68208 Federal Register / Vol. 62, No. 250 / Wednesday, December 31, 1997 / Rules and Regulations

Vg=volume of gasoline with which the

blendstock is blended.

(iii) For each parameter required by

the complex model, calculate the

parameter value that would result by

combining, at the blendstock volume

fraction (F), the blendstock with a

gasoline having properties equal to the

refinery’s or importer’s baseline, using

the following formula:

CP

BAP V BLP V

V V j

j g j b

g b

= ( ) × + × ( )

+

Where:

CPj=calculated value for parameter j

BAPj=baseline value for parameter j

BLPj=value of parameter j for the

blendstock or oxygenate

j=each parameter required by the

complex model

(A) The baseline value shall be the

refinery’s ‘‘summer’’ or ‘‘winter’’

baseline, based on the ‘‘summer’’ or

‘‘winter’’ classification of the gasoline

produced as determined under

paragraphs (g)(5) or (g)(6) of this section.

In the case of a refinery that is

aggregated under paragraph (h) of this

section, the refinery baseline shall be

used, and not the aggregate baseline.

(B) The sulfur content and oxygen

wt% computations under paragraph

(g)(3)(iii) of this section shall be

adjusted for the specific gravity of the

gasoline and blendstock using specific

gravities of 0.749 for ‘‘summer’’ gasoline

and of 0.738 for ‘‘winter’’ gasoline.

(C) In the case of ‘‘summer’’ gasoline,

where the blendstock is ethanol and the

volume fraction calculated under

paragraph (g)(3)(ii) is equal to or greater

than 0.015, the value for RVP calculated

under paragraph (g)(3)(iii) of this section

shall be 1.0 psi greater than the RVP of

the gasoline with which the blendstock

is blended.

(iv) Using the summer or winter

complex model, as appropriate,

calculate the exhaust toxics and NOX

emissions performance, in mg/mi, of:

(A) A hypothetical gasoline having

properties equal to those calculated in

paragraph (g)(3)(iii) of this section

(HEP); and

(B) A gasoline having properties equal

to the refinery’s or importer’s baseline

(BEP).

(v) Calculate the exhaust toxics and

NOX equivalent emissions performance

(EEP) of the blendstock, in mg/mi, using

the following equation:

EEP

HEP BEP F

F j

j j = − ∗ − ( ) ( ) 1

Where:

EEPj=equivalent emissions performance

of the blendstock for emissions

performance j

BEPj=emissions performance j of a

gasoline having the properties of

the refinery’s baseline.

HEPj=emissions performance j of a

hypothetical blendstock/gasoline

blend

F=blendstock volume fraction

j=exhaust toxics or NOX emissions

performance

(vi) For each blendstock batch, the

volume, and exhaust toxics and NOX

equivalent emissions performance (EEP)

shall be included in the refinery’s

compliance calculations.

* * * * *

(8) Emissions performance of

conventional gasoline with parameters

outside the complex model valid range

limits. Notwithstanding the provisions

of § 80.45(f)(2), in the case of any

parameter value that does not fall

within the complex model range limit in

§ 80.45(f)(1)(ii), the refiner or importer

shall determine the emissions

performance of the batch using the

following parameter values:

Parameter outside the range limit

Parameter value to use for calculating

Exhaust toxics NOX

Sulfur ......................................................................................................................................................... Test value1 ................ Test value.1

RVP (summer only):

< 6.4 psi ............................................................................................................................................. 6.4 psi ........................ 6.4 psi.

> 11.0 psi ........................................................................................................................................... Test value1 ................ Test value.1

Aromatics .................................................................................................................................................. Test value1 ................ Test value.1

Olefins ....................................................................................................................................................... Test value1 ................ Test value.1

Benzene .................................................................................................................................................... Test value1 ................ Test value.1

E200:

< 30% ................................................................................................................................................. Test value1 ................ 30%

> 70% ................................................................................................................................................. 70% ........................... Test value.1

E300 < 70% .............................................................................................................................................. Test value1 ................ Test value.1

1Test value is the value for a parameter determined pursuant to paragraph 80.101(i)(1)(i) of this section.

* * * * *

(j) Evasion of standards through

exporting and importing gasoline.

Notwithstanding the requirements of

this section, no refiner or importer shall

export gasoline and import the same or

other gasoline for the purpose of

evading a more stringent baseline

requirement.

12. Section 80.104 is amended by

adding paragraph (a)(2)(xi) to read as

follows:

§ 80.104 Recordkeeping requirements.

* * * * *

(a) * * *

(2) * * *

(xi) In the case of blendstocks that are

included in refinery compliance

calculations using the procedures under

§ 80.101(g)(3), documents that reflect

the volume of blendstock and the

volume of gasoline with which the

blendstock is blended.

* * * * *

[FR Doc. 97–34097 Filed 12–30–97; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300595; FRL–5762–1]

RIN 2070–AB78

Hexythiazox; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time-limited tolerance for combined

residues of hexythiazox (trans-5-(4-
Federal Register / Vol. 62, No. 250 / Wednesday, December 31, 1997 / Rules and Regulations 68209

chlorophenyl)-N-cyclohexyl-4-methyl-2-

oxothiazolidine-3-carboxamide) and its

metabolites containing the (4-

chlorophenyl)-4-methyl-2-oxo-3-

thiazolidine moiety in or on

strawberries. This action is in response

to EPA’s granting of an emergency

exemption under section 18 of the

Federal Insecticide, Fungicide, and

Rodenticide Act authorizing use of the

pesticide on strawberries. This

regulation establishes a maximum

permissible level for residues of

hexythiazox in this food commodity

pursuant to section 408(l)(6) of the

Federal Food, Drug, and Cosmetic Act,

as amended by the Food Quality

Protection Act of 1996. The tolerance

will expire and is revoked on July 1,

1998.

