Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Rules and Regulations 25953 

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 10, 2015. 

Robert McNally, 

Director, Biopesticides and Pollution 

Prevention 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 § 180.1330 to subpart D to read 

as follows: 

§ 180.1330 1-Octanol; exemption from the 

requirement of a tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of 1-octanol in or on root and tuber 

vegetables when applied as a plant 

growth regulator in accordance with 

label directions and good agricultural 

practices. 

[FR Doc. 2015–10364 Filed 5–5–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2006–0075; FRL–9925–97] 

Fenazaquin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of fenazaquin in 

or on almonds and cherries. Gowan 

Company requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective May 

6, 2015. Objections and requests for 

hearings must be received on or before 

July 6, 2015, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2006–0075, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., Rm. 3334, 1301 

Constitution Ave. NW., Washington, DC 

20460–0001. The Public Reading Room 

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

Monday through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: 

Susan Lewis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main telephone 

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

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of 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–2006–0075 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 6, 2015. Addresses for mail 

and hand delivery of objections and 

hearing requests are provided in 40 CFR 

178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2006–0075, 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 April 20, 

2011 (76 FR 22067) (FRL–8869–7), 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 1F7825) by Gowan 

Company, P.O. Box 5569, Yuma, AZ 

85366. The petition requested that 40 

CFR 180.632 be amended by 

establishing tolerances for residues of 

the insecticide fenazaquin, 4-[2-[4-(1,1- 

dimethylethyl)phenyl]

ethoxy]quinazoline, in or on fruit, pome 

group at 0.35 parts per million (ppm); 

cucurbit group at 0.25 ppm; almond, 

hulls at 4.5 ppm; apple, wet pomace at 

0.6 ppm; berry fruit group at 0.6 ppm; 


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vegetable, fruiting group at 0.25 ppm; 

grape at 0.9 ppm; hop at 2.0 ppm; mint 

at 6.0 ppm; stone fruit group at 1.5 ppm; 

strawberry at 1.5 ppm; tree nut group at 

0.02 ppm; alfalfa, forage at 4.5 ppm; 

alfalfa, hay at 8.0 ppm; avocado at 0.15 

ppm; citrus fruit group at 0.3 ppm; 

citrus, oil at 2.5 ppm; cotton, seed 

(undelinted) at 0.5 ppm; cotton, gin 

byproducts at 12.0 ppm; bean, shelled 

dry subgroup at 0.2 ppm; bean, edible 

podded subgroup at 0.3 ppm; beans and 

pea, succulent subgroup at 0.02 ppm; 

corn, field, grain at 0.15 ppm; corn, 

field, forage at 9.0 ppm; corn, field, 

stover at 30 ppm; corn, field, aspirated 

grain fractions at 9.0 ppm; corn, field, 

refined oil at 0.6 ppm; corn, sweet at 

0.04 ppm; and corn, sweet, forage at 9.0 

ppm. That document referenced a 

summary of the petition prepared by 

Gowan Company, 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 EPA review of the data 

supporting the petition, Gowan 

Company, the registrant, revised their 

petition by limiting their request for 

tolerances to almond and cherry. The 

reason for these changes are 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 

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 fenazaquin 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with fenazaquin 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 most 

consistently observed effects of 

fenazaquin exposure across species, 

genders, and treatment durations were 

decreases in body weight, food 

consumption, and food efficiency. Other 

effects noted were mild dehydration and 

certain clinical signs seen at relatively 

high dose levels in the acute 

neurotoxicity study. These clinical 

signs, which included increased foot 

splay, decreased motor activity, sluggish 

arousal, unusual posture, abnormal gait, 

and altered response to auditory stimuli 

were seen in the absence of any 

neuropathological changes and were not 

considered to be related to 

neurotoxicity. In a 90-day study in 

hamsters, treated animals had an 

increased incidence of testicular 

hypospermatogenesis and reduced 

testicular and prostate weight; however, 

these findings were not replicated in the 

hamster carcinogenicity study which 

suggest the effects were transient or 

reversible. 

Fenazaquin did not cause any 

developmental or reproductive toxicity 

at the doses tested in rats and rabbits. 

In the rat study, developmental toxicity 

was not observed in the presence of 

maternal toxicity (i.e. decreases in body 

weight gain, food consumption, and 

food efficiency). In the rabbit study, no 

developmental or maternal toxicity was 

seen. In the reproduction study, 

systemic toxicity manifested in parental 

animals as excessive salivation and 

decreased body weight and food intake; 

in offspring as decreased body weight 

gain; and there was no observed 

reproductive toxicity. Therefore, there is 

no developmental toxicity or 

reproductive susceptibility with respect 

to fetal and developing young animals 

with in utero and postnatal exposures. 

