Federal Register / Vol. 79, No. 48 / Wednesday, March 12, 2014 / Rules and Regulations 13877 

III. EPA’s Final Action 

For the reasons discussed in our 

December 11, 2013 proposal see 78 FR 

75293), EPA is approving California’s 

attainment SIP for the Los Angeles 

County lead nonattainment area for the 

2008 lead NAAQS. This SIP submittal 

addresses CAA requirements and EPA 

regulations for expeditious attainment 

of the 2008 lead NAAQS for the Los 

Angeles County lead nonattainment 

area. 

For the reasons discussed in our 

proposed rulemaking, EPA is proposing 

to approve under CAA section 110(k)(3) 

the following elements of the South 

Coast lead attainment SIP: 

1. The SIP’s base year emissions 

inventory as meeting the requirements 

of CAA section 172(c)(3) and 40 CFR 

51.117(e)(1); 

2. the attainment demonstration, 

including air quality modeling, that 

demonstrates attainment as 

expeditiously as practicable, as meeting 

the requirements of CAA section 

172(c)(1); 

3. the RACM/RACT demonstration, as 

meeting the requirements of CAA 

section 172(c)(1); 

4. the RFP demonstration, as meeting 

the requirements of CAA section 

172(c)(2); 

5. and contingency measures, as 

meeting the requirements of the CAA 

section 172(c)(9). 

VI. Statutory and Executive Order 

Reviews 

Under the Clean Air Act, the 

Administrator is required to approve a 

SIP submission that complies with the 

provisions of the Act and applicable 

Federal regulations. 42 U.S.C. 7410(k); 

40 CFR 52.02(a). Thus, in reviewing SIP 

submissions, EPA’s role is to approve 

State choices, provided that they meet 

the criteria of the Clean Air Act. 

Accordingly, this action merely 

approves State law 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). 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Intergovernmental relations, 

Lead, Reporting and recordkeeping 

requirements. 

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

Dated: February 11, 2014. 

Jared Blumenfeld, 

Regional Administrator, EPA Region IX. 

Part 52, Chapter I, title 40 of the Code 

of Federal Regulations 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. 

Subpart F—California 

■ 2. Section 52.220 is amended by 

adding paragraph (c)(433) to read as 

follows: 

§ 52.220 Identification of plan. 

* * * * * 

(c) * * * 

(433) The following plan was 

submitted on June 20, 2012, by the 

Governor’s Designee. 

(i) [Reserved] 

(ii) Additional materials. 

(A) South Coast Air Quality 

Management District. 

(1) Final 2012 Lead State 

Implementation Plan—Los Angeles 

County (May 2012) (‘‘2012 Los Angeles 

County Lead SIP’’), adopted May 4, 

2012. 

(2) SCAQMD Board Resolution 12–11, 

dated May 4, 2012, adopting the 2012 

Los Angeles County Lead SIP. 

(B) State of California Air Resources 

Board. 

(1) CARB Resolution 12–20, dated 

May 24, 2012, adopting the 2012 Los 

Angeles County Lead SIP. 

[FR Doc. 2014–05227 Filed 3–11–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0161; FRL–9906–99] 

Fenamidone; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of fenamidone in 

or on ginseng; bean, succulent, except 

cowpea; onion, blub, subgroup 3–07A; 

and onion, green, subgroup 3–07B. This 

regulation additionally removes several 

individual tolerances that are 

superseded by inclusion in crop 

subgroup tolerances. Interregional 


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13878 Federal Register / Vol. 79, No. 48 / Wednesday, March 12, 2014 / Rules and Regulations 

Research Project Number 4 (IR–4) 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

March 12, 2014. Objections and requests 

for hearings must be received on or 

before May 12, 2014, and must be filed 

in accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2013–0161, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

a.m. to 4:30 p.m., Monday through 

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7090; email address: 

RDFRNotices@epa.gov . 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2013–0161 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 12, 2014. Addresses for mail 

and hand delivery of objections and 

hearing requests are provided in 40 CFR 

178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2013–0161, 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 June 5, 2013 

(78 FR 33785) (FRL–9386–2), 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 3E8150) by IR–4, 500 

