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Federal Register / Vol. 86, No. 232 / Tuesday, December 7, 2021 / Proposed Rules
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Subsequently, the benzimidazoleopioids at issue here have emerged on the illicit drug market. Law enforcement agencies have encountered etodesnitazene, flunitazene, metonitazene, and protonitazene in several solid e.g., powder and rock and liquid forms. These substances are not approved for medical use anywhere in the world. The Assistant Secretary, by letters dated July 7 and September 10, 2021, informed DEA that there are no FDA-approved NDAs or INDs for them in the United States. Hence, there are no legitimate channels for these substances as marketed drug products. Their appearance on the illicit drug market is similar to other synthetic opioids trafficked for their psychoactive effects.
These seven opioid substances are likely to be abused in the same manner as schedule I opioids such as etonitazene, isotonitazene, and heroin. They have been identified as white to beige powders or in liquid forms, typically of unknown purity or concentration.
In 2020 and 2021, butonitazene, etodesnitazene, flunitazene, metodesnitazene, metonitazene, and protonitazene emerged on the illicit synthetic drug market as evidenced by their identification in forensic drug seizures or biological samples. In July 2020, metonitazene was first reported seized as a white powdery substance in a North Carolina case. Based on data from the National Forensic Laboratory Information System NFLIS,3 law enforcement often encounters etodesnitazene, flunitazene, metonitazene, and protonitazene in mixtures. Substances found in combination with some of these benzimidazole-opioids include cutting agents caffeine, xylazine, etc. or other substances of abuse such as heroin, fentanyl schedule II, fentanyl analogs, and tramadol schedule IV.
In the United States, butonitazene, etodesnitazene, flunitazene, metonitazene, N-pyrrolidino etonitazene, and protonitazene have been identified alone or in combination with other substances such as designer benzodiazepines and fentanyl see Factors 5 and 6. Evidence suggests that individuals are using these substances as a replacement for other opioids, 3 NFLIS represents an important resource in monitoring illicit drug trafficking, including the diversion of legally manufactured pharmaceuticals into illegal markets. NFLIS is a comprehensive information system that includes data from forensic laboratories that handle more than 96% of an estimated 1.0 million distinct annual state and local drug analysis cases. NFLIS includes drug chemistry results from completed analyses only. While NFLIS
data is not direct evidence of abuse, it can lead to an inference that a drug has been diverted and abused. See 76 FR 77330, 77332, Dec. 12, 2011.

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either knowingly or unknowingly.
Information gathered from case histories and autopsy findings show that deaths involving metonitazene were similar to those of opioid-related deaths.
Identified material or paraphernalia from death-scene investigations also were consistent with opioid use. The seven substances are likely to be abused in the same manner as schedule I
opioids such as isotonitazene and heroin.
Factor 5. Scope, Duration, and Significance of Abuse The subject substances have been described as synthetic opioids, and evidence suggests they are abused for their opioidergic effects see Factor 6.
Their abuse has resulted in their identification in toxicology and postmortem cases. Between January and February of 2021, metonitazene has been positively identified in 20 forensic post-mortem cases from seven different states: Tennessee 10, Illinois 5, Florida 1, Iowa 1, Ohio 1, South Carolina 1, and Wisconsin 1. Most 18 of the decedents were male, with ages ranging from 19 to 63 years and an average age of 41 years. Metonitazene was identified as the sole drug detected in only three cases, and the only opioid in six cases.
Detection of N-pyrrolidino etonitazene in a toxicology case first was reported 4 in May 2021. It has been identified in a total of eight post-mortem cases from five different states Colorado 1, Florida 1, New York 1, Pennsylvania 1, and West Virginia 4
between January and April 2021. The decedents ages spanned their 20s to 50s. N-Pyrrolidino etonitazene was the only drug of interest in one of these cases. In the other cases, it was coidentified with designer benzodiazepines 7, fentanyl 4, and methamphetamine 4. Data from law enforcement encounters suggests that etodesnitazene, flunitazene, metonitazene, and protonitazene are abused 5 in the United States as recreational drugs. Law enforcement encounters of etodesnitazene, flunitazene, metonitazene, and protonitazene as reported to NFLIS
Federal, State, and local laboratories includes 270 exhibits since 2020
queried 08/04/2021. NFLIS registered 4 Center for Forensic Science Research and Education. Public Alert: New High Potency Synthetic Opioid N-Pyrrolidino Etonitazene Etonitazepyne Linked to Overdoses across United States. June 17, 2021.
5 While law enforcement data are not direct evidence of abuse, they can lead to an inference that drugs have been diverted and abused. See 76 FR
77330, 77332, Dec. 12, 2011.

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one encounter of etodesnitazene from one state, five encounters of flunitazene from four states, 262 encounters of metonitazene from eight states, and two encounters of protonitazene from two states. Data from NFLIS show that 561.55 grams of metonitazene has been encountered by law enforcement since 2020, and it was often suspected as heroin or fentanyl. This suggests that metonitazene might be presented as a substitute for heroin or fentanyl and likely abused in the same manner as either of these substances. The lack of identification of butonitazene, metodesnitazene, and N-pyrrolidino etonitazene in law enforcement reports might be due to the rapid appearance of these benzimidazole-opioids and underreporting as forensic laboratories try to secure reference standards for these substances. However, butonitazene, metodesnitazene, and N-pyrrolidino etonitazene have been identified in toxicology cases.
The population likely to abuse these seven benzimidazole-opioids appears to be the same as those abusing other opioid substances such as heroin, tramadol, fentanyl, and other synthetic opioids. This is evidenced by the types of other drugs co-identified in biological samples and law enforcement encounters. Because abusers are likely to obtain these substances through unregulated sources, their identity, purity, and quantity are uncertain and likely to be inconsistent, thus posing significant adverse health risks to the end user. The misuse and abuse of opioids have been demonstrated and are well-characterized. According to the most recent data from the National Survey on Drug Use and Health NSDUH,6 as of 2019, an estimated 10.1
million people aged 12 years or older misused opioids in the past year, including 9.7 million prescription pain reliever misusers and 745,000 heroin users. In 2019, an estimated 1.6 million people had an opioid use disorder, including 1.4 million people with a 6 NSDUH, formerly known as the National Household Survey on Drug Abuse NHSDA, is conducted annually by the Department of Health and Human Services Substance Abuse and Mental Health Services Administration SAMHSA. It is the primary source of estimates of the prevalence and incidence of non-medical use of pharmaceutical drugs, illicit drugs, alcohol, and tobacco use in the United States. The survey is based on a nationally representative sample of the civilian, noninstitutionalized population 12 years of age and older. The survey excludes homeless people who do not use shelters, active military personnel, and residents of institutional group quarters such as jails and hospitals. The NSDUH provides yearly national and state level estimates of drug abuse, and includes prevalence estimates by lifetime i.e., ever used, past year, and past month abuse or dependence. The 2019 NSDUH Annual Report.
Last accessed July 26, 2021.

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