Summary of Public Comments received on Regulatory Proposal PRO2016-04, Policy on Cancellations and Amendments Following Re-evaluation and Special Review

Pest Management Regulatory Agency
7 March 2018

Comments received in response to Regulatory Proposal PRO2016-04, Policy on Cancellations and Amendments Following Re-evaluation and Special Review, published on 21 December 2016, are summarized below along with the responses by the PMRA. These comments were taken into consideration to prepare Regulatory Directive DIR2018-01, Policy on Cancellations and Amendments Following Re-evaluation and Special Review.

1. Clarification was sought that while the Minister may take into account the precautionary principle set out in subsection 20(2) of the Pest Control Products Act, the consideration by the Minister under the Act and regulatory regime remains a science-based.

PMRA Response:
Under the Pest Control Products Act, the Minister may cancel or amend the registration of a pest control product if, in the course of a re-evaluation or special review, the Minister has reasonable grounds to believe that the cancellation or amendments is necessary to deal with a situation that endangers human health or safety or the environment, taking into account the precautionary principle (20(1)(b) and 20(2)). The PMRA continues to make science-based decisions while taking into account the precautionary principle for re-evaluation and special reviews. The Pest Control Products Act requires consultation on re-evaluation and special review decisions, which is an opportunity available to the public including stakeholders to review the basis of decisions and provide comment to the PMRA.

2. Concern was expressed that terminology and criteria cited in the policy represent a less rigorous assessment standard and a move away from science-based assessments, while referencing: "current standards for protection of health and the environment" and "information from post market surveillance". Additionally it was commented that cancellations and amendments should occur only if there is significant likelihood of serious and severe effects.

PMRA Response (19(2)(a)):
The PMRA will continue to make re-evaluation and special review decisions derived from risk assessments based on sound scientific data and information. The term "current standards for protection of health and the environment" is a descriptor for well-established scientific regulatory approaches that the PMRA as well as other international pesticide regulatory bodies apply. These approaches evaluate adverse effects against estimated exposure levels, to determine whether the risks are acceptable for human health or the environment. Risk assessments incorporate safety/uncertainty factors, which establish a significant safety margin to levels that may be harmful. These internationally recognized approaches thereby maintain an appropriate standard of health and environmental protection.

While significant likelihood of serious and severe effects would certainly be a basis for regulatory action, as per the internationally recognized approaches to pesticide regulation, action may also be required when current standards for human health and environmental protection are not met.

Adverse effects from incident reports may serve as the primary basis for regulatory action, where reported effects are serious in nature and causally linked. However, where effects are less serious and the causality is less evident, incident reports will be considered in conjunction with a comprehensive science-based assessment.

3. Clarification was sought on whether provisions would be included in the policy for forecasting and supply management, and whether implementation timelines would be extended in consideration of such information.

PMRA Response:
Extensions to implementation timelines, based on consideration of supply forecasting, will not be part of this policy. The timelines in this policy are established to allow registrants sufficient advance notice to manage existing stocks.

Standardized timelines reduce the regulatory burden of collecting, providing and assessing information on a product-by-product basis. Additionally, they clarify expectations, obligations and communications around regulatory decisions.

4. The PMRA should provide further guidance on criteria used to determine suitability of alternatives.

PMRA Response:
The suitability of other registered products as potential alternatives to the cancelled product(s) is determined by considering the availability of all products that are registered to manage the major pest species for a crop, as well as which of these provide a reasonable level of control of the pest.

5. Seeking clarification on the extent of registrant liability for implementing regulatory requirements on product stocks that are outside of the registrant's care and control (for example, stocks in the possession of retailers or users).

PMRA Response:
The Pest Control Products Act provides broad latitude for implementing measures to address health and environmental risks. This could include requiring registrants to take actions pertaining to products beyond their immediate care and control. The PMRA endeavours to identify efficient requirements that are practical for registrants, retailers and users, while being appropriate to the level of risk.

6. A discrepancy in timelines was noted with respect to the amount of time permitted to sell a product subject to cancellation, as compared to a product subject to amendment. Where there are no imminent and serious risks, a product subject to cancellation is permitted 1-year of registrant sale after the decision, whereas an unamended label is permitted 2-years of sale by registrant. It was requested that cancellation timelines be better aligned with amendment timelines.

PMRA Response:
In addition to the primary consideration of addressing risks to human health and the environment, the PMRA takes into account the feasibility of implementing the two different processes. With respect to cancellation of a pesticide product, as discussed in Section 6.0, registrants are provided one (1) year to stop sale from a decision date. Similarly, the label amendment process generally takes one (1) year from the decision date to be completed and the amended label to be listed in the pesticide registry. Additional timelines following this initial one (1) year from the date of regulatory decision are provided to both processes to facilitate the implementation of the regulatory decision in an orderly manner.

7. When decisions are made mid use season, having yearly implementation intervals will result in changes becoming effective mid use season. This presents logistical and communication challenges for registrants, retailers and users. Where there are no imminent and serious risks concerns, these issues could be mitigated by delaying implementation to the end of the use season or end of the calendar year.

PMRA Response:
In accordance with s.21(3) of the Pest Control Products Act, delay of effective data is only permitted when there is a lack of suitable alternative and where health and environmental risks and value of the product are acceptable until the effective date of the amendment or cancellation.

8. Recommendation that the PMRA decision documents and correspondence to registrants clearly state the applicable regulatory requirements and implementation schedule to be followed and whether it is as per the standard process outlined in the policy, or as per an imminent and serious risk scenario.

PMRA Response:
The PMRA will continue to communicate specific regulatory requirements, the reasons for those requirements, as well as implementation timelines via the published decision document. Registrants are also informed via a decision letter, of the implementation timeline and the process to follow.

9. Request that registrants be allowed two years to implement amended label, from the date of receiving the PMRA approval of a label amendment submission, rather than 2 years from the decision date as was proposed in PRO2016-04. It was noted that registrants cannot implement label changes in the marketplace until label amendments are approved by the PMRA.

PMRA Response:
The PMRA's performance standard requires a completion of amendment submission reviews within approximately one year of the re-evaluation decision, therefore, registrants generally have at least one year to implement amended labels once their amendment submission has been approved. This timeline is considered adequate to facilitate implementation of labels.

10. Policy text addressing extensions, where there are no suitable alternatives, provides the timeline for cancellations but not amendments. Clarification sought on whether extensions were also applicable to amendments.

PMRA Response:
The policy has been updated to clarify that a delay of implementation date, rather than extensions, is applicable for both cancellation or amendment in accordance with s.21(3) of the Pest Control Products Act, when there is a lack of suitable alternative and where health and environmental risks and value of the product are acceptable until the implementation date of the amendment or cancellation.

11. Comment regarding requests for extensions, due to a lack of suitable alternatives. If the PMRA has determined that there are no imminent and serious risk concerns, then registrants should not be required to provide a rationale for the acceptability of risk during the requested extension period.

PMRA Response:
In cases where the PMRA determines that imminent and serious human health and/or environmental risks may be of concern, an expedited phase-out period will be implemented on a case by case basis. As such, implementation timelines do not apply to cases where the imminent and serious risks may be of concern. In cases where a registrant wishes to request a delay of implementation date, the onus is on registrants to provide information as to how the continued use of the product would have acceptable risks to human health and the environment until the delayed implementation date. The PMRA will make a determination on such requests on a case-by-case basis.