Evidence of meeting #26 for Environment and Sustainable Development in the 39th Parliament, 1st Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was data.
A recording is available from Parliament.
Conservative
The Chair Conservative Bob Mills
Order.
I would like to get one piece of business out of the way, just at the beginning of the meeting. That's our budget request for payment for witnesses for Bill C-288 in the sum of $14,400. I think everybody has a copy of that item.
Are there any comments? Yes, Mr. Warawa.
Conservative
Conservative
Mark Warawa Conservative Langley, BC
Mr. Chair, I'll be supporting the motion, but begrudgingly.
Bill C-288, as we've heard from the witnesses to this point, would have been relevant in 1998. We've heard to this point that we cannot meet our Kyoto targets, and I expect the science will support that. So Bill C-288, supported by the Liberals and the Bloc, is an irrelevant bill, and for us to be asking for witnesses to support an irrelevant bill, Mr. Chair, is a waste of taxpayers' dollars.
On the other hand, this is before the committee, and we have a list of witnesses, so under that spirt I will be supporting it--but begrudgingly.
Conservative
Bloc
Bernard Bigras Bloc Rosemont—La Petite-Patrie, QC
Yes I do.
I find the comments of the Parliamentary Secretary are unacceptable, who is apparently unhappy that we are studying this bill. This flies in the face of the basic principles of our democracy.
We would never refuse supplementary estimates to study a government bill that passed on second reading. It is normal for the parliamentary committee to study a bill that was passed on second reading; in fact, it is required to do so.
The Parliamentary Secretary can be against the bill, but this shouldn’t be a factor. What is important is that the bill is studied because this is what the majority of MPs, Canadians and Quebecers want. Therefore, I would like to proceed with the vote on the supplementary estimates.
NDP
Denise Savoie NDP Victoria, BC
Thank you, Mr. Chairman.
I would like to add that this not only represents the views of the majority, but also our international commitments. That is why it is very important that we study the issue in depth.
Conservative
The Chair Conservative Bob Mills
Are there any other comments?
(Motion agreed to on division) [See Minutes of Proceedings]
Conservative
The Chair Conservative Bob Mills
I'd like to welcome our guests, as is our practice. I think most of you are here. Certainly those from health and environment are here. We invite you to intervene where necessary and respond to our panellists.
If we could start, we'll try to go ten minutes per witness and then open it up to our members to ask questions.
We'll begin with Ms. Coombs.
Shannon Coombs President, Canadian Consumer Specialty Products Association
Good afternoon, Mr. Chair and members of Parliament. It's a pleasure to be here today to continue discussions on the CEPA review, and in particular how substances are regulated and managed under this important piece of legislation. We appreciate the opportunity to make a presentation.
First I'd like to introduce our association. The Canadian Consumer Specialty Products Association is a national trade association that represents 40 member companies across Canada, collectively a $20 billion industry employing 12,000 in over 100 facilities across the country. Our companies manufacture, process, package, and distribute consumer and institutional specialty products such as soaps and detergents, pest control products, aerosols, hard surface disinfectants, deodorizers, and automotive chemicals. CEPA governs all the ingredients in our products.
For a visual of our products, I have provided a one-pager, “Imagine life without you”, which was passed around by the clerk. I'm sure that most of you have recognized some of the products that are used in your homes.
CCSPA has provided committee members with a brief on today's topic. The questions on the committee's topic list posted on the web for this discussion included the following: What information should the government require of industry and who should assess that information? What level of public disclosure should there be regarding data and its analysis? Where should the burden of proof lie?
In my presentation today I will outline the current processes and our comments on the law and regulations.
First, I wish to clarify that the terms “new” and “existing” that I'll use during this presentation are those used by companies, officials, and involved stakeholders when discussing the regulations and the legislation of CEPA.
To address the first question--how are substances assessed under CEPA and what information is required--I'd like to start with new substances of CEPA.
