2023-23478. Special Surveillance List of Chemicals, Products, Materials and Equipment Used in the Manufacture of Controlled Substances and Listed Chemicals

AGENCY:

Drug Enforcement Administration, Department of Justice.

ACTION:

Notice.

SUMMARY:

The Controlled Substances Act provides for civil penalties 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. The Drug Enforcement Administration is hereby publishing a final notice to update the Special Surveillance List.

DATES:

This Special Surveillance List is effective October 24, 2023.

FOR FURTHER INFORMATION CONTACT:

Terrence L. Boos, Drug and Chemical Evaluation Section, Diversion Control Division, Drug Enforcement Administration; Telephone: [phone].

SUPPLEMENTARY INFORMATION:

The Controlled Substances Act (CSA), as amended by the Comprehensive Methamphetamine Control Act of 1996 (MCA), provides for the publication of a Special Surveillance List by the Attorney General.^[1] The Special Surveillance List identifies laboratory supplies which are used in the manufacture of controlled substances and listed chemicals. The CSA 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.” ^[2] The CSA 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 will be put.^[3] The CSA 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.” ^[4]

The publication of the Special Surveillance List serves two purposes. First, it informs individuals and firms of the potential use of the items on the list in the manufacture of controlled substances and listed chemicals. Second, it reminds individuals and firms that civil penalties may be imposed on them if they distribute a laboratory supply to a person who uses, or attempts to use, that laboratory supply to manufacture a controlled substance or a listed chemical, in violation of the CSA, with reckless disregard for the illegal uses to which such a laboratory supply will be put.^[5] The publication of the updated Special Surveillance List provides an increased level of public awareness and law enforcement control to prevent the diversion of laboratory supplies used for the manufacture of listed chemicals and controlled substances.

The first Special Surveillance List was published in 1999 and has not been updated since.^[6] Although the CSA does not require notice and comment for changes to the Special Surveillance List, DEA provided notice of proposed changes and an opportunity for the public to comment because the list has not been updated in over 23 years.^[7]

Comments Received

DEA received 29 comments in response to the notice of proposed updates to the Special Surveillance List, all of which were in opposition to the proposed changes. According to the commenters, the update to the Special Surveillance List will further regulate the chemical industry, which would impose additional regulatory burdens on small businesses. Several commenters also objected to the addition of three chemicals to the Special Surveillance List: sodium borohydride, propiophenone, and propionyl chloride.

DEA Response: As explained in the notice of proposed updates to the Special Surveillance List, the updates do not impose any new regulatory burden on the public, and they do not impose any recordkeeping or reporting requirements for any of the laboratory supplies. The chemicals that are being added to the Special Surveillance List are not themselves being regulated as listed chemicals or controlled substances under the CSA. The Special Surveillance List is being updated to reflect changes in the chemicals, products, materials, or equipment used in the manufacture of controlled substances and listed chemicals, to include additional laboratory supplies that are used in the illicit manufacture of controlled substances and listed chemicals.

Several commenters objected to the addition of three chemicals to the Special Surveillance List: sodium borohydride, propiophenone, and propionyl chloride. These objections were devoid of acknowledgement that these chemicals are used in the illicit manufacture of controlled substances and listed chemicals. Specifically, sodium borohydride is a reducing agent and can be used in the illicit manufacture of fentanyl and fentanyl analogues. Propionyl chloride is a chemical that can be used in the illicit manufacture of fentanyl and fentanyl analogues. Propiophenone is a chemical that can be used in the illicit manufacture of several substituted cathinones that are controlled in schedule I of the CSA.

In developing the updated Special Surveillance List, DEA consulted with federal, state, local, and foreign law enforcement officials, forensic laboratory authorities, intelligence groups, drug profiling programs, and international organizations. DEA examined clandestine laboratory seizure reports and drug profiling reports for information regarding: (1) illicit drug production methods; (2) chemicals actually used in the clandestine production of controlled substances and listed chemicals; and (3) the role and importance of chemicals used in the synthesis of controlled substances and listed chemicals. The updated Special Surveillance List includes chemicals used in the production of synthetic drugs such as fentanyl, amphetamine, methamphetamine, PCP, LSD, and other controlled substances and listed chemicals.

