Federal Register / Vol. 65, No. 79 / Monday, April 24, 2000 / Rules and Regulations 21645

§ 71.1 [Amended]

2. The incorporation by reference in

14 CFR 71.1 of Federal Aviation

Administration Order 7400.9G,

Airspace Designations and Reporting

Points, dated September 1, 1999, and

effective September 16, 1999, is

amended as follows:

* * * * *

Paragraph 6005 Class E airspace extending

upward from 700 feet or more above the

surface of the earth.

* * * * *

AAL AK E5 Unalaska, AK [Revised]

Unalaska Airport

(Lat. 53°53′57′′ N., long. 166°32′ 42′′ W.)

Dutch Harbor NDB

(Lat. 53°54′19′′ N., long. 166°32′57′′ W.)

That airspace extending upward from 700

feet above the surface within 6.4-mile radius

of the Unalaska Airport and within 2.9 miles

each side of the Dutch Harbor NDB 360°

bearing extending from the 6.4-mile radius to

9.5 miles north of the airport; and that

airspace extending upward from 1,200 feet

above the surface within 20-mile radius north

of the airport between the Dutch Harbor NDB

305° bearing extending clockwise to the 075°

bearing.

* * * * *

Issued in Anchorage, AK, on April 14,

2000.

Anthony M. Wylie,

Acting Manager, Air Traffic Division, Alaskan

Region.

[FR Doc. 00–10015 Filed 4–21–00; 8:45 am]

BILLING CODE 4910–13–P

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1310

[DEA Number 199F]

RIN 1117–AA52

Placement of Gamma-Butyrolactone in

List I of the Controlled Substances Act

(21 U.S.C. 802(34))

AGENCY: Drug Enforcement

Administration, Justice.

ACTION: Final rule.

SUMMARY: Public Law 106–172, signed

into law on February 18, 2000, and

known as the ‘‘Hillory J. Farias and

Samantha Reid Date-Rape Drug

Prohibition Act of 1999,’’ amends

section 102(34) of the Controlled

Substances Act as amended (CSA) by

designating gamma-butyrolactone

(GBL), the precursor to gammahydroxybutyric acid (GHB), as a List I

chemical. Reflecting this change in

stature, the Drug Enforcement

Administration (DEA) is amending its

regulation to reflect the status of GBL as

a List I chemical subject to the

requirements of the CSA and its

regulations. Establishment of a

threshold for GBL will be the subject of

a separate rulemaking. Therefore, unless

and until a threshold is established, any

distribution of GBL is a regulated

transaction as described by 21 CFR

1300.02(b)(28). All handlers of GBL

must comply with the CSA regulatory

requirements pertaining to List I

chemicals as described in the body of

this document.

FOR FURTHER INFORMATION CONTACT:

Frank L. Sapienza, Chief, Drug and

Chemical Evaluation Section, Office of

Diversion Control, Drug Enforcement

Administration, Washington, DC 20537.

DATES: Effective: April 24, 2000.

Registration application deadline:

DEA must receive a properly completed

DEA–510 registration application with

fee from handlers of GBL on or before

July 24, 2000.

SUPPLEMENTARY INFORMATION:

What Is DEA Doing and Whom Does It

Effect?

GBL is gamma-butyrolactone, the

precursor used in the clandestine

production of gamma-hydroxybutyric

acid (GHB). This Final Rule deals solely

with amending 21 CFR 1310.02(a) to

reflect that GBL is a List I chemical as

established by Public Law 106–172.

Consequently any person who imports,

exports, or distributes GBL must register

with DEA and make required records

and reports.

What Authority Does DEA Have To Do

This?

On February 18, 2000, Public Law

106–172 was enacted. This law requires

the Attorney General (AG) to add

gamma-hydroxybutyric acid (GHB) to

Schedule I no later than April 18, 2000.

Effective on February 18, 2000, Congress

also specifically designated the GHB

precursor, gamma-butyrolactone (GBL)

as a List I chemical.

Why Is This Being Published as a Final

Rule?

This publication amends 21 CFR

1310.02(a) to reflect the fact that

Congress made GBL a List I chemical.

For regulatory purposes, this action

leaves DEA no discretion. Therefore,

DEA is publishing this action as a Final

Rule.

Why Was Control of GBL Necessary?

Law enforcement authorities have

identified GBL in many GHB

clandestine laboratories and

documented its use as a precursor in the

clandestine synthesis of GHB. There are

no chemical substitutes for GBL as a

precursor in the clandestine synthesis of

GHB. Congress recognized that control

of GBL as a List I chemical is necessary

to prevent diversion for use in the illicit

production of GHB and made it a List

I chemical. This Final Rule amends 21

CFR 1310.02(a) to reflect the fact that

GBL is a List I chemical subject to the

requirements of the CSA and its

regulations.

