56782 Federal Register / Vol. 77, No. 179 / Friday, September 14, 2012 / Rules and Regulations 

purposes of judicial review nor does it 

extend the time within which a petition 

for judicial review may be filed, and 

shall not postpone the effectiveness of 

such rule or action. Parties with 

objections to this direct final rule are 

encouraged to file a comment in 

response to the parallel notice of 

proposed rulemaking for this action 

published in the proposed rules section 

of today’s Federal Register, rather than 

file an immediate petition for judicial 

review of this direct final rule, so that 

EPA can withdraw this direct final rule 

and address the comment in the 

proposed rulemaking. This action may 

not be challenged later in proceedings to 

enforce its requirements. (See section 

307(b)(2).) 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Intergovernmental relations, 

Nitrogen dioxide, Ozone, Reporting and 

recordkeeping requirements, Volatile 

organic compounds. 

Dated: August 30, 2012. 

Jared Blumenfeld, 

Regional Administrator, Region IX. 

Part 52, Chapter I, Title 40 of the Code 

of Federal Regulations is amended as 

follows: 

PART 52—[AMENDED] 

■ 1. The authority citation for Part 52 

continues to read as follows: 

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

Subpart F—California 

■ 2. Section 52.282 is amended by 

adding paragraph (e) to read as follows: 

§ 52.282 Control strategy and regulations: 

Ozone. 

* * * * * 

(e) Determinations of Attainment. 

Effective November 13, 2012. 

(1) Approval of applications for 

extensions of applicable attainment 

dates. Under section 181(a)(5) of the 

Clean Air Act, EPA is approving the 

applications submitted by the California 

Air Resources Board dated March 23, 

2010 and May 24, 2010 for extensions 

of the applicable attainment date for the 

Mariposa and Tuolumne Counties and 

Nevada County 8-hour ozone 

nonattainment areas, respectively, from 

June 15, 2010 to June 15, 2011. 

(2) Determinations of attainment by 

the applicable attainment date. EPA has 

determined that the Amador and 

Calaveras Counties, Chico, Kern County, 

Mariposa and Tuolumne Counties, 

Nevada County, and Sutter County 8- 

hour ozone nonattainment areas in 

California attained the 1997 8-hour 

ozone national ambient air quality 

standard (NAAQS) by their applicable 

attainment dates. The applicable 

attainment dates are as follows: Amador 

and Calaveras Counties (June 15, 2010), 

Chico (June 15, 2007), Kern County 

(June 15, 2010), Mariposa and 

Tuolumne Counties (June 15, 2011), 

Nevada County (June 15, 2011), and 

Sutter County (June 15, 2007). 

(3) Determination of attainment. EPA 

is determining that the Amador and 

Calaveras Counties, Chico, Kern County, 

Mariposa and Tuolumne Counties, 

Nevada County, Sutter County and 

Ventura County 8-hour ozone 

nonattainment areas have attained the 

1997 8-hour ozone standard, based upon 

complete quality-assured data for 2009– 

2011. Under the provisions of EPA’s 

ozone implementation rule (see 40 CFR 

51.918), these determinations suspend 

the attainment demonstrations and 

associated reasonably available control 

measures, reasonable further progress 

plans, contingency measures, and other 

planning SIPs related to attainment for 

as long as the areas continue to attain 

the 1997 8-hour ozone standard. If EPA 

determines, after notice-and-comment 

rulemaking, that any of these areas no 

longer meets the 1997 ozone NAAQS, 

the corresponding determination of 

attainment for that area shall be 

withdrawn. 

[FR Doc. 2012–22469 Filed 9–13–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–1008; FRL–9361–6] 

Bifenthrin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of bifenthrin in or 

on tea, dried; grass, forage; and grass, 

hay. Interregional Research Project 

Number 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). This 

regulation additionally establishes timelimited tolerances in or on apple, 

nectarine, and peach under section 18 of 

the Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA). The timelimited tolerances expire and are 

revoked on December 31, 2015. Finally, 

this regulation removes time-limited 

tolerances on orchardgrass, forage and 

orchardgrass, hay, as they will be 

superseded by permanent tolerances. 

DATES: This regulation is effective 

September 14, 2012. Objections and 

requests for hearings must be received 

on or before November 13, 2012, 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–2009–1008, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

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

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: 

Laura Nollen, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7390; email address: 

nollen.laura@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, but are not limited 

to those engaged in the following 

activities: 

• 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 


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Federal Register / Vol. 77, No. 179 / Friday, September 14, 2012 / Rules and Regulations 56783 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://ecfr.gpoaccess.gov/cgi/t/ 

text/text-idx?&c=ecfr&tpl=/ecfrbrowse/ 

Title40/40tab_02.tpl. To access the 

OCSPP test guidelines referenced in this 

document electronically, please go to 

http://www.epa.gov/ocspp and select 

‘‘Test Methods and Guidelines.’’ 

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–2009–1008 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 November 13, 2012. 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– 

2009–1008, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http:// 

www.epa.gov/dockets/contacts.htm. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at 

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

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of March 19, 

2010 (75 FR 13277) (FRL–8813–2), EPA 

issued a notice pursuant to FFDCA 

section 408(d)(3), 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide 

petition (PP 9E7652) by IR–4, 500 

College Road East, Suite 201W., 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.442 be 

amended by establishing tolerances for 

residues of the insecticide bifenthrin, (2- 

methyl [1,1′-biphenyl]-3-yl) methyl-3-(2- 

chloro-3,3,3,-trifluoro-1-propenyl)-2,2- 

dimethylcyclopropanecarboxylate, in or 

on tea (import tolerance) at 25 parts per 

million (ppm); and tolerances with 

regional registrations in or on grass, 

forage at 2.5 ppm and grass, hay at 4.5 

ppm. That notice referenced a summary 

of the petition prepared on behalf of IR– 

4 by FMC Corporation, the registrant, 

which is available in the docket, http:// 

www.regulations.gov. One comment was 

received on the notice of filing. EPA’s 

response to this comment is discussed 

in Unit IV.C. 