College Road East, Suite 201 W., 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.579 be 

amended by establishing tolerances for 

residues of the fungicide fenamidone, 

4H-imidazol-4-one, 3,5-dihydro-5- 

methyl-2-(methylthio)-5-phenyl-3- 

(phenylamino)-,(S)-, in or on ginseng at 

0.80 parts per million (ppm); bean, 

succulent at 0.80 ppm; onion, bulb, 

subgroup 03–07A at 0.20 ppm; and 

onion, green, subgroup 03–07B at 1.5 

ppm. The petition additionally 

requested to remove the established 

tolerances in or on garlic at 0.20 ppm; 

garlic, great headed at 0.20 ppm; leek at 

1.5 ppm; onion, bulb at 0.20 ppm; 

onion, green at 1.5 ppm; onion, welsh 

at 1.5 ppm; shallot, bulb at 0.20 ppm; 

and shallot, fresh leaves at 1.5 ppm, as 

they will be superseded by the 

tolerances described in this unit. That 

document referenced a summary of the 

petition prepared on behalf of IR–4 by 

Bayer CropScience, the registrant, 

which is available in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

Based upon review of the data 

supporting the petition, EPA has 

determined that cowpea should not be 

included in the tolerance in or on bean, 

succulent. The reason for this change is 

explained in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

Consistent with FFDCA section 

408(b)(2)(D), and the factors specified in 

FFDCA section 408(b)(2)(D), EPA has 

reviewed the available scientific data 


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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 fenamidone 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with fenamidone 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. 

The target organs in subchronic 

toxicity studies for fenamidone were 

generally the liver; rarely, the thyroid or 

spleen were also affected. Target organs 

for chronic toxicity studies were the 

liver in the mouse and dog, and the liver 

and thyroid in the rat. In the chronic 

toxicity rat study, diffuse C-cell 

hyperplasia of the thyroid in both sexes 

was the most sensitive indicator of 

toxicity, and at higher doses follicular 

cells and the liver were also affected. 

The similarity in the systemic noobserved-adverse-effect-levels 

(NOAELs) and the type of toxicity 

observed (primarily liver) for the 

subchronic rat studies with the parent 

and plant metabolites (RPA 412636, 

RPA 412708, and RPA 410193) 

demonstrated that, on a subchronic 

basis, plant metabolites were not more 

toxic than the parent. 

In the acute neurotoxicity study in 

rats, clinical signs included staining of 

the anogenital region, mucous in the 

feces, hunched posture, and unsteady 

gait. In the subchronic neurotoxicity 

study in rats, marginal decreases in 

brain weights were observed only in 

high dose males. Additionally, 

decreased brain weight occurred in the 

rat reproduction study. In a 

developmental neurotoxicity study in 

Wistar rats, no neurobehavioral effects 

and no neuropathological changes were 

observed at any dose in the offspring, 

but decreased body weight was 

observed during pre- and post-weaning. 

In prenatal developmental toxicity 

studies in rabbits and rats, there were no 

developmental effects up to the highest 

dose tested (HDT). Maternal toxicity in 

these studies was observed as increased 

liver weights in maternal rabbits and 

decreased body weight gains and food 

consumption in maternal rats. In the 

reproduction study in rats, decreased 

absolute brain weight in F2 female pups 

occurred at the same dose levels as 

decreased absolute brain weight in F1 

parental females. There were no effects 

on fertility or other measured 

reproductive parameters conducted 

with fenamidone. 

An immunotoxicity study in rats 

showed a potential immunosuppression 

at the HDT; however, the existing risk 

assessment points of departure are 

lower and are therefore protective of 

this potential effect. No carcinogenic 

potential was observed in chronic 

studies in rat, mice, and dog; therefore, 

EPA has determined that fenamidone is 

not likely to be a human carcinogen by 

all relevant routes of exposure. All 

mutagenicity studies were negative for 

both the parent and plant metabolites, 

except the parent induced mutant 

colonies at the tk locus and increased 

chromosomal aberrations in human 

peripheral blood. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by fenamidone as well as 

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

toxicity studies can be found at http:// 

www.regulations.gov in document: 

‘‘Fenamidone: Human Health Risk 

Assessment to Support the Section (3) 

Registration and the Establishment of 

Tolerances for Uses on Ginseng, 

Succulent Beans (Except Cowpea), Bulb 

Onion (Subgroup 3–07A), and Green 

Onion (Subgroup 3–07B).’’ at pp. 30–34 

in docket ID number EPA–HQ–OPP– 

2013–0161. 

