Vol. 149, No. 5 — March 11, 2015

Registration

SOR/2015-44 February 20, 2015

HUMAN PATHOGENS AND TOXINS ACT

Human Pathogens and Toxins Regulations

P.C. 2015-203 February 19, 2015

Whereas, pursuant to section 66.1 of the Human Pathogens and Toxins Act (see footnote a), the Minister of Health has caused a copy of the proposed Human Pathogens and Toxins Regulations to be laid before each House of Parliament, substantially in the annexed form;

Therefore, His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to section 66 of the Human Pathogens and Toxins Act (see footnote b), makes the annexed Human Pathogens and Toxins Regulations.

HUMAN PATHOGENS AND TOXINS REGULATIONS

INTERPRETATION

Definitions

1. The following definitions apply in these Regulations.

“Act”
« Loi »

“Act” means the Human Pathogens and Toxins Act.

“common-law partner”
« conjoint de fait »

“common-law partner” , in relation to an individual, means a person who is cohabiting with the individual in a conjugal relationship, having so cohabited for a period of at least one year.

“scientific research”
« recherche scientifique »

“scientific research” means the following types of systematic investigation or research that are carried out in a field of science or technology by means of controlled activities:

LICENCES

Period during which licence in effect — factors

2. (1) When determining the period during which a licence is in effect, the Minister must take the following factors into consideration:

Maximum period

(2) The maximum period during which a licence may be in effect is the following:

Renewal

(3) The Minister may renew a licence on application of the licence holder, for further periods set out in subsection (2).

Condition on issuance — risk management plan

3. If the applicant for a licence is a person who intends to carry out scientific research, the Minister must, before issuing the licence, determine that the person has developed a plan that sets out administrative measures for managing and controlling biosafety and biosecurity risks during the period in which the licence is in effect.

Conditions of licence

4. (1) Every licence is subject to the following conditions:

Additional condition — prescribed human pathogens and toxins

(2) Every licence that authorizes controlled activities in respect of a human pathogen or toxin that is prescribed under section 10 is subject to the further condition that, if the intended recipient of such a human pathogen or toxin does not receive it within 24 hours after the expected date and time, they must take all of the following steps:

Notification to licence holder and biological safety officer

5. A person who is conducting controlled activities authorized by a licence must notify the licence holder and the biological safety officer, in writing, whenever they intend to do any of the following:

Notice to Minister before making change

6. (1) A licence holder must — if their licence authorizes controlled activities in respect of a human pathogen that falls into Risk Group 3 or Risk Group 4 or in respect of a prescribed toxin — notify the Minister before they make any change to the physical structure of the facility, to any equipment or to the standard operating procedures that could affect biocontainment.

Notice to Minister after name change

(2) A licence holder must notify the Minister, in writing, within a reasonable time after they make any change to their name.

Section 32 of Act

7. A licence holder must, when informing the Minister under section 32 of the Act of a decision to prohibit the holder of a security clearance from having access to the facility to which the licence applies, include their reasons for the decision.

BIOLOGICAL SAFETY OFFICERS

Qualifications

8. A biological safety officer must have the following qualifications:

Functions

9. (1) A biological safety officer has the following functions:

Power to require records to be provided

(2) A biological safety officer may require any person who conducts controlled activities authorized by the licence to provide them with any records that are necessary to assist them in carrying out their functions.

ACCESS TO FACILITIES

PRESCRIBED HUMAN PATHOGENS AND TOXINS

Section 33 of Act

10. (1) The following human pathogens and toxins are prescribed for the purposes of the Act and, more particularly, are specified for the purpose of section 33 of the Act:

Toxins not prescribed in certain quantities

(2) A toxin that is set out in column 1 of the table to this section is not a prescribed toxin if it is present in a part of a facility in a quantity that is less than or equal to the quantity set out in column 2.

TABLE
Column 1

Toxin		 Column 2

Quantity (mg)
Alpha toxin
Toxine Alpha		 5
Botulinum neurotoxin
Toxine botulique		 0.5
Cholera toxin
Toxine du choléra		 20
Clostridium botulinum C2 and C3 toxins
Toxines C2 et C3 de Clostridium botulinum		 5
Clostridium perfringens Epsilon toxin
Toxine Epsilon de Clostridium perfringens		 5
Hemolysin
Hemolysine		 10
Shiga-like toxin (verotoxin)
Toxine Shiga-like (vérotoxine)		 1
Shigatoxin
Shigatoxine		 1
Staphylococcal enterotoxins, Type B
Entérotoxine de staphylocoques, type B		 1
Staphylococcal enterotoxins, types other than Type B
Entérotoxine de staphylocoques, types autres que le B		 10
Staphylococcus aureus Toxic shock syndrome toxin
Toxine du syndrome du choc toxique de Staphylococcus aureus		 5
SECURITY CLEARANCES

Eligibility

11. (1) The Minister may only issue a security clearance to an individual who is 18 years of age or older.

Refusal or revocation in past five years

(2) An individual is not eligible for a security clearance in either of the following circumstances:

False or inaccurate information

(3) Subsection (2) does not apply if any of the information that formed the basis of the refusal or revocation proves to be false or inaccurate.

Application

12. (1) An individual who wishes to obtain a security clearance must submit an application to the Minister.

Content of application

(2) The application for a security clearance must be signed and dated by the applicant and must contain all of the following information and documents:

One statement per facility

(3) The application must include a statement described in paragraph (2)(m) in respect of each separate facility.

Exception — inspectors

(4) An inspector who is designated under section 40 of the Act need not include the statement described in paragraph (2)(m) in their application.

Record checks

13. (1) On receipt of a completed application, the Minister must conduct the following record checks for the purpose of making a determination of risk under section 14:

Additional information

(2) The Minister may, in writing, request any further relevant information from the applicant for the purpose of making the determination of risk under section 14.

Issuance — risk assessment

14. The Minister must issue a security clearance if the Minister determines that the applicant does not pose an undue risk to the health or safety of the public after considering the information obtained under sections 12 and 13 and taking the following factors into account:

Postponement — outstanding criminal charges

15. If a criminal charge is outstanding against the applicant for a security clearance that would, if they were found guilty of it, be considered by the Minister under paragraph 14(a), the Minister may postpone processing their application until the charge is disposed of by the courts and must notify the applicant in writing of the postponement.

Validity period

16. The Minister must establish the validity period of a security clearance in accordance with the level of risk posed by the applicant as determined under section 14. The validity period must not exceed five years.

Notice of issuance or refusal

17. When the Minister issues or refuses to issue a security clearance, the Minister must notify in writing every licence holder or applicant for a licence who has signed a statement described in paragraph 12(2)(m) with respect to the application for that security clearance.

Additional facility or part of facility

18. The holder of a security clearance who wishes to access a part of a facility described in section 33 of the Act not included in their application for the security clearance must provide the Minister with a statement described in paragraph 12(2)(m) in respect of each new facility or part.

Notice in writing

19. The holder of a security clearance must notify the Minister in writing without delay if they are found guilty of a criminal offence after the issuance of their security clearance.

Suspension

20. The Minister may suspend a security clearance on receipt of any of the following information:

Revocation

21. (1) The Minister must revoke a security clearance if the Minister determines that the holder of the security clearance poses an undue risk to the health or safety of the public after considering any of the information described in paragraphs 20(a) to (c).

Notice to licence holders

(2) On the revocation, the Minister must notify in writing every licence holder who has signed a statement described in paragraph 12(2)(m) with respect to that security clearance.

Reasons in writing

22. A written notice required under subsection 34(1) or 35(5) of the Act must contain the Minister’s reasons for the decision.

ACCOMPANIMENT AND SUPERVISION

One person at a time

23. (1) For the purpose of section 33 of the Act, a person who holds a security clearance may at any time accompany and supervise only one person who does not hold a security clearance.

Continuous supervision

(2) A person who accompanies and supervises another person must at all times be in the same room as them and must monitor their activities at all times.

No access in certain circumstances

24. For the purpose of section 33 of the Act, a person must not enter a part of a facility even under accompaniment and supervision in either of the following circumstances:

Records

25. The licence holder must keep a record of the full name of every person who enters a facility under accompaniment and supervision, together with the date on which they entered and the full name of the person who accompanied and supervised them.

EXEMPTIONS

Exemption from Risk Group 2 — risk reduction

26. (1) A human pathogen that is listed in Schedule 2 to the Act is exempt from the application of the definition “Risk Group 2” in subsection 3(1) of the Act if it has been modified to the extent that it no longer meets the risk profile described in that definition.

Exemption from Risk Group 3 — risk reduction

(2) A human pathogen that is listed in Schedule 3 to the Act is exempt from the application of the definition “Risk Group 3” in subsection 3(1) of the Act if it has been modified to the extent that it no longer meets the risk profile described in that definition.

Exemption from Risk Group 4 — risk reduction

(3) A human pathogen that is listed in Schedule 4 to the Act is exempt from the application of the definition “Risk Group 4” in subsection 3(1) of the Act if it has been modified to the extent that it no longer meets the risk profile described in that definition.

Notice to Minister

(4) In the circumstances described in subsections (1) to (3), the licence holder must notify the Minister without delay after such a modification.

