Order Amending Schedule V to the Controlled Drugs and Substances Act (Novel Fentanyl Precursors): SOR/2022-185

Canada Gazette, Part II, Volume 156, Number 18

Registration
SOR/2022-185 August 9, 2022

CONTROLLED DRUGS AND SUBSTANCES ACT

Whereas, under paragraph 60.1(1)(b)footnote a of the Controlled Drugs and Substances Actfootnote b, the Minister of Mental Health and Addictions and Associate Minister of Health has reasonable grounds to believe that the substances referred to in the annexed Order may pose a risk to public health or safety and that those substances are, with no legitimate purpose, being imported into Canada or being distributed in Canada;

Therefore, the Minister of Mental Health and Addictions and Associate Minister of Health makes the annexed Order Amending Schedule V to the Controlled Drugs and Substances Act (Novel Fentanyl Precursors) under paragraph 60.1(1)(b)footnote a and subsection 60.1(2)footnote a of the Controlled Drugs and Substances Act footnote b.

Ottawa, July 26, 2022

Carolyn Bennett
Minister of Mental Health and Addictions and Associate Minister of Health

Order Amending Schedule V to the Controlled Drugs and Substances Act (Novel Fentanyl Precursors)

Amendments

1 Schedule V to the Controlled Drugs and Substances Act footnote b is amended by adding the following:
Item

Column 1

Substance

Column 2

Period
1 Analogues and derivatives of N-Phenyl-4-piperidinamine and its salts, including
  • (1) 4-anilino-1-boc-piperidine
  • (2) 4-fluoro anilino-1-boc-piperidine
  • (3) N-(4-fluorophenyl)-4-piperidinamine
  • (4) 4-bromo anilino-1-boc-piperidine
 From August 31, 2022 until August 30, 2023

2 Item 1 of Schedule V to the Act is deleted.

Coming into Force

3 (1) Subject to subsection (2), this Order comes into force on the day on which it is published in the Canada Gazette, Part II.

(2) Section 2 comes into force on the earlier of

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Order.)

Issues

There is evidence that substances that are chemically related (i.e. analogues and derivatives) to the fentanyl precursor, N-Phenyl-4-piperidinamine and its salts, are being imported into Canada and used in the illegal production of fentanyl. Although the substance N-Phenyl-4-piperidinamine and its salts is already scheduled as a precursor under the Controlled Drugs and Substances Act (CDSA) and its Precursor Control Regulations (PCR), its related analogues and derivatives are not controlled. It is critical that analogues and derivatives of N-Phenyl-4-piperidinamine and its salts be scheduled under the CDSA to prevent their importation, distribution and use in the illegal production of fentanyl and fentanyl analogues. Further, in March 2022, the United Nations Commission on Narcotic Drugs voted to schedule one such substance (4-anilino-1-boc-piperidine) under the United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988. As a signatory to this convention, Canada is expected to take measures to ensure its control.

Background

Between January 2016 and December 2021, there were a total of 29 052 apparent opioid toxicity deaths in Canada. Fentanyl and fentanyl analogues continue to be major drivers of the opioid overdose crisis, with 86% of all apparent accidental opioid toxicity deaths in 2021 involving fentanyl.

Fentanyl is a highly potent synthetic opioid that is controlled in Canada under Schedule I of the CDSA. The CDSA is the federal statute that provides a framework for the control of substances that can alter mental processes and may produce harm to health or society when diverted to an illegal market or misused. Substances listed in schedules I to V of the CDSA are defined as controlled substances, while substances listed under Schedule VI are defined as precursors. The CDSA also specifies the offences and penalties associated with the conduct of illegal activities with controlled substances and precursors.

Fentanyl and fentanyl analogues are produced using certain chemical substances, known as precursors. The fentanyl precursor, N-Phenyl-4-piperidinamine and its salts (also known as 4-AP), is controlled as a precursor under the CDSA (i.e. listed in Schedule VI to the CDSA and subject to the PCR). However, analogues and derivatives of 4-AP are not currently controlled in Canada.

Within the illegal drug market, substances are often deliberately chemically engineered to circumvent existing international and domestic control measures. A Health Canada scientific assessment has concluded that the following four substances, which are related to 4-AP, but are not yet scheduled under the CDSA and PCR, are being imported into Canada and used in the illegal production of fentanyl and fentanyl analogues in Canada:

All four of these substances are considered analogues or derivatives of 4-AP. Despite being structurally related to 4-AP, these four substances are not currently controlled because the present listing does not include analogues and derivatives of 4-AP (it only includes its salts).

