By Lisa M. Campbell and Lisa R. Burchi
On May 28, 2015, several United States and Canadian regulatory agencies announced the release of Regulatory Partnership Statements (RPS) and updated annual Work Plans outlining the framework for how these agencies will cooperate and coordinate specified agency actions.
The RPS and Work Plans are the most recent steps since the United States and Canada established the Regulatory Cooperation Council (RCC) in 2011 to align regulatory systems and boost North American trade and competitiveness. Information about the RCC and the released RPSs is available at: http://www.trade.gov/rcc/.
There are now RPSs between the following agencies focusing on four main sectors: agriculture and food; environment; transportation; and health and personal care products:
- U.S. Food and Drug Administration (FDA) -- Health Canada (HC);
- U.S. Environmental Protection Agency (EPA) -- Pest Management Regulatory Agency (PMRA);
- U.S. Occupational Safety & Health Administration (OSHA) -- HC;
- U.S. Animal and Plant Health Inspection Service (APHIS) and U.S. Food Safety and Inspection Service (FSIS) -- Canadian Food Inspection Agency (CFIA);
- FDA -- CFIA;
- U.S. Department of Transportation (DOT) -- Transport Canada (TC);
- U.S. Coast Guard (USCG) -- TC;
- U.S. Environmental Protection Agency (EPA) -- TC;
- U.S. Department of Energy (DOE) -- Natural Resources Canada (NRCan);
- U.S. Pipeline and Hazardous Materials Safety Administration (PHMSA) -- NRCan;
- EPA -- Environment Canada (EC); and
- U.S. National Oceanic and Atmospheric Administration (NOAA) -- Fisheries and Oceans Canada (DFO).
With regard to agreements between EPA and PMRA for pesticides, the agencies have agreed to a plan and timeframes for three initiatives:
- Joint Template For Project Chemistry Review: The agencies plan, by March 2016, to commence use of a joint template for product chemistry reviews intended to present study findings in a concise, easily reviewable manner to “facilitate the evaluation of joint review products for new active ingredients, use expansions, and product chemistry only submissions, with the ultimate goal being mutual acceptance of study reviews.” Prior to commencing use of the joint template, EPA and PMRA intend to conduct a webinar, solicit comments, and initiate a pilot project to test the use of the template.
- Neonicotinoid Insecticides: EPA and PMRA are collaborating on a bilateral pesticide re-evaluation process for neonicotinoid pesticides, and implementing a risk assessment framework. Harmonizing re-evaluation schedules and aligning risk assessment approachines are ongoing; a progress report will be published by December 2015, but the completion of risk assessments and mitigation actions are not expected until 2017-2018.
- Joint IT Solutions: EPA and PRMA are working together to develop information technology submissions and “move towards the establishment of a single application for crop protection products that will be accepted in both countries.” The technology platforms include an eDossier Builder based on the Organization for Economic Co-operation and Development (OECD) Global Harmonized Submission Transport Standard and an Electronic Confidential Statement of Product Specifications Form Wizard tool (eCSPS Wizard). The agencies are currently developing these tools and state that the eDossier may be released in 2017, but have not set timeframes for the release of the eCSPS Wizard.
EPA, Health Canada, and Environment Canada also have a RPS regarding two initiatives for chemical substances management:
- Significant New Use Rule (SNUR) and Significant New Activity (SNAc): The agencies are collaborating to develop common approaches for regulatory reporting requirements to improve predictability, understanding, and compliance of SNURs and SNAcs under the Toxic Substances Control Act (TSCA) and the Canadian Environmental Protection Act, 1999 (CEPA), respectively. Working groups have been established with representatives of industries and nongovernmental organizations, and several meetings and web conferences are scheduled through June 2016 to review potential alignment collaboration opportunities. A final summary document outlining the agencies’ findings, recommendations, and short and long term implementation plans is expected by December 2016. A workshop to discuss the final results for both predictability and improved compliance is now planned for January 2017.
- Risk Assessments: The agencies are working to align chemical regulatory processes, “specifically through the development of common approaches to address emerging risk issues and jointly consider how the use of novel data can inform the assessment of chemicals.” The agencies have already formed a Technical Working Group and the first workshop will be held in October 2015 with several web conferences scheduled through December 2016. A draft assessment collaboration framework will thereafter be developed including: (1) common high-level principles for chemical risk assessment; (2) identification of opportunities and impediments to joint work; (3) forward plan to build on opportunities (e.g., peer review); and (4) forward plan to explore mechanisms to address impediments. The final summary document outlining the assessment collaboration framework is expected in December 2017.
The RPS developments are a welcome development for many in industry that conduct business in the U.S. and Canada and are interested in streamlined procedures. The SNUR and SNAc processes, for example, have many similarities that could potentially be leveraged and aligned. The working groups that have been formed to review and discuss the TSCA/CEPA initiatives anticipate industry and nongovernmental organizations’ involvement that should assist these agency partnerships. Continued work with stakeholders and opportunities for comment will be critical moving forward in developing effective regulatory approaches that promote efficiency, safety, trade, and competitiveness.