33458 Federal Register / Vol. 79, No. 112 / Wednesday, June 11, 2014 / Rules and Regulations 

Units. On February 28, 2014, the 

NYSDEC submitted clarifying 

information concerning the State’s plan. 

(b) Identification of sources. The plan 

applies to existing sewage sludge 

incineration (SSI) units that: 

(1) Commenced construction on or 

before October 14, 2010, or 

(2) Commenced a modification on or 

before September 21, 2011 primarily to 

comply with New York’s plan, and 

(3) Meets the definition of a SSI unit 

defined in New York’s plan. 

(c) The effective date of the plan for 

existing sewage sludge incineration 

units is July 11, 2014. 

[FR Doc. 2014–13594 Filed 6–10–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0411; FRL–9910–52] 

Spirodiclofen; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends a 

tolerance for residues of spirodiclofen in 

or on citrus, oil. Bayer CropScience 

requested this tolerance amendment 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective June 

11, 2014. Objections and requests for 

hearings must be received on or before 

August 11, 2014, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2013–0411, 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: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main telephone 

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

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2013–0411 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 August 11, 2014. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2013–0411, 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 February 4, 

2010 (75 FR 5790) (FRL–8807–5), EPA 

issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide petition (PP 9E7632) by IR–4, 

500 College Road East, Suite 201 W., 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.608 be 

amended by establishing tolerances for 

residues of the insecticide spirodiclofen, 

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

oxaspiro[4,5]dec-3-en-4-yl 2,2- 

dimethylbutanoate), in or on bushberry 

subgroup 13–07B at 4.0 parts per 

million (ppm). The petition additionally 

requested to revise the tolerance 

expression under paragraphs (a)(1) and 

(a)(2) to read as follows: ‘‘(a)(1). 

Tolerances are established for residues 

of the insecticide spirodiclofen, 

including its metabolites and 

degradates. Compliance with the 

tolerance levels specified is to be 

determined by measuring only 

spirodiclofen (3-(2,4-dichlorophenyl)-2- 

oxo-1-oxaspiro[4,5]dec-3-en-4-yl 2,2- 

dimethylbutanoate)’’; and ‘‘(a)(2). 

Tolerances are established for residues 

of the insecticide spirodiclofen, 

including its metabolites and 

degradates. Compliance with the 

tolerance levels specified is to be 

determined by measuring only the sum 

of spirodiclofen (3-(2,4-dichlorophenyl)- 

2-oxo-1-oxaspiro[4,5]dec-3-en-4-yl 2,2- 

dimethylbutanoate) and its metabolite, 

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

oxaspiro[4,5]dec-3-en-2-one, calculated 


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Federal Register / Vol. 79, No. 112 / Wednesday, June 11, 2014 / Rules and Regulations 33459 

as the stoichiometric equivalent of 

spirodiclofen.’’ That notice referenced a 

summary of the petition prepared on 

behalf of IR–4 by Bayer CropScience, 

the registrant, which is available in the 

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

In the Federal Register of March 29, 

2011 (76 FR 17374) (FRL–8867–4), EPA 

issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide petition (PP 0E7820) by IR–4, 

500 College Rd. East, Suite 201W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.608 be 

amended by establishing tolerances for 

residues of the insecticide spirodiclofen, 

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

oxaspiro[4.5]dec-3-en-4-yl 2,2- 

dimethylbutanoate), in or on sugar 

apple, cherimoya, atemoya, custard 

apple, ilama, soursop, biriba, guava, 

feijoa, jaboticaba, wax jambu, starfruit, 

passionfruit, persimmon and acerola at 

0.45 ppm; and lychee, longan, Spanish 

lime, rambutan and pulasan at 3.5 ppm. 

That notice referenced a summary of the 

petition prepared on behalf of IR–4 by 

Bayer CropScience, the registrant, 

which is available in the docket, 

http://www.regulations.gov. 

