By Lisa M. Campbell and Lisa R. Burchi
On June 7, 2021, Health Canada’s Pest Management Regulatory Agency (PMRA) announced the issuance of its Interim Order Respecting Ultraviolet Radiation-emitting Devices and Ozone-generating Devices under the Pest Control Products Act (Interim Order), setting forth new requirements for certain devices claiming to control, destroy, make inactive, or reduce the level of bacteria, viruses, and other micro-organisms that are human pathogens. PMRA also issued an “Explanatory Note” and a Questions and Answers document regarding the Interim Order.
PMRA states that it issued the Interim Order following the increased sale of ultraviolet (UV) radiation-emitting and ozone-generating devices such as lights and wands in Canada since the COVID-19 pandemic. These devices are marketed to kill bacteria and viruses, including SARS-CoV-2, the virus that causes COVID-19. According to PMRA, it has not received enough evidence to confirm that UV radiation-emitting and ozone-generating devices are safe for users and the public, or that they are effective.
Thus, PMRA is now requiring that companies register certain UV radiation-emitting devices and ozone-generating devices before they may be sold or used in Canada. In its Explanatory Note, PMRA states:
By bringing certain UV and ozone-generating devices under the [Pest Control Products Act (PCPA)], they need to be registered or otherwise authorized in order to be on the Canadian market. An application to register a pest control product must be submitted to Health Canada in the form and manner directed by the Minister and must include any information and other material that is required by the Pest Control Products Regulations to accompany the application. Applications to register devices consist of a number of information and data requirements, including a cover letter stating the purpose of the application, an application and fee estimate forms, the proposed English and French product labels, as well as data to support the safety and efficacy of the device. A registration will be granted under the PCPA if the Minister considers that the health and environmental risks and the value of the device are acceptable after any required assessments.
The Interim Order clarifies that certain UV radiation-emitting devices and ozone-generating devices claiming to kill bacteria and viruses are not subject to the regulatory requirements of the PCPA and its Regulations. These include:
- Devices that are manufactured, represented, distributed, or used to control, destroy, or inactivate viruses, bacteria, or other micro-organisms that are human pathogens for use in swimming pools, spas, or wastewater treatment systems;
- Devices that meet the definition of “device” in Section 2 of the Food and Drugs Act and are classified as a Class II, III, or IV medical device under the Medical Devices Regulations; and
- UV radiation-emitting devices that satisfy the following conditions:
- The device is certified by a standards development organization accredited by the Standards Council of Canada as meeting the applicable Canadian electrical safety requirements;
- The certification mark of the standards development organization appears on the label of the device;
- Any efficacy claim that is made in respect of the device is only a claim of supplemental sanitization;
- No express or implied reference to prevention, treatment, or mitigation of disease is made in respect of the device;
- The device has at least one of the following mechanisms:
- A mechanism that locks the device during operation, or
- A mechanism that automatically shuts off the device if it is opened during operation; and
- The UV lamp is fully shielded or enclosed in the device in a manner that prevents access to it by users of the device and prevents exposure to UV radiation.
For UV radiation-emitting devices that satisfy these conditions, there are additional labeling requirements for the display panels and operating manual.
This Interim Order changes significantly the requirements applicable to these types of devices that did not previously require registration. PMRA is providing a 30-day transition period after the Interim Order is issued before companies must comply with these requirements. PMRA also is advising Canadians to “stop using UV lights and wands that claim to disinfect against the virus that causes COVID-19 especially if the product is for use on the skin.”
Companies that produce devices that may be subject to this Interim Order should review the new requirements and exemptions carefully. PMRA states that unregistered or unauthorized devices are prohibited and may be subject to compliance and enforcement action.
By Lisa M. Campbell and Carla N. Hutton
On June 14, 2019, Canada’s Pest Management Regulatory Agency (PMRA) began a public consultation on Discussion Document DIS2019-01, “Consultation on Inspecting Confidential Test Data for Post-market Reviews in the Reading Room.” Before a pesticide can be registered for use in Canada, PMRA states that it reviews the available scientific test data to determine whether there are concerns for human health or safety, or the environment, when the product is used according to the label. Some of the data reviewed by the PMRA scientists include confidential test data on:
- Toxicology related to human health;
- Bystander and occupational exposure;
- Food residue trials;
- Environmental toxicology and fate;
- Product efficacy, crop tolerance, and benefits of the product; and
- Other scientific data or studies submitted to, or considered by the PMRA.
According to PMRA, the purpose of the consultation document is to seek input on a proposal to expand access to confidential test data by inviting interested members of the public to inspect these data at the proposed decision stage for post-market reviews such as re-evaluations and special reviews. Currently, PMRA prepares confidential test data for public inspection only after it makes a final decision. PMRA proposes to allow interested parties seeking to understand the scientific basis for a proposed re-evaluation or special review decision to inspect the data used by PMRA earlier in the process. PMRA states that by viewing these data earlier, comments submitted through the existing consultation process may be more well-informed.
