Federal Register / Vol. 80, No. 157 / Friday, August 14, 2015 / Rules and Regulations 48743 

application of those requirements would 

be inconsistent with the CAA; and 

• Does not provide EPA with the 

discretionary authority to address, as 

appropriate, disproportionate human 

health or environmental effects, using 

practicable and legally permissible 

methods, under Executive Order 12898 

(59 FR 7629, February 16, 1994). 

In addition, the SIP is not approved 

to apply on any Indian reservation land 

or in any other area where EPA or an 

Indian tribe has demonstrated that a 

tribe has jurisdiction. In those areas of 

Indian country, the rule does not have 

tribal implications and will not impose 

substantial direct costs on tribal 

governments or preempt tribal law as 

specified by Executive Order 13175 (65 

FR 67249, November 9, 2000). 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this action 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. A major rule 

cannot take effect until 60 days after it 

is published in the Federal Register. 

This action is not a ‘‘major rule’’ as 

defined by 5 U.S.C. 804(2). 

Under section 307(b)(1) of the CAA, 

petitions for judicial review of this 

action must be filed in the United States 

Court of Appeals for the appropriate 

circuit by October 13, 2015. Filing a 

petition for reconsideration by the 

Administrator of this final rule does not 

affect the finality of this action for the 

purposes of judicial review nor does it 

extend the time within which a petition 

for judicial review may be filed, and 

shall not postpone the effectiveness of 

such rule or action. This action may not 

be challenged later in proceedings to 

enforce its requirements. (See section 

307(b)(2).) 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Intergovernmental relations, 

sulfur dioxide, nitrogen dioxide, 

Reporting and recordkeeping 

requirements. 

Dated: August 3, 2015. 

Susan Hedman, 

Regional Administrator, Region 5. 

40 CFR part 52 is amended as follows: 

PART 52— APPROVAL AND 

PROMULGATION OF 

IMPLEMENTATION PLANS 

■ 1. The authority citation for part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

■ 2. In § 52.770 the table in paragraph 

(e) is amended by adding entries in 

alphabetical order for ‘‘Section 110(a)(2) 

Infrastructure Requirements for the 2010 

NO2 NAAQS’’ and ‘‘Section 110(a)(2) 

Infrastructure Requirements for the 2010 

SO2 NAAQS’’ to read as follows: 

§ 52.770 Identification of plan. 

* * * * * 

(e) * * * 

EPA-APPROVED INDIANA NONREGULATORY AND QUASI-REGULATORY PROVISIONS

Title Indiana date EPA Approval Explanation 

*******

Section 110(a)(2) Infrastructure 

Requirements for the 2010 

NO2 NAAQS.

1/15/2013 8/14/2015, [insert Federal 

Register citation].

This action addresses the following CAA elements: 

110(a)(2)(A), (B), (C), (D)(i)(I), (D)(i)(II) except visibility, 

(D)(ii), (E), (F), (G), (H), (J) except visibility, (K), (L), and 

(M). 

Section 110(a)(2) Infrastructure 

Requirements for the 2010 

SO2 NAAQS.

5/22/2013 8/14/2015, [insert Federal 

Register citation].

This action addresses the following CAA elements: 

110(a)(2)(A), (B), (C), (D)(i)(II) except visibility, (D)(ii), (E), 

(F), (G), (H), (J) except visibility, (K), (L), and (M). 

* * * * * * * 

■ 3. Section 52.1891 is amended by 

revising paragraph (h) to read as 

follows: 

§ 52.1891 Section 110(a)(2) Infrastructure 

Requirements. 

* * * * * 

(h) Approval—In a June 7, 2013, 

submittal, Ohio certified that the State 

has satisfied the infrastructure SIP 

requirements of section 110(a)(2)(A) 

through (H), and (J) through (M) for the 

2010 SO2 NAAQS. We are not finalizing 

action on section 110(a)(2)(D)(i)(I)— 

Interstate transport prongs 1 and 2 or 

visibility portions of section 

110(a)(2)(D)(i)(II) and 110(a)(2)(J). 

