Federal Register / Vol. 79, No. 28 / Tuesday, February 11, 2014 / Rules and Regulations 8091 

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, 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, 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 April 14, 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. 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, Intergovernmental 

relations, Incorporation by reference, 

Particulate matter, Reporting and 

recordkeeping requirements. 

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

Dated: January 27, 2014. 

Shaun L. McGrath, 

Regional Administrator, Region 8. 

40 CFR part 52 is amended to read 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 G—Colorado 

■ 2. Section 52.332 is amended by 

adding paragraph (s) to read as follows: 

§ 52.332 Control strategy: Particulate 

Matter. 

* * * * * 

(s) Revisions to the Colorado State 

Implementation Plan, PM10 Revised 

Maintenance Plan for Telluride, as 

adopted by the Colorado Air Quality 

Control Commission on November 19, 

2009, State effective on December 30, 

2009, and submitted by the Governor’s 

designee on March 31, 2010. The 

revised maintenance plan satisfies all 

applicable requirements of the Clean Air 

Act. 

[FR Doc. 2014–02841 Filed 2–10–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0454; FRL–9904–31] 

Fenpropidin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of fenpropidin in 

or on banana. Syngenta, Crop 

Protection, LLC requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

February 11, 2014. Objections and 

requests for hearings must be received 

on or before April 14, 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–2012–0454, 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 


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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–2012–0454 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 April 14, 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– 

2012–0454, 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.htm. 

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 2E7980) by 

Syngenta, LLC, P.O. Box 18300, 

Greensboro, NC 27419–8300. The 

petition requested that EPA establish 

import tolerances for residues of the 

fungicide fenpropidin, in or on banana, 

unbagged fruit at 9.0 parts per million 

(ppm) and banana, pulp from unbagged 

fruit at 0.40 ppm. That document 

referenced a summary of the petition 

prepared by Syngenta Crop Protection, 

LLC, the registrant, which is available in 

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

One comment was received in response 

to the notice of filing. 

Based upon review of the data 

supporting the petition, tolerances for 

banana, unbagged fruit have been 

revised from 9.0 to 10 ppm. The reason 

for this change is explained in Unit 

IV.D. 

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 fenpropidin 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with fenpropidin 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 nervous system, eye, stomach, 

esophagus, and skin are the major target 

organs for fenpropidin. The principal 

toxic effects in laboratory animals 

following oral exposure to fenpropidin 

are irritant effects on the esophagus, 

stomach, and skin, with peripheral parts 

of the body (tail and ears) affected as 

well. The skin lesions in the mouse 

following oral exposure include dry 

and/or flaky skin on tail, paws, and ears, 

loss of tail tip; hyperkeratosis of tail, 

ear, esophagus, subcutis, stomach, 

dermatitis of ear and tail, and 

hyperplasia of the nose. Skin lesions in 

the rat following chronic oral exposure 

include dry and flaky skin around 

mouth, tail tip missing, pustules on tail, 

and damaged or shortened tails. The 

skin lesions in the dog following oral 

exposure via capsules included 

indurated and inelastic pads; scale 

formation on external ear; reddening of 

skin of thoracic, inguinal, and axillary 

regions; hardened foot pads; 

microscopic findings of acanthosis of 

the epidermis and ear; hyperkeratosis of 

footpad and ear; and skin inflammation 

following chronic oral exposure. An 

acute lethality study shows that 

fenpropidin is not acutely toxic by the 

oral route of exposure. 

Clinical signs of neurotoxicity and 

neuropathology are the other major 

toxic effects observed following oral 

exposure in the rat and dog, and the dog 

is the most sensitive species for the 

neurotoxic effects. In the rat 90-day 

neurotoxicity study, hindpaw grip 

strength was decreased in both sexes 

and forepaw grip strength was 

decreased in males during the 

functional observational battery (FOB) 

evaluations. Bilateral hindlimb 

paralysis/paresis, which correlated with 

the histopathological finding of 

demyelination of the spinal cord, 

cranial and spinal nerve roots, and 

proximal peripheral nerve, was 


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observed in one female rat at the highest 

dose tested. In dogs, paresis was 

observed in one male dog that was 

sacrificed on week 38, and 

demyelination of the spinal cord was 

observed in three of four male dogs at 

the high dose. 

