Federal Register / Vol. 79, No. 151 / Wednesday, August 6, 2014 / Rules and Regulations 45693 

will result from aggregate human 

exposure to fluopicolide and that, 

accordingly, the amended fluopicolide 

tolerances on potato, processed potato 

waste and vegetable, tuberous and corm, 

subgroup 1C, are safe. 

D. Revisions to Petitioned-For 

Tolerances 

Based on the data supporting the 

petition, EPA has determined that the 

proposed tolerance in or on potato, 

processed waste at 0.3 ppm should be 

established at 1.0 ppm. That 

determination was based on the 

following: Processing data previously 

provided for the use of fluopicolide on 

potato indicate that residues of 

fluopicolide concentrate in wet peels. 

Residues of fluopicolide found in or on 

potatoes are estimated to be in the range 

of 0.2 ppm to 0.25 ppm following 

directed soil application. Using the 

highest estimated value of residues 

found in or on potato and the theoretical 

concentration factor of 4.0X for potato 

processed waste (in accordance with 

EPA’s Residue Chemistry Test 

Guidelines), EPA has determined that a 

tolerance of 1.0 ppm is appropriate for 

residues on potato, processed waste. 

Additionally, EPA has revised the 

commodity terminology to potato, 

processed potato waste in order to 

reflect the preferred designation. 

V. Conclusion 

Therefore, tolerances are established 

for residues of fluopicolide, 2,6- 

dichloro-N-[[3-chloro-5- 

(trifluoromethyl)-2- 

pyridinyl]methyl]benzamide, in or on 

potato, processed potato waste at 1.0 

ppm; and vegetable, tuberous and corm, 

subgroup 1C at 0.3 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 tolerances in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

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

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

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

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

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

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

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

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: July 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 § 180.627, revise the following 

entries in the table in paragraph (a) to 

read as follows: 

§ 180.627 Fluopicolide; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

***

* *

Potato, processed potato waste 1.0 

***

* *

Vegetable, tuberous and corm, 

subgroup 1C ......................... 0.3 

* * * * * 

[FR Doc. 2014–18458 Filed 8–5–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0904; FRL–9912–92] 

Bifenazate; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of bifenazate in 

or on multiple commodities which are 

identified and discussed later in this 

document including tolerances with 

regional restrictions for timothy hay and 

timothy forage. In addition, this 

regulation removes existing tolerances 

on ‘‘fruit, pome, group 11’’ ‘‘vegetable, 

fruiting, group 8’’ and existing timelimited tolerances for ‘‘timothy, forage’’ 

and ‘‘timothy, hay’’ that are superseded 


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45694 Federal Register / Vol. 79, No. 151 / Wednesday, August 6, 2014 / Rules and Regulations 

by this action. The Interregional 

Research Project Number 4 (IR–4) 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

August 6, 2014. Objections and requests 

for hearings must be received on or 

before October 6, 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–2010–0904, 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: Lois 

Rossi, 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–2010–0904 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 October 6, 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– 

2010–0904, 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 Wednesday, 

July 6, 2011 (76 FR 39358) (FRL–8875– 

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 (PP1E7847) by the 

Interregional Research Project Number 4 

(IR–4), IR–4 Project Headquarters, 500 

College Road East, Suite 201W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.572 be 

amended by establishing tolerances for 

residues of bifenazate: Hydrazine 

carboxylic acid, 2-(4-methoxy-[1,1’- 

biphenyl]-3-yl)-methylethyl ester in or 

on fruit, pome, group 11–10 at 0.75 

parts per million (ppm); herb, subgroup 

19A dried leaves, except chervil, dried 

and chive, dried, at 140 ppm; herb, 

subgroup 19A, fresh leaves at 30 ppm; 

timothy, forage at 140 ppm; timothy, 

hay at 120 ppm; and vegetable, fruiting, 

group 8–10 at 2.0 ppm. That document 

referenced a summary of the petition 

prepared by Chemtura Corporation, the 

registrant, which is available in the 

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

There were no comments received in 

response to the notice of filing. 

Based upon review of the data 

supporting the petition, EPA has revised 

the proposed tolerance level and 

corrected the commodity definition for 

certain commodities, and revised the 

tolerance expression for bifenazate. The 

reasons 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 


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aggregate exposure for bifenazate 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with bifenazate follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered their 

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. 

Bifenazate has low acute toxicity for 

the oral, dermal and inhalation routes of 

exposure. For subchronic oral 

exposures, the dog is the most sensitive 

species. For chronic oral exposures, the 

dog and the rat are equally sensitive. 

