Regulations Amending the Precursor Control Regulations (Novel Fentanyl Precursors): SOR/2023-102
Canada Gazette, Part II, Volume 157, Number 12
Registration
SOR/2023-102 May 19, 2023
CONTROLLED DRUGS AND SUBSTANCES ACT
P.C. 2023-453 May 18, 2023
Her Excellency the Governor General in Council, on the recommendation of the Minister of Mental Health and Addictions and Associate Minister of Health, makes the annexed Regulations Amending the Precursor Control Regulations (Novel Fentanyl Precursors) under subsection 55(1)footnote a of the Controlled Drugs and Substances Act footnote b.
Regulations Amending the Precursor Control Regulations (Novel Fentanyl Precursors)
Amendment
| Item | Column 1 Precursor set out in Part 1 of Schedule VI to the Act |
|---|---|
| 31 | N-Phenyl-4-piperidinamine (N-phenylpiperidin-4-amine), its salts, derivatives and analogues and salts of derivatives and analogues, including:
|
Coming into Force
2 These Regulations come into force on August 30, 2023.
REGULATORY IMPACT ANALYSIS STATEMENT
(This statement is not part of the Regulations or the Order.)
Issues
There is evidence that substances chemically related to (i.e. derivatives and analogues of) the fentanyl precursor N-Phenyl-4-piperidinamine and its salts (4-AP) are being imported into Canada and used in the illegal production of fentanyl and fentanyl analogues. Although 4-AP is already scheduled as a precursor under the Controlled Drugs and Substances Act (CDSA) and subject to the Precursor Control Regulations (PCR), its derivatives and analogues were only recently controlled under a temporary Ministerial Order that is set to expire on August 30, 2023. Unless the derivatives and analogues of 4-AP are scheduled on a long-term basis under the CDSA and the PCR, upon expiration of the Ministerial Order, law enforcement will no longer be able to act against their importation, distribution and use in the illegal production of fentanyl and fentanyl analogues. Additionally, one specific derivative of 4-AP (4-anilino-1-boc-piperidine) was scheduled internationally under the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988 in November 2022. Unless this substance is scheduled on a long-term basis under the CDSA and the PCR, Canada, as a party to this convention, would not be in compliance with its international obligations.
Background
Between January 2016 and September 2022, there were a total of 34 455 apparent opioid toxicity deaths in Canada. Fentanyl and fentanyl analogues continue to be major drivers of the opioid overdose crisis, with 81% of all apparent accidental opioid toxicity deaths from January to September 2022 involving fentanyl. Fentanyl and fentanyl analogues also accounted for 31% of the 3 917 opioid-related poisoning hospitalizations that occurred between January 2022 and September 2022.footnote 2
Fentanyl and fentanyl analogues are highly potent synthetic opioids that are controlled in Canada under Schedule I of the CDSA. Precursors are chemicals that are essential to the production of a controlled substance. While some precursor chemicals have legitimate uses, they can also be used in the illegal production of controlled substances, like fentanyl and fentanyl analogues. In Canada, precursors are controlled under Schedule VI of the CDSA and subject to the PCR.
One known fentanyl precursor, 4-AP, is controlled as a Class A precursor under Schedule VI of the CDSA and the PCR. Despite 4-AP already being subject to control, a recent Health Canada scientific assessment found that illegal drug producers in Canada are now importing derivatives and analogues of 4-AP (i.e. novel fentanyl precursors) and using them in the illegal production of fentanyl and fentanyl analogues. Further, these substances have no known legitimate industrial, commercial, or medical uses in Canada.
Based on this information, the Minister of Mental Health and Addictions and Associate Minister of Health made a temporary Ministerial Order under paragraph 60.1(1)(b) of the CDSA to schedule the derivatives and analogues of 4-AP for a period of one year. The temporary Ministerial Order added the derivatives and analogues of 4-AP to Schedule V of the CDSA and came into force on August 31, 2022. This addition temporarily prohibits the importation, exportation, production, trafficking, and possession for the purposes of trafficking of these substances. The temporary Ministerial Order enables law enforcement officials to take action against any illegal importation, distribution, and use of these substances. All derivatives and analogues of 4-AP were scheduled under the Ministerial Order based on the assumption that illegal drug producers would continue their attempts to use new novel, yet to be detected, derivatives and analogues of 4-AP in the illegal production of fentanyl and fentanyl analogues.
While the analogues and derivatives of 4-AP do not have legitimate industrial, commercial, or medical uses, there are limited circumstances in which they may be used, including for forensic analysis in support of law enforcement activities and for drug verification analysis in support of harm reduction initiatives. To enable these activities to be conducted legally during the period of time the Ministerial Order is in force, Health Canada issued subsection 56(1) exemptions under the CDSA to two Canadian government organizations to import and use these substances for legitimate analytical and research purposes.
