Vol. 136, No. 47 — November 23, 2002

Regulations Amending the Food and Drug Regulations (1094 — Food Irradiation)

Statutory Authority

Food and Drugs Act

Sponsoring Department

Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

Description

Treatment of foods with ionizing radiation, called food irradiation, is one process which can be used during food production to reduce bacterial load and hence improve food safety, prevent spoilage and control insect infestation in food commodities. Provisions currently exist in the Food and Drug Regulations for the use of the irradiation process on a limited number of foods. The Table to Division 26 of the Regulations lists the foods that can be irradiated and the respective purpose and conditions of use for each product. At the present time, food irradiation is permitted on potatoes and onions to inhibit sprouting during storage; on wheat, flour, and whole wheat flour to control insect infestation during storage; and on whole or ground spices and dehydrated seasoning preparations to reduce microbial load.

Before the irradiation process can be applied to other food products, a thorough review must be conducted by Health Canada to establish the chemical, toxicological and microbiological safety, and the nutritional quality of the proposed uses. If the safety of the new areas of use is confirmed, the treatment can only begin once the Regulations have been appropriately amended and the new uses listed in the Table to Division 26.

Requests for additions to the Table to Division 26 can be presented to Health Canada for evaluation and review. The information and data that must be included in a submission are prescribed in the Regulations. Submissions must present the purpose and complete technical details on the proposed use of the irradiation process, minimum and maximum absorbed dosages, efficacy data, process equipment and methodology, effects on nutritional quality of the food, evidence of maintenance of the chemical, physical or microbiological characteristics and safety of the food, recommended conditions of storage and shipment, and other processes that may be applied to the food before or after the proposed irradiation.

By regulation, all prepackaged food products that have been irradiated must carry a statement "treated with radiation," "treated by irradiation" or "irradiated" and display the international symbol identifying irradiated foods, the radura, on the principal display panel of their label. When an irradiated food is not sold in prepackaged form, a sign displaying the radura symbol must be located next to the point of sale of the food.

Health Canada has received several submissions to irradiate fresh and frozen ground beef, fresh and frozen poultry, and prepackaged fresh, frozen, prepared and dried shrimp and prawns to control pathogens, reduce microbial load and to extend durable shelf life. A submission has also been presented to irradiate mangoes as a disinfestation treatment to control fruit flies and the mango seed weevil.

Scientists in Health Canada have reviewed the data provided in the submission, as well as those found in numerous other scientific literature sources, in order to determine whether these new proposed uses of the food irradiation process met regulatory requirements for safety and effectiveness. It has been concluded that:

— the consumption of the irradiated foods would not result in any risk to the health of the consumer;

— the irradiation of the foods would not result in destruction or loss of nutrients in a food recognized as a significant source of those nutrients in the diet; and

— the proposed uses of food irradiation could be beneficial through improved safety of the food products resulting from enhanced control of pathogens or reduction in insect infestation.

Therefore, Health Canada proposes to recommend amendments to the Table to Division 26 of the Regulations to permit the new applications of the food irradiation process as listed above. For chicken, ground beef, shrimp and prawns, the permitted sources of irradiation would be Cobalt-60, Cesium-137, electrons from machine sources operated at or below an energy level of 10 million electron volts (MeV) or X-rays generated from a machine source operated at or below an energy level of 5 MeV. For mangoes, the permitted source of irradiation would be Cobalt-60.

International Environment

During the 1980s, a Joint Food and Agriculture Organization (FAO)/International Atomic Energy Agency (IAEA)/World Health Organization (WHO) Expert Committee on Food Irradiation (JECFI) of the United Nations reviewed the safety of the food irradiation. This review supported the adoption of a General Standard for Irradiated Foods by the Joint FAO/WHO Food Standards Programme, the Codex Alimentarius Commission, in 1983. This document addresses the various aspects of the food irradiation process, namely: general process requirements; hygiene of irradiated foods; technological requirements; re-irradiation; labelling; and methods of sampling and analysis. The Codex General Standard for Irradiated Foods states that, as one of the technological requirements for irradiating food, irradiation should not be used by the food industry as a substitute for good manufacturing practices. Information on the Codex General Standard for Irradiated Foods can be found at ftp://ftp.fao.org/codex/alinorm01/ al0112ae.pdf.

