67042 Federal Register / Vol. 78, No. 217 / Friday, November 8, 2013 / Rules and Regulations 

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 § 180.940, in paragraph (a) 

alphabetically add the following inert 

ingredient to the table to read as 

follows: 

§ 180.940 Tolerance exemptions for active 

and inert ingredients for use in 

antimicrobial formulations (Food-contact 

surface sanitizing solutions). 

* * * * * 

(a) * * * 

Pesticide chemical CAS Reg. No. Limits 

*******

FD&C Green No. 3 ...................................................................... CAS Reg. No. 2353–45–9 .......................................................... None. 

* * * * * * * 

[FR Doc. 2013–26760 Filed 11–7–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0710; FRL–9401–5] 

Boscalid; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of boscalid in or 

on multiple commodities which are 

identified and discussed later in this 

document. Interregional Research 

Project Number 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

November 8, 2013. Objections and 

requests for hearings must be received 

on or before January 7, 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–2012–0710, 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), EPA West 

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–2012–0710, 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 January 7, 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– 

2012–0710, 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 2E8068) by BASF 


wreier-aviles on DSK5TPTVN1PROD with RULES
Federal Register / Vol. 78, No. 217 / Friday, November 8, 2013 / Rules and Regulations 67043 

Corporation, 26 Davis Dr, P.O. Box 

13528, Research Triangle Park, NC 

27709–3528. However, BASF was listed 

in error. It was the IR–4, 500 College Rd. 

East, Suite 201W, Princeton, NJ 08540 

that petitioned EPA for these tolerances. 

The petition requested that 40 CFR 

180.589 be amended by establishing 

tolerances for residues of the fungicide 

boscalid (BAS 510F), 3- 

pyridinecarboxamide, 2-chloro-N-(4′- 

chloro(1,1′-biphenyl)-2-yl)-, in or on 

artichoke, globe at 6.0 parts per million 

(ppm); berry, low growing, subgroup 

13–07G at 4.5 ppm; bushberry, subgroup 

13–07B at 13 ppm; caneberry, subgroup 

13–07A at 6.0 ppm; endive, Belgium at 

5.0 ppm; fruit, citrus, group 10–10 at 1.6 

ppm; fruit, pome, group 11–10 at 3.0 

ppm; fruit, small, vine climbing, except 

fuzzy kiwifruit, subgroup 13–07F, at 3.5 

ppm; oilseed, group 20 at 3.5 ppm; 

persimmon at 7.0 ppm; turnip, greens at 

18.0 ppm; vegetable, bulb group 3–07 at 

3.0 ppm; vegetable, fruiting, group 8–10 

at 1.2 ppm; and vegetable, root subgroup 

1B, except sugarbeet, at 1.0 ppm. The 

petition also requested the removal of 

the established tolerances, in or on 

bushberry, subgroup 13B at 13 ppm; 

caneberry, subgroup 13A at 6.0 ppm; 

canola, seed at 3.5 ppm; cotton, 

undelinted seed at 1.0 ppm; fruit, citrus, 

group 10 at 1.6 ppm; fruit, pome, group 

11 at 3.0 ppm; grape at 3.5 ppm; 

strawberry at 4.5 ppm; sunflower, seed 

at 0.6 ppm; vegetable, bulb, group 3 at 

3.0 ppm; vegetable, fruiting, group 8 at 

1.2 ppm; and vegetable, root, subgroup 

1A except sugarbeet, garden beet, 

radish, and turnip at 1.0 ppm upon 

approval of the tolerances listed in this 

unit, since the proposed new tolerances 

will supersede the existing tolerances. 

That document referenced a summary of 

the petition prepared by BASF, the 

registrant, which is available in the 

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

There were no comments received in 

response to the notice of filing. 

Based upon review of the data 

supporting the petition, EPA has revised 

the levels at which some of the 

tolerances are being established. The 

reason for these changes is explained in 

Unit IV.C. 

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 boscalid 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with boscalid 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. 