Based upon review of the data 

supporting the petition, EPA has revised 

the proposed tolerances for several 

commodities and revised the 

commodity definition for tea to tea, 

dried. The Agency has also revised the 

tolerance expression for all established 

commodities to be consistent with 

current Agency policy. The reasons for 

these changes are explained in Unit 

IV.D. 

To control the brown marmorated 

stink bug, EPA is also establishing timelimited tolerances for the use of 

bifenthrin in or on apple, nectarine, and 

peach at 0.5 ppm. These tolerances 

expire and are revoked on December 31, 

2015. The Agency is establishing the 

time-limited tolerances in response to 

an informal crisis exemption request 

under FIFRA section 18 on behalf of the 

states of Delaware, Maryland, New 

Jersey, North Carolina, Pennsylvania, 

Virginia, and West Virginia for the 

emergency use of bifenthrin to control 

the brown marmorated stink bug on 

these commodities. 

As part of its evaluation of the 

emergency exemption application, EPA 

assessed the potential risks presented by 

residues of bifenthrin in or on apple, 

nectarine, and peach. In doing so, EPA 

considered the safety standard in 

section 408(b)(2) of FFDCA, and the 

Agency decided that the necessary 

tolerances under section 408(l)(6) of 

FFDCA would be consistent with the 

safety standard and with FIFRA section 

18. Consistent with the need to move 

quickly on the emergency exemption in 

order to address an urgent non-routine 

situation and to ensure that the resulting 

food is safe and lawful, EPA is issuing 

these tolerances without notice and 

opportunity for public comment as 

provided in section 408(l)(6) of FFDCA. 

Although these time-limited tolerances 

expire and are revoked on December 31, 

2015, under section 408(l)(5) of FFDCA, 

residues of the pesticide not in excess 

of the amounts specified in the 

tolerances remaining in or on apple, 

nectarine, and peach after that date will 

not be unlawful, provided the pesticide 

was applied in a manner that was lawful 

under FIFRA, and the residues do not 

exceed a level that was authorized by 

these time-limited tolerances at the time 

of that application. EPA will take action 

to revoke these time-limited tolerances 

earlier if any experience with, scientific 

data on, or other relevant information 

on this pesticide indicate that the 

residues are not safe. 

Because these time-limited tolerances 

are being approved under emergency 

conditions, EPA has not made any 

decisions whether bifenthrin meets 

FIFRA’s registration requirements for 

use in or on apple, nectarine, and peach, 

or whether permanent tolerances for 

this use would be appropriate. Under 

these circumstances, EPA does not 

believe that these time-limited 

tolerances serve as a basis for 

registration of bifenthrin by a State for 

Special Local Needs under FIFRA 

section 24(c). Nor does this tolerance 

serve as the basis for persons in any 

State other than those listed to use this 

pesticide on these crops under FIFRA 

section 18 absent the issuance of an 

emergency exemption applicable within 

that State. For additional information 

regarding the emergency exemption for 

bifenthrin, contact the Agency’s 

Registration Division at the address 

provided under FOR FURTHER

INFORMATION CONTACT. 

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 assessment 

includes exposure through drinking 

water and in residential settings, but 

does not include occupational exposure. 

Section 408(b)(2)(C) of FFDCA requires 


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56784 Federal Register / Vol. 77, No. 179 / Friday, September 14, 2012 / Rules and Regulations 

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 bifenthrin 

including exposure resulting from the 

tolerances, including the time-limited 

tolerances, established by this action. 

EPA’s assessment of exposures and risks 

associated with bifenthrin 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. 

Bifenthrin has a low order of acute 

toxicity via the dermal and inhalation 

routes of exposure and has moderate 

acute toxicity via the oral route. It is 

neither an eye nor skin irritant, and it 

is not a dermal sensitizer. Behavioral 

changes characteristic of Type I 

pyrethroids, such as muscle tremors, 

were noted in most of the bifenthrin 

experimental toxicology studies, 

consistent with its mode of action of 

delaying the inactivatation of voltage 

gated sodium channels. Additional 

effects seen in one or more toxicity 

studies for bifenthrin included muscle 

twitching, decreased grip strength, 

altered landing foot splay, depressed 

respiration, increased grooming counts, 

loss of muscle coordination, staggered 

gait, exaggerated hind limb flexion, and 

convulsions at high doses. Decreased 

body weight, body weight gains and 

food consumption were also noted in 

repeat-dosing dietary studies. Evidence 

of increased qualitative or quantitative 

susceptibility of offspring was not 

observed in any of the available 

guideline toxicity studies for bifenthrin. 

Bifenthrin is classified as a ‘‘possible 

human carcinogen’’ based on an 

increased incidence of urinary bladder 

tumors in mice. However, EPA 

concluded that the bladder tumors may 

not be uncommon in mice and are not 

likely to be malignant. Additionally, 

these tumors were observed only in 

male mice at the highest dose tested and 

the incidence was of borderline 

significance. No evidence of 

carcinogenicity was observed in 

bifenthrin carcinogenicity studies in 

rats, and bifenthrin was negative in five 

different tests for mutagenicity but was 

marginally active in a forward mutation 

test in mouse lymphoma cells. Overall, 

based on the available information, 

there is a low concern for mutagenicity. 

Taking into account all of this 

information, the Agency has determined 

that quantification of risk using a nonlinear approach (i.e., acute populationadjusted dose (aPAD)) will adequately 

account for all chronic toxicity, 

including carcinogenicity that could 

result from exposure to bifenthrin. 

