SOR/2016-72: Regulations Amending the Food and Drug Regulations (Part J — 2C-phenethylamines)
REGISTRATION OF FEDERAL REGULATION - VIA OIC DATABASE, PRIOR TO PART II OF THE GAZETTE
April 15, 2016
REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Regulations.) Issues The recreational use of 2C-phenethylamines and related substances (i.e. salts, derivatives, isomers and salts of derivatives and isomers of 2C-phenethylamines) has been on the rise in North America and across Europe over the past decade. Considered designer drugs, these substances are produced at a rapid ... (Click for more)
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Published on April 15, 2016
SOR/2016-72: Regulations Amending the Food and Drug Regulations (Part J — 2C-phenethylamines)
REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Regulations.) Issues The recreational use of 2C-phenethylamines and related substances (i.e. salts, derivatives, isomers and salts of derivatives and isomers of 2C-phenethylamines) has been on the rise in North America and across Europe over the past decade. Considered designer drugs, these substances are produced at a rapid pace and are readily available for sale on the Internet and at raves, nightclubs and head shops. Non-fatal and fatal effects from 2C-phenethylamines and related substances have been reported internationally in the media, and in scientific journals. Reported adverse effects include chills, nausea, anxiety, confusion, agitation, hypertension, seizures and death. (see footnote 2) , (see footnote 3) As use of these substances may lead to violent behaviour, intense hallucinations, and impairment of hand-eye coordination, they pose significant risks to the health and safety of not only the user, but also the general public. (see footnote 4) Risks are further heightened by virtue of the fact that users are unlikely to be aware of the exact dose or substance contained in such designer drugs due to inconsistent manufacturing. (see footnote 5) While one 2C-phenethylamine (2C-B) is currently controlled under Schedule III to the Controlled Drugs and Substances Act (CDSA), other 2C-phenethylamines as well as their derivatives and isomers are not. Scientific evidence indicates that these substances can be synthesized easily, (see footnote 6) , (see footnote 7) and seizures by Canadian law enforcement provide evidence that they are being abused in Canada. In addition, in March 2015, the United Nations scheduled 25B-NBOMe, 25C-NBOMe and 25I-NBOMe (which are derivatives of 2C-phenethylamines) under Schedule I to the Convention on Psychotropic Substances of 1971 (the 1971 Convention). As Canada is a party to the 1971 Convention, it is obliged to impose controls on these substances and their salts. Background 2C-phenethylamines, a class of psychoactive substances, were first synthesized and described in the 1970s. NBOMes were synthesized more recently, with their recreational use beginning around 2010 when they became available online and were reportedly sold as an alternative to lysergic acid diethylamide (LSD). 2C-phenethylamines and related substances are potent synthetic drugs having both stimulant effects at lower doses and hallucinogenic effects at higher doses. They have chemical similarities and similar psychoactive effects to other substances scheduled under the CDSA, such as methamphetamines, amphetamines, LSD, N-methyl-3,4-methylenedioxy-amphetamine (MDMA; ecstasy), and methylenedioxypyrovalerone (MDPV). However, unlike amphetamines, 2C-phenethylamines do not typically cause drug dependence or addiction. These designer drugs are available in tablet, capsule, powder, or liquid forms and are taken orally, nasally, by injection and by smoking. The United Kingdom and the United States have reported non-fatal intoxications and deaths with 2C-phenethylamines derivatives (NBOMes). (see footnote 8) Since 2008, Health Canada’s Drug Analysis Services have identified over a thousand exhibits containing 2C-phenethylamines and their derivatives. These seizures indicate a shift in recent years in the market of these substances. In 2012, the majority of the seized materials contained 2C-E, whereas since 2013, there has been a rising trend towards the availability of three 2C-phenethylamine derivatives, namely 25B-NBOMe, 25C-NBOMe and 25I-NBOMe. The number of 2C-phenethylamines and their derivatives detected in 2014 was 88, of which 70 were identified as 25B-NBOMe, 25C-NBOMe or 25I-NBOMe. These three substances (25B-NBOMe, 25C-NBOMe and 25I-NBOMe) are controlled under drug control legislation in Denmark, Israel, Russia, Sweden and in some areas of Australia (Queensland and New South Wales). In March 2015, the United Nations Commission on Narcotic Drugs scheduled these substances under Schedule I to the 1971 Convention. As a party to this Convention, Canada is required to impose controls on these substances and their salts. Health Canada is not aware of any legitimate therapeutic or industrial use for 2C-phenethylamines and related substances, and is aware of only limited scientific and research uses. The latter involves research being done to determine whether radiolabelled NBOMes can be used as tracers in positron emission tomography (PET) imaging, and as a tool to study certain nerve cells in the brain. In Canada, Health Canada identified two companies selling 2C-phenethylamines for research purposes. Objectives The objectives of these Regulations are to protect the health and safety of Canadians by imposing controls on 2C-phenethylamines and related substances (including 25B-NBOMe, 25C-NBOMe and 25I-NBOMe and their salts), while ensuring access to these substances for legitimate scientific and research purposes; and fulfill Canada’s international obligations under the 1971 Convention to impose controls on 25B-NBOMe, 25C-NBOMe and 25I-NBOMe, and their salts. Description The Order The Order adds a new entry as item 35 to Schedule III to the CDSA for 2C-phenethylamines and for salts, derivatives, isomers, and salts of derivatives and isomers, of 2C-phenethylamines, and deletes the schedule entry for 2C-B (4-bromo-2,5-dimethoxybenzeneethanamine; item 24) in Schedule III to the CDSA. The new entry in Schedule III to the CDSA prohibits activities such as possession, production, trafficking, possession for purpose of trafficking, importation and exportation and possession for the purpose of exportation of 2C-phenethylamines and of salts, derivatives, isomers, and salts of derivatives and isomers, of 2C-phenethylamines, unless authorized under Part J to the Food and Drug Regulations (FDR-J) or by an exemption issued under the CDSA. Any person conducting unauthorized activities with these substances is subject to a range of applicable penalties under the CDSA. The Regulations The Regulations add 2C-phenethylamines and salts, derivatives, isomers, and salts of derivatives and isomers of 2C-phenethylamines, to Part I of the Schedule to FDR-J to allow for research uses as well as the manufacture and sale of test kits containing these substances. Persons intending on conducting certain regulated activities (e.g. selling, importing or exporting) with 2C-phenethylamines and related substances may seek authorization to do so under FDR-J by applying for a licence or for an amendment to their existing licence. In addition, they must submit an import and/or export permit application if they intend to import and/or export 2C-phenethylamines and related substances. Researchers affiliated with institutions engaged in research on drugs intending on using 2C-phenethylamines and related substances for research purposes must, depending on their circumstances, have an authorization under FDR-J, become a licensed dealer under FDR-J or apply for an exemption under the CDSA, to obtain, possess and use these substances. “One-for-One” Rule These amendments may result in administrative costs to the two businesses selling 2C-phenethylamines or salts, derivatives, isomers, or salts of derivatives and isomers of 2C-phenethylamines, for research purposes. In order to continue selling these substances, one of the businesses will face administrative costs associated with amending its existing licence (one hour to prepare an application) and the other business will face administrative costs for applying for a new licence (up to three hours). These businesses may also incur additional administrative costs associated with submitting permit applications (30 minutes per application) if they decide to import or export these substances. Although the number of import/export permits could vary by company, it is assumed that businesses may require as many as 20 permits per year. An average cost of $41.60 per hour to fill an application is used to calculate the administrative costs, assuming an employee in the natural or applied science field would be filling out those forms. In accordance with the Red Tape Reduction Regulations, the administrative burden to businesses, assuming they will have activities with the substances, was calculated over 10 years and discounted using a rate of 7%. The present value (2012) of the total annualized incremental administrative cost to these businesses is estimated to be $792. Since the amendments will result in administrative burden, the “One-for-One” Rule applies and they are considered an “IN” under the Rule. The estimated cost will be offset by an equivalent reduction in the administrative credits available within the health portfolio. Small business lens As indicated earlier, two businesses have been identified that sell, import or export 2C-phenethylamines and related substances for research purposes. Neither of the businesses is identified as a small business. As a result, the small business lens does not apply to these scheduling amendments. Consultation On August 1, 2015, a Notice to Interested Parties was published in Canada Gazette, Part I, describing the regulatory proposal to add 2C-phenethylamines and their salts, derivatives, isomers and salts of derivatives and isomers to Schedule III to the CDSA and to the Schedule to FDR-J. (see footnote 9) A notification to this effect was also posted to the World Trade Organization Technical Barriers to Trade Web portal on August 5, 2015, for a 75-day comment period. (see footnote 10) Three submissions were received in response to the Notice to Interested Parties. One requested that the proposed substances to be scheduled be specified more clearly by using chemical nomenclature. In response, chemical nomenclature has been included in the scheduling entries. Two stakeholders expressed concerns that the proposal may render 2C-phenethylamines unavailable for research and scientific purposes. In response, it was clarified that access to these substances for scientific and research purposes will be authorized and regulated under FDR-J. No comment was received in response to the World Trade Organization notification. Rationale 2C-phenethylamines and related substances, such as NBOMes, have varying degrees of stimulant and hallucinogenic effects. Their hallucinogenic effects are similar to LSD, a controlled substance under Schedule III to the CDSA. While 2C-phenethylamines and related substances have a low potential for dependence or addiction, they nevertheless have a high potential for abuse in a manner similar to LSD. Moreover, it has been reported that they are increasingly used recreationally, and that their abuse causes serious health effects potentially leading to hospitalization and death. The fact that designer drugs containing these substances can vary in formulation and dosage further increases the risks to individuals and to the general public. The presence of 2C-phenethylamines and related substances has been detected in many countries, including Canada, though there are no known industrial or therapeutic uses for these substances. Therefore, the placement of 2C-phenethylamines and related substances in Schedule III to the CDSA is appropriate to help mitigate the risk of their availability and subsequent recreational use, thereby protecting the health and safety of Canadians. Moreover, their addition to FDR-J ensures that access for legitimate scientific and research uses is preserved. In 2015, the United Nations Commission on Narcotic Drugs scheduled three 2C-phenethylamines derivatives, namely 25B-NBOMe, 25C-NBOMe and 25I-NBOMe, under Schedule I to the 1971 Convention. As a party to the 1971 Convention, Canada has an obligation to impose controls on these substances and their salts. However, if the Schedule to the CDSA listed only these three substances, there is a risk that manufacturers and users could switch to other substances not controlled under the CDSA in the 2C-phenethylamine class as a replacement. (see footnote 11) This has been observed in Canada with the previous scheduling of 2C-B. Given the risks identified, Health Canada has determined that scheduling 2C-phenethylamines and salts, derivatives, isomers, and salts of derivatives and isomers, of 2C-phenethylamines, is more appropriate to provide greater protection to the health and safety of Canadians. These amendments also allow Canada to meet its international obligations under the 1971 Convention. These regulatory initiatives may result in costs to stakeholders, such as licensed dealers and researchers who wish to conduct activities with these substances, to comply with regulatory requirements. In the event that interested stakeholders want to enter into or continue activities with the listed substances, they would need to become licensed dealers, amend their existing licence, obtain an authorization or apply for an exemption, as the case may be, and incur the associated incremental costs, including the costs to prepare the appropriate application package and to put in place adequate security, as per regulatory requirements. These costs would include the payment of fees, acquisition