Vol. 134, No. 38 — September 16, 2000

Regulations Amending the Food and Drug Regulations (1107 — Carbon Dioxide)

Statutory Authority

Food and Drugs Act

Sponsoring Department

Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

Description

Provision currently exists in the Food and Drug Regulations for the use of carbon dioxide for carbonation of beverages and for a variety of other purposes in foods. Health Canada has received two submissions to permit the use of carbon dioxide as a pH-adjusting agent in milk used for cheese production and as a shelf life extender in cottage cheese and creamed cottage cheese. Evaluation of available data supports the effectiveness and safety of these uses for carbon dioxide.

Therefore, it is proposed to amend the Food and Drug Regulations to permit the optional addition of carbon dioxide as a pH-adjusting agent to milk used in the production of (naming the variety) cheese and as a shelf life extender in cottage cheese and creamed cottage cheese in an amount consistent with good manufacturing practice.

Alternatives

Under the Food and Drug Regulations, provision for new uses of an approved food additive can only be accommodated by regulatory amendment. Maintaining the status quo was rejected as this would preclude additional uses of a food additive which have been shown to be both safe and effective.

Benefits and Costs

This proposed amendment would provide manufacturers with an alternative and more efficient method for the production of cheese thus improving yield and productivity. In cottage cheese and creamed cottage cheese, the use of carbon dioxide would extend the shelf life of the products benefiting both the industry and the consumer.

The cost of administering this proposed amendment is not anticipated to be greater than the cost of administering the existing Regulations. Compliance costs for industry are not a factor as the use of carbon dioxide as a pH-adjusting agent in milk for cheese production or in cottage cheese and creamed cottage cheese to extend shelf life would be optional.

Consultation

During the development of this proposed amendment, consultation was conducted with the Dairy Farmers of Canada, the National Dairy Council of Canada, provincial dairy councils and provincial ministries of agriculture. There was general support for the proposal to use carbon dioxide as a pH-adjusting agent in the production of cheese and as a shelf life extender in cottage cheese and creamed cottage cheese.

At the request of petitioners, Interim Marketing Authorization (IMA) letters were published in the Canada Gazette, Part I, on February 28, 1998, for the pH adjusting purpose in cheese production, and on January 21, 1999, for the shelf life extender in cottage cheese and creamed cottage cheese. These IMAs permit the immediate use of carbon dioxide for these purposes while the regulatory process to formally amend the Regulations was undertaken.

Compliance and Enforcement

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

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 a) of the Food and Drugs Act, proposes to make the annexed Regulations Amending the Food and Drug Regulations (1107 — Carbon Dioxide).

Interested persons may make representations with respect to the proposed Regulations within 30 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to 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, September 12, 2000

MARC O'SULLIVAN
Assistant Clerk of the Privy Council

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1107 — CARBON DIOXIDE)

AMENDMENTS

1. Paragraph B.08.033(1)(b) of the Food and Drug Regulations(see footnote 1) is amended by striking out the word "and" at the end of subparagraph (ix), by adding the word "and" at the end of subparagraph (x) and by adding the following after subparagraph (x):

2. Paragraph B.08.051(d) of the Regulations is amended by striking out the word "and" at the end of subparagraph (xii), by adding the word "and" at the end of subparagraph (xiii) and by adding the following after subparagraph (xiii):

3. (1) The portion of item C.11 of Table VIII to section B.16.100 of the Regulations in columns II, III and IV is amended by adding the following after subitem (2):

Item No.	Column II Permitted in or Upon	Column III Purpose of Use	Column IV Maximum Level of Use
C.11	(3) Cottage Cheese; Creamed Cottage Cheese	(3) To extend durable life	(3) Good Manufacturing Practice

(2) Table X to section B.16.100 of the Regulations is amended by adding the following after item C.13:

Item No.	Column I Additive	Column II Permitted in or Upon	Column III Maximum Level of Use
C.13A	Carbon Dioxide	(Naming the variety) Cheese	Good Manufacturing Practice