In the United States (US), the Food and Drug Administration (FDA) and the Food Safety and Inspection Service (FSIS) of the Department of Agriculture (USDA) have given clearance for the use of irradiation on a wider range of foods than is permitted or proposed in Canada. The approved areas of use in the US include the areas of use covered in the Canadian regulatory proposal with the exception of shrimps and prawns. Consideration is being given by the US government to new proposed uses of the food irradiation for control of food borne pathogens in crustaceans and processed crustaceans. At the present time, irradiation of shrimp, crustaceans and other seafood products is not yet approved. Further details on the status of food irradiation in the United States can be found at http://www.access.gpo.gov/nara/cfr/waisidx_ 01/21cfr179_01.html.

Australia and New Zealand have a regulatory approach similar to that of Canada and require that each specific application for irradiation or re-irradiation be approved by the Australia New Zealand Food Authority (ANZFA) on the basis of a demonstrated food safety or technological need. Public comment was solicited in October 2000 for the first proposed applications of the food irradiation process to herbs, spices, nuts, oilseeds and tea. On September 13, 2001, these countries approved irradiation of herbs, spices and herbal teas.

In the European Union (EU), food irradiation is controlled through two Directives. The Directive 1999/2/EC covers general and technical aspects for carrying out irradiation, labelling of irradiated foods and conditions for authorizing food irradiation, including a requirement that it must not be used as a substitute for hygiene and health practices, or for good manufacturing or agricultural practices. In addition, the Directive 1999/3/EC seeks to establish a Community list of food and food ingredients treated with ionizing radiation. So far, the list of products authorized for irradiation within the whole EU contains only a single entry: "dried aromatic herbs, spices and vegetable seasonings." The EU Directorate-General for Health and Consumer Protection has undertaken open discussions with consumer organizations, stakeholders and other interested parties as an initial step towards expanding the list. Further details can be found at http://europa. eu.int/comm/food/fs/sfp/fi_index_en.html.

Alternatives

Only those foods listed in the Table to Division 26 of the Regulations may be irradiated and offered for sale in Canada. Under the Regulations, provision for new uses of the food irradiation process can only be accommodated by regulatory amendment. Maintaining the status quo was rejected as this would preclude the use of the food irradiation process which has been shown to be both safe and effective for the foods covered by this proposal.

Benefits and Costs

As the proposed new applications of the food irradiation process would remain optional, the actual benefits and costs of the use of this process cannot be determined. It has been recognized by national and international bodies, such as the WHO and the FAO, that the food irradiation process is one method of reducing levels of pathogenic bacteria, other microorganisms and parasites that cause food borne illness and disease. Irradiation of poultry would destroy any Salmonella, a microorganism commonly associated with food borne disease and poultry. Irradiation would also destroy E. coli O157, if present in ground beef. While not common, illness caused by E. coli O157 has frequently been related to ground beef and can be very severe in some cases. The proposed new uses of food irradiation could contribute to a reduction in disease incidence and consequently result in an associated reduction in public and personal health costs.

Treatment with ionizing radiation can also improve the quality of foods by controlling insect infestations and microbial contamination after harvesting. This is of particular benefit with foods originating in warmer climates, such as mangoes, where insect infestation and microbial loads become problematic when the food must travel considerable distances before distribution and sale to consumers, or for use in manufactured food products. Therefore, irradiation has the potential to assist industry in enhancing the safety and quality of food products.

