Federal Register / Vol. 62, No. 146 / Wednesday, July 30, 1997 / Rules and Regulations 40735

a regulatory flexibility analysis

assessing the impact of any proposed or

final rule on small entities. 5 U.S.C. 603

and 604. Alternatively, EPA may certify

that the rule will not have a significant

impact on a substantial number of small

entities. Small entities include small

businesses, small not-for-profit

enterprises, and government entities

with jurisdiction over populations of

less than 50,000.

SIP approvals under section 110 and

subchapter I, part D of the Clean Air Act

do not create any new requirements but

simply approve requirements that the

State is already imposing. Therefore,

because the Federal SIP approval does

not impose any new requirements, the

Regional Administrator certifies that it

does not have a significant impact on

any small entities affected. Moreover,

due to the nature of the Federal-State

relationship under the CAA, preparation

of a flexibility analysis would constitute

Federal inquiry into the economic

reasonableness of state action. The

Clean Air Act forbids EPA to base its

actions concerning SIPs on such

grounds. Union Electric Co. v. U.S. EPA,

427 U.S. 246, 255–66 (1976); 42 U.S.C.

7410(a)(2)and 7410(k)(3).

C. Unfunded Mandates

Under Section 202 of the Unfunded

Mandates Reform Act of 1995

(‘‘Unfunded Mandates Act’’), signed

into law on March 22, 1995, EPA must

prepare a budgetary impact statement to

accompany any proposed or final rule

that includes a Federal mandate that

may result in estimated costs to State,

local, or tribal governments in the

aggregate; or to private sector, of $100

million or more. Under Section 205,

EPA must select the most cost-effective

and least burdensome alternative that

achieves the objectives of the rule and

is consistent with statutory

requirements. Section 203 requires EPA

to establish a plan for informing and

advising any small governments that

may be significantly or uniquely

impacted by the rule.

EPA has determined that the approval

action promulgated does not include a

Federal mandate that may result in

estimated costs of $100 million or more

to either State, local, or tribal

governments in the aggregate, or to the

private sector. This Federal action

approves pre-existing requirements

under State or local law, and imposes

no new requirements. Accordingly, no

additional costs to State, local, or tribal

governments, or to the private sector,

result from this action.

D. 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, EPA

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 the rule in

today’s Federal Register. This rule is

not a ‘‘major rule’’ as defined by 5

U.S.C. 804(2).

E. Petitions for Judicial Review

Under section 307(b)(1) of the Clean

Air Act, petitions for judicial review of

this action must be filed in the United

States Court of Appeals for the

appropriate circuit by September 29,

1997. Filing a petition for

reconsideration by the Administrator of

this final rule does not affect the finality

of this rule for the purposes of judicial

review nor does it extend the time

within which a petition for judicial

review may be filed, and shall not

postpone the effectiveness of such rule

or action. This action may not be

challenged later in proceedings to

enforce its requirements. (See section

307(b)(2).)

List of Subjects in 40 CFR Part 52

Environmental protection, Air

pollution control, Incorporation by

reference, Intergovernmental relations,

Nitrogen dioxide, Particulate matter,

Reporting and recordkeeping

requirements.

Dated: July 9, 1997.

Michael V. Peyton,

Acting Regional Administrator.

Part 52 of chapter I, title 40, Code of

Federal Regulations, is amended as

follows:

PART 52—[AMENDED]

1. The authority citation for part 52

continues to read as follows:

Authority: 42. U.S.C. 7401–7671q.

Subpart RR—Tennessee

2. Section 52.2220, is amended by

adding paragraph (c)(155) to read as

follows:

§ 52.2220 Identification of plan.

* * * * *

(c) * * *

(155) Revisions to Tennessee state

implementation plan submitted to EPA

by the State of Tennessee on April 30,

1996, regarding emission standards and

monitoring requirements for additional

control areas.

(i) Incorporation by reference.

Tennessee Division of Air Pollution

Control Regulations, Chapter 1200–3–

19, adopted September 7, 1988.

(ii) Other material. None.

* * * * *

[FR Doc. 97–20056 Filed 7–29–97; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300519; FRL–5732–1]

RIN 2070–AB78

Buprofezin; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

time-limited tolerances for combined

residues of buprofezin and its

metabolite BF 12 in or on citrus; dried

citrus pulp; cotton seed; cotton gin

byproducts; milk; and cattle, sheep,

hogs, goats, and horse meat, fat, and

meat by-products . 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 cotton in Arizona and

California, and on citrus in California.