Exemption from licence requirement — laboratories

27. (1) A person who carries out laboratory analyses or diagnostic testing with a human pathogen that is neither a prion nor a prescribed human pathogen is exempt from the application of section 7 of the Act on condition that

Exemption from licence requirement — veterinary practices

(2) A veterinarian who is registered under the laws of a province — and any persons under their supervision — who carry out laboratory analyses or diagnostic testing with a human pathogen that falls into Risk Group 2 are exempt from the application of section 7 of the Act on condition that any controlled activities that they conduct in respect of that pathogen are conducted in the course of providing care to animals in a clinical practice in that province.

Exemption — section 33 of Act

28. A person is exempt from the application of section 33 of the Act with respect to a part of a facility on either of the following conditions:

DOCUMENTS

Document retention

29. (1) Documents that are required under the Act to be prepared must be maintained for five years after the day on which they are prepared and must be provided to the Minister on request.

Exception — incidents

(2) Despite subsection (1), the retention period is 10 years for documents that contain information that relates to the following incidents:

Receipt of documents

30. Any document that is sent by the Minister under the Act is considered to have been received on the earlier of the following days:

TRANSITIONAL PROVISIONS

Continuation of controlled activities

31. (1) A person who, on the day on which these Regulations come into force, conducts controlled activities in respect of a human pathogen or toxin is exempt from the application of section 7 of the Act if they submit an application for a licence under subsection 18(2) of the Act within 90 days after that day.

Duration

(2) Subsection (1) applies until the Minister issues or refuses to issue the licence under subsection 18(1) or (3) of the Act, respectively.

Continuation of controlled activities — prescribed human pathogens and toxins

32. (1) An individual who, on the day on which these Regulations come into force, conducts controlled activities in respect of a prescribed human pathogen or toxin is exempt from the application of section 33 of the Act if they submit an application for a security clearance under section 12 within 90 days after that day.

Duration

(2) Subsection (1) applies until the Minister issues or refuses to issue the security clearance under subsection 34(1) of the Act.

COMING INTO FORCE

December 1, 2015

33. These Regulations come into force on December 1, 2015.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the regulations.)

Executive summary

Issues: Human pathogens and toxins pose a risk to human health and public safety, whether through an accidental release from a laboratory, an infected worker or a deliberate release by way of an act of terrorism or other criminal activity. Prior to 2009, the Human Pathogens Importation Regulations (HPIR) regulatory program had oversight over imported human pathogens and toxins, but not domestic agents. With the passage of the Human Pathogens and Toxins Act (HPTA) in 2009, select provisions came into force to provide interim measures until a complete program and regulatory framework could be developed. The impact of an intentional or unintentional misuse of human pathogens and toxins on public health and safety can be significant, and the proposed Human Pathogens and Toxins Regulations (HPTR) would further reduce that risk.

Description: The objectives of the HPTR are to improve oversight of human pathogens and toxins in Canada, establish national requirements for the safe handling of human pathogens and toxins, and provide assurance that individuals with access to a prescribed list of security-sensitive human pathogens and toxins would hold an appropriate security clearance.

To achieve this, the HPTR would set out a risk-based licensing scheme for facilities conducting controlled activities with human pathogens and toxins. The proposed Regulations would also prescribe a list of specific Risk Group 3 and 4 human pathogens and selected toxins that pose the highest risk of intentional misuse, and would set out security clearance requirements for persons who have access to these agents. The HPTR would be complemented by additional non-regulatory facility and operational standards for activities conducted with human pathogens and toxins in Canada. Previous versions of this standard have been in place since 1990.

Cost-benefit statement: The main costs associated with the proposed HPTR would arise from obtaining and renewing a licence, complying with specific conditions of that licence, and designating a biological safety officer. Laboratories that have previously imported human pathogens or toxins or that have voluntarily adopted the national standards would bear the lowest costs to implement the HPTR. In addition, importing laboratories will no longer be required to obtain individual import permits after the repeal of the HPIR, providing a cost savings. It is estimated that the incremental cost of compliance with these Regulations would be $2.41 million for all regulated parties, representing approximately 8 500 laboratories, in the first year following the coming into force of the HPTR. The Government would incur program administration costs of $6.82 million in this first year. The funding to administer the program was identified in Budget 2008.

The main benefit of the proposed Regulations would be improved public health and safety because of reductions in the risk of an accidental or deliberate release of a human pathogen or toxin into the community. The public health and safety benefits of the proposed Regulations were estimated using historical case studies. While the risk of a release is small, events have demonstrated that there may be significant health and economic impacts associated with the deliberate or accidental release of human pathogens and toxins. The health and economic damages related to a type of outbreak like the severe acute respiratory syndrome (SARS) are more than 200 times the annual costs of these proposed Regulations. Even a 0.5% reduction in the annual risk of such an event would, therefore, more than outweigh the costs of these proposed Regulations. It is therefore expected that these Regulations would provide a net social benefit. Additional qualitative benefits associated with the proposed HPTR include providing national requirements for safe handling in all laboratories and improving the ability to track where human pathogens and toxins are stored and used in Canada in the event of an emergency.

“One-for-One” Rule and small business lens: The “One-for-One” Rule applies to this regulatory proposal. The incremental increase in administrative costs for industry resulting from the proposed Regulations is estimated to be $230,000 per year. These increased administrative costs would mainly be a result of submitting licence applications or security clearance applications (if required), time spent learning about regulatory requirements, and submitting notifications.

The small business lens requirements apply to the proposed HPTR. Based on research undertaken by the Public Health Agency of Canada (the Agency), approximately 7% of the industry working with human pathogens and toxins are small businesses. The flexible option proposed, which benefits all sectors, allows for a longer licence period for those working with Risk Group 2 human pathogens, and a 90-day transition period after the HPTR come into force.

Domestic and international coordination and cooperation: The HPTR would align Canada’s regulatory framework with those of international partners such as the United States and Australia. All three countries would require the equivalent of a biosafety officer and security screening for those working with a defined list of dangerous pathogens and toxins. Each country’s approach would be consistent, which would improve the deterrent for persons with malicious intent.

Throughout regulatory development, the Agency collaborated with provincial and territorial counterparts to identify areas where a common approach could be leveraged. The Agency would continue to explore collaborations to streamline regulatory oversight in areas such as incident reporting and inspections.

Performance measurement and evaluation: An evaluation of the HPTR would occur five years after implementation and every five years thereafter. The evaluation would assess the outcomes of the HPTR along with any administrative and program support systems put in place.

Issues

Human pathogens and toxins pose a risk to human health and public safety because of their ability to cause disease or death. The impact of their release can be significant, resulting in severe infection and outbreaks in the community with potential international consequences. Human pathogens and toxins are found naturally in sick persons (e.g. E. coli bacteria), animals (e.g. rabies virus), or contaminated environmental sources (e.g. anthrax). They can be isolated from these natural sources for research and development purposes (e.g. vaccine development), grown to large quantities, and transported between laboratories and facilities. There are approximately 8 500 laboratories in Canada that possess human pathogens and toxins. These laboratories are found in universities and colleges, health care diagnostic facilities, federal, provincial and territorial governments, pharmaceutical and biotechnological facilities, and commercial distributors.

Prior to 2009, federal oversight of human pathogens and toxins was limited to facilities importing human pathogens and toxins under the Human Pathogens Importation Regulations (HPIR). This limited the Government of Canada’s ability to verify the safe and secure use of human pathogens or toxins acquired from domestic sources. In 2009, the Human Pathogens and Toxins Act (HPTA) received royal assent. The purpose of the HPTA is to establish a national safety and security regime to protect the health and safety of the public against the risks posed by human pathogens and toxins.

As an initial measure, select sections of the HPTA were brought into force in 2009 to establish basic biosafety requirements for persons conducting activities involving human pathogens or toxins in Canada. Key requirements are the registration of persons in possession of human pathogens and toxins (section 70), a general duty of care to take all reasonable precautions to protect the health and safety of the public when knowingly conducting activities with these agents (section 6), a smallpox ban (section 8), and an intentional release prohibition (section 58). In addition, most offence and penalty provisions are in force, as are inspection powers.

However, many sections of the HPTA, particularly those related to security clearances, cannot be brought into force in the absence of regulations. Consequently, the proposed Human Pathogens and Toxins Regulations (HPTR), which benefitted from extensive stakeholder consultation, are intended to further enhance the Government of Canada’s ability to mitigate the public health and safety risks from human pathogens and toxins.

The inherent risk from human pathogens and toxins is that they may be accidentally or deliberately released into the community, either directly or indirectly when someone becomes infected and spreads the disease. A risk assessment (see footnote 1) conducted by the Public Health Agency of Canada (the Agency) confirmed that most incidents have a small or limited impact, but many have the potential to cause catastrophic consequences.

When an incident occurs, it has the potential to lead to serious consequences in terms of lives lost, economic impact, and threat to national security. For example, in October 2001, letters containing anthrax were mailed to various individuals in the United States, resulting in 22 people exposed, 5 deaths and 42 buildings contaminated, at an estimated cost of over one billion dollars. Since these attacks, countries have sought to enhance oversight for biological substances being used within their borders. Consequently, many countries have developed more stringent controls for a range of activities involving human pathogens and toxins. Similarly to other countries, Canada continues its efforts to prevent the accidental or deliberate release of an agent, which could result in substantial social and economic disruption and could have international repercussions. The proposed HPTR would contribute to this objective by providing assurance that individuals with access to a prescribed list of security-sensitive human pathogens and toxins, including anthrax, would hold an appropriate security clearance. In addition, the HPTR would be complemented by non-regulatory standards and guidelines to support biosecurity.

