Vol. 132, No. 39 — September 26, 1998

By-law Amending the Saint John Harbour Dues By-law

Statutory Authority

Canada Ports Corporation Act

Sponsoring Agencies

Canada Ports Corporation and Saint John Port Corporation

REGULATORY IMPACT
ANALYSIS STATEMENT

Description

This Order approves of Saint John Port Corporation (the Corporation) changing harbour dues for Saint John harbour from time to time until January 1, 2002, at a rate not to exceed 4 percent per year.

Alternatives Considered

Section 13 of Schedule I to the Canada Ports Corporation Act requires harbour dues rates for entry into the harbour to be set by by-law made by the Corporation after recommendation by the Canada Ports Corporation and approval by Governor in Council.

Anticipated Impact

As changes in harbour dues pursuant to the Order are restricted to 4 percent per year, any such change would not impede access to the harbour unduly, while helping maintain the financial self-sufficiency of the Corporation, all of which is in accordance with the objective of the national ports policy expressed in section 3 of the Canada Ports Corporation Act. Pleasure craft, most ferries, and Canadian-registered fishing vessels less than 50 tons gross register are exempt from harbour dues.

The Corporation considers that such a change will not have a significant adverse impact on the environment. The assessment report will be made available on request when the Order is published.

Consultation

All major harbour users will be advised of harbour dues changes. In addition, the maximum change has been approved by the board of directors of the Canada Ports Corporation and the actual change will be approved by the board of directors of Saint John Port Corporation. The Canada Ports Corporation Act requires the former to be representative of national, regional and local interests essential to port activities and the latter to be representative of the regional and local population and interests in the management of the port of Saint John.

Compliance Mechanism

The Canada Ports Corporation Act provides for a lien on a vessel, the withholding of Customs clearance, and the seizure, detention and sale of the vessel upon failure to pay harbour dues. That Act also provides that every person who violates the By-law is guilty of an offence and is liable on summary conviction to a fine not exceeding $25,000 or to imprisonment for a term not exceeding six months or to both.

Contact

Capt Alwyn G. Soppitt, President and Chief Executive Officer, Saint John Port Corporation, P.O. Box 6429, Station A, Saint John, New Brunswick E2L 4R8, (506) 636-4869.

PROPOSED REGULATORY TEXT

Notice is hereby given that, pursuant to section 13 (see footnote a) of Schedule I to the Canada Ports Corporation Act, the Saint John Port Corporation proposes to make, by way of a certified resolution in the annexed form, such amendments as may be required from time to time, in the form set out in the annexed By-Law Amending the Saint John Harbour Dues By-law, to the rates set out in column II of the schedule to the Saint John Harbour Dues By-law (see footnote b), provided that, in respect of each rate that is the subject of an amendment made pursuant to the approval of the Governor in Council,

(a) where the rate has not previously been amended pursuant to that approval, the amendment does not change the rate by more than 4 percent per year from the rate effective on January 1, 1997;

(b) where the rate has previously been amended pursuant to that approval, the amendment does not change the rate by more than 4 percent per year from the rate effective on the day on which the most recent amendment of the rate came into effect; and

(c) the amendment does not come into effect after January 1, 2002.

Interested persons may make representations with respect to the proposed By-law 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 Capt Alwyn G. Soppitt, President and Chief Executive Officer, Saint John Port Corporation, P.O. Box 6429, Station A, Saint John, New Brunswick E2L 4R8, (506) 636-4869 (Telephone), (506) 636-4443 (Facsimile).

The representations should stipulate those parts of the representations that should not be disclosed pursuant to the Access to Information Act and, in particular, pursuant to sections 19 and 20 of that Act, the reason why those parts should not be disclosed and the period during which they should remain undisclosed. The representations should also stipulate those parts of the representations for which there is consent to disclosure pursuant to the Access to Information Act.

Ottawa, September 15, 1998

MICHEL GARNEAU
Assistant Clerk of the Privy Council

RESOLUTION

Whereas the Governor in Council, on the recommendation of the Minister of Transport and the Canada Ports Corporation, has, by Order in Council P.C. ————— of ————— , ——— , approved the making of the annexed By-law Amending the Saint John Harbour Dues By-law;

Therefore, the Saint John Port Corporation, pursuant to section 13 (see footnote c) of Schedule I to the Canada Ports Corporation Act, hereby makes the annexed By-law Amending the Saint John Harbour Dues By-law.

I, ————————————— , Secretary of the Saint John Port Corporation, hereby certify that the foregoing resolution was made on _____________________, _____.

