51072 Federal Register / Vol. 62, No. 189 / Tuesday, September 30, 1997 / Proposed Rules

presentation, and approximate amount

of time requested for the presentation.

The agency requests that persons or

groups having similar interests

consolidate their presentations and

present them through a single

representative. Because presentations

will be limited to 1 day, the agency may

not be able to accommodate all requests

for oral presentations. FDA will allocate

the time available for the meeting

among the persons who properly file

requests for oral presentations. If time

permits at the conclusion of the

meeting, FDA may allow participation

from both interested persons attending

the meeting who did not submit a

written request for an oral presentation

and those who requested an opportunity

to make a presentation, but, due to the

time limitations, were not granted the

request.

IV. Requests for Comments

Interested persons may, on or before

November 13, 1997, submit written

comments to the Dockets Management

Branch (address above). Two copies of

any comments are to be submitted,

except that individuals may submit one

copy. Comments are to be identified

with the docket number found in

brackets in the heading of this

document. Received comments may be

seen in the office above between 9 a.m.

and 4 p.m., Monday through Friday.

V. Special Accommodations

In order to accommodate the need for

space or technical support, persons who

are planning on using audiovisual

equipment during their oral

presentations are urged to provide

advance notice of their planned

attendance to one of the contact persons

identified above. If you need special

accommodations due to a disability,

please contact one of the contact

persons listed above at least 7 days in

advance.

VI. Transcripts

Transcripts of the meeting may be

requested in writing from the Freedom

of Information Office (HFI–35), Food

and Drug Administration, 5600 Fishers

Lane, rm. 12A–16, Rockville, MD 20857,

approximately 15 working days after the

meeting at a cost of 10 cents per page.

Dated: September 24, 1997,

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–25937 Filed 9-29-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1310

[DEA–156P]

RIN #1117–aa43

Listed Chemicals; Proposed

Establishment of Thresholds for Iodine

and Hydrochloric Gas (Hydrogen

Chloride Gas)

AGENCY: Drug Enforcement

Administration (DEA), Justice.

ACTION: Notice of proposed rulemaking.

SUMMARY: The Comprehensive

Methamphetamine Control Act of 1996

(MCA) establishes that, effective

October 3, 1996, iodine and hydrogen

chloride gas are List II chemicals under

the Controlled Substances Act (CSA).

The inclusion of these chemicals under

the CSA requires that each regulated

person must keep records and file

reports as specified in Title 21 Code

Federal Regulations (21 CFR) Part 1310.

Since the MCA did not establish

thresholds for iodine and hydrogen

chloride gas, recordkeeping and

reporting requirements became

applicable to all domestic transactions

of these chemicals. While this notice of

proposed rulemaking is proposing a

domestic threshold of 0.0 kilograms for

hydrogen chloride gas, it proposes to set

a domestic threshold of 0.4 kilograms

for iodine. This iodine threshold will

remove the recordkeeping requirement

for many iodine transactions.

This notice of proposed rulemaking

also proposes to reinsert the table in 21

CFR 1310.04(f)(2)(iv), listing thresholds

for exports, transshipments, and

international transactions to designated

countries set forth in 1310.08(b). The

DEA’s final rule regarding

implementation of the Domestic

Chemical Diversion Control Act of 1993,

published on June 22, 1995 [60 FR

32447] inadvertently omitted the table

from the section.

DATES: Written comments or objections

must be received on or before December

1, 1997.

ADDRESSES: Comments and objections

should be submitted in quintuplicate to

the Deputy Assistant Administrator,

Office of Diversion Control, Drug

Enforcement Administration,

Washington, D.C. 20537, Attention: DEA

Federal Register Representative/CCR.

FOR FURTHER INFORMATION CONTACT:

Frank Sapienza, Chief, Drug and

Chemical Evaluation Section, Office of

Diversion Control, Drug Enforcement

Administration, Washington, D.C.

20537, Telephone (202) 307–7183.

SUPPLEMENTARY INFORMATION: The MCA

was signed into law on October 3, 1996,

Section 204 of the MCA amends Section

102(35) of the CSA (21 U.S.C. 802(35))

to include iodine and hydrogen chloride

gas as List II chemicals. Section 204(b)

(1) and (2) of the MCA also states that

‘‘iodine shall not be subject to the

requirements for listed chemicals

provided in section 1018 of the

Controlled Substances Import and

Export Act (21 U.S.C. 971).’’ Therefore,

the MCA does not impose import/export

requirements on iodine. The MCA,

however, does not ‘‘limit the authority

of the Attorney General to impose the

requirements for listed chemicals

provided in section 1018 of the

Controlled Substances Import and

Export Act (21 U.S.C. 971).’’ Although

the DEA is not imposing import/export

restrictions on iodine at this time, the

DEA is currently reviewing available

data on iodine to determine if such

controls are warranted.