[FR Doc. 2015–20020 Filed 8–13–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0496; FRL–9931–06] 

Fludioxonil; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of fludioxonil in 

or on carrots, the stone fruit group 12– 

12, and the rapeseed subgroup 20A, 

except flax seed. Interregional Research 

Project Number 4 (IR–4) requested the 

tolerances for carrots and the stone fruit 

group 12–12, and Syngenta Crop 

Protection requested the tolerance for 

the rapeseed subgroup 20A under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

August 14, 2015. Objections and 

requests for hearings must be received 

on or before October 13, 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–2014–0496, 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 


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

Monday through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: 

Susan Lewis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main telephone 

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

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2014–0496 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 October 13, 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– 

2014–0496, 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 December 

17, 2014 (79 FR 75107) (FRL–9918–90), 

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 4E8272) by IR–4, 

500 College Road East, Suite 201 W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR part 180 be 

amended by establishing tolerances for 

residues of the fungicide fludioxonil [4- 

(2,2-difluoro-1,3-benzodioxol-4-yl)-1Hpyrrole-3-carbonitrile] in or on the raw 

agricultural commodity carrot at 7.0 

ppm, and by changing the existing entry 

for ‘‘fruit, stone, group 12 at 5.0 ppm’’ 

to ‘‘fruit, stone, group 12–12 at 5.0 

ppm.’’ That document referenced a 

summary of the petition prepared by 

Syngenta Crop Protection, the registrant, 

which is available in the docket, http:// 

www.regulations.gov. 

In the Federal Register of October 24, 

2014 (79 FR 63594) (FRL–9916–03), 

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 4F8277) by 

Syngenta Crop Protection, LLC, 410 

Swing Rd., Greensboro, NC 27419. The 

petition requested that 40 CFR part 180 

be amended by establishing tolerances 

for residues of the fungicide fludioxonil 

in or on the rapeseed subgroup 20A, 

except flax seed at 0.01 ppm. That 

document referenced a summary of the 

petition prepared by Syngenta Crop 

Protection, the registrant, which is 

available in the docket, http://

www.regulations.gov. 

Comments were received on the 

notice of filing. EPA’s response to these 

comments is discussed 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 fludioxonil 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with fludioxonil 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. 


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Federal Register / Vol. 80, No. 157 / Friday, August 14, 2015 / Rules and Regulations 48745 

In all species tested, the effects in the 

fludioxonil database are indicative of 

toxicity to the liver and kidney. The 

hematopoietic system was also a target 

in dogs. There were also decreased body 

weights and clinical signs throughout 

the database. Fludioxonil was non-toxic 

through the dermal route, and there was 

no evidence of immunotoxicity when 

tested up to and including the limit 

dose. Fludioxonil was not mutagenic in 

the tests for gene mutations. 

In a rat developmental toxicity study, 

fludioxonil caused an increase in fetal 

incidence and litter incidence of dilated 

renal pelvis at the limit dose (1,000 mg/ 

kg/day). These effects are known to 

occur spontaneously in the rat, in 

addition to being transient and 

reversible which is consistent with the 

fludioxonil hazard database (not seen in 

offspring in the 2-generation 

reproductive study). Under current 

policy, the agency considers 

classification of these effects as 

treatment-related but conservative and 

not indicative of increased fetal 

susceptibility. Maternal toxicity 

occurred at the same dose and 

manifested as body weight decrements. 

In the 2-generation reproduction study, 

parental and offspring effects occurred 

at the same dose and consisted of 

decreased body weights in parental and 

offspring animals, as well as increased 

clinical signs in parental animals. 

There was no evidence of 

carcinogenicity in male or female CD–1 

mice and male Sprague-Dawley rats 

following dietary administration at 

doses that were adequate for assessing 

the carcinogenic potential of 

fludioxonil. In female Sprague-Dawley 

rats, there was a statistically significant 

increase in tumor incidence only when 

hepatocellular adenomas and 

carcinomas were combined (not for 

individual tumor types). The pairwise 

increase for combined tumors was 

significant at p=0.03, which is not a 

strong indication of a positive effect. 

Further, statistical significance was only 

found when liver adenomas were 

combined with liver carcinomas. 

Finally, the increase in these tumors 

was within, but at the high-end, of the 

historical controls. Based on these 

findings and in accordance with the 

Agency’s 1986 ‘‘Guidelines for 

Carcinogen Risk Assessment,’’ 

fludioxonil was classified as a Group D 

carcinogen; therefore, there is no need 

for a quantitative cancer risk 

assessment. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by fludioxonil 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 ‘‘Fludioxonil. Section 3 

Registration for Use on Carrots, Stone 

Fruit, Group 12–12, and Rapeseed, 

Subgroup 20A. Human Health Risk 

Assessment’’ at page 28 in docket ID 

number EPA–HQ–OPP–2014–0496. 

