57972 Federal Register / Vol. 65, No. 188 / Wednesday, September 27, 2000 / Rules and Regulations

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 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. 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: September 12, 2000.

Susan B. Hazen,

Acting Director, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180 — [AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

371.

2. Section 180.563 is added to read as

follows:

§ 180.563 Ethametsulfuron- methyl;

tolerances for residues.

(a)General. [Reserved]

(b)Section 18 emergency exemptions.

A time-limited tolerance is established

for ethametsulfuron-methyl (Methyl 2-

(((((4-ethoxy-6- (methylamino)-1,3,5-

triazin-2-yl)amino)carbonyl)

amino)sulfonyl)benzoate) in or on

canola in connection with the use of the

pesticide under section 18 exemptions

granted by EPA. The time-limited

tolerance will expire on the date

specified in the following table:

Commodity Parts per

million

Expiration/

Revocation

Date

Canola 0.02 12/31/01

(c)Tolerances with regional

registrations. [Reserved]

(d)Indirect of inadvertent residues.

[Reserved]

[FR Doc. 00–24784 Filed 9–26–00; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301047; FRL–6744–4]

RIN 2070–AB78

Bifenthrin; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time–limited tolerance for residues of

bifenthrin in or on potato. 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 potatoes. This

regulation establishes a maximum

permissible level for residues of

bifenthrin in this food commodity. The

tolerance will expire and is revoked on

December 31, 2002.

DATES: This regulation is effective

September 27, 2000. Objections and

requests for hearings, identified by

docket control number OPP–301047,

must be received by EPA on or before

November 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–301047 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Andrea Conrath, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., 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:

Categories NAICS

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

Federal Register / Vol. 65, No. 188 / Wednesday, September 27, 2000 / Rules and Regulations 57973

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,’’ ‘‘Regulations

and Proposed Rules,’’ and then look up

the entry for this document under the

‘‘Federal Register—Environmental

Documents.’’ You can also go directly to

theFederal 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–301047. 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, 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 a tolerance for residues of

the pesticide bifenthrin, in or on potato

at 0.05 part per million (ppm). This

tolerance will expire and is revoked on

December 31, 2002. EPA will publish a

document in the Federal Register to

remove the revoked tolerance 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

established regulations governing such

emergency exemptions in 40 CFR part

166.

III. Emergency Exemption for

Bifenthrin on Potatoes and FFDCA

Tolerances

Two–spotted spider mites have

recently emerged as a major potato pest

in the Pacific Northwest. This pest can

reach damaging numbers as a result of

spray programs to control other pests,

which disrupts natural biological

predators that would normally keep the

spider mite populations in check.

Damaging levels of spider mites have

occurred in Washington and Oregon,

and the registered alternatives do not

provide adequate control. They are more

slow acting, and lack the residual

control of bifenthrin, and do not control

heavier mite populations quickly

enough to prevent economic damage.

Significant economic losses are

expected for the Pacific Northwest

potato growers if this pest cannot be

adequately controlled. Bifenthrin has

been shown to be effective at controlling

spider mites. EPA has authorized under

FIFRA section 18 the use of bifenthrin

on potatoes for control of spider mites

in Washington and Oregon. After having

reviewed the submission, 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 potato. In doing so,

EPA considered the safety standard in

FFDCA section 408(b)(2), and EPA

decided that the necessary tolerance

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 exemption in order to

address an urgent non–routine situation

and to ensure that the resulting food is

safe and lawful, EPA is issuing this

tolerance without notice and

opportunity for public comment as

provided in section 408(l)(6). Although

this tolerance will expire and is revoked

on December 31, 2002, under FFDCA

section 408(l)(5), residues of the

pesticide not in excess of the amounts

specified in the tolerance remaining in

or on potato 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 a level that was authorized by

this tolerance at the time of that

application. EPA will take action to

revoke this tolerance earlier if any

experience with, scientific data on, or

other relevant information on this

pesticide indicate that the residues are

not safe.

