Vol. 135, No. 49 — December 8, 2001

Regulations Amending the Food and Drug Regulations (1251 — Schedule F)

Statutory Authority

Food and Drugs Act

Sponsoring Department

Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

Description

The Therapeutic Products Directorate of Health Canada intends to update Schedule F to the Food and Drug Regulations of the Food and Drugs Act by adding 10 substances to Part I of Schedule F and 1 substance to Part II of Schedule F.

Schedule F is a list of substances, the sale of which is controlled specifically under sections C.01.041 to C.01.046 of the Food and Drug Regulations. Part I of Schedule F lists substances which require a prescription for both human and veterinary use. Part II of Schedule F lists substances which require a prescription for human use, but do not require a prescription for veterinary use if so labelled or if in a form unsuitable for human use. The review and introduction of new drugs onto the Canadian market necessitates periodic revisions to Schedule F.

The Therapeutic Products Directorate's Drug Schedule Status Subcommittee reviews the status of chemical entities proposed for marketing. A decision regarding the necessity for prescription versus non-prescription status was made for each of the substances listed in this proposed amendment on the basis of established and publicly available criteria. These criteria include, but are not limited to, concerns related to toxicity, pharmacologic properties, and therapeutic applications.

It is proposed that the following 10 substances be added to Part I of Schedule F:

1. Basiliximab — a chimeric murine/human monoclonal antibody indicated as an adjunct agent for the prophylaxis of acute organ rejection in renal transplant patients.

2. Cabergoline and its salts — a dopaminergic agent indicated for the treatment of hyperprolactinemic disorders and inhibition of physiological lactation.

3. Clindamycin and its salts and derivatives — a semi-synthetic lincomycin derivative used as an antibiotic in dogs and cats. Currently clindamycin is included in Part II of Schedule F under Lincomycin and its salts and derivatives. Professional veterinary expertise is required to diagnose and treat dental infections and to perform corrective dental procedures.

4. Difloxacin and its salts and derivatives — a synthetic, broad spectrum antibiotic indicated for the treatment of urinary tract infections and for the treatment of skin and soft tissue infections in dogs.

5. Exemestane — a steroidal aromatase inhibitor indicated for the treatment of advanced breast cancer.

6. Ibutilide and its salts and derivatives — an antiarrhythmic agent indicated for the rapid conversion of atrial fibrillation or atrial flutter to sinus rhythm.

7. Pioglitazone and its salts — an anti-diabetic agent indicated in patients with type II diabetes mellitus not controlled by diet and exercise alone.

8. Riluzole and its salts — a benthiazole that has been shown to provide an early increase in survival in patients with amyotrophic lateral sclerosis (ALS). The manufacturer of Riluzole has received a Notice of Compliance with Conditions. The manufacturer will conduct timely, well-designed studies to verify and describe the clinical benefit of this drug. For the purposes of assuring the safe use of the drug product, the conditions under which the drug product is approved must be clearly reflected and highlighted in the product monograph and/or labelling for the product. The sponsor must also undertake to comply with any restrictions imposed by the Therapeutic Products Directorate on the advertisement of Riluzole.

9. Valrubicin and its derivatives — an anti-tumour agent indicated for the treatment of transitional cell carcinoma in situ of the bladder.

10. Zoledronic acid and its salts and derivatives — a bone metabolism regulator indicated for the treatment of tumour- induced hypercalcemia.

It is proposed that the following substance be added to Part II of Schedule F:

1. Meloxicam and its salts and derivatives — a nonsteroidal anti-inflammatory agent indicated for the symptomatic treatment of rheumatoid arthritis and painful osteoarthritis.

Alternatives

This recommended degree of regulatory control coincides with the risk factors associated with each specific substance. The review of the information filed by the sponsor of these drugs has determined that prescription status is required at this time. Advice from a medical practitioner is necessary to ensure that consumers receive adequate risk/benefit information before taking the medication.

