Schedule VI to the Controlled Drugs and Substances Act - Order Amending
Vol. 139, No. 25 December 14, 2005
Registration SOR/2005-364 November 21, 2005
CONTROLLED DRUGS AND SUBSTANCES ACT
Order Amending Schedule VI to the Controlled Drugs and Substances Act
P.C. 2005-2109 November 21, 2005
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 , deeming that it is necessary in the public interest, hereby makes the annexed Order Amending Schedule VI to the Controlled Drugs and Substances Act.
ORDER AMENDING SCHEDULE VI TO THE CONTROLLED DRUGS AND SUBSTANCES ACT
Item 17 of Part 1 of Schedule VI to the Controlled Drugs and Substances Act is replaced by the following:
Safrole (5-(2-propenyl)-1,3-benzodioxole) and any essential oil containing more than 4% safrole
Part 1 of Schedule VI to the Act is amended by adding the following after item 17:
Hypophosphorous acid, its salts and derivatives
Note 1 to Part 2 of Schedule VI to the French version of the Act is replaced by the following:
1 Sont compris parmi les précurseurs de catégorie B les formes synthétiques de ceux-ci.
Item 1 of Part 3 of Schedule VI to the Act is replaced by the following:
Any preparation or mixture that contains a precursor set out in Part 1, except items 20 to 23, or in Part 2.
COMING INTO FORCE
(1) Subject to subsection (2), this Order comes into force on the day on which it is registered.
(2) Sections 2 and 4 of this Order come into force on January 31, 2006.
REGULATORY IMPACT ANALYSIS STATEMENT
(This statement is not part of the Order.)
The purpose of this initiative is to amend Schedule VI to the Controlled Drugs and Substances Act (CDSA) and the Precursor Control Regulations (PCR) to strengthen the regulatory framework and minimize any negative impact of the Regulations on the legitimate trade of precursors. Among other things, the amendments will add six substances to Schedule VI to the CDSA and the PCR: gamma butyrolactone (GBL), 1,4 butanediol (BDO), red phosphorus, white phosphorus, hypophosphorous acid, and hydriodic acid.
The CDSA prohibits the import, export, and possession for export of precursors, except as authorized by regulation. It also provides the authority to develop regulations governing, controlling, limiting, authorizing the importation into Canada, exportation from Canada, production, packaging, sending, transportation, delivery, sale, provision, administration, possession, or obtaining of, or other dealing in any precursor or any class thereof. Contravention of the Regulations is an offence under section 46 of the CDSA.
The PCR, which came into force between January 2003 and January 1, 2004, provide a regulatory framework for the control and monitoring of precursor chemicals frequently used in the clandestine production of illicit drugs. These Regulations enable Canada to fulfill its international obligations under the United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988 (1988 Convention).
There are two classes of precursors under the PCR: Class A and Class B. Class A precursors are essential components of illicit substances such as methamphetamine, MDMA (ecstasy), cocaine, heroin, LSD, and PCP. Class B precursors are mostly solvents and reagents used in clandestine manufacturing processes.
The PCR include: a licence and permit scheme for import and export of Class A precursors; a licence requirement for the production, packaging and sale of Class A precursors; a registration and export permit scheme for Class B precursors; and, general record keeping and reporting requirements for both Classes. The Regulations also include a scheme to exempt mixtures or preparations of precursor chemicals that have been demonstrated to pose little risk of diversion to clandestine laboratories.
Most of the precursors listed in these Regulations have a wide legitimate use in common products such as pharmaceuticals, fragrances, flavouring agents, petroleum products and paints. The Regulations must enable Canada to fulfill its international obligations and address domestic needs to control precursors, while at the same time, remain sensitive and responsive to the licit uses of these chemicals.
When the PCR were published in the Canada Gazette, Part II, in October 2002, the Government committed to an ongoing assessment of the legitimate use and diversion of precursors in Canada and to further development of effective regulatory policy and enforcement strategies. The Government now has over two years of experience with this new regulatory framework. Over this period, Health Canada and stakeholders have identified several issues which can only be effectively resolved through amendment of the Regulations.