The temporary Ministerial Order will expire on August 30, 2023, because, pursuant to subsection 60.1(1) of the CDSA, a substance can only be temporarily scheduled under Schedule V for a period of up to one year (with the possibility of extending the scheduling for an additional year).
Derivatives and analogues of 4-AP have been detected in Canada
The derivatives and analogues of 4-AP that have been identified in Canada as substances implicated in illegal domestic fentanyl production include
- 4-anilino-1-boc-piperidine;
- 4-fluoro anilino-1-boc-piperidine;
- N-(4-fluorophenyl)-4-piperidinamine; and
- 4-bromo anilino-1-boc-piperidine.
Before the temporary Ministerial Order came into force on August 31, 2022, the Canada Border Services Agency (CBSA) had intercepted numerous unauthorized shipments to Canada of 4-anilino-1-boc-piperidine, 4-fluoro anilino-1-boc-piperidine, and N-(4-fluorophenyl)-4-piperidinamine. When detected, these substances have typically been described or declared incorrectly, which suggests their intended end use may be illegal. In addition, 4-anilino-1-boc-piperidine, 4-fluoro anilino-1-boc-piperidine, and 4-bromo anilino-1-boc-piperidine have been detected in samples obtained from clandestine illegal drug laboratories in Canada. After August 31, 2022, using the tools afforded by the temporary Ministerial Order, the CBSA has seized derivatives and analogues of 4-AP at the border, and these substances continue to be detected in samples seized from clandestine illegal drug laboratories in Canada.
Legislative framework for controlled substances and precursors
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. Unless otherwise authorized by regulations or exempted in accordance with section 56, the trafficking, possession for the purposes of trafficking, import, export, and production of all controlled substances and possession of controlled substances listed in Schedules I through III are prohibited. The CDSA specifies the offences and penalties associated with prohibited activities with controlled substances (substances listed in Schedule I to V of the CDSA) and precursors (Schedule VI). The CDSA also authorizes the Governor in Council to make regulations as required and to amend the Schedule to the CDSA by order.
Made under the CDSA in 2002, the PCR set out a framework within which legitimate activities with precursors are regulated. Schedule VI to the CDSA includes a list of controlled Class A and Class B precursors that are commonly used in clandestine production processes. Class A precursors are essential chemical compounds, while Class B precursors are common essential reagents such as solvents, acids, and bases.
Under the PCR, a licence is required for any person to conduct the following activities with Class A precursors: produce, package, sell, provide, import, export, and possess for the purpose of these regulated activities. Typically, this requires a person to have an authorization from Health Canada in the form of a Class A precursor dealer’s licence (and an additional permit for importation or exportation). Any person who acquires a Class A precursor as an “end-user” (i.e. a person who acquires a Class A precursor from a licensed dealer and signs an “end-use declaration”) can possess, transport, send and deliver a Class A precursor without additional authorization. For example, most research activities with Class A precursors typically fall within the scope of permitted end-user activities; as a result, researchers rarely need to seek additional authorization from Health Canada to be able to use such substances.
The Schedule to the PCR also includes specified thresholds, in absolute quantities or package size, for each Class A precursor. Any licensed dealer who conducts certain regulated activities with amounts of the Class A precursor above the listed threshold also must comply with certain record-keeping provisions.
Objective
These amendments are to ensure that the derivatives and analogues of 4-AP are controlled under the CDSA on a long-term basis so that law enforcement can continue to take action following the expiration of the temporary Ministerial Order against any illegal importation, distribution, and use of these substances. This action assists in decreasing the production and supply of toxic illegal drugs that are contributing to substance use harms in Canada and to the overdose crisis.
Description
To help ensure these substances remain controlled under the CDSA following the expiration of the Ministerial Order, the Government of Canada is adding the derivatives and analogues of 4-AP and the salts of the derivatives and analogues to Schedule VI of the CDSA and to the Schedule to the PCR. Of note, the temporary Ministerial Order controls only derivatives and analogues of 4-AP, so these amendments would expand controls to also include the salts of derivatives and analogues. This minor expansion of controls was made to ensure that all chemicals related to 4-AP and its derivatives and analogues, and salts of the derivatives and analogues are scheduled and is consistent with the approach taken to scheduling other precursors with no legitimate uses under the CDSA.