_______________________ , _____

————————————————————————

Secretary

Saint John Port Corporation

BY-LAW AMENDING THE SAINT JOHN HARBOUR DUES BY-LAW

AMENDMENT

1. The schedule(see footnote 1) to the Saint John Harbour Dues By-law (see footnote 2) is replaced by the following:

SCHEDULE
(Section 5)

HARBOUR DUES

Item	Column 1 Description	Column 2 Rate ($)
1.	A vessel that ordinarily uses only the harbour and is engaged in commercial activity therein, for each year or part thereof,
	(a) in the case of a self-propelled vessel,
	(i) not more than 100 registered gross tons
	(ii) more than 100 but not more than 200 registered gross tons
	(iii) more than 200 registered gross tons
	(b) in the case of a scow,
	(i) not more than 50 registered gross tons
	(ii) more than 50 but not more than 100 registered gross tons
	(iii) more than 100 registered gross tons
	(c) in the case of a non-self-propelled vessel other than a scow
2.	(1) A vessel referred to in item 1 that departs from and comes into the harbour again, for each time it comes into the harbour, per registered gross ton
	(2) The minimum payable under subitem (1) is
3.	(1) A vessel, other than a vessel referred to in item 2, that comes into the harbour, for each time it comes into the harbour,
	(a) in the case of a vessel of Canadian registry engaged, at the time it comes into the harbour, in the carriage by water of goods or passengers from a place in Canada to another place in Canada, per registered gross ton
	(b) in the case of a vessel other than a vessel referred to in paragraph (a), per registered gross ton
	(2) The minimum payable under paragraph (1)(a) is
	(3) The minimum payable under paragraph (1)(b) is

COMING INTO FORCE

2. This By-law comes into force on the date on which it is registered.

[39-1-o]

Regulations Amending the Food and Drug Regulations (948)

Statutory Authority

Food and Drugs Act

Sponsoring Department

Department of Health

REGULATORY IMPACT
ANALYSIS STATEMENT

Description

Rapid advances in food science and biotechnology have resulted in the development of a variety of foods that were not previously available in the Canadian marketplace, or that have been modified from their traditional composition. In view of these developments, there is a need for a formal mechanism whereby these foods, commonly referred to as "novel foods", are notified to the Department of Health and, if deemed necessary, are assessed for safety prior to their sale to consumers.

Currently, a voluntary system exists where firms seeking to place a novel food on the market voluntarily submit information to the Department, enabling a safety review. This proposed amendment will formalize the current voluntary system. Public satisfaction with the thoroughness of the approaches implemented for evaluating the safety of novel foods is important to their acceptance by consumers.

The Food and Drug Regulations offer a number of mechanisms to control the sale of food in Canada. These mechanisms include pre-market notification, an approach which entails the submission of information regarding the product in question to the Health Protection Branch of Health Canada (HC) such that a determination can be made with respect to its acceptability as food prior to sale. This is the approach which has been selected with respect to "novel foods".

It is proposed that a new Division (i.e. chapter) of the Food and Drug Regulations be established that defines the concept of a "novel food" and provides for notification prior to the sale or advertising for sale of such products. Foods that are considered novel include:

— substances that have no history of safe use as a food,

— existing foods that have been modified by genetic manipulation and exhibit one or more characteristics that were previously not identified in that food, or food that results from production by a genetically manipulated organism exhibiting such new characteristics,

— food containing microorganisms that have not been previously used as food or to process food before, and

— food that is substantially different from a traditional food, or is manufactured using a process that has been substantially modified from the traditional process.

Further clarification of foods that would require notification is provided in the document entitled "Guidelines for the Safety Assessment of Novel Foods, Volume I" which is available from the Food Directorate, Health Canada, Health Protection Building, Room 200, Tunney's Pasture, Ottawa, Ontario K1A 0L2.

Certain foods, such as infant formulae, already require notification prior to sale to fulfil requirements from other sections of the Food and Drug Regulations. The intent of this proposed amendment is not to duplicate these existing requirements. Similarly, other governmental departments may require notification of certain novel foods to address their specific areas of responsibility. Agreements are being developed with those departments to clarify responsibilities and approaches to these issues. An agreement with the Canadian Food Inspection Agency (CFIA) exists which designates CFIA as the primary contact in the federal government for the agricultural industry. It also identifies Health Canada as being responsible for the food safety assessment of novel plants that are developed for use as food, or as animal feed if the modified feed has the potential to introduce harmful components into the portion of the animal being consumed as food.

This proposed amendment indicates when notification is required, and it establishes criteria for the assessment of novel foods in a timely manner. Written notification would be required at least 45 days prior to the sale or advertising for sale of any novel food. The Department would be required to respond within 45 days of receipt of the notification if the product is considered unacceptable for sale. If additional information is required to properly review the product, such information would be requested in writing. The applicant would not be permitted to sell or advertise their product until the additional information requirement is fulfilled and the Department has agreed to the acceptability of the product.