Because this tolerance is being

approved under emergency conditions,

EPA has not made any decisions about

whether bifenthrin meets EPA’s

registration requirements for use on

potatoes or whether a permanent

tolerance for this use would be

appropriate. Under these circumstances,

EPA does not believe that this tolerance

serves 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

any State other than Washington and

Oregon to use this pesticide on this crop

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

57974 Federal Register / Vol. 65, No. 188 / Wednesday, September 27, 2000 / Rules and Regulations

emergency exemption 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 a

time-limited tolerance for residues of

bifenthrin in or on potato at 0.05 ppm.

EPA’s assessment of the dietary

exposures and risks associated with

establishing the tolerance follows.

A. Toxicological Endpoints

The dose at which no observed

adverse effects level are observed (the

NOAEL) from the toxicology study

identified as appropriate for use in risk

assessment is used to estimate the

toxicological endpoint. However, the

lowest dose at which adverse effects of

concern are identified (the LOAEL) is

sometimes used for risk assessment if no

NOAEL was achieved in the toxicology

study selected. An uncertainty factor

(UF) is applied to reflect uncertainties

inherent in the extrapolation from

laboratory animal data to humans and in

the variations in sensitivity among

members of the human population as

well as other unknowns. An UF of 100

is routinely used, 10X to account for

interspecies differences and 10X for

intra species differences.

For dietary risk assessment (other

than cancer) the Agency uses the UF to

calculate an acute or chronic reference

dose (acute RfD or chronic RfD) where

the RfD is equal to the NOAEL divided

by the appropriate UF (RfD=NOAEL/

UF). Where an additional safety factor is

retained due to concerns unique to the

FQPA, this additional factor is applied

to the RfD by dividing the RfD by such

additional factor. The acute or chronic

Population Adjusted Dose (aPAD or

cPAD) is a modification of the RfD to

accommodate this type of FQPA Safety

Factor.

For non–dietary risk assessments

(other than cancer) the UF is used to

determine the level of concern (LOC).

For example, when 100 is the

appropriate UF (10X to account for

interspecies differences and 10X for

intraspecies differences) the LOC is 100.

To estimate risk, a ratio of the NOAEL

to exposures (margin of exposure

(MOE)= NOAEL/exposure) is calculated

and compared to the LOC.

The linear default risk methodology

(Q*) is the primary method currently

used by the Agency to quantify

carcinogenic risk. The Q* approach

assumes that any amount of exposure

will lead to some degree of cancer risk.

A Q* is calculated and used to estimate

risk which represents a probability of

occurrence of additional cancer cases

(e.g., risk is expressed as 1 x 10-6 or one

in a million). Under certain specific

circumstances, MOE calculations will

be used for the carcinogenic risk

assessment. In this non–linear

approach, a ‘‘point of departure’’ is

identified below which carcinogenic

effects are not expected. The point of

departure is typically a NOAEL based

on an endpoint related to cancer effects

though it may be a different value

derived from the dose response curve.

To estimate risk, a ratio of the point of

departure to exposure (MOEcancer = point

of departure/exposures) is calculated. A

summary of the toxicological endpoints

for Bifentherin used for human risk

assessment is shown in the following

Table 1:

TABLE 1.—SUMMARY OF TOXICOLOGICAL ENDPOINTS FOR BIFENTHRIN FOR USE IN HUMAN RISK ASSESSMENT

Exposure scenario Dose used in risk assessment, UF FQPA SF* and level of concern

for risk assessment

Study and toxicological

effect

Acute dietary (All populations)Oral NOAEL = 1.0 mg/kg/day

UF=100 Acute RfD: 0.01 mg/kg/

day

Acute population adjusted dose (aPAD)

aPAD =acute RfD = 0.01 mg/kg/day FQPA

SF = 1X

Developmental toxicity,

rats—tremors in dams

during & post dosing

Chronic dietary (All populations)Oral dietary exposure NOAEL =1.5

mg/kg/day UF = 100 Chronic RfD:

0.015 mg/kg/day

Chronic population adjusted dose (cPAD)

cPAD = chronic RfD = 0.015 mg/kg/day

FQPA SF = 1X

Chronic oral, dogs—tremors in both sexes

Short term dermal (1–7

days) (Residential)

Dermal exposure Oral NOAEL =1.0

mg/kg/day (Use dermal absorption

rate = 25%)

MOE = 100 FQPA SF = 1X Developmental toxicity, rats

– tremors in dams during

& post dosing

Intermediate term dermal

(one week to several

months) (Residential)

Dermal exposure oral NOAEL =1.0

mg/kg/day (use dermal absorption

rate=25%)

MOE = 100 FQPA SF = 1X Developmental toxicity, rats

– tremors in dams during

& post dosing

Chronic dermal (several

month to lifetime) (Residential)

Dermal exposure oral NOAEL =1.5

mg/kg/day (use dermal absorption

rate = 25%)

MOE=100 FQPA SF = 1X Chronic oral, dogs – tremors in both sexes

All time periods: inhalation

(Residential)

Inhalation exposure Oral NOAEL =

1.0 mg/kg/day (use inhalation absorption rate = 100%)

MOE=100 risk assessment should be inclusive of dietary & inhalation exposure components FQPA SF = 1XDevelopmental toxicity, rats

– tremors in dams during

& post dosing (No appropriate inhalation studies

available)

Cancer Dietary/dermal/inhalation exposure

group C carcinogen

use RfD approach FQPA SF = 1X Carcinogenicity, mice – urinary bladder tumors in

male mice

* The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique to the FQPA. In this case,

the FQPA Safety Factor for enhanced sensitivity of infants and children was reduced to 1X (explained further below under (C)).

Federal Register / Vol. 65, No. 188 / Wednesday, September 27, 2000 / Rules and Regulations 57975

B. Exposure Assessment

1. Dietary exposure from food and

feed uses. Tolerances have been

established (40 CFR 180.442) for the

residues of bifenthrin, in or on a variety

of raw agricultural commodities, (RAC)

ranging from 0.05 ppm for corn grain to

10 ppm for dried hops. Tolerances are

also established on animal commodities

ranging from 0.05 ppm on eggs to 1.0

ppm in milk fat. Risk assessments were

conducted by EPA to assess dietary

exposures from bifenthrin in food as

follows:

i. Acute exposure. 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 one

day or single exposure. The Dietary

Exposure Evaluation Model (DEEMDM)

analysis evaluated the individual food

consumption as reported by

respondents in the USDA [insert 1989–

1992 or 1994–1996] nationwide

Continuing Surveys of Food Intake by

Individuals (CSFII) and accumulated

exposure to the chemical for each

commodity. The following assumptions

were made for the acute exposure

assessments: In this acute analysis,

probabilistic Monte Carlo analysis (Tier

3) was used. For those foods identified

by EPA as single-serving commodities,

the 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 foods considered to be blended or

processed, mean field trial residues

were calculated. For those samples

which contained residues at or below

the limit of detection (LOD), 1/2 of the

LOD was used. It was assumed that

100% of the following crops were

treated with bifenthrin: artichoke,

bananas, brassica vegetable, caneberry,

canola, citrus, cucurbits, eggplants,

garden peas, grape, head lettuce, lima

beans, peanuts, pears, peppers, potatoes,

snap beans, and sweet corn. Processing

factors for grapes were calculated using

concentration factors (grape juice =

1.2X, raisins = 4.2X). Secondary

residues for meat and milk were not

affected since no animal feed items are

associated with these crops. Percent of

crop treated values and anticipated

residues were not used.

ii. Chronic exposure. In conducting

this chronic dietary risk assessment the

Dietary Exposure Evaluation Model

(DEEMDM) analysis evaluated the

individual food consumption as

reported by respondents in the USDA

[insert 1989–1992 or 1994–1996]

nationwide Continuing Surveys of Food

Intake by Individuals (CSFII) and

accumulated exposure to the chemical

for each commodity. The following

assumptions were made for the chronic

exposure assessments: Anticipated

residue values were determined from

field trial data conducted at label

conditions of maximum application

rates and minimum preharvest intervals.

