Government of Canada
Symbol of the Government of Canada


Vol. 133, No. 29 — July 17, 1999

GOVERNMENT NOTICES

DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT

Notice is hereby given that, pursuant to the provisions of Part VI of the Canadian Environmental Protection Act, the conditions of Permit No. 4543-2-04195 are amended as follows:

12. Requirements and Restrictions: Add the following paragraph:

The loading or ocean dumping referred to under this permit shall not be carried out without written authorization from the Permittee.

M.-F. BÉRARD
Environmental Protection
Quebec Region

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DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT

Notice is hereby given that, pursuant to the provisions of Part VI of the Canadian Environmental Protection Act, Permit No. 4543-2-04203 is approved.

1. Permittee: Les Pêcheries Marinard Division La Tabatière Ltée, La Tabatière, Quebec.

2. Type of Permit: To dump or load fish offal.

3. Term of Permit: Permit is valid from July 23, 1999, to July 22, 2000.

4. Loading Site(s): La Tabatière Harbour, 50°50.25' N, 58°58.45' W (NAD27).

5. Dump Site(s): Within a 200 m radius of 50°50.90' N, 58°57.70' W (NAD27).

6. Route to Dump Site(s): Direct navigational route from the loading site to the dump site.

7. Equipment: Towed scow, barge or boat.

8. Method of Dumping: The wastes discharged directly into the sea within the perimeter indicated in condition 5.

9. Rate of Dumping: As required by normal operations.

10. Total Quantity to be Dumped: Not to exceed 500 tonnes.

11. Material to be Dumped: Wastes from fish and shellfish processing.

12. Requirements and Restrictions: It is required that the Permittee report, in writing, to the Regional Director, Environmental Protection, Department of the Environment, Quebec Region, 105 McGill Street, 4th Floor, Montréal, Quebec H2Y 2E7, at least 48 hours prior to the start of the first dumping operation to be conducted under this permit. A written report shall be submitted to the Regional Director within 30 days of the expiry of the permit. This report shall contain the following information: the quantity and type of material disposed of pursuant to the permit, the equipment used and the dates on which the dumping and loading activities occurred.

It is required that the Permittee admit any inspector designated pursuant to subsection 99(1) of the Canadian Environmental Protection Act, to any place, ship, aircraft, platform or anthropogenic structure directly related to the loading or ocean dumping referred to under this permit, at any reasonable time throughout the duration of this permit.

A copy of this permit must, at all times, be kept aboard any vessel involved in the dumping operations.

The Permittee must complete the Registry of Ocean Dumping Operations as provided by the Department of the Environment. This registry must, at all times, be kept aboard any vessel involved in the dumping operations and be accessible to inspectors designated under the Canadian Environmental Protection Act.

The ocean dumping referred to under this permit shall not be carried out without written authorization from the Permittee.

The barge or containers used to transport the wastes must be covered in a manner to prevent access by gulls and other sea-birds.

The loading must be completed in a manner that ensures no material contaminates the marine environment, including the harbour and adjacent beaches. The Permittee must also ensure that the loading sites are cleaned up and, if necessary, that spilled wastes are recovered.

M.-F. BÉRARD
Environmental Protection
Quebec Region

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DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT

Notice is hereby given that, pursuant to the provisions of Part VI of the Canadian Environmental Protection Act, Permit No. 4543-2-06013 is approved.

1. Permittee: Coastal Labrador Fisheries Ltd., St. Lewis, Newfoundland.

2. Type of Permit: To dump or load crab offal.

3. Term of Permit: Permit is valid from August 17, 1999, to August 16, 2000.

4. Loading Site(s): 52°22.10' N, 55°41.00' W, St. Lewis, Newfoundland.

5. Dump Site(s): 52°20.36' N, 55°41.80' W, at an approximate depth of 109 m.

6. Route to Dump Site(s): Most direct navigational route from the loading site to the dump site.

7. Equipment: Vessels, barges or other floating equipment complying with all applicable rules regarding safety and navigation and capable of containing all waste cargo during loading and transit to the approved dump site.

8. Method of Dumping: Crab offal shall be discharged while the equipment or vessel is steaming within 300 m of the approved dump site. Dumping will take place in a manner which will promote the greatest degree of dispersion. All vessels will operate at maximum safe speed while discharging offal.

9. Rate of Dumping: As required by normal operations.

10. Total Quantity to be Dumped: Not to exceed 1 500 tonnes.

11. Material to be Dumped: Crab offal.

12. Requirements and Restrictions:

12.1. It is required that the Permittee report, in writing, to Mr. Rick Wadman, Manager, Environmental Protection, Department of the Environment, 6 Bruce Street, Mount Pearl, Newfoundland A1N 4T3, (709) 772-5097 (Facsimile), at least 48 hours prior to the start of the first dumping operation to be conducted under this permit.

12.2. A written report shall be submitted to the Manager within 30 days of either the completion of the work or the expiry of the permit, whichever comes first. This report shall contain the following information: the quantity and type of material disposed of pursuant to the permit and the dates on which the loading and dumping activities occurred.