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 (1173 — Maximum Residue Limits for Veterinary Drugs)

Statutory Authority

Food and Drugs Act

Sponsoring Department

Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

Description

Under the Canadian Food and Drug Regulations, all veterinary drugs must be approved by Health Canada prior to their sale and administration to prevent and treat diseases in animals. Some drugs are only permitted in certain species not intended to be used for foods while others are used in food producing animals. These proposed amendments would establish safe limits for residues of 16 veterinary drugs in foods originating from animals treated with these particular drugs. These veterinary drugs are an important tool in the production of healthy animals which are destined for use as food.

Acceptable levels of residues of veterinary drugs in food commodities are called maximum residue limits (MRLs). MRLs are the maximum concentrations of residues, expressed in parts per million (ppm) on a fresh weight basis, in edible tissues of food producing animals as a result of the treatment of those animals with veterinary drugs. An MRL is based on the type and amount of residue considered to pose no adverse health effects if ingested daily by humans over a lifetime. There are a number of MRLs already established in Table III to Division 15 of the Food and Drug Regulations.

In order to determine whether MRLs are safe, scientists in Health Canada review the toxicity and residue depletion data submitted by manufacturers, assess the risks and benefits of the resulting use of the drug and the acceptability of the resulting levels of residues of the drugs that are found in food products. Only when there is assurance that the residues found will not pose any health hazards to consumers can the drug be permitted for administration to food producing animals and the related food product sold in Canada. Extensive studies have determined that the food commodities containing the specific veterinary drugs at levels up to the proposed MRLs listed in the amendments are safe for consumption. These MRLs would apply to foods produced domestically or imported into Canada.

Alternatives

The addition of new MRLs for veterinary drugs to Table III in Division 15 of the Food and Drug Regulations, can only be accommodated by regulatory amendment. These proposed amendments would list additional MRLs for specific veterinary drugs which are beneficial to the food industry and do not pose any health hazard to consumers.

Benefits and Costs

These proposed amendments would permit the sale of food containing residues of veterinary drugs used to prevent and treat diseases in food producing animals. These proposed amendments would benefit both industry and the consumer by reducing potential losses in production, increasing quality of products and improving availability of certain foods.

A number of the proposed MRLs are harmonized with MRLs for veterinary drugs already established by Canada's major trading partners such as the United States. In addition, the proposed amendments include MRLs that are harmonized with levels established by the Codex Alimentarius Commission and adopted by many countries.

There would not be an increased cost to government from the administration of these proposed amendments to the Regulations. Compliance costs would not be a factor as the use of these drugs at the production level would be optional.

Consultation

Prior to this prepublication in the Canada Gazette, Part I, consultation was undertaken with provincial and federal health and agriculture authorities, Canadian veterinary colleges, provincial veterinary medical associations, the Canadian Veterinary Medical Association, the Dairy Farmers of Canada, the Aquaculture Association of Canada, the Canadian Feed Industry, the Canadian Chicken Marketing Agency, the Canadian Turkey Marketing Agency, the National Dairy Council of Canada, the Further Poultry Processors Association of Canada, the Canadian Cattlemen's Association, the Canadian Animal Health Institute, the Canadian Meat Council, the Fisheries Council of Canada, the Canadian Pork Council, the Canadian Poultry and Egg Processors Council, the Federal/Provincial/Territorial Committee on Food Safety Policy, the Canadian Beef Export Federation, the Canadian Food Inspection Agency, Agriculture and Agri-Food Canada, and the Department of Fisheries and Oceans.

There were twenty responses received as a result of the above consultation. The letters were generally supportive of the proposed MRLs. The comments provided by the respondents can be summarized as follows: comments on specific proposed MRLs (10), harmonization of these MRLs with those of Canada's major trading partners (6), effects of the proposed MRLs on the use of screening tests and methods of detection (3), adjustment of withdrawal times in different countries for harmonized MRLs (1), requests for information on the basis for approval of MRLs in general or for additional MRLs (6).

