ARCHIVED — Regulations Amending the Class II Nuclear Facilities and Prescribed Equipment Regulations

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Vol. 144, No. 11 — May 26, 2010

Registration

SOR/2010-107 May 13, 2010

NUCLEAR SAFETY AND CONTROL ACT

P.C. 2010-573 May 13, 2010

The Canadian Nuclear Safety Commission, pursuant to paragraphs 44(1)(k) and (l) (see footnote a) of the Nuclear Safety and Control Act (see footnote b), hereby makes the annexed Regulations Amending the Class II Nuclear Facilities and Prescribed Equipment Regulations.

Ottawa, December 17, 2009

MICHAEL BINDER
President of the Canadian Nuclear Safety
Commission

Her Excellency the Governor General in Council, on the recommendation of the Minister of Natural Resources, pursuant to paragraphs 44(1)(k) and (l) (see footnote c) of the Nuclear Safety and Control Act (see footnote d), hereby approves the annexed Regulations Amending the Class II Nuclear Facilities and Prescribed Equipment Regulations, made by the Canadian Nuclear Safety Commission.

REGULATIONS AMENDING THE CLASS II NUCLEAR FACILITIES AND PRESCRIBED EQUIPMENT REGULATIONS

AMENDMENTS

1. (1) The definitions “certificate” and “certified” in section 1 of the English version of the Class II Nuclear Facilities and Prescribed Equipment Regulations (see footnote 1) are replaced by the following:

“certificate” means a document issued by the Commission or by a designated officer authorized under paragraph 37(2)(a) of the Act, indicating that a model of Class II prescribed equipment is certified, or authorized under paragraph 37(2)(b) of the Act, indicating that a person is certified. (homologation et accréditation)

“certified” means certified by the Commission under paragraph 21(1)(h) or (i) of the Act or by a designated officer authorized under paragraph 37(2)(a) or (b) of the Act. (homologué et accrédité)

(2) Section 1 of the French version of the Regulations is amended by adding the following in alphabetical order:

« accréditation » Document délivré par la Commission ou par un fonctionnaire désigné autorisé en vertu de l’alinéa 37(2)b) de la Loi et qui atteste la compétence d’une personne. (certificate)

« accrédité » Accrédité par la Commission en vertu de l’alinéa 21(1)i) de la Loi ou par un fonctionnaire désigné autorisé en vertu de l’alinéa 37(2)b) de la Loi. (certified)

2. The Regulations are amended by adding the following after section 15:

Radiation Safety Officers

Appointment and Certification

15.01 (1) Every licensee who operates a Class II nuclear facility shall appoint a radiation safety officer.

(2) Every licensee who services Class II prescribed equipment shall appoint a radiation safety officer.

15.02 No person shall be appointed to the position of radiation safety officer unless the person has been certified by the Commission or a designated officer authorized under paragraph 37(2)(b) of the Act.

Application for Certification

15.03 An application by a licensee for certification of a person as a radiation safety officer shall include the following information:

(a) the name of the person;

(b) a record of that person’s education, training and experience;

(c) a statement by the licensee that, in their opinion, the person is capable of performing the duties of the position; and

(d) the Class II prescribed equipment in respect of which the person may be certified.

15.04 (1) The Commission, or a designated officer authorized under paragraph 37(2)(b) of the Act, may certify a person for the position of radiation safety officer if

(a) the person has successfully completed an examination that is recognized by the Commission; and

(b) in the opinion of the Commission, or of the designated officer, the person is capable of performing the duties of the position.

(2) A certificate issued under subsection (1) shall specify the Class II prescribed equipment in respect of which it is valid.

15.05 A certificate comes into effect on the day on which it is issued and is valid for the period in which the person is employed by the licensee as a radiation safety officer.

15.06 (1) A person who is employed as a radiation safety officer on the day on which these Regulations come into force is deemed to have been certified in accordance with section 15.04.

(2) A licensee shall notify the Commission of the name of the radiation safety officer and the Class II prescribed equipment in respect of which the deemed certification is valid within 30 days after the day on which these Regulations come into force.

Refusal to Certify

15.07 (1) The Commission or a designated officer authorized under paragraph 37(2)(b) of the Act shall notify a licensee who has applied for the certification of a person, and the person in respect of whom certification is being sought, of a proposed decision not to certify the person and the basis for that proposed decision at least 30 days before refusing to certify the person.

(2) The notice shall include a description of the licensee’s and the person’s right to be provided with an opportunity to be heard in accordance with the procedure referred to in section 15.09.

Decertification

15.08 (1) The Commission or a designated officer authorized under paragraph 37(2)(b) of the Act shall notify a person in respect of whom a certificate has been issued, and the licensee concerned, of a proposed decision to decertify the person and the basis for that proposed decision at least 30 days before decertifying the person.

(2) The notice shall include a description of the licensee’s and the person’s right to be provided with an opportunity to be heard in accordance with the procedure referred to in section 15.09.