Although the SARS virus emerged from a natural environment and not from a laboratory, its rapid spread worldwide demonstrated how quickly an infectious disease can have severe international consequences. In Toronto alone, SARS infected approximately 23 000 people and caused 44 deaths. Infections in laboratory settings due to improper safety procedures also contributed to the rate of illness. It is now known that laboratories hold the only remaining stocks of the SARS virus, which is still highly infectious. The intent of the proposed HPTR is to mitigate against the risk of an outbreak by improving federal oversight of activities involving human pathogens and toxins in Canada.

In addition to the ongoing risks from existing human pathogens and toxins, there is a risk of novel agents, such as a modified strain of highly virulent influenza, being generated and potentially released. The field of synthetic biology has grown to the point where human pathogens and toxins can now be generated in non-laboratory settings. The proposed HPTR aim to establish national requirements for safe and secure handling of human pathogens and toxins that would apply to all persons who possess or use these agents in Canada, in any type of facility, regardless of how they were generated.

Objectives

The HPTR would enable the Government of Canada to authorize a range of controlled activities involving human pathogens and toxins through licensing and security clearances. In general, the proposed Regulations are intended to

  1. improve federal oversight of activities involving human pathogens and toxins in Canada;
  2. establish national requirements for safe and secure handling of human pathogens and toxins;
  3. provide assurance that individuals with access to a prescribed list of security-sensitive human pathogens and toxins have an appropriate security clearance; and
  4. maintain a risk-based approach to this oversight through exemptions for lower-risk activities which pose less of a threat to public health and safety and that are in the public interest.

The HPTR would complete an integrated national program for public health and safety with respect to the inherent risks posed by human pathogens and toxins by bringing the remaining sections of the HPTA into force. The proposed Regulations have been carefully considered and balance public health and safety objectives with the burden placed on regulated parties. Where possible, the use of regulations has been minimized and outcomes would be achieved using more tailored standards, directives, advisories and guidelines.

Description

The proposed regulatory approach is risk-based, with increasingly stringent requirements for higher risk human pathogens and toxins. The Regulations would establish requirements applicable to licensing, security clearances and exemptions.

The Regulations would apply to persons who are knowingly conducting controlled activities with human pathogens and/or toxins, unless they are exempted or excluded by the HPTA or regulations. The HPTA defines and categorizes human pathogens and toxins. There are four risk groups for human pathogens:

Under the HPTA, a toxin is a substance that is produced by, or derived from, a micro-organism and is able to cause disease in a human. Toxins are not classified by risk group as, unlike pathogens, there is no risk of spread in the community.

As an additional level of categorization, the Regulations would prescribe a list of certain Risk Group 3 and 4 human pathogens and certain toxins that are considered to be of sufficient risk to warrant additional biosecurity requirements. These prescribed human pathogens and toxins are also referred to as Security Sensitive Biological Agents (SSBA).

A brief summary of the key elements contained in the proposed Regulations follows.

Licensing

The HPTA requires that a person hold a licence to conduct any of the following controlled activities:

While the HPTA (sections 18 and 19) authorizes the Minister of Health (the Minister) to issue and manage much of the licensing regime administratively, the proposed Regulations would clearly specify the terms of licences and the universal conditions of such licences in order to be transparent to regulated parties and to ensure consistency in application. The HPTR would specify that licences will be issued using a risk-based approach such that the term of a licence will vary from one to five years depending on the risk group of the human pathogen. Other elements of the licensing regime, such as details regarding the form and manner of applications, as well as situation-specific conditions of licence, would be specified administratively by the Agency to allow for flexibility. This approach has advantages for organizations with many laboratories, such as universities. To maintain transparency, guidance documents would be made available to regulated parties.

This licensing scheme would replace the current import permit regime under the HPIR. Once the proposed HPTR come into force, those subject to the new licensing regime would have 90 days to apply for a licence so that ongoing activities would not be interrupted or adversely impacted.

Before a licence is issued, the HPTA (section 36) requires that a biological safety officer (BSO) be designated and given specific functions. In addition to the BSO being the main point of contact, the BSO’s primary responsibilities would be to promote and monitor compliance with the regulatory framework and applicable national biosafety and biosecurity standards. The BSO would be required to do this in a number of ways, including assisting in the maintenance of a biosafety manual and standard operating procedures, and conducting periodic inspections and biosafety audits. Further, to support the BSO in carrying out his or her functions, the HPTR would specify that he or she has the authority to access records, including inventories; training records; and records of import, transfer and export activities.

The Regulations would specify universal conditions of all licences, including a condition that the BSO not be obstructed when carrying out his or her mandatory functions. Additional conditions would require that the BSO be notified before the import, export or transfer of human pathogens and/or toxins, that any missing shipments of human pathogens and/or toxins be reported to the BSO, and that efforts be made to locate these missing shipments. When the proposed Regulations were published in the Canada Gazette, Part I (i.e. prepublished), for public comment, stakeholders indicated that, while they agreed with the intent of the section on movement of agents, there was confusion on when the BSO is to be notified and the role of the BSO in the event of a notification. As a result, the Agency reviewed this section and improved the wording to increase clarity for stakeholders (with no change in scope) with regards to their obligations. There would also be a condition that if persons conducting controlled activities discover that they have inadvertently come into possession of a human pathogen or toxin that they are not licensed to possess, they must immediately notify the BSO of the inadvertent possession; ensure the agent is appropriately handled and stored; and transfer or dispose of the agent within 30 days if they do not wish to become licensed for the agent. The BSO would be responsible for informing the Agency of these events. As a result of questions raised during the information sessions held in July 2014 as well as during the Canada Gazette, Part I, comment period, the Agency has clarified the gain of function notification provision in section 5 of the proposed HPTR to include controlled activities that increase the communicability of a human pathogen or increase the resistance of a human pathogen to preventative or therapeutic treatments. To leverage risk management practices, the notification requirement will be to the licence holder and the BSO rather than the Agency. This change was seen as less burdensome and a better mechanism for the review, assessment and amendment of biosafety protocols in the facility prior to the research being initiated.

There would be an additional condition for licences respecting prescribed SSBA human pathogens or toxins that reflects the increased level of risk these agents may pose. The proposed Regulations would require that a person who does not receive a prescribed SSBA within 24 hours of the date and time it was expected notify the Minister that they have not received it, as well as take reasonable efforts to locate the shipment.

Finally, for facilities conducting scientific research, there would be an additional requirement to submit information on how their facility internally manages biosafety and biosecurity, including information on roles and responsibilities of key biosafety personnel or committees, before the licence would be issued.

Security

The Regulations would prescribe a subset of Risk Group 3 and 4 human pathogens and toxins, which are also referred to by the Agency as Security Sensitive Biological Agents (SSBA). These are defined based on an international consensus of high risk agents requiring control measures, as determined by semi-annual meetings of an organization called the Australia Group, which is dedicated to restricting the spread of biological and chemical weapons. The HPTA (section 33) requires that no person shall enter the part of a facility where controlled activities are authorized with prescribed Risk Group 3 and 4 human pathogens or prescribed· toxins unless they hold a security clearance or they are accompanied and supervised by someone who holds a security clearance. Certain prescribed SSBA toxins would have quantity thresholds at or below which a security clearance would not be required.

The HPTR specify the information that must be submitted by eligible adults to request a security clearance. The Regulations further define the record checks and the factors that the Minister must take into account when determining if the applicant poses an undue risk to the health or safety of the public. The Minister could postpone processing the application if a criminal charge is outstanding against the applicant. Once issued, the security clearance would be valid for up to five years and would be portable to allow access to additional facilities, providing that the licence holder for each new facility confirms that the individual requires access to the facility.

The Minister could suspend or revoke the security clearance if there is information that could change the Minister’s determination, such as a new criminal conviction. The proposed Regulations would stipulate that the Minister will provide, in writing to the applicant, the basis of the decision to refuse, suspend or revoke a security clearance.

The HPTR would also include provisions specifying that a person with a security clearance may only accompany and supervise one person without a security clearance at a time. A person without a security clearance may not be accompanied and supervised if that person’s security clearance has been refused, suspended or revoked. The HPTR would require that the facility maintain a record of each occasion when a person without a security clearance is accompanied and supervised.

Exemptions

The proposed Regulations would include the following exemptions, to reduce the regulatory burden in areas where activities are low-risk and in the public interest.

First, the proposed Regulations would exempt human pathogens from the risk group definitions in the situation where the human pathogen has been modified or attenuated to the extent that it no longer meets its original risk profile. For example, if the agent has been modified such that it poses a much lower individual or community risk (i.e. a vaccine strain of influenza), or if treatment is more readily available (i.e. antibiotics). The Agency would be notified to initiate a discussion about the new risk classification of the modified strain.

Second, the HPTR would exempt persons conducting certain low-risk activities from the licensing requirement. This exemption is based on the criteria that the human pathogens are not cultivated or otherwise produced, or that any production is in a sealed container that is decontaminated before disposal. This would appropriately exempt many rapid diagnostic tests; one example would be the rapid test for the presence of group B Streptococcus that is performed on pregnant women just prior to delivery. Any controlled activities in this category would however remain in the scope of the HPTA and, therefore, all reasonable precautions must be taken to protect the health and safety of the public when they are knowingly conducted (section 6, HPTA). This exemption would only be applicable to activities conducted with agents that are not prions or prescribed SSBA human pathogens.