Health Canada's response on each of these issues is outlined below.

Comments on specific MRLs proposed in this schedule of amendments

One respondent, a representative of the Quebec provincial government, was concerned that specific proposed MRLs would allow antibiotic residues in milk, which would be contrary to their provincial requirements. At the time of the response, Quebec provincial regulations required that milk be free of antiseptics and antibiotics. New legislation, pertaining to agricultural, marine and dairy products, was enacted in Quebec this summer. Further time is needed to examine this legislation to determine what impact, if any, it may have on proposed MRLs for veterinary drug residues in milk. Accordingly, the MRLs of concern to Quebec have been removed from this schedule of amendments to allow the other MRLs to continue through the regulatory process. When this situation has been clarified, the MRLs for veterinary drugs in milk would be considered for inclusion in a future schedule of amendments.

The other nine comments were very technical in nature and responses have been sent directly to the respondents.

Harmonization with Trading Partners

Six respondents commented on harmonization of these proposed MRLs with those of Canada's major trading partners. Currently, some of the proposed MRLs are harmonized with the United States, some with Codex and some with the levels established by the European Union (EU). Complete harmonization with trading partners or international organizations is desirable, but will not occur until countries start conducting joint reviews of scientific data. Efforts to achieve greater harmonization will continue to be supported by Canada and MRLs will be harmonized whenever possible.

Screening Tests and Methods of Detection

Three respondents commented on the continued suitability of screening tests and other methods of detection particularly with regard to the potential for an increased rate of false positives due to the increased number of MRLs for antibiotics in milk. These proposed amendments would establish MRLs for antibiotics that may be used as alternatives for the antibiotics currently listed in Table III to Division 15 of the Regulations. It is not likely that all of the antibiotics currently listed and proposed in these amendments would be used in dairy cattle at the same time. Accordingly, it is not anticipated that the proposed new MRLs would increase the overall residues of antibiotics in milk and result in rejection of a shipment of milk due to an increased rate of false positives in screening tests.

Adjustment of withdrawal times

One respondent inquired whether the proposed MRLs are acceptable in the context of international trade and commercially recognized withdrawal times. The withdrawal period is defined as the period of time between the last administration of a drug to an animal and the collection of edible tissues or products from that animal. This period ensures that the residues in the food comply with the established MRL in the Regulations. The assessment of a withdrawal period may differ depending on the scientific interpretations endorsed by the different countries. Accordingly, the withdrawal periods established by different countries, for a specific veterinary drug, may not be automatically equal even though the MRLs are harmonized for a particular drug in the same tissue.

Basis for Approval of MRLs and Requests for Additional MRLs

Two respondents raised this issue. Under the Food and Drug Regulations, there is a pre-clearance requirement to establish the safety and efficacy of a veterinary drug before it can be used for treating animals. The assessment includes the review of potential adverse effects in humans resulting from the consumption of foods containing the residues of the drug. An MRL can be established only when there is sufficient evidence to indicate that the use of the veterinary drug in food producing animals and the resulting residue of the drug would not pose a hazard to the health of the Canadian consumer.

Four respondents requested additional MRLs for the use of a veterinary drug in an application of interest to them. Interested parties were invited to submit official requests under the process described earlier in accordance with the pre-market assessment requirement. If sufficient data are available to establish the safety of the suggested MRLs, they would be included in a future schedule of amendments.

Compliance and Enforcement

If these proposed amendments are adopted, compliance would be monitored by ongoing domestic and import inspection programs.

Contact

Mr. 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 (1173 — Maximum Residue Limits for Veterinary Drugs).