Opportunity To Be Heard

15.09 (1) If a licensee or a person referred to in section 15.07 or 15.08 has received a notice and has requested, within 30 days after the date of receipt of the notice, an opportunity to be heard orally or in writing, the licensee or the person shall be provided with an opportunity to be heard in accordance with the request.

(2) On completion of a hearing held in accordance with subsection (1), the licensee or the person shall be notified of the decision and the reasons for it.

Temporary Replacement

15.1 Every licensee shall designate in writing a person qualified to replace the certified radiation safety officer during the radiation safety officer’s absence.

15.11 A person designated under section 15.1 may replace the certified radiation safety officer for not more than 60 working days in any consecutive 365-day period.

Exemption from Certification

15.12 The requirement in section 15.01 does not apply in respect of a Class II nuclear facility for which a person who has duties equivalent to those of a radiation safety officer is designated and who is certified under subsection 9(2) of the Class I Nuclear Facilities Regulations.

COMING INTO FORCE

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

REGULATORY IMPACT
ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Issue and objective

The Canadian Nuclear Safety Commission (CNSC) (see footnote 2) regulates the use of nuclear energy and materials to protect the health, safety and security of Canadians and the environment and to respect Canada’s international commitments on the peaceful use of nuclear energy. It does this in accordance with the Nuclear Safety and Control Act (NSCA) and its regulations.

The Class II Nuclear Facilities and Prescribed Equipment Regulations (C2NFPER) prescribe the CNSC regulatory requirements with respect to Class II nuclear facilities and prescribed equipment. Class II nuclear facilities are facilities that include Class II prescribed equipment, such as particle accelerators, irradiators, teletherapy machines and brachytherapy machines used mainly in cancer treatment centres, universities and for commercial applications. These Regulations are also applicable to those companies that service Class II prescribed equipment (service providers).

At a Class II licensed facility, Radiation Safety Officers (RSOs) are appointed by each licensee to

  • ensure the safety of workers, the public and the environment;
  • provide radiation safety training;
  • implement procedures to keep doses As Low As Reasonably Achievable (ALARA);
  • deal with incidents, events and emergency situations; and
  • interface with the CNSC (licence applications, annual compliance reports, inspections, etc.).

The RSO’s role is critical to a licensee’s radiation safety program. Under the existing regulations, the licensee is under no obligation to obtain CNSC approval on appointment or change of an RSO and no regulations prescribe the qualifications required of an RSO. As a result, competency levels of RSO vary considerably across licensees.

Since 2005, the CNSC has had in place an approval process for prospective RSOs of service providers of Class II prescribed equipment and of Class II nuclear facilities, to ensure that RSOs are adequately qualified and trained to perform their duties. The main objective of the amendment is to formalize the current practice in regulations.

Description and rationale

The amendment enables the Commission or an officer designated by the Commission to ensure that the RSO appointed by the licensee has the necessary knowledge and experience and is therefore qualified for the role and responsibility of an RSO through a certification process. This will give added assurance that acceptable radiation safety practices are followed to the benefit of the workers and the public.

The amendment to the C2NFPER requires

  • every licensee who operates a Class II nuclear facility or who services Class II prescribed equipment to appoint an RSO;
  • the licensee to inform the CNSC when there is a change in RSO;
  • the prospective RSO to successfully complete an examination administered by the CNSC;
  • the RSO to be certified by the CNSC; and
  • the licensee to designate in writing a person qualified to replace the certified RSO during the RSO’s absence.

The amendment also includes details as to the information required in an application for certification of a person as an RSO, provisions for the CNSC to refuse to certify a person as an RSO and to decertify a person previously certified as an RSO, as well as provisions to appeal such a decision.

(a) Alternatives

— No verification of RSOs’ qualifications: Health and safety of workers and the public would be compromised by RSOs not having the necessary qualifications required of their position.

— Maintain status quo (informal approval process): This informal process has no legal basis; licensees are not provided with an opportunity to be heard.

— Addition of a licence condition to all Class II licences: For licence conditions applying to every Class II licensee, the legislative powers in the NSCA are set up such that the appropriate and transparent way to have an RSO certification process apply to each Class II licensee is by regulations.

(b) Cost of change

The cost to the licensee will be the time required for the prospective RSO to prepare for and undergo the examination. There will be no incremental cost to the CNSC, as this amendment merely formalizes current practice and therefore all work performed by the CNSC in support of the certification procedures will be funded under existing budgets. The benefit of this amendment is that the certification of RSOs will provide the CNSC with the assurance that an adequate level of oversight of radiation safety practices is undertaken at Class II nuclear facilities and by service providers of prescribed equipment, in order to protect the health and safety of Canadians and the environment.