The information requirements for a notification are identified in the proposed Regulations. Data regarding the safety of the food may be requested if, in the opinion of the Director, a safety assessment is necessary. The evaluation of the product will be expedited if such information is available on request. Development of such data prior to any request is at the discretion of the applicant. The safety assessment criteria for novel plants and microorganisms are identified in the document entitled "Guidelines for the Safety Assessment of Novel Foods, Volume II", which is available from the Food Directorate of Health Canada at the above-noted address.

In view of the nature of the comments and the resulting major modifications made to the definition of novel food following the first pre-publication of this schedule in the Canada Gazette, Part I, of August 26, 1995, the decision was made to pre-publish again the proposed amendment in Canada Gazette, Part I, with a 60-day comment period.

Alternatives

Two options were considered with respect to this issue:

1. pre-market approval similar to that required for food additives, and

2. the current pre-market notification proposal.

The pre-market approval approach was viewed as introducing unnecessary impediments to the marketing of novel foods without providing a corresponding increase in the level of consumer protection.

The most viable option is, therefore, considered to be the current regulatory proposal. This proposal is similar to the regulatory approach in place in the United States and soon to be in effect in the European Union. It incorporates the safety assessment concepts developed by the Group of National Experts on Food Safety of the Organization for Economic Cooperation and Development (OECD).

Benefits and Costs

The benefit of the pre-notification requirement is that the Department would be notified prior to the sale of novel foods in Canada and it would have the opportunity to evaluate their safety for use as food. As such, there would be an enhanced level of protection for the consumer. This process would also facilitate the possible successful marketing of such products by providing a degree of assurance to the public regarding their safety.

The proposed regulatory amendment may result in some increased cost to industry related to notification prior to the sale of a novel food and, if necessary, to the development of data to evaluate its safety. These additional costs would vary from product to product, depending on the nature of each product and the amount of testing that would be required. The Department anticipates that companies developing such products would, in any event, address food safety issues as part of ongoing research programs for such products without the regulation. In these cases, the cost of the regulation would be associated with the notification and not the compilation of the safety assessment data. Thus, the actual cost to industry will be difficult to determine until the number of additional products that require assessment is identified.

Consultation

On August 5, 1992, Information Letter (IL) No. 806 was released by HC. This represented the first public step in the development of regulations in Canada to ensure the safety of novel foods. Additional consultations have been undertaken since that time, including publication of the "Guidelines for the Safety Assessment of Novel Foods", and the co-sponsoring, with CFIA and Environment Canada, of a public workshop concerning the regulation of agricultural products of biotechnology. Numerous meetings, as well as written and verbal communications, have also been undertaken with companies, industry associations, consumers groups and individuals.

Following the publication of the proposed amendments in the Canada Gazette, Part I, on August 26, 1995, a total of 35 responses commenting on the proposed amendments were received. Of these responses, 28 were on behalf of industry or industry associations, 2 were from agencies of one foreign government, 2 from individual citizens, 1 from a labour organization, 1 from an environmental interest group and 1 from a consumers group.

While not numerous, the responses to the proposed amendments of August 26, 1995, were substantial and complex. A number of consultations were subsequently held with specific stakeholder groups in order to clearly determine their concerns and discuss ways to resolve them. The result was, as outlined below, a substantial change to the definition of novel food. The following are the issues raised in the comments and the Department's response.

Unqualified Support

Four responses supported the amendments as proposed. It is noteworthy that all four were received from firms engaged in developing new seed varieties using biotechnology.

Labelling

Seven responses expressed a need for proper labelling of novel foods, especially for those novel foods which are derived using genetic engineering. This amendment does not address labelling; it deals only with pre-market notification and safety assessment of novel foods. Labelling of novel foods derived from genetic engineering is being dealt with by CFIA in cooperation with this department. An Information Letter on the subject has been released in 1997 by CFIA.

Scope

Twenty-five responses centred primarily on the definition of a novel food and on novel food processes. The comments fell into four broad groups: (1) the definition of novel food is not clear and/or is too broad; (2) the definition needs to focus on health and safety rather than on the method of production; (3) the amendment should focus only on foods from genetically modified sources; and (4) the amendment should better reflect a risk based approach to assessment of novel foods.