Finally, in the Federal Register of July 

19, 2013 (78 FR 43115) (FRL–9392–9), 

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 3F8152) by Bayer 

CropScience, 2 TW Alexander Dr., 

Research Triangle Park, NC 27709. The 

petition requested that 40 CFR 180.608 

be amended by amending the 

established tolerance for residues of the 

insecticide spirodiclofen, 3-(2,4- 

dichlorophenyl)-2-oxo-1- 

oxaspiro[4.5]dec-3-en-4-yl 2,2- 

dimethylbutanoate, in or on citrus, oil 

from 20 ppm to 35 ppm. That document 

referenced a summary of the petition 

prepared by Bayer CropScience, the 

registrant, which is available in the 

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

There were no comments received in 

response to the notice of filing. 

IR–4 has since withdrawn PP#s 

9E7632 and 0E7820 due to unresolved 

labeling issues regarding pollinators. 

However, the EPA has determined that 

the proposed changes to the tolerance 

expression under the notice for PP# 

9E7632 are appropriate. Additionally, 

EPA is relying upon the risk 

assessments supporting those actions in 

order to amend the citrus, oil tolerance, 

since the higher citrus, oil level was 

considered in these assessments. 

Therefore, risk estimates characterized 

in the underlying assessments for those 

actions are considered overestimations 

of risk, because the uses associated with 

PP#s 9E7632 and 0E7820 have since 

been withdrawn; however, those 

assessments will support the amended 

citrus, oil tolerance. 

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 spirodiclofen 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with spirodiclofen 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. 

Spirodiclofen has a low acute toxicity 

via the oral, dermal and inhalation 

routes. It is not an eye or dermal irritant; 

however, it is a potential skin sensitizer. 

Following repeated exposures, the 

primary target organs identified are the 

adrenal glands in both sexes and testes 

in males. Increased cytoplasmic 

vacuolation in the Zona fasciculate of 

the adrenal cortex was observed in 

several subchronic and chronic studies 

in rats, mice and dogs of both sexes. 

Female rats and dogs appeared to be the 

more sensitive to adrenal effects, with 

the dog as the most sensitive species. 

The effects on the adrenal glands 

generally coincided with increased 

adrenal weight. Other organs with 

histopathology findings reported in 

male dogs included the testes 

(vacuolation and hypertrophy/activation 

of Leydig cells), epididymis 

(degeneration and/or immaturity of 

germinal epithelium, oligo- and 

aspermia), prostate (immaturity signs), 

and thymus (atrophy). Increased liver 

weights were also reported in male dogs 

along with decreases in prostate 

weights. 

The effects reported in chronic dog 

studies were similar to subchronic 

studies and occurred at lower 

administered oral doses of 

spirodiclofen. As with subchronic 

studies, histopathology of the adrenal 

gland revealed an increased incidence 

of cortical vacuolation in the Zona 

fasciculata of both sexes. In the testes, 

increased incidences of Leydig cell 

vacuolation, slight Leydig cell 

hypertrophy, and tubular degeneration 

were observed in males. Other effects 

reported in chronic studies included 

decreases in cholesterol and 

triglycerides, decreased body weights 

and body-weight gains, increased APh 

levels and increased vacuolated jejunum 

enterocytes in rats, and increased 

incidences of Leydig cell hyperplasia in 

rats and mice. 

There was no evidence of 

developmental toxicity in the rabbit 

developmental toxicity study. The rat 

developmental toxicity study resulted in 

developmental toxicity (an increased 

incidence of slight dilatation of the 

renal pelvis) at the highest dose tested; 

a dose which did not cause maternal 

toxicity. In the 2-generation 

reproductive toxicity study in rats, 

developmental effects were observed in 

F1 males (delayed sexual maturation, 

decreased testicular spermatid and 

epididymal sperm counts/oligospermia; 

and atrophy of the testes, epididymides, 

prostate, and seminal vesicles) and F1

females (increased severity of ovarian 

luteal cell vacuolation/degeneration), 

but at a higher dose than the systemic 

effects seen for parents and offspring. 

