3860 Federal Register / Vol. 65, No. 16 / Tuesday, January 25, 2000 / Rules and Regulations

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300963; FRL–6485–2]

RIN 2070–AB78

Bifenthrin; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

time-limited tolerances for residues of

bifenthrin (2-methyl [1,1’-biphenyl]-3-

yl)methyl-3-(2-chloro-3,3,3,-trifluoro-1-

propenyl)-2,2-

dimethylcyclopropanecarboxylate) in or

on grapes and peanut nutmeats. This

action is in response to EPA’s granting

of emergency exemptions under section

18 of the Federal Insecticide, Fungicide,

and Rodenticide Act authorizing use of

the pesticide on grapes and peanuts.

This regulation establishes maximum

permissible levels for residues of

bifenthrin in these food commodities.

The tolerances will expire and is

revoked on December 31, 2001.

DATES: This regulation is effective

January 25, 2000. Objections and

requests for hearings, identified by

docket control number OPP–300963,

must be received by EPA on or before

March 27, 2000.

ADDRESSES: Written objections and

hearing requests may be submitted by

mail, in person, or by courier. Please

follow the detailed instructions for each

method as provided in Unit VII. of the

‘‘SUPPLEMENTARY INFORMATION.’’

To ensure proper receipt by EPA, your

objections and hearing requests must

identify docket control number OPP–

300963 in the subject line on the first

page of your response.

FOR FURTHER INFORMATION CONTACT: By

mail: Andrea Beard, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, Ariel Rios Building, 1200

Pennsylvania Avenue, NW.,

Washington, DC 20460; telephone

number: (703) 308–9356; and e-mail

address: beard.andrea@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. Potentially

affected categories and entities may

include, but are not limited to:

CategoriesNAICS

codes

Examples of potentially affected entities

Industry 111 Crop production

112 Animal production

311 Food manufacturing

32532 Pesticide manufacturing

This listing is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

affected by this action. Other types of

entities not listed in the table could also

be affected. The North American

Industrial Classification System

(NAICS) codes have been provided to

assist you and others in determining

whether or not this action might apply

to certain entities. If you have questions

regarding the applicability of this action

to a particular entity, consult the person

listed under FOR FURTHER INFORMATION

CONTACT.

B. How Can I Get Additional

Information, Including Copies of This

Document and Other Related

Documents?

1. Electronically. You may obtain

electronic copies of this document, and

certain other related documents that

might be available electronically, from

the EPA Internet Home Page at http://

www.epa.gov/. To access this

document, on the Home Page select

‘‘Laws and Regulations’’ and then look

up the entry for this document under

the ‘‘Federal Register--Environmental

Documents.’’ You can also go directly to

the Federal Register listings at http://

www.epa.gov/fedrgstr/.

2. In person. The Agency has

established an official record for this

action under docket control number

OPP–300963. The official record

consists of the documents specifically

referenced in this action, and other

information related to this action,

including any information claimed as

Confidential Business Information (CBI).

This official record includes the

documents that are physically located in

the docket, as well as the documents

that are referenced in those documents.

The public version of the official record

does not include any information

claimed as CBI. The public version of

the official record, which includes

printed, paper versions of any electronic

comments submitted during an

applicable comment period is available

for inspection in the Public Information

and Records Integrity Branch (PIRIB),

Rm. 119, Crystal Mall 2, 1921 Jefferson

Davis Hwy., Arlington, VA, from 8:30

a.m. to 4 p.m., Monday through Friday,

excluding legal holidays. The PIRIB

telephone number is (703) 305–5805.

II. Background and Statutory Findings

EPA, on its own initiative, in

accordance with sections 408(l)(6) of the

Federal Food, Drug, and Cosmetic Act

(FFDCA), 21 U.S.C. 346a, is establishing

tolerances for residues of the insecticide

bifenthrin (2-methyl [1,1’-biphenyl]-3-

yl)methyl-3-(2-chloro-3,3,3,-trifluoro-2-

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

dimethylcyclopropanecarboxylate), in

or on grapes at 0.2 part per million

(ppm), and in/on peanut nutmeats at

0.05 ppm. These tolerances will expire

and are revoked on December 31, 2001.

EPA will publish a document in the

Federal Register to remove the revoked

tolerances from the Code of Federal

Regulations.

Section 408(l)(6) of the FFDCA

requires EPA to establish a time-limited

tolerance or exemption from the

requirement for a tolerance for pesticide

chemical residues in food that will

result from the use of a pesticide under

an emergency exemption granted by

EPA under section 18 of FIFRA. Such

tolerances can be established without

providing notice or period for public

comment. EPA does not intend for its

actions on section 18 related tolerances

to set binding precedents for the

application of section 408 and the new

safety standard to other tolerances and

exemptions.

Section 408(b)(2)(A)(i) of the 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) 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) 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. . . .’’

Section 18 of the Federal Insecticide,

Fungicide, and Rodenticide Act (FIFRA)

authorizes EPA to exempt any Federal

or State agency from any provision of

FIFRA, if EPA determines that

‘‘emergency conditions exist which

require such exemption.’’ This

provision was not amended by the Food

Quality Protection Act (FQPA). EPA has

Federal Register / Vol. 65, No. 16 / Tuesday, January 25, 2000 / Rules and Regulations 3861

established regulations governing such

emergency exemptions in 40 CFR part

166.