Is GBL Subject to Any Other Controls

Under the CSA?

In addition to GBL functioning as a

chemical precursor for the manufacture

of GHB, it also produces psychoactive

effects. If taken for human consumption,

GBL and other chemicals, including 1,4-

butanediol, are swiftly converted into

GHB by the body. Abuse of these and

other GHB-like substances is a

significant law enforcement and public

health problem. GBL and 1,4-butanediol

are structurally and pharmacologically

similar to GHB and are often substituted

for GHB. Under certain circumstances

they may satisfy the definition of a

controlled substance analogue (21

U.S.C. 802(32)). Congress expressly

contemplated this possibility by

amending 21 U.S.C. 802(32) to state that

the designation of GBL or any other

chemical as a Listed chemical does not

preclude a finding that the chemical is

a controlled substance analogue and

subject to the provisions of 21 U.S.C.

813.

Is There a Threshold for Transactions

in GBL?

Public Law 106–172 did not establish

a threshold for regulated transactions

involving GBL. Therefore, the DEA is

reviewing available data, including that

provided by commenters in response to

the Federal Register publication

‘‘Industrial Uses and Handling of

Gamma-butyrolactone; Solicitation of

Information’’ (63 FR 56941), regarding

an appropriate threshold. This will be

the subject of a separate rulemaking and

will provide an opportunity for public

comment. Until and unless a threshold

is established, all covered transactions

involving any amount of GBL are

subject to the CSA regulatory

requirements.

Each regulated person who engages in

a regulated transaction involving GBL

must keep a record of the transaction

and file reports under certain

circumstances (21 CFR 1300.02(b)(28)).

If a threshold is established for GBL, the

recordkeeping and reporting

requirements will only apply to

transactions, including cumulative

21646 Federal Register / Vol. 65, No. 79 / Monday, April 24, 2000 / Rules and Regulations

transactions, which meet or exceed the

threshold (21 CFR part 1310). These

transactions also include the

importation and exportation of GBL.

Are Chemical Mixtures Containing GBL

Subject to Control?

Chemical mixtures containing GBL

will be treated the same as chemical

mixtures containing any listed

chemical. Currently, chemical mixtures

containing listed chemicals are not

subject to regulation. However, DEA is

conducting a separate rulemaking to

develop regulations governing the

distribution of chemical mixtures that

contain listed chemicals. A Notice of

Proposed Rulemaking that addresses

regulation of chemical mixtures

containing listed chemicals was

published in the Federal Register on

September 16, 1998, (63 FR 49506).

Because GBL was not a listed chemical

at that time, the issue of GBL was not

addressed. Therefore, DEA will publish

a Notice of Proposed Rulemaking

followed by a comment period to

address the regulation of chemical

mixtures containing GBL.

As a List I Chemical, What Specific

Requirements Apply to GBL?

Persons interested in handling GBL

must comply with the following:

1. Registration. Any person who

manufactures or distributes GBL, or

proposes to engage in the manufacture

or distribution of GBL, shall obtain a

registration pursuant to the CSA (21

U.S.C. 822). Regulations describing

registration for List I handlers are set

forth in 21 CFR part 1309.

Separate registration is required for

retail distribution, non-retail

distribution, importing, and exporting.

Different locations operated by a single

entity require separate registration if any

location is involved with the

distribution, import, or export of GBL.

Effective Friday, February 18, 2000, any

person distributing, importing, or

exporting GBL became subject to the

registration requirement under the CSA.

DEA recognizes, however, that it is not

possible for persons who distribute,

import, or export GBL to immediately

complete and submit an application for

registration and for DEA to immediately

issue registrations for those activities.

Therefore, in order to allow continued

legitimate commerce in GBL, DEA is

establishing in 21 CFR 1310.09 a

temporary exemption from the

registration requirement for persons

desiring to distribute, import, or export

GBL, provided that DEA receives a

properly completed application for

registration to DEA on or before July 24,

2000. The temporary exemption for

such persons will remain in effect until

DEA takes final action on their

application for registration. The

temporary exemption applies solely to

the registration requirement; all other

chemical control requirements,

including recordkeeping and reporting,

remain in effect. Additionally, the

temporary exemption does not suspend

applicable federal criminal laws relating

to GBL, nor does it supersede state or

local laws or regulations. All handlers of

GBL must comply with their state and

local requirements in addition to the

CSA regulatory controls.

2. Records and Reports. The CSA (21

U.S.C. 830) requires that records are

kept and reports are made that involve

listed chemicals. Regulations describing

recordkeeping and reporting

requirements are set forth in 21 CFR

part 1310. A record must be made and

maintained for two years after the date

of a transaction involving a List I

chemical, provided the transaction is a

regulated transaction. Because a

threshold has not yet been established,

a distribution, receipt, sale, importation,

or exportation of GBL in any amount is

a regulated transaction (21 CFR

1300.02(b)(28)).

