Vol. 136, No. 40 — October 5, 2002

Regulations Amending the Medical Devices Regulations (1293 — Quality systems)

Statutory Authority

Food and Drugs Act

Sponsoring Department

Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

Description

These proposed amendments pertain to the quality system requirements contained in sections 32 and 43 of the Medical Devices Regulations.

The Medical Devices Regulations were promulgated in July 1998. Because of the complexity and magnitude of the work that needed to be done to implement some of the requirements of the Regulations, Part 5 of the Medical Devices Regulations contained transitional provisions and delayed the coming into force dates of certain requirements including quality systems requirements which were delayed to July 1, 2001. As July 1, 2001, approached, Health Canada decided that more time was needed to prepare for the implementation of the quality system requirements and requested an amendment to delay the coming into force date of the requirements to January 1, 2003. Health Canada anticipated that the 18-month period between July 1, 2001, and January 1, 2003, would serve as a transition phase whereby manufacturers of Class II, III and IV devices would have an opportunity to increase their ability to comply with the Medical Devices Regulations by January 1, 2003. Health Canada also saw the 18-month period as an opportunity for manufacturers of Class II, III and IV devices to voluntarily submit valid ISO 13485 or ISO 13488 quality management system certificates to Health Canada before such certificates become mandatory under the Regulations on January 1, 2003. Information was set out in a guidance document titled "Voluntary Implementation Phase" (VIP) which was published on the Health Canada Web site August 24, 2001.

Under the quality system requirements of the Medical Devices Regulations, manufacturers of Class II medical devices must have their devices manufactured in accordance with the National Standard of Canada CAN/CSA-ISO 13488-98, Quality Systems — Medical devices — Particular requirements for the application of ISO 9002, as amended from time to time, and manufacturers of Classes III and IV medical devices must have their devices designed and manufactured in accordance with the National Standard of Canada CAN/CSA-ISO 13485-98, Quality systems — Medical devices — Particular requirements for the application of ISO 9001, as amended from time to time.

As currently written, the quality system requirements state that a senior official of the manufacturer must submit, with their application for a medical device licence, a written attestation that their device is in compliance with the applicable above-mentioned standard. The Medical Devices Regulations further require that the attestation be based on an audit by an organization that performs quality system audits. Presently, the quality system requirements do not apply to those manufacturers who will have device licences prior to January 1, 2003.

These proposed amendments require that:

— the organization that performs the audit of the manufacturer's quality system be a quality system registrar, who is recognized by the Minister of Health as having the necessary training, experience and technical knowledge in the design and manufacture of medical devices and in the effective implementation of quality systems to determine whether a quality system satisfies the applicable standards referred to above, and conducts quality system audits in accordance with the applicable guidelines and practices established by the International Organization for Standardization (ISO);

— the registrar, upon completing a satisfactory quality system audit, issues, to the manufacturer, a quality system certificate, which will be valid for a maximum of three years;

— the manufacturer, when applying for a medical device licence, submit a copy of its quality system certificate to the Minister, to demonstrate that its device is in compliance with the above-stated standards;

— the manufacturer submit a copy of a new quality system certificate before the three-year expiry date of the certificate previously submitted to the Minister;

— the manufacturer submit a copy of a new or modified quality-system certificate within 30 days of its issuance, when one is issued before the expiration date of the one previously submitted to the Minister, for example, addition of a manufacturing site to the original facility scope;

— if a quality system certificate is suspended or cancelled for whatever reason by the registrar who issued it, the registrar notify Health Canada within 15 days of the suspension or cancellation;

— manufacturers who already have medical devices licences on January 1, 2003, submit a quality system certificate for their licenced medical devices before November 2003, as part of their annual update to the documents and information that they supplied with respect to their devices as required under section 43 of the Medical Devices Regulations, entitled the "Obligation to Inform" section.

Rationale

In developing the Medical Devices Regulations, Health Canada committed to implementing an auditing system whereby audits of manufacturers' quality systems would be conducted to applicable ISO standards, as discussed below, on behalf of Health Canada, by an independent third-party registration organization.