III. Emergency Exemptions for

Bifenthrin on Grapes and Peanuts and

FFDCA Tolerances

1. Bifenthrin on grapes. The

Applicant states that when the special

local needs registration for carbofuran

was canceled in 1997, the grape growers

were left without adequate control for

the black vine weevil, a seriously

damaging pest in vineyards. Black vine

weevil populations build up to

damaging levels gradually, tending not

to be pests in younger vineyards. Thus,

this pest was generally not present at

significant levels immediately following

loss of carbofuran; however, the

applicant states that this year,

populations have been reaching

damaging levels. The applicant stated

that none of the available alternatives

provide adequate control to avoid

significant economic losses from this

pest in grapes.

2. Bifenthrin on peanuts. The

Applicant states that although spider

mite infestations have affected peanut

growers for some years, the infestations

have exceeded economically significant

levels in recent years, and applications

of available pesticides did not prevent

these populations from rebounding

quickly. In 1999, mite populations

established earlier than normal, and the

registered miticides were ineffective at

providing adequate control, particularly

with the hot dry weather conditions

which are conducive to mite outbreaks.

Additionally, it is believed that the mild

winter contributed to a high

overwintering survival rate, thus

infestations were established earlier.

With the infestations beginning so early,

growers had to make multiple

treatments with the alternatives, and

were on the verge of using up their legal

number of applications of these

materials. However, spider mite

outbreaks were still occurring at

significantly damaging levels, and the

Applicant stated that the use of

bifenthrin was needed to avert

significant economic losses from

occurring. EPA has authorized under

FIFRA section 18 the uses of bifenthrin

on grapes for control of black vine

weevil in Washington, and on peanuts

for control of spider mites in Oklahoma.

After having reviewed the submissions,

EPA concurs that emergency conditions

exist for these States.

As part of its assessment of this

emergency exemption, EPA assessed the

potential risks presented by residues of

bifenthrin in or on grapes and peanut

nutmeats. In doing so, EPA considered

the safety standard in FFDCA section

408(b)(2), and EPA decided that the

necessary tolerances under FFDCA

section 408(l)(6) would be consistent

with the safety standard and with

FIFRA section 18. Consistent with the

need to move quickly on the emergency

exemptions in order to address urgent

non-routine situations 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). Although these tolerances will

expire and are revoked on December 31,

2001, under FFDCA section 408(l)(5),

residues of the pesticide not in excess

of the amounts specified in the

tolerances remaining in or on grapes

and peanut nutmeats after that date will

not be unlawful, provided the pesticide

is applied in a manner that was lawful

under FIFRA, and the residues do not

exceed levels that were authorized by

these tolerances at the time of that

application. EPA will take action to

revoke these 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 tolerances are being

approved under emergency conditions,

EPA has not made any decisions about

whether bifenthrin meets EPA’s

registration requirements for use on

grapes and peanuts or whether

permanent tolerances for these uses

would be appropriate. Under these

circumstances, EPA does not believe

that these tolerances serve as a basis for

registration of bifenthrin by a State for

special local needs under FIFRA section

24(c). Nor do these tolerances serve as

the basis for any State other than

Washington or Oklahoma to use this

pesticide on these crops under section

18 of FIFRA without following all

provisions of EPA’s regulations

implementing section 18 as identified in

40 CFR part 166. For additional

information regarding the emergency

exemptions for bifenthrin, contact the

Agency’s Registration Division at the

address provided under FOR FURTHER

INFORMATION CONTACT.

IV. Aggregate Risk Assessment and

Determination of Safety

EPA performs a number of analyses to

determine the risks from aggregate

exposure to pesticide residues. For

further discussion of the regulatory

requirements of section 408 and a

complete description of the risk

assessment process, see the final rule on

Bifenthrin Pesticide Tolerances (62 FR

62961, November 26, 1997) (FRL–5754–

7).

Consistent with 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 bifenthrin and to make a

determination on aggregate exposure,

consistent with section 408(b)(2), for

time-limited tolerances for residues of

bifenthrin (2-methyl [1,1’-biphenyl]-3-

yl)methyl-3-(2-chloro-3,3,3,-trifluoro-2-

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

dimethylcyclopropanecarboxylate) on

grapes at 0.2 ppm, and on peanut

nutmeats at 0.05 ppm. EPA’s assessment

of the dietary exposures and risks

associated with establishing the

tolerances follows.

A. Toxicological Profile

EPA has evaluated the available

toxicity data and considered its validity,

completeness, and reliability as well as

the relationship of the results of the

studies to human risk. EPA has also

considered available information

concerning the variability of the

sensitivities of major identifiable

subgroups of consumers, including

infants and children. The nature of the

toxic effects caused by bifenthrin are

discussed in Unit II.A. of the Final Rule

on Bifenthrin Pesticide Tolerances

published in the Federal Register on

June 30, 1999 (64 FR 35051) (FRL–

6089–9).