There was no evidence of 

neurotoxicity in the acute and 

subchronic neurotoxicity studies for 

spirodiclofen. In a developmental 

neurotoxicity (DNT) study, a decrease in 

retention was observed in the memory 

phase of the water maze for postnatal 

day 60 female offspring at all doses. In 

this DNT study, the morphometric 

measurements were not performed at 

the low- and mid-dose; therefore, 


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33460 Federal Register / Vol. 79, No. 112 / Wednesday, June 11, 2014 / Rules and Regulations 

another DNT study was conducted 

using identical experimental conditions 

as the previous study. The results of the 

second DNT study demonstrated no 

treatment-related neurotoxicity, but the 

two DNT studies for spirodiclofen 

suggest increased susceptibility of 

offspring. An acceptable 

immunotoxicity study, which was 

reviewed by the EPA after the risk 

assessment was finalized, showed no 

treatment related systemic or 

immunotoxic related effects up to the 

highest dose tested. 

Chronic toxicity and carcinogenicity 

studies showed an increased incidence 

of uterine adenocarcinoma in female 

rats, Leydig cell adenoma in male rats, 

and liver tumors in mice. The EPA has 

classified spirodiclofen as ‘‘likely to be 

carcinogenic to humans’’ by the oral 

route based on evidence of Leydig cell 

adenomas in male rat testes, uterine 

adenomas and/or adenocarcinoma in 

female rats, and liver tumors in mice. 

Results of genotoxicity testing were 

negative. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by spirodiclofen as well 

as the no-observed-adverse-effect-level 

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

toxicity studies can be found in the 

document, ‘‘Spirodiclofen. HumanHealth Risk Assessment for Proposed 

Uses in/on Sugar Apple, Cherimoya, 

Atemoya, Custard Apple, Ilama, 

Soursop, Biriba, Lychee, Longan, 

Spanish Lime, Rambutan, Pulasan, 

Guava, Feijoa, Jaboticaba, Wax Jambu, 

Starfruit, Passionfruit, Persimmon, and 

Acerola.’’ At pages 28–30 in docket ID 

number EPA–HQ–OPP–2013–0411. 

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 no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http://

www.epa.gov/pesticides/factsheets/

riskassess.htm. 

A summary of the toxicological 

endpoints for spirodiclofen used for 

human risk assessment is shown in 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR SPIRODICLOFEN 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 (All populations, 

including infants and children).

An appropriate endpoint attributable to a single dose was not identified. Therefore, an acute dietary assessment was not performed. 

Chronic dietary (All populations) NOAEL= 1.38 mg/

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.014 

mg/kg/day.

cPAD = 0.014 mg/

kg/day 

Chronic Oral Toxicity Study in Dogs 

LOAEL = 4.7 mg/kg/day based on increased relative adrenal 

weights in both sexes, increased relative testis weights in 

males and histopathology findings in adrenal glands of both 

sexes. 

Cancer (Oral, dermal, inhalation).Classification: ‘‘Likely to be Carcinogenic to Humans’’; Q1* (mg/kg/day)¥1 = 1.49 x 10¥2. 

UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population 

(intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference 

dose. mg/kg/day = milligram/kilogram/day. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to spirodiclofen, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing spirodiclofen tolerances in 40 

CFR 180.608. EPA assessed dietary 

exposures from spirodiclofen 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. No such effects were 

identified in the toxicological studies 

for spirodiclofen; therefore, a 

quantitative acute dietary exposure 

assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the United States Department of 

Agriculture (USDA) 1994–1996 and 

1998 Nationwide Continuing Surveys of 

Food Intake by Individuals (CSFII). As 

to residue levels in food, EPA utilized 

average field trial residues; 

experimentally determined processing 

factors for citrus fruit, pome fruit and 

grape; and Dietary Exposure Evaluation 

Model (DEEM (ver 7.81)) default 

processing factors for the remaining 

processed commodities. The assessment 

also utilized percent crop treated for 

new uses (PCTn) on hops and blueberry, 

and percent crop treated (PCT) estimates 

for several other registered 

commodities. 

iii. Cancer. EPA determines whether 

quantitative cancer exposure and risk 

assessments are appropriate for a fooduse pesticide based on the weight of the 

evidence from cancer studies and other 

relevant data. If quantitative cancer risk 

assessment is appropriate, Cancer risk 

may be quantified using a linear or 

nonlinear approach. If sufficient 

information on the carcinogenic mode 


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of action is available, a threshold or 

nonlinear approach is used and a cancer 

RfD is calculated based on an earlier 

noncancer key event. If carcinogenic 

mode of action data are not available, or 

if the mode of action data determines a 

mutagenic mode of action, a default 

linear cancer slope factor approach is 

utilized. Based on the data summarized 

in Unit III.A., EPA has concluded that 

spirodiclofen should be classified as 

‘‘Likely to be Carcinogenic to Humans’’ 

and a linear approach has been used to 

quantify cancer risk. Cancer risk was 

quantified using the same food residue 

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

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. 