Carcinogenicity was evaluated in the 

hamster instead of the mouse because 

the hamster was found to be more 

sensitive to the effects of fenazaquin 

than mice due to slower elimination 

kinetics for hamster. In a three-month 

feeding study in the mouse, it was 

found that 6–22x higher dose levels 

were required to elicit a comparable 

effect in mice than in the hamster. The 

results of the rat and hamster 

carcinogenicity studies demonstrated no 

increase in treatment-related tumor 

incidence. Therefore, fenazaquin was 

classified as ‘‘Not likely to be 

Carcinogenic to Humans.’’ 

The database for fenazaquin shows no 

evidence of mutagenicity, genotoxicity, 

neurotoxicity, or immunotoxicity. 

Fenazaquin did not demonstrate any 

systemic toxicity in a 21-day dermal 

toxicity study in rabbits up to the limit 

dose (1,000 milligram/kilogram/day 

(mg/kg/day)). 

Fenazaquin has high acute oral 

toxicity, low acute toxicity by dermal 

and inhalation routes of exposure, is not 

a skin irritant, is minimally irritating to 

the eye, and is considered to be a 

dermal sensitizer. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by fenazaquin as well as 

the no-observed-adverse-effect-level 

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

toxicity studies can be found at http:// 

www.regulations.gov in document 

Fenazaquin: Human Health Risk 

Assessment for Proposed New Uses on 

Almonds and Cherries on page 30 in 

docket ID number EPA–HQ–OPP–2006– 

0075. 

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 


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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 fenazaquin used for 

human risk assessment is shown in 

Table 1 of this unit. 

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

ASSESSMENT

Exposure/scenario 

Point of departure 

and 

uncertainty/safety 

factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Acute dietary (General population including infants and 

children and females 13–50 

years of age).

NOAEL = 15 mg/kg/

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 0.15 

mg/kg/day.

aPAD = 0.15 mg/kg/

day 

[Immunotoxicity—Rat]. 

LOAEL = 30 mg/kg/day based on clinical signs (general ataxia/

hypoactivity) observed in 1 animal on Day 02 and 3 animals 

on Day 03 of dosing. 

Chronic dietary (All populations) NOAEL = 5 mg/kg/

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.05 

mg/kg/day.

cPAD = 0.05 mg/kg/

day 

Co-Critical: Subchronic Toxicity—Dog. 

LOAEL = 15 mg/kg/day based on decreased body weight and 

food consumption/efficiency. 

Chronic Toxicity—Dog. 

LOAEL = 12 mg/kg/day based on decreased body weight and 

food consumption/efficiency. 

Incidental oral short-term (1 to 

30 days).

NOAEL = 5 mg/kg/

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 Co-Critical: Subchronic and Chronic Toxicity—Dog. 

Same as Chronic Dietary. 

Inhalation short-term (1 to 30 

days) and Intermediate Term 

(1 to 6 months).

Inhalation (or oral) 

study NOAEL = 5 

mg/kg/day (inhalation absorption 

rate = 100%).

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 Co-Critical: Subchronic and Chronic Toxicity—Dog. 

Same as Chronic Dietary. 

Cancer (Oral, dermal, inhalation).Classification: ‘‘Not likely to be Carcinogenic to Humans’’ based on the absence of significant tumor increases 

in two adequate rodent carcinogenicity studies. 

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

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

chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFDB = to account for the absence of data or other data deficiency. 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 fenazaquin, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

fenazaquin tolerances in 40 CFR 

180.632. EPA assessed dietary 

exposures from fenazaquin 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 

fenazaquin. In estimating acute dietary 

exposure, EPA used food consumption 

information from the United States 

Department of Agriculture (USDA) 

2003–2008 National Health and 

Nutrition Examination Survey, What We 

Eat in America (NHANS/WWEIA). As to 

residue levels in food, EPA included 

tolerance level residues for all registered 

and proposed crops and 100 percent 

crop treated (PCT). Default processing 

factors were used for all processed 

commodities. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 2003–2008 National 

Health and Nutrition Examination 

Survey, What We Eat in America 

(NHANES/WWEIA). As to residue levels 

in food, EPA included tolerance level 

residues for all registered and proposed 

crops and 100 PCT. Default processing 

factors were used for all processed 

commodities. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that fenazaquin 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 percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for fenazaquin. Tolerance level residues 

and 100 PCT were assumed for all food 

commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for fenazaquin in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of fenazaquin. 

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 II Pesticide Root 

Zone Model/Exposure Analysis 

Modeling System (PRZM/EXAMS) for 

surface water, the estimated drinking 

water concentrations (EDWCs) of 

fenazaquin for acute and chronic 

exposures were estimated to be 5.74 

parts per billion (ppb) and 2.09 ppb, 


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respectively, and were entered directly 

into the dietary exposure model. The 

groundwater EDWC from the screening 

concentration in ground water (SCI– 

GROW) model was estimated to be 

0.704 ppb. The modeled estimates were 

corrected for the default percent 

cropped area of 0.87. The drinking 

water assessment was conducted using 

the total toxic residue (TTR) approach. 