12.3. It is required that the Permittee admit any inspector designated pursuant to subsection 99(1) of the Canadian Environmental Protection Act, to any place, ship, aircraft, platform or anthropogenic structure directly related to the loading or ocean dumping referred to under this permit, at any reasonable time throughout the duration of this permit.

12.4. The Permittee shall periodically determine the water depth in the area of the disposal site. The depth readings shall be taken every eight weeks, beginning with the start date of this permit, and reported to Mr. Rick Wadman, identified in paragraph 12.1.

12.5. The loading and transit of waste material to the dump site must be conducted in such a manner that no material enters the marine environment. Waste material spilled at any place, other than the permitted dump site, must be retrieved. All waste must be contained on shore while the barge is away from the loading site.

12.6. The crab offal must be covered by netting or other material to prevent access by gulls.

12.7. This permit must be displayed in an area of the plant accessible to the public.

12.8. Vessels operating under the authority of this permit must carry and display a radar-reflecting device at all times mounted on the highest practical location.

12.9. The loading or ocean dumping conducted under this permit shall not be carried out without written authorization from the Permittee.

12.10. Crab offal loaded for the purpose of ocean dumping may not be held aboard any vessel for more than 96 hours without the written consent of an inspector designated under the Canadian Environmental Protection Act.

K. G. HAMILTON
Environmental Protection
Atlantic Region

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DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT

Notice is hereby given that, pursuant to the provisions of Part VI of the Canadian Environmental Protection Act, Permit No. 4543-2-06015 is approved.

1. Permittee: Fishery Products International Ltd., St. John's, Newfoundland.

2. Type of Permit: To dump or load fish and shrimp offal.

3. Term of Permit: Permit is valid from August 3, 1999, to August 2, 2000.

4. Loading Site(s): 48°30.20' N, 53°04.90' W, Port Union, Newfoundland.

5. Dump Site(s): 49°29.00' N, 52°56.00' W, at an approximate depth of 130 m.

6. Route to Dump Site(s): Most direct navigational route from the loading site to the dump site.

7. Equipment: Vessels, barges or other floating equipment complying with all applicable rules regarding safety and navigation and capable of containing all waste cargo during loading and transit to the approved dump site.

8. Method of Dumping: Fish offal shall be discharged while the equipment or vessel is steaming within 300 m of the approved dump site. Dumping will take place in a manner which will promote the greatest degree of dispersion. All vessels will operate at maximum safe speed while discharging offal.

9. Rate of Dumping: As required by normal operations.

10. Total Quantity to be Dumped: Not to exceed 7 000 tonnes.

11. Material to be Dumped: Fish and shrimp offal.

12. Requirements and Restrictions:

12.1. It is required that the Permittee report, in writing, to Mr. Rick Wadman, Manager, Environmental Protection, Department of the Environment, 6 Bruce Street, Mount Pearl, Newfoundland A1N 4T3, (709) 772-5097 (Facsimile), at least 48 hours prior to the start of the first dumping operation to be conducted under this permit.

12.2. A written report shall be submitted to the Manager within 30 days of either the completion of the work or the expiry of the permit, whichever comes first. This report shall contain the following information: the quantity and type of material disposed of pursuant to the permit and the dates on which the loading and dumping activities occurred.

12.3. It is required that the Permittee admit any inspector designated pursuant to subsection 99(1) of the Canadian Environmental Protection Act, to any place, ship, aircraft, platform or anthropogenic structure directly related to the loading or ocean dumping referred to under this permit, at any reasonable time throughout the duration of this permit.

12.4. The Permittee shall periodically determine the water depth in the area of the disposal site. The depth readings shall be taken every eight weeks, beginning with the start date of this permit, and reported to Mr. Rick Wadman, identified in paragraph 12.1.

12.5. The loading and transit of waste material to the dump site must be conducted in such a manner that no material enters the marine environment. Waste material spilled at any place, other than the permitted dump site, must be retrieved. All waste must be contained on shore while the barge is away from the loading site.

12.6. The fish offal must be covered by netting or other material to prevent access by gulls.

12.7. This permit must be displayed in an area of the plant accessible to the public.

12.8. Vessels operating under the authority of this permit must carry and display a radar-reflecting device at all times mounted on the highest practical location.

12.9. The loading or ocean dumping conducted under this permit shall not be carried out without written authorization from the Permittee.

12.10. Fish offal loaded for the purpose of ocean dumping may not be held aboard any vessel for more than 96 hours without the written consent of an inspector designated under the Canadian Environmental Protection Act.

K. G. HAMILTON
Environmental Protection
Atlantic Region

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DEPARTMENT OF FISHERIES AND OCEANS

CANADA SHIPPING ACT

Statement by the Minister of Fisheries and Oceans Regarding the Fees Established by Eastern Canada Response Corporation Ltd.

