26158 Federal Register / Vol. 79, No. 88 / Wednesday, May 7, 2014 / Rules and Regulations 

EPA explain the reasons for departing 

from the Codex level. 

There are no Codex, Canadian or 

Mexican MRLs for tebuconazole in/or 

on orange, oil and orange, juice. 

C. Revisions to Petitioned-For 

Tolerances 

Based on the analysis of orange 

processing data, EPA lowered the 

tolerance level for orange, oil to 10 ppm. 

Tolerances for orange, juice were 

unnecessary since the raw agricultural 

commodity tolerance of 1ppm covers 

the proposed juice tolerance. 

V. Conclusion 

Therefore, tolerances are established 

for residues of tebuconazole, in or on 

orange, oil at 10 ppm and orange, juice 

at 1.0 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 

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: April 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 § 180.474, in the table in 

paragraph (a)(1), add alphabetically 

entries for ‘‘Orange 1’’ and ‘‘Orange, 

oil 1’’ and revise footnote 1 to read as 

follows: 

§ 180.474 Tebuconazole; tolerances for 

residues. 

(a) * * * 

(1) * * * 

Commodity Parts per 

million 

* * * * * 

Orange 1 .................................... 1.0 

Orange, oil 1 .............................. 10 

* * * * * 

1There are no U.S. registrations. 

* * * * * 

[FR Doc. 2014–10216 Filed 5–6–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0588; FRL–9909–72] 

Fenoxaprop-ethyl; Pesticide 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of fenoxapropethyl (FE), in or on grass hay. 

Interregional Research Project Number 4 

(IR–4) requested this tolerance under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: This regulation is effective May 

7, 2014. Objections and requests for 

hearings must be received on or before 

July 7, 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–2012–0588, 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. 


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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–2012–0588 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 July 7, 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– 

2012–0588, 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 September 

28, 2012 (77 FR 59578) (FRL–9364–6), 

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 2E8051) by IR–4, 

500 College Road East, Suite 201W., 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.430 be 

amended by establishing tolerances for 

residues of the herbicide fenoxapropethyl, [(±)-ethyl 2-[4- [(6-chloro-2- 

benzoxazolyl)oxy]phenoxy]propanoate] 

and its metabolites 2-[4-[(6:-chloro-2- 

benzoxazolyl) oxy]phenoxy] propanoic 

acid and 6-chloro-2,3- 

dihydrobenzoxazol-2-one, each 

expressed as the parent compound, in or 

on grass, hay at 0.15 part per million 

(ppm). Based on the regional residue 

data submitted from Washington and 

Oregon, and the petitioner’s intent for 

this to be a regional pesticide tolerance, 

the tolerance is being established as a 

‘‘Tolerance with regional registration’’ 

with use restricted to Oregon, 

Washington, and Utah. That document 

referenced a summary of the petition 

prepared by Bayer CropScience, the 

registrant, which is available in the 

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

Comments were received on the 

notice of filing. EPA response to those 

comments is discussed in Unit IV.C. 

Based upon review of the data 

supporting the petition, EPA has 

modified the level at which the 

tolerance is being established. 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 fenoxaprop-pethyl (FPE) including exposure resulting 

from the tolerances established by this 

action. EPA’s assessment of exposures 

and risks associated with FPE 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. 

FPE is an enriched isomer 

formulation (95% d and 5% l 

enantiomers) based on the previously 

registered product FE which is a 50:50 

racemic mixture of d and l enantiomers. 

FE is no longer a registered active 

ingredient. The toxicology database for 

FPE is complete based on studies 

submitted for both FPE and FE. Based 

on the analysis of the submitted studies, 

EPA found that the toxicological effects 

of FE and FPE across species, duration, 

and route of exposure are similar. Most 


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of the toxicological data available 

involved testing of the FE, not FPE. 

However, EPA has concluded that the 

similarity between the FE and FPE data 

is such that the database for FE could be 

bridged with FPE. 

The major target organs following 

short-term and long-term oral 

administration of FE and FPE in rats 

and mice are the liver and kidneys, with 

rats being the most sensitive species. 