Third, there would be an exemption from licensing that would reduce the impact of the HPTR on veterinary clinics. As a result of comments received during the prepublication of the proposed HPTR in the Canada Gazette, Part I, the exemption will apply only to veterinary clinics that carry out laboratory analyses or diagnostic testing with Risk Group 2 human pathogens. These clinics conduct low-risk activities with pathogens that are capable of infecting both humans and animals, such as obtaining rapid laboratory results for illnesses such as ringworm and bovine mastitis. The exempted controlled activities involving human pathogens would also remain in the scope of the HPTA and, therefore, all reasonable precautions must be taken to protect the health and safety of the public when they are knowingly conducted (section 6, HPTA). This exemption would not apply to veterinary clinics working with higher risk human pathogens (i.e. Risk Group 3 agents), veterinary research institutions or to dedicated veterinary diagnostic laboratories that receive samples from multiple clinics. The Agency will collaborate with the Canadian Veterinary Medical Association to develop guidance to support biosafety and biosecurity requirements for veterinary clinics, and with provincial regulatory bodies to incorporate this guidance into veterinary standards of practice.

Finally, recognizing that laboratories can be shared or used for multiple purposes, the HPTR would exempt a person from requiring a security clearance to enter a location if the prescribed (SSBA) human pathogens or toxins authorized for use in that location are either not present or locked away and inaccessible.

Additional non-regulatory program elements

To support the implementation of the proposed Regulations, a suite of standards, guidelines and other tools would be developed and made publicly available before the HPTR come into force.

The Canadian Biosafety Standards (CBS) provide the detailed additional physical and operational requirements for biosafety and biosecurity when conducting controlled activities with respect to all human pathogens and toxins. The CBS will be revised to align with the proposed HPTR.

As appropriate, based on feedback from regulated parties and an assessment of the level of risk, the Agency would develop biosafety directives to provide clarity for a sector-specific approach. For example, the Agency has developed, in collaboration with an expert panel, the Biosafety Directive for Human Immunodeficiency Virus (HIV) and Human T-cell Lymphotropic Virus Type I (HTLV-1) to set specific containment requirements for laboratories working with HIV and HTLV-1. (see footnote 2) This directive provides clarity and guidance to reflect that these viruses can be safely handled in facilities that are designed for work with Risk Group 2 human pathogens, with certain additional precautions, although they have characteristics that define them as Risk Group 3 human pathogens.

The guidelines and other tools, such as Pathogen Safety Data Sheets, will be made available to provide regulated parties with additional clarity and information to assist them in achieving compliance with the HPTA, the HPTR and the CBS.

Regulatory and non-regulatory options considered

Option 1 : Status quo — The HPTA is partially in force with no new regulations

The HPTA was enacted in 2009 to mitigate the risk to public health and safety from human pathogens and toxins. At that time, several key obligations and prohibitions were brought into force, such as a requirement to register with the Agency, a prohibition against conducting any controlled activities with smallpox, and a duty of care to take all reasonable precautions when conducting a controlled activity. However, while the HPTA authorizes the Minister to issue licences and to administratively manage a licensing regime without regulations, regulations are required to prescribe a list of human pathogens or toxins that trigger the security clearance requirements set out in the HPTA.

For this reason, in addition to the fact that it would entail maintaining an Act that is not fully in force, this option was rejected.

Option 2: Regulations made under all authorities in the HPTA

The HPTA provides authorities to make regulations in numerous areas, including the containment levels for human pathogens and toxins, the decontamination of material, equipment and places, the content of inventories, and specific details of facilities, such as their location and physical layout. The Agency’s analysis of program and stakeholder feedback indicates that the increased stringency of fixed regulatory requirements in these areas could have negative impacts on industry, on research and on innovation.

For this reason, this option was rejected.

Option 3: Develop minimal regulations to bring remaining sections of HPTA into force, supported by a risk-based program

This option is preferred as it would bring the HPTA into full force without imposing an undue burden on regulated parties. Regulatory intervention would be limited to areas of specific need, balancing a clear communication of areas requiring regulatory oversight with a flexible regulatory program that can adapt to the requirements of different operating environments. This approach would respond to Parliament’s direction that the regulations should impose less stringent requirements on lower-risk pathogens. The new HPTA program and regulatory policy framework would include a mix of policy instruments designed and informed in such a way as to better ensure compliance while not being unduly burdensome on industry or restricting research and innovation.

Option 3 is the recommended approach.

Benefits and costs

The Agency has identified and analyzed the key costs and benefits of the proposed Regulations. The analysis included impacts of the proposed Regulations on regulated parties, the Government and the Canadian public. This analysis was based on a projected scenario that is believed to represent the most likely outcome of the regulatory changes. Efforts were made to provide quantitative and monetized estimates of the impacts; however, due to limitations with data availability and uncertainties in the available information, it was not possible to quantify and monetize all expected impacts of the proposed Regulations. Qualitative assessments are provided in instances when quantification and/or monetization were not possible. Historical case studies were used to provide orders of magnitude estimates of the potential damages associated with a toxin or pathogen release, and to estimate the level of risk reduction that these Regulations would need to achieve in order for benefits to outweigh costs. Results of the analysis undertaken are summarized below. More details on the analysis conducted and the underlying data are available on request. (see footnote 3)

The cost-benefit analysis (CBA) identifies and quantifies, to the extent possible, the incremental costs and benefits of the proposed Regulations by comparing the proposed Regulations to the status quo. It is expected that stakeholders subject to the proposed HPTR will experience a range of costs depending on their current practices. For example, laboratories that currently import human pathogens and toxins or those that have voluntarily adopted the current standards would experience a smaller incremental cost impact than those that would be newly regulated. Also, it is expected that the cost of the proposed Regulations would decrease as stakeholders become more familiar with the regulatory requirements and program standards and further develop internal accountability systems for their organizations.

Benefits

The analysis quantified and monetized the beneficial impacts of the HPTR in terms of the avoided costs from historical examples of significant public health and safety incidents resulting from the accidental or intentional release of human pathogens and toxins in the community. Benefits were also quantified and monetized in terms of the avoided regulatory requirements under the HPIR, which would be repealed when the HPTR come into force. Additional benefits were estimated in terms of the positive impacts that nationally consistent standards and licensing would have for regulated parties and for the Government.

Public health and safety avoided costs

A key benefit of the proposed Regulations is the human and economic costs avoided through the reduction in the probability of an accidental or intentional release of a human pathogen or toxin. Data are not currently available to quantify exactly what the current risk levels of a release are, and how those risks would change due to the HPTR. However, given the potential for a catastrophic outcome in the event of an accidental or intentional release, even a small reduction in risk is expected to provide a significant benefit to society.

An analysis was conducted of the impacts of past incidents related to the release of human pathogens or toxins in the community. As an example, the 2003 SARS outbreak resulted in 44 deaths, over 200 hospitalizations and over 23 000 people placed in quarantine in Toronto. Some infections were due to improper procedures in laboratory settings. The total impact to society of this incident included the direct costs of illness, lost income, and increased costs related to controlling the outbreak. Impacts to industry were also experienced, with the hospitality and tourism sectors reporting significant lost revenue. Considering published estimates of the economic and financial costs of the outbreak, along with estimated social welfare impacts associated with increased mortality rates, it is estimated that the total socio-economic impact of the SARS outbreak was at least $1.9 billion (in 2012 dollars). This estimate does not include the full social welfare impact of the illness, such as fear, pain or suffering.

Although the risk of another SARS-like outbreak is low, the proposed HPTR have the potential to reduce that risk even further. Given the magnitude of the damages caused by serious pathogen outbreaks, even small reductions in risk have significant social benefits. Based on available data, it is not possible to quantify the reduction in risks that can be achieved by these Regulations. However, comparing the known costs of the Regulations, with the potential costs of a pathogen or toxin release indicates what level of risk reduction these Regulations would need to achieve in order for the benefits to outweigh the costs. For example, if these Regulations could prevent a large-scale outbreak similar to SARS, then the annual benefits would be significant. In other words, it is anticipated that these Regulations would more than break even, with benefits exceeding costs, provided that they are able to reduce the annual risks associated with a SARS-like incident by at least 0.5%.

Avoided requirements of the HPIR

Under the HPTR, licences would be issued using risk-based criteria, with the majority of laboratories eligible for a five-year licence that authorizes possession of, handling, using, producing, storing, permitting any person access to, transferring, importing, and exporting Risk Group 2 human pathogens and non-prescribed (non-SSBA) toxins. The HPIR would be repealed, eliminating the current requirement to obtain an annual permit to import human pathogens and toxins, at an estimated benefit of $0.27 million in 2015, with an overall savings of $3.28 million over 20 years, discounted at 7%. These savings include time to obtain an import permit as well as the time to comply with the conditions of the permit. Not quantified are the benefits of avoiding delays in obtaining a permit.

Qualitative benefits

An additional benefit of the national licensing program would be the clarity provided by national standards for biosafety and biosecurity, as well as the clarification of the roles and responsibilities within the regulated organizations. This is particularly the case for biological safety officers (BSOs), since their minimum qualifications and mandatory functions would be specified in the Regulations.

The national licensing program would bring several requirements into force for incident reports to be filed with the Agency. This national monitoring would provide an opportunity to identify and correct deficiencies in standard operating procedures and provide an opportunity to learn from trend analysis to identify high-risk activities and potential corrective actions.