Whereas, pursuant to subsection 660.4(1)(see footnote 1) of the Canada Shipping Act(see footnote 2), Eastern Canada Response Corporation Ltd. has been designated as a response organization since November, 1995, and received its most recent certificate of designation from the Minister of Fisheries and Oceans on November 1, 1998;

Whereas, pursuant to subsection 660.4(1)(see footnote 3) of the Canada Shipping Act(see footnote 4), Great Lakes Response Corporation of Canada was designated as a response organization in November, 1995, and received its most recent certificate of designation from the Minister of Fisheries and Oceans on November 1, 1998;

Whereas, pursuant to subsection 660.4(2) (see footnote 5) of that Act, Eastern Canada Response Corporation Ltd. at the time of its application for its most recent certificate of designation, filed with the Minister a list of the amended fees that it proposed to charge in relation to the arrangements referred to in paragraphs 660.2(2)(b) and (4)(b) of that Act;

Whereas, pursuant to subsection 660.4(2) (see footnote 6) of that Act, Great Lakes Response Corporation of Canada at the time of its application for its most recent certificate of designation, filed with the Minister a list of the amended fees that it proposed to charge in relation to the arrangements referred to in paragraphs 660.2(2)(b) and (4)(b) of that Act;

Whereas, pursuant to subsection 660.4(3) (see footnote 7) of that Act, the Minister caused a list of the amended fees proposed by Eastern Canada Response Corporation Ltd. and a list of the amended fees proposed by Great Lakes Response Corporation of Canada to be published in the Canada Gazette, Part I, on October 3, 1998;

Whereas, pursuant to subsection 660.4(4) (see footnote 8) of that Act, three notices of objection were filed with respect to the amended fees proposed by Eastern Canada Response Corporation Ltd. and two notices of objection were filed with respect to the amended fees proposed by Great Lakes Response Corporation of Canada;

Whereas, the Minister caused analysis to be conducted to assist him in making this Order;

Whereas, representatives of Eastern Canada Response Corporation Ltd., Great Lakes Response Corporation of Canada and persons and organizations filing notices of objection have been provided with opportunities to be heard by commenting in writing and by making oral representations;

Whereas, the Minister has given full and proper consideration to the written and verbal representations of representatives of Eastern Canada Response Corporation Ltd., Great Lakes Response Corporation of Canada and persons and organizations filing notices of objection;

Whereas, the Minister has given full and proper consideration to all relevant information before him;

Whereas, the Minister was advised that by articles of amalgamation effective January 1, 1999, Eastern Canada Response Corporation Ltd. and Great Lakes Response Corporation of Canada amalgamated and will continue under the name Eastern Canada Response Corporation Ltd.;

Whereas the Minister has been advised that this amalgamation does not affect the response plans based upon which certificates of designation were issued to Great Lakes Response Corporation of Canada and Eastern Canada Response Corporation Ltd.;

And whereas, the Minister of Fisheries and Oceans, pursuant to subsection 660.4(8) (see footnote 9) of the Canada Shipping Act, approved the annexed fees;

Therefore, the Minister of Fisheries and Oceans, pursuant to subsection 660.4(8)(see footnote 10) of the Canada Shipping Act(see footnote 11), hereby causes the annexed fees established by Eastern Canada Response Corporation to be published.

DAVID ANDERSON
Minister of Fisheries and Oceans

LIST OF FEES ESTABLISHED BY EASTERN CANADA RESPONSE CORPORATION LTD.

DEFINITIONS

1. In this List,

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

"Alert" means Atlantic Emergency Response Team (ALERT) Inc. (Alert)

"Alert's geographic area" means the geographic area of response for which Alert has been issued a certificate of designation. (zone géographique d'Alert)

"asphalt" means a derivate of oil that is commercially described as road or paving asphalt or unblended roofers flux, that has a specific gravity equal to or greater than one, that is solid at 15 degrees Celsius and that sinks to the bottom as a solid when immersed in water. (asphalte)

"BOCF" means bulk oil cargo fee. (droits sur les produits pétroliers en vrac (DCPV))

"designated oil handling facility" means an oil handling facility that is designated pursuant to subsection 660.2(8) of the Act and is located in ECRC's geographic area or in the Great Lakes Region. (installation de manutention d'hydrocarbures agréée)

"ECRC" means Eastern Canada Response Corporation Ltd., a company formed as a result of the amalgamation of Eastern Canada Response Corporation Ltd., Great Lakes Response Corporation of Canada and Canadian Marine Response Management Corporation, effective January 1, 1999. (SIMEC)

"ECRC's geographic area" means the geographic area of response for which Eastern Canada Response Corporation Ltd. was issued a certificate of designation on November 1, 1998, which comprises the Newfoundland Region and the Quebec/ Maritime Region. (zone géographique de la SIMEC)

"Great Lakes Region" means the geographic area of response for which Great Lakes Response Corporation of Canada was issued a certificate of designation on November 1, 1998. (région des Grands Lacs)

"Newfoundland Region" means the Province of Newfoundland and Labrador. (région de Terre-Neuve)

"PTMS" means Point Tupper Marine Services Limited. (SPTM)

"PTMS' geographic area" means the geographic area of response for which PTMS has been issued a certificate of designation. (zone géographique des SPTM)

"Quebec/Maritime Region" means ECRC's geographic area excluding the Newfoundland Region. (région des Maritimes/de Québec)

"ship" means a ship within the meaning of section 660.2 of the Act. (navire)

"ship (bulk oil)" means a ship that is constructed or adapted primarily to carry bulk oil in its cargo spaces. (navire (avec produits pétroliers en vrac))

FEES

2. The fees that are established by ECRC and that are payable to ECRC in relation to an arrangement required by paragraphs 660.2(2)(b) and (4)(b) of the Act are the fees set out in Parts I to IV of this List.

