Vol. 136, No. 26 — June 29, 2002

International Boundary Waters Regulations

Statutory Authority

International Boundary Waters Treaty Act

Sponsoring Department

Department of Foreign Affairs and International Trade

REGULATORY IMPACT ANALYSIS STATEMENT

Description

Amendments to the International Boundary Waters Treaty Act provide for the first time the making of regulations.

The Regulations are necessary for the implementation of the amended Act, which: (a) establishes a licencing system for projects affecting waters running along the Canada-United States boundary and rivers flowing into Canada, and (b) prohibits out-of-basin removals from those boundary waters.

The Regulations outline the information that is to be included in a licence application and oblige the Minister of Foreign Affairs to include applicable conditions in a licence. The Regulations also elaborate on the prohibition contained in the Act by:

— limiting the prohibition to removals of waters in bulk;

— defining bulk water removals as any removals that exceed 50 000 litres per day or removals by diversion; and

— defining the water basins to which the removal prohibition applies.

The Regulations ensure that minor removals that may technically fit within the prohibition are excluded from its application for health, safety and humanitarian reasons. These include ballast water, water used for people or goods aboard a conveyance or for the operation of the conveyance, and water used for firefighting or humanitarian purposes. The Regulations make clear that the prohibition applies to both treated and untreated water but does not apply to water contained in manufactured products leaving the basin, including beverages in bottles or packages.

Alternatives

The Regulations limit the boundary water removal prohibition to bulk water removals. To set the definition of bulk removal below 50 000 litres per day, about the capacity of a tanker truck and trailer, would involve the federal government in the control of small water projects that are better left to the provinces. Provinces have legislation or regulations or are in the process of passing legislation or regulations that prohibit lower level water removals. To set the definition higher might permit bulk removal from boundary waters, contrary to a key purpose of the amended Act.

The descriptions of the water basins (Great Lakes — St. Lawrence, Hudson Bay and Saint John — St. Croix) are necessary to implement the prohibition against water removals, since an offence is committed in respect of removals beyond the limits of the water basins where the boundary water are located. Large basin areas are used so as not to interfere unnecessarily with provincial control and regulation of water within a province. There are no water basins described west of the Lake of the Woods because there are no significant boundary waters in that area of Canada, at least not significant enough for a bulk water removal project.

The obvious exceptions to water removals are covered. Should others arise, it is expected that the Regulations would be amended. In clarifying the meaning of bulk water removals, water contained in products manufactured in the basin is excluded as these products have traditionally not been addressed by the Boundary Waters Treaty.

Benefits and Costs

Benefits for proponents of projects include the information requirements to apply for a licence and the advance knowledge that bulk removals of boundary waters out of designated water basins will not receive licences.

An aim of the Regulations is to maintain the traditional approach to the review of projects in boundary and transboundary waters, in the sense that only major projects such as dams, bridges, diversions and tanker traffic are reviewed by the Government and the International Joint Commission (IJC). In this context, there should not be any new major costs associated with the implementation of the Boundary Waters Treaty.

Consultation

Provinces and territories, especially those containing boundary and transboundary waters have been consulted on two occasions. Suggested improvements were incorporated and explanations and reassurances provided about the scope and implications of the Regulations. Provinces with large boundary waters were pleased that the control of minor water removals was left to the provinces while the federal government provided a backstop for bulk removals, i.e. removals of more than 50 000 litres per day and diversions.

Questions were raised as to whether removals or projects obtaining provincial environmental approvals could be exempt from the application of the Act. It was explained that the Boundary Waters Treaty contained obligations between Canada and the United States and that provincial approval could not override or bypass these federal obligations. However, it was pointed out that federal/provincial arrangements might be developed under the Act (section 20) to reduce red tape, such as duplicate environmental assessments.

The IJC and the US State Department have been consulted on the development of the amended legislation and regulations. While the Canadian section of the IJC indicated a preference for the federal government to submit a project to the IJC without prejudice to its possible approval, the IJC acknowledged that the Boundary Waters Treaty provisions require independent approvals by both the IJC and the Canadian government before a project subject to the Treaty can proceed in our territory. It should be noted that the amended legislation and the regulations are consistent with the Final Report to the Governments of Canada and the United States on the Protection of the Waters of the Great Lakes by the IJC (February 2000). That Report was developed after substantial public and expert consultation throughout the Great Lakes region.