Both consumers and industry are likely to benefit from the longer durable shelf life of irradiated foods as a result of the reduction of spoilage bacteria in these foods. In the case of the irradiation of refrigerated fresh chicken, the durable life was found to be in the range of 14 to 22 days, a period two to three times that of non-irradiated fresh chicken. This extended durable life would be expected to reduce product wastage and disposal costs of "spoiled" food at retail and consumer levels.

The costs of installing, operating and monitoring food irradiation facilities are substantial and may be offset by any overall lowering of processing costs and other benefits such as a reduction of product wastage due to pathogen contamination. Furthermore, if the price of the product is increased as a result of the application of the irradiation process, the economic benefits resulting from reduced costs related to longer durable shelf life and reduced spoilage along the distribution chain may also be less apparent to the consumer.

It is anticipated that there would be costs to the Canadian Food Inspection Agency (CFIA) to develop compliance and enforcement activities as a result of these additional applications of food irradiation. Monitoring of labelling of additional irradiated products or of new promotional label statements may also require CFIA resources for the conduct of surveillance and compliance programs.

Consultation

Prior to the prepublication of these proposed amendments in the Canada Gazette, Part I, Health Canada conducted consultation with the affected industries and other departments of the federal government. More precisely, Health Canada consulted with the Canadian Produce Marketing Board, the Canadian Meat Council, the Canadian Poultry and Egg Processors Council, the Canadian Turkey Marketing Agency, the Fisheries Council of Canada, Agriculture and Agri-Food Canada and the CFIA.

The comments from industry stakeholders and the CFIA were generally supportive of the proposal and can be summarized as follows: a recommendation that irradiation be approved by Health Canada for all red meat products; the need for proposed regulations to prevent post-irradiation contamination of irradiated foods; and "Best before date" issues related to the implementation of the irradiation process by the food industry.

Health Canada's responses to these comments are outlined below.

Extension of food irradiation application to all red meat products

The evaluated data are adequate only for the application of the food irradiation process to ground beef products. Accordingly, Health Canada is not in a position to extend the proposed Regulations to include all red meat products.

The need for proposed regulations to prevent post-irradiation contamination of irradiated foods

Health Canada agrees that the post-irradiation handling of foods will be important in avoiding the recontamination of the irradiated foods with pathogenic organisms. Health Canada will develop guidelines, in collaboration with the CFIA, for the handling of irradiated foods.

"Best before date" related to the implementation of the food irradiation process by the food industry

While the issue of "Best before date" is new when applied to irradiated poultry, shrimp and prawns and ground beef products, it is not a new issue as there is a regulatory requirement at present for a "Best before date" for these foods when they have not been irradiated and certain prepackaged foods that have a shelf life of less than 90 days. This issue will be the subject of discussions between the CFIA, Health Canada and the industry. These discussions can take place after the proposed amendments are prepublished in the Canada Gazette, Part I.

Public Environment

Health Canada recognizes that public opinion and perceptions of food irradiation will play an important role in consumer response to the proposed regulatory amendments. When Health Canada proposed amendments to the Food and Drug Regulations in the 1980's with respect to food irradiation, the level of interest and attention was high. In response to the concerns, the Standing Committee on Consumer and Corporate Affairs examined the issues of food irradiation and the labelling of irradiated foods. The current regulatory provisions which require premarket review for each food product and use of irradiation, as well as mandatory labelling, were promulgated in 1989.

In spring 2000, a National Angus Reid Poll on food irradiation, commissioned by Agriculture and Agri-food Canada, revealed that:

— Canadians would likely approach irradiated foods with caution because of uncertainty about their safety;

— when given a brief description of the process, 51 percent thought that irradiation was a good idea and 42 percent thought that it was a bad idea;

— 54 percent said that they would not buy food treated with irradiation because of safety concerns, while 43 percent said that they would buy such food because it would make it safer from harmful bacteria and slow down spoilage;

— 93 percent of the respondents thought that information on food irradiation for the consumer was important.