DATES: This regulation is effective

December 31, 1997. Objections and

requests for hearings must be received

by EPA on or before March 2, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300595],

must be submitted to: Hearing Clerk

(1900), Environmental Protection

Agency, Rm. M3708, 401 M St., SW.,

Washington, DC 20460. Fees

accompanying objections and hearing

requests shall be labeled ‘‘Tolerance

Petition Fees’’ and forwarded to: EPA

Headquarters Accounting Operations

Branch, OPP (Tolerance Fees), P.O. Box

360277M, Pittsburgh, PA 15251. A copy

of any objections and hearing requests

filed with the Hearing Clerk identified

by the docket control number, [OPP–

300595], must also be submitted 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, bring

a copy of objections and hearing

requests to Rm. 1132, CM #2, 1921

Jefferson Davis Hwy., Arlington, VA.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

sending electronic mail (e-mail) to: oppdocket@epamail.epa.gov. Copies of

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect 5.1/6.1 file

format or ASCII file format. All copies

of objections and hearing requests in

electronic form must be identified by

the docket control number [OPP–

300595]. No Confidential Business

Information (CBI) should be submitted

through e-mail. Electronic copies of

objections and hearing requests on this

rule may be filed online at many Federal

Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By

mail: David Deegan, Registration

Division 7505C, Office of Pesticide

Programs, Environmental Protection

Agency, 401 M St., SW., Washington,

DC 20460. Office location, telephone

number, and e-mail address: Crystal

Mall #2, 1921 Jefferson Davis Hwy.,

Arlington, VA, (703) 308-9358, e-mail:

deegan.dave@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA, on

its own initiative, pursuant to section

408(e) and (l)(6) of the Federal Food,

Drug, and Cosmetic Act (FFDCA), 21

U.S.C. 346a(e) and (l)(6), is establishing

a tolerance for combined residues of the

insecticide hexythiazox (trans-5-(4-

chlorophenyl)-N-cyclohexyl-4-methyl-2-

oxothiazolidine-3-carboxamide) and its

metabolites containing the (4-

chlorophenyl)-4-methyl-2-oxo-3-

thiazolidine moiety , in or on

strawberries at 3.0 part per million

(ppm). This tolerance will expire and is

revoked on July 1, 1998. EPA will

publish a document in the Federal

Register to remove the revoked

tolerance from the Code of Federal

Regulations.

I. Background and Statutory Authority

The Food Quality Protection Act of

1996 (FQPA) (Pub. L. 104–170) was

signed into law August 3, 1996. FQPA

amends both the Federal Food, Drug,

and Cosmetic Act (FFDCA), 21 U.S.C.

301 et seq., and the Federal Insecticide,

Fungicide, and Rodenticide Act

(FIFRA), 7 U.S.C. 136 et seq. The FQPA

amendments went into effect

immediately. Among other things,

FQPA amends FFDCA to bring all EPA

pesticide tolerance-setting activities

under a new section 408 with a new

safety standard and new procedures.

These activities are described below and

discussed in greater detail in the final

rule establishing the time-limited

tolerance associated with the emergency

exemption for use of propiconazole on

sorghum (61 FR 58135, November 13,

1996) (FRL–5572–9).

New 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 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

FQPA. EPA has established regulations

governing such emergency exemptions

in 40 CFR part 166.

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.

Because decisions on section 18-

related tolerances must proceed before

EPA reaches closure on several policy

issues relating to interpretation and

implementation of the FQPA, EPA does

not intend for its actions on such

tolerance to set binding precedents for

the application of section 408 and the

new safety standard to other tolerances

and exemptions.

II. Emergency Exemption for

Hexythiazox on Strawberries and

FFDCA Tolerances

The state of California petitioned EPA

to invoke provisions of FIFRA section

18 to allow emergency use of the

chemical hexythiazox (Savey Ovicide/

Miticide 50–WP, EPA Reg. No. 10163–

208, manufactured by Gowan) on 18,000

acres of strawberries in California to

control two-spotted spider mites. EPA

reviewed this request and concluded

that the state is suffering from an urgent

and non-routine situation, qualifying for

use of the requested product under

section 18. EPA’s review concluded that

there are no effective alternative

chemicals available to growers with

which they can control this pest on

strawberries. On November 14, 1997,

EPA authorized California to allow

hexythiazox to be used on 18,000 acres

of strawberries to control two-spotted

spider mites. The exemption expires on

April 1, 1998.
68210 Federal Register / Vol. 62, No. 250 / Wednesday, December 31, 1997 / Rules and Regulations

As part of its assessment of this

emergency exemption, EPA assessed the

potential risks presented by residues of

hexythiazox in or on strawberries. In

doing so, EPA considered the new 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 new 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 under

section 408(e), as provided in section

408(l)(6). Although this tolerance will

expire and is revoked on July 1, 1998,

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

of the pesticide not in excess of the

amounts specified in the tolerance

remaining in or on strawberries 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 hexythiazox meets EPA’s

registration requirements for use on

strawberries 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

hexythiazox 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 California to use

this pesticide on this crop under section

18 of FIFRA without following all

provisions of section 18 as identified in

40 CFR part 166. For additional

information regarding the emergency

exemption for hexythiazox, contact the

Agency’s Registration Division at the

address provided above.

