Federal Register / Vol. 79, No. 53 / Wednesday, March 19, 2014 / Rules and Regulations 15235 

Accordingly, this action merely 

approves a State plan as meeting 

Federal requirements and does not 

impose additional requirements beyond 

those imposed by State law. For that 

reason, this action: 

• Is not a ‘‘significant regulatory 

action’’ subject to review by the Office 

of Management and Budget under 

Executive Order 12866 (58 FR 51735, 

October 4, 1993); 

• does not impose an information 

collection burden under the provisions 

of the Paperwork Reduction Act (44 

U.S.C. 3501 et seq.); 

• is certified as not having a 

significant economic impact on a 

substantial number of small entities 

under the Regulatory Flexibility Act (5 

U.S.C. 601 et seq.); 

• does not contain any unfunded 

mandate or significantly or uniquely 

affect small governments, as described 

in the Unfunded Mandates Reform Act 

of 1995 (Pub. L. 104–4); 

• does not have Federalism 

implications as specified in Executive 

Order 13132 (64 FR 43255, August 10, 

1999); 

• is not an economically significant 

regulatory action based on health or 

safety risks subject to Executive Order 

13045 (62 FR 19885, April 23, 1997); 

• is not a significant regulatory action 

subject to Executive Order 13211 (66 FR 

28355, May 22, 2001); 

• is not subject to requirements of 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) because 

application of those requirements would 

be inconsistent with the Clean Air Act; 

and 

• does not provide EPA with the 

discretionary authority to address 

disproportionate human health or 

environmental effects with practical, 

appropriate, and legally permissible 

methods under Executive Order 12898 

(59 FR 7629, February 16, 1994). 

In addition, this rule does not have 

tribal implications as specified by 

Executive Order 13175 (65 FR 67249, 

November 9, 2000), because the SIP is 

not approved to apply in Indian country 

located in the State, and EPA notes that 

it will not impose substantial direct 

costs on tribal governments or preempt 

tribal law. 

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 Clean 

Air Act, petitions for judicial review of 

this action must be filed in the United 

States Court of Appeals for the 

appropriate circuit by May 19, 2014. 

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. Parties with 

objections to this direct final rule are 

encouraged to file a comment in 

response to the parallel notice of 

proposed rulemaking for this action 

published in the Proposed Rules section 

of today’s Federal Register, rather than 

file an immediate petition for judicial 

review of this direct final rule, so that 

EPA can withdraw this direct final rule 

and address the comment in the 

proposed rulemaking. 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, 

Particulate matter, Reporting and 

recordkeeping requirements. 

Dated: March 5, 2014. 

Jared Blumenfeld, 

Regional Administrator, Region IX. 

Part 52, Chapter I, Title 40 of the Code 

of Federal Regulations is amended as 

follows: 

PART 52 [AMENDED] 

■ 1. The authority citation for Part 52 

continues to read as follows: 

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

Subpart D—Arizona 

■ 2. Section 52.120 is amended by 

adding paragraph (c)(159) to read as 

follows: 

§ 52.120 Identification of plan. 

* * * * * 

(c) * * * 

(159) The following plan was 

submitted on January 23, 2012 by the 

Governor’s Designee. 

(i) [Reserved] 

(ii) Additional Materials. 

(A) Arizona Department of 

Environmental Quality 

(1) Final Update of the Limited 

Maintenance Plan for the Payson PM10

Maintenance Area (December 2011), 

adopted by the Arizona Department of 

Environmental Quality on January 23, 

2012. 

[FR Doc. 2014–05669 Filed 3–18–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0796; FRL–9907–25] 

Ipconazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of ipconazole in 

or on vegetable, legume, group 6. 

Chemtura Corporation requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

March 19, 2014. Objections and requests 

for hearings must be received on or 

before May 19, 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–2012–0796, 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, 


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15236 Federal Register / Vol. 79, No. 53 / Wednesday, March 19, 2014 / Rules and Regulations 

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–2012–0796 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 19, 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– 

2012–0796, 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 

19, 2012 (77 FR 75082) (FRL–9372–6), 

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 2F8076) by 

Chemtura Corporation, 199 Benson Rd., 

Middlebury, CT 06749. The petition 

requested that 40 CFR 180.646 be 

amended by establishing tolerances for 

residues of the fungicide ipconazole (2- 

[(4-chlorophenyl)methyl]-5-(1- 

methylethyl)-1-(1H-1,2,4-triazol-1- 

ylmethyl)cyclopentanol) in or on 

legume vegetables, succulent or dried, 

crop group 6 at 0.01 parts per million 

(ppm). That document referenced a 

summary of the petition prepared by 

Chemtura Corporation, the registrant, 

which is available in the docket, 

http://www.regulations.gov. There were 

no comments received in response to 

the notice of filing. 