PART I

3. This part applies to ECRC's geographic area and to the Great Lakes Region.

4. The annual registration fee for each designated oil handling facility within ECRC's geographic area and the Great Lakes Region is four hundred and fifty dollars ($450) plus all applicable taxes.

5. The annual registration fee for a ship that navigates or engages in a marine activity within ECRC's geographic area, or in the Great Lakes region is four hundred and fifty dollars ($450) plus all applicable taxes.

6. The annual registration fee for a ship that navigates or engages in a marine activity in ECRC's geographic area and in one or more of:

(a) the Great Lakes Region;

(b) Alert's geographic area; or

(c) PTMS' geographic area

is seven hundred and fifty dollars ($750) plus all applicable taxes.

PART II

7. This part applies to the loading and unloading of oil at oil handling facilities located in the Quebec/Maritime Region.

8. The total BOCF payable by a designated oil handling facility that has an arrangement with ECRC shall be determined by multiplying the total number of tonnes of bulk oil unloaded and (in the case of bulk oil intended for international destinations and destinations north of 60° N latitude) loaded at the designated oil handling facility, by the BOCF per tonne for each type of oil set out in sections 10 and 11 of this part.

9. The total BOCF payable by a ship (bulk oil) shall be determined:

(a) in the case of bulk oil loaded onto the ship (bulk oil) and intended for international destinations and destinations north of 60° N latitude, by multiplying the total number of tonnes of bulk oil loaded at an oil handling facility that does not have an arrangement with ECRC, by the BOCF per tonne for each type of oil set out in sections 10 and 11 of this part; and

(b) in the case of bulk oil unloaded from the ship (bulk oil), by multiplying the total number of tonnes of bulk oil unloaded at an oil handling facility that does not have an arrangement with ECRC, by the BOCF per tonne for each type of oil set out in sections 10 and 11 of this part.

10. The BOCF applicable in respect of oil other than asphalt is:

(a) thirty-five and four-tenths cents (35.4¢) per tonne, plus all applicable taxes from October 3, 1998, to December 31, 1998; and

(b) thirty-nine and one-tenth cents (39.1¢) per tonne, plus all applicable taxes from January 1, 1999.

11. The BOCF applicable in respect of asphalt is:

(a) seventeen and seven-tenths cents (17.7¢) per tonne, plus all applicable taxes from October 3, 1998, to December 31, 1998; and

(b) nineteen and six-tenths cents (19.6¢) per tonne, plus all applicable taxes from January 1, 1999.

PART III

12. This part applies to the loading and unloading of oil at oil handling facilities located in the Newfoundland Region.

13. The total BOCF payable by a designated oil handling facility that has an arrangement with ECRC shall be determined by multiplying the total number of tonnes of bulk oil unloaded and (in the case of bulk oil intended for international destinations and destinations north of 60° N latitude) loaded at the designated oil handling facility, by the BOCF per tonne for each type of oil set out in sections 15 and 16 of this part.

14. The total BOCF payable by a ship (bulk oil) shall be determined:

(a) in the case of bulk oil loaded onto the ship (bulk oil) and intended for international destinations and destinations north of 60° N latitude, by multiplying the total number of tonnes of bulk oil loaded at an oil handling facility that does not have an arrangement with ECRC, by the BOCF per tonne for each type of oil set out in sections 15 and 16 of this part; and

(b) in the case of bulk oil unloaded from the ship (bulk oil), by multiplying the total number of tonnes of bulk oil unloaded at an oil handling facility that does not have an arrangement with ECRC, by the BOCF per tonne for each type of oil set out in sections 15 and 16 of this part.

15. The BOCF applicable in respect of oil other than asphalt is eighteen cents (18.0¢) per tonne, plus all applicable taxes.

16. The BOCF applicable in respect of asphalt is nine cents (9.0¢) per tonne, plus all applicable taxes.

PART IV

17. This part applies to the loading and unloading of oil at oil handling facilities located in the Great Lakes Region.

18. All references to arrangements in this part include arrangements with Great Lakes Response Corporation of Canada (now ECRC) made prior to January 1, 1999, and arrangements with ECRC after January 1, 1999.

19. The total BOCF payable by a designated oil handling facility that has an arrangement shall be determined by multiplying the total number of tonnes of bulk oil unloaded and (in the case of bulk oil intended for international destinations and destinations north of 60° N latitude) loaded at the designated oil handling facility, by the BOCF per tonne for each type of oil set out in sections 21 and 22 of this part.

20. The total BOCF payable by a ship (bulk oil) shall be determined:

(a) in the case of bulk oil loaded onto the ship (bulk oil) and intended for international destinations and destinations north of 60° N latitude, by multiplying the total number of tonnes of bulk oil loaded at an oil handling facility that does not have an arrangement, by the BOCF per tonne for each type of oil set out in sections 21 and 22 of this part; and

(b) in the case of bulk oil unloaded from the ship (bulk oil), by multiplying the total number of tonnes of bulk oil unloaded at an oil handling facility that does not have an arrangement, by the BOCF per tonne for each type of oil set out in sections 21 and 22 of this part.