In mammals, the primary targets are 

the liver and the thyroid (indirectly 

from liver adaptive response). In 

subchronic and chronic feeding studies 

in rats, mice, and dogs, boscalid 

generally caused decreased body 

weights and body weight gains 

(primarily in mice) and effects on the 

liver (increase in weights, changes in 

enzyme levels and histopathological 

changes) as well as on the thyroid 

(increase in weights and 

histopathological changes). Mode of 

action studies conducted in rats 

indicated that boscalid has a direct 

effect upon the liver and that the 

thyroid effects are secondary. A 

reversibility study in rats indicated that 

both liver and thyroid parameters 

returned to control values after the 

animals were placed on control diet. 

Absolute and/or relative thyroid weights 

were elevated in rats and dogs, but there 

were no histopathological changes 

observed in the thyroid in either mice 

or dogs. 

In a developmental toxicity study in 

rats, no developmental toxicity was 

observed in the fetuses at the highest 

dose tested (limit dose). No effects were 

noted in the dams in this study. In a 

developmental toxicity study in rabbits, 

an increased incidence of abortions or 

early delivery was observed at the limit 

dose. There was quantitative evidence 

of increased susceptibility in the 2- 

generation reproduction study in rats, 

where decreases in body weights and 

body weight gains in male offspring 

were seen at a dose that was lower than 

the dose that induced parental/systemic 

toxicity. There was quantitative 

evidence of increased susceptibility in 

the developmental neurotoxicity study 

in rats, where decreases in pup body 

weights (PND 4) and body weight gains 

(PND 1–4) were seen in the absence of 

any maternal toxicity. 

Although there is some evidence 

indicating increased incidence of 

thyroid follicular cell adenomas in rats, 

EPA classified boscalid as ‘‘suggestive 

evidence of carcinogenicity’’ and has 

concluded that the endpoint for chronic 

assessment would be protective of these 

effects. This is based on the following: 

The adenomas occurred at dose levels 

above the level used to establish the 

chronic population adjusted dose 

(cPAD), statistically significant 

increases were only seen for benign 

tumors (adenomas) and not for 

malignant ones (carcinomas), the 

increase in adenomas in females was 

slight, and there was no concern for 

mutagenicity. 

There was no evidence of 

neurotoxicity in rats in the acute, 

subchronic, or developmental studies 

up to the limit dose. No neurotoxic 

observations were noted in any of the 

other studies in any species. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by boscalid as well as the 

no-observed-adverse-effect-level 

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

toxicity studies can be found at http:// 

www.regulations.gov in the document 

titled ‘‘Boscalid Human Health Risk 

Assessment for a Section 3 Registration 

of New Uses on Globe Artichoke, 

Belgium Endive, Persimmon, 

Greenhouse Grown Tomato Transplants 

for the Home Consumer Market, and 

Residential Ornamentals, Landscape 

Gardens, Fruit Trees and Nut Trees; 

Plus Crop Group Expansions/Revisions 

for Bulb Vegetable Group 3–07, Fruiting 

Vegetable Group 8–10, Citrus Fruit 

Group 10–10, Pome Fruit Group 11–10, 

Berry Subgroups 13–07A, B, F, and G, 

Vegetable Root Subgroup 1B Except 

Sugar beet, and Oilseed Group 20’’ on 

pp. 42–46 in docket ID number EPA– 

HQ–OPP–2012–0710. 


wreier-aviles on DSK5TPTVN1PROD with RULES
67044 Federal Register / Vol. 78, No. 217 / Friday, November 8, 2013 / Rules and Regulations 

B. Toxicological Points of Departure/

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern (LOC) to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http://

www.epa.gov/pesticides/factsheets/

riskassess.htm. 

A summary of the toxicological 

endpoints for boscalid used for human 

risk assessment is shown in Table 1 of 

this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR BOSCALID 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 

and females 13–49 years of 

age).

No appropriate endpoint attributable to a single dose was identified. 

Chronic dietary (All populations) NOAEL= 21.8 mg/

kg/day.

UFA = 10x ................

UFH = 10x ................

FQPA SF = 1x .........

Chronic RfD = 0.218 

mg/kg/day.

cPAD = 0.218 mg/

kg/day.

Co-critical chronic rat, carcinogenicity rat, and 1-year dog studies. 