Subchronic and chronic studies in 

rats and dogs indicate that the liver and 

hematopoietic system (spleen and bone 

marrow with associated hematological 

findings) are the primary target organs 

in these species. Additional toxicity was 

seen in the kidney (dogs following 

chronic exposure) and adrenal cortex 

(male rats following subchronic 

exposure). Decreases in body weight, 

body-weight gain, and food 

consumption were also associated with 

liver and hematopoietic system toxicity 

in several studies. 

In the rat developmental toxicity 

study, the maternal effects consisted of 

clinical signs of toxicity, decreased body 

weight and body-weight gains, and 

reduced food consumption at the middose. Increases in early fetal resorptions 

occurred at the same doses that caused 

maternal toxicity. In the rabbit 

developmental toxicity study, there 

were no maternal or developmental 

effects up to the highest dose tested 

(HDT). In the 2-generation rat 

reproduction study, the parental effects 

occurred at the mid-dose and consisted 

of decreased body weight and bodyweight gains. There were no 

reproductive or offspring effects up to 

the HDT. 

In the acute neurotoxicity study, 

treatment related effects were seen only 

at the HDT, and consisted of decreased 

motor activity (rearing in females; center 

time in both sexes). In the subchronic 

neurotoxicity study, effects were also 

only seen at the HDT (34.5 milligrams/ 

kilogram/day (mg/kg/day) and consisted 

of decreased landing foot splay (males), 

decreased fore- and hindlimb grip 

strength (males), decreased motor 

activity measurements consisting of 

center times (females) and rearing 

activity (both sexes). The level of 

concern (LOC) for neurotoxicity in the 

bifenazate database is low however 

because; 

• The observed effects are well 

characterized; 

• They occur only at the highest 

doses tested; and 

• They are protected for by the 

studies used in the endpoint selection. 

There were no observed toxicological 

effects in the immunotoxicity study up 

to the HDT. 

In the mouse carcinogenicity study, 

males and females were tested up to 225 

ppm and 175 ppm, respectively, which 

elicited decreased body weight and 

body-weight gains in females. In male 

mice, there was an increase in the 

incidence of liver adenomas only, 

which was not considered statistically 

significant by pair-wise comparison. 

There also was no progression of the 

adenomas to carcinomas in males in this 

study. A full battery of mutagenicity 

studies were negative for mutagenic or 

clastogenic activity. Bifenazate is 

classified as ‘‘not likely’’ to be 

carcinogenic to humans. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by bifenazate 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, 

‘‘Bifenazate. Human-Health Risk 

Assessment. Section 3 Registration 

Request to Add New Uses on Timothy 

Forage and Hay; Herb, Subgroup 19A; 

and to Expand Existing Uses on Pome 

Fruit, Group 11, and Fruiting 

Vegetables, Group 8’’, dated May 15, 

2014, page 40 in docket ID number 

EPA–HQ–OPP–2010–0904. 

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 bifenazate used for human 

risk assessment is shown in the Table of 

this unit. 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR BIFENAZATE 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 = 0.1 mg/kg/day ....

aPAD = 0.1 mg/kg/day 

Prenatal Developmental Toxicity—Rats Developmental. 

LOAEL = 100 mg/kg/day 

based on clinical signs, decreased body weight and 

food consumption during 

the dosing period. 


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

ASSESSMENT—Continued 

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).NOAEL = 600 mg/kg/day .......

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 6 mg/kg/day .......

aPAD = 6 mg/kg/day 

Acute Neurotoxicity Screening 

Battery—Rats. 

LOAEL = 2,000 mg/kg/day 

based on decreased motor 

activity (rearing in females). 

Chronic dietary (All populations) ...................... NOAEL= 1.0 mg/kg/day .........

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.01 mg/kg/day 

cPAD = 0.01 mg/kg/day 

Chronic toxicity—Dogs. 

LOAEL = 8.9/10.4 mg/kg/day 

(M/F) based on changes in 

hematological and clinical 

chemistry parameters, and 

histopathology in bone marrow, liver, and kidney in the 

one-year dog feeding study. 

Co-critical Study .....................

NOAEL = 1.5 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

................................................. Carcinogenicity Study-Mouse. 

LOAEL = 15.4 (M) mg/kg/day 

based on hematology parameters and possibly kidney weights. 

Incidental oral short-term (1 to 30 days) and 

intermediate-term (1 to 6 months).

NOAEL= 0.9 mg/kg/day .........

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Residential LOC for MOE = 

100.

90-Day Subchronic—Dogs. 

LOAEL = 10.4 mg/kg/day 

based on based upon 

changes in hematological 

parameters in both sexes, 

increased bilirubin in the 

urine in males, increased 

absolute and relative liver 

weight in females and liver 

histopathological effects in 

both sexes. 