A draft of the Regulations was submitted to Parliament as background information before review of Bill C-6 by the relevant House and Senate Committees.

Compliance and Enforcement

Persons will not be considered for licences, licence renewal or amendment until they fulfill the information requirements contained in the Regulations. If persons proceed with projects covered by the Act in a way that is not in accordance with a required licence, or if the project is prohibited by the Act, they are subject to the penalties contained in section 22. These include fines of up to $1,000,000 and/or up to three years in prison for each day a contravention continues. This level of punishment is consistent with serious environmental or fisheries offences.

Additional fines can be imposed to confiscate any monetary benefits received over and above the level of fines imposed (section 23). Injunctions can be ordered by courts to prevent actions directed towards the commission of an offence (section 26) and ministerial orders can require removal of works or the stopping of prohibited uses of boundary waters (section 19).

Inspection of projects that may fall under the jurisdiction of this Act are expected to be carried out by existing mechanisms in place, to identify violations of environmental, fisheries and navigation enactments.

Contact

Peter Fawcett, Deputy Director, US Transboundary Division, Department of Foreign Affairs and International Trade, 125 Sussex Drive, Ottawa, Ontario K1A 0G2, (613) 944-6911 (Telephone), (613) 943-2423 (Facsimile), peter.fawcett@dfait-maeci. gc.ca (Electronic mail).

PROPOSED REGULATORY TEXT

Notice is hereby given that the Governor in Council, pursuant to section 21 (see footnote a)  of the International Boundary Waters Treaty Act, proposes to make the annexed International Boundary Waters Regulations.

Interested persons may make representations with respect to the proposed Regulations within 75 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Peter Fawcett, Deputy Director, United States Transboundary Division, Department of Foreign Affairs and International Trade, 125 Sussex Drive, Ottawa, Ontario K1A 0G2.

Ottawa, June 20, 2002

EILEEN BOYD

Assistant Clerk of the Privy Council

INTERNATIONAL BOUNDARY WATERS REGULATIONS

INTERPRETATION

1. The definitions in this section apply in these Regulations.

"Act" means the International Boundary Waters Treaty Act. (Loi)

"non-commercial project" means a project involving the removal of boundary waters in bulk in which no one is required to pay for the waters. (projet non commercial)

2. (1) In these Regulations, "removal of boundary waters in bulk" means the removal of water from boundary waters and taking the water, whether it has been treated or not, outside the water basin in which the boundary waters are located

(a) by any means of diversion, including by pipeline, canal, tunnel, aqueduct or channel; or
(b) by any other means by which more than 50,000 L of boundary waters are taken outside the water basin per day.

(2) The removal of boundary waters in bulk does not include taking a manufactured product that contains water, including water and other beverages in bottles or packages, outside a water basin.

LICENCES

3. An application for a licence or for the renewal or amendment of a licence must be submitted to the Minister and contain the following information:

(a) the name and address of the applicant;
(b) a description of the intended project;
(c) a description of the place where the project is to be located and the waters it will likely affect;
(d) if the project involves the use, obstruction or diversion of boundary waters and the project requires a licence under subsection 11(1) of the Act, a description of the increase or decrease in the natural flow or level of the boundary waters on the other side of the international boundary that would be caused by the project;
(e) if the project consists of the construction or maintenance of any remedial or protective work, dam or other obstruction in waters flowing from boundary waters, or in downstream waters of rivers flowing across the international boundary and the project requires a licence under subsection 12(1) of the Act, a description of the increase in the natural level of waters on the other side of the international boundary that would be caused by the project;
(f) a concise economic analysis of the direct and indirect benefits and costs of the project;
(g) a concise environmental analysis of the project that includes a description of the measures to be taken to protect the integrity of the ecosystem in which the project is located;
(h) a copy of any permit or other authorization issued in respect of the project; and
(i) any other details concerning the project that indicate how the project would be compatible with the management of the resources, environment and economy of Canada.

4. The licence must include the conditions to which the licence is subject.

WATER REMOVAL

5. Subsection 13(1) of the Act applies only in respect of the Canadian portion of the following water basins:

(a) Great Lakes - St. Lawrence Basin, which is the area of land from which water drains into the Great Lakes or the St. Lawrence River;
(b) Hudson Bay Basin, which is the area of land from which water drains into Hudson Bay; and
(c) Saint John - St. Croix Basin, which is the area of land from which water drains into the St. John River or the St. Croix River.