The licensing and security measures proposed would allow for an improved ability to track where dangerous human pathogens and toxins are stored and used within Canada. This is intended to assist the Government of Canada in an emergency response in the event of a deliberate or accidental release of a human pathogen or toxin. In addition, the licensing provisions would allow the Government to rapidly identify people with microbiological expertise that could assist in a national response to an emerging issue or public health infectious disease threat.

By way of the proposed security requirements, the regulatory framework would support national security. Although the potential risk may be low, the deliberate release of a human pathogen could be catastrophic. The HPTR would bring Canada into closer regulatory alignment with biosecurity and biosafety regimes in other countries, such as the United States and Australia. In a globalized world, consistency in the degree of security and risk assigned to the most dangerous pathogens and toxins can effectively deter intentional release.

Costs

The analysis quantified and monetized the regulatory compliance and administrative costs to regulated parties associated with the new requirements under the proposed HPTR. The analysis also takes into account the costs required for the Government to administer the program, which were identified in Budget 2008.

Costs to regulated parties

The quantified costs to all regulated parties were assessed in the areas of licence applications, licence renewals, BSOs functions, security clearances and accompaniment and supervision for security purposes. To arrive at the overall figures presented here, the average costs were estimated on a “per laboratory” basis, and multiplied across the estimated 8 500 laboratories in Canada conducting activities involving human pathogens and toxins. An assumption was made that the number of laboratories in Canada will grow at a rate of 1.0% per year.

The costs to regulated parties are estimated at $2.41 million nationally in the first year after the HPTR come into force. These costs would then decrease in each year thereafter, largely because only new laboratories would need to apply for a licence and because over 98% of the existing laboratories (those working with Risk Group 2 human pathogens) would only renew their licence every five years. The licence renewal costs have been estimated to be less than the cost of a new licence application. The largest cost of the proposed Regulations is the incremental costs for the BSOs functions (representing approximately 85% of the total cost of the proposed Regulations, discounted at 7%). The total costs to regulated parties are estimated at $19.42 million over 20 years, discounted at 7%. Further details can be found in the cost-benefit analysis report, which is available upon request.

Costs to Government

The costs to Government for program administration would include costs associated with dedicated staff, operations and maintenance, training, supplies and other corporate overhead. These ongoing costs ($6.82 million in the first year after the Regulations would come into force) were identified in Budget 2008 for the implementation of this program, and no new funds would be required to establish the program as described.

These costs would be associated with the administration of the licensing program, an inspection program for compliance monitoring and enforcement of the regulatory requirements, and the processing and delivery of security clearances. The cost estimate includes the development and maintenance of an electronic data management system to streamline the program for stakeholders.

Other qualitative costs considered

Initial assessments of the proposed HPTR identified additional areas of potential cost. (see footnote 4) These included costs to regulated parties for inspections, reporting requirements, inventories, maintaining a list of persons authorized to access the facility and possible changes to infrastructure (e.g. secure access systems). These costs have not been quantified in the analysis, based on the following considerations. Inspection authorities have been in place since the HPTA came partially into force in 2009 and no changes are proposed to the duration or requirements of these inspections under the HPTR. Based on stakeholder feedback, the incidents of inadvertent release, stolen or missing agents and exposures that would require reports to the Agency would be sporadic with an unpredictable frequency, making them very difficult to quantify. The inventory requirement would be extremely flexible in terms of systems and mechanisms that may be used to achieve compliance, and most stakeholders indicated that they already had inventory systems in place. The form and scope of the list of persons would also be determined by each licence holder to take advantage of their existing records, documents and systems, and a new list would not be expected to meet this requirement. Finally, federal guidance on laboratory infrastructure for biosafety best practices has been in place since 1990. According to Agency’s research and compliance promotion visits, the vast majority of Canadian laboratories are already compliant with infrastructure requirements. This is in large part because standards and guidelines are performance based to allow organizations flexibility and discretion in how they meet the requirements.

  Base Year: 2015 Year 10: 2024 Final Year: 2034 Total (PV(see reference †)) Annualized Average
A. Quantified impacts (in million CAN$, 2014 price level I/constant dollars)
Benefits            
Canadian public Public health and safety — avoided costs (see reference *) $4.57 $4.68 $4.75 $93.48 $4.68
Regulated parties HPIR — avoided requirements $0.27 $0.16 $0.09 $3.28 $0.16
Total benefits   $4.84 $4.84 $4.84 $96.76 $4.84
Costs            
Regulated parties New HPTR requirements –$2.41 –$0.88 –$0.49 –$19.42 –$0.97
Government Program administration costs –$6.82 –$3.71 –$1.89 –$77.34 –$3.87
Total costs   –$9.23 –$4.59 –$2.38 –$96.76 –$4.84
Net benefits $0
(see reference **)		  
B. Qualitative impacts
  • Universal standards and licence conditions would provide national consistency for all regulated parties.
  • A single licence covering a range of controlled activities would allow institutions to manage their local environment without the unpredictability of the annual import permit process.
  • Organizations that currently import human pathogens and toxins or that have voluntarily adopted the current standards experience less incremental cost impact than those that would be newly regulated.

“One-for-One” Rule

The “One-for-One” Rule was implemented to control new administrative burden imposed on businesses as a result of regulations. In summary, the Rule requires that departments

Stakeholders were extensively consulted on the proposed Regulations and the associated program framework. As a result of their input, the proposed Regulations were developed to minimize, to the extent possible, administrative burden while respecting the objective to protect and maintain the health, safety and security of Canadians. Within this regulatory proposal, the administrative burden costs would be associated with submitting licence applications, submitting security clearance applications (if required), learning about regulatory requirements, and submitting notifications. The administrative changes that would be implemented through the proposed Regulations result in an increased administrative burden to the regulated parties in the private sector (pharmaceutical, biotechnology, diagnostic, and distributors), estimated to be $230,000 per year. The proposed Regulations are considered a new administrative burden under the “One-for-One” Rule.

On the day the HPTR come into force, the proposed Regulations Repealing the Human Pathogens Importation Regulations would repeal the HPIR. The repeal of the HPIR would offset the implementation of the proposed Regulations, satisfying the second element of the “One-for-One” Rule.

Small business lens

The extent to which small business would be impacted by the proposed Regulations is expected to be minimal. Through two Agency-sponsored questionnaires, an internal analysis of industry sectors, and the consultation process, the Agency attempted to identify small businesses that possess human pathogens and toxins. In a comprehensive survey of organizations using human pathogens and toxins in Canada, 7% self-identified as being a small business. The majority of stakeholders that will be regulated under the proposed HPTR are either medium or large businesses or fall into the government, hospital and college or university sectors.

Flexible option

In developing the Regulations, the supporting program and the implementation plan, the Agency considered options that would minimize burden on small businesses, as well as all stakeholders regardless of their size. The proposed Regulations would balance minimizing regulatory burden to business with protecting the health and safety of the public from risks posed by human pathogens and toxins. The regulatory proposal as it is presented would require laboratories working with Risk Group 2 human pathogens to renew their licence every five years instead of annually and would not impose annual retraining requirements for persons conducting controlled activities with human pathogens and toxins. This conservative estimate of a “flexible option” would result in a reduced burden to small businesses, at an estimated national total of $82,000 annually.

Other aspects of the Regulations that would minimize burden are the use of an online tool for licence application, notification and reports; defined trigger quantities for prescribed SSBA toxins at or below which an HPTA security clearance would not be required; and a 90-day transition period after the HPTR would come into force. In addition, the Agency would develop tools such as online training and targeted guidance documents to assist all regulated parties in complying with the proposed Regulations.

  Initial Option Flexible Option
Short description e.g. Renew licence and retrain annually e.g. Renew licence every 5 years and only train/retrain as necessary
Maximum number of small businesses impacted
80
80
  Annualized Average
($ 2012)		 Present Value
($ 2012)		 Annualized Average
($ 2012)		 Present Value
($ 2012)
Compliance costs $71,300 $500,800 $69,930 $491,180
Administrative costs $26,850 $188,590 $11,970 $84,090
Total costs $98,150 $689,390 $81,910 $575,270
Average cost per small business $1,230 $8,620 $1,020 $7,190
Risk considerations   Longer licence terms only apply to the Risk Group 2 (RG2) laboratories (small businesses identified have only RG2 laboratories).
Refresher training has been determined to be appropriate for staff instead of annual retraining.

Consultation

Since September 2007, stakeholders have been given the opportunity to provide input into the development of the program and regulatory framework under the HPTA. Limited consultations regarding the HPTA legislative framework were held across Canada in September 2007. Following the tabling of the first version of the HPTA in the House of Commons in April 2008, information sessions were held across Canada in the summer of 2008 and the winter of 2009 on the draft legislation. These information sessions generated numerous recommendations from stakeholders, including amendments to the HPTA relating to the powers of inspectors and changes to the schedules.

The HPTA was again tabled in the House of Commons in February 2009 and underwent rigorous examination by committees in both the House of Commons and the Senate before becoming law on June 23, 2009.

The Agency held several national consultations in person, online and bilaterally, to inform the development of the program and regulatory framework for the HPTA from 2010 to 2013. Stakeholders from academia, health care, and the private and public sectors participated in the consultations. These sessions are summarized below. (see footnote 6)

Pre-consultations

As recommended by parliamentarians and committee witnesses, the Agency designed a comprehensive consultation process to ensure interested and affected parties would have multiple engagement opportunities at all stages of the regulatory development process. The consultation approach was informed by input and feedback received during preliminary face-to-face discussions with each province and territory in 2010, and electronically with 16 national associations. The pre-consultations were well-received and viewed as a positive first step towards further meaningful and ongoing discussions.