B. Toxicological Points of Departure/

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http://

www.epa.gov/pesticides/factsheets/

riskassess.htm. 

A summary of the toxicological 

endpoints for fludioxonil used for 

human risk assessment is shown in 

Table 1 of this unit. Since the last 

assessment in 2012, (August 15, 2012) 

(77 FR 48907) (FRL–9357–5), the 

Agency has reevaluated the 

toxicological endpoints. Based upon 

current policy, it was determined that 

an acute dietary assessment was no 

longer necessary for fludioxonil. This 

decision was based upon the following 

weight of evidence: (1) After reevaluation of the hazard database, it was 

determined that there were no effects 

that could be attributed to single dose 

and (2) the fetal effects in the 

developmental rat study occurred only 

at the limit dose (1,000 mg/kg/day). 

Additionally, though the same study is 

being used to assess chronic dietary 

risk, the NOAEL and LOAEL have been 

reclassified. Further, the remaining 

endpoints for short-term incidental oral 

toxicity and short-term inhalation 

toxicity have changed as well. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FLUDIOXONIL 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 (General population including infants 

and children).

There were no appropriate toxicological effects attributable to a single exposure (dose) observed in available oral 

toxicity studies, including maternal toxicity in the developmental toxicity studies. Therefore, a dose and endpoint were not identified for this risk assessment. 

Chronic dietary (All populations).NOAEL= 33.1 mg/kg/day 

UFA = 10x.

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

FQPA SF = 1x 

Chronic RfD = 0.33 mg/kg/

day.

cPAD = 0.33 mg/kg/day ....

Chronic toxicity in dogs— 

LOAEL = 297.8 mg/kg/day based upon decreased absolute body weights, increased platelets and fibrin in 

both sexes, cholesterol in males, and increased alkaline phosphatase release in both sexes. Enlarged 

livers in two females were observed along with biliary epithelial cell proliferation in one female. 


tkelley on DSK3SPTVN1PROD with RULES
48746 Federal Register / Vol. 80, No. 157 / Friday, August 14, 2015 / Rules and Regulations 

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

ASSESSMENT—Continued 

Exposure/scenario Point of departure and 

uncertainty/safety factors 

RfD, PAD, LOC for risk 

assessment Study and toxicological effects 

Incidental oral short-term (1 

to 30 days).

NOAEL= 50 mg/kg/day 

UFA = 10x.

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 .......... Subchronic toxicity in dogs— 

LOAEL = 250 mg/kg/day based upon decreased absolute body weights in both sexes, diarrhea, 

hematological alterations (increased platelets and 

fibrin, decreased red cells, hemoglobin, and packed 

cell volume), clinical chemistry alterations (increased 

alpha-1 and alpha-2 globulin in females), increased 

liver weights in both sexes, increased testes and 

ovary weights, and an increased severity (but not incidence) of bile duct proliferation. 

Inhalation short-term (1 to 

30 days).

Oral study NOAEL= 50 

mg/kg/day (inhalation 

absorption rate = 100%).

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 .......... Subchronic toxicity in dogs— 

LOAEL = 250 mg/kg/day based upon decreased absolute body weights in both sexes, diarrhea, 

hematological alterations (increased platelets and 

fibrin, decreased red cells, hemoglobin, and packed 

cell volume), clinical chemistry alterations (increased 

alpha-1 and alpha-2 globulin in females), increased 

liver weights in both sexes, increased testes and 

ovary weights, and an increased severity (but not incidence) of bile duct proliferation. 

Cancer (Oral, dermal, inhalation).Classified as a Group D carcinogen; no cancer assessment is necessary. 

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

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

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

sensitivity among members of the human population (intraspecies). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to fludioxonil, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

fludioxonil tolerances in 40 CFR 

180.516. EPA assessed dietary 

exposures from fludioxonil 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 fludioxonil; 

therefore, a quantitative acute dietary 

exposure assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the 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, 

an unrefined chronic dietary exposure 

and risk assessment was performed 

assuming tolerance-level residues, 100 

percent crop treated (PCT) estimates, 

and DEEM (ver. 7.81) default processing 

factors. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

classified fludioxonil as a group D 

carcinogen. Therefore, a dietary 

exposure assessment for the purpose of 

assessing cancer risk is unnecessary. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue or PCT information 

in the dietary assessment for 

fludioxonil. Tolerance-level residues 

and 100 PCT were assumed for all food 

commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for fludioxonil in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of fludioxonil. 