The new substance notification regulations are regulations that govern how new substances are assessed and approved under CEPA. The regulations have been in place since 1994 but are retroactive and reach back to 1987 to assess new substances. These regulations require that a company or individual proposing to bring a new substance into the Canadian marketplace must provide an information and data package for government assessment to Health Canada and to Environment Canada. The regulations are very clear about what information must be provided so that Environment Canada and Health Canada assessors can make a proper determination. Both departments review the information and data and determine if there are any potential environmental and/or human health concerns.
It is CCSPA's position that these regulations are science-based, rigorous, predictable, and progressive--by “progressive” we mean they're based on volume. What this means is that the higher the volume of a substance manufactured or imported into Canada, the more data a company must provide to the government.
The initial submission determines the potential impacts on human health, safety, and the impacts on the environment. Then there are triggers in place for additional data to be generated and submitted, based on the volume, to ensure that there are no impacts on human health and safety for the environment. Information and data requirements are quite rigorous and are clearly spelled out in the regulations.
Examples of the information and data that's required to be submitted are such things as the annual quantity that will be used in Canada, the uses, including those in end-use products, and whether the substance may be in products intended to be used by or for children. Minimum test data includes water solubility, impurities, biodegradation test data, skin irritation, toxicity to fish, algae, mammalian testing, as well as mutagenicity data. There are 12 schedules of information under the regulations that are required to be submitted to the government, based on the volume.
Canada's new substance notification regulations are as stringent and as robust as any OECD country's new chemical program. I would suggest that if the committee would like to have more discussion on the 12 schedules, you might wish to have Environment Canada or Health Canada outline those provisions.
I would like to note that these regulations have been developed in consultation with stakeholders, and were revised in 2005 after consensus recommendations were made on the regulations and guidelines.
For existing substances, government has recently finished the first phase of the categorization and screening of the domestic substances list--that is, categorization. Canada is the first country in the world to comprehensively review its existing substances, and it's leading the world. This process took six years to complete.
Environment Canada and Health Canada led a process to categorize 23,000 substances on the domestic substances list, the DSL. That program was science-based and was consultative throughout the timeline. As a reminder, the domestic substances list is comprised of many substances, such as gas, building blocks for plastics, food, pharmaceuticals, ingredients for paint, vitamins, fragrances, flavourings--it's quite a range.
The categorization process follows science-based criteria for substances to meet. Those are: persistent and inherently toxic; bioaccumulative and inherently toxic; persistent bioaccumlative and inherently toxic; or the greatest potential for human exposure.
In a prior brief to the committee in June of this year, we stated that the CSDSL program was a success of CEPA. We also included in that brief the success of the new substance notifications applying to the substances in Food and Drugs Act products over the past five years, which again, in our opinion, is most beneficial, since those regulations are science-based, predictable, and rigorous.
It is CCSPA's understanding that as a result of this program of categorization and screening, Canada has identified approximately 4,000 substances as having met the categorization criteria and possibly requiring further in-depth study and assessment by the government. While the results of the programs have yet to be made public with an action plan from Ministers Ambrose and Clement, CCSPA has challenged this committee and the government that the list of potentially 4,000 substances needs to be put in context and communicated properly to Canadians.
As discussed in September, previous witnesses have been quoted in our national newspapers characterizing the list as the baddies of the bad or the worst of the worst. We are told the substances on the list will include such things as tamoxifen , which is a life-saving cancer drug; titanium dioxide , a key ingredient in sunscreen, which prevents cancers; vinegar; almond flavouring; and vitamin A—just to name a few. Instead of scaring Canadians and not advising them of the facts, we should be telling them about the enormous work this government has undertaken and its plans to address concerns with all stakeholders, but most importantly, we should put into context what this list really means to Canadians.
The example of tamoxifen is excellent, because of course that substance meets the criteria because it's designed to kill. We assume that the intent is to keep that substance available to consumers. Therefore, it is critical that these results have some risk-benefit communications.
As per the September 26 submission and presentation to the committee, we are again requesting the government to develop a proactive communication strategy to inform Canadians about the program and the results, so that they're informed and can make balanced decisions. It is also our expectation that the second phase of CSDSL screening will have the two departments conducting both rapid and in-depth screening risk assessments.