The definition of a novel food has been substantially modified. A number of changes were made to make the definition clearer and narrow its scope. For ease of reference, the definition from the August 26, 1995, issue of Canada Gazette, Part I, read as follows:

"'novel food' means

(a) a substance, including a microorganism, that has not previously been manufactured, sold or represented for use as food in Canada,

(b) a food, including a food additive, that is manufactured, prepared, preserved or packaged by a process that has not previously been used to manufacture, prepare, preserve or package that food, where as a result of that process

(c) a food that is derived from a plant, animal or microorganism that has been genetically modified such that

The definition was made more selective by modifying part (a) of the novel food definition. The Department does not wish to review all foods new to the Canadian market; it only wishes to review those that are novel. Therefore, the concept of prior safe use as a food was introduced to exclude foods new to the Canadian market, but which have a history of safe food use elsewhere, from being the target of a novel food notification. Part (a) of the definition was modified to read:

"(a) a substance, including a microorganism, that does not have a history of safe use as a food".

The concept of "major change", which is itself defined in the amendment, has been introduced into part (b) of the novel food definition in order to avoid the potential of a minor processing change to trigger a novel food notification. This approach will restrict novel food notifications due to the introduction of new processes only to those that are truly new and cause substantial changes in the food. Part (b) of the definition was modified to read:

"(b) a food that has been manufactured, prepared, preserved or packaged by a process that

The definition of major change has been added and it states:

"'major change' means, in respect to a food, a change in the food that, based on the manufacturer's experience or generally accepted theory, may have an adverse affect on

(a) the composition, structure or nutritional value of the food or its generally recognized physiological effects,

(b) the manner in which the food is metabolized in the body, or

(c) the microbiological safety, the chemical safety or the safe use of the food."

Part (c) of the novel food definition, which deals with foods derived from genetically modified sources, remains unchanged, i.e.

"(c) a food that is derived from a plant, animal or microorganism that has been genetically modified such that

The Department has concluded that foods derived using genetic engineering should be treated as other foods requiring a safety assessment. In addition, it has also concluded that novel foods not derived using genetic engineering require a similar review to ensure safety as foods derived from genetic engineering. Therefore, the amendment covers the two types of novel foods and both will require notification.

The changes introduced into the definition of novel food are intended to enhance the risk based approach. The narrowing of scope assures that only those foods that may pose a safety risk will be assessed.

Harmonization and Competitiveness

Fourteen responses noted the need to harmonize Canadian requirements with major trading partners for the purposes of international harmonization and the competitiveness of Canadian industry. Canada uses the safety assessment concepts developed by the Group of National Experts on Food Safety of the Organization for Economic Cooperation and Development (OECD). Canada's trading partners, such as the United States and the European Union, use the same assessment approach. New Zealand and Australia are also considering a similar approach. Therefore, the technical aspect of assessing the safety of novel foods is consistent with internationally accepted approaches.

Other

Five responses mentioned the length of the response time in the notification period. The initial response time by the Department, following notification, has been reduced from 90 days to 45 days. The time needed for additional assessment, if required, has been maintained at 90 days.

One response made mention of the need for an appeal mechanism and one response discussed the need for public involvement in the assessment process. The Department is currently reviewing its overall consultation policy with a view to establishing a more comprehensive consultation framework. It is anticipated that an enhanced consultation framework will facilitate public input into all Departmental assessment activities and provide an avenue for discussing results of assessments.

Compliance and Enforcement

If the regulatory proposal is adopted, inspection programs will be undertaken at both domestic and import levels to ensure compliance with the regulatory requirements.

Contact

Director, Bureau of Food Regulatory, International and Interagency Affairs, Health Canada, Address Locator 0702C, Ottawa, Ontario K1A 0L2, (613) 957-1828 (Telephone), (613) 941-3537 (Facsimile).

PROPOSED REGULATORY TEXT

Notice is hereby given that the Governor in Council, pursuant to subsection 30(1) of the Food and Drugs Act, proposes to make the annexed Regulations Amending the Food and Drug Regulations (948).

Interested persons may make representations with respect to the proposed Regulations within 60 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 the Director, Bureau of Food Regulatory, International and Interagency Affairs, Department of Health, Address Locator 0702C, Health Protection Building, Room 200, Tunney's Pasture, Ottawa, Ontario K1A 0L2.

The representations should stipulate those parts of the representations that should not be disclosed pursuant to the Access to Information Act and, in particular, pursuant to sections 19 and 20 of that Act, the reason why those parts should not be disclosed and the period during which they should remain undisclosed. The representations should also stipulate those parts of the representations for which there is consent to disclosure pursuant to the Access to Information Act.

Ottawa, September 15, 1998

MICHEL GARNEAU
Assistant Clerk of the Privy Council

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (948)

AMENDMENT

1. Part B to the Food and Drug Regulations is amended by adding the following after section B.27.005:

DIVISION 28

NOVEL FOODS

Interpretation

B.28.001. The definitions in this section apply in this Division.