Any alternatives to the degree of regulatory control recommended in this initiative would need to be established through additional scientific information and clinical experience.

No other alternatives were considered.

Benefits and Costs

The amendment would impact on the following sectors:

— Public

Prescription access to the drugs affected by Schedule 1251 would benefit Canadians by decreasing the opportunities for improper use, and by ensuring professional guidance and care.

— The Pharmaceutical Industry

The classification of these drugs as prescription products would limit their sale subject to the provision of the advice of a practitioner, thereby reducing misuse and decreasing liability to the manufacturer.

— Health Insurance Plans

These drugs, when assigned prescription status, may be covered by both provincial and private health care plans.

— Provincial Health Care Services

The provinces may incur costs to cover physicians' fees for services. However, the guidance and care provided by the physicians would reduce the need for health care services that may result from improper use of the drugs. The overall additional costs for health care services should therefore be minimal.

Consultation

The manufacturers affected by this proposed amendment were informed of the intent to recommend these substances for inclusion in Part I or Part II of Schedule F at the time of market approval of the drugs.

A letter to the stakeholders dated March 6, 2001, was provided by direct mail to the Pharmaceutical Issues Committee, deans of pharmacy, registrars of medicine, registrars of pharmacy, provincial deputy ministers of health, health and trade associations and other government organizations, with a 30-day comment period. This initiative was also posted on the Therapeutic Products Directorate Web site at http://www.hc-sc.gc.ca/hpb-dgps/therapeut/ zfiles/english/schedule/earlycon/sch-1251_e.pdf. One comment was received; the respondent did not have concerns.

A 30-day comment period will be provided upon prepublication in the Canada Gazette, Part I.

Compliance and Enforcement

This amendment would not alter existing compliance mechanisms under the provisions of the Food and Drugs Act and Regulations enforced by the Health Product and Food Branch Inspectorate.

Contact

Katherine Vesterfelt, Policy Division, Bureau of Policy and Coordination, Therapeutic Products Directorate, Holland Cross, Tower B, 2nd Floor, 1600 Scott Street, Address Locator 3102C5, Ottawa, Ontario K1A 1B6, (613) 957-6446 (Telephone), (613) 941-6458 (Facsimile), Kathy_Vesterfelt@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 a) of the Food and Drugs Act, proposes to make the annexed Regulations Amending the Food and Drug Regulations (1251 — Schedule F).

Interested persons may make representations with respect to the proposed Regulations within 30 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 Kathy Vesterfelt, Therapeutic Products Directorate, Department of Health, Address Locator No. 3102C5, 1600 Scott Street, 2nd Floor, Tower B, Ottawa, Ontario K1A 1B6 (tel.: (613) 957-6446; fax: (613) 941-6458; e-mail: kathy_vesterfelt@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, December 6, 2001

RENNIE M. MARCOUX
Acting Assistant Clerk of the Privy Council

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1251 — SCHEDULE F)

AMENDMENTS

1. Part I of Schedule F to the Food and Drug Regulations (see footnote 1) is amended by adding the following in alphabetical order:

Basiliximab

Basiliximab

Cabergoline and its salts

Cabergoline et ses sels

Clindamycin and its salts and derivatives

Clindamycine et ses sels et dérivés

Difloxacin and its salts and derivatives

Difloxacine et ses sels et dérivés

Exemestane

Exémestane

Ibutilide and its salts and derivatives

Ibutilide et ses sels et dérivés

Pioglitazone and its salts

Pioglitazone et ses sels

Riluzole and its salts

Riluzole et ses sels

Valrubicin and its derivatives

Valrubicine et ses dérivés

Zoledronic acid and its salts and derivatives

Acide zolédronique et ses sels et dérivés

2. Part II of Schedule F to the Regulationsis amended by adding the following in alphabetical order:

Meloxicam and its salts and derivatives

Méloxicam et ses sels et dérivés

COMING INTO FORCE

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

[49-1-o]

Seaway Property Regulations

Statutory Authority

Canada Marine Act

Sponsoring Department

Department of Transport

REGULATORY IMPACT ANALYSIS STATEMENT

Description

These Regulations deal with safety, order and the management of the Seaway and lands used in connection with the Seaway by The St. Lawrence Seaway Management Corporation (the Manager) under the Canada Marine Act (the Act).

