Overview

Title

To amend the Controlled Substances Act to clarify how controlled substance analogues that are imported or offered for import are to be regulated, and for other purposes.

ELI5 AI

The bill tries to update a law to better manage tricky versions of drugs that are brought into the U.S., setting new rules and big fines if someone breaks them, but it's a bit hard to understand and might not have enough money planned to make everything work right.

Summary AI

The proposed bill, H.R. 9879, aims to amend the Controlled Substances Act to address the regulation of synthetic drug analogues imported into the United States. It establishes a new category, Schedule A, for substances with structures and effects similar to controlled substances. The bill outlines the process for temporarily and permanently adding substances to Schedule A, sets penalties for violations involving these substances, and specifies labeling and registration requirements for their importation, exportation, and research use. Additionally, it provides for sentencing review if a substance is later descheduled or rescheduled.

Published

2024-09-27
Congress: 118
Session: 2
Chamber: HOUSE
Status: Introduced in House
Date: 2024-09-27
Package ID: BILLS-118hr9879ih

Bill Statistics

Size

Sections:
10
Words:
4,051
Pages:
19
Sentences:
70

Language

Nouns: 1,113
Verbs: 299
Adjectives: 193
Adverbs: 33
Numbers: 189
Entities: 130

Complexity

Average Token Length:
4.06
Average Sentence Length:
57.87
Token Entropy:
5.16
Readability (ARI):
30.07

AnalysisAI

Bill Summary

The proposed legislation, known as the Stop the Importation and Manufacturing of Synthetic Analogues Act of 2024 or the SIMSA Act of 2024, aims to amend the Controlled Substances Act. The primary objective of the bill is to introduce a new regulatory category called "Schedule A" for synthetic drug analogues that are imported or offered for import into the United States. This new schedule would cover substances with chemical structures and effects similar to existing controlled substances that are not currently scheduled. The bill grants the Attorney General authority to temporarily or permanently schedule substances under Schedule A, sets penalties for violations, and establishes false labeling requirements and registration processes. Additionally, it includes various amendments to conform with existing drug regulations and outlines procedures for sentencing reviews if substances are rescheduled or descheduled.

Significant Issues

A set of critical issues arises from the ambiguous language used in the bill. Terms like "substantially similar" and "predicted" effects in defining Schedule A in Section 2 present potential challenges in legal clarity and enforcement consistency. This vagueness could lead to differing interpretations and legal disputes. Moreover, Section 3 affords substantial power to the Attorney General to schedule substances without judicial oversight, raising questions about checks and balances in the legal framework.

The penalties described in Section 4 are notably severe, including mandatory minimum sentences and significant fines, but lack a clear framework for their application, which could result in inconsistent and potentially unjust enforcement. Complex legal terminology throughout the bill may be difficult for stakeholders and the general public to comprehend, posing transparency challenges. Additionally, sections dealing with registration and labeling requirements are technically intricate, which might complicate compliance, particularly for stakeholders without a background in law or science.

Impact on the Public

The legislation is poised to have a broad impact on the public, particularly in how synthetic drugs are regulated and controlled. By increasing regulation, it could potentially reduce the availability and abuse of synthetic drug analogues, improving public health and safety. However, the vague criteria and absence of judicial review for scheduling decisions could lead to uncertainty or fear among those involved in legitimate scientific research or the manufacturing of substances that might inadvertently fall under these regulations.

Impact on Specific Stakeholders

For law enforcement agencies, the bill could empower action against synthetic drug traffickers, thereby aiding efforts to control illegal substance flows. Pharmaceutical companies and researchers might face increased regulatory hurdles and administrative burden due to the complex requirements for registration and labeling. Legal professionals might find an uptick in advisory roles and legal challenges stemming from the vague language and interpretation challenges presented by the bill.

Individuals previously convicted of offenses involving synthetic drugs might have a ray of hope for sentence reviews if substances are descheduled or rescheduled, potentially reducing their incarceration periods. However, without clear guidelines on the review process, this could also lead to inconsistent application of sentence reductions.

In summary, while the bill intends to bolster the control over synthetic drugs to enhance public safety, its drafting issues and broad regulatory impacts might present challenges in its practical implementation and effects on specific sector stakeholders.