While the Agency would typically use 

a chronic population-adjusted dose 

(cPAD) to protect for cancer concerns, 

use of the aPAD is protective for 

bifenthrin because increasing toxicity 

with increasing duration of exposure is 

not seen for bifenthrin. The no observed 

adverse effect level (NOAEL) observed 

in the mouse chronic study, in which 

tumors were observed, is 6.7 mg/kg/day, 

2-fold higher than the points of 

departure (POD) used for acute risk 

assessment. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by bifenthrin as well as 

the dose at which the motor activity 

change is equal to one standard 

deviation (SD) from the control value 

(BMD1SD), and the lower 95% 

confidence limit of the BMD value (the 

BMDL1SD), resulting from the 

benchmark data (BMD) analysis of the 

toxicity studies can be found at http:// 

www.regulations.gov in document, 

‘‘Bifenthrin: Human Health Risk 

Assessment to Support Section 3 New 

Uses for a Bed Bug Treatment, Grass 

Grown for Seed, Tolerances for 

Imported Tea, and a Section 18 

Emergency Exemption Use on Apple, 

Nectarine, and Peach’’ at pages 62–70 in 

docket ID number EPA–HQ–OPP–2009– 

1008. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological 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. Typically, 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 nonthreshold risks, the Agency assumes 

that any amount of exposure will lead 

to some degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http:// 

www.epa.gov/pesticides/factsheets/ 

riskassess.htm. 

A summary of the toxicological 

endpoints for bifenthrin used for human 

risk assessment is shown in Table 1. of 

this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR BIFENTHRIN 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 (Children < 6 years old) ... BMDL1SD = 3.1 mg/ 

kg.

Acute RfD = 0.031 

mg/kg/day.

Wolansky et al. (2006) BMD1SD = 4.1 mg/kg based on reductions in locomotor activity; supported by multiple 

guideline studies. 

UFA = 10x 

UFH = 10x mg/kg/ 

day 

aPAD = 0.010.


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Federal Register / Vol. 77, No. 179 / Friday, September 14, 2012 / Rules and Regulations 56785 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR BIFENTHRIN 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 

FQPA SF = 3x 

Acute dietary (General population, including ≥ 6 years old).BMDL1SD = 3.1 mg/ 

kg.

Acute RfD = 0.031 

mg/kg/day.

Wolansky et al. (2006) BMD1SD = 4.1 mg/kg based on reductions in locomotor activity; supported by multiple 

guideline studies. 

UFA = 10x 

UFH = 10x aPAD = 0.031 mg/ 

kg/day.

FQPA SF = 3x 

Chronic dietary (All populations) ............ Because of the rapid reversibility of the most sensitive neurotoxicity endpoint used for quantifying 

risks, there is no increase in hazard with increasing dosing duration. Therefore, the acute dietary 

endpoint is protective of the endpoints from repeat dosing studies, including chronic dietary exposures. 

Incidental oral short-term (1 to 30 days) BMDL1SD = 3.1 ......

UFA = 10x 

UFH = 10x 

FQPA SF = 3x 

Residential: < 6 

years old.

LOC is an MOE = 

300 

≥ 6 years old, LOC 

is an MOE = 

100. 

Wolansky et al. (2006). 

BMD1SD = 4.1 mg/kg based on reductions in locomotor activity; supported by multiple guideline studies. 

Dermal short-term (1 to 30 days) ........... BMDL10 = 96.3 mg/ 

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 3x 

Residential: < 6 

years old.

LOC is an MOE = 

300 

≥ 6 years old, LOC 

is an MOE = 

100. 

21-day dermal study in rats. 

BMD10 = 187.0 mg/kg/day, based on exaggerated hind 

limb flexion. 

Occupational: 

Adults, LOC is 

an MOE = 100. 

Inhalation short-term (1 to 30 days) ....... BMDL1SD = 3.1 mg/ 

kg.

UFA = 10x 

UFH = 10x 

FQPA SF = 30x* 

Residential: Adults 

LOC is an MOE 

= 1,000.

Wolansky et al. (2006). 

BMD1SD = 4.1 mg/kg based on reductions in locomotor activity; supported by multiple guideline studies. 

Cancer (Oral, dermal, inhalation) ........... Bifenthrin has been classified as a possible human carcinogen. Because of the rapid reversibility of 

the most sensitive neurotoxicity endpoint used for quantifying risks, there is no increase in hazard with 

increasing dosing duration. Therefore, the acute dietary endpoint is protective of the endpoints from 

repeat dosing studies, including cancer dietary exposures. 

FQPA SF = Food Quality Protection Act Safety Factor. FQPA SF is composed of the 3X factor for increased quantitative susceptibility and the 

10X factor for the inhalation study data gap. 

LOC = level of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. 

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). BMD = benchmark dose. 

SD = standard deviation. BMD1SD = dose level where effect is 1 SD from control value. BMDL1SD = lower 95% confidence limit of the BMD value. 

BMDL10 = dose which has a 10% toxicity change from the controls. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to bifenthrin, EPA considered 

exposure under the petitioned-for 

tolerances and those being established 

in response to the Agency issuing 

section 18 emergency exemptions, as 

well as all existing bifenthrin tolerances 

in 40 CFR 180.442. EPA assessed dietary 

exposures from bifenthrin 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 bifenthrin. In estimating acute 

dietary exposure, EPA used food 

consumption information from the 

United States Department of Agriculture 

(USDA) 1994–1996 and 1998 

Nationwide Continuing Surveys of Food 

Intake by Individuals (CSFII). As to 

residue levels in food, EPA conducted a 

highly-refined, acute probabilistic 

dietary exposure and risk assessment for 

all established food uses as well as the 

petitioned for tolerances and the section 

18 time-limited tolerances. Anticipated 

residues (ARs) were developed based on 

the following: USDA’s Pesticide Data 

Program (PDP) monitoring data from 

1998–2010 for bell pepper, blueberry, 

broccoli, cabbage, cauliflower, cilantro, 

cranberry, cucumber, egg, eggplant, 

grape, grapefruit, orange, orange juice, 

lettuce, pear, cantaloupe, winter squash, 

spinach—canned, succulent bean, 

strawberry, sweet corn, sweet peas, 


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tomato, watermelon and milk; the Food 

and Drug Administration (FDA) 2002 

data for blackberry and raspberry; and 

field trial data for bifenthrin. ARs were 

further refined using percent crop 

treated (PCT) data and processing 

factors, where appropriate. 