III. Risk Assessment and Statutory

Findings

EPA performs a number of analyses to

determine the risks from aggregate

exposure to pesticide residues. First,

EPA determines the toxicity of

pesticides based primarily on

toxicological studies using laboratory

animals. These studies address many

adverse health effects, including (but

not limited to) reproductive effects,

developmental toxicity, toxicity to the

nervous system, and carcinogenicity.

Second, EPA examines exposure to the

pesticide through the diet (e.g., food and

drinking water) and through exposures

that occur as a result of pesticide use in

residential settings.

A. Toxicity

1. Threshold and non-threshold

effects. For many animal studies, a dose

response relationship can be

determined, which provides a dose that

causes adverse effects (threshold effects)

and doses causing no observed effects

(the ‘‘no-observed effect level’’ or

‘‘NOEL’’).

Once a study has been evaluated and

the observed effects have been

determined to be threshold effects, EPA

generally divides the NOEL from the

study with the lowest NOEL by an

uncertainty factor (usually 100 or more)

to determine the Reference Dose (RfD).

The RfD is a level at or below which

daily aggregate exposure over a lifetime

will not pose appreciable risks to

human health. An uncertainty factor

(sometimes called a ‘‘safety factor’’) of

100 is commonly used since it is

assumed that people may be up to 10

times more sensitive to pesticides than

the test animals, and that one person or

subgroup of the population (such as

infants and children) could be up to 10

times more sensitive to a pesticide than

another. In addition, EPA assesses the

potential risks to infants and children

based on the weight of the evidence of

the toxicology studies and determines

whether an additional uncertainty factor

is warranted. Thus, an aggregate daily

exposure to a pesticide residue at or

below the RfD (expressed as 100% or

less of the RfD) is generally considered

acceptable by EPA. EPA generally uses

the RfD to evaluate the chronic risks

posed by pesticide exposure. For shorter

term risks, EPA calculates a margin of

exposure (MOE) by dividing the

estimated human exposure into the

NOEL from the appropriate animal

study. Commonly, EPA finds MOEs

lower than 100 to be unacceptable. This

100-fold MOE is based on the same

rationale as the 100-fold uncertainty

factor.

Lifetime feeding studies in two

species of laboratory animals are

conducted to screen pesticides for

cancer effects. When evidence of

increased cancer is noted in these

studies, the Agency conducts a weight

of the evidence review of all relevant

toxicological data including short-term

and mutagenicity studies and structure

activity relationship. Once a pesticide

has been classified as a potential human

carcinogen, different types of risk

assessments (e.g., linear low dose

extrapolations or MOE calculation based

on the appropriate NOEL) will be

carried out based on the nature of the

carcinogenic response and the Agency’s

knowledge of its mode of action.

2. Differences in toxic effect due to

exposure duration. The toxicological

effects of a pesticide can vary with

different exposure durations. EPA

considers the entire toxicity data base,

and based on the effects seen for

different durations and routes of

exposure, determines which risk

assessments should be done to assure

that the public is adequately protected

from any pesticide exposure scenario.

Both short and long durations of

exposure are always considered.

Typically, risk assessments include

‘‘acute,’’ ‘‘short-term,’’ ‘‘intermediate

term,’’ and ‘‘chronic’’ risks. These

assessments are defined by the Agency

as follows.

Acute risk, by the Agency’s definition,

results from 1–day consumption of food

and water, and reflects toxicity which

could be expressed following a single

oral exposure to the pesticide residues.

High end exposure to food and water

residues are typically assumed.

Short-term risk results from exposure

to the pesticide for a period of 1–7 days,

and therefore overlaps with the acute

risk assessment. Historically, this risk

assessment was intended to address

primarily dermal and inhalation

exposure which could result, for

example, from residential pesticide

applications. However, since enaction of

FQPA, this assessment has been

expanded to include both dietary and

non-dietary sources of exposure, and

will typically consider exposure from

food, water, and residential uses when

reliable data are available. In this

assessment, risks from average food and

water exposure, and high-end

residential exposure, are aggregated.

High-end exposures from all 3 sources

are not typically added because of the

very low probability of this occurring in

most cases, and because the other

conservative assumptions built into the

assessment assure adequate protection

of public health. However, for cases in

which high-end exposure can

reasonably be expected from multiple

sources (e.g. frequent and widespread

homeowner use in a specific

geographical area), multiple high-end

risks will be aggregated and presented

as part of the comprehensive risk

assessment/characterization. Since the

toxicological endpoint considered in

this assessment reflects exposure over a

period of at least 7 days, an additional

degree of conservatism is built into the

assessment; i.e., the risk assessment
Federal Register / Vol. 62, No. 250 / Wednesday, December 31, 1997 / Rules and Regulations 68211

nominally covers 1–7 days exposure,

and the toxicological endpoint/NOEL is

selected to be adequate for at least 7

days of exposure. (Toxicity results at

lower levels when the dosing duration

is increased.)

Intermediate-term risk results from

exposure for 7 days to several months.

This assessment is handled in a manner

similar to the short-term risk

assessment.

Chronic risk assessment describes risk

which could result from several months

to a lifetime of exposure. For this

assessment, risks are aggregated

considering average exposure from all

sources for representative population

subgroups including infants and

children.