In addition to the results of the Angus Reid Poll on food irradiation, Health Canada felt that it was important to obtain feedback on the general knowledge of consumers regarding the application of irradiation technology to food. A series of focus groups was organized in March 2001 to determine attitudes of Canadians towards food irradiation. Eight focus groups were conducted between March 6-8, 2001, in Halifax, Toronto, Montréal and Red Deer (two focus groups in each city). The results of the focus groups indicated that:

— the majority of people were neutral or negative in their predisposition to irradiated foods; however, they expressed a desire for more information;

— a variety of concerns were identified, including long-term impact on health, loss of nutritional value, labelling, unease with the technology, and lack of information;

— many participants expressing concerns grouped food irradiation in with other food technology issues such as genetic modification;

— there was general acceptance that new food technologies are here to stay and that irradiation has a positive role to play in reducing illness related to E. coli or other pathogens in some foods;

— the participants wanted information from a variety of sources, including the Government, and would be mistrustful of materials that present only positive information.

Upon prepublication of these proposed amendments in the Canada Gazette, Part I, Health Canada will conduct a series of information sessions on the proposed amendments in various locations across Canada. In addition, Health Canada will undertake the distribution of information materials on food irradiation. The factual information to be presented in the educational materials and in the information sessions will focus on:

— what "food irradiation" is;

— how food irradiation is used;

— the purpose of this process in the proposed applications;

— the limits of what food irradiation can and cannot do with regard to food safety;

— the regulation of food irradiation in Canada and in other countries;

— the significance of any nutritional, chemical or microbiological effects in the proposed food applications;

— the requirements in Canada for labelling of irradiated foods; and

— the ways in which consumers could identify irradiated foods in the marketplace.

Compliance and Enforcement

If these proposed amendments are adopted, the CFIA would develop and incorporate appropriate inspection and monitoring activities into ongoing domestic and import inspection programs. In addition, the Canadian Nuclear Safety Commission would include any new food irradiation facilities in its licensing, monitoring and inspection programs.

Contact

Ronald Burke, Director, Bureau of Food Regulatory, International and Interagency Affairs, Health Canada, Address Locator 0702C1, Ottawa, Canada K1A 0L2, (613) 957-1828 (Telephone), (613) 941-3537 (Facsimile), sche-ann@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 (1094 — Food Irradiation).

Interested persons may make representations with respect to the proposed Regulations within 90 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 Mr. ` International & Interagency Affairs, Department of Health, Room 2395, Address Locator 0702C1, Health Protection Building, Tunney's Pasture, Ottawa, Ontario K1A 0L2 (tel.: (613) 957-1828; fax: (613) 941-3537; e-mail: sche-ann@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, November 21, 2002

EILEEN BOYD
Assistant Clerk of the Privy Council

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1094 — FOOD IRRADIATION)

AMENDMENTS

1. The portion of item 3 of the table to Division 26 of Part B of the Food and Drug Regulations (see footnote 1)  in column III (see footnote 2)  is replaced by the following:

2. The portion of item 4 of the table to Division 26 of Part B of the Regulations in column II (see footnote 3)  is replaced by the following:

3. The table to Division 26 of Part B of the Regulations is amended by adding the following after item 4:

COMING INTO FORCE

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

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Regulations Amending the Food and Drug Regulations (1259 — Xylanase)

Statutory Authority

Food and Drugs Act

Sponsoring Department

Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

Description

Health Canada has received a submission to allow the use of the xylanase enzyme in the production of bread, flour and whole wheat flour at a maximum level consistent with good manufacturing practice. This enzyme is obtained from a genetically modified Aspergillus oryzae containing the xylanase gene from Thermomyces lanuginosis, A. oryzae Fa 1-1 (pA2X1TI). Evaluation of available data supports the safety and effectiveness for the proposed use of xylanase. This enzyme has been approved for use in the United States, Denmark, France and Spain.