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 ipconazole 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with ipconazole 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. Ipconazole has 

low acute toxicity via the oral, dermal, 

and inhalation routes of exposure. It 

causes low to mild irritation to the eyes 

and skin; it is not a dermal sensitizer. 

Ipconazole may cause local, portal-ofentry irritation via all routes following 

repeated exposure. Systemic effects that 

were noted in dogs, mice, rabbits and/ 

or rats following exposure to ipconazole 

were generally limited to decreased 

body weight, body weight gain, and 

food consumption; and liver and kidney 

effects. Developmental effects were 

observed only at the maternally-toxic 

dose. No consistent evidence of 

neurotoxicity was observed following 

acute, subchronic, or chronic dosing in 

multiple species in the available 

ipconazole database and the triazole 

fungicides as a group typically show 

either no evidence of neurotoxicity or 

neurotoxicity at doses significantly 

higher than the regulatory points of 

departure. Ipconazole is classified as not 

likely to be a human carcinogen and 

there is no concern for mutagenicity. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by ipconazole 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 

‘‘Revised Ipconazole Human Health 

Risk Assessment of the Proposed Use on 


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Legume Vegetables (Crop Group 6)’’ on 

page 23 in docket ID number EPA–HQ– 

OPP–2012–0796. 

B. Toxicological Points of Departure 

(POD)/Levels of Concern (LOC) 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological POD and 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 (SF) 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 nonthreshold 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 ipconazole used for 

human risk assessment is shown in the 

following Table of this unit. 

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

ASSESSMENT

Exposure/scenario 

Point of departure 

and uncertainty/ 

safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Acute dietary (females 13–50 

years of age).

NOAEL = 10 mg/kg/ 

day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 0.1 mg/

kg/day 

aPAD = 0.1 mg/kg/

day 

Co-critical developmental toxicity studies in rats and rabbits. 

LOAELrats = 30 mg/kg/day, based on increased visceral and 

skeletal variations. 

LOAELrabbits = 50 mg/kg/day, based on increased incidence of 

skeletal variations and malformations. 

Acute dietary (general population including infants and 

children).

No appropriate endpoint attributable 

to a single dose of 

ipconazole was 

identified for this 

population. 

Chronic dietary (all populations) NOAEL= 1.5 mg/kg/

day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.015 

mg/kg/day 

cPAD = 0.015 mg/

kg/day 

Chronic toxicity study in dogs. 

LOAEL = 5 mg/kg/day, based on skin reddening (both sexes) 

and decreased body weight gain in females. 

Cancer (oral, dermal, inhalation).No evidence of carcinogenicity. Classification: Not likely to be a human carcinogen, based on two adequate rodent carcinogenicity studies. 

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). 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 ipconazole, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

ipconazole tolerances in 40 CFR 

180.646. EPA assessed dietary 

exposures from ipconazole 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 acute endpoint attributable to a 

single exposure and relevant for the 

general population was identified in the 

toxicity database for ipconazole. A 

developmental endpoint suitable for 

acute assessment was identified; 

therefore an acute dietary assessment 

was performed only for women of childbearing age (females 13–49 years old). In 

estimating acute dietary exposure, EPA 

used the Dietary Exposure Evaluation 

Model software with the Food 

Commodity Intake Database, Version 

3.16 (DEEM–FCID), which uses food 

consumption information from the U.S. 

Department of Agriculture (USDA) 

2003–2008 National Health and 

Nutrition Examination Surveys of What 

We Eat in America (NHANES/WWEIA). 