"genetically modify" means to change the heritable traits of a plant, animal or microorganism by means of intentional manipulation. (modifier génétiquement)

"major change" means, in respect of a food, a change in the food that, based on the manufacturer's experience or generally accepted theory, may have an adverse affect on

(a) the composition, structure or nutritional value of the food or its generally recognized physiological effects,

(b) the manner in which the food is metabolized in the body, or

(c) the microbiological safety, the chemical safety or the safe use of the food. (changement majeur)

"novel food" means

(a) a substance, including a microorganism, that does not have a history of safe use as a food;

(b) a food that has been manufactured, prepared, preserved or packaged by a process that

(c) a food that is derived from a plant, animal or microorganism that has been genetically modified such that

Pre-market Notification

B.28.002. (1) No person shall sell or advertise for sale a novel food unless the manufacturer or importer of the novel food, at least 45 days before the sale or advertising for sale, notifies the Director in writing of the intention to sell or advertise for sale the novel food.

(2) A notification referred to in subsection (1) shall be signed by the manufacturer or importer, or a person authorized to sign on behalf of the manufacturer or importer, and shall include the following information:

(a) the common name under which the novel food will be sold;

(b) the name and address of the principal place of business of the manufacturer and, if the address is outside Canada, the name and address of the principal place of business of the importer;

(c) a description of the novel food, together with

(d) information respecting the estimated levels of consumption by consumers of the novel food;

(e) the text of all labels to be used in connection with the novel food; and

(f) the name and title of the person who signed the notification and the date of signing.

B.28.003. (1) Within 45 days after receiving a notification referred to in subsection B.28.002(1), the Director shall

(a) review the information included in the notification; and

(b) if, on reviewing the information, the Director considers it necessary to assess the safety of the novel food, request in writing that the manufacturer or importer submit the evidence relied on to establish that the novel food is safe for consumption.

(2) A manufacturer or importer who is requested to submit evidence under paragraph (1)(b) in respect of a novel food shall not sell or advertise for sale the novel food until the manufacturer or importer

(a) has submitted the evidence to the Director; and

(b) is notified in writing by the Director pursuant to subsection (3) that the evidence is sufficient.

(3) Within 90 days after receiving the evidence requested under paragraph (1)(b) the Director shall assess it and, if it establishes that the novel food is safe for consumption, notify the manufacturer or importer in writing that the evidence is sufficient.

COMING INTO FORCE

2. These Regulations come into force on the date on which they are registered.

[39-1-o]

Regulations Amending the Food and Drug Regulations (1095)

Statutory Authority

Food and Drugs Act

Sponsoring Department

Department of Health

REGULATORY IMPACT
ANALYSIS STATEMENT

Description

Health Canada has received a submission for the use of Brilliant Blue FCF in Feta type cheeses as a whitener to standardize the colour of this type of cheese to compensate for seasonal variations in milk colour used in the production of the cheese. Seasonal variations are dependent on the feedstuff consumed by the animals.

Provision currently exists in the Food and Drug Regulations for the use of this colouring agent in a variety of foods but not in Feta cheese.

This additional use of Brilliant Blue FCF has been evaluated from the standpoint of safety and efficacy, in accordance with section B.16.002 of the Food and Drug Regulations. It was concluded that the new use would not pose a health nor a fraud risk to consumers.

Therefore, the proposed amendment will provide for the use of Brilliant Blue FCF in Feta cheese at a level of 0.1 part per million (p.p.m.).

Alternatives

Under the Food and Drug Regulations, a new use for approved food additives can only be accommodated by regulatory amendment. Maintaining the status quo was rejected as this would deny the use of a food additive which is beneficial to both the food industry and consumers.

Benefits and Costs

This proposed amendment will provide the industry with a whitener for Feta cheese, allowing for standardized colour of this type of cheese throughout the year.

It is not anticipated that there will be any increased costs to Government from the administration of this proposed amendment to the Regulations.

Compliance costs are not a factor, as the use of Brilliant Blue FCF by manufacturers of Feta cheese is optional.

Consultation

This proposed amendment was developed in consultation with the firm making the submission. Comments were received on this proposal from the Canadian Food Inspection Agency, the Manitoba Ministry of Agriculture, the Ontario Ministry of Agriculture and Food, le Ministère de l'Agriculture, des pêcheries et de l'alimentation du Québec, the National Dairy Council of Canada, the British Columbia Dairy Council, the Dairy Farmers of Canada, the Canadian Dairy Commission and the Conseil de l'industrie laitière du Québec Inc. In general, comments received were favourable to the regulatory amendment.

Compliance and Enforcement

If the proposed amendment is adopted, compliance will be monitored by ongoing domestic and import inspection programs.