The proposed amendment would permit the use of the xylanase enzyme obtained from the genetically modified Aspergillus oryzae Fa 1-1 (pA2X1TI) in the production of bread, flour and wholewheat flour at a maximum level consistent with good manufacturing practice.

Alternatives

Under the Food and Drug Regulations, enzymes used in the production of foods are considered foods additives and must be listed in Division 16 of the Food and Drug Regulations before they are allowed to be used in food products.

At the present time, there is no provision in the Regulations for the use of the enzyme xylanase in foods. Provision for the use of this new food additive can only be accommodated by regulatory amendment. Maintaining the status quo was rejected as this would preclude the use of an enzyme which has been shown to be both safe and effective.

Benefits and Costs

The proposed use of xylanase would benefit the consumer through the greater availability of quality baked goods. This proposed amendment would also benefit the industry by providing a new enzyme for use in the production of bread, flour and wholewheat flour and facilitating the production of quality baked goods.

There is no anticipated increase in costs to Government from the administration of this proposed amendment to the Regulations. Furthermore, compliance costs incurred by manufacturers are not considered to be a factor as the use of this food additive would be optional.

Consultation

Because of the proprietary nature of submissions which deal with food additives, consultation on proposed amendments are not carried out prior to prepublication in the Canada Gazette.

Compliance and Enforcement

If this proposed amendment is adopted, compliance would be monitored by ongoing domestic and import inspection programs conducted by the Canadian Food Inspection Agency.

Contact

Ronald Burke, Director, Bureau of Food Regulatory, International and Interagency Affairs, Health Canada, Address Locator 0702C1, Ottawa, Ontario K1A 0L2, (613) 957-1828 (Telephone), (613) 941-3537 (Facsimile), sche-ann@hc-sc.gc.ca (Electronic mail).

PROPOSED REGULATORY TEXT

Notice is hereby given that the Governor in Council, pursuant to subsection 30(1) (see footnote b)  of the Food and Drugs Act, proposes to make the annexed Regulations Amending the Food and Drug Regulations (1259 — Xylanase).

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 Mr. Ronald Burke, Director, Bureau of Food Regulatory, International and Interagency Affairs, Department of Health, Room 2395, Address Locator 0702C1, Health Protection Building, Tunney's Pasture, Ottawa, Ontario K1A 0L2 (tel.: (613) 957-1828; fax: (613) 941-3537; e-mail: sche-ann@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, November 21, 2002

EILEEN BOYD
Assistant Clerk of the Privy Council

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1259 — XYLANASE)

AMENDMENTS

1. Subparagraph B.13.001(e)(iii) of the Food and Drug Regulations (see footnote 4)  is replaced by the following:

(iii) amylase, amylase (maltogenic), bromelain, glucoamylase, glucose oxidase, lactase, lipase, lipoxidase, pentosanase, protease, pullulanase or xylanase,

2. Subparagraph B.13.005(d)(iii) of the Regulations is replaced by the following:

(iii) amylase, amylase (maltogenic), bromelain, glucoamylase, glucose oxidase, lactase, lipase, lipoxidase, pentosanase, protease, pullulanase or xylanase,

3. Paragraph B.13.021(h) of the Regulations is replaced by the following:

(h) amylase, amylase (maltogenic), bromelain, glucoamylase, glucose oxidase, lactase, lipase, lipoxidase, pentosanase, protease, pullulanase or xylanase;

4. Table V to section B.16.100 of the Regulations is amended by adding the following after item T.1:

COMING INTO FORCE

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

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Regulations Amending the Food and Drug Regulations (1286 — Schedule F)

Statutory Authority

Food and Drugs Act

Sponsoring Department

Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

Description

The Therapeutic Products Directorate (TPD) of Health Canada intends to update Schedule F to the Food and Drug Regulations of the Food and Drugs Act by adding 17 medicinal ingredients to Part I of Schedule F.