Further information regarding EPA 

drinking water models used in pesticide 

exposure assessment can be found at 

http://www.epa.gov/oppefed1/models/

water/index.htm. 

Based on the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and Screening 

Concentration in Ground Water (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of 

fludioxonil for chronic exposures are 

estimated to be 38.5 parts per billion 

(ppb) for surface water and 0.2 ppb for 

ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For the 

chronic dietary risk assessment, the 

water concentration of value 38.5 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). 

Fludioxonil is currently registered for 

the following uses that could result in 

residential exposures: parks, golf 

courses, athletic fields, residential 

lawns, ornamentals, and greenhouses. 

To assess residential handler exposure, 

the Agency used the short-term 

inhalation exposure to adults from 

mixing/loading/applying a wettable 

powder in water-soluble packaging with 

hose end sprayer (both for turf and 

gardens). To assess post-application 

exposure, the Agency used short-term 

incidental oral exposures (hand-tomouth) to children 1<2 years old from 

exposure to outdoor treated turf. 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. 


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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 fludioxonil to 

share a common mechanism of toxicity 

with any other substances, and 

fludioxonil does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that fludioxonil does not have 

a common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s Web site at 

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

cumulative. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA Safety Factor (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 quantitative or qualitative 

evidence of increased susceptibility 

following in utero exposure to rats and 

rabbits or following pre-/postnatal 

exposure. In a rat developmental 

toxicity study, fludioxonil caused an 

increase in fetal incidence and litter 

incidence of dilated renal pelvis at the 

limit dose (1,000 mg/kg/day). Maternal 

toxicity occurred at the same dose and 

manifested as body weight decrements. 

Fludioxonil was not developmentally 

toxic in rabbits. In the 2-generation 

reproduction study, parental and 

offspring effects occurred at the same 

dose and consisted of decreased body 

weights in parental and offspring 

animals, as well as increased clinical 

signs in parental animals. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for fludioxonil 

is complete. 

ii. The only potential indicator of 

neurotoxicity for fludioxonil was 

convulsions in mice following handling 

in the mouse carcinogenicity study at 

the mid- and high-doses. The concern is 

low however since there was no 

supportive neuropathology, the effect 

was not seen at similar doses in a 

second mouse carcinogenicity study, 

there were no other signs of potential 

neurotoxicity observed in the database, 

and selected endpoints are protective of 

the effect seen in mice. Therefore, there 

is no residual uncertainty concerning 

neurotoxicity and no need to retain the 

FQPA 10X safety factor. 

iii. There is no evidence that 

fludioxonil results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2-generation 

reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to fludioxonil in 

drinking water. EPA used similarly 

conservative assumptions to assess postapplication exposure of children as well 

as incidental oral exposure of toddlers. 

These assessments will not 

underestimate the exposure and risks 

posed by fludioxonil. 

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, fludioxonil 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 fludioxonil 

from food and water will utilize 71% 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 fludioxonil 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). 

Fludioxonil 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 fludioxonil. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of 81,000 for adults and 4,800 for 

children 1–2 years old. Because EPA’s 

level of concern for fludioxonil 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, fludioxonil 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 

fludioxonil. 

5. Aggregate cancer risk for U.S. 

population. Based on the discussion 

contained in Unit III.A., fludioxonil is 

not expected to pose a cancer risk to 

humans. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 


tkelley on DSK3SPTVN1PROD with RULES
48748 Federal Register / Vol. 80, No. 157 / Friday, August 14, 2015 / Rules and Regulations 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to fludioxonil 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate high-performance liquid 

chromatography/ultraviolet (HPLC/UV) 

methods (Methods AG–597 and AG– 

597B) are available for enforcing 

tolerances for fludioxonil on plant 

commodities. An adequate liquid 

chromatography, tandem mass 

spectrometry (LC–MS/MS) method 

(Analytical Method GRM025.03A) is 

available for enforcing tolerances for 

residues of fludioxonil in or on 

livestock commodities. 

The methods 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 established MRLs for 

fludioxonil in or on multiple stone fruit 

commodities (peaches, apricots, etc.) at 

5.0 ppm. These MRLs are the same as 

the tolerances established for 

fludioxonil in the United States. 

The Codex has established an MRL for 

fludioxonil in or on carrot roots at 0.7 

ppm. This MRL is different than the 

tolerance established for fludioxonil in 

the United States because it is based on 

a foliar use, whereas the U.S. use is 

based on a post-harvest use. 