This regulation establishes maximum

permissible levels for residues of

buprofezin in these food commodities

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 tolerances

will expire and are revoked on July 31,

1998.

DATES: This regulation is effective July

30, 1997. Objections and requests for

hearings must be received by EPA on or

before September 29, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300519],

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–

300519], must also be submitted to:
40736 Federal Register / Vol. 62, No. 146 / Wednesday, July 30, 1997 / Rules and Regulations

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7506C), 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 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–

300519]. 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: Andrea Beard, 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) 308-9356, e-mail:

beard.andrea@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

tolerances for combined residues of the

insecticide buprofezin, in or on citrus

fruit at 2.0 part per million (ppm); dried

citrus pulp at 10 ppm; cotton seed at 1.0

ppm; cotton gin byproducts at 20 ppm;

milk at 0.03 ppm; and cattle, sheep,

hogs, goats, and horse meat and fat at

0.02 ppm, and meat by-products at 0.5

ppm. These tolerances will expire and

are revoked on July 31, 1998. EPA will

publish a document in the Federal

Register to remove the revoked

tolerances 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 Exemptions for

Buprofezin on Citrus and Cotton and

FFDCA Tolerances

Requests were received from Arizona

and California for use of two insect

growth regulators, buprofezin and

pyriproxyfen (residues and associated

risk assessments of pyriproxyfen are

addressed in a separate Federal Register

document. See July 25, 1997 issue of the

Federal Register) for control of a

recently introduced strain or species of

sweetpotato whitefly, which has had

devestating effects on cotton and

various vegetable crops in the southwest

for the past several years. This newer

strain of whitefly, often referred to as

the silverleaf whitefly, appears to be

capable of quickly developing

resistance, and is resistant to available

alternative controls. Use of two

chemicals was approved because the

use patterns of each only allow one

application, which will not be sufficient

to control whitefly populations

throughout the season.. EPA has

authorized under FIFRA section 18 the

use of buprofezin on cotton for control

of whiteflies in Arizona and California.

After having reviewed the submission,

EPA concurs that emergency conditions

exist.

A request was recieved from

California for use of buprofezin and

imidacloprid on citrus to control red

scale, which has developed resistance in

some localized citrus-producing areas of

California, causing significant losses to

the affected citrus producers. Over the

past several years, control of scale in

citrus has required increasing amounts

of pesticide applications due to the

resistance development. A pesticide

with a different mode of action is

required, and California has requested

the use of two materials based on the

ability of this pest to quickly develop

resistance. After having reviewed the

submission, EPA concurs that an

emergency condition exist, and has

authorized the use of buprofezin on

citrus for control of red scale in

California under FIFRA section 18.

As part of its assessment of these

emergency exemptions, EPA assessed

the potential risks presented by residues

of buprofezin in or on citrus and cotton

commodities, milk, and meat. 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
Federal Register / Vol. 62, No. 146 / Wednesday, July 30, 1997 / Rules and Regulations 40737

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 these tolerances will

expire and are revoked on July 31, 1998,

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

of the pesticide not in excess of the

amounts specified in the tolerances

remaining in or on citrus fruit and dried

pulp, cotton seed, cotton gin

byproducts, meat, and milk after that

date will not be unlawful, provided the

pesticide is applied in a manner that

was lawful under FIFRA. EPA will take

action to revoke these tolerances earlier

if any experience with, scientific data

on, or other relevant information on this

pesticide indicate that the residues are

not safe.

Because these tolerances are being

approved under emergency conditions

EPA has not made any decisions about

whether buprofezin meets EPA’s

registration requirements for use on

citrus and cotton or whether permanent

tolerances for these uses would be

appropriate. Under these circumstances,

EPA does not believe that these

tolerances serve as a basis for

registration of buprofezin by a State for

special local needs under FIFRA section

24(c). Nor do these tolerances serve as

the basis for any State other than

Arizona and California to use this

pesticide on these crops 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

exemptions for buprofezin, 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

hundredfold MOE is based on the same

rationale as the hundredfold 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 enactment

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

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
40738 Federal Register / Vol. 62, No. 146 / Wednesday, July 30, 1997 / Rules and Regulations

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

(non-nursing infants, less than 1 year

old) 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 buprofezin and to make a

determination on aggregate exposure,

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

time-limited tolerances for combined

residues of buprofezin and its

metabolite BF 12 on citrus fruit at 2.0

ppm; dried citrus pulp at 10 ppm;

cotton seed at 1.0 ppm; cotton gin

byproducts at 20 ppm; milk at 0.03

ppm; and cattle, sheep, hogs, goats, and

horse meat and fat at 0.02 ppm, and

meat by-products at 0.5 ppm; . EPA’s

assessment of the dietary exposures and

risks associated with establishing the

tolerances follows.