Evidence that these four substances are being imported and used in the illegal production of fentanyl and fentanyl analogues in Canada includes the following:

Further, in March 2022, the United Nations Commission on Narcotic Drugs voted to schedule 4-anilino-1-boc-piperidine under the International Drug Control Conventions, specifically the United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988.

Based on evidence that multiple different analogues and derivatives of 4-AP are being imported into Canada and used in the illegal production of fentanyl and fentanyl analogues, it is reasonable to anticipate that illegal drug manufacturers will continue their attempts to use additional, yet to be detected, analogues and derivatives of 4-AP. For this reason, all analogues or derivatives of 4-AP, including the four substances listed above, were recommended for scheduling.

Temporary scheduling of controlled substances under Schedule V

In May 2017, the CDSA and Part J of the Food and Drug Regulations (FDR) were amended to include a mechanism to quickly and temporarily schedule new substances as controlled substances in Canada.

Subsection 60.1(1) of the CDSA grants the Minister the authority to temporarily add a substance to Schedule V of the CDSA through a ministerial order, if the Minister has reasonable grounds to believe that the substance

Once a substance is added to Schedule V of the CDSA, importation, exportation, production, trafficking, and possession for the purpose of trafficking of the substance are all prohibited (note that the prohibition on possession in subsection 4(1) of the CDSA does not apply to substances included in Schedule V).

Objective

The objective of this Order is to temporarily schedule analogues and derivatives of 4-AP under the CDSA to prevent their use in the illegal synthesis of fentanyl and fentanyl analogues. This action enables law enforcement to take action against any illegal importation, distribution, and use of these substances in illicit activities.

Description

Given that these substances are known to be used in the illegal synthesis of fentanyl and fentanyl analogues, and because there is evidence to show they are being imported into and distributed in Canada with no legitimate purpose, this Order adds all analogues and derivatives of 4-AP to Schedule V of the CDSA, pursuant to paragraph 60.1(1)(b) of the CDSA, for a period of one year. For greater clarity, Health Canada has expressly listed four specific analogues and derivatives of 4-AP.

As a result of this Order, importing, exporting, producing, trafficking, and possessing for the purpose of trafficking the analogues and derivatives of 4-AP are now subject to criminal prohibitions under the CDSA. As a result, law enforcement and CBSA officers can take action (e.g. seize) to halt their illegal importation, distribution and use.

Pursuant to subsection 60.1(1), a substance may be temporarily added under Schedule V for a period of up to one year, with the possibility of extending the scheduling for an additional year. During this time, Health Canada will determine, through scientific assessment, enhanced information gathering and consultation with stakeholders, the best approach to take with respect to long-term control.

Regulatory development

Consultation

The objective of the Order is to quickly mitigate the risks to public health and safety of substances with no legitimate purposes. To allow for timely action, stakeholders will be notified of the temporary scheduling of all analogues and derivatives of 4-AP once the Order is made. As noted above, consultation with stakeholders will be undertaken with respect to the best approach to long-term control.

Modern treaty obligations and Indigenous engagement and consultation

An assessment of modern treaty implications found that this Order does not have an impact on Canada’s modern treaty obligations.

Instrument choice

No action would have resulted in law enforcement not having the tools needed to take action to halt the importation, distribution and use of these substances.

Health Canada considered whether the analogues and derivatives of 4-AP should be scheduled using the Governor in Council’s authority to schedule substances under the CDSA following the standard regulatory development process. It was determined that these substances needed to be scheduled as quickly as possible, and addition to Schedule V via a ministerial order was the most appropriate pathway for this purpose.

Health Canada also considered whether analogues and derivatives of 4-AP should be added to Part J of the FDR in order to permit certain scientific and research activities with these substances. However, the Department determined that, given there is no evidence to suggest these substances have legitimate uses, there was no need to authorize legitimate activities with these substances during the temporary scheduling period.

Any stakeholders wanting to conduct legitimate activities with analogues and derivatives of 4-AP while it is temporarily scheduled should apply for a subsection 56(1) exemption by contacting hc.exemption.sc@canada.ca.