The residues considered in the 

assessment include fenazaquin (parent), 

Metabolite 1, and Metabolite 29. 

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). 

Fenazaquin is currently registered for 

the following uses that could result in 

residential exposures: Ornamental uses. 

EPA assessed residential exposure using 

the following assumptions: EPA 

assessed potential exposures for 

residential handlers using several 

application methods including 

handwand and backpack sprayers to 

treat ornamental plants. MOEs were 

calculated for the inhalation route of 

exposure only since no systemic toxicity 

associated with dermal exposure to 

fenazaquin was observed. Adult postapplications exposures were not 

quantitatively assessed since no dermal 

hazard was identified for fenazaquin 

and inhalation exposures are typically 

negligible in outdoor settings. 

Furthermore, the inhalation exposure 

assessment performed for residential 

handlers is representative of worst case 

inhalation exposures and is considered 

protective for post-application 

inhalation scenarios. Since there is no 

residential incidental oral exposure 

expected for children 1<2 years old on 

ornamental plants, a post-application 

exposure assessment was not conducted 

and the aggregate assessment for 

children will only include exposure 

from food and water. 

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 fenazaquin to 

share a common mechanism of toxicity 

with any other substances, and 

fenazaquin does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that fenazaquin 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. 

Susceptibility/sensitivity in the 

developing animals was evaluated in 

developmental toxicity studies in rats 

and rabbits as well as a reproduction 

and fertility study in rats. The data 

showed no evidence of sensitivity/

susceptibility in the developing or 

young animal. Clear NOAELs and 

LOAELs are available for all the parental 

and offspring effects. Therefore, there 

are no residual prenatal or postnatal 

concerns. 

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 fenazaquin 

is considered complete and sufficient 

for assessing susceptibility to infants 

and children. 

ii. There is no indication that 

fenazaquin 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 

fenazaquin 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 fenazaquin in 

drinking water. EPA also made 

conservative assumptions in the nondietary residential exposures estimates 

including maximum application rates 

and standard values for unit exposures, 

amount handled. These assessments 

will not underestimate the exposure and 

risks posed by fenazaquin. 

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 

fenazaquin will occupy 10% 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 fenazaquin 

from food and water will utilize 10% of 

the cPAD for children 1–2 years old the 

population group receiving the greatest 

exposure. Based on the explanation in 

Unit III.C.3., regarding residential use 

patterns, chronic residential exposure to 

residues of fenazaquin 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). Fenazaquin 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 

fenazaquin. 


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Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of 5,200 for adults. Because EPA’s 

level of concern for fenazaquin is a MOE 

of 100 or below, the MOE is not of 

concern. Since there is no residential 

exposure expected for children, there is 

no potential that a short-term aggregate 

risk for children could be higher than 

the dietary (food and drinking water) 

risk. 

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, fenazaquin is 

not registered for any use patterns that 

would result in intermediate-term 

residential exposure. 

Intermediate-term risk is assessed 

based on intermediate-term 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 intermediateterm risk), no further assessment of 

intermediate-term risk is necessary, and 

EPA relies on the chronic dietary risk 

assessment for evaluating intermediateterm risk for fenazaquin. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

fenazaquin is not expected to pose a 

cancer risk to humans. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to fenazaquin 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(high performance liquid 

chromatography and tandem mass 

spectrometry (HPLC–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 fenazaquin. 

C. Revisions to Petitioned-For 

Tolerances 

EPA’s review of the data supporting 

the petition, showed that there was not 

sufficient data to support some of the 

tolerances originally proposed by the 

registrant. Gowan Company, the 

registrant, revised their petition by 

limiting their request for tolerances to 

almond and cherry, which are 

supported by the available data. The 

Organization of Economic Cooperation 

and Development (OECD) tolerance 

derivation procedures indicates the 

need for the following changes in the 

proposed tolerances: Cherries from 1.5 

ppm to 2.0 ppm and almond hull from 

0.6 ppm to 4.0 ppm. The Agency is also 

revising the tolerance expression to 

clarify that (1) as provided in FFDCA 

section 408(a)(3), the tolerance covers 

metabolites and degradates of 

fenazaquin not specifically mentioned 

and (2) compliance with the specified 

tolerance levels is to be determined by 

measuring only the specific compounds 

mentioned in the tolerance expression. 

V. Conclusion 

Therefore, tolerances are established 

for residues of fenazaquin, 

4-[2-[4-(1,1-dimethylethyl)

phenyl]ethoxy]quinazoline, in or on 

almond at 0.02 ppm, almond hulls at 4.0 

ppm, and cherry at 2.0 ppm. 