21. BOCF applicable in respect of oil other than asphalt is:

(a) one dollar and four cents ($1.04) per tonne, plus all applicable taxes from October 3, 1998, to December 31, 1998; and

(b) ninety-nine cents (99.0¢) per tonne, plus all applicable taxes from January 1, 1999.

22. BOCF applicable in respect of asphalt is:

(a) fifty-two cents (52.0¢) per tonne, plus all applicable taxes from October 3, 1998, to December 31, 1998; and

(b) forty-nine and five-tenths cents (49.5¢) per tonne, plus all applicable taxes from January 1, 1999.

EXPLANATORY NOTE

The Canada Shipping Act (CSA) was amended in 1993 to enhance the environmental protection of all Canadian waters and shores south of 60° N latitude through the establishment of industry-funded and managed Response Organizations (ROs) capable of mounting an oil spill response to a marine-based incident. The Minister of Fisheries and Oceans is responsible for certifying that ROs meet the required standards to be formally designated as certified ROs. The Canadian Coast Guard (CCG) fulfills this responsibility on behalf of the Minister. CCG also maintains responsibility for ensuring response in Canadian waters north of 60° N latitude.

In accordance with the provisions of the CSA, certain ships and oil handling facilities (OHFs) are required to have an oil spill preparedness arrangement with a certified RO for the provision of response in the event of an oil spill.

In the fall of 1995, CCG certified five ROs, each capable of providing response to a 10 000 tonne oil spill within a specified Geographic Area of Response (GAR), for an initial three year period of certification as follows:

— Atlantic Emergency Response Team (ALERT) Inc.

— Eastern Canada Response Corporation (ECRC)

— Great Lakes Response Corporation (GLRC)

— Point Tupper Marine Services Ltd. (PTMS)

— Western Canada Marine Response Corporation (WCMRC)

Pursuant to the provisions of the Response Organizations and Oil Handling Facilities Regulations enacted under the CSA, ROs are required to apply for a new certificate of designation every three years. In the fall of 1998, following a certification process, CCG certified these five ROs for a second three year period of certification.

It is also a requirement of the CSA that an application filed with the Minister for certification also include a list of the fees the RO proposes to charge in relation to an arrangement, and that the Minister cause their publication in the Canada Gazette, Part I. CCG fulfills these responsibilities on behalf of the Minister.

ECRC's proposed fees were published in the Canada Gazette on October 3, 1998. The Minister approved these fees without amendment, by Order, on July 8, 1999. ECRC established its fees in accordance with the Minister's Order on July 9, 1999. The fees which have been established by ECRC, are the fees that are payable in relation to an arrangement with ECRC.

For information regarding the Minister's Order, please contact: Ted Wallace, Director, Contingency Planning Task Force, Canadian Coast Guard, Rescue, Safety and Environmental Response, 200 Kent Street, 5th Floor, Ottawa, Ontario K1A 0E6, (613) 993-0409 (Telephone), (613) 996-8902 (Facsimile), wallacet@dfo-mpo.gc.ca (Electronic mail).

For information regarding ECRC and its fees, please contact: Paul C. Pouliotte, Chief Financial Officer, Eastern Canada Response Corporation, 275 Slater Street, Suite 1201, Ottawa, Ontario K1P 5H9, (613) 230-7369 (Telephone), (613) 230-7344 (Facsimile), http://www.ecrc.ca (ECRC Web Page).

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DEPARTMENT OF HEALTH

Therapeutic Products Programme — Food and Drug Regulations — Notice to Interested Parties — Proposal to Amend Division 1A — Establishment Licences

This advance notice provides the public and interested stakeholders with the opportunity to comment on a proposed regulatory amendment to the Establishment Licensing (EL) Framework. The proposed changes were identified during the confidence building exercise relating to Canada's Mutual Recognition Agreements (MRAs) in the drugs sector on Good Manufacturing Practices (GMP).

The drug EL regulations currently allow a partial exemption from the EL application requirements. These exemptions apply where the manufacturer operates from a foreign jurisdiction and has been inspected by a recognized regulatory authority in that foreign country. Presently, the distributor and the importer are exempt from some good manufacturing practice requirements. Under the current Regulations, the exemptions do not provide adequate assurance of quality. Therefore, changes are proposed in the following areas:

— To limit the exemptions to drugs fabricated, packaged/labeled or tested in a recognized regulatory authority for only those products and activities assessed as equivalent by the MRAs. The Food and Drug Regulations currently reference a country or association of countries. There may be several regulatory authorities within certain countries and not all these authorities and activities may be recognized as equivalent by the MRAs.

— To maintain in regulation the requirement for a properly constituted and operating Quality Control Department in Canada responsive to Canadian conditions (sections C.02.013 to C.02.015).

— To maintain in regulation the requirement for finished product testing (section C.02.018). This requirement may be fulfilled by providing a Certificate of Analysis from the foreign manufacturer, a condition of the MRAs.

— To maintain in regulation the requirements for appropriate records in Canada [paragraphs C.02.020(1)(b), (c) and (e)].