Each regulated bulk manufacturer of

GBL shall submit manufacturing,

inventory and use data on an annual

basis (21 CFR 1310.05(d)). Bulk

manufacturers that produce GBL solely

for internal consumption are not

required to submit this information.

Existing standard industry reports

containing the required information are

acceptable, provided the information is

readily retrievable from the report.

21 CFR 1310.05 requires that each

regulated person shall report to DEA

any regulated transaction involving an

extraordinary quantity, an uncommon

method of payment or delivery, or any

other circumstance that causes the

regulated person to believe that the

listed chemical will be used in violation

of the CSA.

3. Import/Export. All imports/exports

of GBL shall comply with the CSA (21

U.S.C. 957 and 971). Regulations for

importation and exportation of List I

chemicals are described in 21 CFR part

1313. Separate registration is necessary

for each activity (21 CFR 1309.22).

4. Administrative Inspection. Places,

including factories, warehouses, or

other establishments and conveyances,

where regulated persons may lawfully

hold, manufacture, or distribute,

dispense, administer, or otherwise

dispose of GBL or where records

relating to those activities are

maintained, are controlled premises as

defined in 21 CFR 1316.02(c). The CSA

(21 U.S.C. 880) allows for administrative

inspections of these controlled premises

as provided in 21 CFR part 1316 subpart

A.

Regulatory Flexibility and Small

Business Concerns

Public Law 106–172 amended the

CSA to make GBL a List I chemical

effective February 18, 2000. DEA has no

discretion in this matter. This Final

Rule simply makes the necessary

amendment to the regulations to bring

them into conformance with the new

requirement of the law. However, to

insure the orderly continuation of

legitimate commerce DEA is providing

in the Final Rule temporary exemption

from the registration requirement for

persons handling GBL provided that

DEA receives a properly completed

application for registration on or before

July 24, 2000.

This Final Rule deals solely with

amending 21 CFR 1310.02(a) to reflect

the placement of GBL in List I by Public

Law 106–172. It does not address a

threshold; therefore, economic impact is

based on registration. DEA will address

the issue of a threshold and its impact

in a separate Notice of Proposed

Rulemaking followed by a comment

period.

Prior to enactment of Public Law 106–

172, DEA had been aware of the

possibility that GBL could become

regulated under the CSA pending the

scheduling of GHB in the CSA.

Anticipating this, DEA sought

information on the manufacturing,

distribution, consumption, storage,

disposal, and uses of GBL from

legitimate handlers of GBL. DEA

published a notice in the Federal

Register on October 23, 1998, titled,

‘‘Industrial Uses and Handling of

Gamma-butyrolactone; Solicitation of

Information’’ (63 FR 56941). The DEA

received eight responses, one each from

the three GBL manufacturers, one from

a European association, and four from

end-users. Information on the extent of

distributors and wholesalers of GBL was

not provided.

In the absence of specific information

from the industry, DEA must estimate

the number of companies distributing

GBL. GBL is a common and widely used

industrial solvent, therefore DEA is

assuming that whoever distributes the

common solvents acetone, toluene, or

methyl ethyl ketone is likely to

distribute GBL. DEA has identified

approximately 1,400 firms that

distribute one or more of these

chemicals.

Provided the number of GBL handlers

is 1,400, the initial total registration cost

would be $833,000, based on the current

new application fee of $595.00 for each

Federal Register / Vol. 65, No. 79 / Monday, April 24, 2000 / Rules and Regulations 21647

individual company. The total annual

re-registration cost, based on the present

renewal fee of $477.00 for each

individual company, would be

$667,800. It should be noted that DEA

published a proposed rule in the

Federal Register on December 1, 1999

(64 FR 67216) that proposed to reduce

the new application fee to $326.00 and

the renewal fee to $171.00 for each

individual company, respectively. If

finalized, these revised fees would

reduce the total burden for initial

registration and for annual reregistration to $456,400 and $239,400,

respectively. In addition to the specific

dollar cost, the registration requirement

would require an annual reporting

burden of 700 hours. This is based on

the estimated one-half hour required to

complete and submit an application for

registration or re-registration. Therefore,

in accordance with the Regulatory

Flexibility Act (5 U.S.C. 605(b)), the

Deputy administrator has reviewed this

application and by approving it certifies

that this regulation will not have a

significant economic impact upon a

substantial number of small entities.