Additionally, the uses proposed 

under the section 18 emergency 

exemption program have use patterns 

that are similar to the registered use on 

pear. Therefore, the Agency relied on 

PDP data for pears, including for baby 

food and canned products, when 

assessing anticipated residues on peach, 

nectarine, and apple. EPA believes the 

use of PDP data for pears is appropriate, 

as bifenthrin residues are found mainly 

on the fruit surface and residues on 

peach, nectarine, and apple are 

expected to be similar to those found on 

pear. 

ii. Chronic exposure. Based on the 

data summarized in Unit III.A., there is 

no increase in hazard from repeated 

exposures to bifenthrin; the acute 

dietary exposure assessment is 

protective for chronic dietary exposures 

because acute exposure levels are higher 

than chronic exposure levels. 

Accordingly, a dietary exposure 

assessment for the purpose of assessing 

chronic dietary risk was not conducted. 

iii. Cancer. EPA determines whether 

quantitative cancer exposure and risk 

assessments are appropriate for a fooduse pesticide based on the weight of the 

evidence from cancer studies and other 

relevant data. Cancer risk is quantified 

using a linear or nonlinear approach. If 

sufficient information on the 

carcinogenic mode of action is available, 

a threshold or nonlinear approach is 

used and a cancer RfD is calculated 

based on an earlier noncancer key event. 

If carcinogenic mode of action data are 

not available, or if the mode of action 

data determines a mutagenic mode of 

action, a default linear cancer slope 

factor approach is utilized. Based on the 

data summarized in Unit III.A., the 

Agency has determined that 

quantification of risk using a non-linear 

approach (i.e., aPAD) will adequately 

account for all chronic toxicity, 

including carcinogenicity, that could 

result from exposure to bifenthrin. 

Additionally, since the cancer dietary 

assessment assumed average residue 

levels and the acute assessment used 

high-end residue levels, the acute 

dietary assessment will be protective of 

any cancer effects resulting from 

consumption of bifenthrin residues in 

foods. 

iv. Anticipated residue and 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 estimated the PCT for 

existing uses as follows: 

Alfalfa, 1%; almond, 25%; artichoke, 

30%; beans, green, 50%; broccoli, 6%; 

cabbage, 30%; caneberries, 45%; canola/ 

rapeseed, 3%; cantaloupe, 60%; carrots 

10%; cauliflower, 10%; celery, 1%; 

corn, 5%; cotton, 10%; cucumbers, 

15%; dry beans and peas, 1%; grape, 

table, 1%; grape, wine, 5%; honeydew, 

75%; hazelnut (filberts), 5%; lettuce, 

15%; onion, 1%; lima bean, 35%; 

peanut, 5%; pea, green, 25%; pear, 4%; 

pecan, 5%; pepper, 20%; pistachio, 

40%; potato, 5%; pumpkin, 40%; 

sorghum, 1%; soybean, 5%; squash, 

20%; strawberry, 55%; sweet corn, 50%; 

tomato, 20%; walnut, 25%; watermelon, 

15%; wheat, spring, 1%; and wheat, 

winter, 1%. 

In most cases, EPA uses available data 

from United States Department of 

Agriculture/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 estimated the PCT for the 

new uses associated with the timelimited tolerances as follows: 

Apple, 10%; nectarine, 3%; and 

peach, 7%. 

Bifenthrin is being considered for use 

on apple, nectarine, and peach in 

Delaware, Maryland, New Jersey, North 

Carolina, Pennsylvania, Virginia, and 

West Virginia to control the brown 

marmorated stink bug under FIFRA 

section 18, which allows for the 

emergency use of a pesticide on a site 

for which it is not registered. 

The Agency conservatively estimated 

that 100 percent of the crops in these 

states will be treated with bifenthrin 

and calculated the national PCT given 

the share of utilized production or 

grown acreage from the seven states 

likely to seek the use of bifenthrin. 

EPA used data from 2010 USDA/ 

NASS for apples and peaches. Data on 

the most recent survey years, 2007– 

2009, were used to derive the needed 

PCT estimates. The sum of the utilized 

production in these states was divided 

by the total domestic utilized 

production and multiplied by 100 to 

determine the PCT for each of the crops 

for each of the named years. 

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 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 


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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 bifenthrin 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 bifenthrin in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of bifenthrin. 

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), Pesticide Root 

Zone Model/Exposure Analysis 

Modeling System (PRZM/EXAMS), and 

Screening Concentration in Ground 

Water (SCI–GROW) models, the 

estimated drinking water concentrations 

(EDWCs) of bifenthrin for acute 

exposures are estimated to be 0.0140 

parts per billion (ppb) for surface water 

and 0.0030 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 0.0140 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). Bifenthrin 

is currently registered for several uses 

that could result in residential 

exposures: In indoor residential/ 

household premises as a crack and 

crevice spray, paint additive and as a 

dust, in or on automobiles/recreational 

vehicles, and for termite treatments. 

Residential exposure is also anticipated 

from a pending registration for bed bug 

treatment use, including surfacedirected application to indoor surfaces. 

Outdoor residential uses of bifenthrin 

include broadcast and spot treatments to 

residential lawns and turf; golf course 

turf and outdoor premises by means of 

liquid spray and granular products; and 

ornamental uses (turf, shrubs, vines, 

trees, ground cover). EPA assessed 

residential handler and post-application 

exposures for the existing and proposed 

bed bug uses of bifenthrin. 

The Agency combines risk values 

resulting from separate routes of 

exposure when it is likely they can 

occur simultaneously based on the use 

pattern and the behavior associated with 

the exposed population, and if the 

hazard associated with the points of 

departure is similar across routes. A 

common toxicological endpoint, 

neurotoxicity, exists for dermal, 

incidental oral, and inhalation routes of 

exposure to bifenthrin. Therefore, these 

were combined for all residential 

exposure scenarios assessed. 