Information obtained from law enforcement agencies and drug analysis laboratories at Health Canada have highlighted the need to bring six new substances under the CDSA and the PCR framework due to their extensive use in the illicit manufacture of methamphetamine, sometimes referred to as "crystal meth", and another controlled drug, gamma hydroxybutyrate (GHB), commonly known as the "date rape" drug. The growing trend regarding the illicit use and production of methamphetamine has been well documented. The harms associated with the illicit use and production of methamphetamine can be found in the Regulatory Impact Analysis Statement (RIAS) published in the Canada Gazette, Part II, Vol. 139, No. 17 on August 24, 2005 (http://canadagazetteducanada.gc.ca). In recent years, law enforcement have discovered increased activity regarding the illicit production of GHB. This was demonstrated through the interception of Internet sales of GHB kits (which includes the precursor chemical GBL) from Québec and Ontario.
Law enforcement agencies have identified the need for changes to the regulatory framework which will enhance their ability to detect and take appropriate action when diversion of precursors to the illicit manufacture of controlled drugs is identified. Similarly, Health Canada has identified the need for better tools to assess applications for a licence and to take administrative action in cases where non-compliance with the Regulations is noted.
Industry stakeholders have drawn Health Canada's attention to instances where the PCR have imposed an unnecessary regulatory burden by extending the control framework to certain legitimate trade practices and to certain preparations of precursor chemicals which pose a very low risk of diversion of these substances for use in clandestine laboratories.
Amendments to Schedule VI to the Controlled Drugs and Substances Act and the Schedules to the Precursor Control Regulations
Addition of GBL and BDO to Parts 1 (Class A) and 3 (Preparations) of Schedule VI of CDSA and the PCR
GBL and BDO are chemical and metabolic precursors used in the illicit production of the controlled substance GHB. GHB is a central nervous system depressant which is listed in Schedule III to the CDSA and Part G to the Food and Drug Regulations (FDR). GHB has legitimate medical uses to treat alcohol withdrawal and narcolepsy. Since the publication of this regulatory initiative in the Canada Gazette, Part I, a Notice of Compliance has been issued pursuant to section C08.004 of the FDR for GHB under the brand name Xyrem, for the treatment of cataplexy in patients with narcolepsy. However, the drug is not yet marketed in Canada.
Over the past years, GHB has increasingly become a substance of abuse in clubs and at all-night dance parties. It has become known as a "date rape drug" and implicated in a number of sexual assault cases. GHB is abused for its ability to produce euphoric and sedative effects, as well as for its alleged role as a growth hormone. Canadian law enforcement agencies and drug analysis laboratories at Health Canada have identified GBL and BDO being used for the illicit manufacture of GHB in clandestine laboratories. Both these substances have also been promoted and sold in the US in dietary supplements with claims, albeit unsubstantiated, to build muscles, improve physical performance, enhance sex, reduce stress and induce sleep.
BDO and GBL are unique precursors because when ingested they are rapidly converted to GHB within the body. Both substances can also be used in a laboratory environment to produce GHB. GBL can easily be converted to GHB with the addition of an alkali; however, the conversion of BDO to GHB is more complex. GBL and BDO are considered essential precursors to GHB since they cannot be easily substituted.
While GBL and BDO are not included in the 1988 Convention, a number of countries have elected to impose stricter controls over these substances because of their illicit use in the synthesis of GHB. GBL is explicitly controlled as a List I Chemical under the Controlled Substances Act (CSA) in the United States; both GBL and BDO are also interpreted to be analogues of GHB under the CSA. GBL and BDO are on the voluntary monitoring list of the Drug Precursors Committee of the European Commission.
Both GBL and BDO have a wide range of industrial uses. GBL is used as a solvent in detergents, air fresheners, sun lotions, printing inks, household cleaners, paint removers; as a chemical intermediate for herbicides and insecticides and in photochemical etching. BDO is used as an intermediate for the chemical and textile industries, as an industrial solvent in the manufacture of polyurethanes and thermoplastics; and in the production of cellular plastics, thermoplastic polyesters, hot-melt adhesives and plasticisers. Most of these preparations have a low risk of diversion because GBL or BDO cannot be readily extracted or otherwise used in the illicit production of GHB. To minimize undue regulatory burden on industry, it is proposed that certain activities involving GBL and BDO be exempted from the requirements of the PCR under...
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