Regulatory analysis

Benefits and costs

The Order helps address an illegal source of fentanyl and fentanyl analogue production, thereby mitigating the risks that these analogues and derivatives of 4-AP may pose to public health and safety. Adding these substances to Schedule V allows the Minister to take quick action to control these substances while also providing Health Canada more time to determine the best approach to take with respect to longer-term control.

Given that the analogues and derivatives of 4-AP have no legitimate use and no legitimate activities involving these substances have been identified in Canada, the Order is not expected to have any cost impact on businesses or other stakeholders.

Small business lens

Analysis under the small business lens concluded that the Order will not impact Canadian small businesses.

One-for-one rule

The one-for-one rule does not apply, as there is no impact on businesses.

Regulatory cooperation and alignment

In March 2022, the United Nations Commission on Narcotic Drugs voted to schedule 4-anilino-1-boc-piperidine under International Drug Control Conventions, specifically the United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988. As a signatory to this convention, Canada is expected to take measures to ensure its control. The temporary addition of the analogues and derivatives of 4-AP (including 4-anilino-1-boc-piperidine) on Schedule V of the CDSA fulfills Canada’s obligation to control the substance, while also allowing time for Health Canada to consider longer-term control.

Although this Order has not been developed specifically in cooperation or to align with other jurisdictions, concerns relating to the illegal synthesis, distribution and use of illicit fentanyl are global. As a result, the temporary scheduling of substances used in the illegal production of fentanyl and fentanyl analogues helps address domestic and international illicit drug trafficking concerns.

Strategic environmental assessment

In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a preliminary scan was conducted which concluded that there will be no expected important environmental effects, either positive or negative; therefore a strategic environmental assessment is not required.

Gender-based analysis plus

A preliminary gender-based analysis plus (GBA+) was conducted as part of the development of the Order to determine whether controlling these substances will affect a particular group or subgroup of Canadians differently than others when compared to the status quo. The assessment concluded that all affected groups, as identified in the GBA+, who use illegal fentanyl, would experience any potential benefits associated with the Order. Although there are sex, gender and other socio-economic differences in the use of illicit fentanyl and the resulting adverse health outcomes, the GBA+ did not find any potential for disproportionate impacts among those groups and subgroups identified, based on sex, gender or any other socio-economic characteristics as a consequence of the temporary listing.

Implementation, compliance and enforcement, and service standards

Implementation

This Order comes into force on the fixed date set out in the Order. The Order is in effect for one year and will end on the fixed date set out in the Order, or the day on which an order is made that adds analogues and derivatives of 4-AP to one or more of the schedules I, II, III, IV or VI of the CDSA.

Once the Order is made, Health Canada will send notification emails to all Canadian producers, manufacturers, distributors and sellers of fentanyl to ensure they are aware of this Order and to encourage their comments, as Health Canada considers longer-term control. Partner organizations, such as the Canada Border Services Agency, the Royal Canadian Mounted Police, Public Safety Canada, and the Canadian Chiefs of Police, will also be notified.

Compliance and enforcement

Health Canada is responsible for issuing authorizations (e.g. licences, permits, and exemptions) for legitimate activities with substances scheduled under the CDSA and its regulations and for monitoring compliance with regulatory requirements.

Federal, provincial and local law enforcement agencies are responsible for taking enforcement action in response to contraventions of the CDSA. Under the CDSA, a range of penalties apply to the offences associated with the substances covered by this initiative. These penalties may include the application of a fine and/or a term of imprisonment. For certain offences (trafficking, possession for the purpose of trafficking, importing, exporting, possession for the purpose of exporting, production), there is a maximum penalty of up to 10 years of imprisonment if the offence is prosecuted by indictment or of up to 18 months of imprisonment if the offence is prosecuted by summary conviction.

The criminal prohibition on possession of controlled substances under subsection 4(1) of the CDSA does not apply to substances listed in Schedule V.

The temporary scheduling of analogues and derivatives of 4-AP enables law enforcement and CBSA officers to take action (e.g. seize) against illegal importation and distribution of these substances to prevent their use in the illegal synthesis of fentanyl and fentanyl analogues.

Contact

For enquiries or more information, please contact the Office of Legislative and Regulatory Affairs of Health Canada’s Controlled Substances Directorate at csd.regulatory.policy-politique.reglementaire.dsc@hc-sc.gc.ca.