The primary toxic effect is altered lipid 

metabolism characterized by decreased 

lipids and cholesterol, and increased 

liver weights in rats, and slightly 

increased lipids, cholesterol, proteins, 

and liver weights in mice. Additionally, 

increased enzyme activity (aspartate 

amino transferase (ASAT), alanine 

amino transferase (ALAT), and alkaline 

phosphatase (ALP)), hypertrophy, and 

single cell necrosis were observed in 

mice. In the kidneys, increases in 

ketones and kidney weights were 

observed in rats and evidence of 

proximal renal tubular injury were 

observed in mice following 90-day 

administration of FPE. However, no 

effects on the kidneys were observed 

following chronic administration of FE 

to rats, mice, or dogs. In both species, 

males were slightly more sensitive to 

the liver effects of FE and FPE. It is also 

important to note that no increases in 

toxicity are observed over time for FE 

when comparing the 28-day and 90-day 

subchronic studies, the 2-generation 

reproductive toxicity study, and the 2- 

year chronic toxicity/carcinogenicity 

study in rats, or in FPE when comparing 

the 28-day and 90-day subchronic 

toxicity studies in rats. 

FPE has low acute toxicity following 

the oral, dermal, and inhalation routes 

of exposure. No evidence of 

immunotoxicity, reproductive or 

neurological toxicity was identified in 

the database. Developmental toxicity 

occurred in rats as evidenced by skeletal 

anomalies (longitudinally displaced, 

fragmented, fused, dysplastic sternebrae 

or dislocated sternebrae) and skeletal 

retardations (weak or non-ossification of 

one or several cranial bones). 

Developmental effects only occurred in 

the rat in the presence of maternal 

toxicity (decreased body weight, body 

weight gain, and heart weight). No 

developmental effects were identified in 

rabbits. In mice, a treatment-related 

increase in tumor incidence of 

hepatocellular adenomas and 

carcinomas, mainly adenomas, was 

observed in males at 320 ppm (30%) 

compared to the control (2%). In 

addition, microscopic pathology 

indicated that hepatocellular 

hypertrophy was observed in the 

majority of treated animals (both sexes). 

There was, however, no evidence of a 

mutagenic effect in a comprehensive 

battery of genetic toxicology assays with 

both isomers. No evidence of tumors 

was identified in rats. 

The only tumor response induced by 

FE/FPE occurred in the liver of male 

mice; no liver tumors were seen in the 

female mice or in the guideline chronic/ 

carcinogenicity study in male and 

female rats. The tumors were benign 

with no progression to malignancy. 

Mutagenicity has been ruled out as a 

mode of action (MOA) for this response. 

The presence of a single non-mutagenic 

tumor type in one sex and species— 

here, benign liver tumors in the male 

mouse, a common tumor in mice— 

provides no more than a weak 

suggestion of possible carcinogenic 

effects and thus does not support a 

linear assessment of risk based on the 

tumor incidence. Given the doses at 

which the benign mouse tumors were 

seen, EPA concludes that the chronic 

reference dose (cRfD) for FPE will 

adequately protect for all chronic 

toxicity, including carcinogenicity, that 

could result from exposure to FE/FPE. 

The Agency has waived the 

requirements for acute and subchronic 

neurotoxicity studies based on the 

following rationale: 

1. The lack of neurotoxicity in the 

available toxicology database for FE and 

FPE. 

2. The target organs of FPE and FE are 

the kidney and liver, and the 

mechanism of action for FPE and the 

chemical class do not target the nervous 

system. 

3. Developmental effects and 

decreased total blood lipids/cholesterol 

are the most sensitive effects seen in the 

FE database and provide the most 

sensitive POD for risk assessment. 

4. There is low concern for 

neurotoxicity in other members of this 

class of chemicals (i.e., the arloxy 

phenoxy-propionate class). 

Specific information on the studies 

received and the nature of the adverse 

effects caused by FPE as well as the noobserved-adverse-effect-level (NOAEL) 

and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies 

can be found at http://

www.regulations.gov in the document 

titled ‘‘Fenoxaprop-p-ethyl. Registration 

Review Preliminary Risk Assessment 

and Proposed New Use on Grass Grown 

for Seed’’ on pages 52–57 in docket ID 

number EPA–HQ–OPP–2012–0588. 

