[Federal Register Volume 88, Number 116 (Friday, June 16, 2023)]
[Notices]
[Pages 39479-39482]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-12893]
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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 of proposed updates to special surveillance list.
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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 notice of proposed updates to the Special
Surveillance List.
DATES: Comments must be submitted electronically or postmarked on or
before July 17, 2023. Commenters should be aware that the electronic
Federal Docket Management System will not accept any comments after
11:59 p.m. Eastern Time on the last day of the comment period.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-1086'' on all electronic and written correspondence,
including any attachments.
Electronic comments: The Drug Enforcement Administration
encourages that all comments be submitted electronically through the
Federal eRulemaking Portal which provides the ability to type short
comments directly into the comment field on the web page or attach a
file for lengthier comments. Please go to http://www.regulations.gov
and follow the online instructions at that site for submitting
comments. Upon completion of your submission, you will receive a
Comment Tracking Number for your comment. Please be aware that
submitted comments are not instantaneously available for public view on
Regulations.gov. If you have received a Comment Tracking Number, your
comment has been successfully submitted and there is no need to
resubmit the same comment.
Paper comments: Paper comments that duplicate electronic
submissions are not necessary. Should you wish to mail a paper comment,
in lieu of an electronic comment, it should be sent via regular or
express mail to: Drug Enforcement Administration, Attn: DEA Federal
Register Representative/DPW, 8701 Morrissette Drive, Springfield,
Virginia 22152.
FOR FURTHER INFORMATION CONTACT: Terrence L. Boos, Drug and Chemical
Evaluation Section, Diversion Control Division, Drug Enforcement
Administration; Telephone: (571) 362-3249.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments
Please note that all comments received in response to this docket
are considered part of the public record. They will, unless reasonable
cause is given, be made available by the Drug Enforcement
Administration (DEA) for public inspection online at http://www.regulations.gov. Such information includes personal identifying
information (such as your name, address, etc.) voluntarily submitted by
the commenter. The Freedom of Information Act applies to all comments
received. If you want to submit personal identifying information (such
as your name, address, etc.) as part of your comment, but do not want
it to be made publicly available, you must include the phrase
``PERSONAL IDENTIFYING INFORMATION'' in the first paragraph of your
comment. You must also place all of the personal identifying
information you do not want made publicly available in the first
paragraph of your comment and identify what information you want
redacted.
[[Page 39480]]
If you want to submit confidential business information as part of
your comment, but do not want it to be made publicly available, you
must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the
first paragraph of your comment. You must also prominently identify the
confidential business information to be redacted within the comment.
Comments containing personal identifying information or
confidential business information identified as directed above will be
made publicly available in redacted form. If a comment has so much
confidential business information that it cannot be effectively
redacted, all or part of that comment may not be made publicly
available. Comments posted to http://www.regulations.gov may include
any personal identifying information (such as name, address, and phone
number) included in the text of your electronic submission that is not
identified as directed above as confidential.
An electronic copy of this proposal is available at http://www.regulations.gov for easy reference.
Background
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.
\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 an
updated Special Surveillance List will provide 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 is providing
notice of proposed changes and an opportunity for the public to comment
because the list has not been updated in over 23 years.
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\6\ 64 FR 25910 (May 13, 1999).
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In developing the proposed updates to the 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. In addition, DEA considered the legitimate uses and market
for these chemicals. The proposed updates to the 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 proposing to update 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)
[[Page 39481]]
In addition to the chemicals listed above, DEA is proposing to
update the listing of tableting machines under equipment to explicitly
include punches and dies. DEA proposes to update 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 proposing to
remove 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
proposed update to 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:
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.
(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.These proposed update to the Special
Surveillance List will be finalized upon the publication of a notice
that updates the Special Surveillance List. 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 upon any final notice updating the current
Special Surveillance List. In addition, the Special Surveillance List
will be available on the DEA Diversion Control homepage at https://www.deadiversion.usdoj.gov/upon publication of a notice that updates
the Special Surveillance List.
Regulatory Analyses
The proposed updates to the Special Surveillance List would apply
to all individuals and firms which distribute the listed chemicals and
laboratory supplies (chemicals, products, materials, or equipment) on
the list. This notice to update the Special Surveillance List does not
impose any recordkeeping or reporting requirements for any of the
laboratory supplies. Thus, the surveillance list will have a negligible
impact on affected parties.
As noted above, the notice of proposed updates to 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 any time after
the two-week period following receipt of written notification by the
Attorney 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.
These proposed updates will provide an increased level of law
enforcement
[[Page 39482]]
control to prevent the diversion of laboratory supplies used for the
manufacture of listed chemicals and controlled substances. It will not,
however, impose any new regulatory burden on the public. Nevertheless,
since no updates have been made since May 13, 1999, when DEA originally
published its final rule regarding the Special Surveillance List,\7\
DEA is providing the opportunity for comment. This notice of proposed
updates 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.
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\7\ Id.
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* * * * *
Signing Authority
This document of the Drug Enforcement Administration was signed on
June 12, 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. 2023-12893 Filed 6-15-23; 8:45 am]
BILLING CODE 4410-09-P