[Federal Register Volume 88, Number 204 (Tuesday, October 24, 2023)]
[Notices]
[Pages 73044-73046]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-23478]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1086]


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.

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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: (571) 362-3249.

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\
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    \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).
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    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.
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    \5\ 21 U.S.C. 842(a)(11).
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    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\
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    \6\ 64 FR 25910 (May 13, 1999).
    \7\ 88 FR 39479 (June 16, 2023).
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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

[[Page 73045]]

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)

[[Page 73046]]

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.
[FR Doc. 2023-23478 Filed 10-23-23; 8:45 am]
BILLING CODE 4410-09-P