Human Pathogens and Toxins Act

An Act to promote safety and security with respect to human pathogens and toxins

This bill was last introduced in the 40th Parliament, 2nd Session, which ended in December 2009.

Sponsor

Leona Aglukkaq  Conservative

Status

This bill has received Royal Assent and is now law.

Summary

This is from the published bill. The Library of Parliament often publishes better independent summaries.

This enactment creates measures to promote safety and security with respect to human pathogens and toxins and all activities associated with them. It establishes a comprehensive legislative regime that extends beyond the present importation regime. It requires every person conducting activities involving human pathogens or toxins to take all reasonable measures to protect the health and safety of the public.

Elsewhere

All sorts of information on this bill is available at LEGISinfo, an excellent resource from the Library of Parliament. You can also read the full text of the bill.

Votes

May 5, 2009 Passed That the Bill be now read a third time and do pass.
April 27, 2009 Passed That Bill C-11, An Act to promote safety and security with respect to human pathogens and toxins, {as amended}, be concurred in at report stage [with a further amendment/with further amendments] .

Human Pathogens and Toxins ActGovernment Orders

February 23rd, 2009 / 11:05 a.m.
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Conservative

Gary Lunn Conservative Saanich—Gulf Islands, BC

moved that Bill C-11, An Act to promote safety and security with respect to human pathogens and toxins, be read the second time and referred to a committee.

Human Pathogens and Toxins ActGovernment Orders

February 23rd, 2009 / 11:05 a.m.
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Oshawa Ontario

Conservative

Colin Carrie ConservativeParliamentary Secretary to the Minister of Health

Mr. Speaker, it is a pleasure to have this opportunity at second reading to address the important issues of the safety and security of human pathogens and toxins. That is a primary reason behind Bill C-11, An Act to promote safety and security with respect to human pathogens and toxins.

I want to begin by explaining what a pathogen is. A human pathogen is a micro-organism capable of causing disease or death in humans. Examples include: salmonella bacteria, the agent of anthrax, listeria bacteria and the Ebola virus. The need to enhance biosafety in Canada's laboratories and prevent an inadvertent release of these agents is one of the two primary focuses of Bill C-11.

The need to safeguard Canadians from the risk of an intentional release of these dangerous agents constitutes the second primary focus of the proposed human pathogens and toxins act. As we know, the world changed after September 11, 2001. The events of that day highlighted the need for greater vigilance on our part. This was emphasized in the month that followed when an anthrax attack in the United States resulted in 22 identified cases and five deaths.

The cost of a bioterror attack is high, both in terms of lives lost, lives affected and economic consequences. It is the responsibility of government, of this Parliament, to put in place the necessary measures to minimize the likelihood of such an event.

There are approximately 3,500 laboratories that import human pathogens into Canada. These laboratories are regulated under the existing human pathogens importation regulations which have been in force since 1994. They must also comply with our laboratory biosafety guidelines which are widely accepted as Canada's national biosafety standard.

Unfortunately, these regulations and associated laboratory biosafety guidelines are only mandatory for facilities that import human pathogens. They are not mandatory for the additional 4,000 laboratories that do not import, but which acquire human pathogens within Canada.

While labs working with these pathogens do so in a safe manner and widely apply these guidelines on a voluntary basis, we need legislation and regulations in place to reinforce these safe practices, and establish consistency by ensuring all labs in Canada, whether federal, provincial or private, are adhering to these guidelines.

Canada faces some serious risks as a result of this legislative and regulatory gap. These include risks to the safety of persons working in and around laboratories and risks to our national security. There is always the potential for accidental release of human pathogens or toxins.

As I have said, about 4,000 laboratories in Canada use domestically acquired human pathogens and toxins. The fact that these laboratories are subject only to a voluntary biosafety regime is not acceptable, especially since similar laboratories that import human pathogens operate under a mandatory biosafety regime.

It is time to level the playing field in Canada so that all persons working with these agents, and especially all laboratories, are required to operate under the same rules and to comply with the same national biosafety guidelines.

To this end the new human pathogens and toxins act is designed to ensure that unless exempted, no person may carry on activities with these dangerous substances without a licence and without complying with the laboratory biosafety guidelines.

Beyond accidental release, Canada also faces the risk of a deliberate release of a human pathogen or toxin. This is not a pleasant scenario but one which we must consider fully in order to protect Canadians. To address this risk the new legislation includes a provision for a new national system of security screening for persons handling the most dangerous of these agents. Other than for individuals working in federal government laboratories, there is no such system in place in Canada at this moment.