Mean anticipated residue values were

calculated. 100% of crop treated was

assumed for all crops except hops (43%)

and cottonseed–oil and cottonseed–

meal (4%). Secondary residues for meat

and milk were not affected by this use.

iii. Cancer. For cancer risk the

assessment is the same as the risk

assessment for the chronic exposure,

described above.

iv. Anticipated residue and percent

crop treated information. 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 callin 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 percent crop treated

(PCT) information as follows: 100% of

crop treated was assumed for all crops

except hops (43%) and cottonseed–oil

and cottonseed–meal (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

underestimation. 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. Dietary exposure from drinking

water. The Agency lacks sufficient

monitoring exposure data to complete a

comprehensive dietary exposure

analysis and risk assessment for

bifenthrin in drinking water. Because

the Agency does not have

comprehensive monitoring data,

drinking water concentration estimates

are made by reliance on simulation or

modeling taking into account data on

57976 Federal Register / Vol. 65, No. 188 / Wednesday, September 27, 2000 / Rules and Regulations

the physical characteristics of

bifenthrin.

The Agency uses the Generic

Estimated Environmental Concentration

(GENEEC) or the Pesticide Root Zone/

Exposure Analysis Modeling System

(PRZM/EXAMS) to estimate pesticide

concentrations in surface water and

SCI–GROW, which predicts pesticide

concentrations in ground water. In

general, EPA will use GENEEC (a tier 1

model) before using PRZM/EXAMS (a

tier 2 model) for a screening–level

assessment for surface water. The

GENEEC model is a subset of the PRZM/

EXAMS model that uses a specific high–

end runoff scenario for pesticides.

GENEEC incorporates a farm pond

scenario, while PRZM/EXAMS

incorporate an index reservoir

environment in place of the previous

pond scenario. The PRZM/EXAMS

model includes a percent crop area

factor as an adjustment to account for

the maximum percent crop coverage

within a watershed or drainage basin.

None of these models include

consideration of the impact processing

(mixing, dilution, or treatment) of raw

water for distribution as drinking water

would likely have on the removal of

pesticides from the source water. The

primary use of these models by the

Agency at this stage is to provide a

coarse screen for sorting out pesticides

for which it is highly unlikely that

drinking water concentrations would

ever exceed human health levels of

concern.

Since the models used are considered

to be screening tools in the risk

assessment process, the Agency does

not use estimated environmental

concentrations (EECs) from these

models to quantify drinking water

exposure and risk as a percent RfD or

percent PAD. Instead drinking water

levels of comparison (DWLOCs) are

calculated and used as a point of

comparison against the model estimates

of a pesticide’s concentration in water.

DWLOCs are theoretical upper limits on

a pesticide’s concentration in drinking

water in light of total aggregate exposure

to a pesticide in food, and from

residential uses. Since DWLOCs address

total aggregate exposure to bifenthrin

they are further discussed in the

aggregate risk sections below.

Based on the GENEEC and SCI–

GROW models the estimated

environmental concentration (EEC) of

bifenthrin in surface water for acute

exposures is 0.1 ppb. The EEC for

chronic exposures was estimated to be

0.032 ppb for surface water. The ground

water screening concentration was 0.006

ppb. For the purposes of the acute and

chronic risk assessments, the estimated

maximum concentration for bifenthrin

in surface and ground waters (0.01 ppb

for acute, and 0.023 for chronic) was

used.

3. From non–dietary exposure. The

term ‘‘residential exposure’’ is used in

this document to refer to non–

occupational, 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

use on the following residential non–

dietary sites: lawns to control flea

infestation, pets and as a termiticide.

Registered termiticide use of bifenthrin

constitutes a chronic exposure scenario;

however, the exposure is considered

negligible, considering the application

technique of the termiticide use (buried

underground) and the fact that vapor

pressure of bifenthrin is extremely low.

The Agency conducted a residential

exposure assessment for the lawn care

uses of bifenthrin. 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–term 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 (non–dietary).