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 (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 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 FPE used for human risk 

assessment is shown in Table 1 of this 

unit. 


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

ASSESSMENT

Exposure/scenario 

POD and 

uncertainty/safety 

factors 

RfD, PAD, LOC for 

risk 

assessment 

Study and toxicological effects 

Acute dietary (general population including infants and 

children and females 13–50 

years of age).

No appropriate endpoint attributable to a single dose was identified. An acute RfD was not established. 

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/carcinogenicity (rat) 2-generation reproductive 

toxicity (rat). 

LOAEL = 9 mg/kg/day, based on decreased serum lipids and 

cholesterol, and altered liver weights. 

Incidental oral short-term ..........

(1 to 30 days) ............................

NOAEL = 6 mg/kg/

day.

UFA = 10x ................

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

FQPA SF = 1x .........

LOC for MOE = 100 28-day oral toxicity (rat). 

LOAEL = 26 mg/kg/day, based on altered lipid metabolism (decreased HDL-cholesterol, HDL-phospholipids, and total lipids, 

increased triglycerides, and ketonuria) and increased liver 

and kidney weights. 

Dermal short-term (1 to 30 

days) and intermediate-term 

(1 to 6 months).

Dermal study 

NOAEL = 20 mg/

kg/day.

UFA = 10x ................

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

FQPA SF = 1x .........

LOC for MOE = 100 28-day dermal toxicity (rat). 

LOAEL = 100 mg/kg/day, based on non-regenerative anemia, 

decreased serum cholesterol, total lipids, and protein (beta 1 

globulins), and increased liver and kidney weights were observed. Additionally, cholesterol remained decreased following a 15-day recovery period. 

Inhalation short-term (1–30 

days) and intermediate-term 

(1–6 months).

Inhalation study. 

NOAEL = 0.07 

mg/L (males) 0.3 

mg/L (females).

UFA = 3x ..................

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

FQPA SF = 1x .........

LOC for MOE = 30 .. 21-day inhalation toxicity (rat). 

LOAEL = 0.3 mg/L (males only) Based on slight normocytic 

anemia, decreases in serum cholesterol and total lipids, and 

increases in liver weight and urea nitrogen. 

Cancer (oral, dermal, inhalation).Quantification of risk using a non-linear approach; i.e., RfD, for FPE will adequately account for all chronic toxicity, including carcinogenicity, that could result from exposure to FPE. 

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

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

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

sensitivity among members of the human population (intraspecies). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to FPE, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing FE 

tolerances in 40 CFR 180.430. EPA 

assessed dietary exposures from FPE 

and FE in food as follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1-day or single 

exposure. 

No such effects were identified in the 

toxicological studies for FPE; therefore, 

a quantitative acute dietary exposure 

assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the United States Department of 

Agriculture’s (USDA’s) National Health 

and Nutrition Examination Survey, 

What We Eat in America, (NHANES/

WWEIA). As to residue levels in food, 

EPA use an unrefined analysis based on 

tolerance-level residues, 100 percent 

crop treated (PCT) assumptions, and 

Dietary Exposure Evaluation Model 

(DEEM) default processing factors. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that a nonlinear RfD 

approach is appropriate for assessing 

cancer risk to FPE. Cancer risk was 

assessed using the same exposure 

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

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue or PCT information 

in the dietary assessment for FPE or FE. 

Tolerance level residues and 100 PCT 

were assumed for all food commodities. 

2. Dietary exposure from drinking 

water. The Agency has identified FPE 

and its three degradates, fenoxaprop-p 

acid ((D+)-2-[4-(6-chloro-2- 

benzoxazolyloxy) phenoxy] propanoate, 

AE F088406), chlorobenzoxazolone (4- 

(6-chloro-2-benzoxazolyloxy) phenol, 

AE F054014), and 4-(6-chloro-2- 

benzoxazolyloxy) phenol (AE F040356), 

as residues of concern in drinking 

water. The parent plus the three 

degradates were assessed using a total 

toxic residue (TTR) approach. 