A. Toxicological Profile

EPA has evaluated the available

toxicity data and considered its validity,

completeness, and reliability as well as

the relationship of the results of the

studies to human risk. EPA has also

considered available information

concerning the variability of the

sensitivities of major identifiable

subgroups of consumers, including

infants and children. The nature of the

toxic effects caused by buprofezin are

discussed below.

1. Acute toxicity. EPA has selected the

developmental NOEL of 200 mg/kg/day

from a rat developmental study, for the

acute dietary endpoint; at the LOEL of

800 mg/kg/day, decreased fetal body

weight and delayed ossification was

observed. The population subgroup of

concern is females 13+ years of age.

2. Chronic toxicity. EPA has

calculated a temporary RfD for

buprofezin at 0.002 milligrams/

kilogram/day (mg/kg/day). This RfD is

based on the systemic lowest effect level

(LEL) of 2.0 mg/kg/day (lowest dose

tested) from a 2-year dog study (an

NOEL was not established), and uses a

thousandfold uncertainty factor); an

extra factor of 10 was added to the

standard hundredfold uncertainty factor

since the RfD was based on an LEL

(rather than an NOEL) and the database

is lacking an adequate reproductive

study). At the LEL, slight liver effects

were observed.

3. Carcinogenicity. There is no

concern for cancer risks identified by

the EPA; data from available studies do

not indicate a treatment-related tumor

problem, and cancer risk endpoints

have not been identified.

B. Exposures and Risks

1. From food and feed uses. Risk

assessments were conducted by EPA to

assess dietary exposures and risks from

these section 18 uses of buprofezin 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 risk assessment (only

contribution is tolerances in connection

with this use on cotton) used tolerancelevel residue values and assumed 100%

of crop treated. The resulting high-end

exposure estimate of 0.04 mg/kg/day

results in a dietary MOE of 5,000 for the

population subgroup of concern,

females 13+ years old. This MOE is a

conservative risk assessment;

refinement using anticipated residue

values and percent crop treated data in

conjunction with Monte Carlo analysis

would result in a lower acute dietary

exposure estimate.

ii. Chronic exposure and risk. In

conducting this chronic dietary risk

assessment, the only refinement to the

data estimates used was calculating

anticipated residue levels for citrus

commodities. For the other

commodities, EPA used the very

conservative assumptions that residues

would occur in 100% of the U.S. cotton

and livestock commodities at tolerance

levels; and that the anticiated residues

calculated would occur in 100% of the

U.S. citrus crop. In actuality, under

these exemptions, only a portion of the

cotton crop in Arizona and California

may potentially be treated; and a very

small portion of the citrus crop in

California (portions of Kerns and Tulare

Counties only) may potentially be

treated. Under these very conservative

assumptions, these time-limited

tolerances on citrus, cotton, and

livestock commodites result in an ARC

that is equivalent to the following

percentages of the RfD: U.S. Population,

23%; Non-Nursing Infants (<1 year old),

104%; Nursing Infants, 23%; Children

(1-6 years old), 63%; Children (7-12

years old), 40%. Additional refinement

using anticipated residue values for

cotton and livestock commodities, and

percent of crop treated would result in

much lower dietary exposure

estiomates, especially considering that

this use is only for a small portion of the

cotton grown in California and Arizona,

and an extremely limited area of citrus

in California only.
Federal Register / Vol. 62, No. 146 / Wednesday, July 30, 1997 / Rules and Regulations 40739

2. From drinking water. Because the

Agency lacks sufficient water-related

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 buprofezin 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

buprofezin 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.

Buprofezin is not registered for any

residential uses at this time. Therefore,

no non-dietary, non-occupational

exposure is antipated..

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

buprofezin 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,

buprofezin 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 buprofezin has a common

mechanism of toxicity with other

substances.

C. Aggregate Risks and Determination of

Safety for U.S. Population

1. Acute risk. For the population of

concern (females 13 years and older),

the calculated MOE value (for food

only) is 5,000. Although theoretically

there is the potential for exposure to

buprofezin in dringking water, EPA

does not expect that exposure would

result in an aggregate MOE (food blus

water) that would exceed the levels of

concern for acute dietary exposure.