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.’’

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 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 November 26, 1997 (62 FR

62961).

C. Safety Factor for Infants and Children

1. Safety factor for infants and

children—i. In general. 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 on

toxicity and exposure 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 MOE

analysis or through using uncertainty

(safety) factors in calculating a dose

level that poses no appreciable risk to

humans.

ii. Developmental toxicity studies. In

a developmental study in rats, the

NOAEL for maternal toxicity was 1

milligram/kilogram/day (mg/kg/day),

based upon tremors observed at the

LOAEL of 2 mg/kg/day. The NOAEL for

developmental toxicity was 1 mg/kg/

day, based upon the increased incidence

of hydroureter observed at the LOAEL of

2 mg/kg/day. In a developmental study

in rabbits, the NOAEL for maternal

toxicity was 2.67 mg/kg/day, based

upon head and forelimb twitching seen

at the LOAEL of 4 mg/kg/day. There

were no developmental effects observed.

iii. Reproductive toxicity study. In the

rat reproduction study, parental toxicity

occurred as decreased body weight at

the LOAEL of 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 highest dose

tested (HDT).

iv. Prenatal and postnatal sensitivity.

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. 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.

Federal Register / Vol. 65, No. 188 / Wednesday, September 27, 2000 / Rules and Regulations 57977

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 above, EPA concludes that

reliable data support use of the standard

100–fold UF, and that an additional UF

is not needed to protect the safety of

infants and children. Therefore, the

FQPA safety factor for enhanced

sensitivity of infants and children was

reduced to 1X.

D. Aggregate Risks and Determination of

Safety

To estimate total aggregate exposure

to a pesticide from food, drinking water,

and residential uses, the Agency

calculates DWLOCs which are used as a

point of comparison against the model

estimates of a pesticide’s concentration

in water (EECs). DWLOC values are not

regulatory standards for drinking water.

DWLOCs are theoretical upper limits on

a pesticide’s concentration in drinking

water in light of total aggregate exposure

to a pesticide in food and residential

uses. In calculating a DWLOC, the

Agency determines how much of the

acceptable exposure (i.e., the PAD) is

available for exposure through drinking

water e.g., allowable chronic water

exposure (mg/kg/day)== cPAD (average

food + chronic non–dietary, non–

occupational exposure). This allowable

exposure through drinking water is used

to calculate a DWLOC.

A DWLOC will vary depending on the

toxic endpoint, drinking water

consumption, and body weights. Default

body weights and consumption values

as used by the USEPA Office of Water

are used to calculate DWLOCs: 2L/70 kg

(adult male), 2L/60 kg (adult female),

and 1L/10 kg (child). Default body

weights and drinking water

consumption values vary on an

individual basis. This variation will be

taken into account in more refined

screening–level and quantitative

drinking water exposure assessments.

Different populations will have different

DWLOCs. Generally, a DWLOC is

calculated for each type of risk

assessment used: acute, short-term,

intermediate–term, chronic, and cancer.

When EECs for surface water and

ground water are less than the

calculated DWLOCs, OPP concludes

with reasonable certainty that exposures

to bifenthrin in drinking water (when

considered along with other sources of

exposure for which OPP has reliable

data) would not result in unacceptable

levels of aggregate human health risk at

this time. Because OPP considers the

aggregate risk resulting from multiple

exposure pathways associated with a

pesticide’s uses, levels of comparison in

drinking water may vary as those uses

change. If new uses are added in the

future, OPP will reassess the potential

impacts of bifenthrin on drinking water

as a part of the aggregate risk assessment

process.

1. Acute risk. Using the exposure

assumptions discussed in this unit for

acute exposure, the acute dietary

exposure from food to bifenthrin will

occupy 60% of the aPAD for the U.S.

population, 40% of the aPAD for

females 13 years and older, 75% of the

aPAD for infants (up to 1 year old) and

99.7% % of the aPAD for children (1 to

6 years old). In addition, despite the

potential for acute dietary exposure to

bifenthrin in drinking water, after

calculating DWLOCs and comparing

them to conservative model estimated

environmental concentrations of

bifenthrin in surface and ground water.