Financial Assessment

The proposed legislation, H.R. 9879, seeks to amend the Controlled Substances Act by introducing a new category, Schedule A, aimed at curbing the importation and regulation of synthetic drug analogues. While the bill details legal and procedural changes, it also outlines financial penalties that stakeholders need to consider.

Financial Penalties in Section 4

The bill specifies severe financial penalties as a part of the enforcement measures in Section 4. It establishes that for violations involving Schedule A substances, individuals could face fines up to $1,000,000 and entities or organizations could face fines up to $5,000,000. For repeat offenses or if the violation results in death or serious bodily injury, these penalties double, leading to maximum fines of $2,000,000 for individuals and $10,000,000 for organizations.

These financial references serve as deterrence against the illegal handling of Schedule A substances. However, the lack of clear criteria for applying these penalties could lead to inconsistencies in their imposition, relating to the issue of potential unfairness and unpredictable legal outcomes. The severity of these fines highlights the importance placed on adherence to the regulations but could also result in challenges if not applied uniformly.

Resource Allocation Concerns

Interestingly, the bill does not outline specific budgetary allocations or financial resources required to implement the registration and research processes stipulated under Section 6. As noted in the issues, this absence could be problematic. Without dedicated finances, the challenges in resource allocation could hinder the efficiency and effectiveness of enforcing the new Schedule A regulations. This gap may require stakeholders to lobby for appropriations to cover administrative costs associated with these new regulatory requirements.

Transparency and Complexity

The bill's complexity, particularly in regards to financial penalties and registration requirements, might pose transparency issues due to its technical nature. Stakeholders without legal or scientific expertise might struggle to comprehend the financial implications fully, potentially complicating compliance efforts.

In conclusion, while H.R. 9879 establishes clear financial penalties aimed at deterring the illegal importation and distribution of synthetic analogues, the absence of budgetary provisions for implementation may impact its efficacy. Additionally, ensuring that the new financial penalties are applied consistently and fairly will be crucial to prevent negative legal consequences. The intricate nature of these financial aspects underscores the need for clearer guidelines and potentially additional legislative action to address resource allocation concerns.

Issues

  • The criteria for 'Schedule A' under Section 2 are ambiguous due to the use of terms like 'substantially similar' and 'predicted stimulant, depressant, or hallucinogenic effect,' which could lead to legal challenges and inconsistent enforcement. The vague language is open to interpretation, raising issues about fairness and precision in lawmaking.

  • Section 3 contains provisions granting substantial authority to the Attorney General to temporarily schedule substances without judicial review. This could pose a significant ethical and legal issue regarding checks and balances and limits on power.

  • The penalties outlined in Section 4 are severe and include mandatory minimum sentences and high fines, but lack clear criteria for application. This could lead to inconsistency in sentencing and potentially unjust outcomes, raising legal and ethical concerns.

  • The bill introduces complex legal language, particularly in Sections 2 and 4, that may be difficult for non-specialists to understand. This leads to a transparency issue, as stakeholders may not fully comprehend the implications of the law.

  • Sections 6 and 7 outline registration requirements and conforming amendments that are highly technical and could be problematic for stakeholders lacking a legal or scientific background. This complexity may hinder compliance and complicate enforcement.

  • Section 5 addresses the false labeling of Schedule A substances, but the determination of 'intent to manufacture, distribute, or dispense' may lead to potential ambiguity and requires additional guidelines to avoid improper interpretation and application.

  • The process for sentencing review in Section 8 is unclear, particularly in terms of the timeline and criteria for conducting a sentencing reduction hearing, potentially leading to inconsistencies in legal outcomes.

  • The absence of specific budget allocations or financial planning for implementing the registration and research continuation processes under Section 6 could result in resource allocation challenges, impacting the effectiveness and efficiency of the bill's implementation.

Sections

Sections are presented as they are annotated in the original legislative text. Any missing headers, numbers, or non-consecutive order is due to the original text.

1. Short title; table of contents Read Opens in new tab

Summary AI

The text describes the "Stop the Importation and Manufacturing of Synthetic Analogues Act of 2024", also known as the SIMSA Act of 2024. It outlines the short title, the table of contents, and the main sections of the Act, which include topics like establishing a new drug schedule, penalties for violations, and rules about labeling and registration of certain substances.