It is important that the government take reasonable precautions to ensure that while not interfering with research, people handling the most dangerous human pathogens and toxins in Canada have received appropriate security screening. At the same time, the government will seek to ensure that there is a minimal paper burden on those handling less dangerous human pathogens and toxins.

The new legislation will address both biosafety and biosecurity risks through a range of mechanisms including: new criminal prohibitions, offences, and penalties; expanded inspection and enforcement; a new authority to make regulations; and new security screening requirements for persons having access to the most dangerous human pathogens and toxins.

This proposal would render Canada more consistent with its international partners and allies, including the United States, the United Kingdom and Australia, which have all passed new security legislation. It is time that Canada joined them.

This new legislation is needed now. It is required to safeguard the health and well-being of Canadians, especially those persons working in laboratories. It is also required to demonstrate to the Canadian public, and to our international partners, that the Government of Canada is taking very seriously the issue of national security related to dangerous human pathogens and toxins.

The proposed legislation represents a made in Canada approach that would emphasizes safety and strong security linkages. The urgency in moving ahead with expanded federal oversight over human pathogens and toxins has been widely recognized. We have discussed this proposal with our provincial and territorial public health colleagues and with the diverse laboratory community in Canada, including academia and the private sector. They have agreed with the need to move ahead and they have shown a keen interest in further discussions concerning details about licensing, inventories, security screening, and how they will be included in future discussions.

We will continue to engage our stakeholders as Bill C-11 moves through the parliamentary process.

As well, we will commence in-depth consultations with stakeholders across the country on the program and regulatory framework. These consultations will help us ensure that we have correctly balanced the needs of biosafety and biosecurity, on the one hand, and the interests of ongoing science and research, on the other. In proposing this legislation, we are building on our existing importation program.

It is important that we turn our attention to applying existing biosafety and biosecurity controls equally to all persons carrying on activities with these dangerous agents across Canada. For this reason, I call on my colleagues in this House to support Bill C-11. I am looking forward to questions.

Human Pathogens and Toxins ActGovernment Orders

February 23rd, 2009 / 11:10 a.m.
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Conservative

Joy Smith Conservative Kildonan—St. Paul, MB

Mr. Speaker, I would like to ask the parliamentary secretary to clarify the difference between human pathogens and toxins.

Human Pathogens and Toxins ActGovernment Orders

February 23rd, 2009 / 11:10 a.m.
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Conservative

Colin Carrie Conservative Oshawa, ON

Mr. Speaker, a human pathogen is a micro-organism capable of causing disease or death in a human. For the purposes of this legislation, this includes animal pathogens that can cause disease in humans. For the purposes of this legislation, toxins are defined as substances produced by or derived from micro-organisms which are able to cause disease in humans and which are listed in schedule 1 of the proposed bill. Human pathogens are divided into risk groups, taking into account varying levels of risk.

Human Pathogens and Toxins ActGovernment Orders

February 23rd, 2009 / 11:10 a.m.
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Conservative

Dave Van Kesteren Conservative Chatham-Kent—Essex, ON

Mr. Speaker, I, too, was listening with interest to the proposed bill. I have a question for the parliamentary secretary. How would this relate to existing regulations for import of human pathogens?

Human Pathogens and Toxins ActGovernment Orders

February 23rd, 2009 / 11:10 a.m.
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Conservative

Colin Carrie Conservative Oshawa, ON

Mr. Speaker, my colleague brings up a very important question because right now there are regulations and legislation that exist for importation. However, for laboratories actually using these pathogens in the laboratory, they are not legislated and regulated in the proper way. That is why it is very important that we move this legislation forward, so we level the playing field for all laboratories in Canada.

Human Pathogens and Toxins ActGovernment Orders

February 23rd, 2009 / 11:10 a.m.
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Conservative

Greg Rickford Conservative Kenora, ON

Mr. Speaker, I would like to ask the parliamentary secretary this question. What would be the implications of an intentional release of human pathogens?

Human Pathogens and Toxins ActGovernment Orders

February 23rd, 2009 / 11:10 a.m.
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Conservative

Colin Carrie Conservative Oshawa, ON

Mr. Speaker, as I said in my speech, Canadians are concerned. On September 11, 2001, the world changed. There have been attacks in the United States. The member probably remembers the anthrax incidents. There were 22 cases, resulting in the death of five people.

It is about time that Canada brings our legislation and regulations up to the level that our international partners expect. It is not a scenario that one wants to think about. The release of these pathogens and toxins could have severe consequences on our population. That is why I am calling on all my colleagues to work with me, to work with the minister, and to work in committee to get this legislation passed because it is definitely needed.