Dermal short-term (1 to 30 days) and intermediate-term (1 to 6 months).Dermal study. LOAEL = 80 

mg/kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Residential LOC for MOE = 

100.

21-Day Dermal toxicity—Rat. 

LOAEL = 400 mg/kg/day 

based on decreased body 

weight in females, decreased food consumption 

in both sexes, increased 

urinary ketones, increased 

urinary protein, increased 

urinary specific gravity, and 

decreased urinary volume 

in both sexes, and increased incidence of extra 

medullary hematopoiesis in 

the spleen in both sexes. 

Inhalation short-term (1 to 30 days) and intermediate-term (1 to 6 months).Rat NOAEL = 0.03 mg/L ........

HEC = 0.0009 mg/L 

HED = 0.14mg/kg bw/day 

UFA = 3x 

UFH = 10x 

FQPA SF = 1x 

Residential LOC for MOE = 

30.

28-Day Inhalation Toxicity— 

Rat LOAEL = 0.075 mg/L 

(M/F) on dried red material 

around the nose in females, 

lower body weights and 

body-weight gains, decreased food consumption, 

decreased heart and thymus weights in females, increased incidences of mild 

brown pigmentation of the 

spleen, and minimal to mild 

degeneration of the olfactory epithelium within nasal 

levels III, IV, and V. 

Cancer (Oral, dermal, inhalation) ..................... Bifenazate is classified as ‘‘not likely to be a human carcinogen’’. 

Point of departure (POD) = a data point or an estimated point that is derived from observed dose-response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. Reference Dose = RfD. Male/Female = 

(M/F). 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). Human Equivalent Concentration (HEC) where HEC Calculations for Shortand Intermediate-term Residential Exposure: Assume residents will be exposed for 24 hrs/day and 7 days/week: HEC = NOAELstudy * (daily duration of exposureanimal/daily duration of exposurehuman) * (days/week of exposureanimal/days/week of exposurehuman) * RDDR. 

• HEC = 0.03 mg/L * (6/24) * (5/7) * 0.175 = 0.00094 mg/L. 


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Human Equivalent Dose (HED). HED’s route-to-route extrapolation converts human and animal values from mg/L concentrations to mg/kg oralequivalent doses. The equation uses a single conversion factor to account for default body weights and respiratory volumes. An activity factor is 

used to account for increased exposure resulting from increased respiration. Using the HEC calculated (based upon terminal airway inflammation 

in males), a conversion of the inhalation concentration to a dose (mg/L to mg/kg/day) was conducted as follows: 

• Human-Equivalent Dose (HED, mg/kg/day) = Dose (systemic HEC value, mg/L) × A × CF (L/hr/kg) × D (hours) × AF = mg/kg 

Where: A = absorption: Ratio of deposition and absorption in respiratory tract compared to absorption by the oral route. CF = conversion Factor; a L/hr/kg factor which accounts for respiratory volume and body weight for a given species and strain. D = duration; duration of daily animal 

or human exposure (hours). AF = activity Factor; animal default is 1. The residential human equivalent dose for bifenazate is calculated as follows: 

• Residential HED: (0.0009 mg/L) × 1 × 6 × 8 × 1 = 0.135 mg/kg/day. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to bifenazate, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

bifenazate tolerances in 40 CFR 180.572. 

EPA assessed dietary exposures from 

bifenazate in food as follows: 

i. Acute exposure. In conducting the 

acute dietary exposure assessment EPA 

used the Dietary Exposure Evaluation 

Model—Food Consumption Intake 

Database (DEEM–FCID, ver. 3.16), 

which incorporates consumption 

information from the United States 

Department of Agriculture’s (USDA’s) 

National Health and Nutrition 

Examination Survey, What We Eat in 

America, (NHANES/WWEIA). This 

dietary survey was conducted from 2003 

to 2008. 

As to residue levels in food, the acute 

analysis for the general population, 

including infants and children, was 

unrefined and used tolerance-level 

residues and 100 PCT. The acute 

analysis for females 13 to 49 years old 

was highly refined and incorporated 

data from the USDA’s Pesticide Data 

Program (PDP), crop field trial data, and 

PCT estimates. DEEM (ver. 7.81) default 

processing factors were assumed for all 

commodities excluding apple juice, 

grape juice, and wine/sherry. The 

processing factors for these commodities 

were reduced to 1.0, based on data from 

processing studies. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the DEEM–FCID, ver. 3–16 

which incorporates consumption 

information from the USDA NHANES/

WWEIA; 2003–2008. As to residue 

levels in food, the chronic dietary 

exposure analysis for all population 

subgroups was partially refined and 

used tolerance-level residues and PCT 

estimates. DEEM default processing 

factors were assumed for all 

commodities excluding apple juice, 

grape juice, and wine/sherry. The 

processing factors for these commodities 

were reduced to 1.0 based on data from 

processing studies. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

classified bifenazate as ‘‘not likely’’ to 

be a human carcinogen. Therefore, a 

dietary exposure assessment for the 

purpose of assessing cancer risk was not 

conducted. 

iv. Anticipated residue and percent 

crop treated (PCT) information. 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. 

