[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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\
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \5\ 21 U.S.C. 842(a)(11).
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \6\ 64 FR 25910 (May 13, 1999).
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \7\ Id.
---------------------------------------------------------------------------

* * * * *

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