA’s response to these 

comments is discussed in Unit IV.C. 

Based upon review of the data 

supporting the petition, EPA has 

modified some of the commodity 

vocabulary and rounded the significant 

figures of some of the tolerances. The 

reason for these changes are explained 

in Unit IV.D. 

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 propiconazole 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with propiconazole follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 


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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 primary target organ for 

propiconazole toxicity in animals is the 

liver. Increased liver weights were seen 

in mice after subchronic or chronic oral 

exposures to propiconazole. Liver 

lesions such as vacuolation of 

hepatocytes, ballooned liver cells, foci 

of enlarged hepatocytes, hypertrophy, 

and necrosis are characteristic of 

propiconazole toxicity in rats and mice. 

Decreased body weight gain was also 

seen in subchronic, chronic, 

developmental and reproductive studies 

in animal studies. Dogs appeared to be 

more sensitive to the localized toxicity 

of propiconazole as manifested by 

stomach irritations at 6 milligram/

kilogram/day (mg/kg/day) and above. 

In rabbits, developmental toxicity 

occurred at a higher dose than the 

maternally toxic dose, while in rats, 

developmental toxicity occurred at 

lower doses than maternal toxic doses. 

Increased incidences of rudimentary 

ribs occurred in rat and rabbit fetuses. 

Increased cleft palate malformations 

were noted in two studies in rats. In one 

published study in rats, developmental 

effects (malformations of the lung and 

kidneys, incomplete ossification of the 

skull, caudal vertebrae and digits, extra 

rib (14th rib) and missing sternbrae) 

were reported at doses that were not 

maternally toxic. In the two generation 

reproduction study in rats, offspring 

toxicity occurred at a higher dose than 

the parental toxic dose suggesting lower 

susceptibility of the offspring to the 

toxic doses of propiconazole. 

The acute neurotoxicity study 

produced severe clinical signs of 

toxicity (decreased activity, cold, pale, 

decreased motor activity, etc.) in rats at 

the high dose of 300 milligram/kilogram 

(mg/kg). Limited clinical signs 

(piloerection, diarrhea, tip toe gait) were 

observed in the mid-dose animals (100 

mg/kg), while no treatment related signs 

were observed at 30 mg/kg. The current 

acute dietary assessment for the general 

population is based on the NOAEL of 30 

mg/kg from the acute neurotoxicity 

study. A subchronic neurotoxicity study 

in rats did not produce neurotoxic signs 

at the highest dose tested that was 

associated with decreased body weight. 

Propiconazole was negative for 

mutagenicity in the in vitro BALB/3T3 

cell transformation assay, bacterial 

reverse mutation assay, Chinese hamster 

bone marrow chromosomal aberration 

assay, unscheduled DNA synthesis 

studies in human fibroblasts and 

primary rat hepatocytes, mitotic gene 

conversion assay, and the dominant 

lethal assay in mice. It caused 

proliferative changes in the rat liver 

with or without pretreatment with an 

initiator, like phenobarbital, a known 

liver tumor promoter. Liver enzyme 

induction studies with propiconazole in 

mice demonstrated that propiconazole 

is a strong phenobarbital type inducer of 

xenobiotic metabolizing enzymes. 

Hepatocellular proliferation studies in 

mice suggest that propiconazole induces 

cell proliferation followed by treatmentrelated hypertrophy in a manner similar 

to the known hypertrophic agent 

phenobarbital. 

Propiconazole was carcinogenic to 

male mice but was not carcinogenic to 

rats or to female mice. The Agency 

classified propiconazole as a possible 

human carcinogen and recommended 

that, for the purpose of risk 

characterization, the reference dose 

(RfD) approach be used for 

quantification of human risk. 