Harmonization with the Codex MRL is 

likely to result in tolerance exceedances 

when fludioxonil is applied to carrots in 

accordance with the label. 

The Codex has established an MRL for 

fludioxonil in or on rape seed at 0.02 

ppm. This MRL is different than the 

0.01 ppm tolerance established for 

fludioxonil on the rapeseed subgroup 

20A in the U.S., which is aligned with 

the existing Canadian MRL on rapeseed. 

In their petition, Syngenta requested to 

remain aligned with Canada at 0.01 ppm 

for rapeseed in order to prevent NAFTA 

trade barriers. 

C. Response to Comments 

Several comments were received in 

response to the Notice of Filing 

regarding adverse impacts to bees but 

did not reference any specific active 

ingredient. The commenters by and 

large stated this action should be denied 

due to toxicity to bees and that all use 

of chemicals should be stopped. The 

comments primarily appear directed to 

the registration of the pesticide under 

the Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA). One comment 

referenced the establishment of a 

tolerance for an unnamed Syngenta 

pesticide, so to the extent that comment 

is directed at the present tolerance 

action, the Agency understands the 

commenters’ concerns and recognizes 

that some individuals believe that 

pesticides should be banned on 

agricultural crops. However, the existing 

legal framework provided by section 

408 of the Federal Food, Drug and 

Cosmetic Act (FFDCA) states that 

tolerances may be set when persons 

seeking such tolerances or exemptions 

have demonstrated that the pesticide 

meets the safety standard imposed by 

that statute. The comment appears to be 

directed at the underlying statute and 

not EPA’s implementation of it; no 

contentions have been made that EPA 

has acted in violation of the statutory 

framework. As to bees the EPA 

considers impacts to the environment 

and non-target species under the 

authority of the (FIFRA). 

V. Conclusion 

Therefore, tolerances are established 

for residues of fludioxonil, (4-(2,2- 

difluoro-1,3-benzodioxol-4-yl)-1 Hpyrrole-3-carbonitrile), in or on carrots 

at 7.0 ppm; fruit, stone, group 12–12 at 

5.0 ppm; and the rapeseed subgroup 

20A, except flax seed at 0.01 ppm. In 

addition, upon establishment of these 

tolerances, the existing tolerance for 

rapeseed, seed is removed as 

unnecessary since it is part of the 

rapeseed subgroup 20A. 

VI. Statutory and Executive Order 

Reviews 

This action establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this action 

has been exempted from review under 

Executive Order 12866, this action is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

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 tolerances 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 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 80, No. 157 / Friday, August 14, 2015 / Rules and Regulations 48749 

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: August 6, 2015. 

Susan Lewis, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.516: 

■ a. Remove the entry in the table in 

paragraph (a) for ‘‘Rapeseed, seed’’. 

■ b. Add alphabetically the entries for 

‘‘Carrots’’ and ‘‘Rapeseed subgroup 20A, 

except flax seed’’ to the table in 

paragraph (a). 

■ c. Revise the entry for ‘‘Fruit, stone, 

group 12’’ to read ‘‘Fruit, stone, group 

12–12’’ in the table in paragraph (a). 

The additions and revisions read as 

follows: 

§ 180.516 Fludioxonil; tolerances for 

residues. 

(a) * * * 

(1) * * * 

Commodity Parts per 

million 

*****

Carrots .................................. 7.0 

*****

Fruit, stone, group 12–12 ..... 5.0 

*****

Rapeseed subgroup 20A, except flax seed .................... 0.01 

Commodity Parts per 

million 

*****

* * * * * 

[FR Doc. 2015–20019 Filed 8–13–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0793; FRL–9930–20] 

Acetic Acid; Exemption From the 

Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends the 

exemption from the requirement of a 

tolerance for residues of acetic acid 

(CAS Reg. No. 64–19–7) when used as 

an inert ingredient in antimicrobial 

pesticide formulations used on dairy 

and food-processing equipment and 

utensils, to allow for a limitation of 

1200 ppm. Technology Sciences Group, 

Inc. on behalf of West Agro, Inc. 

submitted a petition to EPA under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), requesting an amendment to 

the existing exemption from the 

requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of acetic acid. 

DATES: This regulation is effective 

August 14, 2015. Objections and 

requests for hearings must be received 

on or before October 13, 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–2014–0793, 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 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at http://

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

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2014–0793 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 October 13, 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 


tkelley on DSK3SPTVN1PROD with RULES