Contact

Director, Bureau of Food Regulatory, International and Interagency Affairs, Health Canada, Address locator 0702C, Ottawa, Ontario K1A 0L2, (613) 957-1828 (Telephone), (613) 941-3537 (Facsimile).

July 24, 1998

PROPOSED REGULATORY TEXT

Notice is hereby given that the Governor in Council, pursuant to subsection 30(1) of the Food and Drugs Act, proposes to make the annexed Regulations Amending the Food and Drug Regulations (1095).

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 the Director, Bureau of Food Regulatory, International and Interagency Affairs, Department of Health, Address Locator 0702C, Health Protection Building, Room 200, Tunney's Pasture, Ottawa, Ontario K1A 0L2.

The representations should stipulate those parts of the representations that should not be disclosed pursuant to the Access to Information Act and, in particular, pursuant to sections 19 and 20 of that Act, the reason why those parts should not be disclosed and the period during which they should remain undisclosed. The representations should also stipulate those parts of the representations for which there is consent to disclosure pursuant to the Access to Information Act.

Ottawa, September 15, 1998

MICHEL GARNEAU
Assistant Clerk of the Privy Council

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1095)

AMENDMENT

1. Item 4 of Table III to section B.16.100 of the Food and Drug Regulations(see footnote 3) is amended by adding the following in columns II and III after subitem (3):

Column II Permitted in or Upon	Column III Maximum Level of Use
(4) Feta cheese (brilliant blue FCF only)	(4) 0.10 p.p.m.

COMING INTO FORCE

2. These Regulations come into force on the date on which they are registered.

[39-1-o]

Regulations Amending the Food and Drug Regulations (1129)

Statutory Authority

Food and Drugs Act

Sponsoring Department

Department of Health

REGULATORY IMPACT
ANALYSIS STATEMENT

Description

The Pest Management Regulatory Agency of Health Canada has received a request for the registration of the acaricide bromopropylate for use against tetranychid and eriophyid mites on grapes and citrus fruits. Health Canada has also been requested to establish maximum residue limits (MRLs) for residues of bromopropylate in food commodities resulting from such use.

To ensure public health and safety, Health Canada establishes MRLs for agricultural chemicals based on scientifically developed acceptable daily intakes (ADIs). Health Canada bases its safety assessment of agricultural chemical residues in food on the critical review of all scientific data available, calculating the probable daily intake of a residue and comparing this to the ADI which was determined by extensive tests on laboratory animals and the application of an appropriate safety factor.

After the review of all available data, it is proposed to amend the Food and Drug Regulations to establish MRLs for bromopropylate in grapes and citrus fruits at 2 parts per million (p.p.m.); and in raisins at 10 p.p.m. These new MRLs would harmonize with the MRLs for bromopropylate in grapes and citrus fruits established by the Joint Food and Agriculture Organization of the United Nations / World Health Organization Food Standards Programme, Codex Alimentarius Commission.

Alternatives

Under the Food and Drug Regulations, MRLs must be established for residues of agricultural chemicals for which the general tolerance of 0.1 p.p.m. specified in subsection B.15.002(1) is not considered appropriate. In the case of bromopropylate, the proposed MRLs for the above listed food commodities are necessary to support the use of an agricultural chemical which has been shown to be both safe and effective.

Benefits and Costs

The establishment of MRLs for bromopropylate on citrus fruits, grapes and raisins will provide joint benefits to consumers and the agriculture industry from improved control of insect pests, higher crop yields and improved crop quality which contribute to a safe, abundant and affordable food supply.

The cost of administering this proposed amendment to the Regulations will not be greater than that of administering the existing Regulations since monitoring for residues of agricultural chemicals, whether or not MRLs have been established, is performed on an ongoing basis. Adequate analytical methodology for analysis of bromopropylate is available.

Consultation

Because of the proprietary nature of submissions to establish MRLs for agricultural chemical residues, consultation prior to publication in the Canada Gazette is not carried out.

However, the safety evaluations conducted by Health Canada include a review of the assessments conducted by international organizations such as the Joint Food and Agriculture Organization of the United Nations / World Health Organization Food Standards Programme, Codex Alimentarius Commission, as well as MRLs adopted by other national health agencies.

Compliance and Enforcement

If the proposed amendment receives final approval, compliance will be monitored by ongoing domestic and import inspection programs.

Contact

The Head, Food Residue Exposure Assessment Section, Pest Management Regulatory Agency, Health Canada, Address Locator 6605E1, 2250 Riverside Drive, Ottawa, Ontario K1A 0K9, (613) 736-3520 (Telephone), (613) 736-3505 (Facsimile).