The Act establishes a framework for the management of the St. Lawrence Seaway system. Pursuant to this framework, the Minister of Transport has entered into a long-term management agreement with a not-for-profit corporation (the Manager) that accords a major role to Seaway users to operate the Seaway system. The management agreement includes terms and conditions that the Minister considers appropriate. In addition to the power given to the Governor in Council to make regulations, the Act gives the Manager powers to control ship traffic for the purpose of promoting safe and efficient navigation and environmental protection (section 99) and to fix fees (sections 92 to 94).

Other statutes also regulate safety and the environment in the Seaway, including the Canada Labour Code, the Canada Shipping Act, the Canadian Environmental Protection Act, 1999, the Fisheries Act, the Migratory Birds Convention Act and the Transportation of Dangerous Goods Act, 1992.

The Seaway Property Regulations replace the Seaway Regulations and the Shore Traffic Regulations which will be repealed when the new Regulations come into force.

Part 1 of the Regulations deals with general safety matters, such as access to Seaway property, operation of vehicles, fire protection, emergencies and precautionary measures. It also establishes activities, such as those that are likely to jeopardize safety or health or adversely affect sediment, soil, air or water quality, which are prohibited in the Seaway and on lands used in connection with the Seaway.

Part 2 regulates the activities of the Manager itself by providing that it must take appropriate measures to mitigate any adverse results of its activities. The Manager is required to assess the impact of its marine works on navigation. The Navigable Waters Protection Act continues to apply in respect of the marine works of the private sector.

Part 3 of the Regulations provides a framework for the authorization of some of the activities that are listed in Schedule 1. If the Manager gives an authorization for an activity that has or is likely to have any of the adverse results set out in section 5, it must make the authorization subject to conditions designed to mitigate or prevent those results. The Manager can also authorize activities by means of a contract, lease or licence and must similarly specify conditions to mitigate or prevent the results set out in section 5.

Alternatives

Fully voluntary standards and lighter forms of regulatory control were considered and rejected as being inconsistent with a high level of safety and environmental protection, which is part of the objective declared in section 4 of the Canada Marine Act.

However, detailed regulations, which would avoid the need for authorization of activities, would be impractical given the complexity and diversity of user activities.

Benefits and Costs

Benefits of the Regulations include:

— a structure which establishes a national standard for safety and environmental protection in the Seaway;

— support for the Manager in the fulfilment of the management agreement with the Minister of Transport;

— a degree of flexibility which recognizes varying conditions and activities in the Seaway and on lands used in connection with the Seaway; and

— replacement of other regulations which are outdated.

The cost of compliance with the Regulations to the Manager and the users will not increase.

Environmental impact

The environmental impact of the Regulations will be positive. The Regulations prohibit some activities in the Seaway and on lands used in connection with the Seaway that are likely to result in an adverse effect on air or water quality or in nuisance or property damage. The Manager may give an authorization in respect of some other activities but, if it is uncertain or likely that the activity will have that result, the Regulations require the Manager to establish conditions designed to mitigate or prevent the result. A Strategic Environmental Assessment is available on request.

Regulatory burden

The Regulations do not impose any additional burden on users.

Consultation

There has been extensive consultation with officials of The St. Lawrence Seaway Management Corporation regarding these Regulations. Major user groups were consulted, as well government departments, and they are in agreement with these Regulations.