As to residue levels in food, EPA 

assumed tolerance level residues and 

100% crop treated. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 2003–2008 National 

Health and Nutrition Examination 

Surveys of What We Eat in America 

(NHANES/WWEIA). As to residue levels 

in food, EPA used tolerance level 

residues and assumed 100% crop 

treated. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that ipconazole is not a likely 

carcinogen. Therefore, a dietary 

exposure assessment for the purpose of 

assessing cancer risk is unnecessary. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for ipconazole. Tolerance level residues 

and/or 100% crop treated 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 ipconazole in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 


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transport characteristics of ipconazole. 

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 Pesticide 

Root Zone Model Ground Water (PRZM 

GW) models, the estimated drinking 

water concentrations (EDWCs) of 

ipconazole for acute exposures are 

estimated to be 0.173 parts per billion 

(ppb) for surface water and 1.01 ppb for 

ground water. 

The EDWCs of ipconazole for chronic 

exposures for non-cancer assessments 

are estimated to be 0.105 ppb for surface 

water and 0.822 ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 1.01 ppb was 

used to assess the contribution from 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 0.822 ppb was used to assess the 

contribution from 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). 

Ipconazole is not registered for any 

specific use patterns that would result 

in residential exposure. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

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

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

Ipconazole is a member of the 

conazole class of pesticides. Although 

conazoles act similarly in plants by 

inhibiting ergosterol biosynthesis, there 

is not necessarily a relationship between 

their pesticidal activity and their 

mechanism of toxicity in mammals. 

Structural similarities do not constitute 

a common mechanism of toxicity. 

Evidence is needed to establish that the 

chemicals operate by the same, or 

essentially the same, sequence of major 

biochemical events (EPA, 2002). In 

conazoles, however, a variable pattern 

of toxicological responses is found; 

some are hepatotoxic and 

hepatocarcinogenic in mice. Some 

induce thyroid tumors in rats. Some 

induce developmental, reproductive, 

and neurological effects in rodents. 

Furthermore, the conazoles produce a 

diverse range of biochemical events, 

including altered cholesterol levels, 

stress responses, and altered DNA 

methylation. It is not clearly understood 

whether these biochemical events are 

directly connected to their toxicological 

outcomes. Thus, there is currently no 

conclusive data to indicate that 

conazoles share common mechanisms of 

toxicity and EPA is not following a 

cumulative risk approach based on a 

common mechanism of toxicity for the 

conazoles. For information regarding 

EPA’s procedures for cumulating effects 

from substances found to have a 

common mechanism of toxicity, see 

EPA’s Web site at http://www.epa.gov/

pesticides/cumulative. 

Ipconazole is a triazole-derived 

pesticide. This class of compounds can 

form the common metabolite 1,2,4- 

triazole and three triazole conjugates 

(triazolylalanine, triazolylacetic acid, 

and triazolylpyrivic acid). To support 

existing tolerances and to establish new 

tolerances for triazole-derivative 

pesticides, including ipconazole, U.S. 

EPA conducted a human health risk 

assessment for exposure to 1,2,4- 

triazole, triazolylalanine, and 

triazolylacetic acid resulting from the 

use of all current and pending uses of 

any triazole-derived fungicide. The risk 

assessment is a highly conservative, 

screening-level evaluation in terms of 

hazards associated with common 

metabolites (e.g., use of a maximum 

combination of uncertainty factors) and 

potential dietary and non-dietary 

exposures (i.e., high end estimates of 

both dietary and non-dietary exposures). 

In addition, the Agency retained the 

additional 10x FQPA SF for the 

protection of infants and children. The 

assessment includes evaluations of risks 

for various subgroups, including those 

comprised of infants and children. The 

Agency’s complete risk assessment is 

found in the propiconazole 

reregistration docket at http://

www.regulations.gov, Docket 

Identification (ID) Number EPA–HQ– 

OPP–2005–0497. 

An updated dietary exposure and risk 

analysis for the common triazole 

metabolites 1,2,4-triazole (T), 

triazolylalanine (TA), triazolylacetic 

acid (TAA), and triazolylpyruvic acid 

(TP) was conducted completed in May 

2013, in association with a registration 

request for several other triazole 

fungicides. That analysis concluded that 

risk estimates were below the Agency’s 

level of concern for all population 

groups. After inclusion of ipconazole 

uses covered by this action, aggregate 

risk estimates for T, TA, TAA, and TP 

for all durations of exposure and for all 

population subgroups are below the 

Agency’s level of concern. This updated 

assessment may be found on http://

www.regulations.gov by searching for 

the following title and docket number: 