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

that the Agency may use data on the 

actual percent of food treated for 

assessing chronic dietary risk only if: 

• Condition a: The data used are 

reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain the pesticide residue. 

• Condition b: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• Condition c: Data are available on 

pesticide use and food consumption in 

a particular area, the exposure estimate 

does not understate exposure for the 

population in such area. 

In addition, the Agency must provide 

for periodic evaluation of any estimates 

used. To provide for the periodic 

evaluation of the estimate of PCT as 

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

EPA may require registrants to submit 

data on PCT. 

The Agency estimated the PCT for 

existing uses as follows: Almond, 5%; 

apple, 5%; apricot, 5%; cherry, 2%; 

grapefruit, 50%; grape, raisin, 10%; 

grape, table, 30%; grape, wine, 5%; 

hazelnuts, 2%; lemon, 1%; nectarine, 

10%; orange, 10%; peach, 5%; pear, 

10%; pecan, 2%; pistachio, 1%; plum/ 

prune, 5%; and walnut, 5%. 

In most cases, EPA uses available data 

from USDA/National Agricultural 

Statistics Service (USDA/NASS), 

proprietary market surveys, and the 

National Pesticide Use Database for the 

chemical/crop combination for the most 

recent 6–7 years. EPA uses an average 

PCT for chronic dietary risk analysis. 

The average PCT figure for each existing 

use is derived by combining available 

public and private market survey data 

for that use, averaging across all 

observations, and rounding to the 

nearest 5%, except for those situations 

in which the average PCT is less than 

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

average PCT and 2.5% is used as the 

maximum PCT. EPA uses a maximum 

PCT for acute dietary risk analysis. The 

maximum PCT figure is the highest 

observed maximum value reported 

within the recent 6 years of available 

public and private market survey data 

for the existing use and rounded up to 

the nearest multiple of 5%. 

The Agency estimated the PCT for 

new uses as follows: Blueberry, 2%; and 

hops, 92%. 

In the Federal Register of May 7, 2008 

(73 FR 25533) (FRL–8362–2), the 

Agency estimated the PCT for the 

proposed use of spirodiclofen on hops 

to be 92%. Since spirodiclofen has only 

been registered on hops since 2008, EPA 

relied on the previously estimated PCT 

for hops. 

The EPA estimate of the percent PCT 

for these new uses of spirodiclofen 

represents the upper bound of use 

expected during the pesticide’s initial 

five years of registration; that is, the PCT 

for spirodiclofen is a threshold of use 

that EPA is reasonably certain will not 

be exceeded for this registered use site. 

The PCT recommended for use in the 

chronic dietary assessment is calculated 

as the average PCT of the miticide with 

the highest usage (i.e., the miticides 

with the greatest PCT) on that crop over 

the three most recent years of available 

data. The PCT recommended for use in 

the chronic dietary assessment is 2% for 

blueberries and 92% for hops. 

Comparisons are only made among 

pesticides of the same pesticide type 

(i.e., the miticide with the highest usage 

on the use crop is selected for 

comparison with a new miticide). The 

highest miticide PCT included in the 

estimation may not be the same for each 

year since different miticides may have 

the highest usage in different years. 

Typically, EPA uses USDA/NASS 

surveys as the source data because they 

are publicly available and directly 

report values for PCT. When a specific 

use crop is not reported by USDA/

NASS, EPA uses proprietary data and 

calculates the PCT based on reported 

data on acres treated and acres grown. 

If no proprietary data are available, EPA 

may extrapolate PCT for new uses from 

other crops if the production area and 

pest spectrum are substantially similar. 

