Classwide Scheduling of Controlled Substances

Contents

• Introduction
• Scheduling Under the CSA
• Permanent Administrative Scheduling
• Temporary Administrative Scheduling
• Legislative Scheduling
• Analogue Enforcement Act
• Classwide Scheduling of FRS
• Effect of Classwide Scheduling on the Illicit Drug Market
• Options for Congress
• Considering Federal Enforcement and Research
• Amending Scheduling Authority
• Considering Classwide Scheduling Legislation

Summary

As new dangerous substances appear on the illicit drug market in the United States, the Drug Enforcement Administration (DEA) may use its emergency scheduling authority to temporarily place those substances in Schedule I of the Controlled Substances Act (CSA) if the agency deems it necessary to avoid imminent hazards to public safety. (DEA was given temporary scheduling authority in the Comprehensive Crime Control Act of 1984 [Title II of P.L. 98-473].) However, as DEA has worked alongside state and foreign authorities to control hazardous substances, new, yet similar, substances have been found to rapidly emerge. Chemists, often operating illicitly, slightly alter a regulated compound to create a similar substance that is in the same structural class, but is not specifically controlled. Law enforcement has described efforts to control each new substance as a game of "whack-a-mole."

The CSA classifies various substances in one of five lists known as "schedules" based on characteristics such as their medical use, potential for abuse, and safety or dependence liability. Schedule I is the most restrictive, containing substances with no accepted medical use and high potential for abuse, such as heroin. The CSA authorizes the Attorney General to schedule substances temporarily or permanently via an administrative rulemaking process, and the Attorney General has delegated that scheduling authority to DEA. Congress may also schedule substances via legislation.

In 2018, when new fentanyl analogues were rapidly emerging, DEA issued a temporary scheduling order (TSO) that placed a class of fentanyl-related substances in Schedule I under the CSA for two years. Congress (and Presidents Trump and Biden) enacted legislation to extend the TSO 10 times before making the classwide scheduling permanent through the Halt All Lethal Trafficking of Fentanyl Act (HALT Fentanyl Act; P.L. 119-26). Until the 2018 TSO, DEA had never scheduled substances as a class, but Congress had previously done so. For example, Congress defined "cannabimimetic agents" and added these substances as a class to Schedule I of the CSA through the Synthetic Drug Abuse Prevention Act of 2012 (P.L. 112-144).

As new classes of substances emerge, Congress may consider how best to control these substances and stem the flow of illicit drugs and their analogues in the United States. Policymakers may evaluate the use and effect of classwide scheduling as one such means of drug control policy.

Introduction

As new dangerous substances appear on the illicit drug market in the United States, the Drug Enforcement Administration (DEA) may use its emergency scheduling authority to temporarily place those substances in Schedule I of the Controlled Substances Act (CSA) if the agency deems it necessary to avoid imminent hazards to public safety.¹ (DEA was given temporary scheduling authority in the Comprehensive Crime Control Act of 1984.²) However, as DEA has worked alongside state and foreign authorities to control hazardous substances, new, yet similar, substances have been found to rapidly emerge. Chemists, often operating illicitly, slightly alter a regulated compound to create a similar substance that is in the same structural class, but is not specifically controlled. Law enforcement has described efforts to control each new analogue substance as a game of "whack-a-mole."³

In 2018, to get ahead of this issue when new fentanyl analogues were rapidly emerging, DEA issued a temporary scheduling order (TSO) that placed a class of fentanyl-related substances (FRS) in Schedule I under the CSA for two years.⁴ Congress (and Presidents Trump and Biden) enacted legislation to extend the TSO 10 times before making the classwide scheduling permanent through the Halt All Lethal Trafficking of Fentanyl Act (HALT Fentanyl Act).⁵ As new substances emerge, Congress may consider how best to control these substances and stem the flow of illicit drugs and their analogues in the United States. This report discusses scheduling under the CSA, previous actions on classwide scheduling, and issues for congressional consideration.