The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for FPE and its three degradates in 

drinking water. These simulation 

models take into account data on the 

physical, chemical, and fate/transport 

characteristics of FPE and its three 

degradates. 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 Tier 1 Rice Model and 

Pesticide Root Zone Model Ground 

Water (PRZM GW), the estimated 

drinking water concentrations (EDWCs) 

of FPE and its degradates (TTR) for 


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chronic exposure assessments are 

estimated to be 68.6 parts per billion 

(ppb) for surface water and 0.032 ppb 

for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

chronic dietary risk assessment, the 

water concentration of value 68.6 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). FPE is 

currently registered for the following 

uses that could result in residential 

exposures: Residential turf and home 

garden. EPA assessed residential 

exposure using the following 

assumptions: For residential handlers, 

both short-term dermal and short-term 

inhalation exposure is expected as a 

result of applying FPE to ornamentals 

and turf. 

There is the potential for short-term 

dermal and incidental short-term oral 

post-application exposure for 

individuals exposed as a result of being 

in an environment that has been 

previously treated with FPE. The 

quantitative exposure/risk assessment 

for residential post-application 

exposures is based on the following 

scenarios: 

• Adults High Contact Lawn Activities 

• Children 1 to <2 years old High 

Contact Lawn Activities 

• Adults Mowing Turf 

• Children 11 to <16 years old Mowing 

Turf 

• Adults Ornamental Garden Activities 

• Children 6 to <11 years old 

Ornamental Garden Activities 

The most conservative residential 

exposure scenario for adults reflects 

dermal exposure from post-application 

exposure to turf and gardens. The most 

conservative residential exposure for 

children reflects dermal and hand-tomouth exposures from post-application 

high contact lawn activity exposure 

from turf applications. 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

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

trac/science/trac6a05.pdf. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

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

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found FPE to share a 

common mechanism of toxicity with 

any other substances, and FPE does not 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that FPE 

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 available data do not provide 

evidence of any increased susceptibility 

in the offspring in either of the two 

developmental toxicity studies for FPE 

or in the 2-generation reproduction 

study for FE. Delayed ossification was 

the primary effect in the developmental 

toxicity study and only occurred in the 

presence of maternal toxicity and a 

clearly defined NOAEL and LOAEL 

were achieved. 

In the rat developmental toxicity 

study with FPE, longitudinally 

displaced, fragmented, fused, dysplastic 

sternebrae or dislocated sternebrae and 

weak or non-ossification of one or 

several cranial bones were noted at 100 

mg/kg (highest dose tested). These 

incidences occurred only in the 

presence of maternal toxicity (decreased 

gestational body weights, body weight 

gains, and food consumption). No 

developmental effects occurred in 

rabbits. In the 2-generation rat 

reproductive toxicity study on FE, no 

reproductive or developmental effects 

were observed. An increase in ALP 

activity and liver weights were 

identified in the offspring at 9.0 mg/kg. 

These effects occurred in the presence 

of parental toxicity (increased liver 

weight and decreased lipids) and are 

consistent with hepatotoxicity, the 

primary toxic effect of FPE, observed 

across the database. 

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 FPE is 

complete. 

ii. There is no indication that FPE is 

a neurotoxic chemical and there is no 

need for a developmental neurotoxicity 

study or additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that FPE 

results in increased susceptibility in in 

utero rats or rabbits in the prenatal 

developmental studies or in young rats 

in the 2-generation reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to FPE in 

drinking water. EPA used similarly 

conservative assumptions to assess postapplication exposure of children as well 

as incidental oral exposure of toddlers. 

These assessments will not 

underestimate the exposure and risks 

posed by FPE. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, FPE is not expected 

to pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 


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Federal Register / Vol. 79, No. 88 / Wednesday, May 7, 2014 / Rules and Regulations 26163 

chronic exposure, EPA has concluded 

that chronic exposure to FPE and FE 

from food and water will utilize 28% of 

the cPAD for all infants less than 1 year 

old, the population group receiving the 

greatest exposure. Based on the 

explanation in Unit III.C.3., regarding 

residential use patterns, chronic 

residential exposure to residues of FPE 

is not expected. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). 