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 of concern 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 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 fenamidone used for 

human risk assessment is discussed in 

Unit III.B., Table 1 of the final rule 

published in the Federal Register of 

November 16, 2011 (76 FR 70890) (FRL– 

9325–4). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to fenamidone, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing fenamidone tolerances in 40 

CFR 180.579. EPA assessed dietary 

exposures from fenamidone 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. Such effects were identified 

for fenamidone. In estimating acute 

dietary exposure, EPA used Dietary 

Exposure Evaluation Model software 

with the Food Commodity Intake 

Database (DEEM–FCID) Version 3.16, 

which uses 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) from 

2003 through 2008. As to residue levels 

in food, EPA used maximum field trial 

residues for plant commodities and 

residues at the limit of quantitation for 

livestock commodities, assumed 100 

percent crop treated (PCT) estimates for 

all commodities, and incorporated 

DEEMTM default processing factors, 

when applicable. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, EPA used the same dietary 

risk assessment assumptions as for the 

acute dietary risk assessment. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that fenamidone does not 

pose a cancer risk to humans. Therefore, 

a dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

iv. Anticipated residue and PCT 

information. EPA did not use PCT 

information in the dietary assessment 

for fenamidone; 100 PCT were assumed 

for all food commodities. However, 

anticipated residues were used as 

maximum field trial residues for plant 


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13880 Federal Register / Vol. 79, No. 48 / Wednesday, March 12, 2014 / Rules and Regulations 

commodities and residues at the limit of 

quantitation for livestock commodities. 

Section 408(b)(2)(E) of FFDCA 

authorizes EPA to use available data and 

information on the anticipated residue 

levels of pesticide residues in food and 

the actual levels of pesticide residues 

that have been measured in food. If EPA 

relies on such information, EPA must 

require pursuant to FFDCA section 

408(f)(1) that data be provided 5 years 

after the tolerance is established, 

modified, or left in effect, demonstrating 

that the levels in food are not above the 

levels anticipated. For the present 

action, EPA will issue such data call-ins 

as are required by FFDCA section 

408(b)(2)(E) and authorized under 

FFDCA section 408(f)(1). Data will be 

required to be submitted no later than 

5 years from the date of issuance of 

these tolerances. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for fenamidone in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of fenamidone. 

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 PRZM 

Ground Water (PRZM GW), the 

estimated drinking water concentrations 

(EDWCs) of fenamidone for surface 

water are expected to be 41.7 parts per 

billion (ppb) for acute exposures and 

11.9 ppb for chronic exposures for noncancer assessments. For groundwater, 

the EDWC of 207 ppb is estimated for 

all acute and chronic exposures. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute and chronic dietary risk 

assessments, the water concentration 

value of 207 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). 

Fenamidone is not registered for any 

specific use patterns that would result 

in residential exposure. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

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

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ EPA has not 

found fenamidone to share a common 

mechanism of toxicity with any other 

substances, and fenamidone does not 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that 

fenamidone 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. 

The pre- and postnatal toxicity database 

for fenamidone includes rat and rabbit 

developmental toxicity studies, a rat 

developmental neurotoxicity study 

(DNT), and a 2-generation reproduction 

toxicity study in rats. No evidence of 

increased quantitative or qualitative 

susceptibility of rat or rabbit fetuses to 

in utero exposure was observed in the 

developmental toxicity studies. There 

was no developmental toxicity in rabbit 

fetuses up to 100 milligrams/kilograms/ 

day (mg/kg/day), the HDT; maternal 

toxicity was exhibited as an increase in 

absolute liver weight, observed at 30 

and 100 mg/kg/day. In the rat 

developmental study, decreased fetal 

body weight and incomplete fetal 

ossification were observed, but were 

considered secondary to maternal 

toxicity observed as decreased body 

weight and food consumption at the 

limit dose (1,000 mg/kg/day). No 

quantitative or qualitative evidence of 

increased susceptibility was observed in 

the 2-generation reproduction study in 

rats. In that study, both the parental and 

offspring LOAELs were based on 

decreased absolute brain weight in 

female F1 adults and female F2 

offspring at 89.2 mg/kg/day. Parental 

effects consisting of decreased body 

weight and food consumption and 

increased liver and spleen weights were 

noted at the same level as decreased 

pup body weight. There were no 

reproductive effects up to the HDT. 