Of the proposed and established uses 

with potential residential handler and 

post-application exposure, the following 

high-end risk estimates were selected 

for use in the bifenthrin short-term 

aggregate assessment: Combined dermal 

and inhalation exposures to adults from 

the outdoor ornamental use and 

combined dermal and incidental oral 

exposures to children from contact with 

treated turf. 

Residential handler and postapplication exposure scenarios are 

generally not combined. Although the 

potential exists for the same individual 

(i.e., adult) to apply a pesticide around 

the home and be exposed by re-entering 

a treated area in the same day, this is an 

unlikely exposure scenario. Combining 

these exposure scenarios would also be 

inappropriate because of the 

conservative nature of each individual 

assessment. 

EPA did not assess intermediate-term 

and chronic residential exposures 

because bifenthrin is acutely toxic and 

does not increase in potency with 

repeated dosing. 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.’’ 

The Agency is required to consider 

the cumulative risks of chemicals 

sharing a common mechanism of 

toxicity. The Agency has determined 

that the pyrethroids and pyrethrins, 

including bifenthrin, share a common 

mechanism of toxicity. The members of 

this group share the ability to interact 

with voltage-gated sodium channels, 

ultimately leading to neurotoxicity. The 

cumulative risk assessment for the 

pyrethroids/pyrethrins was published in 

the Federal Register on November 9, 

2011 (76 FR 69726) (FRL–8888–9), and 

is available at http:// 

www.regulations.gov in the public 

docket, EPA–HQ–OPP–2011–0746. 

Further information about the 

determination that pyrethroids and 

pyrethrins share a common mechanism 

of toxicity may be found in document ID 

number: EPA–HQ–OPP–2008–0489– 

0006. 

The Agency has conducted a 

quantitative analysis of the proposed 

bifenthrin bed bug use and has 

determined that it will not contribute 

significantly or change the overall 

findings presented in the pyrethroid 

cumulative risk assessment. This 

analysis is summarized in the 

document: ‘‘Bifenthrin: Human Health 

Risk Assessment to Support Section 3 

New Uses for a Bed Bug Treatment, 

Grass Grown for Seed, Tolerances for 

Imported Tea, and a Section 18 

Emergency Exemption Use on Apple, 

Nectarine, and Peach’’ at pages 78–81 in 

docket ID number EPA–HQ–OPP–2009– 

1008. Further, the proposed food uses of 

bifenthrin will not contribute 

significantly or change the overall 

findings in the pyrethroid cumulative 

risk assessment, as the dietary risks are 

a minor component of total pyrethroid 

cumulative risk. For information 

regarding EPA’s efforts to evaluate the 

risk of exposure to pyrethroids, refer to 

http://www.epa.gov/oppsrrd1/ 

reevaluation/pyrethroidspyrethrins.html. 

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 (10×) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure, unless EPA determines 

based on reliable data, that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10×, or uses a different 

additional safety factor when reliable 

data are available to EPA support the 

choice of a different factor. 

2. Prenatal and postnatal sensitivity. 

The bifenthrin toxicity database 

includes developmental toxicity studies 

in rats and rabbits, a 2-generation 

reproduction study in rats, and a 


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developmental neurotoxicity (DNT) 

study in rats. Bifenthrin is neither a 

developmental nor a reproductive 

toxicant. In the developmental toxicity 

studies in rat and rabbit, no 

developmental effects of biological 

significance were noted in either species 

in the presence of maternal toxicity. In 

a 2-generation reproduction study in the 

rat, tremors were noted only in females 

of both generations with one parental 

generation rat observed to have clonic 

convulsions. 

There are several in vitro and in vivo 

studies that indicate pharmacodynamic 

contributions to pyrethroid toxicity are 

not age-dependent. A study of the 

toxicity database for pyrethroid 

chemicals also noted no residual 

uncertainties regarding age-related 

sensitivities for the young, based on the 

absence of prenatal sensitivity observed 

in 76 guideline studies for 24 

pyrethroids and the scientific literature. 

However, high-dose studies at LD50

doses noted that younger animals were 

more susceptible to the toxicity of 

pyrethroids. These age-related 

differences in toxicity are principally 

due to age-dependent pharmacokinetics; 

the activity of enzymes associated with 

the metabolism of pyrethroids increases 

with age. Nonetheless, the typical 

environmental exposures to pyrethroids 

are not expected to overwhelm the 

clearance capacity in juveniles. In 

support, at a dose of 4.0 mg/kg 

deltamethrin (near the Wolansky study 

LOAEL value of 3.0 mg/kg for 

deltamethrin), the change in the 

acoustic startle response was similar 

between adult and young rats. 

3. Conclusion. Given different levels 

of uncertainty for various risk 

assessment scenarios, EPA is applying 

different FQPA safety factors for the 

protection of fetuses, infants, and 

children depending on the route of 

exposure and the population exposed. 

For non-inhalation exposure scenarios 

for adults (including women of childbearing age) and children greater than 6 

years of age, EPA is reducing the FQPA 

safety factor to 1X. For non-inhalation 

exposure scenarios for infants and 

children less than six years of age, EPA 

is reducing the FQPA safety factor to 

3X. Finally, for inhalation exposure 

scenarios for all population groups, EPA 

is also retaining a 10X FQPA safety 

factor. Because the 3X factor for infants 

and children less than six years of age 

and the 10X factor for inhalation 

exposure scenarios are in response to 

different uncertainties, these safety 

factors have been combined for 

inhalation exposure scenarios for 

infants and children less than six years 

of age resulting in a FQPA safety factor 

of 30X. That decision on the various 

levels of the FQPA safety factor is based 

on the following considerations: 

i. The toxicity database for bifenthrin 

is not complete. EPA lacks additional 

data on immunotoxicity, inhalation 

toxicity, and adult-juvenile sensitivity. 