Section 408(b)(2)(F) of FFDCA states 

that the Agency may use data on the 

actual percent of food treated for 

assessing chronic dietary risk only if: 

• Condition a: The data used are 

reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain the pesticide residue. 

• Condition b: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• Condition c: Data are available on 

pesticide use and food consumption in 

a particular area, the exposure estimate 

does not understate exposure for the 

population in such area. 

In addition, the Agency must provide 

for periodic evaluation of any estimates 

used. To provide for the periodic 

evaluation of the estimate of PCT as 

required by FFDCA section 408(b)(2)(F), 

EPA may require registrants to submit 

data on PCT. 

The Agency used PCT information as 

follows: 

Maximum PCT estimates were used in 

the acute dietary risk assessment: 

Almonds: 10%; apples: 5%; apricots: 

10%; beans, green: 2.5%; caneberries: 

30%; cantaloupes: 2.5%; cherries: 5%; 

cucumbers: 5%; grapefruit: 5%; grapes: 

20%; nectarines: 10%; oranges: 2.5%; 

peaches: 20%; pears: 30%; pecans: 

2.5%; peppers: 10%; pistachios: 2.5%; 

plums/prunes: 20%; potatoes: 5%; 

pumpkins: 5%; squash: 2.5%; 

strawberries: 65%; tomatoes: 10%; 

walnuts: 5%; and watermelon: 2.5%. 

The following average PCT estimates 

were used in the chronic dietary risk 

assessment: Almonds: 5%; apples: 5%; 

apricots: 5%; beans, green: 1%; 

caneberries: 25%; cantaloupes: 1%; 

cherries: 2.5%; cucumbers: 2.5%; 

grapefruit: 5%; grapes: 10%; nectarines: 

5%; oranges: 1%; peaches: 10%; pears: 

15%; pecans: 1%; peppers: 5%; 

pistachios: 2.5%; plums/prunes: 5%; 

potatoes: 5%; pumpkins: 2.5%; squash: 

1%; strawberries: 45%; tomatoes: 5%; 

walnuts: 2.5%; and watermelon: 1%. 

In most cases, EPA uses available data 

from USDA/National Agricultural 

Statistics Service (USDA/NASS), 

proprietary market surveys, and the 

National Pesticide Use Database for the 

chemical/crop combination for the most 

recent 6–7 years. EPA uses an average 

PCT for chronic dietary risk analysis. 

The average PCT figure for each existing 

use is derived by combining available 

public and private market survey data 

for that use, averaging across all 

observations, and rounding to the 

nearest 5%, except for those situations 

in which the average PCT is less than 

one. In those cases, 1% is used as the 

average PCT and 2.5% is used as the 

maximum PCT. EPA uses a maximum 

PCT for acute dietary risk analysis. The 

maximum PCT figure is the highest 

observed maximum value reported 

within the recent 6 years of available 

public and private market survey data 

for the existing use and rounded up to 

the nearest multiple of 5%. 

The Agency believes that the three 

conditions discussed in Unit III.C.1.iv. 

have been met. With respect to 

Condition a, PCT estimates are derived 

from Federal and private market survey 

data, which are reliable and have a valid 

basis. The Agency is reasonably certain 

that the percentage of the food treated 

is not likely to be an underestimation. 

As to Conditions b and c, regional 

consumption information and 

consumption information for significant 

subpopulations is taken into account 

through EPA’s computer-based model 

for evaluating the exposure of 

significant subpopulations including 


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several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available reliable information on 

the regional consumption of food to 

which bifenazate may be applied in a 

particular area. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for bifenazate in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of bifenazate. 

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 First Index Reservoir 

Screening Tool (FIRST) model and the 

dry bean application scenario (highest 

registered/proposed use rate) and the 

Screening Concentrations in Ground 

Water (SCI–GROW) model, the 

estimated drinking water concentrations 

(EDWCs) of bifenazate acute exposures 

are estimated to be 37.3 ppb for surface 

water and 0.014 ppb for ground water. 

For chronic exposures for non-cancer 

assessments are estimated to be 11.2 

ppb for surface water and 0.014 ppb for 

ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. 