PROPOSED REGULATORY TEXT

Notice is hereby given that the Governor in Council, pursuant to subsection 30(1) of the Food and Drugs Act, proposes to make the annexed Regulations Amending the Food and Drug Regulations (1129).

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 the Head, Food Residue Exposure Assessment Section, Pest Management Regulatory Agency, Health Canada, Address Locator 6605E1, 2250 Riverside Drive, Ottawa, Ontario K1A 0K9.

The representations should stipulate those parts of the representations that should not be disclosed pursuant to the Access to Information Act and, in particular, pursuant to sections 19 and 20 of that Act, the reason why those parts should not be disclosed and the period during which they should remain undisclosed. The representations should also stipulate those parts of the representations for which there is consent to disclosure pursuant to the Access to Information Act.

Ottawa, September 15, 1998

MICHEL GARNEAU
Assistant Clerk of the Privy Council

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1129)

AMENDMENT

1. Table II to Division 15 of Part B of the Food and Drug Regulations (see footnote 4) is amended by adding the following after item B.4:

Item No.	I Common or (Trade Name)	II Chemical Name of Substance	III Maximum Residue Limit p.p.m.	IV Foods
B.5	bromopropylate	isopropyl 4,4'-dibromobenzilate	2	Citrus fruits, grapes
			10	Raisins

COMING INTO FORCE

2. These Regulations come into force on the date on which they are registered.

[39-1-o]

CES Grant Regulations

Statutory Authority

Department of Human Resources Development Act

Sponsoring Department

Department of Human Resources Development

REGULATORY IMPACT
ANALYSIS STATEMENT

Description

The February 24, 1998, Budget introduced The Canadian Opportunities Strategy, which includes a new Canada Education Savings (CES) Grant. The CES Grant is payable on behalf of eligible beneficiaries of Registered Education Savings Plans (RESPs), and the amount is based on the amount of the contributions made to the RESP. The CES Grant is intended to make RESPs more attractive as vehicles for saving for children's post secondary education.

Some of the highlights of the new grant program are:

— Beginning January 1, 1998, the Government will pay a Canada Education Savings Grant of 20 percent on the first $2,000 of annual contributions made to RESPs in each year, on behalf of eligible beneficiaries, up to the year of their 17th birthday. The maximum CES Grant will be $400 per beneficiary, per year.

— A family that has been unable to make contributions for one or more years may catch up in later years on missed contributions. In this case, the CES Grant will be paid on contributions up to $4,000 per year, with the maximum CES Grant payable in any particular year being $800.

— The Government will pay the CES Grant to the trustee of the RESP, to be invested in the subscriber's plan. The CES Grant itself will not be included in calculating the beneficiary's annual and lifetime RESP contribution limits.

— The CES Grant, and the investment income it generates, will be paid to the beneficiary when he or she enrols in eligible full-time, post-secondary education or training programs.

— If the beneficiary does not pursue education or training, the CES Grant must be repaid to the Government. Investment income from the CES Grant may be transferred to the subscriber's RRSP, if certain conditions are met.

— Contributions for beneficiaries aged 16 or 17 will receive a grant only where $2,000 of RESP contributions were made before the year in which the beneficiary attained 16 years of age, or where a minimum of $100 in annual RESP contributions were made in any four years before the year in which the beneficiary attained 16 years of age. During the transitional years of 1998 and 1999, a grant will be payable on behalf of 16 and 17 year olds who were beneficiaries under an RESP for at least four years before 1998.

Alternatives

The Canada Education Savings Grant is a new program which will be administered by Human Resources Development Canada (HRDC). Bill C-36 amended the Human Resources Development Act to add Part III.1, which provides the legislative basis for paying the grant. It also provides authority for making regulations which set out the rules for determining eligibility for the grant, conditions to be met before a grant can be paid, circumstances where a grant must be repaid, and terms and conditions to be included in the agreements between the Minister and the RESP trustees. As such, no other alternatives were explored or considered.

Benefits and Costs

There were approximately 700 000 Registered Education Savings Plans in existence at the time the CES Grant Program was announced in the Budget. This number has already increased significantly, due to widespread interest generated by publicity surrounding the announcement of the CES Grant.

The current estimated cost for the grants to be paid in 1998 is $200-$300 million. It is expected that more and more individuals will be encouraged to open RESPs. As this happens, more and more Canadians will have a savings base to finance their post-secondary education, thereby reducing their reliance on other forms of funding.

This program has the potential to change how Canadians pay for their post secondary education, and to benefit millions of future students.

Consultation

The CES Grant Program was developed to encourage Canadians to use RESPs as a vehicle for saving for post secondary education. The Regulations have been developed in such a way that they clearly define the conditions under which grants may be paid. The Regulations were developed by HRDC, in conjunction with Legal Counsel, and staff of the Department of Justice, Department of Finance and Revenue Canada.

