Controlled Substance Destruction Alternatives to Incineration, 74379-74381 [2023-23984]

Download as PDF Federal Register / Vol. 88, No. 209 / Tuesday, October 31, 2023 / Proposed Rules (1) Model A318–111, –112, –121, and –122 airplanes. (2) Model A319–111, –112, –113, –114, –115, –131, –132, –133, –151N, –153N, and –171N airplanes. (3) Model A320–211, –212, –214, –216, –231, –232, –233, –251N, –252N, –253N, –271N, –272N, and –273N airplanes. (4) Model A321–111, –112, –131, –211, –212, –213, –231, –232, –251N, –252N, –253N, –271N, –272N, –251NX, –252NX, –253NX, –271NX, and –272NX. (d) Subject Air Transport Association (ATA) of America Code 05, Time Limits/Maintenance Checks (e) Unsafe Condition This AD was prompted by a determination that new or more restrictive airworthiness limitations are necessary. The FAA is issuing this AD to address safety-significant latent failures (that are not annunciated), which, in combination with one or more other specific failures or events, could result in a hazardous or catastrophic failure condition. (f) Compliance Comply with this AD within the compliance times specified, unless already done. (g) Requirements Except as specified in paragraph (h) of this AD: Comply with all required actions and compliance times specified in, and in accordance with, European Union Aviation Safety Agency (EASA) AD 2023–0138, dated July 13, 2023 (EASA AD 2023–0138). (h) Exceptions to EASA AD 2023–0138 lotter on DSK11XQN23PROD with PROPOSALS1 (1) This AD does not adopt the requirements specified in paragraphs (1) and (2) of EASA AD 2023–0138. (2) Paragraph (3) of EASA AD 2023–0138 specifies revising ‘‘the approved AMP’’ within 12 months after its effective date, but this AD requires revising the existing maintenance or inspection program, as applicable, within 90 days after the effective date of this AD. (3) The initial compliance time for doing the tasks specified in paragraph (3) of EASA 2023–0138 is at the applicable ‘‘associated thresholds’’ as incorporated by the requirements of paragraph (3) of EASA AD 2023–0138, or within 90 days after the effective date of this AD, whichever occurs later. (4) This AD does not adopt the provisions specified in paragraphs (4) of EASA AD 2023–0138. (5) This AD does not adopt the ‘‘Remarks’’ section of EASA AD 2023–0138. (i) Provisions for Alternative Actions and Intervals After the existing maintenance or inspection program has been revised as required by paragraph (g) of this AD, no alternative actions (e.g., inspections), and intervals are allowed unless they are approved as specified in the provisions of the ‘‘Ref. Publications’’ section of EASA AD 2023–0138. VerDate Sep<11>2014 16:52 Oct 30, 2023 Jkt 262001 (j) Terminating Action for Certain Tasks Required by AD 2023–04–06 Accomplishing the actions required by this AD terminates the corresponding requirements of AD 2023–04–06 for the tasks identified in the service information referenced in EASA AD 2023–0138 only. (k) Additional AD Provisions The following provisions also apply to this AD: (1) Alternative Methods of Compliance (AMOCs): The Manager, International Validation Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or responsible Flight Standards Office, as appropriate. If sending information directly to the International Validation Branch, send it to the attention of the person identified in paragraph (l) of this AD. Information may be emailed to: 9-AVS-AIR-730-AMOC@faa.gov. Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/ certificate holding district office. (2) Contacting the Manufacturer: For any requirement in this AD to obtain instructions from a manufacturer, the instructions must be accomplished using a method approved by the Manager, International Validation Branch, FAA; or EASA; or Airbus SAS’s EASA Design Organization Approval (DOA). If approved by the DOA, the approval must include the DOA-authorized signature. (l) Additional Information For more information about this AD, contact Timothy Dowling, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 206– 231–3367; email Timothy.P.Dowling@faa.gov. (m) Material Incorporated by Reference (1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51. (2) You must use this service information as applicable to do the actions required by this AD, unless this AD specifies otherwise. (i) European Union Aviation Safety Agency (EASA) AD 2023–0138, dated July 13, 2023. (ii) [Reserved] (3) For EASA AD 2023–0138, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999 000; email ADs@easa.europa.eu; website easa.europa.eu. You may find this EASA AD on the EASA website at ad.easa.europa.eu. (4) You may view this service information at the FAA, Airworthiness Products Section, Operational Safety Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206–231–3195. (5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email fr.inspection@nara.gov, or go to: PO 00000 Frm 00011 Fmt 4702 Sfmt 4702 74379 www.archives.gov/federal-register/cfr/ibrlocations.html. Issued on October 26, 2023. Caitlin Locke, Director, Compliance & Airworthiness Division, Aircraft Certification Service. [FR Doc. 2023–23989 Filed 10–30–23; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1301 [Docket No. DEA–1144] RIN 1117–AB84 Controlled Substance Destruction Alternatives to Incineration Drug Enforcement Administration, Department of Justice. ACTION: Advance notice of proposed rulemaking. AGENCY: 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 https:// 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 https:// www.regulations.gov. Please be aware that submitted comments are not SUMMARY: E:\FR\FM\31OCP1.SGM 31OCP1 74380 Federal Register / Vol. 88, No. 209 / Tuesday, October 31, 2023 / Proposed Rules lotter on DSK11XQN23PROD with PROPOSALS1 instantaneously available for public view on https://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 https:// 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 VerDate Sep<11>2014 16:52 Oct 30, 2023 Jkt 262001 https://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 https://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. 