Interested persons may make representations with respect to the proposed Regulations within 30 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Mr. Ronald Burke, Director, Bureau of Food Regulatory, 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, September 12, 2000

MARC O'SULLIVAN
Assistant Clerk of the Privy Council

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1173 — MAXIMUM RESIDUE LIMITS FOR VETERINARY DRUGS)

AMENDMENTS

1. Table III to Division 15 of Part B of the Food and Drug Regulations(see footnote 2) is amended by adding the following before item A.1:

Item No.	Column I Common Name (or Brand Name) of Drug	Column II Name of Substance for Drug Analysis Purposes	Column III Maximum Residue Limit p.p.m.	Column IV Foods
A.01	albendazole	albendazole-2-aminosulfone	0.2	Liver of cattle

2. Table III to Division 15 of Part B of the Regulations is amended by adding the following after item E.1:

Item No.	Column I Common Name (or Brand Name) of Drug	Column II Name of Substance for Drug Analysis Purposes	Column III Maximum Residue Limit p.p.m.	Column IV Foods
F.1	fenbendazole	fenbendazole	0.45 4.5	Liver of cattle Liver of swine
F.2	florfenicol	florfenicol amine	0.8 2	Muscle of salmonids Liver of cattle

3. Table III to Division 15 of Part B of the Regulations is amended by adding the following before item H.1:

Item No.	Column I Common Name (or Brand Name) of Drug	Column II Name of Substance for Drug Analysis Purposes	Column III Maximum Residue Limit p.p.m.	Column IV Foods
H.01	halofuginone	halofuginone	0.1	Liver of chicken

4. The portion of item I.1 of Table III to Division 15 of Part B of the Regulations in columns III(see footnote 3) and IV(see footnote 4) is replaced by the following:

Item No.	Column III Maximum Residue Limit p.p.m	Column IV Foods
I.1	0.015 0.03 0.07	Liver of swine Liver of sheep Liver of cattle

5. Table III to Division 15 of Part B of the Regulations is amended by adding the following before item L.1:

Item No.	Column I Common Name (or Brand Name) of Drug	Column II Name of Substance for Drug Analysis Purposes	Column III Maximum Residue Limit p.p.m.	Column IV Foods
L.01	lasalocid	lasalocid	0.35 0.65	Fat and skin of chicken Liver of cattle

6. Table III to Division 15 of Part B of the Regulations is amended by adding the following before item M.1:

Item No.	Column I Common Name (or Brand Name) of Drug	Column II Name of Substance for Drug Analysis Purposes	Column III Maximum Residue Limit p.p.m.	Column IV Foods
M.01	maduramicin	maduramicin	0.4	Fat and skin of chicken

7. Table III to Division 15 of Part B of the Regulations is amended by adding the following after item M.1:

Item No.	Column I Common Name (or Brand Name) of Drug	Column II Name of Substance for Drug Analysis Purposes	Column III Maximum Residue Limit p.p.m.	Column IV Foods
M.2	morantel tartrate	N-methyl-1,3-propane diamine	0.1 0.5	Milk Liver of cattle
M.3	moxidectin	moxidectin	0.55	Fat of cattle
N.01	narasin	narasin	0.5	Fat of chicken

8. The portion of item P.1 of Table III to Division 15 of Part B of the Regulations in column IV(see footnote 5) is replaced by the following:

Item No.	Column IV Foods
P.1	Milk Edible tissue of turkeys Edible tissue of cattle and swine

9. Table III to Division 15 of Part B of the Regulations is amended by adding the following before item S.1:

Item No.	Column I Common Name (or Brand Name) of Drug	Column II Name of Substance for Drug Analysis Purposes	Column III Maximum Residue Limit p.p.m.	Column IV Foods
S.01	salinomycin	salinomycin	0.35	Fat and skin of chicken; Liver of cattle and swine

10. Table III to Division 15 of Part B of the Regulations is amended by adding the following after item S.3:

Item No.	Column I Common Name (or Brand Name) of Drug	Column II Name of Substance for Drug Analysis Purposes	Column III Maximum Residue Limit p.p.m.	Column IV Foods
S.3.1	sulfadiazine	sulfadiazine	0.1	Muscle of salmonids