B. Toxicological Endpoint

The toxicological endpoints for

bifenthrin are discussed in Unit II.B. of

the Final Rule on Bifenthrin Pesticide

Tolerances published in the Federal

Register on June 30, 1999.

C. Exposures and Risks

1. From food and feed uses.

Tolerances have been established (40

CFR 180.442) for the residues of

bifenthrin (2-methyl [1,1’-biphenyl]-3-

yl)methyl-3-(2-chloro-3,3,3,-trifluoro-2-

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

dimethylcyclopropanecarboxylate), in

or on a variety of raw agricultural

commodities. Tolerances are established

on plant commodities ranging from 0.05

ppm on field corn grain to 10 ppm on

dried hops. Tolerances are also

established on animal commodities

including meat, meat byproducts, and

fat of cattle, goats, hogs, horses, poultry,

sheep, and milk and eggs. Risk

assessments were conducted by EPA to

assess dietary exposures and risks from

bifenthrin as follows:

The acute dietary (food only) risk

assessment was conducted by Novigen

Science, Inc. In this acute analysis,

Monte Carlo analysis (Tier 3) was used.

For those foods identified by EPA as

3862 Federal Register / Vol. 65, No. 16 / Tuesday, January 25, 2000 / Rules and Regulations

single-serving commodities, Monte

Carlo simulation is based on iterative

sampling from individual residue values

from field trial data reflecting maximum

application rates and minimum

preharvest intervals. For those

considered to be blended or processed,

mean field trial residues were

calculated, substituting those samples

for which residues were reported at or

below the limit of detection (LOD) with

one-half of the LOD. It was assumed that

100% of the crop was treated for the

following tolerances: canola, citrus,

snap beans, peas, lima beans, sweet

corn, cucurbits, eggplant, and Brassica

vegetable. One hundred percent crop

treated was also assumed for these

section 18 uses for grapes and peanuts.

Secondary residues for meat and milk

were derived from the total dietary

burden and tissue-to-feed ratio, using

the highest ratio for meat, and the

average ratio for milk.

This analysis evaluates individual

food consumption as reported by

respondents in the USDA Continuing

Surveys of Food Intake by Individuals

(CSFII) conducted in 1989 through

1992. The model accumulates exposure

to the chemical for each commodity and

expresses risk as a function of exposure

to residues in food. This is a highly

refined assessment since percent of crop

treated (PCT) was used (except as

indicated above) and anticipated

residues for all crops.

In conducting this Dietary Exposure

Evaluation Model (DEEM) analysis for

chronic food risk assessment, Novigen

used anticipated residue values which

were determined from field trial data

conducted at maximum label conditions

of maximum application rates and

minimum preharvest intervals. Mean

anticipated residue values were

calculated, substituting one-half of the

LOD for those samples for which

residues were reported below the LOD.

It was assumed that 100% crop treated

for all crops except hops at 43%,

cottonseed-oil and cottonseed-meal at

4%. Secondary residues for meat and

milk were derived from the total dietary

burden and tissue-to-feed ratio, using

the average ratio for meat and milk. The

analysis evaluates individual food

consumption as reported by

respondents in the USDA CSFII

conducted in 1989 through 1992.

i. Acute exposure and risk. Acute

dietary 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. The

percentages of the acute PAD (aPAD)

utilized at the 99.9th percentile of

exposure are 60% for the U.S.

population, 75% for infants (< 1 year),

and 99.7% for children (1 - 6 years old),

the most highly exposed population

subgroup. An acute dietary exposure

(food plus water) of 100% or less of the

aPAD is needed to protect the safety of

all population subgroups.

ii. Chronic exposure and risk. Dietary

exposure (food only) for the most highly

exposed population subgroup (children

1 - 6 years old), will utilize 8.2% of the

chronic PAD (cPAD). The exposure for

the U.S. population is 3% of the cPAD.

A chronic dietary exposure (food plus

water) of 100% or less of the cPAD is

needed to protect the safety or all

population subgroups.

Section 408(b)(2)(E) authorizes EPA to

use available data and information on

the anticipated residue levels of

pesticide residues in food and the actual

levels of pesticide chemicals that have

been measured in food. If EPA relies on

such information, EPA must require 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. Following the initial data

submission, EPA is authorized to

require similar data on a time frame it

deems appropriate. As required by

section 408(b)(2)(E), EPA will issue a

data call-in for information relating to

anticipated residues to be submitted no

later than 5 years from the date of

issuance of this tolerance.

Section 408(b)(2)(F) states that the

Agency may use data on the actual

percent of food treated for assessing

chronic dietary risk only if the Agency

can make the following findings:

Condition 1, that 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 such pesticide residue;

Condition 2, that the exposure estimate

does not underestimate exposure for any

significant subpopulation group; and

Condition 3, if 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 percent crop treated

(PCT) as required by section

408(b)(2)(F), EPA may require

registrants to submit data on PCT.

The Agency used PCT information as

follows. It was assumed that 100% crop

was treated for all crops except hops at

43%, and cottonseed-oil and

cottonseed-meal at 4%.

The Agency believes that the three

conditions listed above have been met.