EPA does not expect the aggregate

exposure to exceed 100% of the aPAD,

as shown in the following Table 2:

TABLE 2.—AGGREGATE RISK ASSESSMENT FOR ACUTE EXPOSURE TO BIFENTHRIN

Population subgroup aPAD (mg/kg) %aPAD (Food) Surface water

EEC (ppb)

Ground water EEC

(ppb) Acute DWLOC (ppb)

U.S. population 0.01 60 0.10 0.10 140

Females 13 + yrs old 0.01 40 0.10 0.10 180

Children (1–6 yrs old) 0.01 99.7 0.10 0.10 0.30

2. Chronic risk. Using the exposure

assumptions described in this unit for

chronic exposure, EPA has concluded

that exposure to bifenthrin from food

will utilize 3% of the cPAD for the U.S.

population, and 8.2% of the cPAD for

children (1 to 6 years old), the

subpopulation at greatest exposure.

Bifenthrin is also registered for

residential use on outdoor lawn/

gardens, inside households, pets and as

a termiticide. Based on the use pattern,

chronic residential exposure to residues

of the bifenthrin is not expected. In

addition, despite the potential for

chronic dietary exposure to bifenthrin

in drinking water, after calculating the

DWLOCs and comparing them to

conservative model estimated

environmental concentrations of

bifenthrin in surface and ground water,

EPA does not expect the aggregate

exposure to exceed 100% of the cPAD,

as shown in the following Table 3:

TABLE 3.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON–CANCER) EXPOSURE TO BIFENTHRIN

Population subgroup cPAD mg/kg/day %cPAD (Food) Surface water

EEC (ppb)

Ground water EEC

(ppb)

Chronic DWLOC

(ppb)

U.S. population 0.015 3.0 0.032 0.032 530

Infants, < 1 yr old 0.015 3.0 0.032 0.032 450

Children (1–6 yrs old) 0.015 3.0 0.032 0.032 140

3. Short–term and intermediate–term

risk. Short–and intermediate–term

aggregate exposure takes into account

residential exposure plus chronic

exposure to food and water (considered

to be a background exposure level).

Bifenthrin is currently registered for

use(s) that could result in short– and

intermediate–term residential exposure.

Registered termiticide use of bifenthrin

constitutes a chronic exposure scenario;

however, the exposure is considered

negligible. The Agency has determined

that it is appropriate to aggregate

chronic food and water and short–term

and intermediate–term exposures for

bifenthrin.

Using the exposure assumptions

described in this unit for short–term and

intermediate–term exposures, EPA has

concluded that food and residential

exposures aggregated result in aggregate

MOEs of 940 for adults, 350 for children

57978 Federal Register / Vol. 65, No. 188 / Wednesday, September 27, 2000 / Rules and Regulations

ages 1 to 6 years, and 470 for infants less

than 1 year old, based on chronic food

and residential use, e.g., turf

representing the worst case residential

exposure scenario. These aggregate

MOEs do not exceed the Agency’s level

of concern for aggregate exposure to

food and residential uses. In addition,

short–term and intermediate–term

DWLOCs were calculated and compared

to the EECs for chronic exposure of

bifenthrin in ground water and surface

water. After calculating DWLOCs and

comparing them to the EECs for surface

and ground water, EPA does not expect

short–term or intermediate–term

aggregate exposure to exceed the

Agency’s level of concern, as shown in

the following Table 4:

TABLE 4.—AGGREGATE RISK ASSESSMENT FOR SHORT–TERM AND INTERMEDIATE–TERM EXPOSURE TO BIFENTHRIN

Population subgroup

Aggregate MOE

(food + residential)

Aggregate level of

concern (LOC)

Surface water

EEC (ppb)

Ground water EEC

(ppb)

Short–Term and Intermediate–Term DWLOC

(ppb)

Adult (male) 940 100 0.032 0.032 320

Adult (female) 940 100 0.032 0.032 270

Children 1–6 yrs old 350 100 0.032 0.032 71

4. Aggregate cancer risk for U.S.

population. A quantitative (Q1*) 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

chronic RfD. For the U.S. population,

only 3.0% of the cPAD (cRfD) is

occupied by chronic food exposure.