Scheduling Under the CSA

The CSA established five lists known as "schedules" into which substances may be classified.⁶ Schedule I is the most restrictive, containing substances with no accepted medical use and high potential for abuse, such as heroin.⁷ The CSA authorizes the Attorney General to schedule substances temporarily or permanently via administrative rulemaking processes.⁸ Although the Attorney General has delegated that scheduling authority to DEA, he also retains the authority to make scheduling decisions.⁹ Congress may also schedule substances via legislation. Further, analogues of controlled substances in Schedules I or II of the CSA may be treated as Schedule I controlled substances for enforcement purposes if they are substantially similar to Schedule I or II controlled substances and intended for human consumption.¹⁰

Permanent Administrative Scheduling

DEA may place substances into schedules under the CSA based upon eight factors: (1) potential for abuse; (2) known scientific evidence of pharmacological effects; (3) current scientific knowledge of the substance; (4) history and current pattern of abuse; (5) scope, duration, and significance of abuse; (6) risk to public health; (7) dependence liability; and (8) whether the substance is a precursor of an already-scheduled substance.¹¹ DEA must consider all eight factors for a substance to be scheduled. Before initiating the rulemaking process, DEA must request a scientific and medical evaluation of the substance at issue from the Department of Health and Human Services (HHS).¹² HHS's scientific and medical findings are binding on DEA, and if HHS recommends against scheduling a substance, DEA cannot schedule it, but DEA otherwise has the authority to make final scheduling decisions.¹³ Permanent administrative scheduling is conducted through formal rulemaking under the Administrative Procedure Act, meaning that interested parties may submit comments, and DEA must provide an opportunity for a hearing on the decision before it becomes final.¹⁴ The decision whether to schedule, reschedule, or deschedule a substance through this administrative process is subject to judicial review.¹⁵

The CSA separately outlines procedures for scheduling controlled substances based on U.S. treaty obligations. If control of a substance is required by U.S. treaty obligations, the CSA directs the DEA administrator to "issue an order controlling such drug under the schedule he deems most appropriate to carry out such obligations."¹⁶ Scheduling pursuant to international treaty obligations does not require the factual findings that are necessary for other administrative scheduling actions, and may be implemented without regard to the procedures outlined for regular administrative scheduling.¹⁷ As of the date of this report, CRS has not identified any instance of DEA implementing classwide scheduling of controlled substances via the formal rulemaking process or pursuant to U.S. treaty obligations.¹⁸

Temporary Administrative Scheduling

Under a 1984 amendment to the CSA, DEA has the authority to temporarily place a substance into Schedule I of the CSA to "avoid imminent hazards to public safety."¹⁹ To do so, DEA must consider the substance's history and current pattern of abuse; scope, duration, and significance of abuse; and risk to public health.²⁰ Emergency scheduling orders are not subject to judicial review.²¹

When a substance is scheduled through this temporary scheduling process, it may remain on Schedule I for two years.²² If DEA undertakes permanent scheduling proceedings for a substance that has been temporarily scheduled, the agency then has the authority to keep the substance on Schedule I for one additional year before it must be removed or permanently scheduled.²³ This process can present an issue in the context of classwide scheduling because DEA and HHS may not have sufficient time or resources to perform the full eight-factor analysis for each substance in a large class of substances to complete permanent scheduling before temporary scheduling expires.²⁴

Legislative Scheduling

As an alternative to the permanent and temporary administrative scheduling procedures outlined above, Congress can schedule substances by enacting legislation. Congress initially placed numerous substances in Schedules I through V when it enacted the CSA in 1970.²⁵ Since the CSA's enactment, most subsequent scheduling changes have been made by DEA via the rulemaking process. However, Congress has at times enacted legislation to schedule controlled substances or change the status of existing controlled substances.²⁶ (The procedural and factfinding requirements for administrative scheduling do not apply to legislative scheduling.) Congress has previously enacted laws that added substances to the CSA on a classwide basis. For instance, the HALT Fentanyl Act added FRS to schedule I of the CSA, and the Synthetic Drug Abuse Prevention Act of 2012 added certain cannabimimetic substances (commonly referred to as synthetic marijuana) to Schedule I.²⁷