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 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 nonretrievable standard.6 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. 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 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 nonretrievable 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 6 117 1 21 U.S.C. 801–971. 2 21 U.S.C. 871; 28 CFR 0.100(b). 3 21 U.S.C. 823. 4 21 U.S.C. 821. 5 Public Law 117–328, 136 Stat. 4459. PO 00000 Frm 00012 Fmt 4702 Sfmt 4702 Cong. Rec. S7921 (2022). CFR 1300.05 8 Public Law 111–273, 124 Stat. 2858. 9 79 FR 53520 (Sept. 9, 2014). 10 21 CFR 1300.05; 21 CFR part 1317. 11 21 CFR 1300.05. 7 21 E:\FR\FM\31OCP1.SGM 31OCP1 Federal Register / Vol. 88, No. 209 / Tuesday, October 31, 2023 / Proposed Rules controlled substances to a nonretrievable 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 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 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 nonretrievability is achieved, and the method is consistent with preventing the diversion of controlled substances.15 lotter on DSK11XQN23PROD with PROPOSALS1 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. 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 12 21 CFR 1317.90(c). CFR 1317.90(a). 14 79 FR 53520, 53527. 15 Id. at 53522. 16 Id. at 53548. 13 21 VerDate Sep<11>2014 16:52 Oct 30, 2023 process utilized to achieve the nonretrievable 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 byproducts 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 Jkt 262001 PO 00000 Frm 00013 Fmt 4702 Sfmt 4702 74381 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 DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT 24 CFR Parts 115 and 125 [Docket No. FR–6355–P–01] RIN 2529–AB07 Removing Criminal Conviction Restrictions for Testers in FHIP- and FHAP-Funded Testing Programs Office of Fair Housing and Equal Opportunity, HUD. ACTION: Proposed rule. AGENCY: Through this proposed rule, the U.S. Department of Housing and Urban Development (HUD) seeks to eliminate the tester restrictions for Fair Housing Initiatives Program (FHIP) grantees and for Fair Housing Assistance Program (FHAP) agencies that forbid FHIP and FHAP recipients from using fair housing testers with prior felony convictions or convictions of crimes involving fraud or perjury. This proposed rule would make HUD’s programs as inclusive as possible for people with criminal records, consistent with Secretary Marcia Fudge’s April 12, 2022 Memorandum, ‘‘Eliminating Barriers That May Unnecessarily Prevent Individuals with Criminal Histories from Participating in HUD Program,’’ and ensure that FHIP and FHAP funded entities are able to fully investigate criminal background screening policies that are potentially discriminatory under federal civil rights laws by using testers with actual criminal backgrounds. DATES: Comment due date: January 2, 2024. SUMMARY: Interested persons are invited to submit comments regarding ADDRESSES: E:\FR\FM\31OCP1.SGM 31OCP1

Agencies

[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.

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

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 
https://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 
https://www.regulations.gov. Please be aware that submitted comments are 
not

[[Page 74380]]

instantaneously available for public view on https://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 https://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 https://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 https://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.
---------------------------------------------------------------------------

    \1\ 21 U.S.C. 801-971.
---------------------------------------------------------------------------

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

    \2\ 21 U.S.C. 871; 28 CFR 0.100(b).
    \3\ 21 U.S.C. 823.
    \4\ 21 U.S.C. 821.
---------------------------------------------------------------------------

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

    \5\ Public Law 117-328, 136 Stat. 4459.
    \6\ 117 Cong. Rec. S7921 (2022).
---------------------------------------------------------------------------

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

    \7\ 21 CFR 1300.05
---------------------------------------------------------------------------

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

    \8\ Public Law 111-273, 124 Stat. 2858.
    \9\ 79 FR 53520 (Sept. 9, 2014).
---------------------------------------------------------------------------

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

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

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

    \14\ 79 FR 53520, 53527.
---------------------------------------------------------------------------

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

    \15\ Id. at 53522.
---------------------------------------------------------------------------

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

    \16\ Id. at 53548.
---------------------------------------------------------------------------

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
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