A retrospective analysis to validate 

this approach shows few cases where 

the PCT for the highest miticides were 

exceeded (EPA, 2006). Further review of 

these cases identified factors 

contributing to the exceptionally high 

use of a new pesticide. To evaluate 

whether the PCT for spirodiclofen could 

be exceeded, EPA considered whether 

or not there may be unusually high pest 

pressure, as indicated in emergency 

exemption requests for spirodiclofen, 

the pest spectrum of the new pesticide 

in comparison with the highest 

miticides, whether or not the highest 

miticides are well-established for that 

use and whether or not pest resistance 

issues with past miticides provide 

spirodiclofen with significant market 

potential. Given currently available 

information, the Agency concludes that 

it is unlikely that actual PCT for 

spirodiclofen will exceed the estimated 

PCT for new uses during the next five 

years. 

The Agency believes that the three 

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

have been met. With respect to 

Condition a, PCT estimates are derived 

from Federal and private market survey 

data, which are reliable and have a valid 

basis. The Agency is reasonably certain 

that the percentage of the food treated 

is not likely to be an underestimation. 

As to Conditions b and c, regional 

consumption information and 

consumption information for significant 

subpopulations is taken into account 

through EPA’s computer-based model 

for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available reliable information on 

the regional consumption of food to 

which spirodiclofen may be applied in 

a particular area. 

2. Dietary exposure from drinking 

water. EPA concluded that the residues 

of concern in drinking water for 

purposes of risk assessment are 

spirodiclofen and its three metabolites 


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(BAJ 2510, BAJ 2740-dihydroxy, and 

BAJ 2740-ketohydroxy). Therefore, the 

Agency used screening level water 

exposure models in the dietary exposure 

analysis and risk assessment for 

spirodiclofen and its metabolites in 

drinking water. These simulation 

models take into account data on the 

physical, chemical, and fate/transport 

characteristics of spirodiclofen and its 

metabolites. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

can be found at http://www.epa.gov/

oppefed1/models/water/index.htm. 

Based on the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and Screening 

Concentration in Ground Water (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of 

spirodiclofen and its metabolites for 

chronic exposures for non-cancer 

assessments are estimated to be 4.99 

parts per billion (ppb) for surface water 

and 0.44 ppb for ground water. The 

EDWCs for chronic exposures for cancer 

assessments are estimated to be 1.67 

ppb for surface water and 0.44 ppb for 

ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

chronic dietary risk assessment, the 

water concentration of value 4.99 ppb 

was used to assess the contribution to 

drinking water. For cancer dietary risk 

assessment, the water concentration of 

value 1.67 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). 

Spirodiclofen is not registered for any 

specific use patterns that would result 

in residential exposure. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ EPA has not 

found spirodiclofen to share a common 

mechanism of toxicity with any other 

substances, and spirodiclofen does not 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that 

spirodiclofen does not have a common 

mechanism of toxicity with other 

substances. For information regarding 

EPA’s efforts to determine which 

chemicals have a common mechanism 

of toxicity and to evaluate the 

cumulative effects of such chemicals, 

see EPA’s Web site at http://

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA 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. 

The spirodiclofen toxicity database is 

adequate to evaluate the potential 

increased susceptibility of infants and 

children, and includes developmental 

toxicity studies in rat and rabbit, a 2- 

generation toxicity study in rat, and two 

rat DNT studies. There is no evidence of 

increased susceptibility in the rabbit 

developmental toxicity study or in the 

2-generation rat reproductive toxicity 

study following in utero/pre- and 

postnatal exposures of spirodiclofen. 

However, evidence for quantitative 

susceptibility was observed in a rat 

developmental toxicity study, where an 

increased incidence of slight dilatation 

of the renal pelvis was observed at the 

highest dose tested (1,000 mg/kg/day) in 

the absence of maternal toxicity. 

Additionally, two rat DNT studies are 

available. The first study demonstrated 

increased quantitative susceptibility of 

offspring based on the observed 

decreased retention in the memory 

phase of the water maze for postnatal 

day 60 female offspring at all doses and 

changes in brain morphometric 

parameters at the highest dose tested of 

135.9 mg/kg/day (including caudate 

putamen, parietal cortex, hippocampal 

gyrus, and dentate gyrus); there was no 

maternal toxicity noted at any dose. 

EPA requested information concerning 

the brain morphometric parameters in 

the low- and mid doses with the 

petitioner indicating that the brain 

tissues were not appropriately preserved 

and analysis was therefore not possible. 