In accordance with the Government of Canada's Regulatory Policy and in an endeavour towards international harmonization, Health Canada has adopted ISO Standards. ISO is a worldwide federation of national standards bodies from some 140 countries (one from each country). It is a non-governmental organization established in 1947. The mission of ISO is to promote the development of standardization and related activities in the world with a view to facilitating the international exchange of goods and services, and developing cooperation in the spheres of intellectual, scientific, technological and economic activity. A member body of ISO is the national body "most representative of standardization in its country". Only one such body for each country is accepted for membership of ISO. Member bodies are entitled to participate and exercise full voting rights on any technical committee and policy committee of ISO. The Standards Council of Canada (SCC) is the member body representing Canada at ISO. The SCC designated the Canadian Standards Association (CSA) to develop quality system standards for medical devices, i.e. CAN/CSA-ISO 13485-98 and CAN/CSA-ISO 13488-98.

Health Canada considers the ISO standards ISO 13485:1996 and ISO 13488:1996 and the National Standard of Canada standards CAN/CSA ISO 13485-98 and CAN/CSA ISO 13488-98 to be equivalent. Under the proposed registration program, a manufacturer will be issued either a CAN/CSA-ISO 13485-98 or an ISO 13485:1996 quality system certificate, a CAN/CSA- ISO 13488-98 or a ISO 13488:1996 quality system certificate by a registrar who is recognized by the Minister. The proposed amendments would require that a copy of the original quality system certificate replace the manufacturer's written attestation, as an assurance that the medical devices are manufactured and/or designed under a quality system in accordance with the specified standards.

During the development of the new Regulations, Health Canada decided that it was more cost effective to partner with the SCC to develop a third-party registrar programme and to maintain an oversight role when the programme is implemented.

Health Canada developed a policy document called the Canadian Medical Device Conformity Assessment System (CMDCAS) which explains and interprets the regulatory criteria required for a person to be recognized as a registrar. It explains the processes and requirements:

— leading to the recognition of registrars as being competent to perform audits of medical device manufacturers' ISO 13485 or ISO 13488 quality management systems; and

— for carrying out ISO 13485 and ISO 13488 audits of medical device manufacturers by recognized registrars.

The CMDCAS recognition programme is based on a third-party registration organization being qualified by the SCC to the requirements of ISO/IEC Guide 62 as well as Health Canada specified requirements, for example, requirements for auditor competency and training that are based on Global Harmonization Task Force (GHTF) guidance documents.

To assure that the Minister always has a copy of a valid quality system certificate, the proposed amendments require that the manufacturer submit a copy of a new certificate before the expiry date of the certificate previously submitted. Certificates are valid for three years unless there is a modification or some other instance that requires a new certificate to be issued. If the manufacturer is issued a new certificate, they must submit a copy of it within 30 days of its issuance. Examples of changes that would require a new or modified certificate to be issued are as follows:

— name change;

— addition to or deletion of devices from their original product scope;

— change in the classification of the device so that the original quality system requirement no longer applies; or

— addition to or deletion of manufacturing sites from the original facility scope.

As presently written, the quality system requirements do not apply to those manufacturers who will already have medical devices licenced under the transitional provisions of the Medical Devices Regulations. The proposed amendments will correct this oversight by requiring those manufacturers to submit a copy of their quality system certificate before November 2003, which is the first annual update after January 1, 2003, when manufacturers are required to update the documents and information in respect to their devices.

Alternatives

Status Quo

The status quo is unacceptable as it doesn't fulfil Health Canada's commitment to establish an auditing system whereby audits of manufacturers' quality systems would be conducted to applicable ISO standards, on behalf of Health Canada, by independent third party audit organizations.

Accreditation Program to be developed and implemented by Health Canada

Health Canada could set up its own accreditation program to recognize a person as a registrar who is qualified to issue a certificate in respect of quality systems. In considering such an option, it was decided that Health Canada does not have the infrastructure to develop and implement such a program. There would also be additional costs in implementation because the program is global in scope and many manufacturers of medical devices sold in Canada operate outside Canada. Health Canada has deemed the development, implementation and maintenance of such a program as not cost effective. The infrastructure and expertise already exist in the National Accreditation Program of the Standards Council of Canada, and therefore it would be less costly and more efficient for Health Canada to contract the services of the SCC rather than develop its own accreditation program.

