Recent Development in Biotechnology

In its 2007 Throne Speech, Canada's Conservative government promised to introduce measures on "product safety to ensure that families have confidence in the quality and safety of what they buy." With the proclamation of the Canada Consumer Products Safety Act (CCPSA) in June 2011, the government could boast of substantial headway toward fulfilling that promise.

The heart of the CCPSA is a general prohibition on manufacturing, importing, selling or advertising any "consumer product" that poses an unreasonable danger to human health or safety.

Although food, drugs, medical devices and cars are not embraced by the CCPSA, the legislation embraces practically everything else. The CCPSA defines a consumer product as any product that "can reasonably be expected to be obtained by an individual to be used for noncommercial purposes," including domestic, recreational and sports purposes.

The CCPSA could well be a harbinger of future amendments to the Food and Drugs Act (FDA). When the government introduced the first version of the CCPSA, it also introduced amendments to the FDA. The FDA amendments have not yet been reintroduced, but could well appear again.

Doubtless, the fact that product recalls and public notices of voluntary withdrawal are at a record high in Canada has made product safety and quality a leading issue for consumers and retailers. Yet lingering questions remain about the scope of the legislation, namely whether all its effects were intended or whether the CCPSA is just another instance of legislative overkill.

The broad definition of "consumer product" means, for example, that the legislation may impact a host of organizations that don't realize they are affected until it's too late. It may even create liability for individuals. To enforce the legislation, the Minister of Health will have broad powers to recall products or take other measures where there is danger to health and safety. These include authority to order tests and compile information necessary to verify compliance, to order corrective measures such as issuing public advisories, and to halt manufacturing, importing or advertising. The CCPSA also requires manufacturers, importers, advertisers, sellers and testers of consumer products to document that they meet set-up and maintenance requirements.

The upshot is that the legislation adds an enormous level of infrastructure throughout the supply chain.

There are also difficulties from a competitive standpoint. If Canada gets too far ahead of other major countries, especially in the recordkeeping and reporting areas, multinationals operating here may balk at the cost of establishing and maintaining separate policies for this jurisdiction alone.

It is the notice requirements of the CCPSA that may prove most problematic. The law requires manufacturers, importers and sellers to report "incidents" to Health Canada within two days. An incident includes an "occurrence in Canada or elsewhere that results, or could reasonably be expected to have resulted, in a death, serious adverse effect on health or serious injury; a defect or characteristic that could reasonably be expected to result in death, serious injury or an adverse effect on health; incorrect or insufficient information on a label or instructions that might reasonably be expected to result in death, serious injury or adverse effect on health; and a recall initiated by a foreign entity, provincial government, public body or Aboriginal government."

Critics say that a strict construction of the legislation might produce a regime fraught with over reporting that impacts adversely on management and enforcement.

Backing up these measures are increased fines and/or imprisonment. Maximum penalties are $25,000, but the legislation makes each day on which an offence is committed or continued a separate offence.

All in all, what the legislation appears to effect is a "seller beware" philosophy, in conformity with the "precautionary principle" described in the preamble: "a lack of full scientific certainty is not to be used as a reason for postponing measures that prevent adverse effects on human health if those effects could be serious or irreversible."