Federal Register / Vol. 80, No. 52 / Wednesday, March 18, 2015 / Rules and Regulations 14009 

whether the plan or issuer qualifies to 

offer such coverage or complies with the 

applicable requirements of this section. 

(2) Reporting by group health plan 

sponsors. The plan sponsor of a group 

health plan offering limited wraparound 

coverage under paragraph (b)(3)(vii) of 

this section, must report to the 

Department of Health and Human 

Services (HHS), in a form and manner 

specified in guidance, information HHS 

reasonably requires. 

(F) Pilot program with sunset—The 

provisions of paragraph (b)(3)(vii) of this 

section apply to limited wraparound 

coverage that is first offered no earlier 

than January 1, 2016 and no later than 

December 31, 2018 and that ends no 

later than on the later of: 

(1) The date that is three years after 

the date limited wraparound coverage is 

first offered; or 

(2) The date on which the last 

collective bargaining agreement relating 

to the plan terminates after the date 

limited wraparound coverage is first 

offered (determined without regard to 

any extension agreed to after the date 

limited wraparound coverage is first 

offered). 

* * * * * 

[FR Doc. 2015–06066 Filed 3–16–15; 11:15 am] 

BILLING CODE 4830–01–P; 4510–29–P; 4120–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket Number USCG–2013–0907] 

RIN 1625–AA00 

Safety Zones; Upper Mississippi River 

Between Mile 38.0 and 46.0, Thebes, IL; 

and Between Mile 78.0 and 81.0, Grand 

Tower, IL. 

AGENCY: Coast Guard, DHS. 

ACTION: Final rule; correction. 

SUMMARY: The Coast Guard published in 

the Federal Register of March 5, 2015, 

a final rule document making final an 

interim rule previously published at 79 

FR 66622 on November 10, 2014. The 

March 5 final rule incorrectly cited the 

interim rule as published at 77 FR 

75850 on December 26, 2012. This 

document corrects the citation and date 

in that final rule to correctly reflect the 

proper interim rule citation and 

effective date. 

DATES: Effective on March 18, 2015. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call or 

email LT Dan McQuate, U.S. Coast 

Guard; telephone 270–442–1621, email 

daniel.j.mcquate@uscg.mil. If you have 

questions on viewing or submitting 

material to the docket, call Cheryl F. 

Collins, Program Manager, Docket 

Operations, telephone (202) 366–9826. 

SUPPLEMENTARY INFORMATION: The Coast 

Guard published a document in the 

Federal Register of March 5, 2015 

making an interim rule final as 

published. The citation to the interim 

rule was published incorrectly. This 

correction removes the incorrect citation 

and amendatory instruction for 33 CFR 

part 165. 

In rule FR Doc. 2015–03331 published 

on March 5, 2015 (80 FR 11885), make 

the following correction. On page 

11887, in the third column, correct the 

last full paragraph of the document to 

read as follows: Accordingly, the 

interim rule amending 33 CFR part 165 

that published at 79 FR 66622 on 

November 10, 2014, is adopted as a final 

rule without change. 

Dated: March 12, 2015. 

Katia Cervoni, 

Chief, Office of Regulations and 

Administrative Law, U.S. Coast Guard. 

[FR Doc. 2015–06174 Filed 3–17–15; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0797; FRL–9921–01] 

Boscalid; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of boscalid in or 

on dill seed, the herb subgroup 19A, the 

stone fruit group 12–12, and the tree nut 

group 14–12. Interregional Research 

Project Number 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). In 

addition, this regulation removes 

established tolerances for certain 

commodities/groups superseded by this 

action, and corrects the spelling of 

papaya. 