With respect to Condition 1, PCT

estimates are derived from Federal and

private market survey data, which are

reliable and have a valid basis. EPA uses

a weighted average PCT for chronic

dietary exposure estimates. This

weighted average PCT figure is derived

by averaging State-level data for a

period of up to 10 years, and weighting

for the more robust and recent data. A

weighted average of the PCT reasonably

represents a person’s dietary exposure

over a lifetime, and is unlikely to

underestimate exposure to an individual

because of the fact that pesticide use

patterns (both regionally and nationally)

tend to change continuously over time,

such that an individual is unlikely to be

exposed to more than the average PCT

over a lifetime. For acute dietary

exposure estimates, EPA uses an

estimated maximum PCT. The exposure

estimates resulting from this approach

reasonably represent the highest levels

to which an individual could be

exposed, and are unlikely to

underestimate an individual’s acute

dietary exposure. The Agency is

reasonably certain that the percentage of

the food treated is not likely to be an

underestimated. As to Conditions 2 and

3, 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

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 information on the

regional consumption of food to which

bifenthrin may be applied in a

particular area.

2. From drinking water. A Drinking

Water Level of Comparison (DWLOC) is

a theoretical upper limit on a pesticide’s

concentration in drinking water in light

of total aggregate exposure to a pesticide

in food, drinking water, and through

residential uses. A DWLOC will vary

depending on the toxic endpoint,

drinking water consumption, and body

weights. Different populations will have

different DWLOCs. The Agency uses

DWLOCs internally in the risk

assessment process as a surrogate

measure of potential exposure

associated with pesticide exposure

Federal Register / Vol. 65, No. 16 / Tuesday, January 25, 2000 / Rules and Regulations 3863

through drinking water. In the absence

of monitoring data for pesticides, it is

used as a point of comparison against

conservative model estimates of a

pesticide’s concentration in water.

DWLOC values are not regulatory

standards for drinking water. They do

have an indirect regulatory impact

through aggregate exposure and risk

assessments. The estimated acute and

chronic drinking water concentrations

were generated with the EPA’s Pesticide

Root Zone Model/Exposure Analysis

Modeling Systems (PRZM/EXAMS)

model using the highest application rate

of 0.5 pounds/acre, which is registered

for use on cotton.

i. Acute exposure and risk. For the

purposes of this acute risk assessment,

the estimated acute maximum

concentration for bifenthrin in surface

and ground waters is 0.10 μg/L, which

was used for comparison to the backcalculated DWLOCs for the acute

endpoint. The DWLOCs for various

population categories are 140 μg/L for

the U.S. population, 180 μg/L for

females 13 years and older, and 0.3 μg/

L for children 1 - 6 years old. Acute

exposure to bifenthrin in drinking water

is below the calculated drinking water

levels of concern.

ii. Chronic exposure and risk. For the

purposes of the chronic risk assessment,

the estimated chronic maximum

concentration for bifenthrin in surface

and ground waters is 0.032 μg/L, which

was used for comparison to the backcalculated human health DWLOCs from

the chronic (non-cancer) endpoint.

These DWLOCs for various population

categories are 530 μg/L for the U.S.

population, 450 μg/L for females 13

years and older, and 140 μg/L for

children 1 - 6 years old. Chronic

exposure to bifenthrin in drinking water

is below the calculated drinking water

levels of concern.

iii.Short- and intermediate-term

exposure and risk (water). For purposes

of short- and intermediate-term risk

assessment, the estimated chronic

maximum concentration for bifenthrin

in surface and ground waters is 0.032

μg/L, which was used for comparison to

the back-calculated human health

DWLOCs from the short- and

intermediate-term endpoints. The

DWLOCs for various population

categories are 320 μg/L for the U.S.

population, 270 μg/L for females 13

years and older, and 77 μg/L for

children 1 - 6 years old. Short- and

intermediate-term exposure to

bifenthrin in drinking water is below

the calculated drinking water levels of

concern.

3. From non-dietary exposure.

Bifenthrin is currently registered for use

on the following residential non-food

sites: outdoor lawn and garden, inside

households, and termiticide use. These

registered uses constitute short- and/or

intermediate and chronic exposure.

i. Chronic exposure and risk.

Although the registered termiticide use

of bifenthrin constitutes a chronic

exposure scenario, the exposure from

this termiticide use is negligible

considering the application technique of

the termiticide use (buried

underground) and the fact that the vapor

pressure of bifenthrin is extremely low.

ii. Short- and intermediate-term

exposure and risk. This risk assessment

is based on post-application to treated

lawns (turf use), a worst case scenario

estimate of residential exposure. An

assessment of applicator exposure was

not included since the registered

products are primarily limited to

commercial use and, therefore, applied

by professional lawn care operators.

Inhalation, dermal, and oral non-dietary

routes of exposure were evaluated by

this short- and intermediate-term risk

assessment. For adults, the routes of

exposure from these registered

residential uses include dermal and

inhalation, and for infants and children,

the routes of exposure include dermal,

inhalation, and oral (nondietary). The

MOEs for residential exposures are

1,600 for adults, 610 for children (1 - 6

years), and 600 for infants (<≤ 1 year).

These MOEs are well above the

acceptable short-term aggregate MOE of

100.