11. The portion of item S.6 of Table III to Division 15 of Part B of the Regulations in columns III(see footnote 6) and IV(see footnote 7) is replaced by the following:

Item No.	Column III Maximum Residue Limit p.p.m.	Column IV Foods
S.6	0.01 0.1	Milk Edible tissue of calves, cattle, chickens, swine and turkeys

12. Table III to Division 15 of Part B of the Regulations is amended by adding the following after item T.3:

Item No.	Column I Common Name (or Brand Name) of Drug	Column II Name of Substance for Drug Analysis Purposes	Column III Maximum Residue Limit p.p.m.	Column IV Foods
T.3.1	tilmicosin	tilmicosin	1.6	Liver of cattle
T.3.2	trimethoprim	trimethoprim	0.1	Muscle of salmonids

COMING INTO FORCE

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

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Regulations Amending the Pest Control Products Regulations

Statutory Authority

Pest Control Products Act

Sponsoring Department

Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

Description

The purpose of this regulatory amendment is to substantially reduce regulatory duplication between the Pest Control Products Act (PCPA) and the Food and Drugs Act (FDA) by exempting disinfectant uses of a control product from the PCPA in order to consolidate their regulation under the FDA. Sanitiser uses associated with exempt disinfectant uses of a control product would also be exempted from the PCPA. Use of a control product in a swimming pool or spa or use as a preservative or slimicide would not be exempt. This is part of the government's plans to reform legislation and eliminate duplication wherever possible.

Disinfectants destroy or inactivate viruses, bacteria or other micro-organisms. These micro-organisms may be pathogenic (disease-causing) or non-pathogenic. Disinfectants that are used to treat, mitigate or prevent disease in humans or animals are included in the definition of "drug" in the FDA and are, therefore, subject to that Act. The definition of "drug" in the FDA also includes disinfectants used in food processing and storage establishments.

Disinfectants are also included in the definition of "control product" in the PCPA because micro-organisms are included in the definition of "pest." Therefore, disinfectants are also subject to the PCPA. The Pest Control Products Regulations currently exempt some disinfectant uses from the PCPA because they are subject to the FDA, for example, use on humans or domestic animals, use on articles that will come directly into contact with humans or animals, and use in food processing and storage establishments.

Nevertheless, there are many uses of disinfectants that are subject to both Acts. In the past, administrative arrangements were made to avoid requiring approval of the same disinfectant use under both Acts. Disinfectants used in health care facilities, food processing establishments and on medical instruments were evaluated by the Health Protection Branch (HPB), Health Canada, under authority of the FDA, while institutional, agricultural, domestic and industrial uses of disinfectants were evaluated by the Pest Management Regulatory Agency (PMRA), Health Canada, under authority of the PCPA. However, products with dual uses (e.g., hospitals and schools) had to be approved by both the Therapeutic Products Programme (TPP) of HPB and the PMRA before they could be marketed.

This regulatory amendment would exempt, from the PCPA, disinfectants used to prevent human and animal disease in order to consolidate their regulation under the FDA.

Sanitisers do not destroy or inactivate all micro-organisms, but rather reduce their levels significantly. Sanitisers may reduce human or animal pathogens to acceptable levels established by federal or provincial health authorities. They may also control or reduce mould, mildew and other pathogenic or non-pathogenic micro-organisms or odours resulting from the presence of micro-organisms. Sanitisers are currently regulated under the PCPA. Because sanitisers lack a high enough level of efficacy to meet the definition of "drug" they are not regulated as such under the FDA.

Sanitisers used in food processing establishments are regulated under the FDA to ensure that they do not present a safety concern to food products. This use is currently exempt from the PCPA.

A large number of disinfectant products are also labelled with sanitiser uses. Many dual disinfectant/sanitiser products, whose disinfectant uses had to be approved under the FDA, also required approval with respect to their sanitiser uses by PMRA under the PCPA.