DEA is updating the Special Surveillance List by adding the following laboratory supplies to the existing Special Surveillance List:

Chemicals, including their salts whenever the existence of such salts is possible

(2-nitroprop-1-en-1-yl)benzene (1-phenyl-2-nitropropene; P2NP)

1-(4-bromophenyl)propan-1-one

1-(4-chlorophenyl)propan-1-one

1-(4-methylphenyl)propan-1-one

1-benzylpiperidin-4-one ( N -benzyl-4-piperidone)

1-chloro- N -methyl-1-phenylpropan-2-amine (chloroephedrine; chloropseudoephedrine)

1-phenylbutan-1-one

1-phenylpentan-1-one

1-phenylpropan-1-one

2-bromo-1-(4-chlorophenyl)propan-1-one

2-bromo-1-(4-methoxyphenyl)propan-1-one

2-bromo-1-(4-methylphenyl)propan-1-one

2-bromo-1-phenylpentan-1-one

2-bromo-1-phenylpropan-1-one

3-methyl-3-phenyloxirane-2-carboxylic acid (BMK glycidic acid; P2P glycidic acid) and its esters ( e.g. methyl 3-methyl-3-phenyloxirane-2-carboxylate (BMK methyl glycidate); ethyl 3-methyl-3-phenyloxirane-2-carboxylate (BMK ethyl glycidate))

phenethyl bromide ((2-bromoethyl)benzene)

3-oxo-2-phenylbutanoic acid and its esters ( e.g., alpha -phenylacetoacetic acid; ethyl 3-oxo-2-phenylbutanoate (EAPA))

5-(2-nitroprop-1-en-1-yl)benzodioxole (3,4-methylenedioxyphenyl-2-nitropropene; 3,4–MDP2NP)

azobisisobutyronitrile

butane-1,4-diol (1,4-butanediol)

ethyl 3-oxo-4-phenylbutanoate

ethyl-3-(1,3-benzodioxol-5-yl)-2-methyloxirane-2-carboxylate (3,4–MDP–2–P ethyl glycidate)

methyl 2-(1,3-benzodioxol-5-yl)-3-oxobutanoate (MAMDPA; MDMAPA)

propionyl chloride

sodium borohydride

sodium triacetoxyborohydride

tert -butyl 4-((4-fluorophenyl)amino)piperidine-1-carboxylate ( para -fluoro 1-boc-4-AP)

thioglycolic acid and its esters ( e.g., methyl thioglycolate)

In addition to the chemicals listed above, DEA is updating the listing of tableting machines under equipment to explicitly include punches and dies. DEA updates the listing of tableting machines to read as follows:

Equipment

tableting machines, including punches and dies

The Special Surveillance List continues to include all listed chemicals as specified in 21 CFR 1310.02(a) or (b). DEA is removing two individually listed chemicals from the Special Surveillance List (hypophosphorus acid and red phosphorus), given that those chemicals have since been added to List I and are, therefore, automatically included as laboratory supplies. 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 updated Special Surveillance List for laboratory supplies used in the manufacture of controlled substances and listed chemicals, including the additions listed above:

Special Surveillance List Published Pursuant to 21 U.S.C. 842(a)

Chemicals, Including Their Salts Whenever the Existence of Such Salts is Possible

The Special Surveillance List of laboratory supplies which are used in the manufacture of controlled substances and listed chemicals includes 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. In addition, the Special Surveillance List includes the following:

(2-nitroprop-1-en-1-yl)benzene (1-phenyl-2-nitropropene; P2NP)

1-(4-bromophenyl)propan-1-one

1-(4-chlorophenyl)propan-1-one

1-(4-methylphenyl)propan-1-one

1,1′-carbonyldiimidazole

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

1-benzylpiperidin-4-one ( N -benzyl-4-piperidone)

1-chloro- N -methyl-1-phenylpropan-2-amine (chloroephedrine; chloropseudoephedrine)

1-phenylbutan-1-one

1-phenylpentan-1-one

1-phenylpropan-1-one

2,5-dimethoxyphenethylamine

2-bromo-1-(4-chlorophenyl)propan-1-one

2-bromo-1-(4-methoxyphenyl)propan-1-one

2-bromo-1-(4-methylphenyl)propan-1-one

2-bromo-1-phenylpentan-1-one

2-bromo-1-phenylpropan-1-one

3-methyl-3-phenyloxirane-2-carboxylic acid (BMK glycidic acid; P2P glycidic acid) and its esters ( e.g., methyl 3-methyl-3-phenyloxirane-2-carboxylate (BMK methyl glycidate); ethyl 3-methyl-3-phenyloxirane-2-carboxylate (BMK ethyl glycidate))

