Canada: The Making of a Toxic Substance in Canada - The Sad Story of bisphenol A

Copyright 2010, Blake, Cassels & Graydon LLP

Originally published in Blakes Bulletin on Environmental Law, October 2010

On October 13, the Canadian government hammered one more stake into the reputation of bisphenol A, the chemical ingredient used to make the hard, clear plastic known as polycarbonate and epoxy resins which line metal-based food and beverage cans around the world. On that day, bisphenol A was officially declared by the Ministers of the Environment and of Health to be a "toxic substance" by adding it to the Toxic Substances List that is part of the Canadian Environmental Protection Act (CEPA). This addition to the Toxic Substances List and the proposed regulations that followed on October 16 (discussed below) fulfills the government's obligation under CEPA to propose regulations or another regulatory instrument within two years of having announced, in October 2008, that bisphenol A was considered to be a toxic substance and that the Ministers intended to add it to the Toxic Substances List.

This milestone is only part of the regulatory morass in which the makers and users of bisphenol A now find themselves. As early as April 2008, the Canadian Ministers of the Environment and Health had issued a news release announcing that, as a result of a screening assessment that was being conducted on bisphenol A, it was believed to be toxic to infant humans and the government would be taking immediate action to ban the importation and sale of baby bottles containing the substance. This news release sent shock waves around the world and a number of major Canadian retailers quickly took steps to remove such baby bottles from their shelves.

Back in 2008, bisphenol A was one of a number of chemicals that were being assessed as part of the Canadian government's "Chemical Management Plan" and "Challenge" programs being carried out under CEPA. The Chemicals Management Plan is a program that was launched by the Canadian government in December 2006 to meet the mandatory requirement of CEPA's toxic substances control provisions to complete a toxic categorization of all substances known to exist in Canada and then conduct toxic screening assessments to determine whether the substances were in fact considered toxic. A key part of the plan was the assessment of 200 priority substances that were publicized to Canadians, and the chemical industry in particular, in 12 batches, under the banner the "Challenge" (that is, the challenge to the chemical industry). The chemical industry was invited (and formally notified) to tell the government what they knew about the health and environmental characteristics of each batch of the 200 substances. For more information concerning the Challenge program, click here.

Bisphenol A was included in Batch 2 of the Challenge program, which was publicly released in May 2007. With each batch, Environment Canada and Health Canada also released "substance profiles" for each substance, summarizing the scientific information and any relevant uncertainties and specifying the information necessary for what they called "improved decision-making". Bisphenol A was initially categorized as presenting both a high-hazard and high-exposure risk to humans. An information-gathering notice issued under section 71 of CEPA accompanied each Challenge batch release and required that any person possessing prescribed information concerning the particular batch substances provide the information to the Minister of the Environment.

The final screening assessment of bisphenol A was published on October 18, 2008, six months after the dramatic April 2008 news release, along with a statement recommending its addition to CEPA's Toxic Substances List. It was announced ahead of the other Batch 2 substances because of the intense public and media interest regarding concerns for human health of exposure to the substance. The final screening assessment concluded that bisphenol A met the CEPA toxicity criteria of possibly posing a harmful effect to the environment and a danger to human life or health.

At this point, a two-year deadline kicked in under section 91 of CEPA for the government to propose specific regulatory action. On May 16, 2009, the government published its proposed order for adding bisphenol A to the CEPA Toxic Substances List, also known as Schedule I. However, even before this time, the Minister of Health had commenced the evaluation of pre-market approval submissions for infant formula under the Food and Drugs Act to ensure the lowest levels of bisphenol A in food packaging, and to investigate alternatives to bisphenol A in canned foods.

In response to these regulatory steps, the American Chemistry Council launched a formal objection in July 2009 and requested a Board of Review, as provided for under section 77 of CEPA. Such reviews are left totally to the discretion of the Ministers of Health or Environment, who may or may not agree to the request. Unfortunately, for those who object to proposed regulatory restrictions to their products under CEPA, this is the only method of appeal, short of an application to the Federal Court requesting a judicial review of the Ministers' decision, which typically requires very unreasonable or unauthorized acts on the part of a government decision-maker. If convened, a Board of Review may inquire into the nature and extent of the danger posed by the substance and, after considering the objection and any evidence, can only report to the Ministers with its recommendations. However, such recommendations may or may not be followed.

Among other reasons, the American Chemistry Council objected to the proposal to list bisphenol A as toxic because it was contrary to the assessment of other jurisdictions, such as the European Union, the European Food Safety Authority and national regulators in Australia, Belgium, Denmark, France, Germany, Japan, New Zealand, Norway, Sweden, Switzerland, the United Kingdom and the United States. The Council criticized the Canadian risk assessment conclusions and said that there was insufficient scientific evidence to support the ultimate finding, even after taking into account the precautionary principle enshrined in section 76.1 of CEPA (which says that scientific uncertainty shall not be used as a reason for environmental inaction). The Council specifically quoted the French Minister of Health as stating:

For more details of the American Chemistry Council objection, click here.

Unfortunately for the advocates of bisphenol A, the Canadian government rejected their plea for a Board of Review or any other change in its direction. On March 11, 2010, the Minister of Health added polycarbonate baby bottles containing bisphenol A to Schedule I to the Hazardous Products Act to provide for the banning of their advertisement, sale or importation in Canada. Then, in October 2010, bisphenol A was added to CEPA's Toxic Substances list, followed closely by the release of proposed regulations requiring industrial establishments that use and generate bisphenol A in their wastewater effluents to prepare and implement pollution prevention plans. The Minister of the Environment is currently awaiting the receipt of any public comments on the proposed regulations, until approximately December 15, 2010. For more details, click here.

Canada is the first jurisdiction in the world to declare bisphenol A to be a toxic substance and ban its use in baby bottles. The entire process occurred relatively quickly, starting in May 2007 and ending in October 2010. Other substances assessed in the 12 Challenge batches are still awaiting news of their fate, after having been found to be potentially toxic. Not all will result in product bans, but many will be subject to some form of regulation, such as requiring pollution prevention plans. The Chemicals Sector Directorate of Environment Canada will continue to be a busy branch of the federal government as it manages its various toxic chemical assessment programs and we await the next set of initiatives that will challenge the chemical and biochemical industries. Canada has become a leader in this regulatory area. However, this may or may not be a good thing in a competitive global economy – only time will tell.

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