Federal Register / Vol. 80, No. 247 / Thursday, December 24, 2015 / Rules and Regulations 80269 

metallic transportable buildings; 

monuments, not of metal. 

20. Furniture, mirrors, picture frames; 

unworked or semi-worked bone, horn, 

ivory, whalebone or mother-of-pearl; 

shells; meerschaum; yellow amber. 

21. Household or kitchen utensils and 

containers; combs and sponges; brushes 

(except paintbrushes); brush-making 

materials; articles for cleaning purposes; 

steelwool; unworked or semi-worked 

glass (except glass used in building); 

glassware, porcelain and earthenware. 

22. Ropes and string; nets; tents, 

awnings and tarpaulins; sails; sacks; 

padding and stuffing materials (except 

of paper, cardboard, rubber or plastics); 

raw fibrous textile materials. 

23. Yarns and threads, for textile use. 

24. Textiles and substitutes for 

textiles; bed covers; table covers. 

25. Clothing, footwear, headgear. 

26. Lace and embroidery, ribbons and 

braid; buttons, hooks and eyes, pins and 

needles; artificial flowers. 

27. Carpets, rugs, mats and matting, 

linoleum and other materials for 

covering existing floors; wall hangings 

(non-textile). 

28. Games and playthings; gymnastic 

and sporting articles; decorations for 

Christmas trees. 

29. Meat, fish, poultry and game; meat 

extracts; preserved, frozen, dried and 

cooked fruits and vegetables; jellies, 

jams, compotes; eggs; milk and milk 

products; edible oils and fats. 

30. Coffee, tea, cocoa and artificial 

coffee; rice; tapioca and sago; flour and 

preparations made from cereals; bread, 

pastries and confectionery; edible ices; 

sugar, honey, treacle; yeast, bakingpowder; salt; mustard; vinegar, sauces 

(condiments); spices; ice. 

31. Agricultural, horticultural and 

forestry products; raw and unprocessed 

grains and seeds; fresh fruits and 

vegetables; natural plants and flowers; 

live animals; foodstuffs for animals; 

malt. 

32. Beers; mineral and aerated waters 

and other non-alcoholic beverages; fruit 

beverages and fruit juices; syrups and 

other preparations for making beverages. 

33. Alcoholic beverages (except 

beers). 

34. Tobacco; smokers’ articles; 

matches. 

Services 

35. Advertising; business 

management; business administration; 

office functions. 

36. Insurance; financial affairs; 

monetary affairs; real estate affairs. 

37. Building construction; repair; 

installation services. 

38. Telecommunications. 

39. Transport; packaging and storage 

of goods; travel arrangement. 

40. Treatment of materials. 

41. Education; providing of training; 

entertainment; sporting and cultural 

activities. 

42. Scientific and technological 

services and research and design 

relating thereto; industrial analysis and 

research services; design and 

development of computer hardware and 

software. 

43. Services for providing food and 

drink; temporary accommodation. 

44. Medical services; veterinary 

services; hygienic and beauty care for 

human beings or animals; agriculture, 

horticulture and forestry services. 

45. Legal services; security services 

for the protection of property and 

individuals; personal and social services 

rendered by others to meet the needs of 

individuals. 

Dated: December 18, 2015. 

Michelle K. Lee, 

Under Secretary of Commerce for Intellectual 

Property and Director of the United States 

Patent and Trademark Office. 

[FR Doc. 2015–32467 Filed 12–23–15; 8:45 am] 

BILLING CODE 3510–16–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2015–0685; FRL–9940–01] 

Propiconazole on Tea; Pesticide 

Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of propiconazole 

in or on tea. The Tea Association of the 

U.S.A., Inc. requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

December 24, 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–2015–0685, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., Rm. 3334, 1301 

Constitution Ave. NW., Washington, DC 

20460–0001. The Public Reading Room 

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

Monday through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: 

Susan Lewis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main telephone 

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

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2015–0685 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 


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80270 Federal Register / Vol. 80, No. 247 / Thursday, December 24, 2015 / Rules and Regulations 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2015–0685, 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 4E8300) by the 

Tea Association of the U.S.A., Inc., 362 

5th Avenue, Suite 801, New York, New 

York, 10001. The petition requested that 

40 CFR 180.434 be amended by 

establishing a tolerance for residues of 

the fungicide propiconazole in or on tea 

at 4.0 parts per million (ppm). That 

document referenced a summary of the 

petition prepared by the Tea 

Association of the U.S.A., Inc., the 

registrant, which is available in the 

docket, http://www.regulations.gov. No 

comments concerning this tolerance 

action were received. 

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 

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 2-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 no-observedadverse-effect-level (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 


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Federal Register / Vol. 80, No. 247 / Thursday, December 24, 2015 / Rules and Regulations 80271 

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 NOAEL and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in document, 

‘‘Propiconazole Human Health Risk 

Assessment for the New Use of 

Propiconazole on Imported Tea’’ at pp. 

41–46 in docket ID number EPA–HQ– 

OPP–2015–0685. 

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://www.epa.gov/

pesticides/factsheets/riskassess.htm. 

A summary of the toxicological 

endpoints for propiconazole used for 

human risk assessment is shown in 

Table 1. 

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 MRID 40425001 

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. 

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 MRID 46604601 

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 

Residential LOC for 

MOE = 100.

Occupational LOC 

for MOE = 100 

Acute Neurotoxicity Study—Rats MRID 46604601 

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 

Residential LOC for 

MOE = 100.