Prior to the MCA, hydrogen chloride

gas, also known as anhydrous

hydrochloric acid, was already a List II

chemical under the CSA (21 CFR

1310.02(b)(8)). Pursuant to 21 CFR

1310.08, all domestic and import

transactions of hydrogen chloride gas

have been exempt from the regulatory

controls under the CSA. In addition, all

exports, transshipments and

international transactions of hydrogen

chloride gas have been exempt from the

regulatory controls except those to all

South American countries and Panama.

Exports to all South American countries

and Panama above a threshold of 27

kilograms have been regulated

transactions (21 CFR 1310.08(b)). The

MCA amends the CSA to impose only

domestic controls on iodine and

domestic and international controls on

hydrogen chloride gas.

The majority of the clandestine

laboratories seized in the United States

manufacture methamphetamine, a

Schedule II controlled substance. Since

1990, more than 2,400

methamphetamine laboratories have

been seized in the United States by the

DEA. The most frequently used

synthesis among clandestine laboratory

operators today is the ephedrine/

pseudoephedrine reduction method

which utilizes hydriodic acid.

Hydriodic acid is a List I chemical with

a domestic threshold of one liter. With

the increased controls on hydriodic

acid, clandestine laboratory operators

have turned to producing their own

hydriodic acid or using iodine directly

in the synthesis. Clandestine laboratory
Federal Register / Vol. 62, No. 189 / Tuesday, September 30, 1997 / Proposed Rules 51073

operators, since 1992, have been

utilizing iodine either directly in the

ephedrine/pseudoephedrine reduction

method or have been using iodine to

produce hydriodic acid, the traditional

reducing agent in the ephedrine/

pseudoephedrine reduction method.

Hydrogen chloride gas, on the other

hand, can be used in the clandestine

synthesis of most controlled substances

to convert the basic form of a controlled

substance to its hydrochloride salt. It is

often used in the illicit production of

methamphetamine.

Certain provisions of the CSA and its

regulations are applicable only to

regulated transactions involving listed

chemicals. For purposes of defining a

regulated transaction (21 U.S.C.

802(39)), the CSA provides that the

Attorney General may impose a

threshold amount for each listed

chemical. A threshold amount is

established to determine whether a

receipt, sale, importation or exportation

within a calendar month or multiple

transactions by an individual within a

calendar month are considered

regulated transactions. If the transaction

is considered a regulated transaction,

then they are recordkeeping and

reporting requirements as specified in

21 CFR 1310.

The DEA examined several types of

information in proposing a domestic

threshold for iodine: legitimate use in

industry, including the quantities

normally required for such uses;

quantities purchased by clandestine

laboratory operators; quantities seized at

clandestine laboratory sites; and its use

in the production of methamphetamine.

The number of clandestine laboratories

using iodine in the synthesis of

methamphetamine has increased

drastically in the past five years. In

1992, the DEA documented that 18 of

the 228 (approximately 6 percent)

methamphetamine clandestine

laboratories seized by DEA used iodine.

During 1996, at least 290

methamphetamine clandestine

laboratories seized by DEA used iodine.

The majority of these clandestine

laboratories are producing small

quantities (i.e., less than one-half

kilogram) of methamphetamine.

Seizures of iodine at the clandestine

laboratory sites ranged from

approximately 10 grams to 3,000

kilograms. The DEA cannot determined

the source of all of the iodine seized at

clandestine laboratory sites due to

clandestine laboratory operators

removing the original labels or

transferring the iodine to other

unmarked containers. At those sites

where iodine was seized in its original

containers, DEA identified that the

iodine was being purchased from either

veterinary supply stores, feed and tack/

farm supply stores or chemical

distributors.

The DEA sought information from

legitimate handlers of iodine (i.e.,

manufacturers, end-users, distributors,

and veterinary, feed and farm supply

stores/companies) to determine the uses

of iodine and the quantities typically

found in legitimate transactions. Of

particular interest to DEA was the sale

of relatively small quantities of iodine

for cauterization of a hoof wound and

for the treatment of thrush. The DEA

sought information from over 300

veterinary suppliers and feed and farm

supply stores to determine if the stores

sold iodine. Of the 300 stores and

suppliers which provided information,

only nine sold iodine. Several suppliers

and end-users stated that a two-ounce

bottle of iodine would last a rancher or

a farrier several months and that,

typically, an individual would purchase

at the most 3–2 ounce bottles

(approximately 0.2 kilograms) at a time.

Based on this information, the DEA is

proposing a domestic threshold of 0.4 kg

for iodine. This would ensure the most

effective controls on the diversion of

iodine while minimizing the impact on

industry, particularly for small

businesses such as veterinary, feed, and

farm supply stores.