Compliance and Enforcement

For the purposes of the Canada Marine Act, the Minister of Transport has designated employees of the Manager as enforcement officers in respect of the Seaway and lands used in connection with the Seaway, including the Regulations. Part 4 of the Act provides enforcement officers with powers of inspection, search and seizure, detention and removal of ships and detention, sale and removal of goods. Section 126 provides that a person is guilty of an offence if the person obstructs or hinders an enforcement officer.

Section 127 of the Canada Marine Act provides that a person who contravenes the Regulations is guilty of an offence and liable to a fine of not more than $5,000, in the case of an individual, and of not more than $50,000 in the case of a corporation. It further provides, however, that no person shall be found guilty of such an offence if the person establishes that the person exercised due diligence to prevent its commission.

In addition, the federal government will rely on annual public meetings, feedback from the public and departmental monitoring programs to monitor compliance with the Regulations.

Contact

Mike Baker, Director General, Marine Policy, Place de Ville, Tower C, 25th Floor, 330 Sparks Street, Ottawa, Ontario K1A 0N5, (613) 991-3536 (Telephone), (613) 998-1845 (Facsimile), bakerm@tc.gc.ca (Electronic mail).

PROPOSED REGULATORY TEXT

Notice is hereby given that the Governor in Council, pursuant to section 98 (see footnote b) of the Canada Marine Act(see footnote c), proposes to make the annexed Seaway Property Regulations.

Interested persons may make representations to the Minister of Transport with respect to the proposed Regulations within 30 days after the date of publication of this notice. All representations must be in writing and cite the Canada Gazette, Part I, and the date of publication of this notice, and be sent to Mike Baker, Domestic Marine Policy, Transport Canada, Place de Ville, Tower C, 25th Floor, 330 Sparks Street, Ottawa, Ontario K1A 0N5 (tel.: (613) 991-3536; fax: (613) 998-1845; e-mail: bakerm@ tc.gc.ca).

Ottawa, December 6, 2001

RENNIE M. MARCOUX
Acting Assistant Clerk of the Privy Council

SEAWAY PROPERTY REGULATIONS

INTERPRETATION

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

"Act" means the Canada Marine Act. (Loi)

"allied petroleum product" means a single hydrocarbon or a mixture of hydrocarbons other than a petroleum product. It includes alcohols, glycols, thinners, solvents, organic chemicals and inks. (produit pétrolier apparenté)

"authorization" means an authorization given under Part 3. (autorisation)

"designated area" means an area designated by sign or in writing by the Manager in respect of an activity set out in column 1 of the schedule. (endroit désigné)

"fee" means a fee referred to in subsection 92(1) or (2) of the Act. (droit)

"hot work" means any work that uses flame or that may produce a source of ignition, such as heating, cutting or welding. (travail à chaud)

"Manager" means The St. Lawrence Seaway Management Corporation. (gestionnaire)

"petroleum product" means a single hydrocarbon or a mixture of at least 70% hydrocarbons, refined from crude oil, with or without additives, that is used or could be used as a fuel, lubricant or power transmitter. It includes gasoline, diesel fuel, aviation fuel, kerosene, naphtha, lubricating oil, fuel oil and engine oil, including used oil; it excludes propane, paint and solvents. (produit pétrolier)

"Seaway property" means land and other property managed, operated or used by the Manager in connection with the Seaway. (biens de la voie maritime)

APPLICATION

Where Regulations Apply

2. These Regulations apply in the Seaway and on Seaway property.

Where Regulations Do Not Apply — Navigable Waters Protection Act

3. These Regulations do not apply in respect of that aspect of a work, within the meaning of the Navigable Waters Protection Act, that involves the issuance of an approval or an opinion by the Minister under Part I of that Act to a person other than the Manager or a person acting on the Manager's behalf.