More specifically, Part I, Class A precursors, item 30 of Schedule VI to the CDSA and item 31 of Column 1 of the Schedule to the PCR are being amended by expanding the existing listings of 4-AP to add all related derivatives and analogues, and salts of derivatives and analogues. The corresponding maximum quantity in Column 2 in the Schedule to the PCR is indicated as “0.” A maximum quantity of “0” means that an end-use declaration must be obtained by the licensed dealer before selling these precursors to a person who is not a licensed dealer. It also means that shipments of any of these precursors must be accompanied by additional documentation as required by the PCR.
The wording of the amended listing of 4-AP also now includes the addition of the International Union of Pure and Applied Chemistry (IUPAC) name of each precursor in brackets. The IUPAC naming system provides an international standard of nomenclature for chemical compounds. These new additions increase transparency by better ensuring accurate interpretation of the listing and standardization with international chemical naming guidelines.
The amended listing for 4-AP in both Schedule VI of the CDSA and the Schedule to the PCR is as follows:
N-Phenyl-4-piperidinamine (N-phenylpiperidin-4-amine), its salts, derivatives and analogues and salts of derivatives and analogues, including
- 4-anilino-1-boc-piperidine (tert-butyl 4-(phenylamino)piperidine-1-carboxylate);
- 4-fluoro anilino-1-boc-piperidine (tert-butyl 4-((4-fluorophenyl)amino)piperidine-1-carboxylate);
- N-(4-fluorophenyl)-4-piperidinamine (N-(4-fluorophenyl)piperidin-4-amine); and
- 4-bromo anilino-1-boc-piperidine (tert-butyl 4-((4-bromophenyl)amino)piperidine-1-carboxylate).
With these amendments, any person who is not authorized to conduct regulated activities with these precursors will be subject to the offences and penalties set out in section 6 of the CDSA. Any person who produces, packages, sells, provides, imports and exports these precursors must comply with the PCR.
Regulatory development
Consultation
The temporary Ministerial Order came into force on August 31, 2022; four parties contacted Health Canada regarding the scheduling. Two of these were federal government organizations requesting exemptions from the CDSA to import and use these precursors for legitimate analytical and research purposes. The other two stakeholders contacted Health Canada with operational questions.
To prepare for long-term scheduling of the substances scheduled by the temporary Ministerial Order, Health Canada conducted targeted consultations with the CBSA, the Royal Canadian Mounted Police, and other law enforcement partners. Health Canada also consulted with the two federal government organizations that were issued exemptions for activities with derivatives and analogues of 4-AP. The purpose of the consultations was to inform key partners of Health Canada’s decision to move forward with long-term scheduling of 4-AP’s derivatives and analogues, and salts of derivatives and analogues. There was no opposition to the recommendation to place the precursors on Schedule VI of the CDSA and the Schedule to the PCR.
Given that risks to public health and public safety are associated with these novel fentanyl precursors, these precursors have no legitimate use in Canada beyond minimal analytical and research purposes, and consulted stakeholders have not raised concerns or objections, the amendments were not prepublished in the Canada Gazette, Part I.
Modern treaty obligations and Indigenous engagement and consultation
An assessment of modern treaty implications found that this initiative does not impact Canada’s modern treaty obligations.
Instrument choice
Scheduling provides law enforcement with the authority to continue to take legal action in relation to activities with the precursors that contravene the CDSA. Without these scheduling amendments, law enforcement would not have the tools needed to take action to halt the importation, distribution, and use of the precursors once the temporary Ministerial Order expires on August 30, 2023.
Because 4-AP is already scheduled as a Class A precursor in Schedule VI of the CDSA and subject to the PCR, the amendment simply expands the existing list to include its derivatives and analogues, and salts of derivatives and analogues. Given that these precursors have no known legitimate industrial, commercial or medical uses in Canada, and given that they have been found to be used in Canada in the illegal production of fentanyl and fentanyl analogues, controlling these substances as precursors under the CDSA is the recommended option.
Regulatory analysis
Benefits and costs
Benefits
The available evidence indicates that fentanyl and fentanyl analogues continue to be major drivers of the opioid overdose crisis, contributing to most apparent accidental opioid toxicity deaths in recent years. Any action to disrupt sources of illegal production of fentanyl and fentanyl analogues assists in the Government of Canada’s comprehensive approach to addressing the overdose crisis. The amendments to the schedules will help address an illegal source of fentanyl and fentanyl analogue production on a long-term basis and help maintain public health and safety benefits by continuing to mitigate the risks associated with derivatives and analogues of 4-AP.
Costs
Costs to industry
Given that no legitimate industrial, commercial, or medical uses associated with these novel fentanyl precursors have been identified and no business has expressed interest in conducting activities with these precursors, it is expected that industry will not be affected by the amendments to the schedules; therefore, no costs to industry are expected.