The proposed domestic threshold of

hydrogen chloride gas is based upon

several items: its legitimate use in

industry; quantities used by legitimate

industry; and quantities of hydrogen

chloride gas seized at clandestine

laboratories.

Hydrogen chloride gas is sold in

cylinders. Traditionally, cylinders of

hydrogen chloride gas have been seen

mostly at methamphetamine clandestine

laboratory sites in the western part of

the United States. Most of the cylinders

seized at the clandestine laboratory sites

contain approximately 60 pounds of

hydrogen chloride gas. Small cylinders

which contain 0.5 pounds of hydrogen

chloride gas have also been seen at some

laboratory sites.

The DEA gathered information on the

legitimate uses of hydrogen chloride gas

in the United States. The major uses of

hydrogen chloride gas were determined

to be in the cotton industry, the

electronic/silicon industry, the

pharmaceutical industry and other

industries for use in chemical syntheses.

All of these industries use large

quantities of hydrogen chloride gas for

their manufacturing processes.

Generally, thousands of pounds are

involved in single transactions with the

exception of smaller quantities (i.e.,

single or multiple cylinders) being used

by research, analytical or synthetic

laboratories. There are also safety issues

regarding the handling of hydrogen

chloride gas. Since the majority of

hydrogen chloride gas transactions

involve thousands of pounds and to

ensure the most effective controls on the

diversion of hydrogen chloride gas, the

DEA proposes a domestic threshold of 0

kg for hydrogen chloride gas. A

threshold of 0 kg means that all sales of

hydrogen chloride gas would be

regulated.

Before the MCA was passed, hydrogen

chloride gas, also known as anhydrous

hydochloric acid, was already a List II

chemical under the CSA (21 CFR

1310.02(b)(8)). All domestic and import

transactions, and exports,

transshipments and international

transactions, except those to all South

American countries and Panama, have

been exempt from regulatory controls

under the CSA. Exports, transshipments

and international transactions of

hydrogen chloride gas to all South

American countries and Panama above

a threshold of 27 kilograms have been

regulated transactions pursuant to 21

CFR 1310.08(b). These transactions

became regulated due to the DEA having

evidence that hydrogen chloride gas was

being diverted from illicit channels to

illicit channels for cocaine

hydrochloride production in these

countries. With the passage of the MCA,

both domestic and international

controls apply to hydrogen chloride gas.

The DEA is also including in this

proposed Federal Register notice the

reinsertion of the table in 21 CFR

1310.04(f)(2)(iv), listing thresholds for

exports, transshipments, and

international transactions to designated

countries set forth in 1310.08(b). The

DEA’s final rule regarding

implementation of the Domestic

Chemical Diversion Control Act of 1993,

published on June 22, 1995 [60 FR

32447] inadvertently omitted the table

from the section.

The Deputy Assistant Administrator

of DEA’s Office of Diversion Control

hereby certifies that this proposed

rulemaking will have no significant

impact upon entities whose interests

must be considered under the

Regulatory Flexibility Act, 5 U.S.C. 601

et seq. Controls on iodine apply to

iodine crystals. These controls do not

pertain to common household products

such as iodine tinctures of iodide salts.

The proposed iodine rulemaking applies

only to those companies manufacturing

and distributing iodine in larger

volumes. Recordkeeping requirements

will not impact researchers or other

end-users. Further, this proposed rule is

not a significant regulatory action
51074 Federal Register / Vol. 62, No. 189 / Tuesday, September 30, 1997 / Proposed Rules

pursuant to the criteria of Executive

Order 12866, since the 0.4 kg iodine

threshold does not affect small

businesses and since there is not a large

industry for hydrogen chloride gas.

Therefore, this proposed rule has not

been reviewed by the Office of

Management and Budget.

This action has been analyzed in

accordance with the principles and

criteria in Executive Order 12612, and it

has been determined that the proposed

rule does not have sufficient federalism

implications to warrant the preparation

of a Federalism Assessment.

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 proposed to be 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 proposed to be

amended by revising paragraph (b)(8)

and adding paragraph (b)(11) to read as

follows:

§ 1310.02 Substances covered.

* * * * *

(b) List II chemicals:

* * * * *

(8) Hydrochloric acid (Including

Hydrogen chloride gas)

* * * * *

(11) Iodine

* * * * *

3. Section 1310.04 is proposed to be

amended by adding new paragraphs

(f)(2)(ii) (H) and (I), and revising

(f)(2)(iv) to read as follows:

§ 1310.04 Maintenance of records.

* * * * *

(f) * * *

(2) * * *

(i) * * *

(ii) Domestic Sales

Chemical Threshold by

volume

Threshold by

weight

* * * * *

(H) Iodine .. N/A .............. 0.4 kilograms.