As a result, a second rat DNT study was 

submitted which also indicated 

increased susceptibility in offspring 

based on decreased pre-weaning body 

weight and body weight gain in males 

and females and decreased postweaning body weights in males. The 

second rat DNT demonstrated no 

treatment-related neurotoxicity in the 

offspring. 

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 

spirodiclofen is complete. Changes to 40 

CFR Part 158 require immunotoxicity 

testing (OPPTS Guideline 870.7800) for 

pesticide registration. At the time of the 

last completed risk assessment for 

spirodiclofen, which was finalized on 

November 11, 2011, an immunotoxicity 

study was a data gap in the toxicity 

database. However, since the time of the 

risk assessment, EPA has received and 

reviewed an acceptable immunotoxicity 

study for spirodiclofen. Upon review of 

the study, the Agency has determined 

that there is no treatment related 

systemic or immunotoxic related effects. 

Therefore, the immunotoxicity study 

does not impact the findings of the 2011 

risk assessment. Additionally, EPA has 

determined a subchronic inhalation 

toxicity study is not required for 

spirodiclofen at this time. This 

approach considered all of the available 

hazard and exposure information for 

spirodiclofen, including: (1) Its low 

acute inhalation toxicity; (2) the lowest 

short- and intermediate-term MOEs 

calculated using an oral POD are 6,200 

and 1,000 respectively; and (3) its 

physical and chemical properties, 

including its low volatility. Therefore, 

an additional UF is not needed to 

account for the lack of this study. 

ii. Two DNT studies have been 

submitted and reviewed by the EPA. 

The Agency has determined that there is 

no concern for the increased 

quantitative susceptibility seen in the 

first DNT study because the results were 

not reproduced in the second DNT 

study conducted using identical doses 

and experimental conditions. The 

second DNT provided no evidence of 

neurotoxicity, and concern for the 

increased quantitative susceptibility 

(slight changes in body weights) noted 

in this study is low because there is a 

well-established NOAEL, only marginal 

developmental toxicity was noted, and 

all developmental/functional 

parameters were comparable to controls. 

In addition, doses selected for risk 

assessment of spirodiclofen are much 

lower than the dose where the effects in 


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Federal Register / Vol. 79, No. 112 / Wednesday, June 11, 2014 / Rules and Regulations 33463 

the second DNT were noted. Finally, 

there was no evidence of neurotoxicity 

or neuropathology in the acute and 

subchronic neurotoxicity studies. 

Therefore, there is no need for an 

additional UF to account for 

neurotoxicity. Additional information 

about the two DNT studies can be found 

at http://www.regulations.gov in the 

Federal Register of May 7, 2008 

(http://www.epa.gov/fedrgstr/EPAPEST/2008/May/Day-07/p9826.htm). 

iii. Quantitative susceptibility was 

noted in the developmental toxicity 

study in rats. However, EPA determined 

that the degree of concern is low for the 

noted effects because the increased 

incidence of slight renal pelvic dilation 

was observed only at the highest dose 

tested, in the absence of statistical 

significance and dose response. 

Additionally, renal pelvic dilation was 

considered to be a developmental delay 

and not a severe effect for 

developmental toxicity. The low 

background incidences in this study 

may also be idiosyncratic to this strain 

(Wistar) of rats since renal pelvic 

dilations are commonly seen at higher 

incidences in other strains (SpragueDawley or Fisher) of rats. Furthermore, 

there is a well-established NOAEL at 

which all developmental/functional 

parameters were comparable to controls, 

and lower doses are being used for the 

risk assessment of spirodiclofen. As 

noted above, concern is low for the 

increased quantitative susceptibility 

noted in offspring in the DNT studies. 

There was no evidence of increased 

susceptibility in the developmental 

toxicity study in rabbits or the 2- 

generation reproduction study in rats. 