The results of the DNT study 

indicated an increased susceptibility of 

offspring. There was no maternal 

toxicity at the HDT (429 mg/kg/day). 

Effects in the offspring included 

decreased body weight (9–11%) and 

body weight gain (8–20%) during preweaning, and decreased body weight (4– 

6%) during post-weaning at 429 mg/kg/ 

day (LOAEL). There were no 

neurobehavioral effects and no 

neuropathological changes at any dose 

in the offspring. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for 

fenamidone is complete. 

ii. The concern for the increased 

susceptibility observed in the DNT is 

low because: 

a. There were no neurobehavioral or 

neuropathological changes in the 

offspring at any dose; 

b. A clear NOAEL for the adverse 

effects in the study was identified; and 

c. The endpoints used for the various 

risk assessment scenarios are much 

more sensitive than that of the 

decreased bodyweight of the offspring. 

Therefore, based on the information 

above, the available data and the 

selection of risk assessment endpoints, 

EPA has determined that all endpoints 

used in the risk assessment for 

fenamidone are protective of neurotoxic 

effects. Accordingly, additional 

uncertainty factors (UFs) to account for 

neurotoxicity are not necessary. 

iii. There is no evidence that 

fenamidone 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, 

maximum field trial residues for plant 

commodities, and residues at the limit 

of quantitation for livestock 

commodities. EPA made conservative 


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Federal Register / Vol. 79, No. 48 / Wednesday, March 12, 2014 / Rules and Regulations 13881 

(protective) assumptions in the ground 

and surface water modeling used to 

assess exposure to fenamidone in 

drinking water. These assessments will 

not underestimate the exposures and 

risks posed by fenamidone. 

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. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

fenamidone will occupy 4.8% of the 

aPAD for children 1–2 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 fenamidone 

from food and water will utilize 89% of 

the cPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. There are no residential uses 

for fenamidone. 

3. Short- and intermediate-term risk. 

Short- and intermediate-term aggregate 

exposures take into account short- and 

intermediate-term residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). Short- and 

intermediate-term adverse effects were 

identified; however, fenamidone is not 

registered for any use patterns that 

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

intermediate-term risk is assessed based 

on short- or intermediate-term 

residential exposure plus chronic 

dietary exposure. Because there are no 

short- or intermediate-term residential 

exposures and chronic dietary exposure 

has already been assessed under the 

appropriately protective cPAD (which is 

at least as protective as the POD used to 

assess short-term risk), no further 

assessment of short- or intermediateterm risks are necessary, and EPA relies 

on the chronic dietary risk assessment 

for evaluating short- and intermediateterm risks for fenamidone. 

4. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

fenamidone is not expected to pose a 

cancer risk to humans. 

5. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population or to infants and children 

from aggregate exposure to fenamidone 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology, 

a liquid chromatography with tandem 

mass spectrometry detection (LC/MS/

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 a MRL 

for fenamidone. 

C. Revisions to Petitioned-For 

Tolerances 

Based on the data supporting the 

petition, EPA has determined that 

cowpea should not be included in the 

bean, succulent tolerance at 0.80 ppm, 

as was proposed. The bean, succulent 

definition includes cowpea, and cowpea 

has forage and hay associated uses that 

are considered significant livestock 

feedstuffs. Because of the significant 

livestock feedstuffs for cowpea, the 

Agency requires a feeding study in order 

to determine the dietary burden 

associated with cowpea. Because an 

appropriate feeding study has not been 

submitted for fenamidone, cowpea has 

been excluded from the tolerance in or 

on bean, succulent. 

