5914 Federal Register / Vol. 62, No. 27 / Monday, February 10, 1997 / Rules and Regulations

Note that these inflation adjustments

are based on the Gross Domestic

Product (GDP) Implicit Price Deflator,

rather than the Gross National Product

(GNP) Implicit Price Deflator, which is

not yet available for 1996. The

Commerce Department advises that in

recent years the annual change has been

virtually the same for both indices.

Further adjustments will be made, if

necessary.

List of Subjects in 18 CFR Part 157

Natural gas.

Kevin P. Madden,

Director, Office of Pipeline Regulation.

Accordingly, 18 CFR Part 157 is

amended as follows:

PART 157—[AMENDED]

1. The authority citation for part 157

continues to read as follows:

Authority: 15 U.S.C. 717–717w, 3301–

3432; 42 U.S.C. 7101–7352.

§ 157.208 [Amended]

2. Table I in § 157.208(d) is revised to

read as follows:

§ 157.208 Construction, acquisition,

operation, and miscellaneous

rearrangement of facilities.

* * * * *

(d) * * *

TABLE I

Year

Limit

Auto. proj.

cost limit

(col. 1)

Prior notice

proj. cost limit

(col. 2)

1982 .......... $4,200,000 $12,000,000

1983 .......... 4,500,000 12,800,000

1984 .......... 4,700,000 13,300,000

1985 .......... 4,900,000 13,800,000

1986 .......... 5,100,000 14,300,000

1987 .......... 5,200,000 14,700,000

1988 .......... 5,400,000 15,100,000

1989 .......... 5,600,000 15,600,000

1990 .......... 5,800,000 16,000,000

1991 .......... 6,000,000 16,700,000

1992 .......... 6,200,000 17,300,000

1993 .......... 6,400,000 17,700,000

1994 .......... 6,600,000 18,100,000

1995 .......... 6,700,000 18,400,000

1996 .......... 6,900,000 18,800,000

1997 .......... 7,000,000 19,200,000

* * * * *

§ 157.215 [Amended]

3. Table II in § 157.215(a) is revised to

read as follows:

§ 157.215 Underground storage testing

and development.

(a) * * *

TABLE II

Year Limit

1982 ...................................... $2,700,000

1983 ...................................... 2,900,000

1984 ...................................... 3,000,000

1985 ...................................... 3,100,000

1986 ...................................... 3,200,000

1987 ...................................... 3,300,000

1988 ...................................... 3,400,000

1989 ...................................... 3,500,000

1990 ...................................... 3,600,000

1991 ...................................... 3,800,000

1992 ...................................... 3,900,000

1993 ...................................... 4,000,000

1994 ...................................... 4,100,000

1995 ...................................... 4,200,000

1996 ...................................... 4,300,000

1997 ...................................... 4,400,000

* * * * *

[FR Doc. 97–3153 Filed 2–7–97; 8:45 am]

BILLING CODE 6717–01–M

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Parts 1309, 1310, and 1313

[DEA Number 154I]

RIN 1117–AA42

Comprehensive Methamphetamine

Control Act of 1996; Possession of List

I Chemicals, Definitions, Record

Retention, and Temporary Exemption

From Chemical Registration for

Distributors of Combination Ephedrine

Products

AGENCY: Drug Enforcement

Administration (DEA), Justice.

ACTION: Interim rule with request for

comments.

SUMMARY: DEA is amending its

regulations to incorporate certain

amendments of the Controlled

Substances Act (CSA) made by the

Comprehensive Methamphetamine

Control Act of 1996 (MCA) and to

provide temporary exemption from

registration for persons who distribute

combination ephedrine drug products.

The MCA amends the CSA with respect

to: possession of listed chemicals

following suspension or revocation of

registration; the record retention

requirements for List I chemical

transactions; certain definitions; and

establishes the requirement that,

effective October 3, 1996, persons that

distribute combination ephedrine

products shall be subject to the

chemical registration requirement. To

avoid interruption in the legitimate

distribution of combination ephedrine

products, DEA is amending its

regulations to provide certain temporary

exemptions from the registration

requirement pending promulgation of

final regulations.