Accreditation Program to be developed and implemented by Standards Council of Canada

This option was considered but not pursued, since Health Canada cannot delegate its regulatory authority and therefore must maintain an oversight role in the accreditation and registration process.

Benefits and Costs

This proposed amendment will have an impact on the following sectors.

Public

Benefits

The general public can be assured that Classes II, III and IV medical devices on the Canadian market have been designed and/ or manufactured under quality systems that satisfy the requirements of paragraphs 32(2)(f), 32(3)(j) and 32(4)(p) of the Medical Devices Regulations, whose purpose is to increase the assurance of the quality, safety and effectiveness of those medical devices.

Costs

There are no costs for these amendments beyond what was noted in the RIAS for the Medical Devices Regulations in 1998.

Medical Device Industry

Benefits

The requirements for quality systems will be uniformly applied throughout the industry to all Classes II, III and IV medical devices on the market in Canada.

Costs

There are no costs for these amendments beyond what was noted in the RIAS for the Medical Devices Regulations in 1998.

Government

Benefits

Health Canada has greater assurance that the medical devices on the Canadian market are safe and effective.

Health Canada has minimized the cost of developing, implementing and maintaining a quality system accreditation program by partnering with the Standards Council of Canada.

Costs

Cost of partnering with the Standards Council of Canada to implement the regulatory quality system requirements.

Consultation

The concerns surrounding the implementation of the quality system requirements have been discussed with medical device industry representatives on an ongoing basis, prior to, and since the coming into force of the Medical Devices Regulations in 1998. A Working Group was formed in March 2000 to provide recommendations and advice regarding the quality system regulatory process. Its responsibilities include the identification of implementation issues of concern to stakeholders that need to be addressed by Health Canada. The members of the Working Group are drawn from persons nominated by the following stakeholder groups: Canadian medical device manufacturer associations, third-party quality system registrars, the Standards Council of Canada and Health Canada.

In December 1999, the Therapeutic Products Programme, which included the now-called Therapeutic Products Directorate (TPD), issued the draft policy document Q19R16: Policy on the Canadian Medical Devices Conformity Assessment System (CMDCAS) for public comment. Following a 30-day comment period, TPD received many responses which were subsequently used to prepare the final version of the CMDCAS Policy issued in May 2000. The most significant change that TPD made to the Policy was the removal of the Canadian incorporation requirement for registrars. This revision means that TPD will now recognize ISO 13485 or ISO 13488 certificates issued by foreign-based registrars, as long as they have been qualified by the Standards Council of Canada to the CMDCAS scope.

Compliance and Enforcement

This amendment would not alter existing compliance mechanisms under the provisions of the Food and Drugs Act, enforced by the Health Products and Food Branch Inspectorate and the Medical Devices Bureau.

Contact

Theresa Burke, Bureau of Policy and Coordination, Policy Division, Therapeutic Products Directorate, Health Products and Food Branch, Department of Health, Holland Cross, Tower B, 2nd Floor, 1600 Scott Street, Ottawa, Ontario K1A 1B6, Address Locator 3102C5, (613) 957-6454 (Telephone), (613) 941-6458 (Facsimile), Theresa_Burke@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 Medical Devices Regulations (1293 — Quality systems).

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 Theresa Burke, Bureau of Policy and Coordination, Therapeutic Products Directorate, Health Products and Food Branch, Department of Health, Address Locator No. 3102C5, 1600 Scott Street, Holland Cross, Tower B, 2nd floor, Ottawa, Ontario K1A 0K9 (fax: (613) 941-6458; e-mail: theresa_burke@ 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 24, 2002

EILEEN BOYD
Assistant Clerk of the Privy Council

REGULATIONS AMENDING THE MEDICAL DEVICES REGULATIONS (1293 — QUALITY SYSTEMS)

AMENDMENTS

1. Section 1 of the Medical Devices Regulations (see footnote 1)  is amended by adding the following in alphabetical order:

"quality system certificate" means a valid quality system certificate described in paragraph 32(2)(f), (3)(j) or (4)(p), as applicable, that is issued by a registrar recognized by the Minister under section 32.1. (certificat de système qualité)

2. (1) Paragraph 32(2)(f) of the Regulations is replaced by the following:

(f) a copy of a quality system certificate certifying that the quality system under which the device is manufactured satisfies National Standard of Canada CAN/CSA-ISO 13488-98, Quality systems — Medical devices — Particular requirements for the application of ISO 9002, as amended from time to time.