V. Conclusion 

Therefore, tolerances are established 

for residues of fenamidone, 4HImidazol-4-one, 3,5-dihydro-5- 

methyl-2-(methylthio)-5-phenyl-3 

(phenylamino)-,(S)-, in or on bean, 

succulent, except cowpea at 0.80 ppm; 

ginseng at 0.80 ppm; onion, bulb, 

subgroup 3–07A at 0.20 ppm; and 

onion, green, subgroup 3–07B at 1.5 

ppm. This regulation additionally 

removes established tolerances at 0.20 

ppm in or on garlic; garlic, great headed; 

onion, bulb; and shallot, bulb. Finally, 

this regulation removes established 

tolerances at 1.5 ppm in or on leek; 

onion, green; onion, welsh; and shallot, 

fresh leaves. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

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

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 


tkelley on DSK3SPTVN1PROD with RULES
13882 Federal Register / Vol. 79, No. 48 / Wednesday, March 12, 2014 / Rules and Regulations 

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: February 28, 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 § 180.579: 

■ a. Remove the commodities ‘‘Garlic’’; 

‘‘Garlic, great headed’’; ‘‘Leek’’; ‘‘Onion, 

bulb’’; ‘‘Onion, green’’; ‘‘Onion, welsh’’; 

‘‘Shallot, bulb’’; and ‘‘Shallot, fresh 

leaves’’ from the table in paragraph 

(a)(1). 

■ b. Add alphabetically the following 

commodities to the table in paragraph 

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

§ 180.579 Fenamidone; tolerances for 

residues. 

(a) * * * 

(1) * * * 

Commodity Parts per 

million 

Bean, succulent, except 

cowpea ................................ 0 .80 

* * * * * 

Ginseng .................................. 0 .80 

* * * * * 

Onion, bulb, subgroup 3–07A 0 .20 

Onion, green, subgroup 3– 

07B ...................................... 1 .5 

* * * * * 

* * * * * 

[FR Doc. 2014–05399 Filed 3–11–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 300 

[EPA–HQ–SFUND–1983–0002; FRL 9907– 

66-Region 1] 

National Oil and Hazardous 

Substances Pollution Contingency 

Plan; National Priorities List: Deletion 

of the O’Connor Superfund Site 

AGENCY: Environmental Protection 

Agency. 

ACTION: Direct final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) Region 1 is publishing a 

direct final Notice of Deletion of the 

O’Connor Superfund Site (Site), located 

in Augusta, Maine, from the National 

Priorities List (NPL). The NPL, 

promulgated pursuant to section 105 of 

the Comprehensive Environmental 

Response, Compensation, and Liability 

Act (CERCLA) of 1980, as amended, is 

an appendix of the National Oil and 

Hazardous Substances Pollution 

Contingency Plan (NCP). This direct 

final deletion is being published by EPA 

with the concurrence of the State of 

Maine, through the Maine Department 

of Environmental Protection, because 

EPA has determined that all appropriate 

response actions under CERCLA, other 

than operation, maintenance, and fiveyear reviews, have been completed. 

However, this deletion does not 

preclude future actions under 

Superfund. 

DATES: This direct final deletion is 

effective May 12, 2014 unless EPA 

receives adverse comments by April 11, 

2014. If adverse comments are received, 

EPA will publish a timely withdrawal of 

the direct final deletion in the Federal 

Register informing the public that the 

deletion will not take effect. 

ADDRESSES: Submit your comments, 

identified by Docket ID no. EPA–HQ– 

SFUND–1983–0002, by one of the 

following methods: 

• http://www.regulations.gov. Follow 

on-line instructions for submitting 

comments. 

• Email: connelly.terry@epa.gov. 

• Fax: 617 918–0373. 

• Mail: Terrence Connelly, US EPA 

Region 1, 5 Post Office Square, Suite 

100, Boston, MA 02109—3919. 

• Hand delivery: US EPA Region 1, 5 

Post Office Square, Suite 100, Boston, 

MA 02109–3912. Such deliveries are 

only accepted during the Docket’s 

normal hours of operation, and special 

arrangements should be made for 

deliveries of boxed information. 

Instructions: Direct your comments to 

Docket ID no. EPA–HQ–SFUND–1983– 

0002. EPA’s policy is that all comments 

received will be included in the public 

docket without change and may be 

made available online at http://

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through http://

www.regulations.gov or email. The 

http://www.regulations.gov Web site is 

an ‘‘anonymous access’’ system, which 

means EPA will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an email comment directly 

to EPA without going through http://

www.regulations.gov, your email 

address will be automatically captured 

and included as part of the comment 

that is placed in the public docket and 

made available on the Internet. If you 

submit an electronic comment, EPA 

recommends that you include your 

name and other contact information in 

the body of your comment and with any 

disk or CD–ROM you submit. If EPA 

cannot read your comment due to 

technical difficulties and cannot contact 

you for clarification, EPA may not be 


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