Information for that second phase of the CSDSL program will be assessing existing substances similar to how new substances are assessed. The major difference there is going to be between the CSDSL program and the new substance program is the possible, as we call them, data gaps. The term data gap is used when some tests have been conducted on a substance, but other tests may not appear to have been conducted. If the government has identified a data gap for a substance, it does not automatically mean that no test exists; companies may have conducted assessments on these substances to ensure human and environmental safety as part of industry's commitment to providing safe and effective products to consumers.
Government will be identifying data gaps, as they may prevent their making informed decisions on the assessment of a substance. Government will undoubtedly be challenging industry to close the data gap and provide the information necessary for the government to reach an assessment conclusion. CCSPA members are providing and are willing to proactively provide these data to fill the gaps, as long as the process for screening and moving forward is science-based and there is due process for comments prior to any public decisions being made.
Government will also likely be using publicly available data and data submitted by companies to make their assessment. Canada will also be using results of studies and substance assessments carried out by other OECD jurisdictions, such as Europe, the U.S., and Japan.
Industry is also involved in other programs to ensure data gaps are filled. For example, the OECD and U.S. high-production-volume challenge programs are producing information sets that are being reviewed by various regulators around the world. These regulatory reviews will be used in Canada, no doubt.
Overall, CCSPA is confident that the second phase of the categorization of screening program will operate efficiently under CEPA.
To answer the question of how much information should be publicly disclosed, it is our opinion that CEPA provides the minister with broad authority to determine what information companies consider to be confidential and the authority to disclose confidential information if the minister deems it to be in the public's interest. I will be speaking to CEPA part 11, sections 313 through 321, which deal with the disclosure of information.
Section 313 allows individuals and companies to request that information they submit to the government be treated as confidential. However, there are many instances where the government, under CEPA, requires companies to submit confidential information concerning the substances they use.
Section 315 of CEPA provides the minister with the extraordinary power to disclose confidential business information that is made available to them, if in the minister's opinion the disclosure of such information is clearly in the public's best interest and outweighs any material or financial loss or competitive position of a company or person who provided that information. Section 316 also allows the minister to disclose confidential information to a physical or medical professional.
Section 319 of the act allows the minister to create regulations for what information must accompany a request of confidentiality. In essence, the minister can set the rules concerning circumstances under which they may consider information submitted to them to be confidential.
To answer the final question on who bears the burden of proof, first and foremost our members' first priority is the health and safety of Canadians and their environment. While industry takes upon itself the responsibility for bringing new technology to Canada, we also determine the proper use and application of substances. Before a substance is brought to market, industry conducts numerous in-house tests and risk assessments to ensure that substances in our products can be used safely and that human health and the environment will not be compromised. Industry also determines how the substance should be used so that risks are mitigated. This is accomplished via handling instructions, precautions on the label, and disposal information. Industry takes its obligation towards the proper and sound management of substances very seriously.
However, it is the government that sets the parameters of what it takes to have the government approve a new substance or continue with the substances on the DSL. It is the government that sets the parameters for the regulations, determines the scientific criteria, and makes the final decision on whether that substance is allowed to be manufactured or imported into Canada. Therefore, it is our opinion that both industry and government have a role to play to ensure that the appropriate assessment of substances is conducted.
Mr. Chair and members of Parliament, CCSPA and our member companies stand by the position that the ingredients are used safely in our products, and our products are safe when used according to directions.
Thank you for your time. I'd be pleased to answer any questions.
Jessica Ginsburg Counsel, Canadian Environmental Law Association
Good afternoon.
My name is Jessica Ginsburg. I am special projects counsel at the Canadian Environmental Law Association, also known as CELA.
I'd like to introduce Kapil Khatter, director of the Pollution Watch program on health and environment, which is a joint initiative of CELA and Environmental Defence. Also sitting with me today is Fe de Leon, a researcher at CELA.
I'll now turn to burden of proof. The issue of burden of proof is extremely important from a number of perspectives, historically, economically, and scientifically.
Historically, approximately 23,000 substances were allowed to enter the Canadian market without any toxicological information or assessment. These substances, now known as “existing substances”, may exhibit any number of hazardous properties. The burden was placed on government to try to identify priority substances requiring assessment, first through the creation of two priority substances lists in 1989 and 1995, and more recently through the categorization exercise.