BINDING ON HER MAJESTY

4. These Regulations are binding on Her Majesty in right of Canada or a province.

PART 1

SAFETY AND ORDER IN THE SEAWAY AND ON SEAWAY PROPERTY

Prohibitions

5. Unless otherwise authorized under these Regulations, no person shall, by act or omission, do anything or permit anything to be done in the Seaway or on Seaway property that has or is likely to have any of the following results:

(a) to jeopardize the safety or health of persons in the Seaway or on Seaway property;

(b) to interfere with navigation in the Seaway;

(c) to obstruct or threaten any part of the Seaway or Seaway property;

(d) to interfere with an authorized activity in the Seaway or on Seaway property;

(e) to divert the flow of a river or stream, cause or affect currents, cause silting or the accumulation of material or otherwise reduce the depth of the waters of the Seaway;

(f) to cause a nuisance;

(g) to cause damage to ships or other property;

(h) to adversely affect sediment, soil, air or water quality; or

(i) to adversely affect Seaway operations or Seaway property.

6. No person shall, in the Seaway or on Seaway property, conduct an activity set out in column 1 of the schedule if an "X" is set out in column 4.

Access to Seaway Property

7. No person shall access any area of Seaway property unless

(a) the person accesses the area to conduct legitimate business there;

(b) the person is authorized by the Manager to access the area; or

(c) access is not restricted by a sign or in some other way such as by a fence.

Signs

8. The Manager may have signs posted for the purpose of ensuring

(a) the safety of persons and property in the Seaway or on Seaway property;

(b) the environmental protection of the Seaway or Seaway property; or

(c) the management of the marine infrastructure of the Seaway and services in connection with the operation of the Seaway in a commercial manner.

9. (1) Every person in the Seaway or on Seaway property shall obey the instructions on signs posted under the authority of the Manager unless the person is authorized by the Manager to do otherwise.

(2) No person shall remove, mark or deface any sign or device in the Seaway or on Seaway property.

Operation of Vehicles

Registration and Permits

10. No person shall operate a vehicle on Seaway property unless the following conditions are met:

(a) the person holds all licences and permits required under the laws of the province and municipality in which the Seaway property is situated to operate the vehicle in that province and municipality; and

(b) the vehicle is registered and equipped as required under the laws of the province and municipality in which the Seaway property is situated.

Compliance with Provincial and Municipal Laws

11. No person shall operate a vehicle on Seaway property otherwise than in accordance with the laws of the province and municipality in which the Seaway property is situated.

12. No person shall operate a vehicle on Seaway property in such a manner as to cause it to enter a roadway at a place other than a place designated for public access to the roadway.

13. Every person who operates a vehicle on Seaway property shall do so in a safe manner and at a speed that does not exceed the lowest of

(a) 40 km/h,

(b) the speed limit posted under the authority of the Manager on signs, and

(c) a lower speed that is warranted by prevailing weather conditions or by the movement or storage of equipment, trains or goods.

14. (1) The Manager may have signs and devices installed on Seaway property respecting

(a) the safe operation of vehicles;

(b) the parking or stopping of vehicles, including signs and devices restricting or prohibiting parking or stopping; and

(c) weight and dimension restrictions of vehicles.

(2) Every person who operates a vehicle on Seaway property shall obey

(a) the instructions on any sign posted or device installed under the authority of the Manager and applicable to the person, the vehicle or the property; and

(b) traffic directions given by a person authorized for that purpose by the Manager.

(3) The owner of a vehicle and any person apparently in possession of a vehicle that is parked or stopped contrary to an instruction or direction referred to in subsection (2) may be held liable.

15. The Manager may have a vehicle moved or stored at the risk and expense of its owner or operator or the person apparently in possession of it at the time at which it is found to be parked or stopped contrary to this section if it is

(a) apparently abandoned;

(b) parked or stopped

(i) in a place or manner that creates a hazard or obstruction, or
(ii) at a time that is not within the posted parking or stopping hours; or

(c) parked or stopped in an area

(i) not posted as a parking or stopping area, or
(ii) posted as a no-parking or no-stopping area.