Schedule F is a list of medicinal ingredients, the sale of which are controlled specifically under sections C.01.041 to C.01.049 of the Food and Drug Regulations. Part I of Schedule F lists medicinal ingredients that, when contained in a drug, are sold on prescription for both human and veterinary 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 medicinal ingredients 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 17 medicinal ingredients be added to Part I of Schedule F:

1. Aminolevulinic acid and its salts and derivatives — a photodynamic therapy photosensitizer — in combination with blue light irradiation, indicated for the treatment of single and multiple non-hyperkeratotic actinic keratoses of the face and scalp.

2. Amlexanox and its salts and derivatives — an anti-inflammatory, anti-histaminic, leukotriene-inhibitor agent — indicated for the treatment of aphthous ulcers in people with normal immune systems.

3. Argatroban and its salts and derivatives — an antithrombotic — indicated as anticoagulant therapy in patients with heparin-induced thrombocytopenia syndrome.

4. Eflornithine and its salts and derivatives — a hair growth inhibitor — indicated for the condition of excessive facial hair growth (hirsutism) whose use is restricted to hirsute women.

5. Entacapone — an adjunct to levodopa and DDC inhibitor/ COMT-inhibitor — indicated as an adjunct to levodopa/carbidopa to treat patients with idiopathic Parkinson's Disease who experience signs and symptoms of end-of-dose "wearing-off".

6. Etanercept — a biological response modifier — indicated for reduction in signs and symptoms of moderately to severely active rheumatoid arthritis in patients who have an inadequate response to one or more disease-modifying antirheumatic drugs.

7. Fomepizole and its salts — a synthetic alcohol dehydrogenase inhibitor — indicated as an antidote for ethylene glycol (antifreeze) poisoning, or for use in suspected ethylene glycol ingestion.

8. Gatifloxacin and its salts and derivatives — an antibacterial agent — indicated for treatment when susceptible bacteria cause community-acquired pneumonia, acute bacterial exacerbations of chronic bronchitis, acute sinusitis, uncomplicated skin and skin structure infections, uncomplicated urinary tract infections (cystitis), complicated urinary tract infections, pyelonephritis, and uncomplicated urethral, rectal and cervical gonorrhoea.

9. Infliximab — a biological response modifier — indicated for the treatment of severe, active Crohn's disease in adult patients who have not responded to a full course of therapy with corticosteroid and/or an immunosuppressant, and for treatment of fistulising Crohn's disease in adult patients who have not responded to a full course of therapy with conventional treatment.

10. Linezolid and its salts — an antibacterial agent — indicated in adult patients for the treatment of:

— intra-abdominal, urinary tract, and skin and skin-structure infections (including cases associated with concurrent bacteremia) caused by Vancomycin-resistant Enterococcus faecium (VREF);

— nosocomial pneumonia or community-acquired pneumonia caused by Staphylococcus aureus (methicillin-susceptible and methicillin-resistant strains) or Streptococcus pneumoniae (penicillin-susceptible strains only, including community-acquired cases with concurrent bacteremia);

— complicated skin and skin-structure infections caused by Staphylococcus aureus (methicillin-susceptible and methicillin-resistant strains), Streptococcus pyogenes, or Streptococcus agalactiae; and

— uncomplicated skin and skin-structure infections caused by Staphylococcus aureus (methicillin-susceptible strains) or Streptococcus pyogenes.

11. Lopinavir — a Human Immunodeficiency Virus (HIV) protease inhibitor — in combination with ritonavir, indicated in conjunction with other antiretroviral agents for the treatment of HIV infection.

12. Moxifloxacin and its salts and derivatives — an antibacterial agent — indicated for treatment when susceptible bacteria cause community-acquired pneumonia, acute bacterial exacerbations of chronic bronchitis, and acute sinusitis.

13. Perflutren — a contrast enhancing imaging agent — indicated for contrast-enhanced ultrasound imaging of cardiac structures and function in adults with suboptimal echocardiograms, and for contrast-enhanced ultrasound imaging of the liver and kidneys in adults to improve the evaluation of pathology.