Identifying and assessing substances using the two priority substances lists proved to be extremely inefficient, expensive, and ultimately ineffectual. Only 69 substances in groups received assessments, and regulatory actions have still not been taken to prohibit or eliminate these substances.
The categorization exercise has attempted to prioritize the remaining backlog of existing substances, but this initiative has been similarly hampered by the scarcity of available information and the lack of onus on industry to provide the missing data.
In July 2006 Environment Canada released figures indicating there were over a thousand substances considered not to have met the categorization criteria simply due to the fact that the department lacked sufficient information on which to base its decisions. At no time during the categorization exercise did government require industry to fill in these data gaps by conducting toxicological testing, despite repeated recommendations to this effect from NGO participants.
The failure to gather data on these substances so as to deal with them in a scientifically valid way runs counter to the precautionary principle. The precautionary principle is a CEPA guiding principle, and government is obliged to exercise its duties in a precautionary manner where possible.
The next phase of work will require government to conduct screening assessments on approximately 4,000 substances that are expected to meet the categorization criteria. If the government continues to bear the burden for investigating the toxicity of these substances, this screening process is anticipated to extend over a period of decades.
Again, it is important to note that these substances are already in Canadian commerce; therefore, our citizens and our environment will continue to be exposed to them over this prolonged period of time. It is important that the act be amended to place greater responsibility on industry for its substances in order that prompt action can be taken on the most threatening ones.
In considering how to amend CEPA, special attention should be paid to paragraph 71(1)(c). Under this section, government can require a proponent of a substance to conduct toxicological tests. However, government authority is curtailed by the requirement in section 72 that the minister must first have a reason to suspect the substance is toxic or capable of becoming toxic. There is a lack of clarity regarding the threshold for suspicion of toxicity and the degree of certainty that is required in order to meet it.
The new substances regime places a greater onus on industry to produce information. Notifiers are required to prepare and submit small data sets before chemicals can be newly introduced into the Canadian market. As with existing substances, however, the ministers may only request additional toxicological tests under section 74 when they suspect a substance is toxic or capable of becoming toxic.
The final report of the multi-stakeholder consultations on the new substances notification regulations identified a number of concerns and confusion around section 84 and said the ultimate goal would be to amend CEPA to incorporate information-gathering authorities.
I'll now turn to our recommendations.
Number one: The ministers' power to require industry to conduct toxicological testing and submit the results under paragraphs 71(1)(c) and 84(1)(c) should be unconstrained by the prerequisite that the ministers suspect a substance is toxic. Such a prerequisite weakens the ministers' ability to shift the burden of proof onto the proponent of a substance.
Number two: At all phases of the information-gathering and assessment process, reverse onus should apply. Accordingly, it should be industry's responsibility to demonstrate the safety of their substances. Examples of this approach can be found in the authorization process under REACH, and in portions of the revised registration regime of the Pest Control Products Act. There should also be a specified time limitation to ensure that industry provides this information promptly upon request.
Number three: In order to achieve this objective, the following sections of CEPA will require amendment: section 73, dealing with the categorization of substances; section 74, dealing with screening assessments; section 75, dealing with substances that have been controlled by other jurisdictions; and section 76, dealing with full assessment for priority substances.
Number four: Precaution should be exercised in the absence of data, and uncertain substances should not be allowed on the market, since industry has not discharged its obligation of demonstrating safety.
Moving on now to confidentiality, the issue of confidentiality has far-ranging implications for transparency, precautionary action, and the public's right to know about substances that may have an impact on their health and their environment. The public's right to know must take precedence over industry claims that competitiveness requires confidentiality. Sections 313 to 321 of CEPA set out the general requirements for claiming confidentiality. They hold that a person who provides information to the minister under this act may request in writing that the information be kept confidential. Section 314 specifies that the minister will not disclose the information unless a legal test is met, as set out in sections 315 to 317. The guidelines for the notification and testing of new substances provide additional details. Under the guidelines, notifiers may claim confidentiality as long as they satisfy six general criteria and sign a certification statement attesting to the accuracy of their claim.