Recent changes to 40 CFR part 158 

imposed new data requirements for 

immunotoxicity testing (OCSPP 

Guideline 870.7800) for pesticide 

registration. The toxicology database for 

bifenthrin does not show any evidence 

of treatment-related effects on the 

immune system, and the overall weightof-evidence suggests that this chemical 

does not directly target the immune 

system. Therefore, the Agency does not 

believe that conducting a functional 

immunotoxicity study will result in a 

lower POD than that currently in use for 

overall risk assessment, and additional 

safety factors are not needed to account 

for a lack of this study. EPA is requiring 

an inhalation toxicity study for 

bifenthrin because inhalation data for 

other pyrethroids show the potential for 

the inhalation route to be more potent 

than the oral route. Currently, the POD 

for inhalation risk assessment scenarios 

is based on an oral toxicity study. 

Reliance on an oral study raises 

uncertainty as to whether the standard 

safety factors are protective of infants 

and children. Finally, in light of the 

literature studies indicating a possibility 

of increased sensitivity to bifenthrin in 

juvenile rats at high doses, EPA has also 

requested proposals for study protocols 

which could identify and quantify 

bifenthrin’s potential juvenile 

sensitivity. For the reasons discussed in 

Unit III.D.3.ii., the uncertainty regarding 

the protectiveness of the intraspecies 

uncertainty factor raised by the 

literature studies and the absence of the 

requested data warrant application of an 

additional 3X for risk assessments for 

infants and children under six years of 

age. 

ii. There is no evidence that 

bifenthrin 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. This is consistent 

with the results of the guideline preand post-natal testing for other 

pyrethroid pesticides. There are, 

however, high dose LD50 studies 

(studies assessing what dose results in 

lethality to 50 percent of the tested 

population) in the scientific literature 

indicating that pyrethroids can result in 

increased quantitative sensitivity in the 

young. Examination of pharmacokinetic 

and pharmacodynamic data indicates 

that the sensitivity observed at high 

doses is related to pyrethroid agedependent pharmacokinetics—the 

activity of enzymes associated with the 

metabolism of pyrethroids. Predictive 

pharmacokinetic models indicate that 

the differential adult-juvenile 

pharmacokinetics will result in 

otherwise equivalent administered 

doses for adults and juveniles producing 

a 3X greater dose at the target organ in 

juveniles compared to adults. No 

evidence of increased quantitative or 

qualitative susceptibility was seen in 

the pyrethroid scientific literature 

related to pharmacodynamics (the effect 

of pyrethroids at the target tissue) both 

with regard to inter-species differences 

between rats and humans and to 

differences between juveniles and 

adults. Specifically, there are in vitro 

pharmacodynamic data and in vivo data 

indicating similar responses between 

adult and juvenile rats at low doses and 

data indicating that the rat is a 

conservative model compared to the 

human based on species-specific 

pharmacodynamics of homologous 

sodium channel isoforms in rats and 

humans. 

In light of the high dose literature 

studies showing juvenile sensitivity to 

pyrethroids and the absence of the 

requested data on juvenile sensitivity to 

pyrethroids, EPA is retaining a 3X 

additional safety factor as estimated by 

pharmacokinetic modeling. For several 

reasons, EPA concludes there are 

reliable data showing that a 3X factor is 

protective of the safety of infants and 

children. First, the high doses that 

produced juvenile sensitivity in the 

literature studies are well above normal 

dietary or residential exposure levels of 

pyrethroids to juveniles and these lower 

levels of exposure are not expected to 

overwhelm the ability metabolize 

pyrethroids as occurred with the high 

doses used in the literature studies. This 

is confirmed by the lack of a finding of 

increased sensitivity in pre- and postnatal guideline studies in any 

pyrethroid, including bifenthrin, despite 

the relatively high doses used in those 

studies. Second, the portions of both the 

inter- and intraspecies uncertainty 

factors that account for potential 

pharmacodynamic differences 

(generally considered to be 

approximately 3X for each factor) are 

likely to overstate the risk of inter- and 

intraspecies pharmacodynamic 

differences given the data showing 

similarities in pharmacodynamics 

between juveniles and adults and 

between humans and rats. Finally, as 

indicated, pharmacokinetic modeling 

only predicts a 3X difference between 

juveniles and adults. 

iii. There are no residual uncertainties 

identified in the bifenthrin databases 


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with regard to dietary (food and 

drinking water), and residential 

exposures. Although the acute dietary 

exposure estimates are refined, as 

described in Unit III.C.1.i., the exposure 

estimates will not underestimate risk for 

the established and proposed uses of 

bifenthrin since the residue levels used 

are based on either monitoring data 

reflecting actual residues found in the 

food supply, or on high-end residues 

from field trials which reflect the use 

patterns which would result in highest 

residues in foods. Furthermore, 

processing factors used were either 

those measured in processing studies, or 

default high-end factors representing the 

maximum concentration of residue into 

a processed commodity. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to bifenthrin in 

drinking water. Further, postapplication 

exposure of children and incidental oral 

exposure of toddlers are based on 

conservative, health-protective 

assumptions that also ensure exposures 

are not underestimated. These 

assessments will not underestimate the 

exposure and risks posed by bifenthrin. 

Further information about the 

reevaluation of the FQPA safety factor 

for pyrethroids may be found in 

document ID number: EPA–HQ–OPP– 

2011–0746–0011. 

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 assumptions 

discussed in this unit for acute 

exposure, at the 99.9th percentile of 

exposure the acute dietary exposure 

from food and water to bifenthrin will 

occupy 5% of the aPAD for the general 

U.S. population and 29% of the aPAD 

for children 1–2 years old, the 

population group receiving the greatest 

exposure. 

2. Chronic risk. Based on the data 

summarized in Unit III.A., there is no 

increase in hazard with increasing 

dosing duration. Furthermore, chronic 

dietary exposures will be lower than 

acute exposures. Therefore, the acute 

aggregate assessment is protective of 

potential chronic aggregate exposures. 

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). Bifenthrin 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 

bifenthrin. 

For children 1–2 years old, the most 

highly exposed children’s subgroup, 

using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded that the 

combined short-term food, water, and 

residential exposures result in an 

aggregate MOE of 330. Because EPA’s 

level of concern for bifenthrin is a MOE 

of 300 or below, this MOE is not of 

concern. 