This regulatory amendment would substantially reduce the duplicate review and approval processes under the PCPA and the FDA as it exempts from the PCPA disinfectant uses and any sanitiser use of a product with an exempt disinfectant use. This would not reduce regulatory oversight because products meeting the FDA requirements for safety would have been deemed acceptable under the PCPA.

Products that are labelled only for sanitiser use will continue to be regulated under the PCPA because these products would not otherwise be subject to any regulatory oversight. However, TPP has agreed to re-examine the therapeutic value of sanitiser-only products in order to consider the possibility of including sanitiser-only products in the regulatory framework under the FDA and to establish an interim arrangement for the pre-market assessment and approval of sanitisers under the PCPA in the meantime.

Swimming pool and spa products would remain subject to the PCPA because these products are used both as algaecides as well as to control micro-organisms that might cause disease. Algaecides are subject to the PCPA but not to the FDA, because they do not control human or animal pathogens. Exempting the uses of these products that could be regulated under the FDA from the PCPA would have introduced, rather than eliminated, a regulatory overlap.

Uses as material preservatives or slimicides would also continue to be subject to the PCPA. The use patterns and methods and rates of application of preservatives and slimicides differ significantly from those of other products used to control micro-organisms and, therefore, a separate assessment of risk and value under the PCPA is required.

Alternatives

The options considered were:

Option 1) regulate all disinfectant products under the FDA only

Option 2) regulate all disinfectant products under the PCPA only

Option 3) status quo

The following key factors were considered in the decision making process to select the most appropriate option:

— Both the PCPA and FDA provide for an effective means for regulation of these products.

— Both the regulatory organizations involved have the expertise and responsibilities for assessing human health and safety and product performance for disinfectants.

— The PCPA primarily regulates sale and use while the FDA primarily regulates manufacture and sale. Option 2 would require the PMRA to become actively involved in compliance and investigations for public health/disease management related to the use of these products in critical health care areas. Investigations related to public health/disease management in critical health care facilities are currently conducted by on-site infection control committees and local and provincial health departments.

— As the primary purpose of disinfectant products is to destroy or inactivate micro-organisms for the purpose of treatment, mitigation or prevention of human or animal disease, these types of products are best regulated under the FDA as drugs, rather than pesticides.

— Regulation of disinfectant products used to destroy or inactivate micro-organisms for the purpose of treatment, mitigation or prevention of human or animal disease is necessary to guarantee their safety and performance.

— The status quo is not acceptable since it would continue unnecessary duplication of regulation and is counter to the federal government's desire to streamline regulation and avoid unnecessary regulatory burdens.

— For products having both sanitiser and disinfectant claims, the disinfectant claim will be subject to an assessment under the FDA. This assessment will effectively address human health and safety concerns for the product and efficacy concerns for the disinfectant use. Products for which the disinfectant use meets the FDA requirements would not be expected to pose a health or safety concern with respect to their sanitiser use. Thus the regulation of disinfectant uses under the FDA should allay any concern about not directly regulating the associated sanitiser use.

In view of the foregoing considerations, the regulation of disinfectant products for the control of disease in humans or animals, other than in swimming pools and spas, under the FDA is the preferred option. This decision was announced to industry on January 29, 1997 and has been implemented operationally in advance of this regulatory amendment.

Benefits and Costs

This regulatory amendment will result in additional costs to some registrants and manufacturers of disinfectant products. These costs would include a one time fee per product for products not currently regulated by FDA. This fee would be either $720 for a Drug Identification Number (DIN) application fee or $310 for a DIN application fee for a standard label or class monograph. In addition, manufacturers will be responsible for the Establishment Licence fee, base fee of $6,000, and a potential cost of implementing the Quality Management System (QMS). The cost of Establishment Licencing and implementing QMS are difficult to estimate because they are dependant on the individual manufacturing facilities and new regulatory framework. The concerns expressed regarding these additional costs have been considered in developing the January 1999 Proposal for Discussion: a revised regulatory framework for disinfectant and sanitiser cleaning products and will be further considered through consultation between TPP and stakeholders.