Therefore, there are no residual 

concerns regarding developmental 

effects in the young. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The chronic and cancer dietary 

exposure assessments were refined, 

utilizing average field trial residues; 

experimentally determined processing 

factors for citrus fruit, pome fruit, and 

grape; and DEEM (ver. 7.81) default 

processing factors for the remaining 

processed commodities. The assessment 

also included PCTn estimates for hops 

and blueberry and PCT data for several 

additional registered commodities. EPA 

made conservative (protective) 

assumptions in the ground water and 

surface water modeling used to assess 

exposure to spirodiclofen and its 

metabolites in drinking water. These 

assessments will not underestimate the 

exposure and risks posed by 

spirodiclofen. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, spirodiclofen is not 

expected to pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to spirodiclofen 

from food and water will utilize 3.2% of 

the cPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. There are no residential uses 

for spirodiclofen. 

3. Short- and intermediate-term risk. 

Short- and intermediate-term aggregate 

exposure takes into account short- and 

intermediate-term residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). A short- and 

intermediate-term adverse effect was 

identified; however, spirodiclofen is not 

registered for any use patterns that 

would result in short- or intermediateterm residential exposure. Short- and 

intermediate-term risk is assessed based 

on short- and intermediate-term 

residential exposure plus chronic 

dietary exposure. Because there are no 

short- or intermediate-term residential 

exposures and chronic dietary exposure 

has already been assessed under the 

appropriately protective cPAD (which is 

at least as protective as the POD used to 

assess short- and intermediate-term 

risk), no further assessment of short- or 

intermediate-term risk is necessary, and 

EPA relies on the chronic dietary risk 

assessment for evaluating short- and 

intermediate-term risk for spirodiclofen. 

4. Aggregate cancer risk for U.S. 

population. Using the exposure 

assumptions described in Unit 

III.C.1.iii., EPA has concluded the 

cancer risk from food and water for all 

existing and proposed spirodiclofen 

uses will result in a lifetime cancer risk 

of 3 × 10¥6. EPA generally considers 

cancer risks in the range of 10¥6 or less 

to be negligible. The precision which 

can be assumed for cancer risk estimates 

is best described by rounding to the 

nearest integral order of magnitude on 

the log scale; for example, risks falling 

between 3 × 10¥7 and 3 × 10¥6 are 

expressed as risks in the range of 10¥6. 

Considering the precision with which 

cancer hazard can be estimated, the 

conservativeness of low-dose linear 

extrapolation, and the rounding 

procedure described above in this unit, 

cancer risk should generally not be 

assumed to exceed the benchmark level 

of concern of the range of 10¥6 until the 

calculated risk exceeds approximately 3 

× 10¥6. This is particularly the case 

where some conservatism is maintained 

in the exposure assessment. 

For the following reasons, EPA 

concludes that there are conservatisms 

in the spirodiclofen exposure 

assessment. Based on a critical 

commodity analysis conducted in 

DEEM-Food Commodity Intake Database 

(DEEM–FCID)TM, the major contributors 

to the cancer risk were hops (44% of the 

total exposure) and water (21% of the 

total exposure). EPA notes the following 

conservative assumptions, which were 

incorporated into the cancer analysis for 

hops and water: 

i. Hops. DEEM–FCIDTM assumes that 

100% of the residues in hops are 

transferred to beer during the brewing 

process (no residues remain in/on the 

spent hops). Since spirodiclofen has low 

water solubility, this is a conservative 

assumption. Additionally, the 

assessment assumed a PCT estimate of 

92% for hops; PCT estimates for new 

uses are designed to provide a 

conservative estimate of the actual PCT 

estimates; and 

ii. Drinking water. The water residue 

estimate assumed 87% of the basin is 

cropped with 100% of the crops treated 

at the maximum labeled rate. 

Therefore, EPA concludes that the 

cancer risk estimate provided in this 

assessment is conservative and actual 

cancer risk will be lower than the 

estimate provided in this document. 

5. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to spirodiclofen 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology, 

a liquid chromatography/mass 

spectrometry/mass spectrometry (LC/ 


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33464 Federal Register / Vol. 79, No. 112 / Wednesday, June 11, 2014 / Rules and Regulations 

MS/MS) method, 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 a MRL 

for spirodiclofen in or on citrus oil. 

V. Conclusion 

Therefore, a tolerance for residues of 

spirodiclofen, 3-(2,4-dichlorophenyl)-2- 

oxo-1-oxaspiro[4.5]dec-3-en-4-yl 2,2- 

dimethylbutanoate, in or on citrus, oil is 

amended from 20 ppm to 35 ppm. 