— To extend the exemption for maintaining a manufacturing control system to ensure GMP compliance for drugs fabricated and packaged/labeled on premises other than their own to distributors of products from firms holding a Canadian Establishment Licence [subsection C.02.012(2)].

— To extend the exemption for product re-testing in Canada to distributors of products from firms holding a Canadian Establishment Licence (section C.02.019).

Comments on this proposal may be sent within 30 days of this publication to: Dorothy Walker, Project Manager, Bureau of Policy and Coordination, Therapeutic Products Programme, Health Canada, Address Locator 3102C5, Holland Cross, Tower B, 1600 Scott Street, Ottawa, Ontario K1A 1B6, dorothy_walker@ hc-sc.gc.ca (Electronic mail).

All comments should cite the Canada Gazette, Part I — Notice of Intent, and the date of the publication of this notice.

Additional opportunities to comment will be provided when the proposed regulatory amendment is published in the Canada Gazette, Part I.

July 8, 1999

DANN M. MICHOLS
Director General
Therapeutic Products Programme

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DEPARTMENT OF NATURAL RESOURCES

CANADA-NOVA SCOTIA OFFSHORE PETROLEUM RESOURCES ACCORD IMPLEMENTATION ACT

Canada-Nova Scotia Offshore Petroleum Board — Call for Bids No. NS99-1

The Canada-Nova Scotia Offshore Petroleum Board (the "Board") has made a call for bids pursuant to the Canada-Nova Scotia Offshore Petroleum Resources Accord Implementation Act, S.C., 1988, c. 28, as amended, and the Canada-Nova Scotia Offshore Petroleum Resources Accord Implementation (Nova Scotia) Act, S.N.S., 1987, c. 3, as amended, for 11 Exploration Licences covering the following parcels of land offshore Nova Scotia (the "Lands"):

Land Parcel No. 1

Grid
Hectares
(Approximate)

Sections
43-50-60-30   49, 50, 56-60, 66-70
44-00-60-30   28-30, 31, 38-40, 44-50,
53-55, 61-65, 71-75,
81-85, 91-95
Total hectares 18 220 (approximate)
Land Parcel No. 2

Grid
Hectares
(Approximate)

Sections
43-30-60-30   6-10, 16-20, 26-30,
36-40, 46-50,
56-60, 66-70, 76-80,
86-90, 96-100
43-40-60-30   1-8, 11-18, 21-28, 31-36,
38, 41-45, 51-54, 61-63,
71-73, 81-83, 91-94
Total hectares 39 267 (approximate)
Land Parcel No. 3

Grid
Hectares
(Approximate)

Sections
43-40-60-30   78, 88, 97-99
43-40-60-45   1-9, 11-19, 21-29, 31-39,
41-49, 51-100
43-40-61-00   1-100
43-50-60-45   51-53, 61-63, 71-73,
81-83, 91-93
43-50-61-00   1-7, 11-17, 21-27, 31-37,
41-47, 51-57, 61-67, 71-77,
81-87, 91-97
Total hectares 106 395 (approximate)
Land Parcel No. 4

Grid
Hectares
(Approximate)

Sections
43-00-61-30   51-100
43-00-61-45   1-50
43-10-61-15   1-100
43-10-61-30   1-100
43-10-61-45   1-50
43-20-61-30   1-100
Total hectares 169 470 (approximate)
Land Parcel No. 5

Grid
Hectares
(Approximate)

Sections
43-00-61-15   6-10, 16-20, 26-30,
36-40, 46-50, 56-60, 66-70,
76-80, 86-90, 96-100
43-00-61-30   1-50
Total hectares 37 740 (approximate)
Land Parcel No. 6

Grid
Hectares
(Approximate)

Sections
43-00-61-45   51-100
43-00-62-00   1-100
43-00-62-15   1-100
43-00-62-30   1-100
Total hectares 106 395 (approximate)
Land Parcel No. 7

Grid
Hectares
(Approximate)

Sections
42-50-62-15   51-100
42-50-62-30   1-100
Total hectares 58 700 (approximate)
Land Parcel No. 8

Grid
Hectares
(Approximate)

Sections
42-20-62-30   1-100
42-30-62-30   1-100
42-40-62-30   1-100
Total hectares 114 200 (approximate)
Land Parcel No. 9

Grid
Hectares
(Approximate)

Sections
42-50-63-15   1-100
42-50-63-30   1-100
42-50-63-45   1-100
Total hectares 113 590 (approximate)
Land Parcel No. 10

Grid
Hectares
(Approximate)

Sections
42-10-63-45   1-100
42-20-63-45   1-100
42-30-63-45   1-100
42-40-63-45   1-100
Total hectares 152 190 (approximate)
Land Parcel No. 11

Grid
Hectares
(Approximate)

Sections
42-10-64-00   1-100
42-10-64-15   1-100
42-10-64-30   1-100
42-20-64-00   1-100
42-20-64-15   1-100
42-20-64-30   1-100
42-30-64-15   1-100
42-30-64-30   1-100
Total hectares 305 400 (approximate)

Bid selection

Bidding on each parcel will be based solely on the amount of money proposed to be spent on exploration during Period 1 of the term of the Exploration Licence, determined in accordance with the schedule of Allowable Expenditures set out below. No other factors will be considered in selecting the winning bid, but the Board is not obligated to accept any bid. The minimum bid per parcel that will be considered is $1,000,000 (Canadian) of work expenditure.