Removal — Property or Waters

16. (1) Unless otherwise authorized under these Regulations, every person who drops, deposits, discharges or spills, in the Seaway or on Seaway property, refuse or a substance that pollutes, an object that interferes with navigation or any cargo or ship's gear shall

(a) immediately make every technically and economically feasible effort to remove it;

(b) notify the Manager of the incident without delay and provide a description of what was dropped, deposited, discharged or spilled and its approximate location and the efforts made by the person, if any, to remove it; and

(c) as soon as possible, submit to the Manager a detailed written report of the incident, including the information referred to in paragraph (b).

(2) If the person does not remove the refuse, substance, object, cargo or ship's gear immediately, the Manager may conduct the removal at the risk and expense of the person.

Fire Protection

17. Every person in the Seaway or on Seaway property shall follow the fire protection and prevention measures reasonably necessary for the safety of persons and property, taking into account the activities and goods in the Seaway and on Seaway property.

Dangerous Situations

18. Every person who by act or omission causes a dangerous situation in the Seaway or on Seaway property shall

(a) take one or both of the following precautions:

(i) post the notices, deploy the lights and erect the fences, barricades or other devices that are necessary to prevent accidents and to protect persons and property, or
(ii) station a person at the site of the dangerous situation to warn persons of the danger;

(b) take appropriate measures to prevent injury to persons or damage to property; and

(c) notify the Manager without delay as to the nature of the dangerous situation and the precautions that have been taken and their location.

Emergencies

19. Despite any other provision of these Regulations, a person may, in the Seaway or on Seaway property, conduct an activity set out in column 1 of the schedule without having a contract, lease or licence or an authorization given by the Manager or complying with the conditions of an authorization for the duration of an emergency situation if

(a) the activity is required as a result of an emergency situation that jeopardizes the safety of persons or threatens to cause damage to property or the environment; and

(b) without delay, the person conducting the activity submits a written report to the Manager describing the activity and explaining why the situation was regarded as an emergency.

20. If a situation causes or is likely to cause death, bodily injury or any other emergency situation in the Seaway or on Seaway property or is likely to damage property or the environment, every person directly involved in the situation and, in the case of an activity conducted under a contract, lease, licence or authorization, the person authorized to conduct the activity shall

(a) without delay, notify the Manager that there is an emergency situation;

(b) submit a detailed written report of the emergency situation to the Manager as soon as possible after it begins; and

(c) at the request of the Manager, submit with the report a copy of each report of the emergency situation that the person makes to municipal, provincial and federal authorities.

Accidents and Incidents

21. A person who does anything in the Seaway or on Seaway property that results in an incident involving material loss or damage or an explosion, fire, accident, grounding, stranding or incident of pollution shall submit a detailed written report of the incident to the Manager without delay.

Precautionary Measures

22. (1) If, in the Seaway or on Seaway property, a person conducts an activity that is likely to have any of the results prohibited under section 5 and the activity does not require an authorization under these Regulations, the Manager may instruct the person conducting the activity to cease the activity or to take the precautions necessary to mitigate or prevent the result.

(2) The person shall immediately comply with the instructions of the Manager.

PART 2

ACTIVITIES OF THE MANAGER

General

23. If the Manager is the proponent of an activity that is set out in column 1 of the schedule and that is likely to have any of the results prohibited under section 5, it shall take appropriate measures designed to mitigate or prevent the result, if technically and economically feasible, taking into account

(a) the safety of persons and property in the Seaway and on Seaway property;

(b) the environmental protection of the Seaway and Seaway property; and

(c) the management of the marine infrastructure of the Seaway and services in connection with the operation of the Seaway in a commercial manner.

Works within the Meaning of the Navigable Waters Protection Act

Authority to Build

24. Subject to any agreement between the Minister and the Manager entered into under subsection 80(5) of the Act, any agreement between Canada and the United States in respect of the Seaway and section 25, the Manager or a person acting on behalf of the Manager may build, place, rebuild, repair or alter in, on, over, under, through or across the navigable waters of the Seaway a work within the meaning of the Navigable Waters Protection Act that may interfere with navigation.