For acute dietary risk assessment, the 

water concentration value of 37.3 ppb 

was used to assess the contribution to 

drinking water. 

For chronic dietary risk assessment, 

the water concentration of value 11.2 

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). 

Bifenazate is currently registered for 

the following uses that could result in 

residential exposures: Ornamental 

plants, including bedding plants, 

flowering plants, foliage plants, bulb 

crops perennials, trees, and shrubs. EPA 

assessed residential exposure using the 

following assumptions: There is a 

potential for short-term dermal and 

inhalation exposures by homeowners 

applying bifenazate. Intermediate-term 

exposures are not likely because of the 

intermittent nature of applications by 

homeowners. 

The residential handler exposure 

assessment estimates dermal and 

inhalation exposures for individuals 

using bifenazate on residential 

ornamentals. The quantitative exposure/ 

risk assessment developed for 

residential handlers is based on the 

following scenarios: 

i. Mixing/loading/applying liquids 

with manually-pressurized handwand, 

ii. Mixing/loading/applying liquids 

with hose-end sprayer, 

iii. Mixing/loading/applying liquids 

with backpack, and 

iv. Mixing/loading/applying liquids 

with sprinkler can. 

Unit exposure values and estimates 

for area treated were taken from the 

2012 Residential SOPs: Gardens and 

Trees. An aggregate risk index (ARI) was 

used since the LOCs for dermal 

exposure (100) and inhalation exposure 

(30) are different. The target ARI is 1; 

therefore, ARIs of less than 1 result in 

risk estimates of concern. The ARI was 

calculated as follows. 

• Aggregate Risk Index (ARI) = 1 ÷ 

[(Dermal LOC ÷ Dermal MOE) + 

(Inhalation LOC ÷ Inhalation MOE)] 

Short-term risk estimates for 

residential handlers are greatest for 

exposure scenarios ‘‘hose-end sprayer’’ 

and ‘‘backpack’’ resulting in ARIs of 80 

and 66, respectively. Short-term dermal 

and inhalation risk estimates to 

residential handlers do not exceed 

EPA’s LOC for all scenarios. All the 

ARIs are above 1 and do not exceed the 

Agency’s LOC for all scenarios. 

Short-term dermal exposure and risk 

from residential post-application have 

been assessed for bifenazate under the 

following scenarios, routes of exposure 

and lifestages: 

• Gardens and Trees: adults (dermal) 

and children 6 to less than or equal 11 

years old (dermal). 

These lifestages are not the only 

lifestages that could be potentially 

exposed for these post-application 

scenarios; however, the assessment of 

these lifestages is health protective for 

the exposures and risks for any other 

potentially exposed lifestages. All adult 

and children dermal post-application 

risk estimates for exposure to treated 

trees and gardens are not of concern 

(MOEs ≥ 100). Details of assumptions 

and factors the Agency applied in 

residential and residential postapplication exposure assessments are 

detailed in the 2012 Residential SOPs at 

http://www.epa.gov/pesticides/science/

residential-exposure-sop.html. 

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 bifenazate to share 

a common mechanism of toxicity with 

any other substances, and bifenazate 

does not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that bifenazate 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 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 prenatal and postnatal toxicology 

database for bifenazate includes rat and 

rabbit developmental toxicity studies 

and a 2-generation reproduction toxicity 

study in rats. In the rat developmental 

toxicity study, the maternal effects 

consisted of clinical signs of toxicity, 

decreased body weight and body-weight 

gains, and reduced food consumption at 

the mid-dose. Increases in early fetal 

resorptions occurred at the same doses 

that caused maternal toxicity. In the 


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rabbit developmental toxicity study, 

there were no maternal or 

developmental effects up to the HDT. In 

the 2-generation rat reproduction study, 

the parental effects occurred at the middose and consisted of decreased body 

weight and body-weight gains. There 

were no reproductive or offspring effects 

up to the HDT. 

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 bifenazate 

is complete. 

ii. There is evidence of neurotoxicity 

in the bifenazate database. The level of 

concern for neurotoxic effects in 

children is low however because 

• The observed effects are well 

characterized; 

• They occur only at the highest 

doses tested; and 

• They are protected for by the 

studies used in the endpoint selection. 

iii. There is no evidence that 

bifenazate results in increased 

susceptibility in in utero rats or rabbits 

in the pre- or postnatal developmental 

studies or in young rats in the 2- 

generation reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The exposure databases are sufficient to 

determine the nature and magnitude of 

the residue in food and water. For acute 

exposure for the general population and 

chronic exposure, the dietary exposure 

analyses are unlikely to underestimate 

exposure as they incorporated tolerancelevel residues, 100 PCT for acute 

exposure, PCT for chronic exposure, 

and modeled drinking water estimates. 

