Vol. 151, No. 25 — December 13, 2017

Registration

SOR/2017-249 November 24, 2017

CONTROLLED DRUGS AND SUBSTANCES ACT

P.C. 2017-1429 November 23, 2017

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to section 60 of the Controlled Drugs and Substances Act (see footnote a), deeming that it is necessary in the public interest, makes the annexed Order Amending Schedule III to the Controlled Drugs and Substances Act (Aminorex).

Order Amending Schedule III to the Controlled Drugs and Substances Act (Aminorex)

Amendments

1 Item 18 of Schedule III to the Controlled Drugs and Substances Act (see footnote 1) is repealed.

2 Item 27 of Schedule III to the Act is replaced by the following:

Coming into Force

3 This Order comes into force on the day on which it is published in the Canada Gazette, Part II.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Order or the Regulations.)

Issues

The World Health Organization has identified the new psychoactive substance (NPS) 4,4′-Dimethylaminorex (4,4′-DMAR) as a substance warranting control. In 2016, it was added to the list of psychotropic substances under the Convention on Psychotropic Substances of 1971. As a Party to this Convention, Canada is proceeding to control 4,4′-DMAR.

NPS such as 4,4′-DMAR are substances with psychoactive effects in humans that may pose a threat to public health. In recent years, there has been a significant increase in the emergence of NPS that mimic the effects of existing controlled substances and are created to circumvent drug control legislation. The continued growth of the global NPS market has created a need for Health Canada to adopt a proactive approach to controlling these new substances to protect the health and safety of Canadians.

The NPS 4,4′-DMAR is an analogue of aminorex, a substance that is currently controlled under Schedule III of the Controlled Drugs and Substances Act (CDSA). Another aminorex analogue, 4-methylaminorex (4-MAR), is also controlled as a distinct item under Schedule III. Under this regulatory proposal, the listing for aminorex will be expanded to include its derivatives, isomers, and analogues, as well as the salts of those substances. Both 4-MAR and 4,4′-DMAR will be listed as analogues controlled under the aminorex class of substances. This will ensure that any NPS related to aminorex that may emerge in the future will be proactively controlled under the CDSA.

Background

The CDSA, in effect since 1997, is the means by which Canada fulfills its obligations under the Single Convention on Narcotic Drugs of 1961, Convention on Psychotropic Substances of 1971 (the 1971 Convention), and the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988. These Conventions form the basis for the current global drug control system.

The CDSA and its regulations provide a framework for the control of substances that can alter mental processes and that may cause harm to health or to society when diverted to an illicit market or used inappropriately. Its purpose is to protect public health and maintain public safety by prohibiting certain activities associated with harmful substances, while allowing access to those substances for legitimate medical, scientific and industrial purposes.

Except as authorized under its related regulations, certain activities (i.e. possession, possession for the purposes of trafficking, trafficking, importation, exportation, possession for the purposes of exportation, and production of controlled substances) are prohibited under the CDSA. The CDSA also specifies the range of penalties associated with the conduct of illegal activities with controlled substances, and authorizes the Governor in Council to make regulations. The CDSA also gives the Governor in Council the authority to amend the schedules to the CDSA by order, provided that such amendments are in the public interest.

Part G of the Food and Drug Regulations (FDR) governs the activities of producers, distributors, importers, exporters, pharmacists, practitioners and hospitals, including possession, sale, distribution, importing, exporting, and production of substances listed in the Schedule to these Regulations referred to as “controlled drugs” such as stimulants, sedatives, and anabolic steroids.

Part J of the FDR regulates the use of controlled substances with no recognized medical use listed in the Schedule to the Regulations. These substances are defined as “restricted drugs” can only be used for scientific and research purposes.

Evidence indicates that the problematic use of 4,4′-DMAR poses a threat to human health. Clinical observations include hyperthermia (i.e. abnormally high fever), pupil dilation, muscular spasm, seizure, increased perspiration, cardiac and respiratory arrest, foaming at the mouth, breathing problems, agitation, confusion, unconsciousness and paranoia. Current research suggests that there is potential for 4,4′-DMAR misuse and addiction. All reports of 4,4′-DMAR use indicate that the substance is used solely for recreational purposes. There are currently no known legitimate therapeutic or industrial uses for this substance.

The European Monitoring Center for Drugs and Drug Addiction in its 2015 European Drug Report, presented the results of a formal risk assessment of 4,4′-DMAR. The substance had been detected in 31 deaths in Hungary, Poland and the United Kingdom over a 12-month period. There are indications that the users did not intentionally buy 4,4′-DMAR on the street market, but that the substance was present in combination with other drugs purchased (predominantly stimulants).