DATES: This regulation is effective 

March 18, 2015. Objections and requests 

for hearings must be received on or 

before May 18, 2015, 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–2013–0797, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., Rm. 3334, 1301 

Constitution Ave. NW., Washington, DC 

20460–0001. The Public Reading Room 

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

Monday through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: 

Susan Lewis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main telephone 

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

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Publishing Office’s eCFR site at http://www.ecfr.gov/cgi-bin/ 

text-idx?&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 


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14010 Federal Register / Vol. 80, No. 52 / Wednesday, March 18, 2015 / Rules and Regulations 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2013–0797 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 May 18, 2015. 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– 

2013–0797, 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 

25, 2014 (79 FR 10458) (FRL–9906–77), 

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 3E8215) by (IR–4), 

500 College Road East, Suite 201 W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.589 be 

amended by establishing tolerances for 

residues of the fungicide boscalid, 3- 

pyridinecarboxamide,2-chloro-N-(4′- 

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

herb, subgroup 19A at 190 parts per 

million (ppm), and dill, seed at 300 ppm 

as well as changing the existing 

tolerance for ‘‘fruit, stone, group 12’’ to 

‘‘fruit, stone, group 12–12’’ and ‘‘nut, 

tree, group 14’’ to ‘‘nut, tree, group 14– 

12’’ and also removing the existing 

tolerance for pistachio at 0.70 ppm. 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 

modified the levels at which some of the 

tolerances are being established. The 

reason for these changes are 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 decreased 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. 

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 in 

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 in body weight 

gains (PND 1–4) were seen in the 

absence of any maternal toxicity, 

however, these effects were shown to be 

reversible in that no treatment-related 

effects on body weight, body weight 

gain or any other parameter were noted 

at PND 21. 

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 


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slight, and there was no evidence of 

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 document, 

‘‘Boscalid—Human Health Risk 

Assessment for a Section 3 Registration 

of New Uses on Herb Subgroup 19A and 

Dill Seed, Plus Crop Group Conversions 

on Stone Fruit Group 12–12 and Tree 

Nut Group 14–12’’ at pg. 35 in docket 

ID number EPA–HQ–OPP–2013–0797. 

B. Toxicological Points of Departure/

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which the NOAEL and the 

LOAEL are identified. Uncertainty/

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

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 discussed in Unit 

III.B. of the final rule published in the 

Federal Register of November 8, 2013 

(78 FR 67042) (FRL–9401–5). 

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 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 above 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. 

• 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 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%; oranges 1%; peaches 

20%; peanuts 1%; pears 15%; peppers 

2.5%; pistachios 30%; plums/prunes 

5%; potatoes 20%; pumpkins 10%; 

squash 5%; strawberries 60%; sugar 

beets 1%; tomatoes 5%; walnuts 1%; 

and watermelons 25%. 

In most cases, EPA uses available data 

from United States Department of 

Agriculture/National Agricultural 

Statistics Service (USDA/NASS), 

proprietary market surveys, and the 

National Pesticide Use Database for the 

chemical/crop combination for the most 

recent 6–7 years. EPA uses an average 

PCT for chronic dietary risk analysis. 

The average PCT figure for each existing 

use is derived by combining available 

public and private market survey data 

for that use, averaging across all 

observations, and rounding to the 

nearest 5%, except for those situations 

in which the average PCT is less than 

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

average PCT and 2.5% is used as the 

maximum PCT. EPA uses a maximum 

PCT for acute dietary risk analysis. The 

maximum PCT figure is the highest 

observed maximum value reported 

within the recent 6 years of available 

public and private market survey data 

for the existing use and rounded up to 

the nearest multiple of 5%. 

The Agency believes that the three 

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

have been met. With respect to 

Condition a, PCT estimates are derived 

from Federal and private market survey 

data, which are reliable and have a valid 

basis. The Agency is reasonably certain 

that the percentage of the food treated 

is not likely to be an underestimation. 

As to Conditions b and c, regional 

consumption information and 

consumption information for significant 

subpopulations is taken into account 

through EPA’s computer-based model 

for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available reliable information on 

the regional consumption of food to 


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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 (PRZM 

GW), 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, 

residential fruit and nut trees, and 

residential ornamentals and landscape 

gardens. 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 

a 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 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 

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 safety factor 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 is lower than the dose that 

caused 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 for inhalation exposures where 

the 10X FQPA SF was retained. 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 a 10X 

FQPA SF for assessing residential 

inhalation risks 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 post-natal toxicity. 

iii There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessment 

assumed tolerance 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 


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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 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, 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 26% of the 

cPAD for all infants less than 1 year 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 380 for adults, 460 for children 

6–11 years old, and 1,100 for youth 11– 

16 years old. Because EPA’s level of 

concern 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, 

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 MRLs 

for herbs or dill seed. For stone fruit, 

Codex has an MRL of 3 ppm and the 

U.S. tolerance is 3.5 ppm. The U.S. 

tolerance cannot be lowered to 3 ppm to 

harmonize with Codex, because the 

cherry residue data used in support of 

the U.S. tolerances necessitate a higher 

value. The Codex tree nut MRL (0.05 

ppm) is lower than the U.S. tolerance 

(0.7 ppm), and harmonization is not 

possible. 