2. Chronic risk. Using the ARC

exposure assumptions described above,

EPA has concluded that aggregate

exposure to buprofezin from food will

utilize 23 percent of the RfD for the U.S.

population. The major identifiable

subgroup with the highest aggregate

exposure is Non-nursing infants, < 1

year old, discussed below. 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 buprofezin in drinking

water and from non-dietary, nonoccupational exposure, 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 buprofezin residues.

Therefore, EPA concludes that there is

reasonable certainty that no harm will

result from exposure to buprofezin

through these uses.

D. Aggregate Cancer Risk for U.S.

Population

There is no concern for cancer risks

identified by the EPA; data from

available studies do not indicate a

treatment-related tumor problem, and

cancer risk endpoints have not been

identified.

E. Aggregate Risks and Determination of

Safety for Infants and Children

1. Safety factor for infants and

children— a. In general. In assessing the

potential for additional sensitivity of

infants and children to residues of

buprofezin, EPA considered data from

developmental toxicity studies in the rat

and rabbit. EPA currently has an

incomplete database (no adequate

reproduction study) and no NOEL for

the chronic study which was used to

determine the temporary RfD. Therefore,

a thousandfold margin/factor was

applied to the chronic study which

provides a reasonable certainty of safety

for infants and children exposed to

residues of buprofezin. The

developmental toxicity studies are

designed to evaluate adverse effects on

the developing organism resulting from

maternal pesticide xeposure 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
40740 Federal Register / Vol. 62, No. 146 / Wednesday, July 30, 1997 / Rules and Regulations

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 hundredfold

safety factor (usually 100 for combined

inter- and intra-species variability) and

not the additional tenfold safety 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 safety factor. As stated above,

EPA currently has an incomplete

database for buprofezin, and therefore

an additional tenfold safety factor was

added onto the standard hundredfold

safety factor, providing a reasonable

certainty of no harm to infants and

children exposed to buprofezin through

these uses.

b. Developmental toxicity studies. In

the rat developmental toxicity study, the

maternal (systemic) NOEL was 200 mg/

kg/day, based on mortality, decreased

pregnancy, and increased resorption

rates, at the LOEL of 800 mg/kg/day.

The developmental (fetal) NOEL was

200 mg/kg/day, based on the increased

incidence of delayed ossifications and

decreased pup weight at the LOEL of

800 mg/kg/day.

In the rabbit developmental study, the

maternal (systemic) NOEL was 50 mg/

kg/day, based on decreased body weight

and food consumption and possibly

increased fetal loss at the LOEL of 250

mg/kg/day. The developmental (fetal)

NOEL was 250 mg/kg/day highest dose

tested.

c. Reproductive toxicity study. While

a 2-generation rat reproductive study

was submitted, it does not satisfy

guideline requirements for a

reproductive study, and is considered a

data gap in the buprofezin database.

d. Pre- and post-natal sensitivity. The

toxicology database is currently

incomplete for evaluating post-natal, but

not pre-natal, risks to infants and

children. Based on the results of the rat

developmental toxicity study, an acute

dietary risk assessment was conduected

for females 13+ years of age. The MOE

of 5,000 obtained for this risk

assessment demonstrates that acute

developmental (pre-natal) risks are low.

e. Conclusion. The rat reproductive

study is a data gap and a tenfold

modifying factor has been added to the

usual hundredfold uncertainty factor for

a total uncertainty factor of 1,000 in

calculation of the RfD. This additional

uncertainty factor provides a reasonable

certainty of safety for infants and

children exposed to dietary residues of

buprofezin.

2. Acute risk. The acute, aggregate

dietary MOE of 5,000 which was

calculated for females 13+ years old,

accounts for both maternal and fetal

exposure. The large aggregate MOE

calculated provides assurance that there

is a reasonable certainty of no harm to

infants and children.

3. Chronic risk. Using the

conservative exposure assumptions

described above, EPA has concluded

that aggregate exposure to buprofezin

from food will utilize from 23% of the

RfD for the subgroup nursing infants, to

104% of the RfD for the subgroup, nonnursing infants (< 1 year old). 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. Although the

percentage of the RfD utilized is 104%

for Non-nursing infants, this estimate

was arrived at using extremely

conservative assumptions, and is an

overestimate of the actual risk. If further

refinement of the estimates, as described

above, were used, the dietary exposure

estimates would be considerably lower.