Allowable Expenditures (Amended October 9, 1998)

Drilling: $450,000/day for jackup rig (including mobilization, demobilization, logistical support, supply vessels and helicopters).

$600,000/day for semi-submersible rig or drillship (including mobilization, demobilization, logistical support, supply vessels and helicopters).

Seismic: at cost (costs are subject to Board approval. Included are wellsite seabed surveys, 2D, 3D and ocean bottom cable seismic and purchased or reprocessed seismic. Included in the determination of actual costs of new seismic is mobilization, demobilization, field acquisition, processing, interpretation and preparation of final report.)

Overheads: included in above rates.

Terms and conditions of Exploration Licence

Environmental Studies

In accordance with the legislation, prior to the authorization of any petroleum-related activities on "the Lands", the operator must demonstrate to the satisfaction of the Board that such activities can be conducted in an environmentally safe manner.

Term

The term of each Exploration Licence will be nine years, consisting of two consecutive periods referred to as Period 1 and Period 2.

Period 1 is five years long, but will be extended by one year if a well is commenced or a Drilling Deposit in the amount of $250,000 is posted before the end of the fifth year. If a Drilling Deposit is posted it will be refunded in full if the licence is validated for Period 2 by the drilling of a well. If a validation well is not drilled, the Drilling Deposit will be forfeited upon the termination of the licence. Allowable Expenditures cannot be applied against the Drilling Deposit.

Period 2 immediately follows Period 1 and consists of the balance of the nine-year term of the licence. In order to validate the licence for Period 2, the drilling of a well must be commenced within Period 1 and diligently pursued to termination in accordance with good oilfield practice. Failure to fulfill this drilling requirement will result in the termination of the licence at the end of Period 1. The validation well must adequately test a valid geological target to be declared to the Board by the interest owner prior to the commencement of the well.

Work Deposit

The successful bidder will be required to post security for the performance of work in the amount of 25 percent of its work expenditure bid (the "Work Deposit"). The successful bidder must post this Work Deposit within 15 days of being notified that its bid was successful, as a condition of issuance of the Exploration Licence. Work Deposits must be in the form of cash or bonds, or promissory notes, payable on demand to the Receiver General for Canada, that a Canadian chartered bank has agreed to honour on presentment for payment. The form of security documents must be acceptable to the Board.

Upon the completion of work, from time to time the interest owner may apply to the Board for approval of Allowable Expenditures incurred. The Work Deposit will be refunded to the extent of 25 percent of approved Allowable Expenditures. Allowable Expenditures which are expended in Period 2 shall not be credited against the Work Deposit. No interest is paid on the Work Deposit.

The interest owner is not obligated to perform work under the licence. However if the interest owner does not perform work in the full amount of its work expenditure bid, the unrefunded balance of the Work Deposit will be forfeited upon the termination of this licence.

Rentals

No rentals are payable in respect of Period 1. Refundable rentals are payable during Period 2 at the rate of $2.50 a hectare for each year of Period 2. Rentals are payable annually, in advance. Rentals will be refunded upon application to the Board to the extent of approved Allowable Expenditures incurred during Period 2. Allowable Expenditures incurred in a particular year of Period 2 that are in excess of what is required to reduce rentals to zero in that year may be carried backward or forward for the purpose of reducing rentals paid or payable in previous or subsequent years of Period 2. Allowable Expenditures incurred in Period 1 after completion of the first well may also be carried forward for this purpose into Period 2 to the extent that they have not been taken into account in refunding all or part of the Work Deposit.

Indemnity

Interest Holders are required to indemnify the Board and Her Majesty the Queen in right of Canada and in right of the province of Nova Scotia against all claims that may be made by any person by reason of anything done or omitted to be done under the licence by, through or under the interest owner or an interest holder, in relation to those portions of the Lands with respect to which they hold shares.

Submission of bids

Bids must be received by the Board before 4:00 p.m. on Thursday, October 28, 1999, at the following address: Canada-Nova Scotia Offshore Petroleum Board, T.D. Centre, 6th Floor, 1791 Barrington Street, Halifax, Nova Scotia B3J 3K9.

Bids must be in the form attached as Appendix II to the call for bids and must be submitted in a sealed envelope marked "CALL FOR BIDS NS99-1 (PARCEL —)." The bid form is available from the Board (see below). Bids not meeting the requirements of the call will not be considered.

Bids may be submitted as a Single Parcel Bid or as a Priority of Parcels Bid. Each bidder has the option of either restricting a particular bid to a single parcel or allowing a particular bid to apply to more than one parcel (up to a maximum of four parcels) in the order of the bidder's stated preference. Where a bidder exercises the Priority of Parcels Bid option, that particular bid will continue to apply in the order as stated, as a separate bid for each of the preferred parcels in turn, until the bid becomes the highest acceptable bid for that particular parcel. Should that occur, the bid would then affix itself to that parcel. For greater certainty, no more than one parcel can be awarded for a particular Priority of Parcels Bid, nor can such a bid be combined with any other bid submitted.