Propiconazole is not genotoxic and this 

fact, together with special mechanistic 

studies, indicates that propiconazole is 

a threshold carcinogen. Propiconazole 

produced liver tumors in male mice 

only at a high dose that was toxic to the 

liver. At doses below the RfD, liver 

toxicity is not expected; therefore, 

tumors are also not expected. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by propiconazole 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, ‘‘Propiconazole Human Health 

Risk Assessment for the New Uses of 

Propiconazole on dill, leafy brassicas 

crop subgroup 5B, ti palm, watercress, 

and quinoa, along with expansion to 

fruit, stone, group 12–12; except plum, 

and nut, tree, group 14–12’’ on pp. 37 

in docket ID number EPA–HQ–OPP– 

2014–0788. 

B. Toxicological Points of Departure/

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which the NOAEL and the 

LOAEL are identified. Uncertainty/

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

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://www2.epa.gov/

pesticide-science-and-assessingpesticide-risks/assessing-human-healthrisk-pesticides. 

A summary of the toxicological 

endpoints for propiconazole used for 

human risk assessment is shown in 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR PROPICONAZOLE 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 (Females 13–50 

years of age).

NOAEL = 30 mg/kg/

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 0.3 mg/

kg/day.

aPAD = 0.3 mg/kg/

day 

Developmental Study—Rat 

LOAEL = 90 mg/kg/day based on increased incidence of rudimentary ribs, un-ossified sternebrae, as well as increased incidence of shortened and absent renal papillae and increased cleft palate. 


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

ASSESSMENT—Continued 

Exposure/scenario 

Point of departure 

and uncertainty/safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Acute dietary (General population including infants and 

children).

NOAEL = 30 mg/kg/

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 0.3 mg/

kg/day.

aPAD = 0.3 mg/kg/

day 

Acute neurotoxicity study—Rat 

LOAEL = 100 mg/kg/day based on clinical signs of toxicity 

(piloerection in one male, diarrhea in one female, tip toe gait 

in 3 females). 

Chronic dietary (Adult Males 

and Females 50+ yrs).

NOAEL= 10 mg/kg/

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.1 

mg/kg/day.

cPAD = 0.1 mg/kg/

day 

24-Month carcinogenicity study on CD–1 mice. MRID 

00129918 

LOAEL = 50 mg/kg/day based on non-neoplastic liver effects 

(increased liver weight in males and increase in liver lesions: 

Masses/raised areas/swellings/nodular areas mainly). 

Incidental oral short-term (1 to 

30 days).

NOAEL= 30 mg/kg/

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 Acute Neurotoxicity Study—Rats 

LOAEL = 100 mg/kg/day based on clinical signs of toxicity 

(piloerection in one male, diarrhea in one female, tip toe gait 

in 3 females). 

Incidental oral intermediateterm (1 to 6 months).NOAEL= 10 mg/kg/

day.

UFA= 10x 

UFH= 10x 

FQPA SF = 1x 

LOC for MOE = 100 24-Month carcinogenicity Study—Mice 

LOAEL = 50 mg/kg/day based on non-neoplastic liver effects 

(increased liver weight in males and increase in liver lesions: 

Masses/raised areas/swellings/nodular areas mainly). 

Dermal short-term (1 to 30 

days).

Oral study NOAEL = 

30 mg/kg/day (dermal absorption 

rate = 40%).

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 Acute Neurotoxicity Study—Rats 

LOAEL = 100 mg/kg/day based on clinical signs of toxicity 

(piloerection in one male, diarrhea in one female, tip toe gait 

in 3 females). 

Dermal intermediate-term (1 to 

6 months).

Oral study NOAEL= 

10 mg/kg/day (dermal absorption 

rate = 40%).

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 24-Month carcinogenicity Study—Mice 

LOAEL = 50 mg/kg/day based on non-neoplastic liver effects 

(increased liver weight in males and increase in liver lesions: 

Masses/raised areas/swellings/nodular areas mainly). 

Inhalation short-term (1 to 30 

days).

Oral study NOAEL= 

30 mg/kg/day (inhalation absorption 

rate = 100%).

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 Acute Neurotoxicity Study—Rats 

LOAEL = 100 mg/kg/day based on clinical signs of toxicity 

(piloerection in one male, diarrhea in one female, tip toe gait 

in 3 females). 

Cancer (Oral, dermal, inhalation).Classification: Group C, possible human carcinogen, RfD approach for risk characterization. 