DATES: Effective February 10, 1997.

Written comments or objections must be

submitted on or before April 11, 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: G.

Thomas Gitchel, Chief, Liaison and

Policy Section, Office of Diversion

Control, Drug Enforcement

Administration, Washington, D.C.

20537, Telephone (202) 307–7297.

SUPPLEMENTARY INFORMATION: The

Comprehensive Methamphetamine

Control Act of 1996 was enacted on

October 3, 1996. Among its provisions,

the MCA contained revisions of the

Controlled Substances Act (CSA) with

respect to possession of listed chemicals

following revocation or suspension of

registration, the record retention

requirements for transactions involving

List I chemicals and tableting or

encapsulating machines, and

definitions, of ‘‘regulated transaction’’,

‘‘retail distributor’’, and ‘‘combination

ephedrine product’’. To accommodate

the amendments made by the MCA,

DEA is making the following changes to

Title 21, Code of Federal Regulations

(CFR):

21 CFR 1309.43 Suspension or

Revocation of Registration

The MCA amends Section 404 of the

CSA (21 U.S.C. 844) to make it unlawful

for any person to knowingly or

intentionally possess any list I chemical

obtained under the authority of a

registration or an exemption from

registration granted by the

Administrator by regulation, if that

registration or exemption has been

revoked or suspended. The revised

language also makes it illegal to possess

list I chemicals obtained under the

authority of a registration or an

exemption granted by regulation by the

Administrator, if the registration has

expired or if the registrant has ceased to

do business as originally intended

under that registration.

To reflect the amendments in the law,

DEA is revising 21 CFR 1309.43, to

include seizure and forfeiture

instructions. Persons whose

registrations or exemptions have been

revoked or suspended shall be required,

upon service of the notice of revocation

or suspension, to surrender all List I
Federal Register / Vol. 62, No. 27 / Monday, February 10, 1997 / Rules and Regulations 5915

chemicals in their possession obtained

under the authority of a registration or

an exemption from registration granted

by the Administrator by regulation, to

the nearest office of the Administration

or authorized agent of the

Administration, or place such List I

chemicals under seal as described in 21

U.S.C. 824(f). When the suspension or

revocation is limited to certain

chemicals, the registrant shall surrender

those chemicals affected by the

revocation or suspension as indicated

above.

21 CFR 1309.02, 1310.01 & 1313.02

Definitions

The definition of ‘‘retail distributor’’

found in § 1309.02(f) has been amended

by the MCA. As defined by the MCA,

the term refers to persons, such as

grocery stores, general merchandise

stores, drug stores, etc., that engage in

sales of pseudoephedrine,

phenylpropanolamine, and combination

ephedrine drug products almost

exclusively to individuals for personal

use in face-to-face transactions. The new

definition will apply to all retail

distributors of regulated drug products,

including single entity ephedrine

products.

The MCA also amends the definition

of ‘‘regulated transaction’’ to make all

ephedrine products and certain drug

products containing pseudoephedrine

and phenylpropanolamine subject to

regulation. However, because the

provisions relating to pseudoephedrine

and phenylpropanolamine products will

not become effective until October 3,

1997, the definition of ‘‘regulated

transaction’’, as found in 21 CFR

1310.01(f) and 1313.02(d), is being

amended only with respect to ephedrine

products at this time. The MCA also

defines ‘‘combination ephedrine

product’’; that definition, together with

the appropriate guidelines clarifying the

specific criteria established by the

definition, has been added to §§ 1309.02

and 1310.01.

As a result of the amendment to the

definition of ‘‘regulated transaction’’,

persons who distribute, import, or

export combination ephedrine products

are now subject to the chemical

registration, recordkeeping, and

reporting requirements. As noted later

in this document, DEA is establishing

certain temporary exemptions from the

registration requirement pending

promulgation of regulations, subject to

notice and comment, relating to the

control of combination ephedrine

products.