LOAEL = 57–58 mg/kg/day based on liver and thyroid effects. 

Dermal Short-Term (1–30 days) Oral study NOAEL = 

21.8 mg/kg/day 

(dermal absorption 

rate = 15%).

UFA = 10x ................

UFH = 10x ................

FQPA SF = 1x .........

LOC for MOE = 100 Co-critical chronic rat, carcinogenicity rat, and 1-year dog studies. 

LOAEL = 57–58 mg/kg/day based on liver and thyroid effects. 

Inhalation Short-Term (1–30 

days).

Oral study NOAEL= 

21.8 mg/kg/day.

UFA = 10x ................

UFH = 10x ................

FQPA SF UFDB = 

10x.

LOC for MOE = 

1,000.

Co-critical chronic rat, carcinogenicity rat, and 1-year dog studies. 

LOAEL = 57–58 mg/kg/day based on liver and thyroid effects. 

Cancer (oral, dermal, inhalation).Classification: ‘‘Suggestive evidence of carcinogenicity.’’ The cPAD is considered to be protective of any cancer effects; therefore, a separate cancer assessment is not required. 

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 (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 boscalid, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

boscalid tolerances in 40 CFR 180.589. 

EPA assessed dietary exposures from 

boscalid 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 boscalid; 

therefore, a quantitative acute dietary 

exposure assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used food consumption 

information from the 2003–2008 food 

consumption data from the U.S. 

Department of Agriculture’s (USDA’s) 

National Health and Nutrition 

Examination Survey, What We Eat in 

America, (NHANES/WWEIA). As to 

residue levels in food, EPA assumed 

tolerance-level residues and used some 

percent crop treated (PCT) information 

as described in Unit III.C.1.iv. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that the chronic endpoint 

will be protective of potential cancer 

effects. EPA’s estimate of chronic 

exposure as described in this unit is 

relied upon to evaluate whether any 

exposure could exceed the cPAD and 

thus pose a cancer risk. 

iv. Anticipated residue and PCT 

information. 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. 


wreier-aviles on DSK5TPTVN1PROD with RULES
Federal Register / Vol. 78, No. 217 / Friday, November 8, 2013 / Rules and Regulations 67045 

• 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: Almonds 40%; 

apples 15%; apricots 25%; blueberries 

35%; broccoli 2.5%; cabbage 5%; 

caneberries 45%; cantaloupes 5%; 

carrots 15%; cauliflower 5%; celery 

2.5%; cherries 45%; cucumbers 5%; dry 

beans/dry peas 2.5%; garlic 5%; grapes 

30%; green beans 5%; green peas 1%; 

hazelnuts 5%; lettuce 25%; nectarines 

15%; onions 20%; peaches 20%; 

peanuts 1%; pears 15%; peppers 2.5%; 

pistachios 30%; plums/prunes 5%; 

potatoes 20%; pumpkins 10%; squash 

5%; strawberries 55%; tomatoes 5%; 

walnuts 1%; and watermelons 25%. 

In most cases, EPA uses available data 

from USDA/National Agricultural 

Statistics Service (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 1. 

In those cases, 1% is used as the average 

PCT and 2.5% is used as the maximum 

PCT. EPA uses a maximum PCT for 

acute dietary risk analysis. The 

maximum PCT figure is the highest 

observed maximum value reported 

within the recent 6 years of available 

public and private market survey data 

for the existing use and rounded up to 

the nearest multiple of 5%. 

The Agency believes that the three 

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

have been met. With respect to 

Condition a, PCT estimates are derived 

from Federal and private market survey 

data, which are reliable and have a valid 

basis. The Agency is reasonably certain 

that the percentage of the food treated 

is not likely to be an underestimation. 

As to Conditions b and c, regional 

consumption information and 

consumption information for significant 

subpopulations is taken into account 

through EPA’s computer-based model 

for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available reliable information on 

the regional consumption of food to 

which boscalid may be applied in a 

particular area. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for boscalid in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of boscalid. 