VI. Statutory and Executive Order 

Reviews 

This action establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this action 

has been exempted from review under 

Executive Order 12866, this action is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This action does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

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

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the 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 action directly regulates growers, 

food processors, food handlers, and food 

retailers, not States or tribes, nor does 

this action alter the relationships or 

distribution of power and 

responsibilities established by Congress 

in the preemption provisions of FFDCA 

section 408(n)(4). As such, the Agency 

has determined that this action will not 

have a substantial direct effect on States 

or tribal governments, on the 

relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

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

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this action. In addition, this action 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

Mandates Reform Act (UMRA) (2 U.S.C. 

1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 


tkelley on DSK3SPTVN1PROD with RULES
25958 Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Rules and Regulations 

12(d) of the National Technology 

Transfer and Advancement Act 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

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

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

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

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: April 27, 2015. 

Susan Lewis, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.632, the section heading 

and paragraph (a) are revised to read as 

follows: 

§ 180.632 Fenazaquin; Tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the 

insecticide fenazaquin, 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 fenazaquin, or 4-[2-[4-

(1,1-dimethylethyl)phenyl]

ethoxy]quinazoline. 

Commodity Parts per 

million 

Almond ...................................... 0 .02 

Almond, hulls ............................ 4 .0 

Apple ......................................... 0 .2 

Cherry ....................................... 2 .0 

Citrus Oil ................................... 10 

Fruit, Citrus, Group 10 except 

Grape fruit ............................. 0 .5 

Pear .......................................... 0 .2 

* * * * * 

[FR Doc. 2015–10375 Filed 5–5–15; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 423 

[CMS–6107–IFC] 

RIN 0938–AS60 

Medicare Program; Changes to the 

Requirements for Part D Prescribers 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Interim final rule with comment 

period. 

SUMMARY: This interim final rule with 

comment period revises requirements 

related to beneficiary access to covered 

Part D drugs. Under these revised 

requirements, pharmacy claims and 

beneficiary requests for reimbursement 

for Medicare Part D prescriptions, 

written by prescribers other than 

physicians and eligible professionals 

who are permitted by state or other 

applicable law to prescribe medications, 

will not be rejected at the point of sale 

or denied by the plan if all other 

requirements are met. In addition, a 

plan sponsor will not reject a claim or 

deny a beneficiary request for 

reimbursement for a drug when 

prescribed by a prescriber who does not 

meet the applicable enrollment or optout requirement without first providing 

provisional coverage of the drug and 

individualized written notice to the 

beneficiary. This interim final rule with 

comment period also revises certain 

terminology to be consistent with 

existing policy and to improve clarity. 

DATES: 

Effective date: These regulations are 

effective on June 1, 2015. 

Applicability date: The provisions at 

§ 423.120(c)(6) are applicable January 1, 

2016. 

Comment date: To be assured 

consideration, comments must be 

received at one of the addresses 

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

July 6, 2015. 

ADDRESSES: In commenting, please refer 

to file code CMS–6107–IFC. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (please choose only one of the 

ways listed) 

1. Electronically. You may submit 

electronic comments on this regulation 

to http://www.regulations.gov. Follow 

the ‘‘Submit a comment’’ instructions. 

2. By regular mail. You may mail 

written comments to the following 

address ONLY: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–6107–IFC, P.O. Box 8013, 

Baltimore, MD 21244–8013. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments to the 

following address ONLY: Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–6107–IFC, 

Mail Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

4. By hand or courier. Alternatively, 

you may deliver (by hand or courier) 

your written comments ONLY to the 

following addresses prior to the close of 

the comment period: a. For delivery in 

Washington, DC—Centers for Medicare 

& Medicaid Services, Department of 

Health and Human Services, Room 445– 

G, Hubert H. Humphrey Building, 200 

Independence Avenue SW., 

Washington, DC 20201. 

(Because access to the interior of the 

Hubert H. Humphrey Building is not 

readily available to persons without 

Federal government identification, 

commenters are encouraged to leave 

their comments in the CMS drop slots 

located in the main lobby of the 

building. A stamp-in clock is available 

for persons wishing to retain a proof of 

filing by stamping in and retaining an 

extra copy of the comments being filed.) 

b. For delivery in Baltimore, MD— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

If you intend to deliver your 

comments to the Baltimore address, call 

telephone number (410) 786–9994 in 

advance to schedule your arrival with 

one of our staff members. 

Comments erroneously mailed to the 

addresses indicated as appropriate for 

hand or courier delivery may be delayed 

and received after the comment period. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Frank Whelan, (410) 786–1302 for 

enrollment issues. 

Lisa Thorpe, (410) 786–3048, for 

provisional coverage, notice, and all 

other issues. 

SUPPLEMENTARY INFORMATION: 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 


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