Consultations on policy direction

Between January and June 2012, formal sessions were held in 10 provinces and 3 territories via in-person and Web-based processes with stakeholders representing the pharmaceutical industry, the biotechnology industry, academic institutions, government laboratories, private diagnostic laboratories, and hospitals. These consultations were designed to seek input on the design of key HPTA program elements raised during the parliamentary process, namely

The Agency heard that stakeholders were engaged in different activities involving pathogens, that risk was not uniform and that different sectors managed the risks differently. Stakeholders favoured a licensing framework that would result in low administrative burden and reflect the risk of the human pathogen or toxin. Many stakeholders provided input on the role and responsibility of the BSOs, suggesting that the BSOs should be involved in compliance activities and be assigned functions and powers that would assist in exercising their role. All sectors agreed that maintaining an inventory is important but, to minimize burden, the inventory requirements should be risk-based, with less information required for lower-risk human pathogens and toxins. Preference for a centralized versus decentralized inventory system depended on the sector; for example, the hospital sector indicated a preference for a centralized system. Stakeholder concern was noted with respect to the time required to obtain a security clearance and the possible impact on their ability to conduct research. There was also a concern that some employees might experience challenges in obtaining a clearance. Finally, the Agency learned that academia might benefit from enhanced engagement to ensure that biosecurity requirements would not negatively impact Canada’s science and innovation capacity.

Consultations on key policy elements

Additional formal consultations, held from March to June 2013, presented and sought stakeholder input on the Agency’s proposed policy approaches for the five key program elements (i.e. licensing, biological safety officers, inventory, exposure reporting, and security clearances). These sessions also provided stakeholders with an opportunity to identify potential cost drivers and implementation challenges. There were in-person sessions in addition to electronic consultations.

Overall, stakeholders continued to voice support for a regulatory framework with questions focusing more on the operational aspects of implementing the proposed Regulations and non-regulatory elements. The Agency heard that the proposed licensing framework was not well understood and that stakeholders would like more information on BSO qualifications and functions, as well as support such as training programs. The Agency took this input into account and will be developing materials to support implementation, such as online training tools and guidance documents.

With regard to security clearances, stakeholders, and particularly the academic community, were concerned that the inclusion of some toxins on the SSBA list might significantly increase the need for security clearance to account for those using the prescribed SSBA toxins in minute quantities. As a result, trigger quantities for prescribed SSBA toxins were established. Based on concerns that the security application might place additional burden on foreign applicants, flexibility was added to the HPTR to allow foreign applicants to submit alternate documents for consideration.

In addition to the formal consultations, the Agency developed an engagement strategy to inform stakeholders about the HPTR and to seek the input of selected governments, specialized organizations and associations, and subject matter experts regarding the development of the program and regulatory framework. Input was specifically sought from all provinces and territories; over 50 key national associations, including teaching associations, associations of diagnostic facilities, standards councils, medical and veterinarian associations, and specific associations such as Consumer Health Products Canada, the Canadian Federation of Independent Business, and the Canadian Laboratory Food Forum; and various federal partners.

This engagement strategy also included targeted discussions with universities and academic associations, to obtain input from administrators, researchers and biosafety personnel on specific challenges facing the academic sector, and to identify areas where further support or tools could assist academic institutions in implementing the proposed Regulations. As one example, the U15 Secretariat provided a link for the Agency to share information with their members. The U15 is comprised of Canada’s 15 research intensive universities that undertake 80% of all competitive university research in Canada. These universities contribute to national and global public policy goals, as well as, foster innovation, partnerships and advance Canada’s international influence and effectiveness. The Agency discussed the regulatory development process with the U15 Research sub-committee and extended invitations through this group for a targeted discussion. Other examples of academic outreach include Agency presentations and discussions on risk management at Canadian universities with the Alliance of Canadian Comprehensive Research Universities, the Canadian Association of University Business Officers and the Canadian Association of University Research Administrators, in addition to smaller bilateral and multilateral meetings.

Recommendations adopted following the analysis of stakeholder feedback

The feedback received from stakeholders was carefully considered by the Agency. Recommendations to improve the regulatory framework that were put forward by stakeholders and adopted by the Agency in this proposal include

Consultation on the proposed Regulations following publication in the Canada Gazette, Part I

The proposed Regulations and the accompanying Regulatory Impact Analysis Statement (RIAS) were prepublished in the Canada Gazette, Part I (CGI), followed by a 75-day public comment period from June 21, 2014, to September 4, 2014. Concurrent to the prepublication of the proposed Regulations, the Agency held 26 live webcast information sessions (in English and French) in July 2014 on the proposed program and regulatory framework. The objective of the information sessions was to provide stakeholders with information on the proposed regulatory requirements, to provide an opportunity for participants to see how the requirements would be implemented in their areas of work; and, to ensure that participants were prepared to provide feedback on the proposed HPTR. The information sessions were attended by over 350 registrants representing academia; federal and provincial government; and non-governmental associations.

The Agency received 21 letters with comments and suggestions from the following sectors: academic; federal and provincial government representatives; and a non-governmental association. The comments received were mainly positive in tone and constructive, focusing on the operational aspects of implementing the proposed Regulations. Several organizations took the opportunity to acknowledge the comprehensive consultations that the Agency conducted and expressed that they could see their input reflected in the proposed HPTR.

For the academic sector, the vast majority of comments focused on information requests to better understand regulatory requirements and how the program would be implemented. For example, there were questions on how to structure their licence for their organization, if the limits of prescribed SSBA human pathogens and toxins determined at individual level or institutional level, notification requirements and maintaining lists. With this feedback, the Agency is currently developing a full suite of tools and templates that will respond to these questions as well as supported regulated parties with implementation. These products will be available prior to the HPTR coming into force in December 2015.

Similar to previous phases of consultations, stakeholders wanted more information on what qualifications a BSO should have and how the BSO can be supported. Stakeholders expressed a need for BSO training programs, online tools, and/or accreditation, as well as support to assist in assessing the competencies of the BSO. Questions were raised regarding the roles and responsibilities of BSOs within the entity, as well as their relationship with the Agency. Stakeholders were also interested to know how to implement the BSO role within their institution, for instance, whether multiple BSOs would be required under a licence, if diagnostic laboratories would require a BSO, and whether the BSOs should be independent of a laboratory manager. The Agency is working with BSO associations and networks, including participating in meetings and conferences to provide guidance, advice and tools in order to support implementation applicable to their environments.

The security clearance requirements and specifics of the SSBA list were the subject of numerous questions from stakeholders, particularly in the academic sector. Stakeholders sought guidance on what security measures would be appropriate to meet biosecurity requirements in shared laboratory spaces and they had questions on the security clearance application process, for example, how would the application be processed, who would be required to hold a security clearance and the purpose of the requirement. A regulatory amendment has been adopted to reflect stakeholder input that the licence holder should be notified on both issuance or refusal of a security clearance. Representatives from the government sector did question if the current federal security clearance procedure would also meet the requirement of the HPTA framework. When developing the security clearance requirements, the Agency did consider other security clearance programs and found that they would not respond to the unique risks posed by human pathogens and toxins. Finally, at the request of another federal government department, the Agency included activities that constitute a threat to national security as a factor that would be considered when making a decision to issue a security clearance.

Stakeholders from the academic sector asked about the content and application of the prescribed SSBA pathogens and toxins list. Based on these comments, the prescribed amount of the cholera toxin that would trigger the needed for a security clearance was increased from 10 mg to 20 mg to reflect stakeholder input and minimize any negative impact on science and innovation. Based on the Agency’s risk assessment to the health and safety of the public, a similar request to increase the trigger quantity for the staphylococcal enterotoxin B was not accepted.

The majority of comments from the academic and government sector relating to BSO functions were also requests for clarification or implementation support that will be addressed in guidance. Stakeholders supported the role and function of the BSO, but there were suggestions on the academic qualification of the BSO, as well as questions related to operations (e.g. how many laboratories a BSO could oversee). Clarity was sought with regard to the regulatory requirement when human pathogens and/or toxins are transferred or moved. With this feedback, the Agency has amended section 4 of the proposed HPTR to more clearly state the requirements for the movement of human pathogens and toxins.

A few representatives from the academic sector and the government sector provided comments with regard to the financial impact of the proposed Regulations. The vast majority of laboratories in Canada are compliant with federal guidance for infrastructure requirements for biosafety that have been in place since 1990. In addition, the time associated to carry out the BSOs’ functions was included in the economic analysis of the proposed Regulations and this report is available upon request.

Some stakeholders from the academic and government sectors requested clarification for when notification is required before conducting gain of function research. Based on analysis, the Agency has clarified the gain of function notification provisions in section 5 of the proposed HPTR. Gain of function includes increasing the virulence or pathogenicity of a human pathogen; increasing the communicability of a human pathogen; increasing the resistance of a human pathogen to preventative or therapeutic treatments; or increasing the toxicity of a toxin. Notification was changed to the licence holder and the BSO, instead of the Agency as in the initial regulatory proposal, as this is consistent with other risk management practices at the institutional level. Targeted consultations with stakeholders indicated support for this regulatory change noting it will be less burdensome and in keeping with internal risk management oversight plans.