These additional costs will be offset by benefits to both government and registrants. Government will have consolidated the regulatory responsibility for this group of products within TPP, thus reducing the duplicate evaluations, administration and compliance activities. Applications for disinfectant approvals will be charged a single fee for assessment under the FDA.

Registered products will be required to pay only FDA maintenance fees instead of maintenance fees under both PCPA and FDA, resulting in an estimated average savings of $490 per product per year.

As of August 1997, there were 615 Commercial and 58 Domestic Class disinfectant products registered under the PCPA by 312 different companies that could be affected by this regulatory amendment. Approximately 20 products with sanitiser-only uses will remain under the PCPA, but pre-market assessment and approval will be consolidated within TPP.

Consultation

The Canadian Manufacturers of Chemical Specialities (CMCS) which includes approximately 20 members from the more than 1 000 companies belonging to the disinfectant and sanitiser industry asked the federal government to streamline the regulatory framework for these products by creating a single window for the pre-market assessment of disinfectants and sanitisers. They were supported by Industry Canada in presenting their proposals to Health Canada. A meeting with CMCS was held January 26, 1996, to discuss the issue of regulatory overlap for disinfectants. The industry association reiterated its request for a simpler, less costly regulatory system.

Consultation with respect to the selected option was held during CMCS/Health Canada meetings on January 30-31, 1997. Representatives of various organizations within Health Canada, i.e., the PMRA, the Bureau of Pharmaceutical Assessment, HPB, and the Food Directorate, HPB, as well as a representative of Industry Canada, attended. Industry stakeholders expressed concerns on the level and timing of consultation as part of the development of a revised regulatory system for disinfectants under the FDA and the need for an efficient regulatory system.

To address these concerns, a workshop between industry, regulators and other stakeholders was held on June 25-26, 1997, to obtain stakeholders' recommendations for a program review of the regulation of disinfectants and sanitisers. Industry was asked to identify key elements that should be included in a risk management framework to reflect the level of risk for these products. Industry was invited to identify a possible approach to address product quality components required for the regulation of these products.

While industry expressed support for the consolidation of the regulation of disinfectants under the FDA, the CMCS indicated disappointment that all sanitisers could not also be regulated under that Act. Since TPP had determined that sanitiser uses lack a high enough level of efficacy to be consistent with the definition of "drug" under the FDA, this was not possible.

A letter, guidance document and a set of questions and answers were sent on December 8, 1997, to registrants of disinfectant and sanitiser products with the Canada Gazette, Part I publication of the proposed regulatory amendment. The purpose of this communication was to explain the changes in jurisdiction for these products, in order to facilitate comments on the proposed regulatory amendment. Six replies were received in response to the Canada Gazette, Part I publication. All comments were in support of establishing a single jurisdiction for disinfectants and sanitisers but requested a delay in finalizing the Canada Gazette, Part II publication to allow for further development of the new regulatory framework under the FDA.

On November 9-10, 1998, a multi-stakeholder workshop was held by TPP to more fully address the concerns of the CMCS and the Canadian Sanitation Supply Association (CSSA) as well as the consumer and user groups who had not been involved in earlier stages of the consultation process. The workshop focussed on the elements of a re-designed, flexible, appropriate regulatory framework for therapeutic products in Canada. This workshop built on previous consultation activities of June 25-26, 1997 and complemented the broader public consultation process on Health Protection Legislative Renewal. Documentation from the workshop is posted on the TPP web site. At the conclusion, TPP committed to develop a draft regulatory framework for stakeholder comment.

On January 19, 1999, more than 2 000 copies of the document entitled Proposal for Discussion: a revised regulatory framework for disinfectant and sanitiser cleaning products, were distributed. More than 200 manufacturers, public health, environmental and consumer groups responded to the proposal with written comments and a survey response form. Analysis of these comments revealed there was support in general for the regulatory framework, especially for a risk-based approach for the regulation of disinfectant products and disinfectants with associated sanitiser uses.