6. (1) Subsection 13(1) of the Act does not apply to the removal of boundary waters other than the removal of boundary waters in bulk.

(2) Despite subsection (1), subsection 13(1) of the Act does not apply to boundary waters used in a conveyance, including a vessel, aircraft or train,

(a) as ballast;
(b) for the operation of the conveyance; or
(c) for people, animals or goods on or in the conveyance.

(3) Despite subsection (1), subsection 13(1) of the Act does not apply to boundary waters used in a non-commercial project on a short term basis for firefighting or humanitarian purposes.

COMING INTO FORCE

7. These Regulations come into force on the day on which An Act to amend the International Boundary Waters Treaty Act, chapter 40 of the Statutes of Canada, 2001, comes into force.

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Regulations Amending the Food and Drug Regulations (Schedule F)

Statutory Authority

Food and Drugs Act

Sponsoring Department

Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

Description

The main purpose of these amendments is to add three drugs, zaleplon, zolpidem, and zopiclone, to the list of substances controlled under the Controlled Drugs and Substances Act (CDSA) and the Benzodiazepines and Other Targeted Substances Regulations (1091) (Targeted Substances Regulations). Zolpidem and zoplicone are currently listed in Schedule F of the Food and Drug Regulations. Zaleplon is not yet scheduled.

Zaleplon, zolpidem and zopiclone belong to a class of drugs referred to as non-benzodiazepine hypnotics. They are used in the short-term treatment and symptomatic relief of insomnia in patients who have difficulty falling asleep. While zaleplon, zolpidem, and zopiclone have a chemical structure that is unrelated to the benzodiazepines, they have similar pharmacological properties. Clinical studies have indicated that these drugs also have an abuse potential comparable to benzodiazepine and benzodiazepine-like hypnotics among known sedative users. Based on these findings, the World Health Organization (WHO) recommended that zolpidem be controlled in the same manner as the benzodiazepines and placed in Schedule IV of the United Nations Convention on Psychotropic Substances, 1971 (71 Convention). Zolpidem was added to Schedule IV of the 71 Convention in December 2001. In a number of other countries, all three of these drugs are regulated as controlled substances due to their potential for abuse or misuse.

These proposed amendments will bring the scheduling of zolpidem in Canada in line with the requirements of the 71 Convention. Although zaleplon and zopiclone are not presently listed in the 71 Convention, the same scheduling is proposed for them because of the similarities in the pharmacological profiles and abuse liability of the three drugs.

The Legislative Framework

The control measures for substances listed in Schedule IV of the CDSA and in the schedules to the Targeted Substances Regulations are more stringent than for drugs regulated under the Food and Drugs Act (FDA) and Schedule F to the FDR. The FDA and FDR ensure the safety, efficacy, and quality of drug products offered for sale in Canada. Listing on Schedule F requires that the drug can only be provided to patients upon receipt of a prescription. Approved drugs containing controlled substances that are subject to abuse must meet the added requirements of the CDSA and its related Regulations to allow for closer monitoring of their use and to reduce the risk of abuse and diversion to illicit uses.

A symbol must be added to the label of controlled drug products to identify them as controlled substances. Like Schedule F drugs, most controlled drugs can only be dispensed to patients upon receipt of a prescription. Movement to the schedules of the Targeted Substances Regulations adds several requirements to minimize the risk of diversion. Manufacturers and wholesalers must be licenced to manufacture, import, export or distribute these drugs and obtain a permit for each shipment that is imported or exported across Canadian borders. Additional controls and security measures are imposed with respect to the storage and distribution of these drugs and responsible persons at licenced dealer sites are subject to criminal record checks. Readers are directed to the Benzodiazepines and Other Targeted Substances Regulations (1091) available on the Department of Justice Web site (http://laws.justice.gc.ca/en/C-38.8/SOR-2000-217/text.html) and the Information Bulletins for the Regulations on Benzodiazepines and other Targeted Substances on the following Health Canada Web site (http://www.hc-sc.gc.ca/hpb-dgps/therapeut/ htmleng/cds.html) for details of the administrative changes that must occur as a result of this scheduling action.