4. Cumulative exposure to substances

with a common mechanism of toxicity.

Section 408(b)(2)(D)(v) 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.’’

Bifenthrin is a member of a class of

chemicals commonly referred to as

‘‘Synthetic Pyrethroids.’’ Other

members of the class include cyfluthrin,

cypermethrin, lambda-cyhalothrin, zetacypermethrin, deltamethrin,

esfenvalerate, fenpropathrin, tefluthrin,

and tralomethrin.

EPA does not have, at this time,

available data to determine whether

bifenthrin has a common mechanism of

toxicity with other substances or how to

include this pesticide in a cumulative

risk assessment. Unlike other pesticides

for which EPA has followed a

cumulative risk approach based on a

common mechanism of toxicity,

bifenthrin does not appear to produce a

toxic metabolite produced by other

substances. For the purposes of this

tolerance action, therefore, EPA has not

assumed that bifenthrin has a common

mechanism of toxicity with other

substances. For more 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 the final rule for

Bifenthrin Pesticide Tolerances (62 FR

62961, November 26, 1997).

D. Aggregate Risks and Determination of

Safety for U.S. Population

1. Acute risk (food plus water). Using

the Monte Carlo analysis, it is estimated

that the acute exposure to bifenthrin

from food for the U.S. population

subgroup will utilize 60% of the aPAD.

Children 1 to 6 years are the most highly

exposed population subgroup, with

99.7% of the aPAD utilized. (See

discussion in Unit II.E.) An acute

dietary exposure (food plus water) of

100% or less of the aPAD is needed to

protect the safety of all population

subgroups. Despite the potential for

exposure to bifenthrin in drinking

water, EPA does not expect the

aggregate exposure to exceed 100% of

the aPAD for adults, infants and

children. The estimated maximum

concentration of bifenthrin in surface

and ground water for acute exposure is

below all DWLOCs.

2. Chronic risk (food plus water plus

residential). Using the exposure

assumptions described in this unit, EPA

has concluded that aggregate exposure

to bifenthrin from food will utilize 3%

of the cPAD for the U.S. population. The

major identifiable subgroup with the

highest aggregate exposure is children 1

to 6 years, with 8.2% of the cPAD

utilized. [See discussion in Unit II.E. in

the preamble of this document]. EPA

generally has no concern for exposures

below 100% of the cPAD because the

cPAD represents the level at or below

which daily aggregate dietary exposure

over a lifetime will not pose appreciable

risks to human health. Despite the

potential for exposure to bifenthrin in

drinking water, EPA does not expect the

aggregate exposure to exceed 100% of

the cPAD, the estimated maximum

concentration of bifenthrin in surface

and ground water for chronic exposure

is very small compared to the DWLOCs.

Although the registered termiticide use

of bifenthrin constitutes a chronic

exposure scenario, the exposure from

this termiticide use is negligible

considering the application technique of

the termiticide use (buried

underground) and the fact that vapor

pressure of bifenthrin is extremely low.

3. Short- and intermediate-term risk.

Short- and intermediate-term aggregate

3864 Federal Register / Vol. 65, No. 16 / Tuesday, January 25, 2000 / Rules and Regulations

exposure takes into account chronic

dietary food and water (considered to be

a background exposure level) plus

indoor and outdoor residential

exposure.

In the case of bifenthrin, the

registered residential use sites include

outdoor lawn/gardens, inside

households and termiticide. These uses

constitute a short- and intermediateterm exposure scenario. The short- and

intermediate-term aggregate risk

assessment for bifenthrin includes

inhalation, dermal, oral non-dietary,

chronic food, and water exposure

routes. The acceptable MOEs for shortand intermediate-term exposures are all

at 100. For adults, the routes of

exposure from these registered,

residential uses include dermal and

inhalation, and for infants and children,

the routes of exposure include dermal,

inhalation, and oral (non-dietary). The

MOEs for food (excluding water) and

residential exposures is 1,100 for adults,

420 for children 1 to 6 years, and 500

for infants < 1 year. These MOEs are all

above the acceptable short-term

aggregate MOE of 100.

Since residue values in drinking

water are not available, the DWLOCs

have to be back-calculated. The shortand intermediate-term DWLOCs are 290

μg/L for adult males, 250 μg/L for adult

females, 77 μg/L for children 1 to 6

years, and 77 μg/L for infants (< 1 year

old). The estimated maximum

concentration of bifenthrin in surface

and ground water for chronic exposure

0.032 μg/L is very small compared to the

DWLOCs.

4. Aggregate cancer risk for U.S.

population. Bifenthrin has been

classified as a group C carcinogen, using

the Reference Dose (RfD) approach.

Based on the recommendation that the

RfD approach be used, a quantitative

(q*) dietary cancer risk assessment was

not performed. Dietary risk concerns

due to long-term consumption of

bifenthrin are adequately addressed by

the DEEM chronic exposure analysis

using the cPAD RfD. For the U.S.

population, only 3% of the cPAD RfD is

occupied by chronic food exposure. As

stated previously, based on a

comparison of the calculated DWLOCs

and the estimated exposure to bifenthrin

in drinking water (0.032 μg/L), EPA

does not expect the aggregate exposure

to exceed 100% of the cPAD RfD for

adults.