21 CFR 1310.02 Substances Covered

and 21 CFR 1310.04 Maintenance of

Records

The MCA amends Section 802(34) of

the CSA to correct the spelling of

‘‘Isosafrole’’ and ‘‘hydriodic acid’’ and

Section 830(a) to modify the record

retention period from the current 4

years to 2 years for all transactions

involving a listed chemical or a

tableting or encapsulating machine. The

corresponding amendments are being

made in the regulations. With respect to

the change in the record retention

period, the new language of the law

does not distinguish between records

created before and after the change in

the retention requirement. Thus,

effective October 3, 1996, a regulated

person’s records must only contain

records of those regulated transactions

that occurred within the past two years;

records of transactions that are more

than two years old are no longer

required.

Temporary Exemptions From

Registration Pending Promulgation,

With Notice and Comment, of

Regulations

As noted earlier, combination

ephedrine products became subject to

the CSA’s chemical registration,

recordkeeping, and reporting provisions

effective October 3, 1996. Under this

new requirement, any person who

distributes, imports, or exports

combination ephedrine products must

first obtain a DEA registration. Because

implementation of this provision will

require amendment to DEA’s

regulations, DEA is establishing

temporary exemptions from the

registration requirement for persons

handling combination ephedrine

products, to allow for continuation of

legitimate commerce in the products. In

addition, the existing exemptions from

chemical registration for persons

registered with DEA to handle

controlled substances, which is

contained in 21 CFR 1309.25 and for

distributors of prescription drug

products, which is contained in 21 CFR

1309.28, are continued for combination

ephedrine products.

The first new exemption applies to

retail distributors of combination

ephedrine products. A single

transaction limit of 24 grams has been

established by the MCA for combination

ephedrine products in retail

distributions. Consistent with previous

proposals regarding the regulation of

retail distributions of drug products that

contain List I chemicals, DEA is

temporarily exempting retail

distributors from the registration

requirement. This interim rule is subject

to public comment. Under this

exemption, retail distributors will not be

required to obtain a registration if they

engage exclusively in distributions of

combination ephedrine products below

the 24 gram limit in a single transaction

for legitimate medical use either directly

to walk-in customers or in face-to-face

transactions by direct sales. This

exemption is set out in the new section

21 CFR 1309.29. Retail distributors that

operate under this exemption are

reminded that they will be subject to

civil penalties for violations of the 24

gram single transaction limit, as set out

in Section 401(f)(2) of the MCA.

The second exemption applies to

those persons (other than retail

distributors, as described above, or

persons subject to the existing

exemptions regarding CSA registrants

and prescription drug products) who are

required to obtain a registration. Any

such person who submits an application

for registration for activities involving

combination ephedrine products on or

before May 12, 1997 will be exempt

from the registration requirement for

their lawful activities with combination

ephedrine products until the

Administration has taken final action

with respect to that application. This

exemption is set out in 21 CFR 1310.09.

DEA recognizes that, unlike the

second exemption, which provides a

general benefit to all affected persons,

the first exemption is limited in its

benefit. Therefore, while the regulatory

changes in this interim rule take effect

upon publication, the notice is open for

public comment or objection until May

12, 1997. Further, the exemptions are

temporary and may be subject to

change, based on the comments or

objections received.

The Deputy Assistant Administrator

for the Office of Diversion Control

hereby certifies that this interim

rulemaking will not have a significant

economic impact upon a substantial

number of entities whose interests must

be considered under the Regulatory

Flexibility Act, 5 U.S.C. 601 et seq. This

interim rulemaking is an administrative

action to make the regulations

consistent with the law and to avoid

interruption of legitimate commerce by

granting temporary exemptions from

registration pending promulgation,

through notice and comment, of the

regulations necessary to implement the

provisions of the MCA pertaining to

combination ephedrine products.