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 First Index Reservoir 

Screening Tool (FIRST) and Pesticide 

Root Zone Model Ground Water 

(PRZMGW), the estimated drinking 

water concentrations (EDWCs) of 

boscalid for chronic exposure 

assessments are estimated to be 26.4 

parts per billion (ppb) for surface water 

and 697 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 697 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). 

Boscalid is currently registered for the 

following uses that could result in 

residential exposures: Golf course turf. 

Additionally, new residential uses 

proposed by the registrants Bonide (use 

on residential fruit and nut trees) and 

BASF (new uses on residential 

ornamentals and landscape gardens) 

were evaluated as part of this action. 

EPA assessed residential exposure using 

the following assumptions: All 

residential exposures are considered 

short-term in duration. The residential 

handler assessment included short-term 

exposures via the dermal and inhalation 

routes from treating residential 

ornamentals, landscape gardens, and 

trees. 

In terms of post-application exposure, 

there is the potential for dermal postapplication exposure for individuals as 

result of being in an environment that 

has been previously treated with 

boscalid. Short-term dermal exposures 

were assessed for adults, youth 11 to 16 

years old, and children 6 to 11 years 

old. Incidental oral exposure to children 

1 to <2 years old is not expected from 

treated turf because boscalid is 

registered for use only on golf course 

turf and proposed for use on residential 

gardens and trees. 

The scenarios used in the aggregate 

assessment were those that resulted in 

the highest exposures. The highest 

exposures for all age groups were 

associated with only residential postapplication dermal exposures, not 

inhalation exposures, and consist of the 

following: 

• The residential dermal exposure for 

use in the adult aggregate assessment 

reflects dermal exposure from postapplication activities on treated gardens. 

• The residential dermal exposure for 

use in the youth (11–16 years old) 

aggregate assessment reflects dermal 

exposure from post-application golfing 

on treated turf. 

• The residential dermal exposure for 

use in the child (6–11 years old) 

aggregate assessment reflects dermal 

exposure from post-application 

activities in treated gardens. 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

found at http://www.epa.gov/pesticides/ 

trac/science/trac6a05.pdf. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

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

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found boscalid to share 

a common mechanism of toxicity with 

any other substances, and boscalid does 

not appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that 

boscalid 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 


wreier-aviles on DSK5TPTVN1PROD with RULES
67046 Federal Register / Vol. 78, No. 217 / Friday, November 8, 2013 / Rules and Regulations 

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 

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 SF when reliable data 

available to EPA support the choice of 

a different factor. 

2. Prenatal and postnatal sensitivity. 

There was no evidence of increased 

susceptibility in the rat developmental 

study as no developmental toxicity was 

seen at the highest dose tested (limit 

dose). 

There was evidence of increased 

qualitative susceptibility in the rabbit 

developmental study as characterized 

by an increased incidence of abortions 

or early delivery at the limit dose. It 

could not be ascertained if the abortions 

were the result of a treatment-related 

effect on the dams, the fetuses or both. 

It was concluded that the degree of 

concern is low because the increased 

abortions or early delivery was seen 

only at the limit dose and the abortions 

may have been due to maternal stress. 

There was evidence of increased 

quantitative susceptibility seen in the 

rat 2-generation reproduction study and 

the developmental neurotoxicity study, 

in that reduced body weights were seen 

in the offspring at dose levels where no 

parental toxicity was observed. 

However, the degree of concern is low 

because the dose selected for chronic 

dietary and non-dietary exposure risk 

assessments would address the concern 

for the body weight effects, and the 

effect was shown to be reversible in the 

developmental neurotoxicity study. 

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 for all scenarios, 

except residential handler inhalation 

exposure. That decision is based on the 

following findings: 

i. The toxicity database is complete, 

with the exception of a subchronic 

inhalation study. EPA is retaining the 

10X FQPA SF for assessing residential 

inhalation risk to adult applicators. 

ii. For the reasons listed in Unit 

III.D.2., the Agency has concluded that 

there are no residual uncertainties 

concerning the potential for prenatal 

and postnatal toxicity. 

iii. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessment 

assumed tolerances-level residues and 

was moderately refined using some PCT 

data. The use of the PCT data for some 

crops is based on reliable data and will 

not underestimate the exposure and 

risk. EPA made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to boscalid in drinking water. EPA used 

similarly conservative assumptions to 

assess post-application exposure of 

children. These assessments will not 

underestimate the exposure and risks 

posed by boscalid. 