In February 2015, the United Kingdom classified 4,4′-DMAR as a Class A drug under Part 1 of Schedule 2 of the Misuse of Drugs Act 1971, the main law to control and classify drugs that are “dangerous or otherwise harmful” when misused. Class A captures drugs that are considered to be the most likely to cause harm. 4,4′-DMAR was also subjected to control measures across the European Union through the Council Implementing Decision (EU) 2015/1873 of October 8, 2015. In January 2016, the United States issued a notice indicating its intent to control 4,4′-DMAR.

In March 2016, 4,4′-DMAR was added to Schedule II of the 1971 Convention at the 59th Commission on Narcotic Drugs in Vienna.

Objectives

The objectives of these regulatory amendments are to fulfill Canada’s international obligation under the 1971 Convention to control 4,4′-DMAR under the CDSA, and to protect the health and safety of Canadians from the risk of problematic use of related NPS that may emerge in the future.

Under this regulatory proposal, the listing for aminorex in Schedule III of the CDSA and Part G of the FDR will be expanded to include its derivatives, isomers, and analogues, as well as the salts of those substances, with 4,4′-DMAR and 4-MAR consolidated under that listing. This approach will proactively and effectively ensure that any NPS related to aminorex that may emerge in the future will be controlled under the CDSA.

Description

The regulatory amendments mainly consist of consolidating aminorex and its related substances, including 4-MAR and 4,4′-DMAR, under item 27 of Schedule III to the CDSA and item 9 of Part G to the FDR. The amendments are described in detail below.

Order Amending Schedule III to the Controlled Drugs and Substances Act

This Order expands the scope of the listing of aminorex and its salts in Schedule III to the CDSA by adding “derivatives, isomers, and analogues and salts of derivatives, isomers and analogues” to the wording of the listing.

The Order adds the analogue 4,4′-DMAR as a substance included under the aminorex listing and moves the existing item 4-MAR under that same listing. The entry for 4-MAR as a separate item in Schedule III to the CDSA is repealed. The consolidation of 4-MAR and 4,4′-DMAR under aminorex in Schedule III to the CDSA provides additional clarity to individuals or companies intending to conduct legitimate activities with the aminorex class of substances.

Regulations Amending the Food and Drugs Regulations (Parts G and J)

The Regulations expand the scope of the listing of aminorex and its salts in Part G to the FDR by adding “derivatives, isomers, and analogues, and salts of derivatives, isomers and analogues” to the wording of the listing.

The Regulations also consolidate the entries under aminorex and its analogues by listing 4-MAR and 4,4′-DMAR as substances included under the aminorex listing in Part G to the FDR. As a result, 4-MAR is repealed from Part J to the FDR. This consolidation also provides clarity to individuals or companies who intend to conduct legitimate activities with the aminorex class of substances.

“One-for-One” Rule

These regulatory amendments may impose administrative costs on two identified companies currently offering 4,4′-DMAR for sale. The increase in administrative burden will be associated with time spent preparing and submitting a licence application (up to 4 hours) and subsequent annual renewal applications (1.5 hours) or a licence amendment (0.75 hour); acquiring information such as criminal record checks and education credentials (at a unit cost of $70 and $40, respectively) for designated employees; and undertaking record keeping and reporting of incidences of losses and thefts (0.75 hour).

One of the two companies is already a licensed dealer and would incur costs to have its licence amended to include 4,4′-DMAR and/or any derivatives, isomers and analogues and salts of the derivatives, isomers and analogues of aminorex with which it intends to conduct activities.

The one-time administrative burden cost to this company to prepare an amendment package is estimated to be less than $40.

Additional administrative burden costs to these two companies with regards to import and/or export permit applications may be incurred if they intend to import and/or export 4,4′-DMAR or the derivatives, isomers and analogues and salts of the derivatives, isomers and analogues of substances of the aminorex class. There is no information indicating that these substances were imported or exported in the past and no reasonable assumption can be made with regards to the number of potential import or export permit applications, if any, that may be submitted in the future. Given these limitations, the potential administrative burden cost that may be incurred was not considered in the cost estimates. (see footnote 2)

Assuming an employee in the natural or applied science field would be filling out these application forms at an average cost of $48 per hour, the total administrative burden cost to the companies (estimated over 10 years, from 2017–2026, and discounted to 2012 using a 7% discount rate) would amount to $1,960 (2012 dollars) or an annualized value of $280. This incremental administrative cost would be incurred mainly by the currently unlicensed business.

Given this increase in administrative burden costs, the “One-for-One” Rule applies and the amendments are considered an “IN” under the Rule.