Costs to researchers
It is expected that a very limited number of researchers from universities and government laboratories who may conduct research with these precursors will incur small costs to comply with the regulatory requirements. Depending on the activities being conducted, a researcher may need to submit a signed end-use declaration to the licensed dealer who provides them with these precursors. In addition, a researcher may need to apply for an authorization from Health Canada in the event they want to produce a controlled substance as part of research involving these precursors. Any associated administrative costs will be small.
Costs to Government
A small number of federal government organizations who possess a dealer’s licence under the PCR may incur administrative costs associated with submitting requests to amend their dealer’s licence and/or apply for an import permit to import reference standards for these precursors. The overall cost to these affected entities is not expected to be significant. Additional but small costs will also be incurred by Health Canada for processing these requests.
Minimal incremental costs related to compliance and enforcement activities may be incurred by Health Canada and agency partners, as small updates to guidance, training materials, etc., may be needed. Limited implementation activities such as publishing web promotional materials to raise awareness about the permanent scheduling of these precursors and responding to stakeholder inquiries will be undertaken; however, the costs associated with implementation are expected to be minimal.
Small business lens
Analysis under the small business lens concluded that these amendments to the schedules will not impact Canadian businesses, including small businesses.
One-for-one rule
Since no legitimate industrial, commercial, or medical activities associated with these precursors have been identified and no businesses have expressed interest in conducting activities with these precursors, it is expected that business will not be affected by these amendments. Therefore, the one-for-one rule does not apply, as there is no impact on business.
Regulatory cooperation and alignment
On November 23, 2022, both 4-AP and one of its derivatives, 4-anilino-1-boc-piperidine, were added to Table I of the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988 (PDF). As a signatory to these conventions, Canada is expected to take measures to ensure long-term control of, at minimum, 4-anilino-1-boc-piperidine.
Although the amendments have not been developed specifically in cooperation or to align with other jurisdictions, concerns relating to the production, distribution and use of illegal fentanyl are global. For instance, the United States has also taken steps to control certain derivatives and analogues of 4-AP. As a result, the long-term scheduling of precursors used in the illegal production of fentanyl and fentanyl analogues helps address domestic and international illegal 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, positive or negative. As a result, a strategic environmental assessment was not required.
Gender-based analysis plus (GBA+)
The amendments to the schedules are intended to prevent the availability and use of these precursors and will potentially help to mitigate the risks to public health and public safety associated with the illegal production and sale of fentanyl on a long-term basis. According to currently available information, it is not possible to determine the extent to which these novel fentanyl precursors are being used in the illegal production of fentanyl and fentanyl precursors in Canada.
The presence of fentanyl and fentanyl analogues in the toxic illegal drug supply has been a main driver of the overdose crisis in Canada. It is worth noting that certain populations have been disproportionately impacted by the overdose crisis in Canada, including men aged 20 to 59, Indigenous and racialized populations, and persons experiencing homelessness or poverty, dealing with chronic pain, and with underlying mental health conditions. That said, there is no evidence suggesting that these amendments will result in any behavioural changes by the affected individuals or have any potential for disproportionate impacts to any subgroups based on sex/gender or any other socioeconomic characteristics.
Implementation, compliance and enforcement, and service standards
Implementation
The Order and regulatory amendments come into force on August 30, 2023, preventing a lapse in scheduling under the CDSA following the expiration of the temporary Ministerial Order. This transition provides sufficient time for stakeholders to apply for authorizations (i.e. licence or permit) under the CDSA and the PCR, as needed.
Upon publication in the Canada Gazette, Part II, Health Canada will notify stakeholders, including Canadian producers, distributors and sellers of fentanyl, federal and other law enforcement partners, and federal laboratories of the changes. The Department will also reply to stakeholder inquiries as needed.
Compliance and enforcement
Health Canada is responsible for authorizing (through licences, permits, and exemptions) legitimate activities with substances scheduled under the CDSA and its regulations and for monitoring compliance with regulatory requirements.
The CBSA supports compliance monitoring for controlled substances and precursors at the border. Federal, provincial and local law enforcement are responsible for taking enforcement action in response to contraventions of the CDSA and its regulations. Under the CDSA, a range of penalties apply to the offences associated with the precursors covered by these regulatory amendments. The maximum penalty for indictable offences with respect to substances in Schedule VI to the CDSA is imprisonment for a term not exceeding 10 years.
Service standards
No additional service standards are being created. Service standards already exist for issuing licences and permits under the CDSA.
Contact
Office of Legislative and Regulatory Affairs
Controlled Substances Directorate
Health Canada
Email: csd.regulatory.policy-politique.reglementaire.dsc@hc-sc.gc.ca