B. Aggregate Exposure

In examining aggregate exposure,

FFDCA section 408 requires that EPA

take into account available and reliable

information concerning exposure from

the pesticide residue in the food in

question, residues in other foods for

which there are tolerances, residues in

groundwater or surface water that is

consumed as drinking water, and other

non-occupational exposures through

pesticide use in gardens, lawns, or

buildings (residential and other indoor

uses). Dietary exposure to residues of a

pesticide in a food commodity are

estimated by multiplying the average

daily consumption of the food forms of

that commodity by the tolerance level or

the anticipated pesticide residue level.

The Theoretical Maximum Residue

Contribution (TMRC) is an estimate of

the level of residues consumed daily if

each food item contained pesticide

residues equal to the tolerance. In

evaluating food exposures, EPA takes

into account varying consumption

patterns of major identifiable subgroups

of consumers, including infants and

children.The TMRC is a ‘‘worst case’’

estimate since it is based on the

assumptions that food contains

pesticide residues at the tolerance level

and that 100% of the crop is treated by

pesticides that have established

tolerances. If the TMRC exceeds the RfD

or poses a lifetime cancer risk that is

greater than approximately one in a

million, EPA attempts to derive a more

accurate exposure estimate for the

pesticide by evaluating additional types

of information (anticipated residue data

and/or percent of crop treated data)

which show, generally, that pesticide

residues in most foods when they are

eaten are well below established

tolerances.

Percent of crop treated estimates are

derived from Federal and private market

survey data. Typically, a range of

estimates are supplied and the upper

end of this range is assumed for the

exposure assessment. By using this

upper end estimate of percent of crop

treated, the Agency is reasonably certain

that exposure is not understated for any

significant subpopulation group.

Further, regional consumption

information is taken into account

through EPA’s computer-based model

for evaluating the exposure of

significant subpopulations including

several regional groups, to pesticide

residues. For this pesticide, the most

highly exposed population subgroup

(infants and children) was not

regionally based.

IV. Aggregate Risk Assessment and

Determination of Safety

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 hexythiazox and to make a

determination on aggregate exposure,

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

time-limited tolerance for combined

residues of hexythiazox (trans-5-(4-

chlorophenyl)-N-cyclohexyl-4-methyl-2-

oxothiazolidine-3-carboxamide) and its

metabolites containing the (4-

chlorophenyl)-4-methyl-2-oxo-3-

thiazolidine moiety on strawberries at

3.0 ppm. EPA’s assessment of the

dietary exposures and risks associated

with establishing the tolerance 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 hexythiazox are

discussed below.

1. Acute toxicity. An acute dietary risk

assessment is not required, since EPA

did not identify an acute toxicological

endpoint.

2. Short - and intermediate - term

toxicity. For short and intermediateterm Margin of Exposure (MOE)

calculations, EPA recommended use of

the maternal NOEL of 240 milligrams/

kilogram/day (mg/kg/day) from the

developmental toxicity study in rats. At

the Lowest Eeffect Level (LEL) of 740

mg/kg/day, there was decreased food

consumption, decreased body weight

and increased ovarian weights.

3. Chronic toxicity. EPA has

established the RfD for hexythiazox at

0.025 mg/kg/day. This RfD is based on

a one year feeding study in dogs with a

NOEL of 2.5 mg/kg/day and an

uncertainty factor of 100. The Lowest

Observed Eeffect Level (LOEL) of 12.5

mg/kg/day was based on hypertrophy of

the adrenal cortex in both sexes.

4. Carcinogenicity. Hexythiazox has

been classified as a Group C chemical

(possible human carcinogen) by EPA,

based on an increased incidence of

female mouse liver tumors. EPA uses

the Q1* approach to assess this risk. The

Q1* is 0.039 mg/kg/day-1.

B. Exposures and Risks

1. From food and feed uses.

Tolerances have been established (40

CFR 180.448) for the combined residues

of hexythiazox (trans-5-(4-

chlorophenyl)-N-cyclohexyl-4-methyl-2-

oxothiazolidine-3-carboxamide), in or

on a variety of raw agricultural

commodities. Risk assessments were

conducted by EPA to assess dietary

exposures and risks from hexythiazox as

follows:

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 one day or single exposure. The acute

dietary (food only) risk assessment is

not required for this pesticide use, as

the EPA did not identify an acute

dietary risk endpoint.

ii. Chronic exposure and risk. In

conducting this chronic dietary risk

assessment, EPA has made conservative

assumptions -- 100% of strawberries, in

addition to cotton seed commodities (oil

and meal) (previously approved under

provisions of section 18) and apple

commodities will contain residues of

hexythiazox and its metabolites and

those residues will be at the level of the

tolerance. Percent crop treated data

were utilized for pear commodities.

These conservative assumptions result

in an overestimate of human dietary

exposure. Thus, in making a safety

determination for this tolerance, EPA is

taking into account this conservative

exposure assessment.

The published tolerances for the

regulated residue of hexythiazox, plus

this proposed section 18 use, result in

a Anticipated Residue Contribution

(ARC) that is equivalent to the following

percentages of the RfD:

Subgroup Percent

U.S. Population ......................... <1

Nursing Infants .......................... <1
68212 Federal Register / Vol. 62, No. 250 / Wednesday, December 31, 1997 / Rules and Regulations

Subgroup Percent

Non-Nursing Infants (<1 year

old) ........................................ <1

Children (1–6 years old) ........... <1

Children (7–12 years old) ......... <1

The subgroups listed above are: (1)

the U.S. population (48 states); and (2)

those for infants and children; and (3)

the other subgroups for which the

percentage of the RfD occupied is

greater than that occupied by the

subgroup U.S. population (48 states).