The Directive on Physical Security Requirements for Controlled Substances (Security Directive) referenced in Section 1 of the Targeted Substances Regulations establishes minimum security standards for the storage of controlled substances by licenced dealers. Most benzodiazepines are included in Appendix B, Table 1, Section F of the Security Directive. Zaleplon, zolpidem, and zopiclone will require the same security provisions as the benzodiazepines. The Security Directive will be amended to include zaleplon, zolpidem, and zopiclone in Appendix B, Table 1, Section F.

Additional Regulatory Amendments

In addition to the scheduling amendments for zaleplon, zolpidem and zopiclone, this initiative seeks to effect a few minor housekeeping amendments to the Benzodiazepines and Other Targeted Substance Regulations (1091).

The definition of "Security Directive" in section 1(1) of the Benzodiazepines and Other Targeted Substance Regulations (1091) is being updated to reflect changes since the publication of these Regulations. In July 2000, the Office of Controlled Substances (OCS) was moved within Health Canada from the Therapeutic Products Programme to the Drug Strategy and Controlled Substances Programme, Healthy Environments and Consumer Safety Branch. While OCS continues to be responsible for the update and administration of the Security Directive, the definition will now refer to the Security Directive as published by the Department. Furthermore, the December 1999 amendment date referenced in the current definition will no longer be valid with the addition of zaleplon, zolpidem, and zopiclone to Appendix B. The definition will be amended to state as amended from time to time rather than give a specific date because the Security Directive is reviewed and updated whenever new drugs are added to the schedules of the CDSA. Corresponding amendments to the Security Directive will be identified in the Regulatory Impact Analysis Statement for any future schedule amendment.

The current name of the Benzodiazepines and Other Targeted Substances Regulations (1091) will also be modified slightly. At present, the official name is the Benzodiazepines and Other Targeted Substances Regulations (1091), where the 1091 refers to the Schedule number that was associated with the Regulations while they were being developed. This amendment seeks to remove the (1091) from the name.

Alternatives Considered

In order to comply with its obligations under the United Nations Convention on Psychotropic Substances, 1971, Canada must control zolpidem in the same manner it controls the benzodiazepines. To do so, zolpidem must be moved from Schedule F of the FDR to Schedule IV of the CDSA and the schedules of the Benzodiazepines and Other Targeted Substances Regulations (1091). No other alternatives were considered for zolpidem since it is not currently sold in Canada and there is no identifiable economic impact to this scheduling amendment.

At the time zaleplon, zolpidem and zopiclone were each approved for sale in Canada, Health Canada recommended that they be scheduled and controlled in the same manner as the benzodiazepines. Zolpidem and zopiclone were placed in Schedule F of the FDR pending passage of the Benzodiazepines and Other Targeted Substances Regulations (1091) which came into effect on September 1, 2000. Three alternatives were considered with respect to scheduling of zaleplon and zopiclone prior to the selection of option 2. No other alternatives were considered.

Alternative One:

Add zaleplon to Schedule IV of the CDSA and to the Targeted Substances Regulations; leave zopiclone in Schedule F of the FDR.

Pros: Zaleplon would be scheduled in accordance with the recommendations made by Health Canada when the drug was first reviewed and approved for market. Zaleplon would be monitored and controlled in the same manner as zolpidem and the benzodiazepines giving consideration to the similarities between the pharmacological properties and abuse liability.

Cons: Zaleplon, zolpidem and zopiclone would be subject to different controls despite the similarities in their pharmacological and abuse profiles. Although anticipated, the manufacturers and distributors of zaleplon would be subject to additional requirements such as licences, permits, security measures and record keeping. The potential exists for affording a competitive advantage to the one product remaining in Schedule F in terms of somewhat easier access and handling.

Alternative Two:

Add zaleplon to Schedule IV of the CDSA and to the Targeted Substances Regulations; move zopiclone from Schedule F of the FDR to Schedule IV of the CDSA and the schedules of the Targeted Substances Regulations.

Pros: All three drugs would be monitored and controlled in the same manner giving consideration to the similarities between their pharmacological properties and abuse liability. Consistent regulatory control should simplify interpretation of the regulatory requirements for licenced dealers, pharmacists, practitioners, and hospitals and avoid the potential of affording any competitive advantage of one product over the other. All recommendations regarding scheduling made when zaleplon, zolpidem, and zopiclone were approved for sale in Canada will be implemented.