For acute analysis for females 13 to 49 

years, the dietary analysis is unlikely to 

underestimate exposure as PDP, crop 

field trial data, PCT estimates and 

modeled drinking water estimates were 

utilized. 

EPA made conservative (protective) 

assumptions in the ground water and 

surface water modeling used to assess 

exposure to bifenazate in drinking 

water. The dietary food and drinking 

water exposure assessments will not 

underestimate the potential exposures 

for infants and children. The residential 

use (ornamentals) is not expected to 

result in post-application exposure to 

infants and children as well as 

incidental oral exposure of toddlers. 

The post-application exposure 

assessments are based upon the 

residential SOPs, which are based upon 

reasonable worst-case assumptions and 

are not expected to underestimate risk. 

These assessments will not 

underestimate the exposure and risks 

posed by bifenazate. 

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 aPAD and 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 

bifenazate will occupy <1.9% of the 

aPAD for children 1 to 2 years old, the 

population group receiving the greatest 

exposure. The acute dietary exposure 

estimates are not of concern to EPA 

(<100% aPAD) for the general U.S. 

population and all population 

subgroups 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to bifenazate from 

food and water will utilize 74% of the 

cPAD for children 1 to 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 bifenazate is not expected. 

3. Short- and intermediate-term risks. 

Short- and intermediate-term aggregate 

exposures take into account short- and 

intermediate-term residential exposures 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). Bifenazate is currently 

registered for uses that could result in 

short- and intermediate-term residential 

exposures. 

The short- and intermediate-term 

toxicological PODs for bifenazate are the 

same for each route of exposure. 

Therefore, for residential exposure 

scenarios, only short-term exposures 

were assessed, and are considered to be 

protective of intermediate-term 

exposure and risk. 

It was appropriate to aggregate 

postapplication dermal exposures with 

dietary (food and water) exposures. The 

dermal postapplication exposure to 

gardens and ornamentals scenario is the 

residential exposure scenario with the 

greatest risk estimate for both adults and 

children 6 ≤ 11 years old; therefore, the 

exposure estimates for this scenario are 

protective of any other exposure 

scenarios. 

For the adult and children 6 ≤ 11 

years old short- and intermediate-term 

aggregate risk assessment, the MOE 

approach was used to estimate aggregate 

exposures as there are different PODs 

for oral and dermal routes of exposure 

but the LOC are the same. The chronic 

dietary exposure estimate for Adults 20– 

49 years old and Children 6–12 years 

old were used in the aggregate risk 

estimate for adults and children 6 ≤ 11 

years old, respectively. 

All of the adult and children 6 ≤ 11 

years old chronic dietary + dermal 

aggregate risk estimates do not exceed 

EPA’s LOC (MOEs ≥ 100). 

4. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

bifenazate (classified as ‘‘not likely’’ to 

be a human carcinogen) is therefore not 

expected to pose a cancer risk to 

humans. 

5. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to bifenazate 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodologies 

are available to enforce the tolerance 

expression. 

For plant commodities, highperformance liquid chromatography 

with oxidative coulometric 

electrochemical detector (HPLC/ELCD) 

Method UCC–D2341 is available as a 

primary enforcement method for the 

combined residues of bifenazate and its 

metabolite D3598. The method has been 

forwarded to the United States Food and 

Drug Administration (FDA) for 

inclusion in the Pesticides Analytical 

Manual, Volume II (PAM II). The limit 

of quantification (LOQ) and limit of 

detection (LOD) of Method UCC–D2341 

are 0.01 and 0.005 ppm, respectively. In 

addition, a liquid chromatographic 

system with tandem mass spectrometers 

(LC–MS/MS) method (NCL ME 245) was 

recently submitted as a confirmatory 

method and has been forwarded to FDA. 

For livestock commodities, HPLC 

methods with fluorescence detection or 

ELCD are available as primary methods 

for the enforcement of tolerances for 

residues of bifenazate and its regulated 

metabolites in livestock matrices. The 

methods have undergone a successful 

validation by the Agency and have been 

forwarded to FDA for inclusion in PAM 


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II. In addition, the LC–MS/MS Method 

NCL ME 259 was recently submitted as 

a confirmatory method, and this method 

was also forwarded to FDA. The 

validated LOQ was 0.01 ppm for each 

analyte. The LOD was reported as 0.005 

ppm. 

The methods 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. 

There are currently no established 

Codex MRLs for bifenazate in/on herbs, 

and timothy forage and hay. Codex 

MRLs are established for pome fruits 

(0.7 ppm), chili peppers (3 ppm), sweet 

peppers (2 ppm) and tomato (0.5 ppm), 

but not for other members of Vegetable, 

fruiting, group 8–10. 