2. Establishment of Schedule A Read Opens in new tab

Summary AI

The section amends the Controlled Substances Act to introduce a new "Schedule A" for drugs. This schedule includes substances that are imported into the U.S. and have chemical structures and effects on the central nervous system similar to other controlled substances but are not yet listed in the existing schedules; it allows the Attorney General to temporarily or permanently add substances to this new schedule based on specific criteria.

Schedule A Read Opens in new tab

Summary AI

The section outlines that any substance can be temporarily or permanently regulated by the Attorney General according to a specific legal provision, section 201(k).

3. Temporary and permanent scheduling of schedule A substances Read Opens in new tab

Summary AI

The Attorney General has the authority to temporarily add drugs to schedule A to prevent abuse if they meet certain criteria and can make this temporary status permanent after three years unless the Secretary of Health and Human Services determines the drug lacks the potential for abuse. The temporary scheduling lasts up to five years and cannot be reviewed by a court.

4. Penalties Read Opens in new tab

Summary AI

The amendment to Section 1010 of the Controlled Substances Import and Export Act introduces harsher penalties for violations involving substances in schedule A. If someone breaks the law and causes serious injury or death with a schedule A substance, they can face up to life in prison and hefty fines, with even stricter consequences if they have previous drug offense convictions.

Money References

  • Section 1010 of the Controlled Substances Import and Export Act (21 U.S.C. 960) is amended— (1) in subsection (a), by inserting “or a drug or substance in schedule A” after “controlled substance” each place it appears; and (2) in subsection (b), by adding at the end the following: “(8) In the case of a violation under subsection (a) involving a controlled substance in schedule A, the person committing such violation shall be sentenced to a term of imprisonment of not more than 20 years and if death or serious bodily injury results from the use of such substance shall be sentenced to a term of imprisonment for any term of years or for life, a fine not to exceed the greater of that authorized in accordance with the provisions of title 18, United States Code, or $1,000,000 if the defendant is an individual or $5,000,000 if the defendant is other than an individual, or both.
  • If any person commits such a violation after a prior conviction for a felony drug offense has become final, such person shall be sentenced to a term of imprisonment of not more than 30 years and if death or serious bodily injury results from the use of such substance shall be sentenced to a term of imprisonment for any term of years or for life, a fine not to exceed the greater of twice that authorized in accordance with the provisions of title 18, United States Code, or $2,000,000 if the defendant is an individual or $10,000,000 if the defendant is other than an individual, or both.

5. False labeling of schedule A controlled substances Read Opens in new tab

Summary AI

The section outlines that it's illegal to import or export a schedule A controlled substance with the intent to manufacture, distribute, or dispense it unless it's labeled using the IUPAC nomenclature, except if the product complies with specific FDA labeling requirements. It also updates penalties for violations related to false labeling of these substances.

6. Registration requirements for schedule A substances Read Opens in new tab

Summary AI

The amendment to the Controlled Substances Import and Export Act requires the Attorney General to register applicants for importing or exporting schedule A substances for research, analytical, or industrial purposes, if public interest and international obligations are considered. Additionally, it outlines conditions for ongoing research of substances newly added to schedule A, allowing continuation under certain registrations and detailing application processes.

7. Additional conforming amendments Read Opens in new tab

Summary AI

The section of the bill amends the Controlled Substances Import and Export Act by adding "schedule A" drugs or substances to various sections, which means that these substances, similar to those already listed in schedule I or II, now face the same regulatory controls and restrictions.

8. Sentencing review Read Opens in new tab

Summary AI

In Section 8 of the bill, a "covered offense" refers to crimes related to certain substances with penalties established by this act. If such substances are later moved to a lower penalty schedule, individuals convicted of these offenses can ask the court for a reduced sentence. The court must hold a hearing within 30 days of the request and may change the sentence as if the new scheduling was in place when the crime occurred.

9. Rules of construction Read Opens in new tab

Summary AI

The section states that nothing in the Act, or its amendments, should be understood as restricting the prosecution of crimes related to controlled substance analogues or affecting the Attorney General's power to control the scheduling of drugs as established before the Act was passed.