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 aPAD and 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, boscalid 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 boscalid from 

food and water will utilize 56% 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 boscalid 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). 

Boscalid 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 boscalid. EPA used the 

dermal exposure scenarios mentioned in 

Unit III.C.3., in the aggregate assessment 

because those scenarios resulted in the 

highest exposures and corresponding 

lowest MOEs. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded that the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of 290 for adults, 310 for children 

6–11 years old, and 690 for youth 11– 

16 years old. Because EPA’s LOC for 

boscalid is a MOE of 100 or below, these 

MOEs are 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). 

An intermediate-term adverse effect 

was identified; however, boscalid is not 

registered for any use patterns that 

would result in intermediate-term 

residential exposure. Intermediate-term 

risk is assessed based on intermediateterm residential exposure plus chronic 

dietary exposure. Because there is no 

intermediate-term residential exposure 

and chronic dietary exposure has 

already been assessed under the 

appropriately protective cPAD (which is 

at least as protective as the POD used to 

assess intermediate-term risk), no 

further assessment of intermediate-term 

risk is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating intermediate-term risk for 

boscalid. 

5. Aggregate cancer risk for U.S. 

population. Based on the data 

summarized in Unit III.A., EPA has 

concluded that the cPAD is protective of 

possible cancer effects. Given the results 

of the chronic risk assessment, cancer 

risk resulting from exposure to boscalid 

is not of concern. 

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 boscalid 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(gas chromatography/mass spectrometry 

(GC/MS)) is available to enforce the 

tolerance expression. 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 


wreier-aviles on DSK5TPTVN1PROD with RULES
Federal Register / Vol. 78, No. 217 / Friday, November 8, 2013 / Rules and Regulations 67047 

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 boscalid in/on globe artichoke, 

Belgian endive, or persimmon. 

The tolerances being established by 

this document for the bulb vegetable 

group 3–07; the caneberry subgroup 13– 

07A; the citrus fruit group 10–10; the 

fruiting vegetable group 8–10; the small, 

vine climbing fruit, except fuzzy 

kiwifruit, subgroup 13–07F; and turnip 

greens align with existing Codex MRLs. 

The tolerances being established for 

the bushberry subgroup 13–07B; the low 

growing berry subgroup 13–07G, except 

cranberry and the pome fruit group 11– 

10; do not align with established MRLs. 

Harmonization with Codex is not 

possible because the corresponding 

commodity group/subgroup tolerance in 

the United States is higher than the 

Codex MRL. The higher U.S. tolerance 

level reflects the likely residues 

resulting from use in accordance with 

the approved application rates on the 

domestic boscalid pesticide label. 

Reducing the tolerance value to 

harmonize with Codex levels could 

result in violations of the tolerance 

when boscalid is used according to the 

label. 

C. Revisions to Petitioned-for Tolerances 

Based on evaluation of the field trial 

data with the Organization of Economic 

Cooperation and Development (OECD) 

tolerance calculation procedure, EPA 

has modified the proposed tolerance for 

Belgium endive from 5.0 ppm to 6.0 

ppm and the proposed tolerance for 

persimmon from 7.0 ppm to 8.0 ppm. 

The tolerances for the bulb vegetable 

group 3–07; the caneberry subgroup 13– 

07A; the citrus fruit group 10–10; the 

fruiting vegetable group 8–10; the small, 

vine climbing fruit, except fuzzy 

kiwifruit, subgroup 13–07F; and turnip 

greens to align with existing Codex 

MRLs. 

With the establishment of the 

tolerance for oilseed group 20 the flax, 

seed; cotton, gin byproducts; and cotton, 

undelinted seed will be deleted from 40 

CFR 180.589(d) since the oilseed group 

20 tolerance will supersede these 

existing tolerances. 