(2) Paragraph 32(3)(j) of the Regulations is replaced by the following:

(j) a copy of a quality system certificate certifying that the quality system under which the device is designed and manufactured satisfies National Standard of Canada CAN/CSA- ISO 13485-98, Quality systems — Medical devices — Particular requirements for the application of ISO 9001, as amended from time to time.

(3) Paragraph 32(4)(p) of the Regulations is replaced by the following:

(p) a copy of a quality system certificate certifying that the quality system under which the device is designed and manufactured satisfies National Standard of Canada CAN/CSA- ISO 13485-98, Quality systems — Medical devices — Particular requirements for the application of ISO 9001, as amended from time to time.

3. The Regulations are amended by adding the following after section 32:

Quality System Certificate

32.1 The Minister shall recognize a person as a registrar for the purpose of issuing quality system certificates if the person

(a) has sufficient training, experience and technical knowledge in the design and manufacture of medical devices and in the effective implementation of quality systems to determine whether a quality system satisfies a standard referred to in paragraph 32(2)(f), (3)(j) or (4)(p); and
(b) conducts quality system audits in accordance with the applicable guidelines and practices established by the International Organization for Standardization.

32.2 A quality system certificate is valid for the period, not exceeding three years, specified in it.

32.3 A registrar shall notify the Minister in writing within 15 days after suspending or cancelling a quality system certificate.

32.4. The Minister may cease to recognize a person as a registrar if the person no longer meets the requirements of section 32.1 or fails to comply with section 32.3.

4. Paragraph 43(1)(b) of the Regulations is replaced by the following:

(b) describing any change to the information and documents supplied by the manufacturer with respect to the device, other than those to be submitted pursuant to section 34, 43.2 or 43.3.

5. The Regulations are amended by adding the following after section 43:

43.1 If, after a medical device licence has been issued in respect of a medical device, a new requirement comes into force with respect to the information and documents to be contained in an application for a medical device licence, the manufacturer of the device shall include, with the next statement that the manufacturer furnishes to the Minister under subsection 43(1), the information and documents that the new requirement would require the manufacturer to include in a licence application in respect of that device.

Obligation to Submit Certificate

43.2 The manufacturer of a licensed medical device shall submit to the Minister a copy of a new quality system certificate before the expiry of the certificate previously submitted to the Minister in respect of that device.

43.3 If a new or modified quality system certificate is issued in respect of a licensed medical device, the manufacturer of the device shall submit a copy of it to the Minister within 30 days after it is issued.

COMING INTO FORCE

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

[40-1-o]

Saskatchewan Canola Order

Statutory Authority

Agricultural Products Marketing Act

Sponsoring Agency

National Farm Products Council

REGULATORY IMPACT ANALYSIS STATEMENT

Description

The Agricultural Products Marketing Act provides the authority for the Governor in Council to make orders granting authority to any board or agency authorized under the law of any province to exercise powers of regulation in relation to the marketing of any agricultural product locally within the province, to regulate the marketing of such agricultural product in interprovincial and export trade and for such purposes to exercise all or any powers like the powers exercisable by such board or agency in relation to the marketing of such agricultural product locally within the province.

This new Order would replace the existing Saskatchewan Canola Order. The changes are significant enough that a new Order is warranted rather than amendments only.

In the new Order, the definition of "Act" has been added. The definition of "Canola" has been changed to reflect the definition that is in the Saskatchewan Canola Development Plan and the definition of "Commission" in the french text has been replaced by the english version as no official french translation exists. The definition of "Plan" has also been added to this Order. Other housekeeping changes have been made to the text of this Order to reflect a format consistent with the recent drafting style adopted by Justice Canada.