Cons: Manufacturers and distributors would be subject to additional requirements such as licences, permits, security measures and record keeping.

Alternative Three:

Add zaleplon to Schedule F of the FDR; leave zopiclone in Schedule F of the FDR.

Pros: No change to current requirements, therefore no impact on manufacturers and distributors of the two drugs.

Cons: Recommendations made regarding the scheduling of zaleplon and zopiclone at the time of approval would not be taken into consideration. The three drugs would be subject to different controls despite the similarities in their pharmacological and abuse profiles.

Benefits and Costs

These schedule amendments are predicated on the belief that increasing the monitoring and control of the use of substances with demonstrated abuse liability, and thereby reducing the opportunity for misuse and diversion, will benefit society through reductions in the health, crime and safety costs generally associated with drug abuse. This philosophy is consistent with that adopted within international treaties related to drug abuse and control.

A detailed cost analysis was not conducted in this case. The total impact of rescheduling approximately 45 benzodiazepines and other substances from Schedule F to Schedule IV of the CDSA and the Targeted Substances Regulations was characterized as low (SOR/2000-217). Consequently, the benefits to Canadians of this scheduling amendment are expected to outweigh the incremental costs associated with adding these three drugs to an already long list of controlled drugs distributed on the Canadian market.

The scheduling amendment for zolpidem is not expected to have any notable impact as this drug is not presently sold in Canada. The scheduling amendments for zaleplon and zopiclone may have an impact on a number of sectors including the general public, practitioners, pharmacists, hospitals, pharmaceutical manufacturers and distributors, law enforcement agencies, Canada Customs and Revenue Canada, and Health Canada.

General Public

The public should see little or no impact in terms of appropriate medical access to zaleplon and zopiclone by means of a prescription. The controlled status of these drugs should raise awareness of their abuse potential and benefit the public by promoting enhanced professional guidance and care in their short-term use.

Practitioners, Pharmacists, and Hospitals

In a few provinces, other health professionals such as podiatrists, midwives and nurse practitioners have authority under provincial legislation to prescribe Schedule F drugs. With these schedule amendments, only practitioners as defined under the CDSA (e.g. physicians) will be able to prescribe zaleplon and zopiclone in the short-term treatment and symptomatic relief of insomnia in patients who have difficulty falling asleep. This change should not hinder appropriate medical access to these drugs by patients and may assist prescribers in moderating use of these drugs by patients prone to abuse of hypnotics.

A small burden of additional record keeping will be required by practitioners, pharmacists and hospitals with respect to receipt, disposal, and destruction which can be easily implemented using existing systems in place for the Targeted Substances Regulations. The regulatory burden on practitioners, pharmacists, and hospitals is expected to be minimal.

Pharmaceutical Industry

All but two of the identified manufacturers of zaleplon and zopiclone in Canada are currently licenced under the Regulations to the CDSA to deal in controlled drugs, and most pharmaceutical wholesalers already deal in controlled drugs as well. These manufacturers and wholesalers therefore have experience in operating under the regulatory requirements and already have in place the appropriate systems for compliance. Manufacturers will incur a one-time cost to make the necessary labelling changes to their product. The ongoing incremental operating costs for those already licenced are not expected to be significant. The two other manufacturers may incur additional one-time costs to implement the required physical security measures and may have slightly higher incremental costs due to the new requirement to obtain a licence and renew it annually. Manufacturers may benefit from reduced liability due to the decreased potential for diversion and misuse of these drugs resulting from increased control measures. The total cost to industry is considered to be low in comparison to the overall costs of doing business and the revenues generated.

Law Enforcement Agencies

Although the quantities have been relatively small, there have been a number of reports of forgeries, thefts, losses and seizures related to illicit activities involving zopiclone. Similar reports were not identified for zaleplon or zolpidem. Placement within the Targeted Substances Regulations will allow for closer monitoring of the movement of these three drugs into and within the country. These amendments will provide law enforcement agencies with the necessary tools to take action with respect to illegal activities involving any one of the three drugs. More stringent penalties should deter any illicit traffic and abuse.

Canada Customs and Revenue Canada (CCRA)

New requirements for import and export permits for these three drugs may result in a slight increase in monitoring and enforcement costs to CCRA. Customs officers will be required to validate that shipments are in accordance with permits issued. The improved import/export documentation should facilitate detection of unauthorized shipments and subsequent enforcement activity.