5. Determination of safety. Based on

these risk assessments, EPA concludes

that there is a reasonable certainty that

no harm will result from aggregate

exposure to bifenthrin residues.

E. Aggregate Risks and Determination of

Safety for Infants and Children

1. Safety factor for infants and

children— i. In general. In assessing the

potential for additional sensitivity of

infants and children to residues of

bifenthrin, EPA considered data from

developmental toxicity studies in the rat

and rabbit and a 2-generation

reproduction study in the rat. The

developmental toxicity studies are

designed to evaluate adverse effects on

the developing organism resulting from

maternal pesticide exposure during

gestation. Reproduction studies provide

information relating to effects from

exposure to the pesticide on the

reproductive capability of mating

animals and data on systemic toxicity.

FFDCA section 408 provides that EPA

shall apply an additional tenfold 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 data base unless

EPA determines that a different margin

of safety will be safe for infants and

children. Margins of safety are

incorporated into EPA risk assessments

either directly through use of a margin

of exposure (MOE) analysis or through

using uncertainty (safety) factors in

calculating a dose level that poses no

appreciable risk to humans. EPA

believes that reliable data support using

the standard MOE and uncertainty

factor (usually 100 for combined

interspecies and intraspecies variability)

and not the additional tenfold MOE/

uncertainty factor when EPA has a

complete data base under existing

guidelines and when the severity of the

effect in infants or children or the

potency or unusual toxic properties of a

compound do not raise concerns

regarding the adequacy of the standard

MOE/safety factor.

ii. Developmental toxicity studies. In

the rabbit developmental study, there

were no developmental effects observed

in the fetuses exposed to bifenthrin. The

maternal NOAEL was 2.67 mg/kg/day

based on head and forelimb twitching at

the LOAEL of 4 mg/kg/day. In the rat

developmental study, the maternal

NOAEL was 1 mg/kg/day, based on

tremors at the LOAEL of 2 mg/kg/day.

The developmental (pup) NOAEL was

also 1 mg/kg/day, based upon increased

incidence of hydroureter at the LOAEL

2 mg/kg/day. There were 5 of 23 (22%)

litters affected with each litter having

only 1 affected pup in the 2 mg/kg/day

group, compared with zero in the

control, 1 and 0.5 mg/kg/day groups.

According to recent historical data

(1992-1994) for this strain of rat,

incidence of distended ureter averaged

11% with a maximum incidence of

90%.

iii. Reproductive toxicity study. In the

rat reproduction study, parental toxicity

occurred as decreased bwt at 5.0 mg/kg/

day with a NOAEL of 3.0 mg/kg/day.

There were no developmental (pup) or

reproductive effects up to 5.0 mg/kg/day

(HDT).

iv. Prenatal and postnatal

sensitivity— a.Prenatal. Since there was

not a dose-related finding of hydroureter

in the rat developmental study and in

the presence of similar incidences in the

recent historical control data, the

marginal finding of hydroureter in rat

fetuses at 2 mg/kg/day (in the presence

of maternal toxicity) is not considered a

significant developmental finding. Nor

does it provide sufficient evidence of a

special dietary risk (either acute or

chronic) for infants and children which

would require an additional safety

factor.

b. Postnatal. Based on the absence of

pup toxicity up to dose levels which

produced toxicity in the parental

animals, there is no evidence of special

postnatal sensitivity to infants and

children in the rat reproduction study.

v. Conclusion. There is a complete

toxicity data base for bifenthrin and

exposure data are complete or are

estimated based on data that reasonably

accounts for potential exposures. Based

on the completeness of the toxicity data

and prenatal and postnatal toxicity of

bifenthrin, no additional safety factor is

needed to protect infants and children.

2. Acute risk (food plus water.) The

percentages of the aPAD utilized at the

99.9th percentile of exposure are 75%

for infants (< 1 year) and 99.7% for

children (1 to 6 years), the most highly

exposed population subgroup. An acute

dietary exposure (food plus water) of

100% or less of the aPAD is needed to

protect the safety of all population

subgroups. Despite the potential for

exposure to bifenthrin in drinking

water, EPA does not expect the

aggregate exposure to exceed 100% of

the aPAD for infants and children. The

estimated maximum concentration of

bifenthrin in surface and ground water

for acute exposure is below the

DWLOCs.

3. Chronic risk. Using the exposure

assumptions described in this unit, EPA

has concluded that aggregate exposure

to bifenthrin from food will utilize 8.2%

of the cPAD for children (1 - 6 years

old), the most highly exposed subgroup

for infants and children. EPA generally

has no concern for exposures below

100% of the cPAD because the cPAD

represents the level at or below which

daily aggregate dietary exposure over a

lifetime will not pose appreciable risks

Federal Register / Vol. 65, No. 16 / Tuesday, January 25, 2000 / Rules and Regulations 3865

to human health. Despite the potential

for exposure to bifenthrin in drinking

water and from non-dietary, nonoccupational exposure, EPA does not

expect the aggregate exposure to exceed

100% of the cPAD.