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

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

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

sensitivity among members of the human population (intraspecies). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to propiconazole, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing propiconazole tolerances in 40 

CFR 180.434. EPA assessed dietary 

exposures from propiconazole 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 

propiconazole. In estimating acute 

dietary exposure, EPA used food 

consumption information from the 

United States Department of Agriculture 

(USDA) National Health and Nutrition 

Examination Survey, What We Eat in 

America, (NHANES/WWEIA). This 

dietary survey was conducted from 2003 

to 2008. As to residue levels in food, 

EPA conducted an acute dietary 

analysis for propiconazole residues of 

concern using tolerance levels and 100 

percent crop treated (PCT) for all 

existing and proposed uses. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA’s NHANES/WWEIA. 

This dietary survey was conducted from 

2003 to 2008. As to residue levels in 

food, EPA conducted a chronic dietary 

analysis for propiconazole residues of 

concern using tolerance levels for some 

commodities, average field trial residues 

for the remaining commodities, and 100 

PCT for all existing and proposed uses. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 


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concluded that a nonlinear RfD 

approach is appropriate for assessing 

cancer risk to propiconazole. Cancer 

risk was assessed using the same 

exposure estimates as discussed in Unit 

III.C.1.ii., chronic exposure. 

iv. Anticipated residue 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. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for propiconazole in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

propiconazole. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

can be found at 

http://www2.epa.gov/pesticide-scienceand-assessing-pesticide-risks/aboutwater-exposure-models-used-pesticide. 

Based on the Surface Water 

Concentration Calculator (SWCC) and 

Pesticide Root Zone Model—Ground 

Water (PRZM–GW) models, the 

estimated drinking water concentrations 

(EDWCs) of propiconazole for acute 

exposures are estimated to be 35.2 parts 

per billion (ppb) for surface water and 

37.9 ppb for ground water, and for 

chronic exposures are estimated to be 

18.6 ppb for surface water and 35.1 ppb 

for ground 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 37.9 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 35.1 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). 

Propiconazole is currently registered 

for the following uses that could result 

in residential exposures: Turf, 

ornamentals, and in paint. The highest 

incidental oral and dermal exposure 

scenarios are expected from residential 

use on turf. EPA assessed short-term 

risk to toddlers from incidental oral and 

dermal exposure and short-term risk to 

adults from dermal and inhalation 

residential handler exposure as well as 

from post-application dermal exposure. 

The highest post-application exposure 

from residential use on turf was used to 

assess risk to short-term aggregate 

exposures. 

The only residential use scenario that 

will result in potential intermediate 

term exposure to propiconazole is wood 

treatment, which the Agency assumes 

may result in dermal and incidental oral 

post-application exposures to children. 

No chronic exposures are expected. 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

found at http://www2.epa.gov/pesticidescience-and-assessing-pesticide-risks/

standard-operating-proceduresresidential-pesticide. 

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.’’ 

Propiconazole is a member of the 

triazole-containing class of pesticides. 

Although conazoles act similarly in 

plants (fungi) by inhibiting ergosterol 

biosynthesis, there is not necessarily a 

relationship between their pesticidal 

activity and their mechanism of toxicity 

in mammals. Structural similarities do 

not constitute a common mechanism of 

toxicity. Evidence is needed to establish 

that the chemicals operate by the same, 

or essentially the same, sequence of 

major biochemical events (EPA, 2002). 

In conazoles, however, a variable 

pattern of toxicological responses is 

found; some are hepatotoxic and 

hepatocarcinogenic in mice. Some 

induce thyroid tumors in rats. Some 

induce developmental, reproductive, 

and neurological effects in rodents. 

Furthermore, the conazoles produce a 

diverse range of biochemical events 

including altered cholesterol levels, 

stress responses, and altered DNA 

methylation. It is not clearly understood 

whether these biochemical events are 

directly connected to their toxicological 

outcomes. Thus, there is currently no 

evidence to indicate that conazoles 

share common mechanisms of toxicity 

and EPA is not following a cumulative 

risk approach based on a common 

mechanism of toxicity for the conazoles. 