Analogue Enforcement Act

Some individuals and criminal organizations engaged in the illicit manufacturing and trafficking of illicit drugs seek to circumvent the CSA and other drug laws by slightly modifying the molecular structures of synthetic controlled substances (i.e., creating analogues).²⁸ In response, Congress and President Reagan enacted the Controlled Substances Analogue Enforcement Act of 1986,²⁹ which amended the CSA to impose controls on certain controlled substance analogues that are not specifically scheduled under the CSA. Under this act, a controlled substance analogue is a substance that is substantially similar to the chemical structure of a Schedule I or II controlled substance or has an effect on the nervous system similar to the effect of a Schedule I or II controlled substance.³⁰ If a substance falls within the definition of "controlled substance analogue" and is intended for human consumption, it is treated as a controlled substance in Schedule I.³¹ This treatment means that DEA and the Department of Justice (DOJ) can restrict activities involving these unscheduled controlled substance analogues as they would for unauthorized activities involving Schedule I controlled substances and prosecute individuals engaged in such restricted activities.

Classwide Scheduling of FRS

As the U.S. opioid crisis evolved and law enforcement identified more fentanyl analogues, DEA struggled to keep pace with the scheduling of each new analogue.³² Further, DOJ has reportedly had difficulty using the Analogue Enforcement Act to prosecute cases, as analogue prosecutions require "expending a great deal of time and resources" and each new jury must evaluate technical information on the analogues that can yield inconsistent prosecution outcomes.³³ As such, DEA issued the 2018 TSO, and controlled FRS as a class (based on their chemical structure) in Schedule I.³⁴ This effort was the first time substances had been administratively scheduled as a class under the CSA. DEA did not initiate permanent scheduling of the full class of FRS, though the agency continued to take temporary and permanent scheduling actions with respect to specific fentanyl analogues, including selected FRS subject to the Fentanyl TSO.³⁵

The Fentanyl TSO was set to expire in February 2020. On February 6, 2020, due to the time limits of DEA's temporary scheduling authority and wanting to keep FRS scheduled as a class, Congress extended the TSO through the Temporary Reauthorization and Study of the Emergency Scheduling of Fentanyl Analogues Act.³⁶ Congress went on to extend the TSO 9 more times³⁷ before permanently scheduling FRS as a class through the HALT Fentanyl Act.

In addition to permanently scheduling the class of FRS, the HALT Fentanyl Act also made other changes to the law, including expressly providing that the CSA's quantity-based mandatory minimum prison sentences that apply to certain offenses involving fentanyl analogues also apply to offenses involving FRS and streamlining research with Schedule I controlled substances.³⁸

Effect of Classwide Scheduling on the Illicit Drug Market

Drug traffickers may attempt to skirt laws regulating fentanyl and its analogues by slightly altering the chemistry of those controlled substances. This method appears to be true not only for individual substances but for entire classes of substances as well. Scheduling FRS as a class contributed to a shift to the production of other classes of uncontrolled psychoactive substances.³⁹ Some experts argue that the international and classwide controls of FRS contributed to the emergence of nitazenes (also known as benzimidazole-opioids) on the illicit drug market.⁴⁰ Further, some point to the People's Republic of China's actions to control nitazenes as the reason that orphines (or "orphine analogues") have emerged in the street market.⁴¹ Both nitazenes and orphines are potent synthetic opioids that elicit effects similar to those of fentanyl.⁴²

Options for Congress

In considering future synthetic drug control efforts, there are several issues on which Congress may deliberate. Congress may consider the effect of classwide scheduling on federal enforcement and on researchers. Given the enforcement challenges involving synthetic drugs and the utility of classwide scheduling for FRS, Congress may consider expanding classwide scheduling for other classes of substances aside from FRS, such as nitazenes and orphines, or whether to adjust DOJ and DEA's authority to impose classwide scheduling or conduct additional oversight over DEA's scheduling processes.