EPA does not expect that aggregate

exposure will exceed 100% of the RfD

for any of the infant and children

population subgroups. Taking into

account the completeness and reliability

of the toxicity data and this conservative

exposure assessment, EPA concludes

that there is reasonable certainty that no

harm will result to infants and children

from chronic aggregate exposure to

buprofezin residues.

V. Other Considerations

A. Metabolism In Plants and Animals

For the puposes of these uses under

section 18, the nature of the residues in

plants and animals is adequately

undersotood. The residue of concern is

the parent buprofezin BF 01, 2-tertbutylimino-3-isopropyl-5-phenyl-1,3,5-

thiadiazinan-4-one] only.

B. Analytical Enforcement Methodology

Adequate methodology is available to

enforce these tolerances. The

methodology for buprofezin and its

mtebolites is summarized in the

following reports: ‘‘Determination of

Buprofezin and BF 12 Residues in

Cottonseed and Gin Trash,’’ method BF01-96; ‘‘Determination of Residues of

Buprofezin and the Metabolite BF 12 in

Beef Tissues via Solid Phase Extraction

and Gas Chromatography With MS

Detection,’’ method BF-05-97;

‘‘Determination of BF 02 Residues in

Beef Tissues by Gas Chromatography

Using Nitrogen Phosphorus Detection,’’

method BF-06-97; ‘‘An Analytic Method

for the Determination of Residues of

Buprofezin at Estimated Tolerance

Levels in Almonds, Cotton Seed, Citrus

(lemons), and Grapes by Gas

Chromatography Using Nitrogen

Phosphorous Detection,’’ method BF-09-

97; AgrEvo Corporation, Wilmington,

Delaware.

C. Magnitude of Residues

Residues of buprofezin are not

expected to exceed the following, as a

result of these emergency exemption

uses: 2.0 ppm in citrus fruit; 10 ppm in

dried citrus pulp; 1.0 ppm in cotton

seed; 20 ppm in cotton gin byproducts;

0.03 ppm in milk; 0.02 ppm in meat and

fat, and 0.5 ppm in meat byproducts, of

cattle, sheep, hogs, goats, and horses.

D. International Residue Limits

There are no maximum residue levels

(MRLs) established for buprofezin on

any cotton or livestock commodities,

and Canadian or Mexican MRLs

established for buprofezin in/on citrus.

A temporary Codex MRL of 0.3 mg/kg

has been established for buprofezin on

oranges.

VI. Conclusion

Therefore, the tolerances are

established for residues of buprofezin in

the various commodities at the levels

given as follows: 2.0 ppm in citrus fruit;

10 ppm in dried citrus pulp; 1.0 ppm in

cotton seed; 20 ppm in cotton gin

byproducts; 0.03 ppm in milk; 0.02 ppm

in meat and fat, and 0.5 ppm in meat

byproducts, of cattle, sheep, hogs, goats,

and horses.

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 September 29,

1997, file written objections to any

aspect of this regulation and may also

request a hearing on those objections.
Federal Register / Vol. 62, No. 146 / Wednesday, July 30, 1997 / Rules and Regulations 40741

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

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

Confidential Business Information (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 Docket

EPA has established a record for this

rulemaking under docket control

number [OPP–300519] (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

Room 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 Hwy., 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

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. 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).

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: July 16, 1997.

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. 346a and 371.

2. By adding § 180.511, to read as

follows:

§ 180.511 Buprofezin; Tolerances for

Residues.

(a) General .

(b) Section 18 emergency exemptions.

Time-limited tolerances are established

for the residues of the insect growth

regulator buprofezin, in connection with

use of the pesticide under section 18

emergency exemptions granted by EPA.

The tolerances will expire on the dates

specified in the following table.
40742 Federal Register / Vol. 62, No. 146 / Wednesday, July 30, 1997 / Rules and Regulations

Commodity Parts per million Expiration/Revocation Date

Cattle, fat ............................................................................................. 0.02 July 31, 1998

Cattle, MBYP ....................................................................................... 0.5 July 31, 1998

Cattle, meat ......................................................................................... 0.02 July 31, 1998

Citrus fruit ............................................................................................ 2.0 July 31, 1998

Citrus, pulp, dried ................................................................................ 10 July 31, 1998

Cotton seed ......................................................................................... 1.0 July 31, 1998

Cotton, gin byproducts ........................................................................ 20 July 31, 1998

Goats, fat ............................................................................................. 0.02 July 31, 1998

Goats, MBYP ....................................................................................... 0.5 July 31, 1998

Goats, meat ......................................................................................... 0.02 July 31, 1998