Further, since this is a temporary action

which provides affected persons with a

means to comply with the law pending

promulgation of regulations

implementing the MCA, this action is
5916 Federal Register / Vol. 62, No. 27 / Monday, February 10, 1997 / Rules and Regulations

not a significant regulatory action and

therefore has not been reviewed by the

Office of Management and Budget

pursuant to Executive Order 12866.

Consideration of the significance and

impact of the new requirements of the

MCA will be addressed as part of a

future proposed rulemaking by DEA

proposing regulations to implement the

MCA.

This action has been analyzed in

accordance with the principles and

criteria in Executive Order 12612, and it

has been determined that this interim

rule does not have sufficient federalism

implications to warrant the preparation

of a Federalism Assessment.

List of Subjects

21 CFR Part 1309

Administrative practice and

procedure, Drug traffic control, List I

and List II chemicals, Security

measures.

21 CFR 1310

Drug traffic control, List I and List II

chemicals, Reporting and recordkeeping

requirements.

21 CFR Part 1313

Drug traffic control, Exports, Imports,

list I and List II chemicals,

Transshipment and in-transit

shipments.

For the reasons set out above, 21 CFR

Parts 1309, 1310, and 1313 are to be

amended as follows:

PART 1309—REGISTRATION OF

MANUFACTURERS, DISTRIBUTORS,

IMPORTERS AND EXPORTERS OF

LIST I CHEMICALS

1. The authority citation for part 1309

continues to read as follows:

Authority: 21 U.S.C. 821, 822, 823, 824,

830, 871(b), 875, 877, 958.

2. Section 1309.29 is added to read as

follows:

§ 1309.29 Exemption of retail distributors

of combination ephedrine drug products.

The requirement of registration is

waived for any retail distributor whose

activities with respect to List I

chemicals are restricted to the

distribution of below-threshold

quantities of a combination ephedrine

drug product in a single transaction to

an individual for legitimate medical use.

The threshold for a distribution of a

combination ephedrine drug product in

a single transaction to an individual for

legitimate medical use is 24 grams of

ephedrine base.

2. Section 1309.43 is amended by

revising paragraph (d) and adding a new

paragraph (e) to read as follows:

§ 1309.43 Suspension or revocation of

registration.

* * * * *

(d) Upon service of the order of the

Administrator suspending or revoking

registration, the registrant shall

immediately deliver his or her

Certificate of Registration to the nearest

office of the Administration. Also, upon

service of the order of the Administrator

revoking or suspending registration, the

registrant shall, as instructed by the

Administrator:

(1) Deliver all List I chemicals in his

or her possession that were obtained

under the authority of a registration or

an exemption from registration granted

by the Administrator by regulation, to

the nearest office of the Administration

or to authorized agents of the

Administration; or

(2) Place all such List I chemicals in

his or her possession under seal as

described in section 304(f) of the Act (21

U.S.C. 824(f)).

(e) In the event that revocation or

suspension is limited to a particular

chemical or chemicals, the registrant

shall be given a new Certificate of

Registration for all substances not

affected by such revocation or

suspension; no fee shall be required for

the new Certificate of Registration. The

registrant shall deliver the old

Certificate of Registration to the nearest

office of the Administration. Also, upon

service of the order of the Administrator

revoking or suspending registration with

respect to a particular chemical or

chemicals, the registrant shall, as

instructed by the Administrator:

(1) Deliver to the nearest office of the

Administration or to authorized agents

of the Administration all of the

particular chemical or chemicals in his

or her possession that were obtained

under the authority of a registration or

an exemption from registration granted

by the Administrator by regulation,

which are affected by the revocation or

suspension; or

(2) Place all of such chemicals under

seal as described in section 304(f) of the

Act (21 U.S.C. 824(f)).

3. Section 1309.44 is amended by

revising paragraph (b) to read as follows:

§ 1309.44 Suspension of registration

pending final order.