Health Canada

This regulatory amendment will ensure that Health Canada, as Canada's competent authority under the 71 Convention, meets its international commitments. Further, it will facilitate Health Canada's mandate to protect the health and safety of Canadians. There may be a minimal increase in costs to Health Canada associated with the issuance of licences and permits and the conduct of inspections related to these drugs.

Consultation

On September 19, 2000, a letter of intent to proceed with the schedule amendments respecting zaleplon, zolpidem and zopiclone was sent to stakeholders including the relevant pharmaceutical manufacturers, provincial ministries of Health, provincial registrars of medicine and pharmacy, and key health and industry associations. Interested parties were given thirty days to provide comments for consideration.

Responses were received from twelve stakeholders. Most were simply requests for additional time to review the proposal in light of the then recent passage of the Targeted Substances Regulations. Two responses questioned the criteria used to determine misuse and requested further evidence of the concern for public safety in relation to these drugs. All respondents were assured that the comments received would be taken into consideration and that there would be a further comment period following prepublication in the Canada Gazette, Part I. Overall, no substantive objections to the proposal were raised.

Compliance and Enforcement

The Controlled Drugs and Substances Act and Benzodiazepines and Other Targeted Substances Regulations (1091) provide the necessary tools to monitor and control drugs with demonstrated abuse potential. These provisions will now be available to control the distribution and use of zaleplon, zolpidem, and zopiclone.

Periodic inspections and review of information required to be maintained or submitted under the Targeted Substances Regulations will be used by Health Canada to monitor compliance of licenced dealers, practitioners, pharmacists and hospitals. Customs officials will assist in monitoring compliance with requirements for import and export of these drugs. Failure to comply with the Regulations could lead to administrative sanctions such as the revocation of a licence or permit.

Enforcement tools, offences, and penalties provided under the CDSA will now be available to law enforcement agencies to combat any illegal trafficking, importation, exportation, and production of these drugs.

Coming into Force

The effective date of these amendments will be the date of registration thereof with the Clerk of the Privy Council.

Contact

Theresa Schopf, Policy and Regulatory Affairs Division, Office of Controlled Substances, Health Canada, MacDonald Building, 3rd Floor, Address Locator 3503D, 123 Slater Street, Ottawa, Ontario K1A 1B9, (613) 946-6435 (Telephone), (613) 946-4224 (Facsimile), Theresa_Schopf@hc-sc.gc.ca (Electronic mail).

PROPOSED REGULATORY TEXT

Notice is hereby given that the Governor in Council, pursuant to subsection 30(1) (see footnote b)  of the Food and Drugs Act, proposes to make the annexed Regulations Amending the Food and Drug Regulations (Schedule F).

Interested persons may make representations with respect to the proposed Regulations within 75 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Theresa Schopf, Office of Controlled Substances, Department of Health, Address Locator 3503D, Ottawa, Ontario K1A 1B9 (Fax: (613) 946-4224; e-mail: theresa_schopf@hc-sc.gc.ca).

Persons making representations should identify any of those representations the disclosure of which should be refused under the Access to Information Act, in particular under sections 19 and 20 of that Act, and should indicate the reasons why and the period during which the representations should not be disclosed. They should also identify any representations for which there is consent to disclosure for the purposes of that Act.

Ottawa, June 20, 2002

EILEEN BOYD

Assistant Clerk of the Privy Council

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (SCHEDULE F)

AMENDMENTS

1. The reference to

Zolpidem and its salts Zolpidem et ses sels

in Part I of Schedule F to the Food and Drug Regulations (see footnote 1)  is repealed.

2. The reference to

Zopiclone and its salts Zopiclone et ses sels

in Part I of Schedule F to the Regulations is repealed.

COMING INTO FORCE

3. These Regulations come into force on the day on which they are registered.

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Order Amending Schedule IV to the Controlled Drugs and Substances Act

Statutory Authority

Controlled Drugs and Substances Act

Sponsoring Department

Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

For the Regulatory Impact Analysis Statement, see Regulations Amending the Food and Drug Regulations (Schedule F).

PROPOSED REGULATORY TEXT

Notice is hereby given that the Governor in Council, pursuant to section 60 of the Controlled Drugs and Substances Act (see footnote c) , proposes to make the annexed Order Amending Schedule IV to the Controlled Drugs and Substances Act.