Alternatives

The only alternative is to amend the existing Order. This was not done since the changes are significant enough to warrant a new Order, even though the changes are of a housekeeping nature only. The new Order is an appropriate way to recognize the legislative changes that have taken place at both the federal and provincial levels, since the existing Order was created in 1992.

Benefits and Costs

This amendment does not change the authority which the commodity board previously enjoyed with respect to the marketing of canola in Saskatchewan. Thus, it will not have any new impact on the marketing of canola, on the collection of levies or charges on sales of canola, or on the sale of canola outside the Province of Saskatchewan. There is no anticipated impact on consumer prices.

Activities resulting from the proposed amendment will not have any adverse environmental impact.

Consultation

The new Order is being made to comply with the observations brought forward by the Standing Joint Committee for the Scrutiny of Regulations. These changes have also been reviewed and approved by the Saskatchewan Canola Development Commission and the Saskatchewan Agri-Food Council, which is the provincial government supervisory board. Officials of the National Farm Products Council have reviewed the amendments and believe they are in the public interest.

Compliance and Enforcement

This Order, and any regulation or levy order which is made pursuant to it, will be administered by the Saskatchewan Canola Development Commission. The compliance mechanism is found in sections 2.1 and 4 of the Agricultural Products Marketing Act. Section 2.1 states that unpaid levies or charges imposed under the Act by a marketing board or agency constitute a debt due to that board or agency and may be sued for and recovered by it in any court of competent jurisdiction. Section 4 provides for fines of up to $500 or imprisonment for a term of up to three months or to both for the violation of any order or regulation made by a board or agency under the Act. It should be noted that this has rarely or never been employed.

Contact

Carola McWade, Deputy Executive Director and Registrar, National Farm Products Council, Canada Building, 10th Floor, 344 Slater Street, Ottawa, Ontario K1R 7Y3, (613) 995-9697 (Telephone), (613) 995-2097 (Facsimile), mcwadec@em.agr.ca (Electronic mail).

PROPOSED REGULATORY TEXT

Notice is hereby given that the Governor in Council, pursuant to section 2 (see footnote b)  of the Agricultural Products Marketing Act, proposes to make the annexed Saskatchewan Canola Order.

Interested persons may make representations with respect to the proposed Order 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 Carola McWade, Deputy Executive Director, National Farm Products Council, 344 Slater Street, 10th Floor, Canada Building, Ottawa, Ontario K1R 7Y3. (Tel.: (613) 995-9697; fax: (613) 995-2097; E-mail: mcwadec@em.agr.ca).

Ottawa, September 24, 2002

EILEEN BOYD
Assistant Clerk of the Privy Council

SASKATCHEWAN CANOLA ORDER

INTERPRETATION

1. The following definitions apply in this Order.

"Act" means The Agri-Food Act of the Province of Saskatchewan. (Loi)

"canola" means canola, rapeseed or oilseed, of the genus Brassica, that is produced in Saskatchewan. (colza)

"Commission" means the Saskatchewan Canola Development Commission. (Commission)

"Plan" means The Saskatchewan Canola Development Plan Regulations made under the Act. (plan)

INTERPROVINCIAL AND EXPORT TRADE

2. The Commission is authorized to regulate the marketing of canola in interprovincial and export trade and for that purpose may, with respect to persons and property situated within the Province of Saskatchewan, exercise all or any powers like the powers exercisable by it in relation to the marketing of canola locally within the Province under the Act and the Plan.

LEVIES OR CHARGES

3. The Commission may, in relation to the powers granted to it under section 2,

(a) fix and impose, by Order, and collect levies or charges from persons referred to in that section who are engaged in the production or marketing of canola, and for those purposes may classify those persons into groups and fix the levies or charges payable by the members of the different groups in different amounts; and
(b) use the levies or charges for the purposes of the Commission, including the creation of reserves, the payment of expenses and losses resulting from the sale or disposal of canola and the equalization or adjustment among the producers of canola of money realized from the sale of canola during any period that the Commission may determine.