* * * * *

(b) Upon service of the order of

immediate suspension, the registrant

shall promptly return his Certificate of

Registration to the nearest office of the

Administration. Also, upon service of

the order of immediate suspension, the

registrant shall, as instructed by the

Administrator:

(1) Deliver to the nearest office of the

Administration or to authorized agents

of the Administration all of the

particular chemical or chemicals in his

or her possession that were obtained

under the authority of a registration or

an exemption from registration granted

by the Administrator by regulation,

which are affected by the revocation or

suspension; or

(2) Place all of such chemicals under

seal as described in section 304(f) of the

Act (21 U.S.C. 824(f)).

* * * * *

4. Section 1309.62 is to be amended

by revising the existing text and

redesignating it as paragraph (a) and

adding a new paragraph (b) to read as

follows:

§ 1309.62 Termination of registration.

(a) The registration of any person

shall terminate if and when such person

dies, ceases legal existence, or

discontinues business or professional

practice. Any registrant who cases legal

existence or discontinues business or

professional practice shall promptly

notify the Special Agent in Charge of the

Administration in the area in which the

person is located of such fact and seek

authority and instructions to dispose of

any List I chemicals obtained under the

authority of that registration.

(b) The Special Agent in Charge shall

authorize and instruct the person to

dispose of the List I chemical in one of

the following manners:

(1) By transfer to person registered

under the Act and authorized to possess

the substances;

(2) By delivery to an agent of the

Administration or to the nearest office

of the Administration;

(3) By such other means as the Special

Agent in Charge may determine to

assure that the substance does not

become available to unauthorized

persons.

PART 1310—RECORDS AND

REPORTS OF LISTED CHEMICALS

AND CERTAIN MACHINES

1. The authority citation for part 1310

continues to read as follows:

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

2. Section 1310.01 is amended by

revising paragraphs (f)(1)(iv)(A) and (B)

redesignating paragraphs (g) through (l)

as paragraphs (h) through (m),

redesignating paragraph (m) as

paragraph (o), and adding new

paragraphs (g) and (n) to read as follows:

§ 1310.01 Definitions.

* * * * *

(f) * * *

(1) * * *
Federal Register / Vol. 62, No. 27 / Monday, February 10, 1997 / Rules and Regulations 5917

(iv) * * *

(A) (1) the drug contains ephedrine or

its salts, optical isomers, or salts of

optical isomers; or

(2) The Administrator has determined

pursuant to the criteria in 1310.10 that

the drug or group of drugs is being

diverted to obtain the listed chemical

for use in the illicit production of a

controlled substance; and

(B) The quantity of ephedrine or other

listed chemical contained in the drug

included in the transaction or multiple

transactions equals or exceeds the

threshold established for that chemical.

* * * * *

(g) The term combination ephedrine

product means a drug product

containing ephedrine or its salts, optical

isomers, or salts of optical isomers and

therapeutically significant quantities of

another active medicinal ingredient.

The term ‘‘therapeutically significant

quantities’’ shall apply if the product

formulation (i.e., the qualitative and

quantitative composition of active

ingredients within the product) is listed

in American Pharmaceutical

Association (APHA) Handbook of

NonPrescription Drugs; Drug Facts and

Comparisons (published by Wolters

Kluwer Company); or USP DI

(published by authority of the United

States Pharmacopeial Convention, Inc.);

or the product is listed in § 1310.15 as

an exempt drug product. For drug

products having formulations not found

in the above compendiums, the

Administrator shall determine, pursuant

to a written request as specified in

§ 1310.14 whether the active medicinal

ingredients are present in quantities

considered therapeutically significant

for purposes of this paragraph.

* * * * *

(n) The term retail distributor means

a grocery store, general merchandise

store, drug store, or other entity or

person whose activities as a distributor

relating to drug products containing

pseudeophedrine,

phenylpropanolamine, or ephedrine are

limited almost exclusively to sales for

personal use, both in number of sales

and volume of sales, either directly to

walk-in customers or in face-to-face

transactions by direct sales. For the

purposes of this paragraph, sale for

personal use means the distribution of

below-threshold quantities in a single

transaction to an individual for

legitimate medical use. Also for the

purposes of this paragraph, a grocery

store is an entity within Standard

Industrial Classification (SIC) code

5411, a general merchandise store is an

entity within SIC codes 5300 through

5399 and 5499, and a drug store is an

entity within SIC code 5912.

