On October 1, 2012, Ontario’s Ministry of the Environment brought into force a seemingly innocuous regulation entitled, “Collection of Pharmaceuticals and Sharps — Responsibilities of Producers.”
Belied by its title, the regulation, made under a 40-year-old environmental statute, takes Ontario on a path sharply away from the approach to waste diversion that has been the default for a decade under the Waste Diversion Act, 2002 (WDA).
The regulation assigns end-of-life responsibility for waste pharmaceuticals and sharps to individual producers of pharmaceuticals and sharps (i.e., manufacturers, brand owners or importers).
In discharging their responsibilities, producers may choose to establish and operate such a system on their own or, “… in conjunction with other producers, or to engage one or more service providers for this purpose.”
Producers are required to utilize service providers who themselves are subject to existing provisions of the EPA that require environmental compliance approvals for the operation of waste management systems (specific to the collection and proper end-of-life management of the specific wastes in question).
In addition, the ministry is requiring minimum collection coverage (to ensure collections from the 3,000 or so retail pharmacy locations with residentially-generated returns of waste pharmaceuticals and sharps). Also required are proper handling and management standards and annual reporting to the ministry regarding collection performance.
Unlike the EPR approach taken by many Canadian EPR jurisdictions (notably Ontario under its own WDA and British Columbia under the Recycling Regulation of its Environmental Management Act), the Ontario waste pharmaceuticals and sharps regulation does not require producers to file “stewardship plans.” In eliminating this requirement, the ministry won’t approve the approach by which producers discharge their obligations; it will not, therefore, implicate itself in producer decisions.
Furthermore, and unlike the WDA, the regulation does not require the government to delve into how producers finance their obligations, nor does it require producers to develop methodologies for setting fees. Instead, commercial arrangements are left to producers and service providers to negotiate amongst themselves, through conventional free-market transactions.
In taking an EPA-based approach, the ministry has noted that, “[t]he proposed regulation sees the government setting the policy outcomes that producers must achieve while allowing producers the flexibility to determine how best to meet the outcomes.”
This outcomes-based approach to EPR is an emerging best practice: it fully embraces the idea of EPR as a market-driven activity. Responsibilities are assigned to individual producers; these are discharged in market transactions between producers and service providers. The government focuses on setting standards, ensuring compliance and measuring performance.
In its 2009 review of the WDA, the environment ministry stated its intent to reform the WDA by moving to an “outcomes-based individual producer responsibility” framework with the following goals:
• Making individual producers fully responsible to meet waste diversion requirements for waste discarded in both the residential and IC&I sectors;
• Allowing those individual producers to meet their waste diversion requirements either by joining a materials management scheme or by developing their own individual waste diversion plan;
• Requiring individual producers to annually report information on sales into the Ontario marketplace of designated products and packaging;
• Requiring that any waste diversion plan must meet outcome-based requirements;
• Requiring producers who fail to meet outcome-based requirements to meet prescriptive requirements (“default” option) or face penalties for non-compliance; and
Regulating EPR for pharmaceutical and sharps under the Ontario’s long-established EPA environmental liability program achieves the outcomes listed above simply and expediently. Without ever having to table a bill, EPR under the EPA offers an approach that will transform waste diversion from what is currently a complicated, process-driven endeavor into an approach that delivers environmental protection simply and effectively by focusing on outcomes and not process.
(This is a condensed version of an article that first appeared in Enviro-news, a newsletter of the Ontario Bar Association, Volume 22, No. 1 — May 2012.)
Usman Valiante is a Senior Policy Analyst at
Corporate Policy Group LLP in Orangeville, Ontario.
Contact Usman at