REPEAL

4. The Saskatchewan Canola Order (see footnote 2)  is repealed.

COMING INTO FORCE

5. This Order comes into force on the day on which it is registered.

[40-1-o]

Regulations Amending the DNA Identification Regulations

Statutory Authority

DNA Identification Act

Sponsoring Department

Department of the Solicitor General

REGULATORY IMPACT ANALYSIS STATEMENT

Description

The proposed Regulations would amend the DNA Identification Regulations to establish procedures for implementing subsection 487.06(3) of the Criminal Code, which authorizes the taking of fingerprints from convicted offenders when DNA samples are collected for entry in the Convicted Offenders Index of the DNA data bank. Subsection 487.06(3) was added to the DNA data bank legislation when Bill S-10 was under consideration by the Standing Senate Committee on Legal and Constitutional Affairs. The DNA data bank relies on fingerprint information to verify each DNA donor's identity.

The proposed Regulations list the items that must be included in an unused DNA sample kit, and the elements that must be present in a completed sample kit. The proposed Regulations outline procedures for police officers to follow in situations where it is impossible for fingerprints to be taken at the same time as a DNA sample. The proposed Regulations also require that the name of one witness to the taking of the DNA sample and the offender's fingerprints be recorded on the sample kit in instances where two police officers have been involved in the collection of DNA samples and fingerprints. This amendment will provide for continuity and certainty in such instances, and is intended to reduce the likelihood of improper completion of a sample kit or a related identification error.

The proposed Regulations would also correct two inconsistencies between the English and French versions of the DNA Identification Regulations. To ensure consistency with the English version of subsection 2(1), the French version of new subsection 2(1) would replace the term "une trousse de prélèvement" with the term "une trousse de prélèvement d'échantillon biologique de la banque de données génétiques." To ensure consistency with the English version of paragraph 3(2)(a) of the DNA Identification Regulations, section 2 of the proposed Regulations replaces the words "dans le cas où les renseignements ne sont pas sur support électronique, du fait de détruire matériellement, par déchiquetage ou brûlage" in the French version of paragraph 3(2)(a) with the words "dans le cas où les renseignements ne sont pas sur support électronique, du fait de détruire matériellement, notamment par déchiquetage ou brûlage."

Alternatives

The proposed Regulations are considered to be preferable to the status quo. The DNA data bank, which is operated by the Royal Canadian Mounted Police (RCMP) and was established by the DNA Identification Act in 2000, relies on fingerprint information to verify each DNA donor's identity. However, there are currently no regulations governing the manner in which subsection 487.06(3) of the Criminal Code, which authorizes the taking of fingerprints at the same time as DNA samples, is to be carried out. In its first two years of operation, the data bank received more than 200 sample kits that did not contain adequate fingerprint information. Currently, when a DNA sample kit is submitted to the data bank with a defective fingerprint submission or without a fingerprint submission, the data bank must either seek an affidavit from the collection officer in order to establish the donor's identity, or attempt to obtain a second sample.

Benefits and Costs

The proposed fingerprint procedures will contribute to the integrity of the national DNA data bank by providing clear guidelines for implementing subsection 487.06(3) of the Criminal Code, so that fewer DNA samples submitted to the DNA data bank will be accompanied by defective fingerprint submissions, and assisting in verifying the identity of persons whose samples are included in the Convicted Offender Index. In situations where it is impossible for a police officer to take fingerprints at the same time as DNA sampling, the procedures continue to protect the integrity of the data bank by requiring the police officer to document the steps that were taken to identify the individual.

In addition, the proposed Regulations will ensure that the French and English versions of the DNA Identification Regulations are consistent.

There are no cost implications associated with these proposals.

Consultation

Crown prosecutors from several provinces and territories were advised of the federal government's plan to develop the proposed Regulations in July 2001. They supported this proposal.

