[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]
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