4. Short- or intermediate-term risk.

The MOEs for food (excluding water)

and residential exposures is 430 for

children (1 to 6 years), and 500 for

infants (< 1 year). These MOEs are well

above the acceptable short-term

aggregate MOE of 100. The short- and

intermediate-term DWLOCs are 77 μg/L

for children (1 to 6 years), and 77 μg/

L for infants (< 1 year). The estimated

maximum concentration of bifenthrin in

surface and ground water for chronic

exposure ( 0.032 μg/L) is very small

compared to the DWLOCs.

5. Determination of safety. Based on

these risk assessments, EPA concludes

that there is a reasonable certainty that

no harm will result to infants and

children from aggregate exposure to

bifenthrin residues.

V. Other Considerations

A. Metabolism in Plants and Animals

The metabolism of bifenthrin in

plants and animals is adequately

understood. Studies conducted to

delineate the metabolism of radiolabeled bifenthrin in various crops and

animals show similar results. The

residue of concern is the parent

compound only.

B. Analytical Enforcement Methodology

Adequate enforcement methods are

available for determination of the

regulated bifenthrin residue in plants

and animals. Residues of bifenthrin are

recoverable under Protocols D and E of

the FDA Multiresidue Methods.

C. Magnitude of Residues

Residues of bifenthrin are not

expected to exceed 0.2 ppm in/on

grapes, and 0.05 ppm in/on peanut

nutmeats, as a result of these uses. Since

the use on peanuts prohibits the feeding

of peanut hay to livestock, the existing

tolerances for livestock commodities are

considered to be adequate.

D. International Residue Limits

There are no Codex Maximum

Residue Levels (MRLs) for these

commodities.

E. Rotational Crop Restrictions

Crops with established U.S. tolerances

may be rotated at any time. Leafy

vegetable and root crops may be rotated

30 days following the final application.

All other crops may be rotated 7 months

following the final application.

VI. Conclusion

Therefore, the tolerances are

established for residues of bifenthrin (2-

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

chloro-3,3,3,-trifluoro-2-chloro-3,3,3,-

trifluoro-1-propenyl)-2,2-

dimethylcyclopropanecarboxylate) in

grapes at 0.2 ppm, and in peanut,

nutmeats, at 0.05 ppm.

VII. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as

amended by the FQPA, any person may

file an objection to any aspect of this

regulation and may also request a

hearing on those objections. The EPA

procedural regulations which govern the

submission of objections and requests

for hearings appear in 40 CFR part 178.

Although the procedures in those

regulations require some modification to

reflect the amendments made to the

FFDCA by the FQPA of 1996, EPA will

continue to use those procedures, with

appropriate adjustments, until the

necessary modifications can be made.

The new section 408(g) provides

essentially the same process for persons

to ‘‘object’’ to a regulation for an

exemption from the requirement of a

tolerance issued by EPA under new

section 408(d), as was provided in the

old FFDCA sections 408 and 409.

However, the period for filing objections

is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an

Objection or Request a Hearing?

You must file your objection or

request a hearing on this regulation in

accordance with the instructions

provided in this unit and in 40 CFR part

178. To ensure proper receipt by EPA,

you must identify docket control

number OPP–300963 in the subject line

on the first page of your submission. All

requests must be in writing, and must be

mailed or delivered to the Hearing Clerk

on or before March 27, 2000.

1.Filing the request. Your objection

must specify the specific provisions in

the regulation that you object to, and the

grounds for the objections (40 CFR

178.25). If a hearing is requested, the

objections must include a statement of

the factual issues(s) on which a hearing

is requested, the requestor’s contentions

on such issues, and a summary of any

evidence relied upon by the objector (40

CFR 178.27). Information submitted in

connection with an objection or hearing

request may be claimed confidential by

marking any part or all of that

information as CBI. Information so

marked will not be disclosed except in

accordance with procedures set forth in

40 CFR part 2. A copy of the

information that does not contain CBI

must be submitted for inclusion in the

public record. Information not marked

confidential may be disclosed publicly

by EPA without prior notice.

Mail your written request to: Office of

the Hearing Clerk (1900), Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. You may also

deliver your request to the Office of the

Hearing Clerk in Rm. M3708, Waterside

Mall, 401 M St., SW., Washington, DC

20460. The Office of the Hearing Clerk

is open from 8 a.m. to 4 p.m., Monday

through Friday, excluding legal

holidays. The telephone number for the

Office of the Hearing Clerk is (202) 260–

4865.

2. Tolerance fee payment. If you file

an objection or request a hearing, you

must also pay the fee prescribed by 40

CFR 180.33(i) or request a waiver of that

fee pursuant to 40 CFR 180.33(m). You

must mail the fee to: EPA Headquarters

Accounting Operations Branch, Office

of Pesticide Programs, P.O. Box

360277M, Pittsburgh, PA 15251. Please

identify the fee submission by labeling

it ‘‘Tolerance Petition Fees.’’

EPA is authorized to waive any fee

requirement ‘‘when in the judgement of

the Administrator such a waiver or

refund is equitable and not contrary to

the purpose of this subsection.’’ For

additional information regarding the

waiver of these fees, you may contact

James Tompkins by phone at (703) 305–

5697, by e-mail at

tompkins.jim@epa.gov, or by mailing a

request for information to Mr. Tompkins

at Registration Division (7505C), Office

of Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460.