14. Rabeprazole and its salts — a H⁺, K⁺ — ATPase inhibitor — indicated in the treatment of conditions where a reduction of gastric acid secretion is required.

15. Sirolimus and its derivatives — an immunosuppressive agent — in combination with cyclosporine and corticosteroids, indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal transplants.

16. Tegafur and its salts — an antineoplastic agent and folic acid derivative — in combination with uracil and its salts, indicated for the treatment of metastatic colorectal cancer.

17. Uracil and its salts — an antineoplastic agent and folic acid derivative — in combination with tegafur and its salts, indicated for the treatment of metastatic colorectal cancer.

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 regulatory 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 1286 would benefit Canadians by decreasing the opportunities for improper use, and by ensuring professional guidance and care.

— 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 on Part I of Schedule F at the time of market approval of the drugs.

A Letter to the Stakeholders dated September 11, 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, and Health and Trade Associations, with a 30-day comment period. This initiative was also posted on the Therapeutic Products Directorate Web site: http://www.hc-sc.gc.ca/hpb-dgps/therapeut/zfiles/english/ schedule/earlycon/letter_stakeholder-1286_e.pdf. No comments were received regarding the 17 medicinal ingredients appearing in this proposed amendment.

A 75-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 Therapeutic Products Directorate Inspectors.

Contact

Mary Raphael, Policy Division, Bureau of Policy, Therapeutic Products Directorate, Department of Health, Holland Cross, Tower B, 2nd Floor, 1600 Scott Street, Address Locator 3102C5, Ottawa, Ontario K1A 1B6, (613) 957-6448 (Telephone), (613) 941-6458 (Facsimile), Mary_Raphael@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 c)  of the Food and Drugs Act, proposes to make the annexed Regulations Amending the Food and Drug Regulations (1286 — Schedule F).

Interested persons may make representations with respect to the proposed Regulations within 75 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice and be addressed to Mary Raphael, Therapeutic Products Directorate, Department of Health, Address Locator 3102C5, 1600 Scott Street, 2nd Floor, Tower B, Ottawa, Ontario K1A 1B6 (Tel.: (613) 957-6448; fax: (613) 941-6458; E-mail: Mary_Raphael@ 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, November 21, 2002

EILEEN BOYD
Assistant Clerk of the Privy Council

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1286 — SCHEDULE F)

AMENDMENT

1. Part I of Schedule F to the Food and Drug Regulations (see footnote 5)  is amended by adding the following in alphabetical order:

Aminolevulinic acid and its salts and derivatives

Aminolévulinique (acide), ses sels et dérivés

Amlexanox and its salts and derivatives

Amlexanox, ses sels et dérivés

Argatroban and its salts and derivatives

Argatroban, ses sels et dérivés

Eflornithine and its salts and derivatives

Éflornithine, ses sels et dérivés

Entacapone

Entacapone

Etanercept

Étanercept

Fomepizole and its salts

Fomépizole et ses sels

Gatifloxacin and its salts and derivatives

Gatifloxacine, ses sels et dérivés

Infliximab

Infliximab

Linezolid and its salts

Linézolide et ses sels

Lopinavir

Lopinavir

Moxifloxacin and its salts and derivatives

Moxifloxacine, ses sels et dérivés

Perflutren

Perflutrène

Rabeprazole and its salts

Rabéprazole et ses sels

Sirolimus and its derivatives

Sirolimus et ses dérivés

Tegafur and its salts

Tégafur et ses sels

Uracil and its salts

Uracile et ses sels

COMING INTO FORCE

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

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Footnote a 

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

Footnote 1 

C.R.C., c. 870

Footnote 2 

SOR/89-175

Footnote 3 

SOR/89-175

Footnote b 

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

Footnote 4 

C.R.C., c. 870

Footnote c 

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

Footnote 5 

C.R.C., c. 870