PMRA notes that the proposed change would still require the inspection of confidential test data to take place at its National Head Office in Ottawa, Ontario. PMRA states that it is aware that this could be burdensome and is investigating alternative approaches for the future that may allow the inspection of data through other means, such as satellite reading rooms or secure portals. Publication of the consultation document began a 60-day comment period.
By Lisa M. Campbell and Lisa R. Burchi
On May 31, 2019, Health Canada’s Pest Management Regulatory Agency (PMRA) issued its Proposed Re-evaluation Decision PRVD2019-05, Chlorpyrifos and Its Associated End-use Products: Updated Environmental Risk Assessment (Updated Environmental Risk Assessment). PMRA states that this re-evaluation “considers data and information from pesticide manufacturers, published scientific reports, and other regulatory agencies” and that “Health Canada applies internationally accepted risk assessment methods as well as current risk management approaches and policies.”
PMRA is proposing the cancellation of most uses of chlorpyrifos, including almost all agricultural uses, due to PMRA’s belief that they pose unacceptable risks to the environment. The proposal would allow a small number of uses to continue if certain label changes are made. More specifically, PMRA states that its evaluation of available scientific information “has not found acceptable risks to beneficial arthropods, birds, mammals and all aquatic biota in the environment for most current chlorpyrifos uses” but “[g]reenhouse ornamental, outdoor ornamentals (container stock only) for control of Japanese beetle larvae, indoor and outdoor structural, adult and larval mosquito uses of chlorpyrifos have been shown to be acceptable from the environmental perspective.” The label changes that PMRA states would be required for these uses to continue include the following: (1) standard environmental hazard statements to inform users of the potential toxic effects to non-target species; and (2) standard environmental advisory statements for prevention of contamination of aquatic systems and to reduce volatilization.
There is a 90-day public consultation period on the proposal, which began on May 31, 2019, during which the public may submit written comments and additional information to PMRA. PMRA states that the public may submit additional information that could be used to refine risk assessments and that the final re-evaluation decision will take into consideration the comments and information received during the comment period, which could result in revised risk mitigation measures. The re-evaluation decision document will include the final re-evaluation decision, the reasons for it, and a summary of comments received on the proposed re-evaluation decision with Health Canada’s responses.
More information on chlorpyrifos issues, including California’s recent announcement that it would be initiating cancellation proceedings of chlorpyrifos, can be found on our blog.
By Carla N. Hutton
On April 10, 2018, the U.S. Environmental Protection Agency (EPA) announced the availability of a draft Science Policy document intended to reduce the use of animals in testing chemicals to evaluate whether they cause an allergic reaction, inflammation, or sensitization of the skin. According to EPA, the document, Draft Interim Science Policy: Use of Alternative Approaches for Skin Sensitization as a Replacement for Laboratory Animal Testing, “describes the science behind the non-animal alternatives that can now be used (in vitro, in silico, in chemico) to identify skin sensitization.” The draft Science Policy states that the Office of Pesticide Programs (OPP) and Office of Pollution Prevention and Toxics (OPPT) will immediately begin to accept submissions of new approach methodologies (NAM) and defined approaches (DA) as described in the draft Science Policy. EPA notes that there are multiple domestic and international activities ongoing that will allow for refinement and expansion of this draft Science Policy to other DAs and additional NAMs and support global harmonization of DAs for skin sensitization. According to the draft Science Policy, OPP and OPPT “will continue to be active participants in these activities to ensure regulatory acceptance and will continue to support cross-sector collaborations that enhance animal welfare, and accelerate the implementation of NAMs.” Comments on the draft Science Policy document must be submitted to Docket Number EPA-HQ-OPP-2016-0093 by June 9, 2018.
The draft Science Policy is the result of national and international collaboration between the Interagency Coordinating Committee on the Validation of Alternative Methods, the National Toxicology Program’s Interagency Center for the Evaluation of Alternative Toxicological Methods, the European Union Reference Laboratory for Alternatives to Animal Testing, and Health Canada’s Pest Management Regulatory Agency.
By Lisa R. Burchi and Lisa M. Campbell
On January 22, 2016, Ontario released for consultation a draft Health Action Plan (Plan) to reduce losses of honeybees and other pollinators caused by several “stressors” stated in the Plan to include: (1) reduced habitat and poor nutrition; (2) diseases, pests, and genetics; (3) exposure to pesticides; and (4) extreme weather and climate change. This action plan is part of a broader strategy to protect pollinators, with Ontario’s aim, in part, to reach an 80 percent reduction in the number of acres planted with neonicotinoid-treated corn and soybean seeds by 2017. Other actions taken by Ontario related to pollinators and the regulation of corn and soybean seeds treated with neonicotinoids are discussed in our blog item Canadian Province Finalizes Neonic Reduction Rule.
Comments can be submitted through the Environmental Registry until March 7, 2016.