In the chronic toxicity/carcinogenicity 

study in rats, benign pancreatic cell 

adenomas were seen in high-dose male 

rats. Tumors were not increased in the 

mouse carcinogenicity study in either 

sex or in the female rat. Mutagenicity is 

not of concern. Although the rat study 

showed that fenpropidin was associated 

with benign pancreatic islet cell 

adenomas in the male, the Agency 

determined that quantification of risk 

using a non-linear approach; i.e., the 

chronic reference dose (RfD), for 

fenpropidin will adequately account for 

all chronic toxicity, including 

carcinogenicity, that could result from 

exposure to fenpropidin. The 

conclusion is based on the following 

considerations: (i) The tumors found 

were benign; (ii) the tumors are common 

age-related tumors; (iii) the tumors 

occurred in only one sex in one species; 

(iv) fenpropidin is not mutagenic; and 

(v) no carcinogenic response was seen 

in either sex in the mouse. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by fenpropidin 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 

‘‘Fenpropidin: Human Health Risk 

Assessment to Support the Proposed 

Tolerance for Imported Bananas’’ at 

page 10 in docket ID number EPA–HQ– 

OPP–2012–0454. 

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 fenpropidin used for 

human risk assessment is shown in the 

following table. 

SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FENPROPIDIN 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 13–49 years of 

age).

NOAEL = 10 mg/kg/

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 0.10 mg/

kg/day.

aPAD = 0.10 mg/kg/

day.

Developmental toxicity study (rabbit). 

LOAEL = 20 mg/kg/day based on [on increased fetal (litter) incidence of malformations (persistent truncus arteriosus, severely 

malaligned sternebrae) and decreased male 

fetal body weight in the absence of maternal 

effects. (does dosed on GD 7–28). 

Acute dietary (Infants and children) ............ NOAEL = 7 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 0.07 mg/

kg/day.

aPAD = 0.07 mg/kg/

day.

Developmental neurotoxicity study (rat). 

LOAEL = 27 mg/kg/day based on [decreased 

brain weight, decreased radial thickness of 

the cortex at level 3, and decreased vertical 

height of the dentate hilus at level 3 in females on PND 72. 

Chronic dietary (All populations) ................. NOAEL= 2.3 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.023 

mg/kg/day.

cPAD = 0.023 mg/kg/

day.

Rat chronic/carcinogenicity. 

LOAEL = 11.8 mg/kg/day based on [decreased 

body weight and body weight gains in females, clinical signs in males and females 

(pustules on tail, missing tail tip, and dry, 

flaky skin around mouth), and microscopic 

liver lesions (centrilobular fat) in females. 

Cancer (Oral, dermal, inhalation) ............... Quantification of risk using a non-linear approach; i.e., RfD, for fenpropidin will adequately account 

for all chronic toxicity, including carcinogenicity, that could result from exposure to fenpropidin. 

Point of Departure (POD) = A data point or an estimated point derived from observed dose-response data and used to mark the beginning of 

extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no observed adverse effect level. 

LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = extrapolation from animals to humans (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor. cPAD = chronic population adjusted dose. RfD = reference dose. N/A = not applicable. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to fenpropidin, EPA assessed 

dietary exposures from fenpropidin 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 


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exposure. Such effects were identified 

for fenpropidin. In estimating acute 

dietary exposure, EPA used food 

consumption information from the 

United States Department of 

Agriculture’s (USDA) National Health 

and Nutrition Examination Survey, 

What We Eat In America (NHANES/

WWEIA) conducted from 2003–2008. As 

to residue levels in food, EPA made the 

following assumptions for the acute 

exposure assessment: Residues will be 

present in bananas at the highest field 

trial value from banana pulp (the edible 

portion of the fruit), 100 percent crop 

treated (PCT), and Dietary Exposure 

Evaluation Model software with the 

Food Commodity Intake Database 

(DEEM–FCID) Version 3.16. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA’s NHANES/WWEIA 

conducted from 2003–2008 as well. As 

to residue levels in food, EPA made the 

following assumptions for the chronic 

exposure assessment: Residues will be 

present in bananas at the average field 

trial values from banana pulp, 100 PCT, 

and DEEM–FCID Version 3.16. 

