Human Pathogens and Toxins Act (S.C. 2009, c. 24)

Marginal note:Factors to be considered

26 A committee to which a decision is referred shall consider

• (a) the reasons for the decision;

• (b) the reasons stated by the person who requested the review; and

• (c) any representations, information or material submitted to it by the Minister or the person who requested the review.

Marginal note:Protection of information

27 The committee members shall not disclose any information or material submitted to them as part of the review to any person other than the Minister unless the disclosure is authorized by the person to whom the information or material relates or is otherwise authorized or required by law.

Marginal note:Committee’s report

28 Within 60 days after the referral of a decision to a committee, or within any longer period that the Minister may allow, the committee shall report its findings and recommendations to the Minister and to the person who requested the review.

Marginal note:Final decision

• 29 (1) Within 60 days after receiving a committee’s report, the Minister shall, taking into account its findings and recommendations,

  • (a) reconsider the decision in respect of which the report was made; and

  • (b) send the Minister’s final decision by registered mail to the person who requested the review.

• Marginal note:Effect

  (2) The Minister’s final decision takes effect on the day after the day on which it is received.

Marginal note:Duty to inform

• 30 (1) A person whose licence is suspended or revoked shall, without delay, inform all persons conducting controlled activities authorized by it of its suspension or revocation.

• Marginal note:Return of revoked licence

  (2) A person whose licence is revoked shall return it by registered mail to the Minister as soon as feasible after the Minister’s decision takes effect or, if the decision is reviewed, as soon as feasible after the Minister’s final decision takes effect.

Access to Facility to Which Licence Applies

Marginal note:List of authorized persons

31 A licence holder shall establish and maintain a list of all persons authorized by the licence holder to access the facility to which the licence applies, including persons holding a security clearance for that facility and visitors. The licence holder shall provide the Minister with that list if requested to do so.

Marginal note:Obligation to inform Minister

32 If a licence holder decides to prohibit the holder of a security clearance from having access to the facility to which the licence applies, the licence holder shall, without delay, inform the Minister in writing of their decision.

Security Clearances

Marginal note:Access to facilities

33 No person shall enter the part of a facility in which controlled activities are authorized in relation to human pathogens that fall into Risk Group 3 or Risk Group 4 and are prescribed by regulation or toxins prescribed by regulation unless

• (a) they hold a security clearance for that part of the facility; or

• (b) they are, in accordance with the regulations, if any, accompanied and supervised by a person who holds a security clearance for that part of the facility.

Marginal note:Issuance, suspension and revocation

• 34 (1) The Minister may, in accordance with the regulations, issue a security clearance to any individual or suspend or revoke a security clearance. The Minister shall notify the individual concerned in writing of the decision.

• Marginal note:Agreement

  (2) The Minister may, by way of an agreement, authorize any federal department or agency to issue, suspend or revoke security clearances and section 35 applies with any necessary modifications.

Marginal note:Reconsideration of decision

• 35 (1) If the Minister refuses to issue a security clearance or suspends or revokes a security clearance, the individual concerned may, within 30 days after the day on which the notice is received, request in writing that the Minister reconsider the decision.

• Marginal note:Request for reconsideration

  (2) The request for reconsideration must set out

  • (a) the decision that is the subject of the request;

  • (b) the reasons for the request, including any new information that the individual concerned wishes the Minister to consider; and

  • (c) any information prescribed by regulation.

• Marginal note:Opportunity to make representations

  (3) On receipt of a request made in accordance with this section, the Minister shall give the individual concerned a reasonable opportunity to make representations.

• Marginal note:Confirmation or variation of decision

  (4) Within a reasonable time after representations have been made or an opportunity to do so has been given, the Minister shall reconsider the decision, in accordance with the regulations, if any, and confirm or vary it.

• Marginal note:Notice

  (5) The Minister shall notify the individual concerned in writing of the decision made following the reconsideration.

Biological Safety Officers

Marginal note:Designation

• 36 (1) An applicant shall, before a licence may be issued, designate an individual as a biological safety officer for the requested licence. The individual designated may also be the applicant.

• Marginal note:Obligations not limited

  (2) A designation does not have the effect of limiting the obligations of the licence holder or any other person under this Act.

• Marginal note:Qualifications

  (3) An individual may be designated as a biological safety officer only if the individual has the qualifications set out in the regulations.

• Marginal note:Effect of designation

  (4) A designation takes effect on the day on which the designated individual provides the Minister with their written consent to the designation or the day on which the individual begins to act as a biological safety officer, whichever is earlier.

• Marginal note:Powers and functions

  (5) The biological safety officer may exercise the powers and shall carry out the functions set out in the regulations.

• Marginal note:Replacement

  (6) If an individual ceases to act as a biological safety officer, the licence holder shall, without delay, designate another individual and inform the Minister of the new designation.

Exemptions

Marginal note:Non-application

37 Subsection 7(1) and section 8 do not apply to

• (a) an inspector or analyst carrying out their functions under this Act;

• (b) a peace officer carrying out their functions under any federal or provincial Act or a person providing assistance to that peace officer;

• (c) any person who, in the course of their employment, outside a facility in which controlled activities are authorized, collects a sample for the purpose of laboratory analysis or diagnostic testing; or

• (d) in exigent circumstances, any person carrying out their functions under any federal or provincial Act.