In general, there was support for the exemption provisions in the proposed HPTR, with some requests for clarification of individual situations. However, there were two submissions from representatives of the academic sector questioning the policy exempting veterinary clinical practices from the licensing provisions. As a result, the Agency has reviewed and revised this provision to limit the exemption to veterinary clinics conducting activities with Risk Group 2 human pathogens. Residual biosafety and biosecurity risks will be addressed by developing guidance with the Canadian Veterinary Medical Association for biosafety in veterinary clinics and working with provincial licensing bodies to incorporate this guidance into veterinary standards.

Changes made as a result of comments received following prepublication in the Canada Gazette, Part I

The changes made as a result of the stakeholders feedback (including comments received during prepublication in the Canada Gazette, Part I) will result in a substantial reduction in regulatory burden for stakeholders compared to what was originally presented as a policy proposal while, at the same time, maintaining the public health and safety objectives of the HPTR. Overall, stakeholders have been supportive of the objectives of this regulatory proposal, and have expressed constructive comments that have informed many of the specific approaches and requirements. To be responsive to stakeholders questions and information requests, the Agency has begun to develop products to support them. For example, the Agency has developed and published online statements of administrative intent (SAI) that clarify certain aspects of the HPTA program. (see footnote 7) Further SAIs will be developed, along with other documents, such as frequently asked questions, and toolkits, to support regulated parties. The Agency is committed to supporting stakeholders understand and meet the new regulatory requirements.

Regulatory cooperation

International consistency in the approach to controlling access to the most dangerous human pathogens and toxins can be a deterrent for those with malicious intent. In developing the proposed Regulations, the Agency analyzed approaches used in other countries and consulted with international regulators. The proposed HPTR would align Canada with other like-minded countries, such as the United States and Australia. With the proposed Regulations, Canada, Australia and the United States would require the equivalent of a biosafety officer and security screening for those working with a defined list of dangerous pathogens and toxins. Regimes in Canada, Australia and the United States would also exempt similar activities that do not pose a significant threat to either safety or security, such as certain diagnostic testing.

There are some differences in Canada’s proposed regulatory approach to those other international regimes. For example, the HPTA and the proposed HPTR would apply to those human pathogens or toxins that pose a risk to the health and safety of Canadians, not just those agents that could be weaponized (which is the focus of the Australian and U.S. legislation). Canada would be the first country to introduce a risk-based licensing system, which is a progressive approach to regulating human pathogens and toxins. The Canadian approach would have the advantage of providing oversight of dual-use research, or legitimate technology that can be co-opted for illegal use.

The Regulations would also advance Canada’s objectives as they relate to meeting its international commitments under the Biological and Toxin Weapons Convention, the United Nations Security Council Resolution 1540 and the World Health Organization Global Polio Eradication Initiative.

As part of regulatory development, the Agency conducted a thorough analysis of provincial and territorial legislation related to human pathogens and toxins to identify potential implementation options that would minimize regulatory duplication and burden. The two main areas where some potential for overlap has been identified by provincial counterparts are with medical and diagnostic laboratory accreditation programs (where they exist) and provincial/territorial occupational health and safety schemes.

The Agency would continue to work bilaterally with provincial and territorial counterparts to identify options that effectively reduce any potential overlap and build upon synergies where there are similar goals or objectives.

Rationale

The proposed Regulations are a critical component that would bring the HPTA into full force. Human pathogens and toxins pose a risk to human health and public safety whether through an accidental release from a laboratory, an infected worker or a deliberate re lease by way of an act of terrorism or other criminal activity. Prior to 2009, the HPIR regulatory program had oversight over imported human pathogens and toxins but not domestic agents. With the passage of the HPTA in 2009, selected provisions came into force to provide interim measures until a complete program and regulatory framework could be developed. The impact of an intentional or unintentional misuse of human pathogens and toxins to public health and safety can be significant, and the proposed HPTR would further reduce that risk.

The proposed Regulations and other program components were based on a collaborative consultation with stakeholders. The proposed Regulations would be risk-based so that stakeholders working with lower-risk human pathogens or toxins are not subject to the same regulatory requirements as those conducting controlled activities with higher-risk agents. This would protect public health and safety while minimizing any adverse impact on research and innovation.

Implementation, enforcement and service standards

Repeal of the Human Pathogens Importation Regulations (HPIR)

The HPIR would be repealed under the Department of Health Act and replaced by the HPTR under the HPTA. A licence under the HPTR would allow regulated parties to import human pathogens, in addition to other controlled activities as specified in their licence application.

Compliance and enforcement

Compliance and enforcement activities under the HPTR would continue to be guided by the Agency’s compliance and enforcement policy (see footnote 8) for human pathogens and toxins. The policy outlines the approach that would be taken for compliance promotion, compliance monitoring and enforcement.

Compliance promotion is a proactive approach to assist regulated parties to achieve compliance through education and information sharing. The Agency’s compliance promotion activities would continue to include training programs, participating in national symposia, publication and distribution of standards and guidance, including directives, advisories and Pathogen Safety Data Sheets. The Agency would continue to monitor emerging trends, science and technologies to inform evidence and risk-based decision-making with regard to biosafety, biocontainment and biosecurity.

Compliance monitoring would be achieved by verifying that regulated activities are carried out in accordance with the HPTA and the proposed HPTR. Compliance monitoring could take the form of on-site inspections, evaluation of biosafety programs and/or analysis of information provided by regulated parties. When verifying compliance, considerations would include the level of risk of the human pathogen or toxin, the activity undertaken, and the risk to the health and safety of the public.

The Agency would continue to respond to non-compliance through one or a combination of tools where the primary objective is to manage the risk and bring the regulated party into compliance using the most appropriate level of intervention. Considerations would include the level of risk, the degree of potential harm caused by the infraction, the compliance history of the regulated party, the likelihood that the problem will recur and the outcome of the enforcement action. If deemed necessary, enforcement action that may be taken by the Agency would include a letter of non-compliance; variance, suspension or cancellation of a licence; voluntary disposal; issuance of orders by inspectors; seizure, detention or forfeiture; or investigation and prosecution.

Service standards

In keeping with the Agency’s commitment to improve service delivery in support of red tape reduction initiatives, service standards would be developed for the licensing, security clearance and stakeholder communications portions of the new regulatory program. These service standards would be available on the Agency’s Web site at www.phac-aspc.gc.ca/about_apropos/act-reg-lois/ss-ns-eng.php.

Performance measurement and evaluation

In keeping with the Government’s life-cycle approach to regulatory development, the Agency would evaluate the effectiveness of the proposed HPTR in meeting its objectives. The performance measurement and evaluation plan would specify the variables to be measured and would include elements such as compliance and enforcement activities, incident reporting, and stakeholder inquiries and feedback. Performance standards would be developed for regulatory authorizations such as licensing, HPTA security clearance and other key program elements, as required. To the extent possible, the evaluation of the Regulations would be incorporated into existing performance frameworks and reporting time periods, with the first evaluation to take place no more than five years after the HPTR come into force and at least every five years thereafter.

Contact

Lisa Hogan
Office of Stakeholder Engagement and Regulatory Affairs
Centre for Biosecurity
Public Health Agency of Canada
100 Colonnade Road
Postal Locator: 6201C
Ottawa, Ontario
KIA 0K9
Email: Lisa.hogan@phac-aspc.gc.ca

Small Business Lens Checklist

1. Name of the sponsoring regulatory organization:

Public Health Agency of Canada

2. Title of the regulatory proposal:

Human Pathogens and Toxins Regulations

3. Is the checklist submitted with a RIAS for the Canada Gazette, Part I or Part II?

Check box Canada Gazette, Part I Check box checked Canada Gazette, Part II

A. Small business regulatory design

I Communication and transparency Yes No N/A
1. Are the proposed Regulations or requirements easily understandable in everyday language? Check box checked Check box Check box
The Public Health Agency of Canada (the Agency) has made efforts so that the Regulations are clear and easy to understand. Extensive consultations with stakeholders were the primary means to ensure that the requirements were understandable. The draft Regulations were reviewed internally and by Department of Justice staff to improve readability and language.
2. Is there a clear connection between the requirements and the purpose (or intent) of the proposed Regulations? Check box checked Check box Check box
In developing the Regulations, the Agency carefully analyzed and considered the regulatory authority making provisions in the enabling act, the Human Pathogens and Toxins Act (HPTA), as well as the desired policy outcomes of the Regulations to ensure that they were aligned and required to meet Government objectives. Each provision was reviewed and analyzed to ensure that it was required, if it was risk-based and, if possible, performance-based in order to reduce burden and provide industry with flexibility when demonstrating compliance.
3. Will there be an implementation plan that includes communications and compliance promotion activities that informs small business of a regulatory change and guides them on how to comply with it (e.g. information sessions, sample assessments, toolkits, Web sites)? Check box checked Check box Check box
The Agency is committed to supporting stakeholders throughout the full implementation of the HPTA and in particular the Regulations and key policy documents. The Agency is developing a comprehensive implementation plan that will consist of tailored guidance documents, training, scenarios to explain what the Regulations mean, frequently asked questions, etc. This is in addition to a transition period prior to the Regulations’ coming into force that provides stakeholders with time to familiarize themselves with the Regulations and make changes to their organization if needed. Throughout this period, the Agency will be available to stakeholders to answer inquiries and provide support.
4. If new forms, reports or processes are introduced, are they consistent in appearance and format with other relevant government forms, reports or processes? Check box checked Check box Check box
The Agency will ensure that material produced is consistent with Treasury Board Guidelines and other guidelines as appropriate, to ensure a common look and feel. The Agency is working closely with its Information Technology and Communications experts to ensure guidelines are followed.
II Simplification and streamlining Yes No N/A
1. Will streamlined processes be put in place (e.g. through BizPaL, Canada Border Services Agency single window) to collect information from small businesses where possible? Check box checked Check box Check box
As part of implementing the HPTA, the need for electronic tools for submission and retention of information submitted by laboratories or their entities was identified. The tool that is being developed will streamline the reporting and provision of information. This tool will be available to all stakeholders, regardless of size, as it was seen as a means to reduce burden and improve efficiencies.