The U.S. is establishing a tolerance for 

Vegetable, fruiting, group 8–10 at 4.0 

ppm for residues of bifenazate (and its 

metabolite). There is an existing U.S. 

tolerance of 2 ppm for Vegetables, 

fruiting, crop, group 8. This tolerance 

was established in 2003 prior to the 

implementation of the Organization for 

Economic Co-Operation and 

Development (OECD) calculation 

procedures. In 2007 Codex established 

the MRLs for chili peppers, sweet 

peppers and tomato and relied on the 

U.S. field trial data. Codex chose not to 

establish a group tolerance for the 

fruiting vegetables but instead 

established separate Codex MRLs for 

tomato, peppers and chili peppers using 

the highest observed residue approach. 

The approach taken by Codex is not in 

line with how the U.S. establishes crop 

group tolerances. Further, using the 

OECD calculation procedures and based 

on data from bell and non-bell pepper 

studies conducted in the U.S., and 

tomato studies conducted in Canada 

and the U.S. results in the 

recommended tolerance of 4.0 ppm. 

EPA is establishing the U.S. tolerance 

for residue in or on pome fruit at 0.7 

ppm, in harmonization with the 

established Codex MRL. 

C. Revisions to Petitioned-For 

Tolerances 

After reviewing supporting data and 

information, EPA modified certain 

elements of the petition as proposed in 

the notice of filing, as follows: 

1. EPA corrected the proposed 

commodity definitions, ‘‘Herb, subgroup 

19A, fresh leaves’’ and ‘‘Herb, subgroup 

19A, dried leaves, except chervil, dried 

and chive, dried’’ to read ‘‘Herb 

subgroup 19A, except chervil and 

chive’’ to specify crop coverage and for 

accuracy and consistency in naming of 

commodities. 

2. Using the OECD tolerancecalculation procedures, the Agency 

modified proposed tolerance levels for 

certain commodities as follows: 

i. A proposed tolerance at 140 ppm 

for ‘‘Herb, subgroup 19A, dried leaves, 

except chervil, dried and chive, dried’’ 

was established for ‘‘Herb, subgroup 

19A, except chervil and chive’’ at 300 

ppm, and 

ii. A proposed tolerance at 140 ppm 

on timothy, forage, was established at 

200 ppm (tolerance with regional 

registrations), and a proposed tolerance 

of 120 ppm on timothy, hay, was 

established at 150 ppm (tolerance with 

regional registrations). 

3. As petitioned-for, EPA is 

establishing tolerances with regional 

registrations for timothy, forage and 

timothy, hay for regional use in two 

counties, Eureka and Humboldt, in the 

State of Nevada. Applications of 

bifenazate can only be made to timothy 

that is intended for use as horse feed. 

Livestock feedstuffs are not derived 

from the proposed crops of the subject 

petition, except for timothy. The Agency 

is removing existing time-limited 

tolerances established for bifenazate 

under section 18 emergency exemptions 

for timothy, forage and timothy, hay at 

50 ppm and 150 ppm, respectively, as 

they are superseded by this action. 

4. As previously stated, the U.S. 

tolerance for Vegetable, fruiting, group 

8–10 is being changed to 4.0 ppm. This 

is based the use of the OECD calculation 

procedures on data from bell and nonbell pepper studies conducted in the 

United States, and tomato studies 

conducted in Canada and the United 

States. 

In addition, the Agency is revising the 

tolerance expressions for bifenazate 

tolerances in order to conform to current 

EPA policy as follows: 

5. 40 CFR § 180.572(a)(1) is revised to 

read as follows: Tolerances are 

established for residues of bifenazate (1- 

methylethyl 2-(4-methoxy[1,1′- 

biphenyl]-3-yl)hydrazinecarboxylate) 

including its metabolites and 

degradates, in or on the commodities 

listed in the following table. 

Compliance with the tolerance levels 

specified are to be determined by 

measuring only the sum of bifenazate 

and its metabolite, diazinecarboxylic 

acid, 2-(4-methoxy-[1,1’-biphenyl]-3-yl), 

1-methylethyl ester, (calculated as the 

stoichiometric equivalent of bifenazate) 

in or on food commodities, and 

6. The tolerance expression for 40 

CFR § 180.572(a)(2) is modified as 

follows: Tolerances are established for 

residues of bifenazate (1-methylethyl 2- 

(4-methoxy[1,1′-biphenyl]-3-yl) 

hydrazinecarboxylate) including its 

metabolites and degradates, in or on the 

commodities listed in the following 

table. Compliance with the tolerance 

levels specified are to be determined by 

measuring only the sum of bifenazate 

and its metabolites diazinecarboxylic 

acid, 2-(4-methoxy-[1,1′-biphenyl]-3-yl), 

1-methylethyl ester; 1,1′-biphenyl, 4-ol; 

and 1,1′-biphenyl, 4-oxysulfonic acid 

(calculated as the stoichiometric 

equivalent of bifenazate) in or on food 

commodities. 