Hogs, fat .............................................................................................. 0.02 July 31, 1998

Hogs, MBYP ........................................................................................ 0.5 July 31, 1998

Hogs, meat .......................................................................................... 0.02 July 31, 1998

Horses, fat ........................................................................................... 0.02 July 31, 1998

Horses, MBYP ..................................................................................... 0.5 July 31, 1998

Horses, meat ....................................................................................... 0.02 July 31, 1998

Milk ...................................................................................................... 0.03 July 31, 1998

Sheep, fat ............................................................................................ 0.02 July 31, 1998

Sheep, MBYP ...................................................................................... 0.5 July 31, 1998

Sheep, meat ........................................................................................ 0.02 July 31, 1998

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 97–20061 Filed 7-29-97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 721

[OPPTS–50581E; FRL–5733–5]

Revocation of Significant New Use

Rule for Certain Chemical Substances;

Correction

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule; technical correction.

SUMMARY: EPA issued a document (FR

Doc. 97–17178) in the Federal Register

of July 2, 1997 (62 FR 35690) revoking

two significant new use rules (SNUR).

That document inadvertently contained

an incorrect CFR section number. EPA

intended to revoke the SNURs as stated

in the preamble of the proposed

revocation for these two substances (62

FR 6160, February 11, 1997) (FRL–

5580–8). This action is necessary so that

the correct SNURs are removed from

part 721. Because this is a

nonsubstantive change, notice and

public comment are not required.

DATES: This document is effective on

August 1, 1997.

FOR FURTHER INFORMATION CONTACT:

Susan Hazen, Director, Environmental

Assistance Division (TS–799), Office of

Pollution Prevention and Toxics,

Environmental Protection Agency,

Room E–543A, 401 M St., SW.,

Washington, DC 20460; telephone: (202)

554–1404; TDD: (202) 554–0551; e-mail:

TSCA-Hotline@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA

issued a document (FR Doc. 97–17178)

in the Federal Register of July 2, 1997

(62 FR 35690) (FRL–5715–3)

inadvertently removing § 721.3020. This

document correctly removes § 721.3060.

On page 35691, in the first column,

amendatory item 2 should read: ‘‘2. By

removing § 721.3060.’’

Dated: July 22, 1997.

Charles M. Auer,

Director, Chemical Control Division, Office

of Pollution Prevention and Toxics.

[FR Doc. 97–20062 Filed 7–29–97; 8:45 am]

BILLING CODE 6560–50–F

FEDERAL COMMUNICATIONS

COMMISSION

47 CFR Parts 36 and 54

[CC Docket No. 96–45; FCC 97–246]

Universal Service

AGENCY: Federal Communications

Commission.

ACTION: Final rule; order on

reconsideration; errata.

SUMMARY: On May 8, 1997, we adopted

the Universal Service Report and Order

(Order) implementing section 254 of the

Communications Act of 1934, as

amended (the Act). We reconsider on

our own motion several issues with

respect to school and library contracts,

the school and library discount matrix,

the method used to calculate the limit

placed on the amount of corporate

operations expense, the source of

support and administration of support

for high loop costs, and the new

monitoring program and Monitoring

Report. In addition, we reiterate our

holdings in the Order with respect to

the Commission’s authority to assess

universal service contributions from

intrastate and interstate revenues, the

Commission’s authority to require any

carrier to seek state authority to recover

a share of its contribution through

intrastate rates, section 254(k), and the

Commission’s review of decisions by

state commissions not to waive the ‘‘nodisconnect’’ requirement for the Lifeline

program. The intended effect of these

rules is to implement fully the universal

service provisions of the Act.

DATES: All policies and rules adopted

herein shall be effective August 29,

1997, except for the amendments to

§ 54.500, which will take effect July 30,

1997.

FOR FURTHER INFORMATION CONTACT:

Valerie Yates, Legal Counsel, Common

Carrier Bureau, (202) 418–1500, or

Sheryl Todd, Common Carrier Bureau,

(202) 418–7400.

SUPPLEMENTARY INFORMATION: This is a

summary of the Commission’s Order on

Reconsideration adopted and released

on July 10, 1997 and reflecting the

changes included in errata released on

July 14, 1997 and on July 24, 1997. The

full text of the Order on Reconsideration

and the errata is available for inspection

and copying during normal business

hours in the FCC Reference Center

(Room 239), 1919 M St., NW.,

Washington, DC.

Pursuant to the Telecommunications

Act of 1996, the Commission released a

Notice of Proposed Rulemaking and