The RCMP consulted with the National DNA Data Bank Advisory Committee regarding the issue of defective fingerprint submissions in 2001. The 2000-2001 Annual Report of the National DNA Data Bank Advisory Committee recommended amendments to the DNA Identification Regulations "which will clarify the fingerprinting process which occurs when bodily substances are collected from a convicted offender. The present wording of section 2(2) does not provide sufficient detail to allow the Officer-in-Charge of the Data Bank to deal effectively with samples accompanied by defective fingerprint submissions. Any priority assigned to processing of these amendments would certainly assist the efficacy of the Data Bank operations."

The Department of the Solicitor General undertook consultations on a draft of these provisions with representatives from the RCMP and the Department of Justice (Criminal Law Policy Section), who supported the proposed regulations.

Compliance and Enforcement

The RCMP is responsible for enforcing the Regulations.

Contact

Rebecca Thompson, Policing and Law Enforcement Branch, Department of the Solicitor General, 340 Laurier Avenue W, Ottawa, Ontario K1A 0P8, (613) 991-4765 (Telephone), (613) 993-5252 (Facsimile), thompsr@sgc.gc.ca (Electronic mail).

PROPOSED REGULATORY TEXT

Notice is hereby given that the Governor in Council, pursuant to section 12 of the DNA Identification Act, proposes to make the annexed Regulations Amending the DNA Identification Regulations.

Interested persons may make representations with respect to the proposed Regulations within 30 days after the date of publication of this notice. All such representation must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Ms. Rebecca Thompson, Policing and Law Enforcement Branch, Department of the Solicitor General, 340 Laurier Avenue West, 10th Floor, Ottawa, Ontario K1A 0P8.

Ottawa, September 24, 2002

EILEEN BOYD
Assistant Clerk of the Privy Council

REGULATIONS AMENDING THE DNA IDENTIFICATION REGULATIONS

AMENDMENT

1. Section 2 of the DNA Identification Regulation (see footnote 3)  is replaced by the following:

2. (1) In order to ensure the integrity of the convicted offenders index of the DNA Data Bank, only samples of bodily substances that were collected with a DNA Data Bank Sample Kit that meets the requirements of subsection (2) may be included in the DNA Data Bank.

(2) A DNA Data Bank Sample Kit shall contain

(a) detailed instructions on the procedure required to collect and preserve a sample and how to prevent its contamination;
(b) a sample collection form that provides space for

(i) the identification and signature of the person who took the samples from the convicted offender; and
(ii) two finger prints of the convicted offender;

(c) sample collection media that are capable of preserving samples safely and free from contamination; and
(d) a fingerprint form that provides for the fingerprints of the convicted offender.

(3) Each sample of DNA that is transmitted to the Commissioner for inclusion in the DNA Data Bank shall be securely packed, sealed and transmitted with all of the following:

(a) a copy of the judicial authorization that authorized the collection of the sample from the convicted offender;
(b) a sample from the convicted offender on the sample collection form and inserted in the sample collection media referred to in subsection (2);
(c) on the sample collection form, a plain impression of two fingerprints of the convicted offender and the identification and signature of the person who took those fingerprints; and
(d) on the separate fingerprint form, a rolled and a plain impression of all of the fingerprints of the convicted offender and the identification and signature of the person who took those fingerprints.

(4) If the fingerprints of a convicted offender are not taken, the following explanations in writing shall also be transmitted to the DNA Data Bank together with the items referred to in subsection (3):

(a) the reasons why no fingerprints were taken; and
(b) the means that were used to confirm the identity of the convicted offender together with the identification and signature of the person who made the confirmation.

WITNESS

2.1 If any sample on the sample collection form and any fingerprints of the convicted offender were not taken by the same person, the fingerprint form referred to in paragraph 2(2)(d) shall contain the identification and signature of a person who witnessed both the taking of the sample and the taking of the fingerprints.

2. Paragraph 3(2)(a) of the French version of the Regulations is replaced by the following:

a) dans le cas où les renseignements ne sont pas sur support électronique, du fait de détruire matériellement, notamment par déchiquetage ou brûlage;

COMING INTO FORCE

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

[40-1-o]

Footnote a 

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

Footnote 1 

SOR/98-282

Footnote b 

S.C. 1991, c. 34, s. 2

Footnote 2 

SOR/92-271

Footnote 3 

SOR/2000-300

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).