For information regarding EPA’s 

procedures for cumulating effects from 

substances found to have a common 

mechanism of toxicity, see EPA’s Web 

site at http://www2.epa.gov/pesticidescience-and-assessing-pesticide-risks/

cumulative-assessment-risk-pesticides. 

Propiconazole is a triazole-derived 

pesticide. This class of compounds can 

form the common metabolite 1,2,4- 

triazole and two triazole conjugates 

(triazolylalanine and triazolylacetic 

acid). To support existing tolerances 

and to establish new tolerances for 

triazole-derivative pesticides, including 

propiconazole, EPA conducted a human 

health risk assessment for exposure to 

1,2,4-triazole, triazolylalanine, and 

triazolylacetic acid resulting from the 

use of all current and pending uses of 

any triazole-derived fungicide. The risk 

assessment is a highly conservative, 

screening-level evaluation in terms of 

hazards associated with common 

metabolites (e.g., use of a maximum 

combination of uncertainty factors) and 

potential dietary and non-dietary 

exposures (i.e., high end estimates of 

both dietary and non-dietary exposures). 

The Agency retained a 3X for the 

LOAEL to NOAEL safety factor when 

the reproduction study was used. In 

addition, the Agency retained a 10X for 

the lack of studies including a DNT. The 

assessment includes evaluations of risks 

for various subgroups, including those 

comprised of infants and children. The 

Agency’s complete risk assessment is 

found in the propiconazole 

reregistration docket at http://

www.regulations.gov, Docket ID Number 

EPA–HQ–OPP–2005–0497. 

An updated dietary exposure and risk 

analysis for the common triazole 

metabolites 1,2,4-triazole (T), 

triazolylalanine (TA), triazolylacetic 

acid (TAA), and triazolylpyruvic acid 

(TP) was completed on April 9, 2015, in 

association with registration requests for 

several triazole fungicides, 

propiconazole, difenoconazole, and 

flutriafol. That analysis concluded that 

risk estimates were below the Agency’s 

level of concern for all population 

groups. This assessment may be found 

on http://www.regulations.gov by 

searching for the following title and 

docket number: ‘‘Common Triazole 

Metabolites: Updated Aggregate Human 

Health Risk Assessment to Address The 

New Section 3 Registrations For Use of 

Propiconazole on Tea, Dill, Mustard 


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Greens, Radish, and Watercress; Use of 

Difenoconazole on Globe Artichoke, 

Ginseng and Greenhouse Grown 

Cucumbers and Conversion of the 

Established Foliar Uses/Tolerances for 

Stone Fruit and Tree Nut Crop Groups 

to Fruit, Stone, Group 12–12 and the 

Nut, Tree, Group 14–12.; and Use of 

Flutriafol on Hops’’ (located in docket 

ID number EPA–HQ–OPP–2014–0788). 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

Food Quality Protection Act Safety 

Factor (FQPA SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

In the developmental toxicity study in 

rats, fetal effects observed in this study 

at a dose lower than that evoking 

maternal toxicity are considered to be 

quantitative evidence of increased 

susceptibility of fetuses to in utero 

exposure to propiconazole. Neither 

quantitative nor qualitative evidence of 

increased susceptibility was observed in 

utero or postnatally in either the rabbit 

developmental or 2-generation 

reproduction rat study. There is no 

evidence of neuropathology or 

abnormalities in the development of the 

fetal nervous system from the available 

toxicity studies conducted with 

propiconazole. In the rat acute 

neurotoxicity study, there was evidence 

of clinical toxicity at the high dose of 

300 mg/kg, but no evidence of 

neuropathology from propiconazole 

administration. 

Although there was quantitative 

evidence of increased susceptibility of 

the young following exposure to 

propiconazole in the developmental rat 

study, the Agency determined there is a 

low degree of concern for this finding 

and no residual uncertainties because 

the increased susceptibility was based 

on minimal toxicity at high doses of 

administration, clear NOAELs and 

LOAELs have been identified for all 

effects of concern, and a clear doseresponse has been well defined. 