Little information has been reported about whether and how the confidentiality provisions have been applied. Confidentiality requests are not dealt with in a consistent manner across government departments. For instance, the certification statement is not uniformly applied, and at times the six criteria to be met by notifiers are listed without an “and” separating them, causing confusion about whether one or all of the criteria must be met. In some departments all information received from a notifier is treated as confidential unless the company provides explicit written consent for the government to disclose it.
Additionally, confidentiality is maintained between government agencies that have not signed information-sharing agreements, so it's possible that notification packages may not be shared where the same substance is notified to different agencies under two or more acts. As a result, public access to information is jeopardized and consistency in government decision-making is challenged.
I'll turn now to recommendations.
Number one: The committee should call and review evidence on the actual use of confidentiality under CEPA in order to determine how and to what extent the provisions have been used in the interest of public health, public safety, and the protection of the environment.
Number two: According to Canada's international commitments, CEPA provisions should ensure that information on chemicals relating to the health and safety of humans and the environment is not regarded as confidential.
Number three: CEPA should contain legally binding requirements to be met by a notifier in order to claim confidentiality. There should be a presumption that confidentiality will not be granted unless certain conditions are met, rather than the opposite presumption, which currently exists.
Number four: Notifiers should always be required to provide evidence substantiating their claims of confidentiality.
Number five: Summaries of all notification packages with confidentiality claims should be made public prior to the final assessment decisions.
Number six: Where confidentiality is claimed, the company's chief executive officer should be required to attest to the fact that the confidentiality criteria have been met. Currently, only the individuals submitting the notification package are required to sign the certification statement.
Finally, number seven: Confidential information should be shared freely among all government departments involved in the assessment of substances. Formally negotiated information-sharing agreements should not be required between government departments that are involved in reviewing notification packages.
Thank you for taking the time to hear from me today.
Conservative
The Chair Conservative Bob Mills
Thank you very much.
We'd like to welcome Mr. Larson. Just for members' information, he has filled infor Mr. Graham, the vice-president, who was unable to attend. So we have the president, Mr. Larson, here in his place.
Thank you.
Roger Larson President, Canadian Fertilizer Institute
Thank you very much, Mr. Chairman and members of the committee. I apologize for our last-minute substitution. Getting the president rather than the vice-president may be a step down in the world.
I would like to take a moment to talk with the committee about our views on the science assessment and focus on the use of the science assessment as a basis for the toxics determination under CEPA.
My industry has been involved in this issue since the mid-1990s with a priority substances list proposal, a PSL, to evaluate road salt and ammonia in the aquatic environment as CEPA-toxic. So our experience on this is very real and very directly affected our industry, which manufactures plant nutrients for use by farmers to grow food.
The proposal for ammonia in the aquatic environment hinged on a problem that we have with municipal waste water treatment plant effluent. The challenge with road salt was a concern that municipalities were exceeding the necessary requirements for public safety. And when they decided to define the package for road salt, they included three chloride-based products: sodium chloride, which is of course salt; potassium chloride, which is potash, which is a fertilizer; and another one. Now, the reason that there was an inclusion of potassium chloride was simply because it was a residual product, you might say an impurity when the refining of the salt process was completed. Nevertheless, potash was included in the proposal to declare toxicity on road salt.
The need for a science assessment probably is viewed as a process to establish federal jurisdiction in order to regulate a substance. The assessment process in the case of salt and ammonia did not add any scientific knowledge to the equation. When a science assessment is used in legislation as a measure to define constitutionality, then we end up with the difficulties of whether or not you can remove the word “toxic” from CEPA and still have legislation that is constitutional. This politicizes the science assessment and effectively destroys its validity as an effective tool for decision-making. If the only way you can establish jurisdiction is to declare something toxic, then every word in the science assessment that's going to be written down is going to be one that intends to drive the decision in that particular direction. Whether or not the assessment is meaningful in any peer-reviewed science meaning of the word effectively becomes irrelevant.