3-oxo-2-phenylbutanoic acid and its esters ( e.g., alpha-phenylacetoacetic acid; ethyl 3-oxo-2-phenylbutanoate (EAPA))

5-(2-nitroprop-1-en-1-yl)benzodioxole (3,4-methylenedioxyphenyl-2-nitropropene; 3,4-MDP2NP)

ammonia gas

ammonium formate

azobisisobutyronitrile

bromobenzene

butane-1,4-diol (1,4-butanediol)

cyclohexanone

diethylamine and its salts

ethyl 3-oxo-4-phenylbutanoate

ethyl-3-(1,3-benzodioxol-5-yl)-2-methyloxirane-2-carboxylate (3,4-MDP-2-P ethyl glycidate)

formamide

formic acid

lithium aluminum hydride

lithium metal

magnesium metal (turnings)

mercuric chloride

methyl 2-(1,3-benzodioxol-5-yl)-3-oxobutanoate (MAMDPA; MDMAPA)

N -methylformamide

organomagnesium halides (Grignard reagents) ( e.g., ethylmagnesium bromide and phenylmagnesium bromide)

ortho -toluidine

phenethyl bromide ((2-bromoethyl)benzene)

phenylethanolamine and its salts

phosphorus pentachloride

potassium dichromate

propionyl chloride

pyridine and its salts

sodium borohydride

sodium dichromate

sodium metal

sodium triacetoxyborohydride

tert -butyl 4-((4-fluorophenyl)amino)piperidine-1-carboxylate ( para -fluoro 1-boc-4-AP)

thioglycolic acid and its esters ( e.g., methyl thioglycolate)

thionyl chloride

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

trichlorotrifluoroethane ( e.g., Freon 113)

Equipment

hydrogenators

tableting machines, including punches and dies

encapsulating machines

22 liter heating mantels

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 Special Surveillance List may be updated as needed to reflect changes in the chemicals, products, materials, or equipment used in the manufacture of controlled substances and listed chemicals by publication of a notice in the Federal Register . DEA will disseminate the updated Special Surveillance List as widely as possible. In addition, the Special Surveillance List will be available on the DEA Diversion Control homepage at https://www.deadiversion.usdoj.gov /.

Regulatory Analyses

The updated 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. As noted above, the Special Surveillance List serves two purposes. First, it informs individuals and firms of the potential use of the items on the list in the manufacture of controlled substances and listed chemicals. Second, it reminds individuals and firms that civil penalties may be imposed on them if they distribute a laboratory supply to a person with reckless disregard for the illegal use to which such a laboratory supply will be put.

This update provides an increased level of law enforcement control to prevent the diversion of laboratory supplies used for the manufacture of listed chemicals and controlled substances. It does not impose any new regulatory burden on the public as there are no corresponding recordkeeping or reporting requirements of the laboratory supplies. However, it does impose potential civil penalties 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. This update fulfills the requirement imposed by section 205 of the MCA that the Attorney General shall publish a Special Surveillance List which contains chemicals, products, materials, or equipment used in the manufacture of listed chemicals and controlled substances.

* * * * *

Signing Authority

This document of the Drug Enforcement Administration was signed on October 18, 2023, by Administrator Anne Milgram. That document with the original signature and date is maintained by DEA. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DEA Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of DEA. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .

Scott Brinks,

Federal Register Liaison Officer, Drug Enforcement Administration.

Footnotes

1.  21 U.S.C. 842(a).

2.  Id.

3.  21 U.S.C. 842(c)(2)(C). This civil monetary penalty has been adjusted for inflation. For penalties assessed after January 30, 2023, with respect to violations occurring after November 2, 2015, the maximum penalty is $470,640. 88 FR 5776, 5780 (Jan. 30, 2023).

4.  21 U.S.C. 842(a).

5.  21 U.S.C. 842(a)(11).

6.  64 FR 25910 (May 13, 1999).

7.  88 FR 39479 (June 16, 2023).