In addition, the Agency is working with the Canada Border Services Agency (CBSA) on the Single Window Initiative (SWI) to facilitate the importation of goods while also balancing the security needs of the Government. The intent of the SWI is to facilitate trade and align regulatory approaches to protect health, safety and the environment while supporting economic growth. The SWI will provide importers with a single window through which they can electronically submit information required to comply with import-related border transactions, resulting in more efficient border processes. Implementation of the SWI will provide the Agency with improved business processes and will eventually lead to completely paperless interactions with the CBSA and traders.
2. Have opportunities to align with other obligations imposed on business by federal, provincial, municipal or international or multinational regulatory bodies been assessed? Check box checked Check box Check box
At the outset of regulatory development, the Agency consulted with each province and territory, as well as 16 national associations, to ensure that the consultation approach was meaningful and to allow concerns to be voiced. In addition, the Agency analyzed elements that may, or could be perceived to, overlap with practices or authorities found in other jurisdictions. As the Agency developed regulations for three elements (licensing, biosecurity and exemptions), the extent to which there may be overlap with other obligations is significantly reduced.

The Agency also proactively meets with regulatory partners/counterparts to align approaches and policy outcomes to the extent possible. This was done nationally with Government of Canada partners as well as with the United States. The Agency has met with various provincial and territorial bodies to learn more about program and processes that may be areas of overlap, specifically in the fields of occupational health and safety and laboratory diagnostic accreditation programs with a goal to reduce burden from any duplication with existing programs.
3. Has the impact of the proposed Regulations on international or interprovincial trade been assessed? Check box checked Check box Check box
Under the current regime, there are limited regulatory controls on domestically acquired human pathogens and toxins. The proposed Regulations will address this gap. Under the proposed licensing framework, licence holders will be able to import and transfer human pathogens and toxins that fall under conditions of their licence. This provision should streamline current processes. The licensing process should also assist industry in receiving shipments from the United States, as licence holders will be able to demonstrate that they comply with an equivalent safety program. The issue of equivalency was identified as a concern by a small business.
4. If the data or information, other than personal information, required to comply with the proposed Regulations is already collected by another department or jurisdiction, will this information be obtained from that department or jurisdiction instead of requesting the same information from small businesses or other stakeholders? (The collection, retention, use, disclosure and disposal of personal information are all subject to the requirements of the Privacy Act. Any questions with respect to compliance with the Privacy Act should be referred to the department’s or agency’s ATIP office or legal services unit.) Check box checked Check box Check box
To the extent possible, the Agency will leverage data or information provided to other jurisdictions to support the Agency’s requirements. This may include some information contained in reports of incidents involving human pathogens and toxins.
5. Will forms be pre-populated with information or data already available to the department to reduce the time and cost necessary to complete them? (Example: When a business completes an online application for a licence, upon entering an identifier or a name, the system pre-populates the application with the applicant’s personal particulars such as contact information, date, etc. when that information is already available to the department.) Check box checked Check box Check box
The Agency is developing the online tool to be “smart” such that fields will be pre-populated based on user identification (such as licence numbers) and triaged (meaning that industry may only be prompted to provide input based on responses to earlier entries).
6. Will electronic reporting and data collection be used, including electronic validation and confirmation of receipt of reports where appropriate? Check box checked Check box Check box
The Agency will use electronic means to support data reporting and collection. For example, the Agency will issue receipts of licence applications, reports or data. These will be validated electronically by date and time stamping the transactions and sending out notices by email through the kiosk/portal where appropriate.
7. Will reporting, if required by the proposed Regulations, be aligned with generally used business processes or international standards if possible? Check box checked Check box Check box
Reporting will be aligned with the current system for regulated parties and it will be linked to the licensing database so that some information fields can be pre-populated. Forms will contain intelligence to incorporate business rules to ensure information is captured as prescribed, or to reveal and hide information depending on previous choices. The system is expected to be adaptable should generally used processes or international standards change.
8. If additional forms are required, can they be streamlined with existing forms that must be completed for other government information requirements? Check box Check box Check box checked
The Agency will be replacing current forms, such as information required to obtain an importation permit, with new forms for licence application. The HPTA security clearance is a new requirement and unique to the Agency. Similar requirements could not be identified in other equally sensitive application forms.

In early 2013, the Agency and the Canadian Food Inspection Agency (CFIA) demonstrated their commitment to streamlining business processes by consolidating the importation permit application to include human and animal pathogens. The Agency continues to investigate opportunities for similar collaboration.
III Implementation, compliance and service standards Yes No N/A
1. Has consideration been given to small businesses in remote areas, with special consideration to those that do not have access to high-speed (broadband) Internet? Check box Check box Check box checked
The Agency is not aware of any business that would require an HPTA licence that does not have access to high-speed Internet. If the Agency becomes aware of any such business, the Agency will work with them to identify alternate mechanisms for submitting licence applications, amendments and notifications.
2. If regulatory authorizations (e.g. licences, permits or certifications) are introduced, will service standards addressing timeliness of decision making be developed that are inclusive of complaints about poor service? Check box checked Check box Check box
The Agency has developed two service standards for regulatory authorizations as part of the Government’s commitment under the Red Tape Reduction Action Plan. Each of these standards, and those that will be developed for regulatory authorizations under the Regulations, will include all required elements, such as service feedback, performance target and a description of the application process. Service standards will be regularly monitored to ensure optimum service delivery.
3. Is there a clearly identified contact point or help desk for small businesses and other stakeholders? Check box checked Check box Check box
The Agency has established program-specific contact points to address inquiries related to specific aspects of the regulatory programs, such as licensing, the Canadian Biosafety Standards and Guidelines, as well as contact information for inquiries that are more general in nature or related to service delivery. These points of contact are available to all sectors.

B. Regulatory flexibility analysis and reverse onus

IV Regulatory flexibility analysis Yes No N/A
1. Does the RIAS identify at least one flexible option that has lower compliance or administrative costs for small businesses in the small business lens section?

Examples of flexible options to minimize costs are as follows:
  • Longer time periods to comply with the requirements, longer transition periods or temporary exemptions;
  • Performance-based standards;
  • Partial or complete exemptions from compliance, especially for firms that have good track records (legal advice should be sought when considering such an option);
  • Reduced compliance costs;
  • Reduced fees or other charges or penalties;
  • Use of market incentives;
  • A range of options to comply with requirements, including lower-cost options;
  • Simplified and less frequent reporting obligations and inspections; and
  • Licences granted on a permanent basis or renewed less frequently.
 Check box checked Check box Check box
The Regulations and program were developed in such a way as to minimize burden across all stakeholder groups regardless of size. This is aligned with the Agency’s risk-based approach, where regulatory oversight increases as the risk of the human pathogen or toxin increases. In addition, the cost analysis has indicated that the costs of the proposal are proportionate to the number of laboratories in an organization, resulting in a lower-cost impact on smaller organizations.

Other elements to minimize burden, such as online reporting tools, no licence application fee, and a transition period, are available to all sectors, regardless of size.
2. Does the RIAS include, as part of the Regulatory Flexibility Analysis Statement, quantified and monetized compliance and administrative costs for small businesses associated with the initial option assessed, as well as the flexible, lower-cost option?
  • Use the Regulatory Cost Calculator to quantify and monetize administrative and compliance costs and include the completed calculator in your submission to TBS-RAS.
 Check box checked Check box Check box
The extent to which small businesses will be impacted by the proposed Regulations is expected to be minimal. The Agency made several attempts to identify small businesses who work with human pathogens and toxins through outreach during the consultations process, two Agency-sponsored questionnaires, and internal analysis of industry sectors. Through these efforts, the Agency has concluded that there are few small businesses conducting controlled activities with human pathogens and toxins.

As part of the Agency’s commitment to minimizing regulatory burden and supporting a risk-based approach to its regulatory program, all sectors, including small businesses, should be spared unnecessary regulatory oversight. The Agency did analyze and cost the initial option as well as the flexible option. This is described in the RIAS.
3. Does the RIAS include, as part of the Regulatory Flexibility Analysis Statement, a consideration of the risks associated with the flexible option? (Minimizing administrative or compliance costs for small business cannot be at the expense of greater health, security or safety or create environmental risks for Canadians.) Check box checked Check box Check box
Information discussing the risks associated with reduced regulatory burden is discussed in the RIAS as it relates to all stakeholders, regardless of size.
4. Does the RIAS include a summary of feedback provided by small business during consultations? Check box checked Check box Check box
As noted, while the Agency attempted to identify small businesses through its consultation process, there was limited response. All feedback received throughout the extensive consultations was considered by the Agency and assisted in regulatory development. Feedback from stakeholders is summarized in the RIAS.
V Reverse onus Yes No N/A
1. If the recommended option is not the lower-cost option for small business in terms of administrative or compliance costs, is a reasonable justification provided in the RIAS? Check box Check box Check box checked
The recommended option provided in the RIAS is the lower-cost option for all sectors.