Special Surveillance List of Chemicals, Products, Materials and Equipment Used in the Clandestine Production of Controlled Substances or Listed Chemicals

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[DEA-172N]

Special Surveillance List of Chemicals, Products, Materials and

Equipment Used in the Clandestine Production of Controlled Substances

or Listed Chemicals

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Publication of Proposed Special Surveillance List.

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SUMMARY: On October 3, 1996, the Comprehensive Methamphetamine Control

Act of 1996 (MCA) was signed into law. The MCA provides for a civil

penalty of not more than $250,000 for the distribution of a laboratory

supply to a person who uses, or attempts to use, that laboratory supply

to manufacture a controlled substance or a listed chemical, if that

distribution was made with reckless disregard for the illegal uses to

which such laboratory supply will be put. The term ``laboratory

supply'' is defined as ``a listed chemical or any chemical, substance,

or item on a special surveillance list published by the Attorney

General which contains chemicals, products, materials, or equipment

used in the manufacture of controlled substances and listed

chemicals.'' DEA is hereby providing notice of its intent to publish

this Special Surveillance List. Upon review of written comments or

objections, DEA will publish the Special Surveillance List in a final

notice.

DATES: Written comments or objections must be received no later than

December 31, 1998.

ADDRESSES: Comments and objections should be submitted in quintuplicate

to the Acting Deputy Administrator, Drug Enforcement Administration,

Washington, DC, Attention: DEA Federal Register Representative/CCR.

FOR FURTHER INFORMATION CONTACT:

[[Page 66200]]

Frank Sapienza, Chief, Drug and Chemical Evaluation Section, Office of

Diversion Control, Drug Enforcement Administration, Washington, DC

20537, Telephone (202) 307-7183.

SUPPLEMENTARY INFORMATION: On October 3, 1996, the Comprehensive

Methamphetamine Control Act of 1996 (MCA) was signed into law. The MCA

broadens controls on listed chemicals used in the production of

methamphetamine and other controlled substances, increases penalties

for the trafficking and manufacturing of methamphetamine and listed

chemicals, and expands regulatory controls to include the distribution

of lawfully marketed drug products which contain the listed chemicals

ephedrine, pseudoephedrine and phenylpropanolamine. The MCA (Section

205) also provides for the publication of a Special Surveillance List

by the Attorney General. The proposed Surveillance List identifies

laboratory supplies which are used in the manufacture of controlled

substances or listed chemicals. The MCA defines ``laboratory supply''

as ``a listed chemical or any chemical, substance, or item on a special

surveillance list published by the Attorney General which contains

chemicals, products, materials, or equipment used in the manufacture of

controlled substances and listed chemicals.'' (21 U.S.C. 842 (a))

The MCA provides for a civil penalty of not more than $250,000 for

the distribution of a laboratory supply to a person who uses, or

attempts to use, that laboratory supply to manufacture a controlled

substance or a listed chemical, if that distribution was made with

``reckless disregard'' for the illegal uses to which such a laboratory

supply would be put. For purposes of this provision, the term

``distribution'' includes the exportation of a laboratory supply. For

any succeeding violation, the MCA provides for a civil fine of not more

than $250,000 or double the last previously imposed penalty, whichever

is greater.

Section 205 of the MCA further states that, for purposes of 21

U.S.C. 842(a)(11), there is a ``rebuttable presumption of reckless

disregard at trial if the Attorney General notifies a firm in writing

that a laboratory supply sold by the firm, or any other person or firm,

has been used by a customer of the notified firm, or distributed

further by that customer, for the unlawful production of controlled

substances or listed chemicals a firm distributes and 2 weeks or more

after the notification the notified firm distributes a laboratory

supply to the customer.''

The CSA contains other sections relating to the illegal manufacture

of controlled substances. Section 841(d)(2) of Title 21 provides that

any person who knowingly or intentionally distributes a listed chemical

knowing, or having reasonable cause to believe, that it will be used in

the illegal manufacture of a controlled substance, is subject to

criminal prosecution. Section 843(a)(7) of Title 21 provides that any

person who distributes any chemical, product, equipment or material

which may be used to manufacture a controlled substance or listed

chemical, knowing, or having reasonable cause to believe, that it will

be used in the illegal manufacture of a controlled substance or listed

chemical, is subject to criminal prosecution.

In developing the proposed Special Surveillance List, the DEA

consulted with both DEA and State/Local law enforcement and forensic

laboratory authorities. The DEA examined clandestine laboratory seizure

reports for information regarding (1) illicit drug production methods;

(2) chemicals actually used in clandestine production of controlled

substances and listed chemicals; and (3) the role and importance of

chemicals used in the syntheses. In addition, the DEA considered the

legitimate uses and market for these chemicals.

The proposed Special Surveillance List focuses on chemicals used in

the domestic production of controlled substances and listed chemicals.

Therefore the list includes those chemicals used not only in the

production of methamphetamine, but also of controlled substances such

as PCP, LSD, methcathinone and amphetamine. The list does not focus on

chemicals used in the production of heroin or cocaine since these drugs

are seldom produced domestically. However, the proposed Special

Surveillance List includes all listed chemicals as specified in 21 CFR

1310.02 (a) or (b). The phrase ``all listed chemicals'' includes all

chemical mixtures and all over-the-counter (OTC) pharmaceutical

products and dietary supplements which contain a listed chemical,

regardless of their dosage form or packaging and regardless of whether

the chemical mixture, drug product or dietary supplement is exempt from

regulatory controls.