The CESG Program held consultations with the RESP promoters and trustees in July, 1998, which included information concerning the development of the rules which would be incorporated in the Regulations. Further consultations held at the end of August and the beginning of September, 1998, provided the opportunity for the promoters and trustees to provide their input into the development of the Regulations.

Compliance and Enforcement

The agreements which will be implemented with each of the trustees and the promoters of the RESPs and the Minister specify the roles and responsibilities of HRDC and the promoters and trustees in relation to the payment of the grant. They include provisions for audit, payment of and charging of interest, and penalties for breach of agreement.

It is expected that these provisions, as well as existing compliance mechanisms contained in HRDC's control procedures will ensure that these Regulations are properly implemented and subsequently evaluated.

Contact

Mary Flynn-McRae, Manager, Operations Strategy and Support, Canada Education Savings Grant Program, Learning and Literacy Directorate, Human Resources Investment Branch, Human Resources Development Canada, 15 Eddy Street, 10th Floor, Hull, Quebec K1A 0M5, (819) 953-3836 (Telephone), (819) 953-6500 (Facsimile).

PROPOSED REGULATORY TEXT

Notice is hereby given that the Governor in Council, pursuant to Part III.1 of the Department of Human Resources Development Act, proposes to make the annexed CES Grant Regulations.

Interested persons may make representations concerning the proposed Regulations within 15 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 Mary Flynn-McRae, Manager, Operations Strategy and Support, Canada Education Savings Grant Program, Learning and Literacy Directorate, Human Resources Development Canada, 15 Eddy Street, 10th Floor, Hull, Quebec K1A 0M5, (819) 953-3836 (Telephone), (819) 953-6500 (Facsimile).

September 24, 1998

MICHEL GARNEAU
Assistant Clerk of the Privy Council

CES GRANT REGULATIONS

INTERPRETATION

1. (1) The definitions in this subsection apply in these Regulations.

"Act" means the Department of Human Resources Development Act. (Loi)

"assisted contribution" means a contribution made to a RESP by a subscriber under the RESP in respect of which a CES grant has been paid. (cotisation subventionnée)

"CES grant agreement" means an agreement entered into by the Minister and a trustee under a RESP that relates to the payment of a CES grant to the RESP. (convention de subvention)

"EAP" means an educational assistance payment. (PAE)

"grant account" means, in respect of a RESP, an account that is

(a) credited with

(b) debited with

"group RESP" means a RESP that is part of an arrangement that includes other RESPs issued by the same promoter for beneficiaries who share the same year of eligibility, where the EAPs to which beneficiaries under the arrangement are entitled are determined on the basis of the number of beneficiaries who are eligible to receive EAPs in a year of eligibility. (REEE collectif)

"RESP" means a registered education savings plan. (REEE)

"unassisted contribution" means a contribution made to a RESP by a subscriber under the RESP in respect of which no CES grant has been paid. (cotisation non subventionnée)

"year of eligibility" means, in respect of a group RESP, the year in which a beneficiary may be eligible to receive an EAP. (année d'admissibilité)

(2) Unless the contrary intention appears,

(a) an expression in these Regulations that is defined for the purposes of section 146.1 of the Income Tax Act has the same meaning in these Regulations as it has for the purposes of that section; and

(b) all other expressions in these Regulations have the same meanings as in the Income Tax Act.

ORDERING OF WITHDRAWALS

2. For the purposes of these Regulations, where both assisted and unassisted contributions have been made to a RESP, withdrawals of contributions from the RESP are considered to be made in the following order:

(a) assisted contributions are considered to be withdrawn before unassisted contributions; and

(b) unassisted contributions made after 1997 are considered to be withdrawn before unassisted contributions made before 1998.

ROUNDING OF AMOUNTS

3. If, when determined, an amount payable by or to the Minister under the Act or these Regulations is not a multiple of one dollar, it shall be rounded to the nearest multiple of one dollar or, if equidistant from two such consecutive multiples, to the higher of the multiples.

MANNER OF DETERMINING AMOUNT OF CES GRANTS

4. (1) Subject to subsection (3), the amount of a CES grant that may be paid at any time in respect of a contribution made in a year to a RESP by a subscriber under the RESP in respect of a beneficiary under the RESP is equal to the lesser of

(a) 20% of the contributions, and

(b) the amount, if any, by which the lesser of

exceeds

(2) For the purpose of subsection (1), the unused CES grant room of a beneficiary for a particular year at any time is

(a) if the beneficiary was 17 years of age or older at the end of the preceding year, nil; or

(b) in any other case, determined by the formula

$400 (A - B - C) - D

where

A is

exceeds

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