Human Pathogens and Toxins ActGovernment Orders

February 23rd, 2009 / 11:10 a.m.
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NDP

Judy Wasylycia-Leis NDP Winnipeg North, MB

Mr. Speaker, I appreciate the remarks made by the Parliamentary Secretary to the Minister of Health and his description of Bill C-11. I agree with him that this is a very important issue and we have learned a lot based on some very traumatic episodes in our history over the last little while.

My concern is that all of these great plans will come to nought if in fact the government does not have an underlying framework that respects the question of government supported or sponsored initiatives, whether it be in terms of emergency services or laboratories.

My question to the parliamentary secretary is quite simple. Could he give the House assurances that the government, unlike in other areas, has absolutely no intention of privatizing our public laboratories?

Human Pathogens and Toxins ActGovernment Orders

February 23rd, 2009 / 11:15 a.m.
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Conservative

Colin Carrie Conservative Oshawa, ON

Mr. Speaker, that is a very important question. Our laboratories play an important role for public health in Canada and I would like to assure the member that federal laboratories are going to remain in that framework.

Extensive consultations were held with stakeholders, particularly the laboratories. I want to let the member know that stakeholders, including the biosafety officers at laboratory institutions, welcomed these proposals and generally support the expanded federal oversight of human pathogens and toxins.

However, some important issues were raised at the stakeholder consultations. These include: the documentation requirements for permits, registration, inventory maintenance, security screening of personnel with access to dangerous human pathogens, and potential cost implications of compliance with these new biosafety requirements. The government intends to address all of these concerns by engaging in a wide range of consultations with stakeholders over specific elements of security screening in order that the legislative and regulatory framework is implemented in such a way to allow for efficient compliance.

Stakeholders involved in research and development also asked whether the proposed legislation could have negative implications on their research. As the member brought forward, it is very important that these labs continue with their research.

The focus of the proposed legislation is the strengthening of biosafety. The principles of biosafety do not in any way impede research and development but, rather, aim at those activities proceeding without harming the scientist or the public. The Public Health Agency of Canada will aim to find the appropriate balance between safety and security, and supporting this very important scientific research.

Human Pathogens and Toxins ActGovernment Orders

February 23rd, 2009 / 11:15 a.m.
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NDP

Pat Martin NDP Winnipeg Centre, MB

Mr. Speaker, I with to thank the parliamentary secretary for some of the references he made to the handling protocols of these pathogens. I want to ask him, what specifically in the bill would give satisfaction to the people of my riding, where the level 4 federal laboratory is located?

In the case of what happened recently, a car accident occurred where a FedEx truck ran into a car and its contents spilled out. Guess what was in the FedEx truck? There was anthrax, the Newcastle disease virus, and a number of other serious toxins. People who farm chickens will know that Newcastle disease is not something we want in the community.

There was a level 4 virology lab shipping anthrax and Newcastle by FedEx with no protocols whatsoever, any more than one would give to sending a Christmas gift to a relative. I want to see very strict protocols within this bill and some satisfaction, so that I can tell the people of my riding that we are addressing this appalling issue.

Human Pathogens and Toxins ActGovernment Orders

February 23rd, 2009 / 11:15 a.m.
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Conservative

Colin Carrie Conservative Oshawa, ON

Mr. Speaker, I have actually had the privilege of visiting the hon. member's riding and the very important level 4 lab in Canada. He is correct that these labs handle extremely pathogenic substances, such as Ebola.

That is exactly why the government is moving forward on this very important legislation. We need those specific controls when laboratories handle these substances and transfer them from one lab to another. In the present legislation, it is only mandatory when the laboratories import those pathogens into the country. However, for transfer within the country, as the member so rightly pointed out, it is voluntary. I would point out that the lab in his riding is exceptional and has very high standards, but it is important that the Government of Canada is able to regulate and watch over the particular instances that the member mentioned.

It is a very good question and I am looking forward to getting this important legislation before a committee, so the experts can appear to be asked those very specific questions. Hopefully, we can support this bill and move it forward for specifically the reasons that the hon. member brings forward.

Human Pathogens and Toxins ActGovernment Orders

February 23rd, 2009 / 11:20 a.m.
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Liberal

Carolyn Bennett Liberal St. Paul's, ON

Mr. Speaker, I seek consent to share my time with the member for Etobicoke North.

Human Pathogens and Toxins ActGovernment Orders

February 23rd, 2009 / 11:20 a.m.
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Conservative

The Acting Speaker Conservative Barry Devolin

Is there unanimous consent?

Human Pathogens and Toxins ActGovernment Orders

February 23rd, 2009 / 11:20 a.m.
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Some hon. members

Agreed.