Assessments and Reports

25. (1) Before carrying out an activity referred to in section 24, the Manager shall conduct an assessment of the impact of the work on navigation in the Seaway.

(2) The Manager shall ensure that a written report that summarizes the assessment is prepared before the activity in respect of the work is begun.

(3) The Manager shall

(a) if the assessment indicates that the work would be likely to have an adverse effect on safety in respect of navigation in the Seaway, take appropriate measures designed to mitigate the effect, if technically and economically feasible; and

(b) if the assessment indicates that the work would be likely to interfere with any other aspect of navigation, take measures to ensure that the work is consistent with the objective declared in section 4 of the Canada Marine Act.

PART 3

AUTHORIZATIONS AND INSTRUCTIONS FOR ACTIVITIES IN THE SEAWAY OR ON SEAWAY PROPERTY

Activities under Contracts, Leases and Licences

26. A person may, in the Seaway or on Seaway property, conduct an activity set out in column 1 of the schedule if authorized to do so in writing expressly or by necessary implication under a contract or lease entered into with, or a licence granted by, the Manager.

27. If, by entering into a contract or lease or granting a licence, the Manager authorizes an activity set out in column 1 of the schedule that has or is likely to have any of the results prohibited under section 5, the Manager shall stipulate as a condition of the contract, lease or licence that the person with whom the contract or lease is made or to whom the licence is granted shall take measures designed to mitigate or prevent the result, if technically and economically feasible.

[28 and 29 reserved]

Authorizations to Persons

30. (1) The Manager may give a written authorization under this section to a person to conduct, in the Seaway or on Seaway property, an activity set out in column 1 of the schedule if an "X" is set out in column 3.

(2) On receipt of a request for an authorization, along with payment of the applicable fee, if any, and the information required under subsection 31(2), the Manager shall

(a) give its authorization;

(b) if the results of the conduct of the activity are uncertain or if the conduct of the activity is likely to have any of the results prohibited under section 5,

(i) refuse to give its authorization, or
(ii) give its authorization subject to conditions designed to mitigate or prevent the results; or

(c) if the Manager required that the person obtain insurance coverage, performance security or damage security in respect of the conduct of the activity and none is obtained or that which is obtained is inadequate, refuse to give its authorization.

31. (1) No person shall, in the Seaway or on Seaway property, conduct an activity set out in column 1 of the schedule if an "X" is set out in column 3 unless the person

(a) obtains an authorization under section 30 or is covered by an authorization given to an undertaking or organization under that section; and

(b) complies with the conditions, if any, of the authorization.

(2) A person that seeks an authorization from the Manager to conduct an activity in the Seaway or on Seaway property shall provide to the Manager

(a) the name and address of the person;

(b) the applicable fee, if any;

(c) information relevant to the proposed activity and required by the Manager to assess the likelihood of the occurrence of any of the results prohibited under section 5;

(d) if required by the Manager, proof that the applicant has an insurance policy that provides adequate coverage for the activity, names the Manager as an additional insured and provides for the insurer to notify the Manager in the event that the policy is amended or cancelled; and

(e) if required by the Manager, performance security and damage security in respect of the conduct of the activity.

32. The Manager may cancel an authorization given under section 30 or change the conditions to which an authorization is subject if

(a) the conduct of the activity has a result that is prohibited under section 5 or, because of a change in circumstances, it becomes likely to have such a result or the result of it becomes unclear;

(b) the insurance coverage, performance security or damage security obtained by the person in respect of the conduct of the activity becomes inadequate for the activity or is cancelled;

(c) the authorization was based on incorrect or misleading information; or

(d) the person to whom the authorization is given or any person covered by the authorization does not comply with a condition of the authorization.

33. (1) If an authorization given under section 30 is cancelled, the Manager shall give notice of the cancellation to the person to whom the authorization was given.