Information

Marginal note:Provision of information to Minister

• 38 (1) The Minister may order an applicant, a licence holder or a biological safety officer to provide the Minister, in accordance with any conditions that the Minister may specify, with any information that is under that person’s control, including personal information and confidential business information, and that the Minister believes, on reasonable grounds, is relevant to the administration of this Act or the regulations.

• Marginal note:Information

  (2) The information that is to be provided may include information regarding

  • (a) the human pathogens or toxins in the possession of the applicant, licence holder or biological safety officer;

  • (b) the persons having access to the human pathogens or toxins referred to in paragraph (a);

  • (c) the facility in which the controlled activities are authorized or in respect of which an application for a licence has been submitted; and

  • (d) the controlled activities that are authorized by a licence or in respect of which an application for a licence has been submitted.

• Marginal note:Obligation to provide information

  (3) An applicant, a licence holder or a biological safety officer shall provide the Minister with the information, in accordance with any conditions that the Minister may specify.

• Marginal note:Excluded information

  (4) Despite subsections (1) to (3), the Minister of National Defence may refuse to disclose any information the disclosure of which could reasonably be expected to be injurious to the defence or security of Canada or of a state allied or associated with Canada.

Marginal note:Disclosure by Minister

• 39 (1) The Minister may, without the consent of the person to whom the information relates, disclose personal information and confidential business information obtained under this Act to a person from whom the Minister seeks advice, to a department or agency of the government of Canada or a province, to a foreign government or to an international organization if

  • (a) the disclosure is necessary for the administration or enforcement of this Act or the regulations;

  • (b) the Minister has reasonable grounds to believe that the disclosure is necessary to address a serious and imminent danger to the health or safety of the public; or

  • (c) the disclosure is necessary to enable Canada to fulfil its international obligations.

• Marginal note:Adequate protection

  (2) Except in the circumstances described in paragraph (1)(b), before disclosing the information to any person other than Her Majesty in right of Canada or an agent of Her Majesty, the Minister must obtain the person’s written agreement that they will maintain the confidentiality of the information unless they are required by law to disclose it.

Administration and Enforcement

Marginal note:Designation of inspectors

• 40 (1) The Minister may designate any individual, or class of individuals, as an inspector for the administration and enforcement of this Act and the regulations and may restrict in any manner that the Minister considers appropriate the powers that an inspector may exercise under this Act.

• Marginal note:Certificate to be produced

  (2) The Minister shall provide an inspector with a certificate of designation and, on entering any place or conveyance under subsection 41(1), the inspector shall produce the certificate to the person in charge of that place or conveyance if requested to do so.

Marginal note:Entry by inspectors

• 41 (1) Subject to section 42, an inspector may, for the purpose of verifying compliance or preventing non-compliance with this Act or the regulations, enter at any reasonable time any place or conveyance in which the inspector believes on reasonable grounds that an activity to which this Act or the regulations apply is conducted or that there is any material, equipment or document relevant to the administration of this Act or the regulations.

• Marginal note:Inspector’s powers

  (2) An inspector who enters a place or conveyance may, for the purpose referred to in subsection (1),

  • (a) examine the place — including any building — or conveyance and any material or equipment found there;

  • (b) require any person in the place or conveyance to produce, in the manner and form requested by the inspector, any material or equipment found there;

  • (c) seize and detain for any time that may be necessary any material, equipment or document found there, or any conveyance;

  • (d) open and examine any receptacle or package found there;

  • (e) take, or require any person in the place or conveyance to produce, free of charge, a sample of any material found there;

  • (f) direct the owner or the person having possession, care or control of any material, equipment or document found in the place or conveyance — or of the conveyance — to move it or, for any time that may be necessary, not to move it or to restrict its movement;

  • (g) conduct, or require any person in the place or conveyance to conduct, any test or analysis or take any measurement of any material or equipment found there;

  • (h) take photographs or make recordings or sketches;

  • (i) examine and make copies, in whole or in part, of any book, document or other record found there;

  • (j) require any person in the place or conveyance to produce any book, document or other record found there for examination or copying;

  • (k) use or cause to be used any computer system or other device found there to examine information that is contained in or available to the computer system or device;

  • (l) reproduce any information in the form of a printout or other intelligible output for examination or copying; and

  • (m) use or cause to be used any copying equipment.

• Marginal note:Conveyance

  (3) For the purpose of entering the conveyance, the inspector may order the owner or person having possession, care or control of the conveyance to stop it or move it to a place where the inspector can enter it.

• Marginal note:Excluded information

  (4) Despite subsection (2), the Minister of National Defence may refuse to disclose any information the disclosure of which could reasonably be expected to be injurious to the defence or security of Canada or of a state allied or associated with Canada.

• Marginal note:Assistance to inspector

  (5) The owner or person in charge of a place or conveyance that is entered by an inspector who is carrying out their functions and every person in that place or conveyance shall give the inspector all reasonable assistance and provide them with any information that they may reasonably require.

• Marginal note:Obstruction and false statements

  (6) No person shall knowingly obstruct or hinder, or make a false or misleading statement either orally or in writing to, an inspector who is carrying out their functions.

• Marginal note:Private property

  (7) An inspector who is carrying out their functions and any person accompanying the inspector may enter on and pass through or over private property, and they are not liable for doing so.