Bloomberg BNA

Environment Canada to publish summaries of risk assessments for new chemicals

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Courtesy of Bloomberg BNA

OTTAWA--Environment Canada this fall will begin publishing summaries of risk assessments it conducts on certain chemical substances when they are first proposed for domestic use.

The initiative by the department's New Substances Program has the support of industry and nongovernmental organizations, but industry remains concerned about the potential release of confidential business information while NGOs have ongoing concerns about whether enough information will be released.

The publication of risk assessment summaries is part of an effort to improve the transparency of the department's review process for new chemicals. It was supposed to start in late 2012 but was delayed to take into account issues raised in a 2012 pilot project, the department told BNA in an emailed statement. The summaries are to be published every six months.

“One of the challenges that was faced during the pilot phase was how to ensure overall transparency of decision-making, while protecting confidential business information,” the department said. “We are addressing these challenges, and anticipate publishing summaries this fall.”

Environment Canada said it has until recently been reviewing comments it received during the pilot phase, which ended in June 2012, and is now preparing to proceed with the implementation phase.

The initiative could involve new chemicals manufactured, imported, or used by major chemical companies such as Akzo Nobel Chemicals Ltd., BASF Canada Inc., Celanese EVA Performance Polymers, Dow Chemical Canada LLC, E.I. du Pont Canada Co., Ethyl Canada Inc., Imperial Oil Ltd., Methanex Corp., Nalco Canada Co., Nova Chemicals Corp., Olin Canada LLC, and Shell Chemicals Canada Ltd.

Government to Provide Details

The government has previously not made public any details of its risk assessments of new substances. It has issued notices requiring notification of significant new activity or imposing conditions on the use of new substances, but without identifying them as new substances or indicating on what basis the requirements were being applied.

For existing chemicals, the government publishes draft versions of their screening assessment reviews for public comment, including details of how the substances are used, what risks they pose to the environment or human health, and how environmental and human exposure might occur. If a substance is deemed to pose a potential risk, the draft assessment is often accompanied by a proposed risk management approach. After the comment period ends, a final assessment is published, along with a finalized risk management approach and any regulatory or other control instruments deemed necessary.

Environment Canada said it will publish summaries of completed risk assessments for new chemicals and polymers for which the government has received notification from industry as of Jan. 1, 2013, and for which a Canada Gazette notice has been issued to impose restrictions--whether ministerial conditions on their use or requirements for notification of significant new manufacture, import, or use of the substance.

Transparency Stressed in Pilot Project

The 2012 pilot project conducted by Environment Canada and Health Canada under the New Substances Program published summaries of risk assessments of three new chemicals: carbopolycyclic diol polymer with carbonic dichloride and substituted phenol ester; alkoxy-alkylamine blocked aromatic isocyanate polymer; and poly(oxy-1,2-ethanediyl), alpha-monoalkyl ethers- omega-mono-(hydrogen maleate).

The substances had risk assessments completed, final notification of results provided to industry, and requirements for notification to the government of significant new activities published in the Canada Gazette between August and December 2010, Environment Canada said in a background document.

The summaries provide an overview of each substance, its use, hazards, potential exposure, environmental fate, assessment of ecological risk and human health risk, and proposed regulatory decisions, the department said. The evaluations do not address potential exposure and health risks specifically associated with occupational exposure, nor any assessment of uses of the substance already addressed under the Food and Drugs Act or other federal legislation, the department said.

The pilot phase of the initiative was open to comment through July 5, 2012. The department proposed publication of risk assessment summaries of new chemicals on a biannual basis each year, starting in the fall of 2012, it said.

Strong Support for Initiative

Environment Canada conducted extensive consultations on the proposal to publish summaries of risk assessments of new chemicals, and has the chemical industry's full support as the initiative will build public confidence in new products, said Gordon Lloyd, vice president of technical affairs with the Chemistry Industry Association of Canada.

“We're fine with what they're doing here,” Lloyd, an industry representative on the stakeholder advisory panel to the federal government's Chemicals Management Plan, told BNA.

The Canadian government has been assessing new chemicals since 1994, requiring industry to provide the information needed to determine the risk the substances pose to the environment and human health.

The effort is in line with successful approaches taken by other Organization for Economic Cooperation and Development member nations, Lloyd said. “It has generally been seen as a good program, but there have been questions about transparency,” he said.

The Canadian government has always said that it planned to publicly release information on its assessments, but deferred it in response to an increasing public focus on the dangers posed by legacy chemicals, he said.

The focus on legacy chemicals led to the creation in December 2006 of the Chemicals Management Plan (CMP), which prioritized assessments for existing chemicals deemed to pose the greatest risk and significantly increased the overall transparency of the risk assessment process, Lloyd said. The CMP made draft risk assessments public and opened them to public comment before final regulatory decisions were made (37 CRR 394, 4/1/13).

“Now they're trying to catch up [with] the new chemicals program,” he said. “Industry supported this. Both of these programs are good ideas.”

Confidential Business Information a Worry

The Industry Coordinating Group for the Canadian Environmental Protection Act supports the initiative to increase the transparency of new chemical assessments as long as it ensures that confidential business information is protected, said Amardeep Khosla, a consultant who represents the group on the CMP stakeholder advisory council.

The initiative will build public confidence that chemicals are properly assessed and safely managed, and a risk-based approach to assessment, management, and communication clearly provides the most relevant information to promote protection of human health and the environment, Khosla told BNA in an email.