iii. Cancer. Based on the data 

summarized in Unit III.A., the Agency 

has concluded that a nonlinear RfD 

approach is appropriate for assessing 

cancer risk to fenpropidin. Cancer risk 

was assessed using the same exposure 

estimates as discussed in Unit III.C.1.ii. 

iv. Anticipated residue and PCT 

information. EPA used anticipated 

residues in the dietary assessment for 

fenpropidin. One hundred PCT and 

field trial residues were assumed for all 

food 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 proposed tolerance in or on 

imported banana will not impact 

residues in the U.S. drinking water. 

Therefore, a drinking water assessment 

was not needed. 

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). 

Fenpropidin 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 fenpropidin to 

share a common mechanism of toxicity 

with any other substances, and 

fenpropidin does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that fenpropidin 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. 

The potential impact of in utero 

fenpropidin exposure was investigated 

in two developmental toxicity studies 

(one in the rat and one in the rabbit), a 

rat developmental neurotoxicity study 

(DNT) and a two multi-generation 

reproduction toxicity study in rats. In 

the rat developmental toxicity study, a 

quantitative susceptibility was 

observed; asymmetrically shaped 

sternebrae #5 occurred at the high dose 

in the absence of maternal toxicity. In 

the rabbit developmental study, a 

quantitative susceptibility was noted 

with an increase in fetal (litter) 

incidence of malformations (persistent 

truncus arteriosus and severely 

malaligned sternebrae) in the absence of 

maternal toxicity. A qualitative 

susceptibility was noted in the rat 

developmental neurotoxicity study 

(DNT). In that study, the pup effects 

were: Increased number of dead pups/ 

cannibalized pups; decreased brain 

weight; decreased radial thickness of the 

cortex (level 3); decreased male pup 

body weight during the preweaning 

period; and decreased vertical height of 

the dentate hilus (level 3) in PND 72 

females. At the same dose in the 

maternal animals, the only adverse 

effect observed was skin irritation 

(scabbing and hair loss around the 

mouth and forelimbs). Qualitative 

susceptibility in the 2-generation 

reproduction study was based on the 

decrease in pup body weights and 

delayed onset of sexual maturation 

observed at the same dose that resulted 

in decreased maternal body weight and 

increased incidence/severity of cortical 

fatty changes in adrenals. The apparent 

enhanced sensitivity may be due to the 

limited number of evaluations 

conducted in dams in these studies 

rather than a true sensitivity of the 

young. Clear NOAELs were established 

for the endpoints of concern, and these 

are the basis for the acute dietary 

endpoints for females 13+ and for 

infants and children. 

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 

fenpropidin is complete. 

ii. The level of concern for 

neurotoxicity is low because there is a 

developmental neurotoxicity study in 

rats, the effects are well characterized, 

the dose-response curve for these effects 

are well characterized, and clear 

NOAELs have been identified. 

iii. Though there is evidence of 

quantitative susceptibility in the rat and 

rabbit developmental toxicity studies 

and qualitative susceptibility in the 2- 

generation reproduction study in rats 

and the DNT in rats, the endpoints and 

doses selected for risk assessment are 

protective for these effects. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on conservative 


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high-end assumptions in the dietary 

exposure assessment, including the use 

of 100 PCT assumptions and field trial 

residues. This is an import tolerance; 

therefore, there is no drinking water, no 

residential, and no occupational 

exposure. 

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. Partially refined acute dietary 

exposure assessments were performed 

using individual points of departure 

(PODs) for the two population 

subgroups all infants and children, and 

females 13–49 years old. Using the 

exposure assumptions discussed in this 

unit for acute exposure, the acute 

dietary exposure to fenpropidin from 

food will occupy 3% of the aPAD for 

infants <1 year old and <1% of the 

aPAD for females 13–49 years old, for 

the populations at the 95th percentile of 

exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to fenpropidin 

from food 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 fenpropidin. 