Based on a comparison of the calculated

DWLOCs and the estimated exposure to

bifenthrin in drinking water (0.032 ppb),

the Agency does not expect the chronic

aggregate exposure to exceed 100% of

the cPAD (cRfD) for adults. Thus, EPA

concludes with reasonable certainty that

the carcinogenic risk is within

acceptable limits.

5. Determination of safety. Based on

these risk assessments, EPA concludes

that there is a reasonable certainty that

no harm will result to the general

population, and to infants and children

from aggregate exposure to bifenthrin

residues.

V. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methods are

available for determination of the

regulated bifenthrin residue in plants.

The data gathering method is FMC

method P–2132M, with a limit of

quantitation of 0.05 ppm (given as 0.055

in some cases). This method is a

variation of two other methods which

have been submitted for inclusion in

PAM II (FMC’s Methods P–1031 and

RAN–0140. This method has been

adequately validated and is adequate for

data collection. The method may be

requested from: Calvin Furlow, PIRIB,

IRSD (7502C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number: (703) 305–5229; e-mail address:

furlow.calvin@epa.gov.

B. International Residue Limits

No Codex, Canadian, or Mexican

maximum residue levels (MRL) have

been established for residues of

bifenthrin in/on potatoes. International

harmonization is therefore not an issue

for this tolerance.

VI. Conclusion

Therefore, the tolerance is established

for residues of bifenthrin, in or on

potato 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. 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–301047 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 November 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, 1200 Pennsylvania

Ave., NW., Washington, DC 20460. You

may also deliver your request to the

Office of the Hearing Clerk in Rm. C400,

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.’’

Federal Register / Vol. 65, No. 188 / Wednesday, September 27, 2000 / Rules and Regulations 57979

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, 1200 Pennsylvania

Ave., NW., 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, 1200 Pennsylvania

Ave., NW., Washington, DC 20460.

3. Copies for the dcket. 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–301047 to: Public

Information and Records Integrity

Branch, Information Resources and

Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., 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 your request via e-mail to: opp–

commat;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 a tolerance

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). 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 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. 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: September 15, 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), (346a) and

371.

2. Section 180.442 is amended by

alphabetically adding the commodity

‘‘potato’’ to the table in paragraph (b) to

read as follows:

57980 Federal Register / Vol. 65, No. 188 / Wednesday, September 27, 2000 / Rules and Regulations

§ 180.442 Bifenthrin; tolerances for

residues.

* * * * *

(b)* * *

Commodity Parts per million Expiration/Revocation date

* * * **

Potato 0.05 12/31/2002

* * * **

* * * * *

[FR Doc. 00–24785 Filed 9–26–00; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 300

[FRL–6877–9]

National Oil and Hazardous

Substances Pollution Contingency

Plan National Priorities List

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of deletion of Newsom

Brothers Superfund Site from the

National Priorities List (NPL).

SUMMARY: EPA Region 4 (EPA)

announces the deletion of the Newsom

Brothers Superfund Site from the NPL.

The NPL constitutes appendix B of 40

CFR part 300 which is the National Oil

and Hazardous Substances Pollution

Contingency Plan (NCP), which EPA

promulgated pursuant to section 105 of

the Comprehensive Environmental

Response, Compensation, and Liability

Act of 1980 (CERCLA). EPA and the

State of Mississippi (State) have

determined that all appropriate CERCLA

actions have been implemented and that

no further cleanup by responsible

parties is appropriate under CERCLA.

Moreover, EPA and the State have

determined that remedial activities

conducted at the site to date have been

protective of public health, welfare, and

the environment.

EFFECTIVE DATE: September 27, 2000.