‘‘Common Triazole Metabolites: 

Updated Aggregate Human Health Risk 

Assessment to Address The New 

Section 3 Registrations For Use of 

Prothioconazole on Bushberry Crop 

Subgroup 13–07B, Low Growing Berry, 

Except Strawberry, Crop Subgroup 13– 

07H, and Cucurbit Vegetables Crop 

Group 9; Use of Flutriafol on Coffee; and 

Ipconazole on Crop Group 6’’ (located in 

docket ID number EPA–HQ–OPP–2012– 

0876). 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10x) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA SF. In applying this provision, 

EPA either retains the default value of 

10x, or uses a different additional safety 

factor when reliable data available to 

EPA support the choice of a different 

factor. 

2. Prenatal and postnatal sensitivity. 

Offspring effects only occurred in the 

presence of maternal toxicity and were 

not considered more severe than the 

parental effects. Therefore, EPA 

concluded that there is no quantitative 

or qualitative evidence of increased 

susceptibility to rat or rabbit fetuses 

exposed in utero and/or post-natally to 

ipconazole. 

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 ipconazole 

is complete. The Agency waived the 

requirement for an Immunotoxicity 

study for ipconazole as there is minimal 

evidence that ipconazole targets the 

immune system, nor are the conazoles 

of a chemical class expected to have an 

adverse effect on the immune system. 

An increase in leukocytes was observed 

in females at 78.3 mg/kg/day in the 28- 

day inhalation study, however this was 

not of concern because it was the only 

evidence of potential immunotoxicity in 


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Federal Register / Vol. 79, No. 53 / Wednesday, March 19, 2014 / Rules and Regulations 15239 

the entire ipconazole database, the effect 

occurred at a dose 10-fold higher than 

the dose (7.8 mg/kg/day) that caused 

portal-of-entry effects in the same study, 

and the effect occurred at a dose much 

greater than the PODs chosen for risk 

assessment. The overall weight of 

evidence suggests that ipconazole does 

not target the immune system. 

ii. There is no consistent evidence of 

neurotoxicity in the available databases. 

Clinical signs suggestive of 

neurotoxicity were observed in the in 

vivo mammalian cytogenetics study; 

however, they were seen at relatively 

high doses, which far exceed the 

anticipated dietary exposure, and no 

other signs were observed in any of the 

other studies, including studies with 

neurotoxicity assessments. Based on the 

lack of evidence in the database, EPA 

waived the requirement for the acute 

neurotoxicity study. Also, the 

subchronic neurotoxicity study 

requirement is considered to be satisfied 

by the neurotoxicity assessments 

performed in both the rat subchronic 

and chronic toxicity/carcinogenicity 

studies in which no signs of 

neurotoxicity were observed. This is 

consistent with what is known about the 

triazole fungicides as a class, which 

typically show either no evidence of 

neurotoxicity or neurotoxicity at doses 

significantly higher than the regulatory 

points of departure. Therefore, 

ipconazole is not considered to be 

neurotoxic and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that 

ipconazole results in increased 

susceptibility following in utero 

exposure for rats or rabbits in the 

prenatal developmental studies or in 

young rats in the 2-generation 

reproduction study, and there are no 

residual uncertainties with respect to 

pre- or postnatal exposure. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

EPA made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to ipconazole in drinking water. These 

assessments will not underestimate the 

exposure and risks posed by ipconazole. 

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 exposure 

estimates from acute dietary 

consumption of food and drinking 

water. Using the exposure assumptions 

discussed in this unit for acute 

exposure, the acute dietary exposure 

from food and water to ipconazole will 

occupy <1% of the aPAD for females 

13–49 years old, the population group 

receiving the greatest exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to ipconazole 

from food and water will utilize <1% of 

the cPAD for children 1–2 years old the 

population group receiving the greatest 

exposure. There are no residential uses 

for ipconazole. 

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). 

A short-term adverse effect was 

identified; however, ipconazole is not 

registered for any use patterns that 

would result in short-term residential 

exposure. Because there is no short-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 short-term risk), 

no further assessment of short-term risk 

is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating short-term risk for 

ipconazole. 

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, ipconazole is 

not registered for any use patterns that 

would result in intermediate-term 

residential 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 

ipconazole. 

