[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.
    <bullet> 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.
    <bullet> 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