The following is the proposed Special Surveillance List for

laboratory supplies used in the manufacture of controlled substances

and listed chemicals:

Special Surveillance List Published Pursuant to Title 21, United States

Code, Section 842(a)(11)

Chemicals

All listed chemicals as specified in 21 CFR 1310.02 (a) or (b).

This includes all chemical mixtures and all over-the-counter (OTC)

products and dietary supplements which contain a listed chemical,

regardless of their dosage form or packaging and regardless of

whether the chemical mixture, drug product or dietary supplement is

exempt from regulatory controls.

Ammonia Gas

Ammonium Formate

Bromobenzene

1,1-Carbonyldiimidazole

Cyclohexanone

1,1-Dichloro-1-fluoroethane (e.g. Freon 141B)

Diethylamine and its salts

2,5-Dimethoxyphenethylamine and its salts

Formamide

Formic Acid

Hypophosphorous Acid

Lithium Metal

Lithium Aluminum Hydride

Magnesium Metal (Turnings)

Mercuric Chloride

N-Methylformamide

Organomagnesium Halides (Grignard Reagents) (e.g. ethylmagnesium

bromide and phenylmagnesium bromide)

Phenylethanolamine and its salts

Phosphorus Pentachloride

Potassium Dichromate

Pyridine and its salts

Red Phosphorus

Sodium Dichromate

Sodium Metal

Thionyl Chloride

ortho-Toluidine

Trichloromonofluoromethane (e.g. Freon-11, Carrene-2)

Trichlorotrifluoroethane (e.g. Freon 113)

Equipment

Hydrogenators

Tableting Machines

Encapsulating Machines

22 Liter Heating Mantels

Individuals and firms which distribute listed chemicals and

chemicals, products, materials, or equipment on the above list, are

hereby officially notified that these materials may be used in the

illicit production of certain controlled substances or listed

chemicals.

The Attorney General has delegated authority under the CSA and all

subsequent amendments to the CSA to the Administrator of the DEA

pursuant to 28 CFR 0.100. The Administrator, in turn, has redelegated

this authority to the Deputy Administrator pursuant to 28 CFR 0.104.

This surveillance list may be revised as appropriate. The list will

be re-published as changes occur. While publication in the Federal

Register satisfies the notification requirements for the Surveillance

List, DEA is attempting to disseminate the list as widely as possible.

Therefore, copies of

[[Page 66201]]

the list will be sent to appropriate industry associations and trade

journals, and to the extent practical, to individual manufacturers and

distributors of ``laboratory supplies.'' In addition, a current

surveillance list will be available on the DEA homepage at http://

www.usdoj.gov/dea/.

Small Business Impact and Regulatory Flexibility Concerns

The proposed Special Surveillance List applies to all individuals

and firms which distribute the listed chemicals and laboratory supplies

(chemicals, products, materials, or equipment) on the list. The notice

does not impose any recordkeeping or reporting requirements for any of

the laboratory supplies which are not listed chemicals. Thus the

suveillance list will have a negligible impact on affected parties.

The notice serves two purposes. First, it informs individuals and

firms of the potential use of the items on the list for the production

of listed chemicals and illicit drugs. Second, it advises individuals

and firms that civil penalties may be imposed on them if they

distribute a laboratory supply to a person anytime after the two week

period following receipt of written notification by the Attoney General

that the person has used, attempted to use, or distributed the

laboratory supply further for the unlawful production of controlled

substances or listed chemicals.

DEA chose to limit the number of chemicals on the proposed Special

Surveillance List to those most frequently used in the clandestine

production of controlled substances or listed chemicals. Limiting the

number of chemicals on the list minimizes the impact on wholesalers and

retailers of the chemicals.

The Acting Deputy Administrator hereby certifies that this proposed

notice has been drafted in a manner consistent with the principles of

the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). This proposed

notice will provide an increased level of law enforcement control to

prevent the diversion of laboratory supplies used for the production of

listed chemicals and controlled substances. It will not however impose

any new regulatory burden on the public. This proposed notice fulfills

the requirement imposed by section 205 of the Methamphetamine Control

Act (MCA) of 1996 that the Attorney General shall publish a special

surveillance list which contains chemicals, products, materials, or

equipment used in the manufacture of listed chemcials and controlled

substances. A copy of this proposed notice has been provided to the

Chief Counsel for Advocacy at the Small Business Administration.

This proposed notice has been drafted and reviewed in accordance

with Executive Order 12866. This proposed notice has not been

determined to be a significant action. Therefore, this proposed notice

has not been reviewed and approved by the Office of Management and

Budget.

This proposed action has been analyzed in accordance with the

principles and criteria in Executive Order 12612, and it has been

determined that this proposed notice does not have sufficient

federalism implications to warrant the preparation of a Federalism

Assessment.

This proposed notice 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.

This proposed notice is not a major rule as defined by Section 804

of the Small Business Regulatory Enforcement Fairness Act of 1996. This

proposed notice will not result in an annual effect on the economy of

$100,000,000 or more; a major increase in costs or prices; or

significant adverse effects on competition, employment, investment,

productivity, innovation, or on the ability of United States-based

companies to compete with foreign-based companies in domestic and

export markets.

Dated: July 24, 1998.

Donnie R. Marshall,

Acting Deputy Administrator.

[FR Doc. 98-31962 Filed 11-30-98; 8:45 am]

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