For adults, although the short-term 

dermal and inhalation risks were 

estimated using the same oral POD, 

these exposure estimates could not be 

directly combined for the adult shortterm exposure assessment because the 

LOCs for dermal and inhalation routes 

of exposure are not the same (an MOE 

of < 100 defines the LOC for dermal 

exposure while inhalation risk is 

defined by an MOE of < 1,000). 

Accordingly an aggregate risk index 

(ARI) was required to estimate aggregate 

risk for adults. EPA identifies an ARI at 

or below one as a risk estimate of 

concern. The short-term aggregate ARI 

for adults is 2.0. An ARI greater than 1 

indicates risks that are not of concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). An 

intermediate-term aggregate risk 

assessment was not conducted because 

bifenthrin is acutely toxic and does not 

increase in potency with repeated 

dosing. Because the neurotoxicity POD 

used for acute risk assessment is lower 

(more protective) than PODs for longer 

durations of exposure and acute and 

short-term exposure levels are higher 

than longer term exposure levels, the 

acute and short-term aggregate 

assessments are protective for 

intermediate-term aggregate risks 

anticipated from bifenthrin exposure. 

5. Aggregate cancer risk for U.S. 

population. For the reasons discussed in 

Unit III.A. (cancer effects are non-linear 

and appear at higher doses than acute 

effects) and Unit III.E.2. (chronic 

exposures are lower than acute 

exposures), the acute aggregate 

assessment is protective of potential 

cancer risk. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

with reasonable certainty that no harm 

will result to the general population, or 

to infants and children from aggregate 

exposure to bifenthrin residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

An adequate method, utilizing gas 

chromatography with electron capture 

detection (GC/ECD), is available to 

enforce the proposed tolerances for 

plant commodities. 

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 an 

MRL for bifenthrin. However, Codex has 

proposed a 30 ppm MRL for green and 

black tea (fermented and dried). The 

United States has recommended a 

tolerance on tea, dried at 30 ppm in 

order to harmonize with the proposed 

Codex MRL. 

C. Response to Comments 

EPA received one comment to the 

notice of filing that stated, in part, that 

no residue should be allowed for 

bifenthrin. The Agency understands the 

commenter’s concerns and recognizes 

that some individuals believe that 

pesticides should be banned on 

agricultural crops. However, the existing 


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legal framework provided by section 

408 of the FFDCA states that tolerances 

may be set when persons seeking such 

tolerances or exemptions have 

demonstrated that the pesticide meets 

the safety standard imposed by that 

statute. This citizen’s comment appears 

to be directed at the underlying statute 

and not EPA’s implementation of it; the 

citizen has made no contention that 

EPA has acted in violation of the 

statutory framework. 

D. Revisions to Petitioned-for 

Tolerances 

Based on the data supporting the 

petitions, EPA revised the proposed 

tolerance on grass, forage from 2.5 ppm 

to 4.0 ppm; and grass, hay from 4.5 ppm 

to 15 ppm. The Agency revised these 

tolerance levels based on analysis of the 

residue field trial data using the 

Organization for Economic Cooperation 

and Development (OECD) tolerance 

calculation procedures. Additionally, 

EPA revised the proposed tolerance on 

tea from 25 ppm to 30 ppm, in order to 

harmonize with the proposed Codex 

MRL associated with the commodity. 

EPA also revised the proposed 

commodity definition for tea to tea, 

dried in order to reflect the correct 

commodity nomenclature. 

Finally, the Agency has revised the 

tolerance expression to clarify (1) that, 

as provided in FFDCA section 408(a)(3), 

the tolerance covers metabolites and 

degradates of bifenthrin not specifically 

mentioned; and (2) that 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 bifenthrin, (2-methyl 

[1,1′-biphenyl]-3-yl) methyl-3-(2-chloro3,3,3,-trifluoro-1-propenyl)-2,2- 

dimethylcyclopropanecarboxylate, in or 

on grass, forage at 4.0 ppm; grass, hay 

at 15 ppm; and tea, dried at 30 ppm. 

This regulation additionally establishes 

time-limited tolerances for residues of 

bifenthrin in or on apple, nectarine, and 

peach at 0.5 ppm. Finally, this 

regulation removes time-limited 

tolerances in or on orchardgrass, forage 

at 2.5 ppm; and orchardgrass, hay at 4.5 

ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA), 44 

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

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

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

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (2 U.S.C. 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: September 10, 2012. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR part 180 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 § 180.442: 

■ a. Revise paragraph (a)(1) introductory 

text. 

■ b. Add alphabetically the commodity 

to the table in paragraph (a)(1). 

■ c. Revise the footnote to the table in 

paragraph (a)(1). 

■ d. Revise paragraph (b). 

■ e. Revise paragraph (c). 

The revisions and addition read as 

follows: 

§ 180.442 Bifenthrin; tolerances for 

residues. 

(a) General. (1) Tolerances are 

established for residues of the 

insecticide bifenthrin, 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 bifenthrin, (2-methyl 

[1,1′-biphenyl]-3-yl) methyl-3-(2-chloro3,3,3,-trifluoro-1-propenyl)-2,2- 

dimethylcyclopropanecarboxylate. 

Commodity Parts per 

million 

* * * * * 

Tea, dried 1 ................................. 30 

* * * * * 

1There are no U.S. registrations. 

* * * * * 


wreier-aviles on DSK5TPTVN1PROD with RULES
Federal Register / Vol. 77, No. 179 / Friday, September 14, 2012 / Rules and Regulations 56791 

(b) Section 18 emergency exemptions. 

Time-limited tolerances are established 

for residues of the insecticide 

bifenthrin, including its metabolites and 

degradates, in connection with use of 

the pesticide under a Section 18 

emergency exemption granted by EPA. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only bifenthrin, (2-methyl 

[1,1′-biphenyl]-3-yl) methyl-3-(2-chloro3,3,3,-trifluoro-1-propenyl)-2,2- 

dimethylcyclopropanecarboxylate. 