Additionally, the tolerance expression is 

amended for spirodiclofen in order to 

clarify (1) that, as provided in FFDCA 

section 408(a)(3), the tolerance covers 

metabolites and degradates of 

spirodiclofen not specifically 

mentioned; and (2) that compliance 

with the specified tolerance levels is to 

be determined by measuring only 

spirodiclofen. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

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

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

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

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (2 U.S.C. 1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

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

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

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

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: June 2, 2014. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.608 is amended by: 

■ a. Revising the introductory text of 

paragraphs (a)(1) and (a)(2); and 

■ b. Revising the commodity ‘‘Citrus, 

oil’’ in the table in paragraph (a)(1) to 

read as follows: 

§ 180.608 Spirodiclofen; tolerances for 

residues. 

(a) General. (1) Tolerances are 

established for residues of spirodiclofen, 

including its metabolites and 

degradates, in or on the commodities 

listed below. Compliance with the 

following tolerance levels is to be 

determined by measuring only 

spirodiclofen (3-(2,4-dichlorophenyl)-2- 

oxo-1-oxaspiro[4.5]dec-3-en-4-yl 2,2- 

dimethylbutanoate). 

Commodity Parts per million 

*****

Citrus, oil ................... 35 

*****

(2) Tolerances are established for 

residues of spirodiclofen, including its 

metabolites and degradates, in or on the 

commodities listed below. Compliance 

with the following tolerance levels is to 

be determined by measuring only 

spirodiclofen (3-(2,4-dichlorophenyl)-2- 

oxo-1-oxaspiro[4.5]dec-3-en-4-yl 2,2- 

dimethylbutanoate) and its metabolite 3- 

(2,4-dichlorophenyl)-4-hydroxy-1- 

oxaspiro[4,5] dec-3-en-2-one, calculated 


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Federal Register / Vol. 79, No. 112 / Wednesday, June 11, 2014 / Rules and Regulations 33465 

as the stoichiometric equivalent of 

spirodiclofen. 

* * * * * 

[FR Doc. 2014–13233 Filed 6–10–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0903; FRL–9910–39] 

Tricyclazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of tricyclazole in 

or on imported rice. Dow AgroSciences, 

LLC, requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: This regulation is effective June 

11, 2014. Objections and requests for 

hearings must be received on or before 

August 11, 2014, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2012–0903, 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: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; 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–2012–0903, 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 August 11, 2014. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2012–0903, 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 January 16, 

2013 (78 FR 3377) (FRL–9375–4), 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 2E8114) by Dow 

AgroSciences, LLC, 9330 Zionsville 

Road, Indianapolis, IN 46268. The 

petition requested that 40 CFR part 180 

be amended by establishing tolerances 

for residues of the fungicide 

tricyclazole, 5-methyl-1,2,4-triazolo[3.4- 

b] benzothiazole, including its 

metabolites and degradates, in or on rice 

at 3.0 parts per million (ppm). That 

document referenced a summary of the 

petition prepared by Dow AgroSciences, 

LLC, the registrant, which is available in 

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

There were no comments received in 

response to the notice of filing. 

Tricyclazole is a new active 

ingredient and is not currently 

registered or proposed for use in the 

United States. The only anticipated 

exposure to tricyclazole residues is from 

the dietary consumption of imported 

rice. Therefore, acute and chronic 

dietary assessments were conducted for 

tricyclazole residues of concern in food 

only. 

Based upon review of the data 

supporting the petition, EPA has 

determined that the parent compound, 

tricyclazole, is suitable as a residue 

definition for purposes of both tolerance 

enforcement and risk assessment in rice. 

This determination is based on 

tricyclazole being the only major 

residue in rice grain and the observation 

that in samples from field trials with 

quantifiable levels of the alcohol 

metabolite, the metabolite is reduced to 

less than the level of detection upon 

husking. EPA has not revised the 

tolerance proposed by Dow in the notice 

of filing. EPA has added the compliance 

statement which clarifies that only the 

parent compound is to be analyzed for 

enforcement purposes. 


wreier-aviles on DSK6TPTVN1PROD with RULES