V. Conclusion 

Therefore, tolerances are established 

for residues of bifenazate (1-methylethyl 

2-(4-methoxy[1,1′-biphenyl]-3- 

yl)hydrazinecarboxylate) including its 

metabolites and degradates, in or on 

Herb subgroup 19A, except chervil and 

chive at 300 ppm, Timothy, forage at 

200 ppm, Timothy, hay at 150 ppm, 

Fruit, pome, group 11–10 at 0.7 ppm 

and Vegetable, fruiting, group 8–10 at 

4.0 ppm. In addition, this regulation 

removes existing tolerances on ‘‘fruit, 

pome, group 11’’ ‘‘vegetable, fruiting, 

group 8’’ and existing time-limited 

tolerances for ‘‘timothy, forage’’ and 

‘‘timothy, hay’’ that are superseded by 

this action. 

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 


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Federal Register / Vol. 79, No. 151 / Wednesday, August 6, 2014 / Rules and Regulations 45701 

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: July 21, 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. Section 180.572 is amended as 

follows: 

■ a. Revise the introductory text in 

paragraph (a)(1); 

■ b. Alphabetically add commodities to 

the table in paragraph (a)(1); 

■ c. Remove from the table in paragraph 

(a)(1) the entries for ‘‘Fruit, pome, group 

11’’ and ‘‘Vegetable, fruiting, group 8’’; 

■ d. Revise the introductory text in 

paragraph (a)(2); 

■ e. Remove and reserve paragraph (b); 

and 

■ f. Add paragraph (c) to read as 

follows: 

§ 180.572 Bifenazate; tolerance for 

residues. 

(a) General. (1) Tolerances are 

established for residues of bifenazate (1- 

methylethyl 2-(4-methoxy[1,1′- 

biphenyl]-3-yl)hydrazinecarboxylate) 

including its metabolites and 

degradates, in or on the commodities 

listed in the following table. 

Compliance with the tolerance levels 

specified are to be determined by 

measuring only the sum of bifenazate 

and its metabolite, diazinecarboxylic 

acid, 2-(4-methoxy-[1,1′-biphenyl]-3-yl), 

1-methylethyl ester, (calculated as the 

stoichiometric equivalent of bifenazate) 

in or on the following food 

commodities: 

Commodity Parts per 

million 

* * * * * 

Fruit, pome, group 11–10 ........... 0 .7 

* * * * * 

Herb, subgroup 19A, except 

chervil and chive ..................... 300 

* * * * * 

Vegetable, fruiting, group 8–10 .. 4 .0 

* * * * * 

(2) Tolerances are established for 

residues of bifenazate (1-methylethyl 2- 

(4-methoxy[1,1′-biphenyl]-3-yl) 

hydrazinecarboxylate) including its 

metabolites and degradates, in or on the 

commodities listed in the following 

table. Compliance with the tolerance 

levels specified are to be determined by 

measuring only the sum of bifenazate 

and its metabolites diazinecarboxylic 

acid, 2-(4-methoxy-[1,1′-biphenyl]-3-yl), 

1-methylethyl ester; 1,1′-biphenyl, 4-ol; 

and 1,1′-biphenyl, 4-oxysulfonic acid 

(calculated as the stoichiometric 

equivalent of bifenazate) in or on the 

following food commodities: 

* * * * * 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. Tolerances with regional 

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

established for residues of bifenazate (1- 

methylethyl 2-(4-methoxy[1,1′- 

biphenyl]-3-yl)hydrazinecarboxylate) 

including its metabolites and 

degradates, in or on the commodities 

listed in the following table. 

Compliance with the tolerance levels 

specified are to be determined by 

measuring only the sum of bifenazate 

and its metabolite, diazinecarboxylic 

acid, 2-(4-methoxy-[1,1′-biphenyl]-3-yl), 

1-methylethyl ester, (calculated as the 

stoichiometric equivalent of bifenazate) 

in or on the following food 

commodities: 

Commodity Parts per 

million 

Timothy, forage ............................. 200 

Timothy, hay ................................. 150 

* * * * * 

[FR Doc. 2014–18041 Filed 8–5–14; 8:45 am] 

BILLING CODE 6560–50–P 


tkelley on DSK3SPTVN1PROD with RULES