“The government's pilot project to publish risk assessment summaries for certain new substance notifications provides the usual protections for confidential business information and occurs within the clearly risk-based framework of the relevant legislation,” he said. “The summaries published in the pilot program have not led to our members identifying any significant concerns in these two areas.”

The Industry Coordinating Group represents 24 industry associations and major companies, including the Canadian Association of Chemical Distributors, American Chemistry Council, Canadian Petroleum Products Institute, Canadian Plastics Industry, Canadian Paint and Coatings Association, Archer Daniels Midland Co., Celanese Corp., and Northern Nanotechnologies Corp.

Breadth of Disclosures Uncertain

The confidentiality of proprietary business information has been a key focus of the discussions with Environment Canada and Health Canada on the proposed public release of risk assessment summaries for new substances, said Chemistry Industry Association spokesman Lloyd.

The government clearly recognizes that there are differences in the kinds of information that can be released on new chemicals compared with legacy chemicals, and evidence from other countries that have started releasing risk assessments of new chemicals has shown no significant issues with holding back proprietary information, he said.

The chemical industry also is concerned about the breadth of the disclosure program, specifically how many summaries of risk assessments of new chemicals Environment Canada will make public, Lloyd said. Environmental groups involved in discussions on the transparency initiative have particularly highlighted the issue of problem chemicals, so problem chemicals may initially be the program's focus, he said.

But it would be unfortunate if Environment Canada publishes assessment summaries of only chemicals deemed to pose a risk of environmental or human health, he said, as that would effectively bury information on the many chemicals that raise no concern and create a false impression of an overall lack of safety of new chemical substances.

“We want to make sure there's some context. [The government] reviewed about 500 chemicals this year, but there were only four that raised problems,” he said. “I'm always disappointed that kind of information hasn't come out about the Chemicals Management Plan. There isn't contextual information that there are thousands of chemicals that don't cause issues.”

NGOs Seek More Information

Environmental nongovernmental organizations will continue to push Environment Canada to release the maximum amount of detail on chemicals that pose concerns, Maggie MacDonald, toxics program manager with Environmental Defence, told BNA.

The 2012 pilot project offered a few examples of risk assessment summaries, but those provided only general overviews of the substances and how they were assessed, said MacDonald, who represents the environmental group on the CMP stakeholder advisory body. “It gives us at least an idea, which is a step forward, but we could use more information,” she said.

NGOs are particularly concerned about the risks posed by potential endocrine disruptors, she said. A report released earlier this year by the World Health Organization and the United Nations underlined the fact that many chemicals have that potential and that much more research and testing is needed to assess their impacts, she said (37 CRR 222, 2/25/13).

There are also concerns that Environment Canada's risk assessments often focus on the level of exposure suspected of causing serious environmental or human health effects, although there are growing indications that exposure to lower dosages does not necessarily mean no risk of negative effects, just a risk of different types of negative effects, she said. “That's an example of the additional information that we'd like to have,” she said.

Delays Questioned

MacDonald stressed that the CMP stakeholder advisory body has been a “great forum” that promotes productive dialogue and exchanges of opinion on the assessment and management of chemicals. The CMP initiative has significantly improved Canada's process of assessing chemical substances, but questions remain about whether the process is sufficiently transparent, she said. “There are lots of areas for improvement,” she said.

The initiative to publish summaries of assessments of new chemicals, for example, highlights Environment Canada's “great intentions” in wanting to promote greater transparency, she said. “But it was supposed to be rolled out some time ago. We have to ask, 'Why the delays?'” she said.

Bruce Cran, president of the Consumers' Association of Canada, said his group hopes Environment Canada will release as much information as possible about the new chemical substances it assesses for toxicity. The sample risk assessment summaries published for comment in 2012 included very brief details on the identity of the substances and identified potential uses and estimated annual quantities to be used, how environmental exposure occurs, ecological and human health assessments, and proposed regulatory action, if any.

“Consumers can't get enough information. Anything they release of a reliable nature is of great value to consumers,” Cran, who also sits on the CMP advisory body, told BNA.

More transparency on risk assessments of new chemicals also serves the interests of industry by reminding them of their responsibilities to the public to ensure the safety of new products, he said.

The collaboration of Environment Canada and Health Canada on the Chemicals Management Plan, and particularly their interaction with industry groups and nongovernmental organizations through the stakeholder advisory body, is an experiment that has worked and consistently has been of value to all of the parties involved, Cran said.

“It's very well run and very well managed by both departments--something I wish I could say about other government initiatives,” he said.

Act, Regulations Require Risk Assessments

The Canadian Environmental Protection Act and its New Substances Notification Regulations ensure that new substances that meet certain requirements, whether they are chemicals or organisms, undergo a risk assessment of their potential adverse effects on the environment and human health before they enter the Canadian marketplace, Environment Canada said in the background document.

Sample assessments of new living organisms have been published since 2005, the department said.

Any company or individual that plans to import or manufacture a substance subject to notification under the regulations must provide Environment Canada with a new substance notification package containing all information required to determine whether the substance is potentially harmful to human health or the environment, it said.

The regulations apply to any substance that is not listed on the Domestic Substances List under CEPA and that exceeds specific regulatory triggers, including a specified quantity of production, import, or use over a specified period of time; that is on the Domestic Substances List but is to be used for a significant new activity; or that is listed on the Domestic Substances List and is a polymer that does not qualify for the reduced regulatory requirements criteria specified for polymers in the regulations, Environment Canada said.

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