5. Aggregate cancer risk for U.S. 

population. Ipconazole has been 

classified as not likely to be 

carcinogenic, and 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 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to ipconazole 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(liquid chromatography/mass 

spectrometry/mass spectrometry (LC/

MS/MS) (AC/3020)) is available to 

enforce the tolerance expression. The 

method may be requested from: Chief, 

Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: residuemethods@

epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has not established a MRL 

for ipconazole on vegetable, legume, 

group 6. 

C. Revisions to Petitioned-for Tolerances 

The petitioner requested a tolerance 

for residues of ipconazole in or on 

‘‘legume vegetables succulent or dried, 

crop group 6’’. EPA is correcting the 

commodity term and establishing a 

tolerance for ‘‘vegetable, legume, group 

6’’. 

V. Conclusion 

Therefore, tolerances are established 

for residues of ipconazole (2-[(4- 

chlorophenyl)methyl]-5-(1- 


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15240 Federal Register / Vol. 79, No. 53 / Wednesday, March 19, 2014 / Rules and Regulations 

methylethyl)-1-(1H-1,2,4-triazol-1- 

ylmethyl)cyclopentanol) in or on 

vegetable, legume, group 6 at 0.01 ppm. 

EPA is revising the tolerance expression 

for ipconazole to clarify that metabolites 

and degradates are covered by the 

tolerances and to specify how 

compliance with the tolerances is to be 

measured. The existing tolerances for 

pea and bean, dried shelled, except 

soybean, subgroup 6C at 0.01 ppm and 

soybean, seed at 0.01 ppm will be 

removed from paragraph (a) of § 180.646 

as these tolerances are encompassed 

within vegetable, legume, group 6. 

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 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 final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

Tribes. Thus, the Agency has 

determined that Executive Order 13132, 

entitled ‘‘Federalism’’ (64 FR 43255, 

August 10, 1999) and Executive Order 

13175, entitled ‘‘Consultation and 

Coordination with Indian Tribal 

Governments’’ (65 FR 67249, November 

9, 2000) do not apply to this final rule. 

In addition, this final rule does not 

impose any enforceable duty or contain 

any unfunded mandate as described 

under Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (2 U.S.C. 

1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

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

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

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

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: March 12, 2014. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.646: 

■ a. Revise the introductory text in 

paragraph (a). 

■ b. Remove ‘‘Pea and bean, dried 

shelled, except soybean, subgroup 6C’’, 

and ‘‘Soybean, seed’’ from the table in 

paragraph (a). 

■ c. Add alphabetically ‘‘Vegetable, 

legume, group 6’’ to the table in 

paragraph (a). 

The amendments read as follows: 

§ 180.646 Ipconazole; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of ipconazole, 

including its metabolites and 

degradates, in or on the commodities 

listed in the table below. Compliance 

with the tolerance levels specified 

below is to be determined by measuring 

only ipconazole (2-[(4- 

chlorophenyl)methyl]-5-(1- 

methylethyl)-1-(1H-1,2,4-triazol-1- 

ylmethyl)cyclopentanol) in or on the 

commodity. 

Commodity Parts per 

million 

* * * * * 

Vegetable, legume, group 6 0.01 

* * * * * 

[FR Doc. 2014–06059 Filed 3–18–14; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

45 CFR Part 156 

[CMS–9943–IFC] 

RIN 0938–AS28 

Patient Protection and Affordable Care 

Act; Third Party Payment of Qualified 

Health Plan Premiums 

AGENCY: Centers for Medicare and 

Medicaid Services, Department of 

Health and Human Services (HHS). 

ACTION: Interim final rule with comment 

period. 

SUMMARY: This interim final rule 

requires issuers of qualified health plans 

(QHPs), including stand-alone dental 

plans (SADPs), to accept premium and 

cost-sharing payments made on behalf 

of enrollees by the Ryan White HIV/

AIDS Program, other Federal and State 

government programs that provide 

premium and cost sharing support for 

specific individuals, and Indian tribes, 

tribal organizations, and urban Indian 

organizations. 

DATES: Effective Date: This interim final 

rule is effective on March 14, 2014. 

Comment date: To be assured 

consideration, comments must be 

received at one of the addresses 

provided below, no later than 5 p.m. on 

May 13, 2014. 

ADDRESSES: In commenting, please refer 

to file code CMS–9943–IFC. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. You may submit 


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