2. From drinking water. Based on

information currently available to EPA,

hexythiazox is considered persistent in

soil. EPA’s current data also indicates

that hexythiazox and soil metabolites

are not likely to leach to groundwater.

There are no established Maximum

Contaminant Levels for residues of

hexythiazox in drinking water. No

health advisory levels for hexythiazox

in drinking water have been established.

Chronic exposure and risk. Because

the Agency lacks sufficient waterrelated exposure data to complete a

comprehensive drinking water risk

assessment for many pesticides, EPA

has commenced and nearly completed a

process to identify a reasonable yet

conservative bounding figure for the

potential contribution of water-related

exposure to the aggregate risk posed by

a pesticide. In developing the bounding

figure, EPA estimated residue levels in

water for a number of specific pesticides

using various data sources. The Agency

then applied the estimated residue

levels, in conjunction with appropriate

toxicological endpoints (RfD’s or acute

dietary NOEL’s) and assumptions about

body weight and consumption, to

calculate, for each pesticide, the

increment of aggregate risk contributed

by consumption of contaminated water.

While EPA has not yet pinpointed the

appropriate bounding figure for

exposure from contaminated water, the

ranges the Agency is continuing to

examine are all below the level that

would cause hexythiazox to exceed the

RfD if the tolerance being considered in

this document were granted. The

Agency has therefore concluded that the

potential exposures associated with

hexythiazox in water, even at the higher

levels the Agency is considering as a

conservative upper bound, would not

prevent the Agency from determining

that there is a reasonable certainty of no

harm if the tolerance is granted.

3. From non-dietary exposure.

Hexythiazox is not currently registered

for use on any residential non-food

sites. The Agency does not expect there

to be any meaningful non-dietary

residential exposure to hexythiazox.

4. Cumulative exposure to substances

with 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.’’

The Agency believes that ‘‘available

information’’ in this context might

include not only toxicity, chemistry,

and exposure data, but also scientific

policies and methodologies for

understanding common mechanisms of

toxicity and conducting cumulative risk

assessments. For most pesticides,

although the Agency has some

information in its files that may turn out

to be helpful in eventually determining

whether a pesticide shares a common

mechanism of toxicity with any other

substances, EPA does not at this time

have the methodologies to resolve the

complex scientific issues concerning

common mechanism of toxicity in a

meaningful way. EPA has begun a pilot

process to study this issue further

through the examination of particular

classes of pesticides. The Agency hopes

that the results of this pilot process will

increase the Agency’s scientific

understanding of this question such that

EPA will be able to develop and apply

scientific principles for better

determining which chemicals have a

common mechanism of toxicity and

evaluating the cumulative effects of

such chemicals. The Agency anticipates,

however, that even as its understanding

of the science of common mechanisms

increases, decisions on specific classes

of chemicals will be heavily dependent

on chemical specific data, much of

which may not be presently available.

Although at present the Agency does

not know how to apply the information

in its files concerning common

mechanism issues to most risk

assessments, there are pesticides as to

which the common mechanism issues

can be resolved. These pesticides

include pesticides that are

toxicologically dissimilar to existing

chemical substances (in which case the

Agency can conclude that it is unlikely

that a pesticide shares a common

mechanism of activity with other

substances) and pesticides that produce

a common toxic metabolite (in which

case common mechanism of activity

will be assumed).

EPA does not have, at this time,

available data to determine whether

hexythiazox 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,

hexythiazox does not appear to produce

a toxic metabolite produced by other

substances. According to information

evaluated related to this action,

hexythiazox is a member of the

thiazolidinone class of pesticides and

there are no other members of this class.

For the purposes of this tolerance

action, therefore, EPA has not assumed

that hexythiazox has a common

mechanism of toxicity with other

substances.

C. Aggregate Risks and Determination of

Safety for U.S. Population

1. Chronic risk. Using the

conservative exposure assumptions

described above, and taking into

account the completeness and reliability

of the toxicity data, EPA has concluded

that dietary exposure (food only) to

hexythiazox will utilize <1% of the RfD

for the U.S. population. The major

identifiable subgroup with the highest

aggregate exposure is non-nursing

infants. EPA generally has no concern

for exposures below 100% of the RfD

because the RfD 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

hexythiazox in drinking water EPA does

not expect the aggregate exposure to

exceed 100% of the RfD. EPA concludes

that there is a reasonable certainty that

no harm will result from aggregate

exposure to hexythiazox residues.

2. Short- and intermediate-term risk.

Short- and intermediate-term aggregate

exposure takes into account chronic

dietary food and water (considered to be

a background exposure level) plus

indoor and outdoor residential

exposure. EPA believes that uses of

hexythiazox may constitute a shortand/or intermediate-term exposure

scenario. However, the Agency is not, at

this time, able to complete a

comprehensive residential risk

assessment for many pesticides,

including hexythiazox. Because there

are no residential non-food uses

registered for hexythiazox, and because

there are no other chemicals that share

its class, and based on the lack of an

identified acute toxicological endpoint

for hexythiazox, and the low percentage

(<1%) of the RfD occupied by food and

water, in the best scientific judgment of

EPA, short- and intermediate-term

aggregate risk will not exceed the

Agency’s level of concern.
Federal Register / Vol. 62, No. 250 / Wednesday, December 31, 1997 / Rules and Regulations 68213

D. Aggregate Cancer Risk for U.S.

Population

Based on published tolerances (none

are currently pending) and this

proposed section 18 use, an upper

bound lifetime dietary (food only)

cancer risk estimate of 9.6 × 10-7 was

calculated for the hexythiazox regulated

residue. The calculation used the

conservative exposure assumptions

described above for generating ARC’s

and amortized the cancer risk over a 70–

year lifetime (i.e., 5/70, for this 1st year

section 18 use). This section 18 use

contributes 4.1 × 10-6 to the upper

bound lifetime dietary (food only)

cancer risk and 2.9 × 10-7 if the cancer

risk is amortized over a 70–year

lifetime.