ADDRESSES: Comprehensive information

on this Site is available through the EPA

Region 4 public docket, which is located

at the Region 4 office and is available for

viewing by appointment only from 9

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

excluding holidays. Requests for

appointments or copies of the

background information from the

regional public docket should be

directed to the EPA Region 4 Docket

Office.

The address for the Regional Docket

Office is: Ms. Debbie Jourdan, U.S.

Environmental Protection Agency,

Region 4, 61 Forsyth Street, SW.,

Atlanta, Georgia 30303. Telephone No.:

(404) 562–8862.

Background information from the

regional public docket is also available

for viewing at the Site information

repository located at the following

address: South Mississippi Regional

Library, 900 Broad Street, Columbia,

Mississippi 39429.

FOR FURTHER INFORMATION CONTACT:

Carolyn B. Thompson, Remedial Project

Manager, U.S. Environmental Protection

Agency, Region 4, 61 Forsyth Street,

SW., Atlanta, Georgia 30303, (404) 562–

8913; Michael T. Slack, P.E., CERCLA

Division, Mississippi Department of

Environmental Quality, Office of

Pollution Control, 101 West Capitol

Street, Jackson, MS 39201, (601) 961–

5217.

SUPPLEMENTARY INFORMATION: EPA

announces the deletion of the Newsom

Brothers Superfund Site, Columbia,

Mississippi, from the National Priorities

List (NPL), which is appendix B of the

National Oil and Hazardous Substances

Pollution Contingency Plan (NCP). EPA

identifies sites that appear to present a

significant risk to public health, welfare,

or the environment and it maintains the

NPL as the list of those sites. Sites on

the NPL may be the subject of remedial

actions financed by the Hazardous

Substances Superfund Response Trust

Fund (Fund). Pursuant to 42 U.S.C.

9605 (40 CFR 300.425(e)(3) of the NCP),

any site deleted from the NPL remains

eligible for Fund-financed remedial

actions in the unlikely event that

conditions at the site warrant such

action in the future.

EPA published a Notice of Intent to

Delete the Newsom Brothers Site from

the NPL on August 2, 2000 in the

Federal Register (65 FR 47364–47366).

The closing date for comments on the

Notice of Intent to Delete was

September 1, 2000. EPA received one

comment and the responsiveness

summary is attached to this Notice of

Deletion. Deletion of a site from the NPL

does not affect responsible party

liability or impede agency efforts to

recover costs associated with response

efforts.

The Congressional Review Act, 5

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

Business Regulatory Enforcement

Fairness Act of 1996, does not apply

because this action is not a rule, as that

term is defined in 5 U.S.C. 804(3).

List of Subjects in 40 CFR Part 300

Environmental protection, Air

pollution control, Chemicals, Hazardous

substances, Hazardous waste,

Intergovernmental relations, Penalties,

Reporting and recordkeeping

requirements, Superfund, Water

pollution control, Water supply.

Dated: September 20, 2000.

A. Stanley Meiburg,

Acting Regional Administrator, Region 4.

40 CFR part 300 is amended as

follows:

PART 300—[AMENDED]

1. The authority citation for part 300

continues to read as follows:

Authority: 33 U.S.C. 9601–9657; 42 U.S.C.

1321(c)(2); E.O. 12777, 56 FR 54757, 3 CFR

191 Comp., p. 351; E.O. 12580, 52 FR 2923,

3 CFR, 1987 Comp., p. 193.

Appendix B—[Amended]

2. Table 1 of appendix B to part 300

is amended by removing the site

‘‘Newsom Brothers/Old Reichhold

Chemicals,’’ Columbia, Mississippi.

[FR Doc. 00–24787 Filed 9–26–00; 8:45 am]

BILLING CODE 6560–50–P

DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety

Administration

49 CFR Part 571

[Docket No. NHTSA–98–4515; Notice 2]

RIN 2127–AF43

Federal Motor Vehicle Safety

Standards

AGENCY: National Highway Traffic

Safety Administration (NHTSA), DOT.

ACTION: Final rule.

SUMMARY: This document establishes a

new Federal motor vehicle safety