(2) The cancellation is effective at the earliest of

(a) the end of the fifth day after the notice of cancellation is sent by registered mail to the address provided in the application for the authorization,

(b) two hours after a facsimile or electronic transmission of the notice of cancellation is sent to the address provided in the application for the authorization, and

(c) immediately on service of the notice of cancellation at the address provided in the application for the authorization.

Instructions to Cease, Remove, Return and Restore

34. (1) The Manager may instruct a person to take any of the actions prescribed under subsection (2) if

(a) the person conducts an activity that is prohibited under section 6;

(b) the person conducts an activity for which an authorization is required under section 30 without first obtaining the authorization or without being covered by one;

(c) the person or any person covered by an authorization fails to comply with a condition of the authorization;

(d) the authorization to conduct the activity is cancelled under section 32; or

(e) in the case of an activity for which no authorization is required under these Regulations, the conduct of the activity has a result prohibited under section 5.

(2) The actions are

(a) to cease the activity or comply with the conditions for conducting the activity; and

(b) if the person is instructed to cease the activity,

(i) to remove anything brought into the Seaway or onto Seaway property in connection with the activity,
(ii) to return to the Seaway or Seaway property anything that was removed from it in connection with the activity, and
(iii) to restore the property affected by the activity to its former state.

(3) The person shall immediately comply with the instructions of the Manager.

(4) If the person fails to remove the thing or to restore the property immediately, the Manager may conduct the removal or restoration and may store the thing at the risk and expense of the person.

PART 4

REPEALS AND COMING INTO FORCE

Repeals

35.The Seaway Regulations (see footnote 2) are repealed.

36.The Shore Traffic Regulations (see footnote 3) are repealed.

Coming Into Force

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

SCHEDULE
(Sections 1, 6, 19, 23, 26, 27, 30 and 31)

ACTIVITIES AND AUTHORIZATIONS

Item	Column 1 Activity	Column 2 [reserved]	Column 3 Authorization to a specific person (section 30)	Column 4 Prohibited (section 6)
1.	operating a vehicle in an area not intended for vehicular traffic		X
2.	conducting a diving operation		X
3.	conducting salvage operations		X
4.	building, installing, modifying, replacing, dismantling or decommissioning a petroleum product storage tank or an allied petroleum product storage tank		X
5.	releasing any material or substance onto or over a lock wall or tie-up wall by any means, including overboard discharge pipes			X
6.	conducting a dredging operation		X
7.	excavating or removing any material or substance		X
8.	transhipping, loading or unloading cargo in an area other than a designated area		X
9.	placing, altering, removing or relocating an aid to navigation, buoy, mooring, float, picket, mark or sign		X
10.	casting adrift a ship, log or other object		X
11.	hunting
	(a) in a designated area		X
	(b) anywhere else			X
12.	building, placing, rebuilding, repairing, altering, moving or removing any structure or work on, in, over, under, through or across land or water		X
13.	fishing
	(a) in a designated area under a scientific permit issued by the Department of Fisheries and Oceans		X
	(b) in a designated area without a scientific permit issued by the Department of Fisheries and Oceans			X
	(c) anywhere else			X
14.	conducting a race, regatta, trial, demonstration, organized event or similar activity		X
15.	causing a fire or explosion, conducting blasting or setting off fireworks		X
16.	placing a placard, bill, sign or device		X
17.	selling or offering for sale goods or services		X
18.	distributing circulars, leaflets or advertising materials		X
19.	engaging in any form of solicitation		X
20.	venturing out onto ice		X
21.	engaging in any type of recreational water activity			X

[49-1-o]

Footnote a

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

Footnote 1

C.R.C., c. 870

Footnote b

S.C. 2001, c. 4, s. 150

Footnote c

S.C. 1998, c. 10

Footnote 2

C.R.C., c. 1397

Footnote 3

C.R.C., c. 1398

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