The cancer risk estimate for the

existing hexythiazox uses plus the

amortized risk estimate for strawberries

does not exceed EPA’s level of concern.

EPA believes the registered uses do

not constitute a chronic exposure

scenario. Thus, no non-dietary, nonoccupational chronic exposure to

hexythiazox is expected, or is a factor in

aggregate cancer risk .

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

hexythiazox, EPA considered data from

developmental toxicity studies in the rat

and rabbit and a two-generation

reproduction study in the rat. This is

generally the case -- edit if different

studies. 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

pre-and post-natal toxicity and the

completeness of the database 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. EPA believes that reliable data

support using the standard MOE and

uncertainty factor (usually 100 for

combined inter- and intra-species

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 —

a. Rats. In the rat developmental study,

the maternal (systemic) NOEL was 240

mg/kg/day. The maternal LOEL of 720

mg/kg/day was based on decreased food

consumption and decreased body

weight. The developmental (fetal) NOEL

was 240 mg/kg/day. The developmental

LOEL was based on slight delayed

ossification.

b. Rabbits. In the rabbit

developmental toxicity study, the

maternal (systemic) NOEL was 1080 mg/

kg/day at the highest dose tested (HDT).

The developmental (fetal) NOEL was

1080 mg/kg/day at the highest dose

tested.

iii. Reproductive toxicity study —

Rats. In the 2–generation reproductive

toxicity study in rats, the parental

(systemic) NOEL was 20 mg/kg/day. The

LOEL of 120 mg/kg/day was based on

decreased body weight and decreased

food consumption. The developmental

NOEL was 20 mg/kg/day. The

developmental LOEL of 120 mg/kg/day

was based on decreased body weight

and delayed maturation. The

reproductive NOEL was 120 mg/kg/day

at the highest dose tested.

iv. Pre- and post-natal sensitivity. The

pre- and post-natal toxicology data base

for hexythiazox is complete with respect

to current toxicological data

requirements. There are no pre- or postnatal toxicity concerns for infants and

children, based on the results of the rat

and rabbit developmental toxicity

studies and the 2–generation rat

reproductive toxicity study. In the

developmental study in rats, the

developmental NOEL and LOEL is the

same as the maternal NOEL and LOEL

demonstrating that no extra-sensitivity

for infants and children is present. In

rabbits, there are no maternal or

developmental effects up to the limit

dose of 1080 mg/kg/day HDT. In the 2–

generation reproductive toxicity study

in rats, there are no pup effects at doses

below maternal effects and the common

effects in both pups and parental

animals decreased body weight also

demonstrates that there is no extrasensitivity for infants and children.

v. Conclusion. Based on the above,

EPA concludes that reliable data

support use of the standard 100-fold

uncertainty factor and that an the

additional safety factor is not needed to

protect the safety of infants and

children.

2. Chronic risk. Using the

conservative exposure assumptions

described above, EPA has concluded

that aggregate exposure to hexythiazox

from food will utilize less than 1% of

the RfD for infants and children. EPA

generally has no concern for exposures

below 100% of the RfD because the RfD

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 hexythiazox in drinking

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

expect the aggregate exposure to exceed

100% of the RfD. Therefore, taking into

account the completeness and reliability

of the toxicity data, the conservative

exposure assessment and the fact that

residential uses do not fall under a

chronic exposure scenario, EPA

concludes that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to hexythiazox residues.

V. Other Considerations

A. Metabolism In Plants and Animals

1. For the purpose of this section 18

request, the nature of the residue in

plants is adequately understood. The

residue of concern is hexythiazox and

its metabolites containing the (4-

chlorophenyl)-4-methyl-2-oxo-3-

thiazolidine moiety (as specified in 40

CFR 180.448).

2. Although no livestock commodity

tolerances are established, the nature of

the residue in animals is considered to

be understood. The residue of concern

is hexythiazox and its metabolites

containing the (4-chlorophenyl)-4-

methyl-2-oxo-3-thiazolidine moiety.

B. Analytical Enforcement Methodology

Adequate methods to enforce the

tolerance expression have been

submitted for publication in PAM II.

The approved method is designated as

AMR 985–87 which has been used in a

variety of commodities. This method is

available in PP#5F3254, and by request

from U.S. EPA, IRSD/PIRIB (7502C), 401

M St., SW., Washington DC 20460.

C. Magnitude of Residues

1. Residues of hexythiazox and its

metabolites containing the (4-

chlorophenyl)-4-methyl-2-oxo-3-

thiazolidine moiety (expressed as parent

compound) are not expected to exceed

0.10 ppm in/on cotton, undelinted seed.

A time-limited tolerance is being

established at this level.
68214 Federal Register / Vol. 62, No. 250 / Wednesday, December 31, 1997 / Rules and Regulations

2. It is unknown if residues will

concentrate in processed products of

cotton seed. Therefore, the tolerance

level for the RAC has been adjusted to

account for any possible concentration

of the residue. Additional tolerances on

processed products of cotton are not

required for this section 18 request.