C. Revisions to Petitioned-For 

Tolerances 

The petitioned for tolerance of 190 

ppm for the herb subgroup 19A is not 

supported by the field trial data and the 

processing data and therefore, the 

tolerance is being established at 150 

ppm based on the highest average field 

trial (HAFT) data for basil and the 

processing factor for drying. The 

tolerance for dill seed is being 

established at 100 ppm, not the 

petitioned for level of 300 ppm, based 

on an evaluation of the residue data 

using the Organization for Economic 

Cooperation and Development (OECD) 

calculation procedure. 

V. Conclusion 

Therefore, tolerances are established 

for residues of boscalid in or on dill, 

seed at 100 ppm; fruit, stone, group 12– 

12 at 3.5 ppm; herb subgroup 19A at 150 

ppm; and nut, tree, group 14–12 at 0.70 

ppm. In addition, due to the 

establishment of these tolerances, the 

existing tolerances for fruit, stone, group 

12; nut, tree, group 14; and pistachio are 

removed as unnecessary. Lastly, as an 

administrative correction, the existing 

entry for ‘‘papya’’ is changed to its 

correct spelling ‘‘papaya.’’ 

VI. Statutory and Executive Order 

Reviews 

This action establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 


wreier-aviles on DSK5TPTVN1PROD with RULES
14014 Federal Register / Vol. 80, No. 52 / Wednesday, March 18, 2015 / Rules and Regulations 

October 4, 1993). Because this action 

has been exempted from review under 

Executive Order 12866, this action is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This action does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

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

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This action directly regulates growers, 

food processors, food handlers, and food 

retailers, not States or tribes, nor does 

this action alter the relationships or 

distribution of power and 

responsibilities established by Congress 

in the preemption provisions of FFDCA 

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

has determined that this action will not 

have a substantial direct effect on States 

or tribal governments, on the 

relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

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

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this action. In addition, this action 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

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

1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act 

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

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: March 3, 2015. 

Susan Lewis, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Revise § 180.589(a)(1) as follows: 

■ a. Add in alphabetical order entries 

for ‘‘Dill, seed’’ and ‘‘Herb subgroup 

19A’’. 

■ b. Remove the entries for ‘‘Fruit, 

stone, group 12’’ and ‘‘Nut, tree, group 

14’’ and add in their place entries for 

‘‘Fruit, stone, group 12–12’’ and ‘‘Nut, 

tree, group 14–12’’, respectively. 

■ c. Remove the entry for ‘‘Pistachio.’’ 

■ d. Remove the entry for ‘‘Papya’’ and 

add in its place an entry for ‘‘Papaya.’’ 

The addition and revisions read as 

follows: 

§ 180.589 Boscalid; tolerances for 

residues. 

(a) * * * 

(1) * * * 

Commodity Parts per 

million 

*****

* * 

Dill, seed ............................... 100 

*****

* * 

Fruit, stone, group 12–12 ..... 3.5 

*****

* * 

Herb subgroup 19A .............. 150 

Commodity Parts per 

million 

*****

* * 

Nut, tree, group 14–12 ......... 0.70 

*****

* * 

Papaya .................................. 1.5 

*****

* * 

* * * * * 

[FR Doc. 2015–06141 Filed 3–17–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0483; FRL–9923–59] 

Dimethomorph; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of dimethomorph 

in or on papaya at 1.5 parts per million 

(ppm). BASF Corporation requested this 

tolerance under the Federal Food, Drug, 

and Cosmetic Act (FFDCA) to cover 

residues of dimethomorph in papaya 

imported into the United States; there 

are currently no U.S. registrations for 

pesticides containing dimethomorph 

that are used on papaya. 

DATES: This regulation is effective 

March 18, 2015. Objections and requests 

for hearings must be received on or 

before May 18, 2015, and must be filed 

in accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2014–0483, 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 


wreier-aviles on DSK5TPTVN1PROD with RULES