3. Short- and Intermediate-term risk. 

Short- and intermediate-term aggregate 

exposure takes into account short- and 

intermediate-term residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). Since the petitioner is 

proposing a tolerance in/on imported 

banana and since fenpropidin is not 

registered for any use patterns that 

would result in short-term and 

intermediate-term residential exposure, 

selection of incidental oral, dermal, and 

inhalation point of departures for 

assessment of residential exposure is 

not required. 

4. Aggregate cancer risk for U.S. 

population. In the chronic toxicity/

carcinogenicity study in rats, benign 

pancreatic cell adenomas were seen in 

high-dose male rats. Tumors were not 

increased in the mouse carcinogenicity 

study in either sex or in the female rat. 

Mutagenicity is not of concern. 

Although the rat study showed that 

fenpropidin was associated with benign 

pancreatic islet cell adenomas in the 

male, the Agency determined that 

quantification of risk using a non-linear 

approach; i.e., the chronic reference 

dose (RfD), for fenpropidin will 

adequately account for all chronic 

toxicity, including carcinogenicity, that 

could result from exposure to 

fenpropidin. The conclusion is based on 

the following considerations: (i) The 

tumors found were benign; (ii) the 

tumors are common age-related tumors; 

(iii) the tumors occurred in only one sex 

in one species; (iv) fenpropidin is not 

mutagenic; and (v) no carcinogenic 

response was seen in either sex in the 

mouse. 

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 fenpropidin 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(independent laboratory validation trial 

(ILV) and liquid chromatography with 

mass spectrometric (LC–MS/MS) 

detection method (Method No. REM 

164.09)) are available to enforce the 

tolerance expression. The method may 

be requested from: Chief, Analytical 

Chemistry Branch, Environmental 

Science Center, 701 Mapes Rd., Ft. 

Meade, MD 20755–5350; telephone 

number: (410) 305–2905; email address: 

residuemethods@epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has not established MRLs 

for fenpropidin. 

C. Response to Comments 

One comment was received from an 

anonymous commenter objecting to 

increasing the tolerances. The comment 

contained no scientific data or evidence 

to rebut the Agency’s conclusions that 

no harm will result to infants and 

children from aggregate exposure to 

fenpropidin residues. 

D. Revisions to Petitioned-for 

Tolerances 

Based on the analysis of the residue 

field trial data and Organization for 

Economic Cooperation and 

Development (OECD) tolerance 

calculator procedure, a banana tolerance 

of 10 ppm for residues of fenpropidin is 

appropriate. The Agency excluded 

residue values from one of the field 

trials. The study author reported that 

samples from that field trial may have 

been mislabeled as residues were higher 

in the control samples; therefore, results 

from this test were not used in the 

tolerance calculations. A tolerance for 

banana pulp is not required; tolerances 

are to be established on the whole 

banana fruit. 

V. Conclusion 

Therefore, tolerances are established 

for residues of fenpropidin, (1-[3-[4-(1,1- 

dimethylethyl)phenyl]-2- 

methylpropyl]piperidine), including its 

metabolites and degradates, in or on 

banana at 10 ppm. 

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 


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8096 Federal Register / Vol. 79, No. 28 / Tuesday, February 11, 2014 / Rules and Regulations 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

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

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

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

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (2 U.S.C. 1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

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

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: January 31, 2014. 

Steven P. Bradbury, 

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. Add § 180.676 to subpart C, to read 

as follows: 

§ 180.676 Fenpropidin; tolerances for 

residues. 

(a) General. Tolerances are 

established for the residues of 

fenpropidin, including its metabolites 

and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only fenpropidin (1-[3-[4- 

(1,1-dimethylethyl)phenyl]-2- 

methylpropyl]piperidine). 

Commodity Parts per 

million 

Banana 1 ............................... 10 

1There are no U.S. registrations as of December 13, 2013. 

(b) Section 18 tolerance. [Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 2014–02936 Filed 2–10–14; 8:45 am] 

BILLING CODE 6560–50–P 


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