3. Residue data are not available for

cotton gin byproducts. For the purpose

of this section 18 request, EPA has

estimated residue levels in cotton gin

byproducts. A search by EPA of the data

currently available indicates two

chemicals for which tolerances are

established on both cotton gin

byproducts and cotton seed. One use is

for an at-planting use of an insecticide.

The other cotton seed/cotton gin

byproducts tolerance pair, 6 ppm and

100 ppm respectively, was established

for a preharvest desiccant use of a

herbicide. Since this preharvest

desiccant use would be considered a

worst case scenario, the hexythiazox

residues on cotton gin byproducts will

be estimated based on the concentration

factor from that use, 16.6x (100/6).

Thus, EPA estimates that the residue

level of hexythiazox on cotton gin

byproducts will be 2 ppm. A timelimited tolerance is being established at

2 ppm for hexythiazox residues in/on

cotton gin byproducts. EPA notes that

residue data for hexythiazox in/on

cotton gin byproducts will be required

for a section 3 registration decision to be

made.

4. Tolerances for secondary residues

of hexythiazox in livestock commodities

are not established. Livestock feedstuffs

for cattle (dairy and beef), poultry

(discussed below)and swine are derived

from cotton (meal,seed, and hulls). The

maximum dietary burden from

established tolerances on apples and

this time-limited tolerance are 0.53 ppm

for beef cattle, and 0.51 ppm for dairy

cattle. EPA has previously reviewed a

hexythiazox feeding study in dairy

cows, in which the only measurable

residues were in kidney and liver. For

the purpose of this time-limited

tolerance, EPA has translated these data

to swine commodities. Based upon

available data, EPA would not expect

detectable residues of hexythiazox and

its metabolites in commodities derived

from cattle (beef and dairy), and swine.

5. Poultry feedstuffs are derived from

cotton (cotton seed meal). Data

concerning the potential for secondary

residues in poultry are available. The

maximum dietary burden from poultry,

resulting from use associated with this

time-limited tolerance is 0.02 ppm.

Hexythiazox tolerances are not

established on other poultry feed items.

Based upon the total radioactive residue

levels from the poultry metabolism

study, tolerances for secondary residues

of hexythiazox in poultry commodities

are not required for this section 18

request.

D. International Residue Limits

There are no Codex, Canadian or

Mexican maximum residue limits

established for hexythiazox and its

metabolites on cotton seed. Thus,

harmonization is not an issue for this

time-limited tolerance.

E. Rotational Crop Restrictions

Strawberries are not normally rotated

in southern California. Thus, rotational

crop considerations are not an issue for

this section 18.

VI. Conclusion

Therefore, the tolerance is established

for combined residues of hexythiazox

(trans-5-(4-chlorophenyl)-N-cyclohexyl4-methyl-2-oxothiazolidine-3-

carboxamide) in strawberries at 3.0

ppm.

VII. Objections and Hearing Requests

The new FFDCA section 408(g)

provides essentially the same process

for persons to ‘‘object’’ to a tolerance

regulation issued by EPA under new

section 408(e) and (l)(6) as was provided

in the old section 408 and in section

409. However, the period for filing

objections is 60 days, rather than 30

days. EPA currently has procedural

regulations which govern the

submission of objections and hearing

requests. These regulations will require

some modification to reflect the new

law. However, until those modifications

can be made, EPA will continue to use

those procedural regulations with

appropriate adjustments to reflect the

new law.

Any person may, by March 2, 1998,

file written objections to any aspect of

this regulation and may also request a

hearing on those objections. Objections

and hearing requests must be filed with

the Hearing Clerk, at the address given

above (40 CFR 178.20). A copy of the

objections and/or hearing requests filed

with the Hearing Clerk should be

submitted to the OPP docket for this

rulemaking. The objections submitted

must specify the provisions of the

regulation deemed objectionable and the

grounds for the objections (40 CFR

178.25). Each objection must be

accompanied by the fee prescribed by

40 CFR 180.33(i). If a hearing is

requested, the objections must include a

statement of the factual issues on which

a hearing is requested, the requestor’s

contentions on such issues, and a
Federal Register / Vol. 62, No. 250 / Wednesday, December 31, 1997 / Rules and Regulations 68215

summary of any evidence relied upon

by the requestor (40 CFR 178.27). A

request for a hearing will be granted if

the Administrator determines that the

material submitted shows the following:

There is 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 in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

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.

VIII. Public Record and Electronic

Submissions

EPA has established a record for this

rulemaking under docket control

number [OPP–300595] (including any

comments and data submitted

electronically). A public version of this

record, including printed, paper

versions of electronic comments, which

does not include any information

claimed as CBI, is available for

inspection from 8:30 a.m. to 4 p.m.,

Monday through Friday, excluding legal

holidays. The public record is located in

Rm. 1132 of the Public Information and

Records Integrity Branch, Information

Resources and Services Division

(7506C), Office of Pesticide Programs,

Environmental Protection Agency,

Crystal Mall #2, 1921 Jefferson Davis

Highway, Arlington, VA.

Electronic comments may be sent

directly to EPA at:

opp-docket@epamail.epa.gov.

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption.

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer any copies of objections and

hearing requests received electronically

into printed, paper form as they are

received and will place the paper copies

in the official rulemaking record which

will also include all comments

submitted directly in writing. The

official rulemaking record is the paper

record maintained at the Virginia

address in ‘‘ADDRESSES’’ at the

beginning of this document.

