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.