Regulatory Developments

Canada’s PMRA Releases Proposed Special Review Process

January 21, 2014

On December 30, 2013, Health Canada's Pest Management Regulatory Agency (PMRA) released a consultation document entitled Proposed Approach to Special Reviews – Consultation Document. The Consultation Document outlines the Pest Control Products Act legislative requirements for special reviews and PMRA's proposed approach to conduct such special reviews. The document is available online. PMRA is accepting comments until January 29, 2014. PMRA states that any comments will be considered before PMRA publishes a Regulatory Directive on the final approach for special reviews. Clients and friends with Canadian pesticide products may wish to review the Consultation Document carefully and provide comment. As discussed below, there are several important proposed aspects to the special review process that could have an important impact on the commercialization of pesticide products in Canada.

Background

Section 17 of Canada's Pest Control Products Act states:

  1. The Minister shall initiate a special review of the registration of a pest control product if the Minister has reasonable grounds to believe that the health or environmental risks of the product are, or its value is, unacceptable.
     
  2. Without limiting the generality of subsection (1), when a member country of the Organization for Economic Co-operation and Development [OECD] prohibits all uses of an active ingredient for health or environmental reasons, the Minister shall initiate a special review of registered pest control products containing that active ingredient.
     
  3. Without limiting the generality of subsection (1), the Minister shall initiate a special review of the registration of a pest control product if a federal or provincial government department or agency has provided information to the Minister that relates to the health or environmental risks or the value of the product and if, after considering the information provided, the Minister has reasonable grounds to believe that the health or environmental risks of the product are, or its value is, unacceptable.
     
  4. Any person may request a special review of the registration of a pest control product by making a request to the Minister in the form and manner directed by the Minister.

In addition, Section 14 states:

After considering any information reported under [PMRA] sections 12 [related to submission of additional information] or 13 [related to mandatory reporting requirements], the Minister shall determine whether a special review of the registration of the pest control product should be initiated.

Thus, the Act sets forth the conditions under which the Minister is required to initiate a special review.

Proposed Approach to Special Reviews

PMRA is proposing a five step approach to conducting special reviews. PMRA notes that under this approach, "the depth of and length of time to conduct a special review would be dependent on the complexity of issues associated with a given pest control product as well as the amount of information requiring assessment." The approach is as follows:

  • Step 1 -- Preliminary Analysis: In this initial step, PMRA will conduct a preliminary analysis of the information provided to determine whether a special review is warranted. This includes determining whether the necessary criteria are met, what aspect(s) of concern warrant further investigation, and what additional information may be required from registrants. With regard to the different criteria to be satisfied, PMRA states the following:
    • Regulatory Decisions by an OECD Member Country: Before a special review is initiated on the basis of an OECD member country's decision to prohibit all uses of an active ingredient, a preliminary analysis of the decision is necessary to confirm that it meets the conditions prescribed under PMRA Section 17(2): (1) the decision is from a member country of the OECD; (2) all pest control product uses relating to the active ingredient have been prohibited; and (3) the prohibition is based on health or environmental reasons.
       
    • Other Potential Special Reviews: For scenarios other than an OECD decision, PMRA will consider relevant information relating to the aspect(s) of concern to determine whether there are reasonable grounds to believe that the health or environmental risks of a registered pest control product are, or its value is, unacceptable. PMRA states:
       
      A special review will be initiated if the preliminary analysis indicates that there are reasonable grounds to believe that the health or environmental risks of a registered pest control product are, or its value is, unacceptable. A special review may not be initiated, for example, if the aspect(s) of concern is not applicable to the Canadian situation or the pest control product(s) is not registered in Canada.
       
      With regard to any person request a special review under Section 17(4), PMRA states that the reasons for requesting a special review must be relevant to registered Canadian uses and, if based on Sections 17(1) or 17(3), must include scientific information relating to health or environmental risks or to the value of the product. If a person is requesting a special review under Section 17(2), the requestor must indicate the applicable decision from an OECD member country that prohibits all uses of an active ingredient for health or environmental reasons.
  • Step 2 -- Announcement of Special Review: When PMRA determines a special review is required based on the preliminary analysis, it will publish an announcement. If considered necessary, PMRA will require the registrant to provide information relating to the aspect(s) of concern under special review. In addition, PMRA will request that other federal/provincial government departments and agencies provide available information relevant to the aspect(s) of concern subject to special review.
     
  • Step 3 -- Science-Based Assessment on the Aspect(s) of Concern: Under this step, PMRA will use a scientifically based approach to evaluate the aspect(s) of concern related to the pest control product that prompted the special review. PMRA states: "A registration may be cancelled or amended at any time during the course of the special review if the Minister has reasonable grounds to believe that the cancellation or amendment is necessary to deal with a situation that endangers human health or safety or the environment."
     
  • Step 4 -- Publish a Proposed Special Review Decision and Consult the Public: Upon completion of its science-based assessment, PMRA will publish a proposed decision for consultation and seek comments from the public and stakeholders.
     
  • Step 5 -- Publish a Final Special Review Decision: After considering any comments received, PMRA will publish a final decision statement. Following publication of a final regulatory decision for a special review, any person may file a Notice of Objection within 60 days of the decision date.

Discussion

There have been lawsuits filed in the past few years arguing that Health Canada has not initiated special reviews when requested by the public and required under the Act. While PMRA does not reference any past actions, this consultation document may, in part, be a reaction to those cases and a desire on PMRA's part to clarify the procedures under which it will determine when a special review will be initiated.

The release of this consultation document also coincides with PMRA's announcement that it is initiating special reviews for 23 active ingredients under Section 17(2) based upon their regulation by an OECD Member State. While this consultation document is a proposal that will not be issued in final until after the comment period expires and relevant comments are incorporated, PMRA would seemingly be at Step 3 in the process with regard to the 23 substances such that PMRA will now commence a science-based assessment. All companies with pesticide products in Canada are urged to monitor these developments.


 
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