and installation of physical security measures, and additional monitoring for losses and thefts. Conservatively, it is assumed that both companies currently selling 2C-phenethylamines would apply for the necessary permissions to continue selling these substances. The licensed business would need to amend its existing licence and the non-licensed business would need to bear the cost of implementing all of the regulatory requirements to become a licensed dealer. It is estimated that the present value of the total cost of these scheduling amendments would amount to $55,600 over a 10-year period and using a 7% discount rate, or an annualized cost of $8,000. This scheduling initiative is expected to result in benefits to Canadians. As indicated earlier, the recreational use of 2C-phenethylamines and related substances can result in a range of fatal and non-fatal negative health effects. These include intense hallucinations, violent behaviour, hypertension, seizures and death. Controlling activities with these substances under the CDSA will help mitigate the risk of their availability and subsequent recreational use, thereby protecting the health and safety of Canadians. Implementation, enforcement and service standards These amendments will come into force 180 days after the date of publication. This delay in coming into force will provide sufficient time for stakeholders to apply for an authorization, a licence, a licence amendment or an exemption. As part of the implementation of these amendments, Health Canada will notify stakeholders of the changes and provide additional information on the Department’s Web site. Health Canada is responsible for authorizing (for example through licences, permits, and exemptions) 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 applies 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 (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. No incremental cost is expected to be incurred by the government. There are no additional service standards other than those that already exist for issuing licences and permits under the CDSA. Contact Denis Arsenault Healthy Environments and Consumer Safety Branch Health Canada Main Statistics Canada Building 150 Tunney’s Pasture Driveway Ottawa, Ontario K1A 0T6 Email: OCS_regulatorypolicy-BSC_ [email protected] Footnote a S.C. 2015, c. 22, s. 4(1) Footnote b S.C. 1996, c. 19 Footnote 1 C.R.C., c. 870 Footnote 2 Dean, B.V., Stellpflug, S.J., Burnett, A.M. & Engebretsen, K.M. (2013) 2C or not 2C: Phenethylamine designer drug review. J. Med. Toxicol. 9:172-178. Footnote 3 EMCDDA (2014, January) EMCDDA-Europol Joint Report on a new psychoactive substance: 25I-NBOMe. Submitted to the Council of the EU, the European Commission and the EMA, Lisbon, Portugal. Footnote 4 WHO (2014, June) 25B-NBOMe, 25C-NBOMe and 25I-NBOMe Critical Review Reports. Presented at the 36th Expert Committee on Drug Dependence meeting, Geneva, Switzerland. Footnote 5 Davies, S., Wood, D.M., Smith, G., Button, J., Ramsey, J., Archer, R., Holt, H.W. & Dargan, P.I. (2010) Purchasing “legal highs” on the internet – is there consistency in what you get? Q. J. Med. 103:489-493. Footnote 6 Kyriakou, C., Marinelli, E., Frati, P., Santurro, A., Afxentiou, M., Zaami, S. & Busardo, F.P. (2015) NBOMe: new potent hallucinogens – pharmacology, analytical methods, toxicities, fatalities: a review. Eur. Rev. Med. Pharmacol. Sci. 19:3270-3281. Footnote 7 Nikolaou, P., Papoutsis, I., Stefanidou, M., Spiliopoulou, C. & Athanaselis, S. (2015) 2C-I-NBOMe, an “N-bomb” that kills with “Smiles”. Drug Chem. Toxicol. 38:113-119. Footnote 8 WHO (2014, June) 25B-NBOMe, 25C-NBOMe and 25I-NBOMe Critical Review Reports. Presented at the 36th Expert Committee on Drug Dependence meeting, Geneva, Switzerland. Footnote 9 www.gazette.gc.ca/rp-pr/p1/2015/2015-08-01/html/notice-avis-eng.php#nb4. Footnote 10 https://docs.wto.org/dol2fe/Pages/FE_Search/FE_S_S007.aspx? NotifyingCountryList=%22Canada%22&IssuingDateFrom= 01%2f08%2f2015&IssuingDateTo=31%2f12%2f2016&All TranslationsCompleted=1&Id=133712&IsFullTextFull=False&PageAnchorPosition=133712&SearchPagePageNumber=10& SearchPageCurrentIndex=5&SearchPageViewStatePageIndex= 0&SearchPageStartRowIndex=50&returnedPage=FE_S_S008.aspx&IsNotification=True&LeftTabFieldText=&NumberOfHits=91&DreReference=&AttachmentSelection=&FullTextHash= 371857150&Query=&Context=&btsType=&SearchPage=FE_S_ S003&SourcePage=FE_S_S003. Footnote 11 Zawilska, J.B. (2015) Next generation of novel psychoactive substances on the horizon – A complex problem to face. Drug Alcohol Depend. 157:1-17.
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