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 

propiconazole is complete. 

ii. Other than the mild effects seen at 

300 mg/kg in the acute neurotoxicity 

study, neurotoxicity and 

neurobehavioral effects were not seen in 

the propiconazole toxicity database. The 

liver, not the nervous system, is the 

primary target organ of propiconazole 

toxicity. 

iii. Although an apparent increased 

quantitative susceptibility was observed 

in fetuses and offspring, for the reasons 

noted in this Unit residual uncertainties 

or concerns for prenatal and/or 

postnatal toxicity are minimal. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The acute dietary food exposure 

assessments were performed based on 

100 PCT and tolerance-level residues, 

while the chronic used a combination of 

tolerance-level residues and reliable 

data on average field trial residues and 

100 PCT. EPA made conservative 

(protective) assumptions in the ground 

and surface water modeling used to 

assess exposure to propiconazole in 

drinking water. EPA used similarly 

conservative assumptions to assess postapplication exposure of children as well 

as incidental oral exposure of toddlers. 

A turf transferable residue study is 

unavailable but being requested from 

the registrant for registration review of 

propiconazole. In all probability this 

study will reduce exposure estimates for 

both the incidental oral and postapplication exposure to children. These 

assessments will not underestimate the 

exposure and risks posed by 

propiconazole. 

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. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

propiconazole will occupy 84% 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 propiconazole 

from food and water will utilize 25% 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 propiconazole is not 

expected. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). Propiconazole is 

currently registered for uses that could 

result in short-term residential 

exposure, and the Agency has 

determined that it is appropriate to 

aggregate chronic exposure through food 

and water with short-term residential 

exposures to propiconazole. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs from post-application activities 

(the highest exposure scenario) of 200 

for adults and 96 for children 1–2 years 

old. Although the MOE for children 1– 

2 years old is slightly below the target 

MOE of 100, the Agency does not 

believe that propiconazole poses shortterm risks of concern because the 

difference is small and more than offset 

by the use of conservative endpoints 

and conservative exposure assumptions. 

This assessment is considered 

conservative since the short-term 

endpoints are based on a conservative 

LOAEL that is 3x higher than the 

NOAEL. Therefore, the true NOAEL is 

likely higher and would result in MOEs 

greater than 100. Further, the 

assessment combines conservative 

assumptions by using tolerance-level 

residues and reliable data on average 

field-trial residues and 100 PCT, 

conservative assumptions in the ground 

and surface water modeling, and 

conservative assumptions to assess postapplication exposure of children as well 

as incidental oral exposure of toddlers. 

Refining any one of these conservatisms 

would result in MOEs for this age group 

that are not of concern. Although 

dietary (food and water) is not the 

aggregate exposure driver, incorporating 

PCT would likely increase the aggregate 

MOE further above 100. For example, 

using the Agency’s highest average PCT 


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reported for propiconazole residues on 

crops (i.e., 55%), which is 

approximately half the currently 

assumed dietary exposure, the MOE for 

this age group would exceed the target 

MOE of 100 and not be of concern. 

Therefore, the Agency has determined 

that there is no short-term risk of 

concern from exposure to 

propiconazole. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Propiconazole is currently registered 

for use as a wood treatment that could 

result in intermediate-term residential 

exposure, and the Agency has 

determined that it is appropriate to 

aggregate chronic exposure through food 

and water with intermediate-term 

residential exposures to propiconazole. 

Using the exposure assumptions 

described in this unit for intermediateterm exposures, EPA has concluded that 

the combined intermediate-term food, 

water, and residential exposures result 

in an aggregate MOE of 110 for children 

1–2 years old. Because EPA’s level of 

concern for propiconazole is a MOE of 

100 or below, this MOE is not of 

concern. 

5. Aggregate cancer risk for U.S. 

population. Based on the discussion in 

Unit III.A., EPA considers the chronic 

aggregate risk assessment to be 

protective of any aggregate cancer risk. 