(I) Hydrogen chloride gas.N/A .............. 0.0 kilograms.

(iii) * * *

(iv) Exports, Transshipments and

International Transactions to Designated

Countries As Set Forth in § 1310.08(b).

Chemical Threshold by

volume

Threshold by

weight

(A) Hydrochloric

acid.

50 gallons ... N/A.

(1) Hydrogen chloride gas.N/A .............. 27 kilograms.

(B) Sulfuric

acid.

50 gallons ... N/A.

* * * * *

4. Section 1310.08 is proposed to be

amended by adding new paragraphs (f)

and (g) to read as follows:

§ 1310.08 Excluded transactions

* * * * *

(f) Import and export transactions of

iodine.

(g) Import transactions of hydrogen

chloride gas.

Dated: July 21, 1997.

John H. King,

Deputy Assistant Administrator, Office of

Diversion Control.

[FR Doc. 97–25362 Filed 9–29–97; 8:45 am]

BILLING CODE 4410–09–M

LEGAL SERVICES CORPORATION

45 CFR Part 1643

Restriction on Assisted Suicide,

Euthanasia, and Mercy Killing

AGENCY: Legal Services Corporation.

ACTION: Proposed rule.

SUMMARY: This rule is intended to

implement a new statutory restriction

that amends the Legal Services

Corporation Act (‘‘LSC’’ or

‘‘Corporation’’) and is applicable to

recipients of grants from the Legal

Services Corporation. The restriction

prohibits the use of LSC funds by

recipients for legal or other assistance

that would cause, assist in, advocate for,

or fund assisted suicide, euthanasia, or

mercy killing.

DATES: Comments should be received on

or before October 30, 1997.

ADDRESSES: Comments should be

submitted to the Office of the General

Counsel, Legal Services Corporation,

750 First St. NE., 11th Floor,

Washington, DC 20002–4250.

FOR FURTHER INFORMATION CONTACT:

Office of the General Counsel, (202)

336–8817.

SUPPLEMENTARY INFORMATION: The

Assisted Suicide Funding Restriction

Act of 1997 (‘‘Assisted Suicide Act’’ or

‘‘Act’’), Pub. L. 105–12, was enacted and

became effective on April 30, 1997.

Several provisions of the Assisted

Suicide Act expressly apply to the Legal

Services Corporation, one of which

amends Section 1007(b) of the LSC Act,

42 U.S.C. 2996f(b)(11). This rule is

intended to implement this legislation

as it applies to the Corporation and its

recipients.

Background and Summary of Law

The stated purpose of the Assisted

Suicide Act is to maintain current

Federal policy that Federal funds not be

used to support, assist in, or advocate

for assisted suicide, euthanasia or mercy

killing. H. Rep. No. 46, 105th Cong., 1st

Sess. at 3 (April 8, 1997). Although

assisted suicide, euthanasia and mercy

killing are illegal in almost all states,

Congress was concerned that pending

litigation might change the status quo

and wanted to make it clear by

legislation that, regardless of a change in

State law, Federal policy would remain

the same. H. Rep. at 3–4. Subsequent to

the passage of the Act, the Supreme

Court upheld as constitutional laws in

the States of New York and Washington

which prohibit assisted suicide and

euthanasia. See Vacco v. Quill, 117 S.

Ct. 2293 (1997); Washington v.

Glucksberg, 117 S. Ct. 2302 (1997). The

State of Oregon, on the other hand,

adopted an initiative in 1996 that

legalized physician-assisted suicide for

competent, terminally ill adults. H. Rep.

at 4. Court challenges have kept the law

from going into effect and a new

initiative to repeal the law will be on

the ballot this November. See

Associated Press, September 15, 1997

(1997 WL 2549490); Lee v. Oregon, 107

F.3d 1382 (9th Cir. Feb. 27, 1997);

Petition for Certiorari Filed, 65 USLW

3783 (May 16, 1997) (No. 96–1824).

The Assisted Suicide Act applies to

numerous Federally funded health care

programs and facilities, such as

Medicare, Medicaid, CHAMPUS and the

veterans’ and military health care

systems. It also applies to certain legal

aid and advocacy programs, including

the Legal Services Corporation.

Section 9 of the Assisted Suicide Act

amends Section 1007(b) of the LSC Act

to provide that ‘‘ No funds made

available by the Corporation under this

title, either by grant or contract, may be

used * * * to provide legal assistance

in a manner inconsistent with the

Assisted Suicide Funding Restriction

Act of 1997.’’ Section 5 of the Assisted

Suicide Act sets out the restrictions as

they apply to LSC funds by generally

prohibiting the use of appropriated

funds for legal or other assistance for the

purpose of (1) securing or funding any