In regards to the request for a 

tolerance for ‘‘vegetable, root subgroup 

1B, except sugarbeet,’’ at 1.0 ppm, the 

petitioner did not submit the data 

necessary to support establishment of a 

tolerance for this crop subgroup; 

therefore, this tolerance is not being 

established at this time. 

V. Conclusion 

Therefore, tolerances are established 

for residues of boscalid in or on 

artichoke, globe at 6.0 ppm; berry, low 

growing, subgroup 13–07G, except 

cranberry at 4.5 ppm; bushberry 

subgroup 13–07B at 13.0 ppm; 

caneberry subgroup 13–07A at 10.0 

ppm; endive, Belgium at 6.0 ppm; fruit, 

citrus, group 10–10 at 2.0 ppm; fruit, 

pome, group 11.10 at 3.0 ppm; fruit, 

small vine climbing, except fuzzy 

kiwifruit, subgroup 13–07F at 5.0 ppm; 

oilseed group 20 at 3.5 ppm; persimmon 

at 8.0 ppm; turnip, greens at 40.0 ppm; 

vegetable, bulb, group 3–07 at 5.0 ppm; 

and vegetable, fruiting, group 8–10 at 

3.0 ppm. 

In addition, due to the establishment 

of the new tolerances, the following 

tolerances are removed as unnecessary 

from 40 CFR 180.589(a), bushberry 

subgroup 13B; caneberry subgroup 13A; 

canola, seed; cotton, undelinted seed; 

fruit, citrus, group 10; fruit, pome, group 

11; grape; strawberry; sunflower, seed; 

vegetable, bulb, group 3; and vegetable, 

fruiting, group 8; from 40 CFR 180.589 

(d), cotton, gin byproducts; cotton, 

undelinted seed and flax, seed. 

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). 


wreier-aviles on DSK5TPTVN1PROD with RULES
67048 Federal Register / Vol. 78, No. 217 / Friday, November 8, 2013 / Rules and Regulations 

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: October 29, 2013. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.589: 

■ a. Remove from the table in paragraph 

(a)(1) the commodities bushberry 

subgroup 13B; caneberry subgroup 13A; 

canola, seed; cotton, undelinted seed; 

fruit, citrus, group 10; fruit, pome, group 

11; grape; strawberry; sunflower, seed; 

vegetable, bulb, group 3; and vegetable, 

fruiting, group 8. 

■ b. Remove from the table in paragraph 

(d) the commodities cotton, gin 

byproducts; cotton, undelinted seed, 

and flax, seed. 

■ c. Add alphabetically the following 

commodities to the table in paragraph 

(a)(1). The additions read as follows: 

§ 180.589 Boscalid; tolerances for 

residues. 

(a) * * * 

(1) * * * 

Commodity Parts per 

million 

* * * * * 

Artichoke, globe .................... 6.0 

* * * * * 

Berry, low growing, subgroup 

13–07G, except cranberry 4.5 

* * * * * 

Bushberry subgroup 13–07B 13.0 

Caneberry subgroup 13–07A 10.0 

* * * * * 

Endive, Belgium .................... 6.0 

Commodity Parts per 

million 

Fruit, citrus, group 10–10 ..... 2.0 

Fruit, pome, group 11–10 ..... 3.0 

Fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13–07F .................... 5.0 

* * * * * 

Oilseed group 20 .................. 3.5 

* * * * * 

Persimmon ............................ 8.0 

* * * * * 

Turnip, greens ...................... 40.0 

* * * * * 

Vegetable, bulb, group 3–07 5.0 

* * * * * 

Vegetable, fruiting, group 8– 

10 ...................................... 3.0 

* * * * * 

* * * * * 

[FR Doc. 2013–26765 Filed 11–7–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0876; FRL–9400–4] 

Prothioconazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of 

prothioconozole in or on bushberries 

(crop subgroup 13–07B); low growing 

berries, except strawberry (crop 

subgroup 13–07H); and cucurbit 

vegetables (crop group 9). Bayer 

CropScience requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

November 8, 2013. Objections and 

requests for hearings must be received 

on or before January 7, 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–2012–0876, 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), EPA West 

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 (RD), 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–2012–0876, 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 


wreier-aviles on DSK5TPTVN1PROD with RULES