Small business lens

Since the only two known companies identified as conducting business with 4,4′-DMAR are considered medium/large businesses, the small business lens does not apply.

Consultation

Affected and interested parties were consulted during the development of the proposed regulatory amendments in order to provide them with opportunities to comment.

On December 24, 2016, Health Canada published a Notice to Interested Parties in the Canada Gazette, Part I, to notify stakeholders and the general public regarding this regulatory initiative. No comments were received.

Rationale

These regulatory amendments will fulfill Canada’s international obligations under the 1971 Convention by controlling 4,4′-DMAR under Schedule III of the CDSA under the aminorex class of substances with its salts, derivatives, isomers and analogues and the salts of derivatives, isomers and analogues. This approach will also help to protect Canadians from potential health and safety risks that may be posed by new aminorex-related substances by proactively controlling those substances before they emerge.

Aminorex has possible therapeutic applications. It is therefore reasonable to expect that 4,4′-DMAR and 4-MAR, which are analogues of aminorex, may potentially have similar applications in the future. The inclusion of 4,4′-DMAR and 4-MAR in Part G to the FDR would therefore allow for legitimate activities to be conducted, should potential therapeutic applications emerge.

It is expected that regulating the aminorex class of substances, their salts, derivatives, isomers and analogues, and the salts of derivatives, isomers and analogues under the CDSA will limit their availability and will prevent potential cases of misuse and negative health incidents associated with these substances, including intoxication and death.

Impacts on businesses

Of the two companies currently supplying 4,4′-DMAR in Canada, one is already a licensed dealer and will need to have its licence amended and the other company will need to become a licensed dealer in order for them to continue supplying 4,4′-DMAR, including the derivatives, isomers and analogues (as well as the salts of the derivatives, isomers and analogues) of aminorex, 4-MAR and 4,4′-DMAR. Meeting the licensing requirements will result in both compliance and administrative costs to the unlicensed company, and in administrative costs to the licensed company.

Compliance costs

The unlicensed company will bear costs associated with the payment of fees for licence renewal as well as other costs associated with acquiring and installing physical security measures at its facility. The present value of these compliance costs (estimated over 10 years and using a 7% discount rate) amounts to $49,620.

Administrative costs

Additional administrative costs related to preparing licence application and licence renewal packages, acquiring additional information such as criminal record checks and education credentials, as well as conducting record keeping and reporting of incidences of losses and thefts will be incurred by the unlicensed company while the licensed company will incur a small one-time administrative cost of less than $40 to have its licence amended. The total administrative cost over the period of analysis will amount to about $2,750 (2012 dollars) or $390 annually. This cost would be incurred mainly by the currently unlicensed company.

There may also be additional ongoing administrative costs to all companies to prepare and submit import and/or export permit applications if they intend to import and/or export these substances, in addition to the cost to prepare and submit their licence applications. The department is not aware of any import or export of these substances in the past and the likelihood of this happening in the future is unknown. As a result, potential costs associated with import or export of these substances have not been estimated for the purpose of this impact analysis.

Impacts on researchers

Researchers intending to use these substances for research purposes are required to be exempted under Section 56 of the CDSA. There are no fees associated with applying for an exemption, however, applicants will incur costs to prepare and submit applications. Health Canada is not aware of any research activities involving the derivatives, isomers and analogues (as well as their salts) of aminorex, 4-MAR and 4,4′-DMAR. Therefore, the costs to researchers were not estimated.

Impacts on the government

No additional costs are expected to be incurred by the Government of Canada. Compliance promotion and enforcement in relation to these amendments will be undertaken as part of current activities under the CDSA and no additional resources will be required.

Total cost

Overall, the present value of the total compliance and administrative cost of these amendments over a 10-year period will amount to $52,370 or $7,460 annually.

Implementation, enforcement and service standards

Coming into force

The Order and the Regulations come into force on the date of their publication in the Canada Gazette, Part II. As part of the implementation of the amendments, Health Canada will notify stakeholders of the changes and provide additional information on the Department’s website.

Enforcement

Health Canada is responsible for issuing authorizations (e.g. licences, permits and exemptions) for 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 involve the application of a fine and/or a term of imprisonment. For certain offences (i.e. 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.

Service standards

There are no additional service standards other than those that already exist for issuing licences and permits under regulations made under the CDSA.

Contact

Louise Lazar
Healthy Environments and Consumer Safety Branch
Health Canada
Main Stats Building
150 Tunney’s Pasture Driveway
Ottawa, Ontario
K1A 0K9
Email: OCS_regulatorypolicy-BSC_politiquereglementaire@hc-sc.gc.ca