IX. Regulatory Assessment

Requirements

This final rule establishes a timelimited tolerance under FFDCA section

408(l)(6). 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) (Pub. L.

104–4). Nor does it require any prior

consultation as specified by Executive

Order 12875, entitled Enhancing the

Intergovernmental Partnership (58 FR

58093, October 28, 1993), or 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 in

accordance with Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

Risks (62 FR 19885, April 23, 1997).

In addition, since these tolerances and

exemptions that are established under

FFDCA section 408(l)(6), 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. Nevertheless, the

Agency has previously assessed whether

establishing tolerances, exemptions

from tolerances, raising tolerance levels

or expanding exemptions might

adversely impact small entities and

concluded, as a generic matter, that

there is no adverse economic impact.

The factual basis for the Agency’s

generic certification for tolerance

acations published on May 4, 1981 (46

FR 24950), and was provided to the

Chief Counsel for Advocacy of the Small

Business Administration.

X. Submission to Congress and the

General Accounting Office

Under 5 U.S.C. 801(a)(1)(A), as added

by the Small Business Regulatory

Enforcement Fairness Act of 1996, the

Agency has submitted 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 General

Accounting Office prior to publication

of this rule in today’s Federal Register.

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

5 U.S.C. 804(2).
68216 Federal Register / Vol. 62, No. 250 / Wednesday, December 31, 1997 / Rules and Regulations

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: December 19, 1997.

Peter Caulkins,

Acting 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. 346a and 371.

2. In § 180.448, paragraph (b) is

amended by adding and alphabetically

inserting the following commodity to

the table to read as follows:

§ 180.448 Hexythiazox; tolerances for

residues.

* * * * *

(b) * * *

Commodity Parts per million Expiration/Revocation Date

* * * * * * *

Strawberries ............................................. 3.0 7/1/98

* * * * *

[FR Doc. 97–34104 Filed 12–30–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 300

[FRL–5941–6]

National Oil and Hazardous

Substances Pollution Contingency

Plan National Priorities List

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of deletion for North

Hollywood dump superfund site,

Shelby County, Tennessee, from the

national priorities list.

SUMMARY: The Environmental Protection

Agency (EPA) Region 4 announces the

deletion of the North Hollywood Dump

Superfund Site from the National

Priorities List (NPL), Appendix B of 40

CFR part 300 which is the National Oil

and Hazardous Substances Pollution

Contingency Plan (NCP). EPA and the

State have determined that all

appropriate Fund-financed responses

under the Comprehensive

Environmental Response,

Compensation, and Liability Act

(CERCLA), as amended, have been

implemented and that no further

cleanup is appropriate. Moveover, EPA

and the State have determined that

remedial actions conducted at the site to

date have been protective of public

health, welfare and the environment.

This deletion does not preclude future

action under Superfund.

EFFECTIVE DATE: December 31, 1997.

FOR FURTHER INFORMATION CONTACT:

Robert Morris, Site Manager, U.S.

Environmental Protection Agency,

Region 4, North Site Management

Branch, 61 Forsyth Street, S.W., Atlanta,

Georgia 30303, (404) 562–8794.

SUPPLEMENTARY INFORMATION: The Site

to be deleted from the NPL is: North

Hollywood Superfund Site in Shelby

County, Tennessee.

A Notice of Intent to Delete for this

site was published on October 10, 1997,

(62 FR 52961). The closing date for

comments on the Notice of Intent to

Delete was November 10, 1997. EPA

received no comments.

EPA identifies sites that appear to

present a significant risk to the public

health, welfare and the environment

and it maintains the NPL as the list of

those sites. Any site deleted from the

NPL remains eligible for Fund-financed

remedial actions in the future. Section

300.425(e)(3) of the NCP states that

Fund-financed actions may be taken at

sites deleted from the NPL. Deletion of

a site from the NPL does not affect

responsible party liability or impede

agency efforts to recover costs

associated with response efforts.

List of Subjects in 40 CFR Part 300

Environmental protection, Air

pollution control, Chemicals, Hazardous

waste, Hazardous substances,

Intergovernmental relations, Penalties,

Reporting and recordkeeping

requirements, Superfund, Water

pollution control, Water supply.

Dated: December 16, 1997.

A. Stanley Meiburg,

Deputy Regional Administrator, Region 4.

For reasons set out in the preamble,

40 CFR part 300 is amended as follows:

PART 300—[AMENDED]

1. The authority citation for part 300

continues to read as follows:

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

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

1991 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 for

North Hollywood Dump, Memphis,

Tennessee.

[FR Doc. 97–33743 Filed 12–30–97; 8:45 am]

BILLING CODE 6560–50–P

GENERAL SERVICES

ADMINISTRATION

41 CFR Parts 101–42 and 101–43

RIN 3090–AF39

Criteria for Reporting Excess Personal

Property

AGENCY: Office of Governmentwide

Policy, GSA.

ACTION: Temporary regulation; extension

of effective date.

SUMMARY: The General Services

Administration (GSA) is extending

Federal Property Management

Regulations provisions regarding criteria

for reporting excess personal property to

GSA.

DATES: Effective date: The temporary

regulation published January 15, 1997

was effective from January 15, 1997

through January 15, 1998. The period of

effectiveness is extended through

January 15, 1999.

FOR FURTHER INFORMATION CONTACT:

Martha Caswell, Office of

Governmentwide Policy, GSA, 202–

501–3828.

SUPPLEMENTARY INFORMATION: FPMR

Temporary Regulation H–29 was

published in the Federal Register and

became effective January 15, 1997, 62