We had weak science assessments for road salt and ammonia in the aquatic environment because of the politicized process. Early on, CFI did a literature review on the ammonia issue and showed the science assessors what everybody in the world already knew: that if you put excessive quantities of ammonia in water it will kill fish. It's also a life-giving substance that is absolutely essential to make plants grow. It's an issue not of inherent toxicity but one in which a certain quantity is necessary for life and very beneficial, and too much can cause harm to certain species.
I would like to conclude my brief comments by suggesting that the one thing the science assessment does not do is ask what a meaningful risk management for a substance would be. Rather than focusing efforts on risk assessments or on risk management, we spend years politically fighting over what the risk assessment should say on a substance. This is a huge misallocation of public resources within the Department of the Environment. It's a huge waste of economic resources on the part of the affected industries. It is detrimental, in my view, to effective public policy development.
Mr. Chairman, thank you.
Conservative
Liberal
John Godfrey Liberal Don Valley West, ON
Thank you, Mr. Chair.
Today we're looking at these three issues: information requirements, burden of proof, and disclosure. I suppose the challenge is to try to get from the witnesses, in terms of the existing act if we look at these three issues, whether we think CEPA has been too harsh, just about right, or not strong enough. I would have some difficulty relating that question to Mr. Larson's presentation, but perhaps he can help in the question I'm now about to put.
I would read into what Ms. Coombs said that as far as these three issues are concerned, CEPA is strong enough, that the minister has the power, and that basically—if I understood correctly—she was arguing for maintenance of the status quo.
Unfortunately, Ms. Ginsburg, we didn't have all of your comments translated in either official language, so we had to listen very carefully to what you had to say. I would gather that on all three of these issues you felt we should go further. I think that would be the layman's summary of what you said in your fairly dense ten minutes.
Since we've eliminated that it has been too strong, my question is to Ms. Coombs, having heard Ms. Ginsburg give her critique on these three points of information requirement, burden of proof, and disclosure. Which of those points would you have argument with, realizing that you can't have argument with all of them because we don't have enough time? Pick your top-line criticisms, and then we'll have Ms. Ginsburg come back, or perhaps Dr. Khatter.
President, Canadian Consumer Specialty Products Association
Thank you, Mr. Chair, for the question.
I was intrigued by some of the comments that were provided, because while we may have summarized that, yes, we are supportive of the status quo, we are supportive of a science-based, rigorous system when it comes to the new substance notification. We're very pleased with how that process works, as it is predictable and rigorous, and we're pleased that it also works for substances in Food and Drugs Act products.
I was a little bit surprised about the comments with respect to confidentiality, and I didn't understand some of the concerns. I would put that forward as something that maybe we could further explore, since CCSPA believes the powers within CEPA provide provisions to protect confidential test data, but also to provide information to people who wish to ask for that information, and that's through the Access to Information Act. It's my understanding that if a notifier makes a submission to the department and designates everything as confidential—test information or confidential business information—there are still pieces within the submission that can be accessible through the Access to Information Act.
November 20th, 2006 / 4:05 p.m.
Liberal
John Godfrey Liberal Don Valley West, ON
Would that be your only criticism of what Ms. Ginsburg had to say?
She was suggesting that we need a much more proactive regime. I'm thinking, for example, of burden of proof. She was suggesting that we look more to what the Europeans are doing, and that this is the time to realign our legislation with the most forward-looking jurisdictions in the world. Do you see any difficulty with that?
President, Canadian Consumer Specialty Products Association
As I mentioned in my comments, our member companies do in-house testing and rigorous risk assessments prior to those substances coming into Canada. As well, with respect to the government, they set out the criteria and the parameters for how the science and the information should be compiled and submitted to them prior to any decisions being made. We think there are the provisions in place to ensure that substances that are beneficial to consumers are brought into the marketplace without harming human health and the environment.
Liberal
John Godfrey Liberal Don Valley West, ON
But Ms. Ginsburg was arguing that we need stronger authority to use the precautionary principle to ban or significantly reduce the most dangerous substances. In other words, in her testimony she said she felt CEPA was inadequate.
President, Canadian Consumer Specialty Products Association
May I clarify whether that was for new or existing substances?