There were, however, objections to the proposal expressed by the CMCS as well as 15 individual CMCS member companies. CMCS objected to requirements associated with the FDA drug quality assurance standards (i.e., Good Manufacturing Practices) and Establishment Licensing, and also to TPP's inability to regulate, under the FDA, products solely for use as sanitisers.

TPP held discussions with CMCS and agreed in December 1999 to work with the industry to develop a Quality Management System (QMS) for disinfectant and disinfectant/sanitiser products.

TPP also agreed to review the possibility of including sanitiser-only products in the regulatory framework under the FDA and to establish an interim arrangement to administer the regulation of sanitisers under the PCPA in the meantime.

These steps will address the objections to the previous Part I publication. CMCS, CSSA and other smaller, independent companies are all now supportive of the regulatory amendment.

Because of the significant elapsed time since the December 6, 1997 publication in Canada Gazette, Part I, which was needed to resolve the concerns of stakeholders, this proposed amendment will be pre-published again for final comment in Canada Gazette, Part I.

Compliance and Enforcement

The FDA compliance tools which currently only apply to disinfectants used in health care facilities and food processing establishments would apply to all disinfectant products used to control disease in humans or animals. This will provide a uniform approach to compliance for these products. Investigations in hospitals related to microbial control will continue under the established infection control committees and local and provincial medical officers of health. It is the expectation of both the PMRA and the HPB that products will continue to meet performance standards as specified by the Association of Official Analytical Chemists (AOAC) or the Canadian General Standards Board (CGSB) standards.

Contact

Grace Lewis, Publications Coordinator, Pest Management Regulatory Agency, Health Canada, Address Locator 6606D1, 2250 Riverside Drive, Ottawa, Ontario K1A 0K9 (613) 736-3592 (Telephone), (613) 736-3666 (Facsimile), grace_lewis@hc-sc. gc.ca (Electronic mail).

PROPOSED REGULATORY TEXT

Notice is hereby given that the Governor in Council, pursuant to subsection 6(1)(see footnote c) of the Pest Control Products Act, proposes to make the annexed Regulations Amending the Pest Control Products Regulations.

Interested persons may make representations with respect to the proposed Regulations within 75 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Publications Coordinator, Pest Management Regulatory Agency, Department of Health, Address Locator 6606D1, 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 12, 2000

MARC O'SULLIVAN
Assistant Clerk of the Privy Council

REGULATIONS AMENDING THE PEST CONTROL PRODUCTS REGULATIONS

AMENDMENTS

1. Section 3 of the Pest Control Products Regulations(see footnote 8) is replaced by the following:

3. (1) The following control products are exempt from the Act:

(2) Where a control product is exempt under paragraph (1)(c), (d) or (e), the product is exempt only in respect of the uses described in that paragraph.

(3) A control product described in paragraph (1)(d) is not exempt from the Act in respect of its use in a swimming pool or spa.

(4) A control product described in paragraph (1)(e) is not exempt from the Act in respect of

(a) its use as a preservative for wood or other material;

(b) its use as a slimicide; or

(c) its use in a swimming pool or spa.

2. Sections 5 to 7(see footnote 9) of Schedule II to the Regulations are repealed.

COMING INTO FORCE

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

[38-1-o]

Footnote a

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

Footnote 1

C.R.C., c. 870

Footnote b

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

Footnote 2

C.R.C., c. 870

Footnote 3

SOR/91-255

Footnote 4

SOR/91-255

Footnote 5

SOR/91-255

Footnote 6

SOR/91-255

Footnote 7

SOR/91-255

Footnote c

S.C. 1993, c. 44, s. 200

Footnote 8

C.R.C., c. 1253

Footnote 9

SOR/92-585

NOTICE:
The format of the electronic version of this issue of the Canada Gazette was modified in order to be compatible with extensible hypertext markup language (XHTML 1.0 Strict).