Each bid must be accompanied by a Bid Deposit in the amount of $10,000, in the form of a certified cheque or bank draft payable to the Receiver General for Canada. Bid Deposits will be returned to unsuccessful bidders, without interest, following announcement of the winning bid. The Bid Deposit of the successful bidder will be returned, without interest, when the Work Deposit is posted and any outstanding Environmental Studies Research Fund (ESRF) levies are paid.

The failure of the successful bidder to post the Work Deposit within the specified time will result in forfeiture of the Bid Deposit and disqualification of the bid, and in that event the Board may, if it sees fit, award the Exploration Licence to the second highest bidder without making another call for bids.

Further Information

This notice contains a summary only of the terms and conditions of the call for bids. Interested persons should obtain a copy of the full text of the call for bids, which will prevail over this summary in the case of any conflict or inconsistency. A complete bid package, including the bid form and the form of Exploration Licence, may be obtained free of charge from the Board at the above address, or may be requested by facsimile sent to (902) 422-1799 or by telephone at (902) 422-5588.

Halifax, June 11, 1999

CANADA-NOVA SCOTIA OFFSHORE
PETROLEUM BOARD

J. E. (JIM) DICKEY
Chief Executive Officer

[29-1-o]

DEPARTMENT OF NATURAL RESOURCES

CANADA-NOVA SCOTIA OFFSHORE PETROLEUM RESOURCES ACCORD IMPLEMENTATION ACT

Canada-Nova Scotia Offshore Petroleum Board — Issuance of Exploration Licences

As required by subsection 62(4) of the Canada-Nova Scotia Offshore Petroleum Resources Accord Implementation Act, S.C., 1988, c. 28, and subsection 65(4) of the Canada-Nova Scotia Offshore Petroleum Resources Accord Implementation (Nova Scotia) Act, S.N.S., 1987, c. 3, notice is hereby given that the Canada-Nova Scotia Offshore Petroleum Board has issued exploration licences 2366 and 2367 as a result of Call For Bids No. NS98-1. The effective date of these licences is January 1, 1999. In addition, the Canada-Nova Scotia Offshore Petroleum Board has issued exploration licences 2368 to 2386 inclusive as a result of Call For Bids No. NS98-2. The effective date of these 19 licences is July 1, 1999.

A summary of the terms and conditions of all relevant licences was previously published in the Canada Gazette and in the Royal Gazette (Nova Scotia), as part of the notices of Call For Bids No. NS98-1 and Call For Bids No. NS98-2. The full text of both calls for bids and copies of the exploration licences are available from the Board on request.

CANADA-NOVA SCOTIA OFFSHORE
PETROLEUM BOARD

J. E. (JIM) DICKEY
Chief Executive Officer

[29-1-o]

OFFICE OF THE SUPERINTENDENT OF FINANCIAL INSTITUTIONS

BANK ACT

Foreign Bank Orders

Notice is hereby given, pursuant to subsection 521(3) of the Bank Act, that His Excellency the Governor General in Council, on the recommendation of the Minister of Finance, pursuant to subsection 521(1) of the Bank Act, has consented to the following foreign bank acquiring shares of or ownership interests in one or more Canadian entities in such numbers as to cause the entities to become non-bank affiliates of the foreign bank:

Privy Council Number Foreign Bank Non-Bank
Affiliates
Effective Date
P.C. 1999-1011 First Union Corporation First Union
Commercial
Mortgage
Services Inc.
06/03/99

July 7, 1999

JAMES SCOTT PETERSON
Secretary of State
(International Financial Institutions)

[29-1-o]

OFFICE OF THE SUPERINTENDENT OF FINANCIAL INSTITUTIONS

INSURANCE COMPANIES ACT

Canada Life Financial Corporation

Notice is hereby given of the issuance on June 21, 1999, pursuant to section 22 of the Insurance Companies Act, of letters patent incorporating Canada Life Financial Corporation.

July 9, 1999

JOHN PALMER
Superintendent of Financial Institutions

[29-1-o]

OFFICE OF THE SUPERINTENDENT OF FINANCIAL INSTITUTIONS

INSURANCE COMPANIES ACT

Manulife Financial Corporation

Notice is hereby given of the issuance on April 26, 1999, pursuant to section 22 of the Insurance Companies Act, of letters patent incorporating Manulife Financial Corporation.

July 9, 1999

JOHN PALMER
Superintendent of Financial Institutions

[29-1-o]

Footnote 1

S.C., 1993, c. 36, s. 6

Footnote 2

R.S., 1985, c. S-9

Footnote 3

S.C., 1993, c. 36, s. 6

Footnote 4

R.S., 1985, c. S-9

Footnote 5

S.C., 1993, c. 36, s. 6

Footnote 6

S.C., 1993, c. 36, s. 6

Footnote 7

S.C., 1993, c. 36, s. 6

Footnote 8

S.C., 1993, c. 36, s. 6

Footnote 9

S.C., 1993, c. 36, s. 6

Footnote 10

S.C., 1993, c. 36, s. 6

Footnote 11

R.S., 1985, c. S-9


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