Considering Federal Enforcement and Research

Policymakers may consider the implications of scheduling on the federal criminal justice system and on researchers. Data gathered by the U.S. Sentencing Commission (USSC) and the Government Accountability Office (GAO) appear to indicate that, in the first few years FRS classwide scheduling was in place, DOJ obtained convictions for trafficking in FRS relatively infrequently (in Table 1, non-scheduled fentanyl analogues) compared to convictions for trafficking fentanyl or fentanyl analogues (see Table 1). In this section, CRS refers to "non-scheduled fentanyl analogues" as those fentanyl analogues that might fall under the FRS classwide scheduling order but are not specifically scheduled.

While USSC does not indicate in its data whether U.S. attorneys relied on the FRS classwide scheduling order, GAO reported that in FY2019 and FY2020, U.S. attorneys relied on the order for those three cases involving analogues that were not individually scheduled.⁴³

Over the years, medical researchers have created various synthetic substances that have been used in medical treatment. Some researchers have expressed concern over the challenges of researching FRS due to their Schedule I status. One concern is the amount of time required to obtain approval for their research.⁴⁴ CSA requirements are most stringent for Schedule I controlled substances. In response to concerns over the additional requirements for Schedule I research, Congress included several provisions in the HALT Fentanyl Act⁴⁵ meant to ease some of the requirements for all Schedule I research. Congress may evaluate those provisions and may further amend CSA requirements.

Amending Scheduling Authority

In considering classwide scheduling via administrative rulemaking, Congress may choose to amend this scheduling authority in any number of ways. Similar to what was done through the Synthetic Drug Abuse Prevention Act of 2012,⁴⁶ Congress could adjust the amount of time for which substances or classes of substances may be temporarily scheduled or make other adjustments to this authority. Congress could also prohibit DEA from scheduling in a classwide capacity or continue to allow it. Further, Congress could conduct additional oversight over DEA's scheduling processes.

Considering Classwide Scheduling Legislation

Because Congress legislatively placed the class of FRS in Schedule I, those substances will remain subject to the requirements of Schedule I unless Congress or DEA takes further action to change their status. Congress has the authority to modify the status of FRS by legislation and could reschedule or deschedule the class as a whole or specific substances within the class. Congress could also enact legislation retaining the class of FRS in Schedule I but creating targeted exceptions or modifications to that Schedule I status. For instance, as noted above, the HALT Fentanyl Act expressly provided that mandatory minimum prison sentences that apply to certain CSA offenses involving specified amounts of fentanyl analogues also apply to offenses involving threshold amounts of FRS.⁴⁷ Other legislation proposed during the 119^th Congress would have taken a different approach by scheduling the class of FRS while excepting offenses involving FRS from those mandatory minimum prison sentences.⁴⁸ Proposed FRS scheduling legislation would have included an "off-ramp" provision allowing for expedited administrative descheduling or rescheduling of FRS that were later found not to pose a serious danger to public health.⁴⁹ These provisions were not included in the HALT Fentanyl Act as enacted.

Congress may also consider legislation to control other classes of substances. When considering such legislation, one question that arises for Congress is whether to impose controls via legislation or to leave scheduling to DEA. Congress often defers to DEA to schedule controlled substances in consultation with HHS because the agencies have expertise in this area. There may be benefits to legislative scheduling, however, including the ability to control substances quickly without needing to go through administrative rulemaking, reduction in fact-finding burdens on the agencies, and greater ability to tailor controls beyond what is already contained in the CSA's schedules. If Congress chooses to act via legislation, it may consider factors such as how to define the class of substances subject to control, what schedule to place the class in, and whether to create any class-specific modifications of CSA control.

Footnotes