FPE is currently registered for uses 

that could result in short-term 

residential exposure, and the Agency 

has determined that it is appropriate to 

aggregate chronic exposure through food 

and water with short-term residential 

exposures to FPE. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

worst case MOEs of 249 for adults and 

302 for children. Because EPA’s level of 

concern for FPE is a MOE of 100 or 

below, these MOEs are not of concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

An intermediate-term adverse effect 

was identified; however, FPE is not 

registered for any use patterns that 

would result in intermediate-term 

residential exposure. Intermediate-term 

risk is assessed based on intermediateterm residential exposure plus chronic 

dietary exposure. Because there is no 

intermediate-term residential exposure 

and chronic dietary exposure has 

already been assessed under the 

appropriately protective cPAD (which is 

at least as protective as the POD used to 

assess intermediate-term risk), no 

further assessment of intermediate-term 

risk is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating intermediate-term risk for 

FPE. 

5. Aggregate cancer risk for U.S. 

population. EPA considers the chronic 

aggregate risk assessment to be 

protective of any aggregate cancer risk. 

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 FPE and FE 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(gas chromatography with electron 

capture detection (GD–ECD) method, 

based on Hoechst HRAV Analytical 

Method HRAV–4B) is available to 

enforce the tolerance expression. 

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 FPE in or on grass hay. 

C. Response to Comments 

Two comments that were received 

were not related to FPE and therefore, 

do not need to be addressed here. A 

third comment was received stating that 

FPE is an endocrine disruptor and 

America does not need any more of 

those. In the available toxicity studies 

on FPE, there was no estrogen, 

androgen, and/or thyroid mediated 

toxicity. The Agency currently has no 

evidence that FPE is an endocrine 

disruptor. 

D. Revisions to Petitioned-For 

Tolerances 

EPA has modified the tolerance from 

the proposed level of 0.15 ppm to 0.09 

ppm for the following reason: The 

method used for data-collection (as well 

as tolerance enforcement) converts the 

residues of concern for FPE to acyl 6- 

chlorobenzoxazolone for detection. It is 

necessary to then convert this residue 

value to parent equivalents. Since the 

residues found on grass, hay were less 

than the limit of quantitation (LOQ) of 

0.05 ppm for acyl 6- 

chlorobenzoxazolone, EPA multiplied 

this 0.05 ppm value by the ratio of the 

molecular weights (1.71) to arrive at a 

recommended tolerance of 0.09 ppm. 

V. Conclusion 

Therefore, a tolerance with regional 

registration is established for residues of 

fenoxaprop-ethyl, [(±)-ethyl 2-[4- [(6- 

chloro-2- 

benzoxazolyl)oxy]phenoxy]propanoate] 

and its metabolites 2-[4-[(6:-chloro-2- 

benzoxazolyl) oxy]phenoxy] propanoic 

acid and 6-chloro-2,3- 

dihydrobenzoxazol-2-one, each 

expressed as the parent compound, in or 

on grass, hay at 0.09 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 

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 


pmangrum on DSK3VPTVN1PROD with RULES
26164 Federal Register / Vol. 79, No. 88 / Wednesday, May 7, 2014 / Rules and Regulations 

1Application fees are calculated based upon the 

process set forth in 47 CFR 1.1115. The increase in 

the CPI–U between October 2009 (the month used 

to calculate the last CPI–U adjustment of the 

Schedule of Application Fees) and October 2013 is 

17.369 index points, or 8 percent. However, the 

actual calculation in fees is based on index points 

that are averaged over a time period beginning in 

December 1989. See Bureau of Labor Statistics CPI– 

U Index, http:/www.bls.gov/cpi/cpid1402.pdf 

(showing a CPI–U Index of 216.177 for October 

2009 and 233.546 for October 2013). 

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: April 29, 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 § 180.430, revise paragraph (c) to 

read as follows: 

§ 180.430 Fenoxaprop-ethyl; tolerances for 

residues. 