If you would like to request a waiver

of the tolerance objection fees, you must

mail your request for such a waiver to:

James Hollins, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460.

3. Copies for the Docket. In addition

to filing an objection or hearing request

with the Hearing Clerk as described in

Unit VII.A., you should also send a copy

of your request to the PIRIB for its

inclusion in the official record that is

described in Unit I.B.2. Mail your

copies, identified by the docket control

number OPP–300963, to: Public

Information and Records Integrity

Branch, Information Resources and

Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person or by

courier, bring a copy to the location of

the PIRIB described in Unit I.B.2. You

may also send an electronic copy of

3866 Federal Register / Vol. 65, No. 16 / Tuesday, January 25, 2000 / Rules and Regulations

your request via e-mail to: oppdocket@epa.gov. Please use an ASCII

file format and avoid the use of special

characters and any form of encryption.

Copies of electronic objections and

hearing requests will also be accepted

on disks in WordPerfect 6.1/8.0 file

format or ASCII file format. Do not

include any CBI in your electronic copy.

You may also submit an electronic copy

of your request at many Federal

Depository Libraries.

B. When Will the Agency Grant a

Request for a Hearing?

A request for a hearing will be granted

if the Administrator determines that the

material submitted shows the following:

There is a genuine and substantial issue

of fact; there is a reasonable possibility

that available evidence identified by the

requestor would, if established resolve

one or more of such issues in favor of

the requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issues(s) in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

VIII. Regulatory Assessment

Requirements

This final rule establishes time

limited tolerances under FFDCA section

408. 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). 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., or impose any

enforceable duty or contain any

unfunded mandate as described under

Title II of the Unfunded Mandates

Reform Act of 1995 (UMRA) (Public

Law 104–4). Nor does it require any

prior consultation as specified by

Executive Order 13084, entitled

Consultation and Coordination with

Indian Tribal Governments (63 FR

27655, May 19, 1998); special

considerations as required by Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994); or require OMB review or any

Agency action under Executive Order

13045, entitled Protection of Children

from Environmental Health Risks and

Safety Risks (62 FR 19885, April 23,

1997). 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), Public Law 104–113, section

12(d) (15 U.S.C. 272 note). Since

tolerances and exemptions that are

established on the basis of a FIFRA

section 18 petition under FFDCA

section 408, 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. In addition, the

Agency has determined that this action

will not have a substantial direct effect

on States, on the relationship between

the national government and the States,

or on the distribution of power and

responsibilities among the various

levels of government, as specified in

Executive Order 13132, entitled

Federalism (64 FR 43255, August 10,

1999). Executive Order 13132 requires

EPA to develop an accountable process

to ensure ‘‘meaningful and timely input

by State and local officials in the

development of regulatory policies that

have federalism implications.’’ ‘‘Policies

that have federalism implications’’ is

defined in the Executive Order to

include regulations that have

‘‘substantial direct effects on the States,

on the relationship between the national

government and the States, or on the

distribution of power and

responsibilities among the various

levels of government.’’ This final rule

directly regulates growers, food

processors, food handlers and food

retailers, not States. This action does not

alter the relationships or distribution of

power and responsibilities established

by Congress in the preemption

provisions of FFDCA section 408(n)(4).

IX. Submission to Congress and the

Comptroller General

The Congressional Review Act, 5

U.S.C. 801 et seq., as added by the Small

Business Regulatory Enforcement

Fairness Act of 1996, generally provides

that before a rule may take effect, the

agency promulgating the rule must

submit a rule report, which includes a

copy of the rule, to each House of the

Congress and to the Comptroller General

of the United States. EPA will submit a

report containing this 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 this final

rule in the Federal Register. This final

rule is not a ‘‘major rule’’ as defined by

5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: January 7, 2000.

James Jones,

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), 346(a) and

371.

2. Section 180.442 is amended, by

adding and alphabetically inserting the

following entries to the table under

paragraph (b) to read as follows:

§ 180.442 Bifenthrin; tolerances for

residues.

* * * * *

(b) * * *

Commodity Parts per

million

Expiration/

revocation

date

* ****

Grapes .................. 0.2 12/31/01

* ****

Peanuts, nutmeats 0.05 12/31/01

* ****

*****

[FR Doc. 00–1667 Filed 1–24–00; 8:45 am]

BILLING CODE 6560–50–F

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

50 CFR Part 17

RIN 1018–AE44

Endangered and Threatened Wildlife

and Plants; Endangered Status for the

Plant Plagiobothrys hirtus (Rough

Popcornflower)

AGENCY: Fish and Wildlife Service,

Interior.

ACTION: Final rule.

SUMMARY: We, the U.S. Fish and

Wildlife Service, have determined

endangered status pursuant to the

Endangered Species Act of 1973 (Act),

as amended, for the plant Plagiobothrys

hirtus (rough popcornflower). This

species is restricted to wet swales and

meadows in Douglas County, Oregon,

where only 17 habitat patches exist for

this species. Most populations are small

with few individuals. The total