* * * * *

3. Section 1310.02 is amended by

revising paragraphs (a)(16) and (a)(21) to

read as follows:

§ 1310.02 Substances covered.

* * * * *

(a) * * *

(16) Isosafrole ....................................... 8704

* * * * *

(21) Hydriodic Acid ............................ 6695

* * * * *

4. Section 1310.04 is amended by

revising paragraph (a) to read as follows:

§ 1310.04 Maintenance of records.

(a) Every record required to be kept

subject to § 1310.03 for a List I chemical,

a tableting machine, or an encapsulating

machine shall be kept by the regulated

person for two years after the date of the

transaction.

* * * * *

5. Section 1310.09 is revised to read

as follows:

§ 1310.09 Temporary exemption from

registration.

Each person required by section 302

of the Act (21 U.S.C. 822) to obtain a

registration to distribute, import, or

export an combination ephedrine

product is temporarily exempted from

the registration requirement, provided

that the person submits a proper

application for registration on or before

May 12, 1997. 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.

PART 1313—IMPORTATION AND

EXPORTATION OF PRECURSORS AND

ESSENTIAL CHEMICALS

1. The authority citation for part 1313

continues to read as follows:

Authority: 21 U.S.C. 802, 830, 871(b), 971.

2. Section 1313.02 is amended by

revising paragraphs (d)(1)(iv)(A) and (B),

to read as follows:

§ 1313.02 Definitions.

* * * * *

(d) * * *

(1) * * *

(iv) * * *

(A)(1) the drug contains ephedrine or

its salts, optical isomers, or salts of

optical isomers; or

(2) The Administrator has determined

pursuant to the criteria in 1310.10 that

the drug or group of drugs is being

diverted to obtain the listed chemical

for use in the illicit production of a

controlled substance; and

(B) The quantity of ephedrine or other

listed chemical contained in the drug

included in the transaction or multiple

transactions equals or exceeds the

threshold established for that chemical.

* * * * *

Dated: January 28, 1997.

Gene R. Haislip,

Deputy Assistant Administrator, Office of

Diversion Control.

[FR Doc. 97–3086 Filed 2–7–97; 8:45 am]

BILLING CODE 4410–09–M

DEPARTMENT OF TRANSPORTATION

Saint Lawrence Seaway Development

Corporation

33 CFR Parts 404 and 407

RIN 2135–AA08

Seaway Regulations and Rules: Great

Lakes Pilotage Rates

AGENCY: Saint Lawrence Seaway

Development Corporation, DOT.

ACTION: Final rule.

SUMMARY: The Saint Lawrence Seaway

Development Corporation (SLSDC)

amends the Seaway Regulations and

Rules by increasing Great Lakes Pilotage

Rates by: 8% in District 1 (9% in Area

1; 6% in Area 2); 19% in District 2 (0%

in Area 4; 31% in Area 5); 6% in

District 3 (7% in Area 6; 6% in Area 7;

4% in Area 8); and 11% for mutual

rates.

The pilotage rate adjustments

contained in this final rule are different

from the rates proposed by the SLSDC

in the Notice of Proposed Rulemaking

published in the Federal Register (61

FR 50258) on September 25, 1996, (the

NPRM), because adjustments have been

made based on comments received in

response to the NPRM. These

adjustments are discussed in the section

of this rule entitled ‘‘Discussion of

Comments and Changes.’’

The increase in Great Lakes pilotage

rates is necessary because, after review,

the SLSDC has determined that, in

accordance with 33 CFR 407.1(b), pilot

compensation is not meeting pilot

compensation targets established in 33

CFR Part 407, Appendix A, Step 2.

EFFECTIVE DATE: This rule becomes

effective on March 1, 1997.

FOR FURTHER INFORMATION CONTACT:

Scott A. Poyer, Chief Economist, Saint