As there is no chronic risk of concern, 

EPA does not expect any cancer risk to 

the U.S. population from aggregate 

exposure to propiconazole. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to 

propiconazole residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology, 

a high performance liquid 

chromatography with ultraviolet 

detection method (HPLC/UV Method 

AG–671A) is available to enforce the 

tolerance expression. The method may 

be requested from: Chief, Analytical 

Chemistry Branch, Environmental 

Science Center, 701 Mapes Rd., Ft. 

Meade, MD 20755–5350; telephone 

number: (410) 305–2905; email address: 

residuemethods@epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

There are no Codex MRLs for 

dillweed (fresh or dried), dill seed, the 

brassica leafy greens subgroup 5B, ti 

palm, watercress, quinoa or radish. 

Codex does have MRLs in place for 

peach and plums (part of the U.S. stone 

fruit group), and pecans (part of the U.S. 

tree nut group) that are different than 

the U.S. tolerances. The U.S. tolerance 

expression is not harmonized with the 

Codex expression, which is expressed in 

terms of propiconazole per se, and 

therefore, the U.S. tolerance level for 

stone fruit and tree nuts cannot be 

harmonized with the Codex MRLs that 

are currently established. 

C. Response to Comments 

Two comments were received in 

response to the October 21, 2015 notice 

of filing. The first comment asserted that 

no residues should be allowed and that 

the pesticide should not be approved for 

sale or use. The Agency understands the 

commenter’s concerns and recognizes 

that some individuals believe that 

pesticides should be banned on 

agricultural crops. However, the existing 

legal framework provided by section 

408 of the FFDCA states that tolerances 

may be set when persons seeking such 

tolerances or exemptions have 

demonstrated that the pesticide meets 

the safety standard imposed by that 

statute. The comment appears to be 

directed at the underlying statute and 

not EPA’s implementation of it; the 

citizen has made no contention that 

EPA has acted in violation of the 

statutory framework. 

The second comment was from the 

Center for Biological Diversity and 

concerned endangered species; 

specifically stating that EPA cannot 

approve this new use prior to 

completion of consultations with the 

U.S. Fish and Wildlife Service and the 

National Marine Fisheries Service (‘‘the 

Services’’). This comment is not 

relevant to the Agency’s evaluation of 

safety of the propiconazole tolerances; 

section 408 of the FFDCA focuses on 

potential harms to human health and 

does not permit consideration of effects 

on the environment. 

D. Revisions to Petitioned-for 

Tolerances 

The Agency is revising the petitionedfor tolerance requests for ‘‘dill, fresh’’ 

and ‘‘dill, dried’’ to ‘‘dillweed, fresh 

leaves’’ and ‘‘dillweed, dried leaves’’, 

respectively, for consistency with the 

Agency’s commodity vocabulary for 

those commodities. For the same reason, 

the Agency is revising the petitioned-for 

tolerance request for ‘‘leafy Brassica 

greens, subgroup 5B’’ to ‘‘Brassica leafy 

greens, subgroup 5B’’. In addition, EPA 

is revising the tolerance values for 

radish, tops; ti palm, roots; and 

watercress to be consistent with EPA’s 

policy on significant figures for 

tolerances. 

V. Conclusion 

Therefore, tolerances are established 

for residues of propiconazole, 1-[[2-(2,4- 

dichlorophenyl)-4-propyl-1,3-dioxolan2-yl] methyl]-1H-1,2,4-triazole and its 

metabolites determined as 2,4,- 

dichlorobenzoic acid (2,4-DCBA), 

expressed as the stoichiometric 

equivalent of propiconazole, in or on 

brassica leafy greens, subgroup 5B at 20 

ppm; dill seed at 15 ppm; dillweed, 

dried leaves at 80 ppm; dillweed, fresh 

leaves at 30 ppm; quinoa, grain at 3.0 

ppm; radish, roots at 0.04 ppm; radish, 

tops at 0.20 ppm; ti palm, leaves at 10 

ppm; ti palm, roots at 0.30 ppm; and 

watercress at 6.0 ppm. In addition, the 

existing fruit, stone, group 12, except 

plum and nut, tree, group 14 tolerances 

are modified to read ‘‘fruit, stone, group 

12–12, except plum’’ and ‘‘nut, tree, 

group 14–12,’’ respectively. 

