[Federal Register Volume 88, Number 209 (Tuesday, October 31, 2023)]
[Proposed Rules]
[Pages 74379-74381]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-23984]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1301
[Docket No. DEA-1144]
RIN 1117-AB84
Controlled Substance Destruction Alternatives to Incineration
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Advance notice of proposed rulemaking.
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SUMMARY: The Drug Enforcement Administration (DEA) is seeking
information about destruction processes which may be used to render
controlled substances to a non-retrievable state. DEA invites comment
from stakeholders in the controlled substance disposal industry, as
well as registrants engaged in the destruction and disposal of
controlled substances in their possession or inventory, to the
questions provided below.
DATES: Electronic comments must be submitted, and written comments must
be postmarked, on or before January 2, 2024. Commenters should be aware
that the electronic Federal Docket Management System will not accept
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
``RIN 1117-AB84/Docket No. DEA-1144'' on all correspondence, including
any attachments.
Electronic comments: DEA encourages that all comments be
submitted electronically through the Federal eRulemaking Portal, which
provides the ability to type comments directly into the comment field
on the web page or to attach a file containing 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 generated by
http://www.regulations.gov. Please be aware that submitted comments are
not
[[Page 74380]]
instantaneously available for public view on http://www.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 the
electronic submission are discouraged. Should you wish to mail a paper
comment in lieu of submitting a comment electronically, 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. Hand-delivered comments will not be
accepted.
FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Regulatory Drafting
and Policy Support Section, Diversion Control Division, Drug
Enforcement Administration; Telephone: (571) 776-3882.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments
Please note that all comments received in response to this docket
are considered part of the public record. The Drug Enforcement
Administration (DEA) will make all comments available for public
inspection online at http://www.regulations.gov. Such information
includes personal or business identifiers (such as name, address, state
or Federal identifiers, etc.) voluntarily submitted by the commenter.
Generally, all information voluntarily submitted by the commenter,
unless clearly marked as Confidential Information in the method
described below, will be publicly posted. Comments may be submitted
anonymously. The Freedom of Information Act applies to all comments
received.
Commenters submitting comments which include personal identifying
information (PII), confidential, or proprietary business information
that the commenter does not want made publicly available should submit
two copies of the comment. One copy must be marked ``CONTAINS
CONFIDENTIAL INFORMATION'' and should clearly identify all PII or
business information the commenter does not want to be made publicly
available, including any supplemental materials. DEA will review this
copy, including the claimed PII and confidential business information,
in its consideration of comments. The second copy should be marked ``TO
BE PUBLICLY POSTED'' and must have all claimed confidential PII and
business information already redacted. DEA will post only the redacted
comment on http://www.regulations.gov for public inspection.
For easy reference, an electronic copy of this document and a plain
language summary of this advanced notice of proposed rulemaking are
available at http://www.regulations.gov.
Legal Authority
DEA implements and enforces the Comprehensive Drug Abuse Prevention
and Control Act of 1970, often referred to as the Controlled Substances
Act (CSA) and the Controlled Substances Import and Export Act, as
amended.\1\ DEA publishes the implementing regulations for these
statutes in 21 CFR parts 1300 to end. These regulations are designed to
ensure a sufficient supply of controlled substances for medical,
scientific, and other legitimate purposes, and to deter the diversion
of controlled substances for illicit purposes.
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\1\ 21 U.S.C. 801-971.
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As mandated by the CSA, DEA establishes and maintains a closed
system of control for the manufacturing, distribution, and dispensing
of controlled substances. DEA's regulations require that persons
involved in the manufacture, distribution, research, dispensing,
import, export, and disposal and destruction of controlled substances
register with DEA (unless exempt), keep track of all stocks of
controlled substances, and maintain records to account for all
controlled substances received, distributed, or otherwise disposed of.
The CSA authorizes the DEA Administrator (Administrator), by
delegation from the Attorney General,\2\ to register an applicant to
manufacture, distribute, or dispense controlled substances if such
registration is determined to be consistent with the public
interest.\3\ The CSA further authorizes the Administrator to promulgate
regulations necessary and appropriate to execute the functions of the
CSA relating to the registration and control of the manufacture,
distribution, and dispensing of controlled substances.\4\
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\2\ 21 U.S.C. 871; 28 CFR 0.100(b).
\3\ 21 U.S.C. 823.
\4\ 21 U.S.C. 821.
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Background
On December 29, 2022, the President signed the Consolidated
Appropriations Act, 2023.\5\ In a related report issued by the United
States Senate Appropriations Subcommittee on Commerce, Justice,
Science, and Related Agencies, Congress encouraged DEA to engage in
substantive conversations with industry stakeholders on alternatives to
incineration that meet the non-retrievable standard.\6\
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\5\ Public Law 117-328, 136 Stat. 4459.
\6\ 117 Cong. Rec. S7921 (2022).
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DEA regulations do not specify a particular required means for
destruction of controlled substances. Instead, DEA regulations
establish a result, by requiring registrants to dispose of controlled
substances in their inventory using a method of destruction that
permanently alters that controlled substance's physical or chemical
condition or state through irreversible means, and thereby renders the
controlled substance unavailable and unusable for all practical
purposes.\7\ The registrants are able to choose any method of
destruction that satisfies this standard.