Consultation

Pre-consultation

The CNSC undertook consultation on the proposed amendment to the C2NFPER with Class II licensees and stakeholders between May 2006 and April 2008. A written notice describing the proposed amendment was sent to all Class II licensees, with an invitation to comment. The comment period closed on March 30, 2007. Presentations were given by CNSC staff at the annual meetings of the Canadian Radiation Protection Association in May 2006 and the western Canadian group of health professionals in medical physics and radiotherapy in March 2007. In October 2007, information was distributed by CNSC at the annual meeting of the Canadian Organization of Medical Physicists, and in April 2007 and again in April 2008, articles were published in the “Canadian Medical Physics Newsletter” informing the medical physics community of CNSC’s intent to amend the C2NFPER to require certification of RSOs.

The interest and the written submissions by respondents to this regulatory initiative contributed to improving and strengthening the proposed amendment. The comments were evaluated by the CNSC and many of the recommendations or suggestions made by the respondents were considered in drafting the proposed amendment. The two most significant comments received were as follows:

  • “Grandfathering” of a person employed as an RSO on the day in which this amendment comes into force

A stakeholder suggested that a person who is employed as an RSO on the day on which this amendment comes into force should be required to be certified under the provisions of this amendment. The CNSC has been following an approval process since 2005. Therefore, the CNSC determined that the objectives of this amendment will be met if a person who has been appointed as an RSO since 2005 and before this amendment comes into force is deemed to be certified. In addition, a person appointed as an RSO prior to the 2005 implementation of the approval process and who continues to be employed in this role will also be deemed to be certified if the person has demonstrated to the CNSC the knowledge and capability to perform the duties of an RSO in the course of past licensing and compliance activities. A grandfathered RSO’s certificate will be valid only for a facility (or facilities) that includes Class II prescribed equipment (as defined in the C2NFPER) for which the RSO was certified.

  • Temporary replacement of an RSO

A stakeholder expressed concern as to the radiation safety of a facility in the event of the unplanned absence (e.g. due to resignation, injury or death) of its certified RSO. The proposed amendment was revised to make a provision for a licensee to designate a qualified person to replace a certified RSO for not more than 60 working days in any consecutive 365 day period. The temporary RSO will not be required to be certified.

Pre-publication in the Canada Gazette, Part I

The proposed amendment to the C2NFPER was pre-published in the Canada Gazette, Part I, on June 6, 2009, with a comment period closing on July 6, 2009. Written submissions were received from the British Columbia Cancer Agency, MDS Nordion, McGill University Health Centres and CNSC staff. Comments consisted of four clarifications and six proposals to the amendment. There were no objections received from stakeholders to formalize the current practice in regulations.

At the close of the pre-publication period, the CNSC then undertook a final 30-day consultation period during which time the comments received during pre-publication in the Canada Gazette, Part I, were made available on the CNSC external Web site and all interested parties were invited to provide feedback. No additional feedback was received from stakeholders. Consultations on the proposed amendment to the Class II Nuclear Facilities and Prescribed Equipment Regulations were concluded on August 7, 2009.

Comments with respect to the proposed amendment dealt with the following issues:

  • certification status of RSO should remain the same should the RSO change position;
  • certification renewal should be every five years;
  • certification requirement for RSO should be required in all Class I nuclear facilities;
  • minimum requirements of back-up RSO should be specified in the Regulations;
  • requirement for a back-up to the certified RSO should be removed; and
  • time period for which a back-up person can replace the RSO should be limited to not more than 90 days.

All comments received were dispositioned by CNSC staff. After due consideration, no changes were made to the proposed amendments to these regulations.

Implementation, enforcement and service standards

Since the CNSC is currently using an approval process for prospective RSOs of Class II nuclear facilities and of service providers of Class II prescribed equipment, this amendment will require minimal changes to be implemented. Oversight to ensure that Class II licensees employ certified RSOs will be undertaken as part of the regular licensing and compliance program.

It is an offence under the NSCA not to comply with the Act, Regulations or licence conditions. Licensee compliance is verified through inspections, reviews, audits and assessments. The CNSC also requires any licensee found to be non-compliant with either its licence conditions or the regulatory framework to resolve the issue and demonstrate improvement by a specified deadline, or face enforcement action. Each non-compliance event must be individually evaluated using a risk-based approach; any subsequent enforcement is appropriate to the particular case. Service standards for certification will be developed as part of the CNSC-wide performance measurement program.

Contact

Director
Class II Nuclear Facilities and Equipment Division
Canadian Nuclear Safety Commission
P.O. Box 1046, Station B
280 Slater Street
Ottawa, Ontario
K1P 5S9
Fax: 613-995-5086
Email: info@cnsc-ccsn.gc.ca

Footnote a
S.C. 2001, c. 34, s. 61

Footnote b
S.C. 1997, c. 9

Footnote c
S.C. 2001, c. 34, s. 61

Footnote d
S.C. 1997, c. 9

Footnote 1
SOR/2000-205

Footnote 2
In this document, the Canadian Nuclear Safety Commission is referred to as the “CNSC” when referring to the organization and its staff in general, and as the “Commission” when referring to the Commission tribunal.