These tolerances will expire and are 

revoked on the dates specified in the 

following table: 

Commodity Parts per 

million 

Expiration/ 

revocation 

date 

Apple ............... 0.5 12/31/2015 

Nectarine ........ 0.5 12/31/2015 

Peach .............. 0.5 12/31/2015 

(c) Tolerances with regional 

registrations. Tolerances with regional 

registrations are established for residues 

of the insecticide bifenthrin, 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 bifenthrin, (2-methyl 

[1,1′-biphenyl]-3-yl) methyl-3-(2-chloro3,3,3,-trifluoro-1-propenyl)-2,2- 

dimethylcyclopropanecarboxylate. 

Commodity Parts per 

million 

Grass, forage ........................ 4.0 

Grass, hay ............................ 15 

* * * * * 

[FR Doc. 2012–22772 Filed 9–13–12; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 665 

[Docket No. 120628195–2414–02] 

RIN 0648–XC089 

Main Hawaiian Islands Deep 7 

Bottomfish Annual Catch Limits and 

Accountability Measures for 2012–13 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Final specifications. 

SUMMARY: In this rule, NMFS specifies a 

quota of 325,000 lb of Deep 7 bottomfish 

in the main Hawaiian Islands for the 

2012–13 fishing year, based on an 

annual catch limit of 346,000 lb. The 

action supports the long-term 

sustainability of Hawaii bottomfish. 

DATES: The final specifications are 

effective October 15, 2012 through 

August 31, 2013, unless NMFS 

publishes a document in the Federal 

Register superseding these 

specifications. 

ADDRESSES: Copies of the Fishery 

Ecosystem Plan for the Hawaiian 

Archipelago are available from the 

Western Pacific Fishery Management 

Council (Council), 1164 Bishop St., 

Suite 1400, Honolulu, HI 96813, tel 

808–522–8220, fax 808–522–8226, or 

www.wpcouncil.org. 

FOR FURTHER INFORMATION CONTACT: 

Jarad Makaiau, NMFS PIR Sustainable 

Fisheries, 808–944–2108. 

SUPPLEMENTARY INFORMATION: On August 

2, 2012, NMFS published proposed 

specifications that are finalized here, 

and a request for public comments (77 

FR 46014). Additional background 

information on this action is found in 

the preamble to the proposed 

specifications, and is not repeated here. 

Through this action, NMFS is 

specifying a quota (annual catch target, 

ACT) of 325,000 lb of Deep 7 bottomfish 

in the main Hawaiian Islands (MHI) for 

the 2012–13 fishing year, based on an 

annual catch limit (ACL) of 346,000 lb. 

The MHI Management Subarea is the 

portion of U.S. Exclusive Economic 

Zone around the Hawaiian Archipelago 

lying to the east of 161° 20′ W. 

longitude. The Deep 7 bottomfish are 

onaga (Etelis coruscans), ehu (E. 

carbunculus), gindai (Pristipomoides 

zonatus), kalekale (P. sieboldii), 

opakapaka (P. filamentosus), lehi 

(Aphareus rutilans), and hapuupuu 

(Epinephelus quernus). The Council 

recommended the quota and ACL based 

on the best available scientific, 

commercial, and other information, 

taking into account the associated risk 

of overfishing. 

The MHI bottomfish fishing year 

starts September 1, 2012. NMFS will 

monitor the fishery, and if the is quota 

is projected to be reached before August 

31, 2013, NMFS will close the noncommercial and commercial fisheries 

for Deep 7 bottomfish in Federal waters 

through August 31, 2013. During a 

fishery closure for Deep 7 bottomfish, 

no person may fish for, possess, or sell 

any of these fish in the MHI, except as 

otherwise authorized by law 

(specifically, vessels with valid Pacific 

Remote Island Areas bottomfish fishing 

permits are not affected by the closure). 

There is no prohibition on fishing for or 

selling other non-Deep 7 bottomfish 

species throughout the year. All other 

management measures continue to 

apply in the MHI bottomfish fishery. 

Comments and Responses 

The comment period for the proposed 

specifications ended on August 17, 

2012. NMFS received comments and 

responds as follows: 

Comment 1: The annual catch limit is 

a management tool that will ensure fish 

stocks for future generations to come. 

Response: NMFS agrees. Federal law 

requires NMFS and the Council to 

manage fisheries using annual catch 

limits. NMFS and the Council 

developed the annual catch limit using 

the best available scientific and 

commercial information and in 

consideration of scientific uncertainty 

and social and economic factors. The 

use of an annual catch limit, annual 

catch target and accountability measure 

will help prevent overfishing and 

ensure sustainable, long-term catches 

for fishermen. 

Comment 2: The combination of 

measures to prevent overfishing by the 

Federal government (through ACL and 

AM), and by the State of Hawaii 

(through spatial restrictions, or 

bottomfish restricted fishing areas) are 

duplicative, disadvantaging certain 

fishing communities, and NMFS should 

remove the bottomfish restricted fishing 

areas, or at least those in Federal waters. 

Response: While the State and Federal 

bottomfish regulations may appear to be 

duplicative, they are not. In 1998, the 

State of Hawaii established by 

administrative rule the bottomfish 

restricted fishing areas. At that time, in 

the absence of Federal regulations these 

areas were intended specifically to 

prevent overfishing. Some of the 

restricted areas were located in Federal 

waters. The Council and NMFS 

recognized that the administration and 

enforcement of these areas were and 

continue to be, the responsibility of the 

State, and any change to the 

management of the bottomfish restricted 

fishing areas is the purview of the State. 

The Council subsequently (in 2008) 

developed, and NMFS implemented, the 

first Hawaii bottomfish quota system. 

The Federal quota measures 

complement, but do not duplicate, State 

restricted area measures. The combined 

State and Federal bottomfish 

management programs include a mix of 

minimum fish sizes, non-commercial 

bag limits, restricted fishing areas, catch 

limits, gear restrictions, permits and 


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