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.