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Federal Register / Vol. 86, No. 134 / Friday, July 16, 2021 / Proposed Rules
that contain synthetic cathinones, the packages of products that contain Nethylhexedrone, a-PHP, 4-MEAP, MPHP, PV8, or 4-chloro-a-PVP also probably contain the warning not for human consumption, most likely in an effort to circumvent statutory restrictions for these substances. Law enforcement data indicate that Nethylhexedrone, a-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-a-PVP are available for illicit use and are being abused. Demographic data collected from published reports and mortality records suggest that the main users of Nethylhexedrone, a-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-a-PVP, similar to other schedule I synthetic cathinones permanently placed in schedule I, are young adults. Toxicology reports also revealed that Nethylhexedrone, a-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-a-PVP are being ingested with other substances including other synthetic cathinones, common cutting agents, or other recreational substances. Consequently, products containing synthetic cathinones, including Nethylhexedrone, a-PHP, 4-MEAP, MPHP, PV8, or 4-chloro-a-PVP, are distributed to users, often with unpredictable outcomes. Thus, the recreational abuse of N-ethylhexedrone, a-PHP, 4-MEAP, MPHP, PV8, and 4chloro-a-PVP is a significant concern.
These data indicate that Nethylhexedrone, a-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-a-PVP have a history and current pattern of abuse.
5. Scope, Duration and Significance of Abuse: N-ethylhexedrone, a-PHP, 4MEAP, MPHP, PV8, and 4-chloro-a-PVP
are recreational drugs that emerged on the United States illicit drug market after the scheduling of other synthetic cathinones e.g., N-ethylpentylone, ethylone, mephedrone, methylone, pentylone, and MDPV see DEAs Eight Factor Analysis for a full discussion.
Forensic laboratories have confirmed the presence of N-ethylhexedrone, aPHP, 4-MEAP, MPHP, PV8, and 4chloro-a-PVP in drug exhibits received from Federal, State, and local law enforcement agencies. MPHP was first identified in June 2012 in seized drug evidence although MPHP was identified in blood samples from a 27year-old decedent in 2011see Factor 6
for details, followed by 4-MEAP and PV8 August and December 2013, respectively, alpha-PHP May 2014, 4chloro-a-PVP December 2015 and most recently N-ethylhexedrone August 2016. From January 2012 through December 2020 query date: May 3, 2021, NFLIS database registered a total
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of 2,289 reports from forensic laboratories pertaining to the 6 synthetic cathinones N-ethylhexedrone, 613
reports; a-PHP984 reports; 4-MEAP
131 reports; MPHP92 reports; PV8
174 reports; and 4-chloro-a-PVP295
reports. HHS reported that there were 13,238 calls to United States poison control centers PCCs 4 involving synthetic cathinones from 2010 to 2019
and 39 mentions of cathinones of which 23 were for a-PHP on the Dashboard 5
from July 2018 to July 2020.
Accordingly, concerns over the continuing abuse of synthetic cathinones have led to the control of many synthetic cathinones. A full presentation of the NFLIS reports by substance and year, PCC, and Dashboard data are available in both DEAs and HHSs eight-factor analyses within the Supporting Documents section of the public docket available at http
www.regulations.gov.
6. What, if Any, Risk There Is to the Public Health: HHS reported that the public health risks of N-ethylhexedrone, a-PHP, 4-MEAP, MPHP, PV8, and 4chloro-a-PVP result from their ability to induce stimulant-like responses, which may lead to impaired judgement and dangerous behavior. Adverse health effects associated with the abuse of Nethylhexedrone, a-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-a-PVP
include a number of stimulant-like adverse health effects such as diaphoresis, insomnia, mydriasis, hyperthermia, vomiting, agitation, disorientation, paranoia, and abdominal pain. Serious adverse events such as acute kidney failure, cardiac arrest, rhabdomyolysis, and coma have been associated with the use of Nethylhexedrone, a-PHP, 4-MEAP, and PV8. In addition, N-ethylhexedrone, aPHP, MPHP, and PV8 have been involved in the deaths of individuals.
The identification of N-ethylhexedrone, a-PHP, 4-MEAP, MPHP, PV8, or 4chloro-a-PVP in toxicological samples associated with fatal and non-fatal overdoses as reported in the medical and scientific literature, forensic laboratory reports, and public health 4 PCC data are derived from the National Poison Data System, a database managed by the American Association of Poison Control Centers AAPCC.
AAPCC is a nationwide network of PCCs that receive calls from individuals, healthcare professionals, and other interested persons in the general U.S. population regarding exposures to prescription drugs and other substances.
5 The Dashboard is an online, interactive tool that reports on the identification of certain novel psychoactive substances in de-identified sample extracts from forensic investigations, including medicolegal death investigations and toxicology testing. The Dashboard was accessed on February 26, 2021.

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documents confirms these adverse effects of N-ethylhexedrone, a-PHP, 4MEAP, MPHP, PV8, or 4-chloro-a-PVP.
Like schedule I synthetic cathinones, Nethylhexedrone, a-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-a-PVP have caused acute health problems leading to emergency department ED admissions, violent behaviors causing harm to self or others, and/or death. Specifically, evidence demonstrate that all six synthetic cathinones have resulted in ED visits that required medical attention, but only N-ethylhexedrone, aPHP, MPHP, and PV8 abuse have been associated with the deaths of individuals. It remains highly likely that additional cases of adverse health effects involving N-ethylhexedrone, aPHP, 4-MEAP, MPHP, PV8, and 4chloro-a-PVP in the United States have occurred and will continue to be underreported as these substances are not part of standard panels for toxicological analyses of biological specimens. Thus, the abuse of N-ethylhexedrone, a-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-aPVP, like that of the abuse of schedule I synthetic cathinones and stimulant drugs, poses significant adverse health risks including death.
Furthermore, because abusers of synthetic cathinones obtain these substances through unregulated sources, the identity, purity, and quantity are uncertain and inconsistent. These unknown factors pose an additional risk for significant adverse health effects to the end user.
Based on information received by DEA, the abuse of N-ethylhexedrone, aPHP, 4-MEAP, MPHP, PV8, and 4chloro-a-PVP has led to, at least, the same qualitative public health risks as other schedule I synthetic cathinones and the schedule II stimulant methamphetamine. The public health risks attendant to the abuse of synthetic cathinones, including Nethylhexedrone, a-PHP, 4-MEAP, MPHP, PV8, or 4-chloro-a-PVP, are well established and have resulted in large numbers of ED visits and fatal overdoses.
7. Its Psychic or Physiological Dependence Liability: According to HHS, the psychic or physiological dependence liability of Nethylhexedrone, a-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-a-PVP is demonstrated by their positive abuserelated studies in animals and reported stimulant effects in humans. The results from two behavioral studies drug discrimination and locomotor studies demonstrate that N-ethylhexedrone, aPHP, 4-MEAP, MPHP, PV8, or 4-chloroa-PVP produced behavioral effects that are similar to those of substances with
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