Executive Order 12866

This regulation has been drafted and

reviewed in accordance with Executive

Order 12866, Section 1(b), Principles of

Regulation. The DEA has determined

that this rule is not a ‘‘significant

regulatory action’’ under Executive

Order 12866, Section 3(f), Regulatory

Planning and Review, and accordingly

this rule has not been reviewed by the

Office of Management and Budget.

Administrative Procedure Act—Good

Cause Exemption

DEA finds that there is good cause to

exempt this action from the notice and

comment requirements of Section 553 of

the Administrative Procedures Act on

the grounds that notice and comment

are unnecessary. Public Law 106–172

amended the CSA to make GBL a List

I Chemical effective February 18, 2000.

This action is a conforming amendment

to 21 CFR 1310.02(a) to make the

regulations consistent with the

requirements of the law. DEA has no

discretion in this action and can not

deviate from what Congress has enacted.

Therefore, DEA is publishing this action

as a Final Rule. To ameliorate this final

action, DEA has included a temporary

exemption from the registration

requirement for persons handling GBL

provided that DEA receives a properly

completed application for registration

on or before July 24, 2000.

Unfunded Mandates Reform Act of

1995

This rule will not result in the

expenditure by State, local, and tribal

governments, in the aggregate, or by the

private sector, of $100,000,000 or more

in any one year, and will not

significantly or uniquely affect small

governments. Therefore, no actions were

deemed necessary under the provisions

of the Unfunded Mandates Reform Act

of 1995.

Small Business Regulatory Enforcement

Fairness Act of 1996

This rule is not a major rule as

defined by Section 804 of the Small

Business Regulatory Enforcement

Fairness Act of 1996. This rule will not

result in an annual effect on the

economy of $100,000,000 or more; a

major increase in cost or prices; or

significant adverse effects on

competition, employment, investment,

productivity, innovation, or on the

ability of United States-based

companies to compete with foreignbased companies in domestic and

export markets.

Executive Order 13132

This regulation will not have

substantial direct effects on the States,

on the relationship between the national

government and the States, or on

distribution of power and

responsibilities among the various

levels of government. Therefore, in

accordance with Executive Order 13132,

it is determined that this rule does not

have sufficient federalism implications

to warrant the preparation of a

Federalism Assessment.

Plain Language Instructions

The Drug Enforcement

Administration makes every effort to

write clearly. If you have suggestions as

to how to improve the clarity of this

regulation, call or write Patricia M.

Good, Chief, Liaison and Policy Section,

Office of Diversion Control,

Washington, DC 20537, Telephone (202)

307–7297.

List of Subjects in 21 CFR Part 1310

Drug traffic control, Reporting and

recordkeeping requirements.

For reasons set out above, 21 CFR part

1310 is amended as follows:

PART 1310—[AMENDED]

1. The authority citation for part 1310

continues to read as follows:

Authority: 21 U.S.C. 802, 830, 871(b).

2. Section 1310.02 is amended by

adding a new paragraph (a)(24) to read

as follows:

§ 1310.02 Substances covered

* * * * *

(a) List I chemicals:

* * * * *

(24) gamma-Butyrolactone (Other

names include: GBL; Dihydro-2

(3H)-furanone; 1,2-Butanolide; 1,4-

Butanolide; 4-Hydroxybutanoic

acid lactone; gamma-hydroxybutyric acid lactone) ........................ 2011

3. Section 1310.09 is amended by

adding a new paragraph (c) to read as

follows:

§ 1310.09 Temporary exemption from

registration

* * * * *

(c) Each person required by section

302 of the act (21 U.S.C. 822) to obtain

a registration to distribute, import, or

export GBL is temporarily exempted

from the registration requirement,

provided that the DEA receives a proper

application for registration on or before

July 24, 2000. The exemption will

remain in effect for each person who has

made such application until the

Administration has approved or denied

that application. This exemption applies

only to registration; all other chemical

control requirements set forth in parts

1309, 1310, and 1313 of this chapter

remain in full force and effect.

Dated: April 14, 2000.

Donnie R. Marshall,

Deputy Administrator.

[FR Doc. 00–9988 Filed 4–21–00; 8:45 am]

BILLING CODE 4410–09–M

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 100

[CGD07–00–029]

RIN 2115–AE46

Special Local Regulations: Annual

Suncoast Kilo Run, Sarasota Bay,

Sarasota, FL

AGENCY: Coast Guard, DOT.

ACTION: Temporary final rule.

SUMMARY: The Coast Guard is amending

the final rule for the Annual Suncoast

Kilo Run to change the date from the

first Friday in July to the last Friday in

June for 2000 only. The high-speed boat

race event will be held from 8 a.m. to

1 p.m. Eastern Daylight Time (EDT) on

June 30, 2000, in Sarasota Bay, Sarasota,

Florida. These regulations are needed to

provide for the safety of life on

navigable waters during the event.