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\7\ 21 CFR 1300.05
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In an effort to identify chemical and technological methods of
destruction of controlled substances other than incineration which may
meet the disposal requirements of DEA registrants, and to promote the
public exchange of technology and process development information, DEA
invites comment to the questions provided in this advanced notice of
proposed rulemaking (ANPRM).
History
Congress amended the CSA to include the Secure and Responsible Drug
Disposal Act of 2010 (SRDDA).\8\ In 2014, DEA published a final rule
entitled, ``Disposal of Controlled Substances,'' that implemented the
provisions of the SRDDA and established parameters for registrants to
safely and securely dispose of controlled substances that remain in
their inventory.\9\
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\8\ Public Law 111-273, 124 Stat. 2858.
\9\ 79 FR 53520 (Sept. 9, 2014).
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Non-Retrievable Standard of Destruction
In the final rule, DEA defined the term ``non-retrievable,'' and
implemented it as the standard of destruction to be achieved by
registrants that dispose of and destroy controlled substances from
their inventory.\10\ A controlled substance is considered non-
retrievable when it cannot be transformed to a physical or chemical
condition or state as a controlled substance or controlled substance
analogue.\11\ Specifically, the rule provides that the method of
destruction used shall be consistent with the purpose of rendering all
of the
[[Page 74381]]
controlled substances to a non-retrievable state in order to prevent
diversion and protect the public health and safety.\12\ The rule also
provides that controlled substances in a registrant's inventory shall
be destroyed in compliance with applicable Federal, State, tribal, and
local laws and regulations.\13\
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\10\ 21 CFR 1300.05; 21 CFR part 1317.
\11\ 21 CFR 1300.05.
\12\ 21 CFR 1317.90(c).
\13\ 21 CFR 1317.90(a).
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DEA established the non-retrievable standard as the intended final
result of a registrant's disposal and destruction process in order to
prevent the potential diversion of controlled substances into
illegitimate channels. DEA believes the permanent and irreversible
alteration of controlled substances is the cornerstone of the non-
retrievable standard.\14\
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\14\ 79 FR 53520, 53527.
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In the final rule, in order to allow public and private entities to
develop a variety of destruction methods that are secure, convenient,
and responsible, DEA explained that it would not require a particular
method of destruction, so long as the desired result of non-
retrievability is achieved, and the method is consistent with
preventing the diversion of controlled substances.\15\
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\15\ Id. at 53522.
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Comments Requested
DEA is aware that since the publication of the final rule in 2014,
various chemical and technological processes have been developed and
employed to render controlled substances non-retrievable. In the final
rule, DEA stated its intent that methods of destruction should remain
current with continuously changing technology.\16\ DEA now invites
stakeholders engaged in the destruction and disposal of controlled
substances to respond to the questions provided in this ANPRM. If
proprietary information is included in the response, please submit two
copies, and clearly indicate which copy ``Contains Confidential
Information'', and which is the redacted version ``To Be Publicly
Posted'' to ensure the correct information is posted on
Regulations.gov. See Submitting Public Comments section, above.
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\16\ Id. at 53548.
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ANPRM Questions
Please identify destruction methods or technology currently being
utilized or developed to render the controlled substances non-
retrievable. For each method or technology identified, please include:
1. If known, the potential users of this method or technology.
2. A detailed description of the method of destruction or technical
process utilized to achieve the non-retrievable standard. Does this
method or technology involve incineration at any point to attain the
non-retrievable standard?
3. The controlled substance(s) to which the method of destruction
or technology to render the controlled substance(s) non-retrievable may
be applicable.
4. If known, list any controlled substances that will not be
rendered non-retrievable by this method.
5. The volume or throughput (per hour) required to render the
controlled substance non-retrievable.
6. The registrant's anticipated cost to execute, implement, or
utilize the method of destruction or technology discussed above.
7. The analytical process utilized to evaluate the effectiveness of
the method of destruction or technology. Provide the analytical results
validating attainment of the non-retrievable standard.
8. The characteristics or constituents of any by-products or waste
generated through the process used to render the controlled substance
non-retrievable. Provide the waste profile sheet or similar
documentation showing analytical results of the by-products or waste
generated.
9. The disposal process of the by-products or waste generated.
10. The Federal, state, or local regulatory requirements associated
with the disposal process and/or disposal of the by-products or waste.
Regulatory Analysis
This ANPRM was developed in accordance with the principles of
Executive Order (E.O.) 12866, ``Regulatory Planning and Review,'' E.O.
13563, ``Improving Regulation and Regulatory Review,'' and E.O. 14094,
``Modernizing Regulatory Review.'' Since this action is an ANPRM, it
does not create or propose to create any new requirements. Therefore,
this regulatory action is not significant under section 3(f) of E.O.
12866.
Furthermore, the requirements of the Regulatory Flexibility Act do
not apply to this action because, at this stage, it is an ANPRM and not
a ``rule'' as defined in 5 U.S.C. 601. Following review of the comments
received in response to this ANPRM, if DEA proceeds with a notice of
proposed rulemaking regarding this matter, DEA will conduct all
relevant analyses as required by statute or Executive Order.
Signing Authority
This document of the Drug Enforcement Administration was signed on
October 26, 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. 2023-23984 Filed 10-30-23; 8:45 am]
BILLING CODE 4410-09-P