* * * * * 

(c) Tolerances with regional 

registrations. Tolerances with regional 

registration, as defined in § 180.1(l), are 

established for residues of the herbicide 

fenoxaprop-ethyl, including its 

metabolites and degradates, in or on the 

commodities in the table in this 

paragraph when fenoxaprop-ethyl is 

used in the states of Oregon, 

Washington, and Utah. Compliance 

with the tolerance levels specified in 

this paragraph is to be determined by 

measuring only the sum of fenoxapropethyl, (±)-ethyl 2-[4-[(6-chloro-2- 

benzoxazolyl)oxy]phenoxy]propanoate, 

and its metabolites, 2-[4-[(6-chloro-2- 

benzoxazolyl)oxy]phenoxy]propanoic 

acid and 6-chloro-2,3- 

dihydrobenzoxazol-2-one, calculated as 

the stoichiometric equivalent of 

fenoxaprop-ethyl, in or on the 

commodity 

Commodity Parts per 

million 

Grass, hay ............................ 0.09 

* * * * * 

[FR Doc. 2014–10214 Filed 5–6–14; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 1 

[GEN Docket No. 86–285; FCC 14–24] 

Schedule of Application Fees 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule. 

SUMMARY: In this document, the 

Commission amends its rules to revise 

its Schedule of Application Fees per 

section 8(b)(1) of the Communications 

Act of 1934. The Commission is 

required to revise its application fee 

rates every two years based on changes 

in the Consumer Price Index. For FY 

2014, calculated from October 2009 and 

October 2013, the Consumer Price Index 

for all Urban Consumers (‘‘CPI–U’’) 

increased 8 percent. The Schedule of 

Application Fees reflects revised fee 

rates based on a CPI–U rate increase of 

8 percent. 

DATES: Effective June 6, 2014. 

FOR FURTHER INFORMATION CONTACT: 

Roland Helvajian, Office of Managing 

Director at (202) 418–0444. 

SUPPLEMENTARY INFORMATION: 

1. By this Order, adopted March 24, 

2014 and released March 25, 2014, the 

Commission makes rule changes to part 

1 of the Commission’s rules, and 

amends its Schedule of Application 

Fees, 47 CFR 1.1102 et seq. to adjust its 

fees for processing applications and 

other filings. Section 8(a) of the 

Communications Act of 1934, as 

amended (‘‘the Act’’), requires the 

Commission to ‘‘assess and collect 

application fees at such rates as the 

Commission shall establish or at such 

modified rates as it shall establish 

pursuant to’’ section 8(b). Section 8 

contains the Schedule of Charges for a 

broad range of application categories as 

well as procedures for modifying and 

collecting these charges. The 

Commission began assessing such 

application fees in 1987, and, as 

required by section 8(b), it began 

reviewing the fees every two years 

beginning after October 1, 1991 to make 

adjustments to reflect changes in the 

Consumer Price Index. As required by 

section 8(e) of the Act, collected fees are 

deposited in the general fund of the 

United States Treasury. As required by 

the statute and consistent with our prior 

practice, this Order increases 

application fees to reflect the net change 

in the Consumer Price Index for all 

Urban Consumers (‘‘CPI–U’’) of 8 

percent, calculated from October 2009 

to October 2013.1 The adjustments made 

to the fee schedule comport with the 

statutory formula set forth in section 

8(b). 

2. The Commission will send a copy 

of this Order in a report to be sent to 

Congress and the Government 

Accountability Office pursuant to the 

Congressional Review Act, see 5 U.S.C. 

801(a)(1)(A). 

3. Accordingly, IT IS ORDERED, that, 

pursuant to sections 1, 4(i), 4(j), and 8 

of the Communications Act of 1934, as 

amended, 47 U.S.C. 151, 154(i), 154(j), 

and 158, the rule changes specified 

herein ARE ADOPTED and the 

Schedule of Application Fees, 47 CFR 

1.1102 et seq., IS AMENDED as set forth 

in the attached Appendices. 

4. It is further ordered that the rule 

changes and amendment to the 

Schedule of Application Fees made 

herein shall become effective 30 days 

after date of publication in the Federal 

Register. 

List of Subjects in 47 CFR Part 1 

Administrative practice and 

procedure. 


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