The Plan “identifies potential actions that have been informed through an ongoing consultation process with key stakeholders and the broader public.” For each of the four stressors identified as a cause of the pollinator decline, the Plan summarizes what information Ontario has gathered, what potential actions it is considering, and what potential additional action areas exist. With regard to the exposure to pesticides, the Plan states the following regarding potential actions for Ontario to take and additional measures under consideration.
Potential Actions by the Province:
- Increase education and outreach activities to stakeholder groups on Best Management Practices (BMP) and integrated pest management to support the implementation of Ontario Regulation 63/09 under the Pesticides Act;
- Support integrated pest management training for growers;
- Enhance sector outreach to support beekeeper education around the use of appropriate pest treatments in-hive;
- Continue to work with industry to support agricultural production and land stewardship practices that reduce pollinator pesticides exposure;
- Explore opportunities to facilitate completion and launch of an e-tool to alert pesticide applicators of nearby beehives for the purpose of reducing bee exposures;
- Provide financial support for producers to acquire dust deflectors for planting equipment through the Great Lakes Agricultural Stewardship Initiative;
- Enhance provincial monitoring efforts to track changes in agricultural practices stemming from the implementation of Ontario Regulation 63/09; and
- Monitor neonicotinoid concentrations in the environment.
Potential Additional Action Areas:
- Profile and highlight BMPs for pesticide use in agriculture;
- Improve beekeeper education on the effectiveness of honey bee pest treatments; and
- Support research in selective breeding strategies for honey bees resistant to pests and diseases.
The Plan also discusses Ontario’s research and monitoring efforts, including its intent to align and leverage existing research programs and its consideration to launch a special “Call for Proposals” to “fund new pollinator health research projects to fill knowledge gaps for example, understanding how varroa infestations interact with other stressors, studying implications of climate change for Ontario’s pollinators and assessing the effectiveness of various land management practices.”
In addition to submitting comments on the Plan, Ontario also developed an online survey for input on what priorities should be the focus to improve pollinator health and what steps should be taken to improve pollinator health.
By Lisa M. Campbell, James V. Aidala, and Lisa R. Burchi
The Canadian province of Ontario has issued its final regulations under the Ontario Pesticides Act aimed at reducing the area planted with maize and soybean seed treated with neonicotinoid insecticides. These changes have been made as part of its broader strategy to protect pollinators, and aim to reach an 80 percent reduction in the number of hectares planted with neonicotinoid-treated corn and soybean seed by 2017.
The new rules create a new class of pesticides, known as “Class 12 pesticides.” This class applies to corn seed grown for grain or silage, and soybean seeds treated with the following neonicotinoid insecticides: imidacloprid; thiamethoxam; and clothianidin. The new regulations will not apply to popping corn, sweet corn, corn used for the production of seed, or soybean seeds planted for the purpose of producing a soybean seed crop of certified status.
The new system established by these regulations will take effect on July 1, 2015, and be phased in over time. The elements include but are not limited to the following:
- Integrated Pest Management Training: The regulations will require farmers to complete training on integrated pest management methods. To encourage participation, training will be offered for free until September 1, 2016; after that time, training will be provided at a cost. After August 31, 2016, any person (e.g., farmer) who purchases neonicotinoid-treated seeds will be required to have completed the integrated pest management training course and received a certification number, which will be valid for five years.
- Pest Assessment Reports: Farmers wanting to buy and plant neonicotinoid-treated seed on more than 50 percent of the total area of their corn and soybean crop will need to complete a pest assessment report and provide it to the sales representative or seed vendor from which they purchase the seeds.
- Requirements for Vendor Licenses for the Sale of Neonicotinoid-Treated Seeds: The regulations will require companies selling neonicotinoid-treated seeds to obtain a treated seed vendor’s license, notify purchasers that the seed is a neonicotinoid-treated seed, and offer untreated seed for purchase, among other requirements. Growers will only be able to buy and use neonicotinoid-treated seeds that vendors have put on the "Class 12 Pesticides List," a list updated by August of each year.
- Tracking of the Sale of Neonicotinoid-Treated Seeds: The regulations will require the annual submission of the sales of treated seeds “to ensure an open and transparent system to track progress.” The Ministry of the Environment will publicly report amalgamated sales and seed treatment data for neonicotinoid-treated corn and soybean seed.
The regulations do not include requirements for the transport and storage of Class 12 pesticides.
Further information is available at the below links:
It is important to consider these new requirements in conjunction with those being developed in the U.S. EPA’s approach to date in considering additional restrictions to neonicotinoid pesticides to protect pollinators appears to focus not as much on reducing the use of products, but instead on controlling and preventing unwanted exposure of pollinators to these products.
In recent weeks, the U.S. government issued a “National Strategy to Promote the Health of Honey Bees and Other Pollinators” on May 19, and on May 28, EPA released for comment: “EPA’s Proposal to Mitigate Exposure to Bees from Acutely Toxic Pesticide Products.”
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.