Occupational LOC 

for MOE = 100 

24 Month carcinogenicity Study—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). 

Dermal Short Term (1–30 days) NOAEL= 30 mg/kg/

day.

UFA= 10x 

UFH= 10x 

Residential LOC for 

MOE = 100.

Occupational LOC 

for MOE = 100 

Acute Neurotoxicity Study—Rats MRID 46604601 

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 (1–6 

months).

NOAEL= 10 mg/kg/

day.

UFA= 10x 

UFH= 10x 

Residential LOC for 

MOE = 100.

Occupational LOC 

for MOE = 100 

24 Month carcinogenicity Study—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). 

Inhalation Short-term (1 to 30 

days).

NOAEL= 30 mg/kg/

day.

UFA = 10x 

UFH = 10x 

Occupational LOC 

for MOE = 100.

Acute Neurotoxicity Study—Rats MRID 46604601 

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). 

Inhalation Intermediate-Term (1 

to 6 months).

NOAEL = 10 mg/kg/

day.

UFA = 10x 

UFH = 10x 

Occupational LOC 

for MOE = 100.

24 Month carcinogenicity Study—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). 


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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 

Cancer (all routes—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). 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 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 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 average field trial residues, 

tolerance levels and 100 PCT for all 

existing and proposed uses. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that a nonlinear RfD 

approach is appropriate for assessing 

cancer risk to propiconazole. Cancer 

risk was assessed using the same 

exposure estimates as discussed in Unit 

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

iv. Anticipated residue and percent 

crop treated (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. 

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://www.epa.gov/

oppefed1/models/water/index.htm. 

The Agency does not expect any 

additional residues of propiconazole in 

drinking water as a result of the 

imported tea use. Therefore, the Agency 

is relying on the previous drinking 

water assessment for assessing 

propiconazole tolerances. The 

previously assessed turf EDWCs are 

approximately one order of magnitude 

higher and more protective than the 

EDWCs for the new use. 

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). 

Although there are no proposed 

residential uses associated with the 

imported tea use, propiconazole is 

currently registered for the following 

uses that could result in residential 

exposures: Turf, landscapes, 

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 as well as from postapplication 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 intermediateterm exposure to propiconazole is wood 

treatment, which the Agency assumes 

may result in dermal and incidental oral 

post-application exposures to children. 

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.’’ 


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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 

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 rand 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 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. 

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 aggregate human health 

risk assessment 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 the 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 ID 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 

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 under 

docket ID number EPA–HQ–OPP–2015– 

0685. 

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 post-natally 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 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 


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80274 Federal Register / Vol. 80, No. 247 / Thursday, December 24, 2015 / Rules and Regulations 

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 85% 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 24% 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. 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 is based on a combination of 

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 

post-application exposure of children as 

well as incidental oral exposure of 

toddlers. Additionally, the assessment 

could be further refined by using PCT 

estimates and anticipated residues for 

all crops. Although dietary (food and 

water) is not the aggregate exposure 

driver, incorporating PCT would likely 

increase the aggregate MOE further 

above 100. For example, the Agency’s 

latest PCT figures indicate that the 

highest average PCT reported for 

propiconazole residues on crops is 55%, 

which is much less than the 100 PCT 

the Agency used for all commodities in 

its assessment. Accordingly, even 

though this MOE for children 1–2 years 

old is slightly below the target MOE of 

100, the difference is small and is more 

than offset by the conservative exposure 

assumptions and therefore not of 

concern. 

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 uses 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 aggregate MOEs 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. 

The Codex has not established an 

MRL for propiconazole on tea. 

V. Conclusion 

Therefore, tolerances are established 

for residues of propiconazole, including 

its metabolites and degradates, in or on 

tea at 4.0 ppm. As there are currently no 

U.S. registrations for propiconazole for 

use on tea, EPA is adding a footnote to 

the regulation to clarify that fact. 

VI. 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, 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 80, No. 247 / Thursday, December 24, 2015 / Rules and Regulations 80275 

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). 

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 16, 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. Redesignate paragraph (a) as 

paragraph (a)(1). 

■ b. Add a new paragraph (a)(2). 

The amendments read as follows: 

§ 180.434 Propiconazole; tolerances for 

residues. 

(a) General. (1) * * * 

(2) Tolerances are established for 

propiconazole, 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 propiconazole, 1-[[2- 

(2,4-dichlorophenyl)-4-propyl-1,3- 

dioxolan-2-yl]methyl]-1H-1,2,4-triazole, 

in or on the commodity. 

Commodity Parts per 

million 

Tea 1 ..................................... 4.0 

1There are no United States registrations 

for use of propiconazole on tea as of December 24, 2015. 

* * * * * 

[FR Doc. 2015–32328 Filed 12–23–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0730; FRL–9933–39] 

Spinetoram; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of spinetoram in 

or on multiple commodities that are 

identified and discussed later in this 

document. In addition, this regulation 

removes a number of existing tolerances 

for residues of spinetoram that are 

superseded by this action. Interregional 

Research Project # 4 (IR-4) requested 

these tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

December 24, 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–2013–0730, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., Rm. 3334, 1301 

Constitution Ave. NW., Washington, DC 

20460–0001. The Public Reading Room 

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

Monday through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: 

Susan Lewis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main telephone 

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

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. 

Potentially affected entities may 

include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 


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