VI. Statutory and Executive Order 

Reviews 

This action 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 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 


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79718 Federal Register / Vol. 80, No. 246 / Wednesday, December 23, 2015 / Rules and Regulations 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This action does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

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

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This action directly regulates growers, 

food processors, food handlers, and food 

retailers, not States or tribes, nor does 

this action alter the relationships or 

distribution of power and 

responsibilities established by Congress 

in the preemption provisions of FFDCA 

section 408(n)(4). As such, the Agency 

has determined that this action will not 

have a substantial direct effect on States 

or tribal governments, on the 

relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this action. In addition, this action 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

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

1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

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: December 14, 2015. 

Susan Lewis, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.434: 

■ a. Revise the entries for ‘‘Fruit, stone, 

group 12, except plum’’ and ‘‘Nut, tree, 

group 14.’’ 

■ b. Add alphabetically the following 

commodities to the table in paragraph 

(a). 

The revisions and additions read as 

follows: 

§ 180.434 Propiconazole; tolerances for 

residues. 

(a) * * * 

Commodity Parts per million 

* * * * * 

Brassica leafy greens, subgroup 5B ......................... 20 

* * * * * 

Dill, seed ............................. 15 

Dillweed, dried leaves ........ 80 

Dillweed, fresh leaves ........ 30 

* * * * * 

Fruit, stone, group 12–12, 

except plum ..................... 4 .0 

* * * * * 

Nut, tree, group 14–12 ....... 0 .10 

* * * * * 

Quinoa, grain ...................... 3 .0 

Radish, roots ...................... 0 .04 

Radish, tops ........................ 0 .20 

* * * * * 

Ti palm, leaves ................... 10 

Ti palm, roots ...................... 0 .30 

* * * * * 

Watercress .......................... 6 .0 

* * * * * 

* * * * * 

[FR Doc. 2015–32327 Filed 12–22–15; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF TRANSPORTATION 

National Highway Traffic Safety 

Administration 

49 CFR Parts 591 and 592 

[Docket No. NHTSA–2015–0076] 

RIN 2127–AL63 

Allowing Importers To Provide 

Information to U.S. Customs and 

Border Protection in Electronic Format 

AGENCY: National Highway Traffic 

Safety Administration (NHTSA), 

Department of Transportation (DOT). 

ACTION: Final rule. 

SUMMARY: On September 2, 2015, the 

National Highway Traffic Safety 

Administration (NHTSA) published an 

interim final rule and request for 

comment entitled ‘‘Allowing Importers 

to Provide Information to U.S. Customs 

and Border Protection in Electronic 

Format.’’ No comments were received in 

response to the interim final rule. 

Accordingly, this final rule confirms 

that the September 2, 2015 interim final 

rule will not be changed and its 

effective date is September 2, 2015. 

DATES: Effective December 23, 2015. 

FOR FURTHER INFORMATION CONTACT: 

Arija Flowers, Trial Attorney, Office of 

the Chief Counsel, National Highway 

Traffic Safety Administration, 1200 New 

Jersey Avenue SE., Washington, DC 

20590 (telephone: 202–366–5263). 

SUPPLEMENTARY INFORMATION: As 

NHTSA received no comments on its 

interim final rule published on 

September 2, 2015 (80 FR 53011), the 

agency is making no changes to the rule 

and its effective date is September 2, 

2015. For regulatory analyses and 

notices associated with this action, 

please see the interim final rule 

published at 80 FR 53011. 

Accordingly, the interim rule 

amending 49 CFR parts 591 and 592, 

published at 80 FR 53011 on September 

2, 2015, is adopted as final without 

change. 

Issued in Washington, DC, on December 

17, 2015 under authority delegated in 49 CFR 

part 1.95. 

Mark R. Rosekind, 

Administrator. 

[FR Doc. 2015–32260 Filed 12–22–15; 8:45 am] 

BILLING CODE 4910–59–P 


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