Interested persons may make representations with respect to the proposed Regulations within 75 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Theresa Schopf, Office of Controlled Substances, Department of Health, Address Locator 3503D, Ottawa, Ontario K1A 1B9 (Fax: (613) 946-4224; e-mail: theresa_schopf@hc-sc. gc.ca).

Persons making representations should identify any of those representations the disclosure of which should be refused under the Access to Information Act, in particular under sections 19 and 20 of that Act, and should indicate the reasons why and the period during which the representations should not be disclosed. They should also identify any representations for which there is consent to disclosure for the purposes of that Act.

Ottawa, June 20, 2002

EILEEN BOYD

Assistant Clerk of the Privy Council

ORDER AMENDING SCHEDULE IV TO THE CONTROLLED DRUGS AND SUBSTANCES ACT

AMENDMENT

1. Schedule IV to the Controlled Drugs and Substances Act (see footnote 2)  is amended by adding the following after item 24:

25. Zaleplon (3'-(3-cyanopyrazolo[1,5-a]pyrimidin-7-yl)-N-ethylacetanilide) and any salt thereof

26. Zolpidem (N,N,6-trimethyl-2-(4-methylphenyl)imidazo[1,2-a]pyridine-3-acetamide) and any salt thereof

27. Zopiclone (6-(5-chloropyrid-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-yl-4-methylpiperazine-1-carboxylate) and any salt thereof

COMING INTO FORCE

2. This Order comes into force on the day on which it is registered.

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Regulations Amending the Benzodiazepines and Other Targeted Substances Regulations (1091)

Statutory Authority

Controlled Drugs and Substances Act

Sponsoring Department

Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

For the Regulatory Impact Analysis Statement, see Regulations Amending the Food and Drug Regulations (Schedule F).

PROPOSED REGULATORY TEXT

Notice is hereby given that the Governor in Council, pursuant to subsection 55(1) of the Controlled Drugs and Substances Act (see footnote d) , proposes to make the annexed Regulations Amending the Benzodiazepines and Other Targeted Substances Regulations (1091).

Interested persons may make representations with respect to the proposed Regulations within 75 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Theresa Schopf, Office of Controlled Substances, Department of Health, Address Locator 3503D, Ottawa, Ontario K1A 1B9 (Fax: (613) 946-4224; e-mail: theresa_schopf@hc-sc.gc.ca).

Persons making representations should identify any of those representations the disclosure of which should be refused under the Access to Information Act, in particular under sections 19 and 20 of that Act, and should indicate the reasons why and the period during which the representations should not be disclosed. They should also identify any representations for which there is consent to disclosure for the purposes of that Act.

Ottawa, June 20, 2002

EILEEN BOYD

Assistant Clerk of the Privy Council

REGULATIONS AMENDING THE BENZODIAZEPINES AND OTHER TARGETED SUBSTANCES REGULATIONS (1091)

AMENDMENTS

1. The title of the Benzodiazepines and Other Targeted Substances Regulations (1091) (see footnote 3)  is replaced by the following:

BENZODIAZEPINES AND OTHER TARGETED SUBSTANCES REGULATIONS

2. The definition "Security Directive" in subsection 1(1) of the Regulations is replaced by the following:

"Security Directive" « Directive en matière de securité »

"Security Directive" means the Directive on Physical Security Requirements for Controlled Substances (Security Requirements for Licensed Dealers for the Storage of Controlled Substances) published by the Department, as amended from time to time.

3. Part 1 of Schedule 1 to the Regulations is amended by adding the following after item 11:

4. Schedule 2 to the Regulations is amended by adding the following after item 45:

COMING INTO FORCE

5. These Regulations come into force on the day on which they are registered.

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 Footnote a 

S.C. 2001, c. 40, s. 1

 Footnote b 

S.C. 1999, c. 33, s. 347

 Footnote 1 

C.R.C., c. 870

 Footnote c 

S.C. 1996, c. 19

 Footnote 2 

S.C. 1996, c. 19

 Footnote d 

S.C. 1996, c. 19

 Footnote 3 

SOR/2000-217

NOTICE:
The format of the electronic version of this issue of the Canada Gazette was modified in order to be compatible with hypertext language (HTML). Its content is very similar except for the footnotes, the symbols and the tables.

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