(a) It does not take significantly longer to review and approve a pesticide in Canada as compared to the United States. In fact, for new active ingredient submissions, the review and approval time is shorter in Canada. It may seem to take longer in Canada because historically most companies submit applications for registration in Canada long after submitting an application for registration in the United States. The result of this company practice has been that a number of new pesticide active ingredients and the related end use products are available on the U.S. market before they come to the Canadian market. The Pest Management Regulatory Agency, PMRA, has addressed this problem through implementation of joint review programs with the U.S. Environmental Protection Agency, EPA . One of the goals of the joint review process and other work sharing initiatives with the EPA has been to make the new products available to users in both countries at the same time. The North American Milestone Report may be found at: http://www.hc-sc.gc.ca/pmraarla/english/pdf/-nafta/docs/naftawgrep-e.pdf.
(b) There is no specific part of the approval process that can be considered a ‘roadblock’.
(c) The step by step description of the approval process is contained in the PMRA publication 96-01 Management of Submissions Policy, MOSP, found on http://www.hc-sc.gc.ca/pmra-arla/english/pdf/pro/pro9601-e.pdf. In general there are five steps: verification, screening, review, public consultation/final decision, and verification of final label. The quality of a submission has a major impact on the length of time it takes a submission to proceed through the submission examination process. For example, a high quality, ideal submission for a new active ingredient has a timeline of 737 days or less. For a submission of the poorest quality, there are seven possible points in the process where the applicant has the opportunity to provide missing data, missing fees and/or corrected labels. The PMRA requires time to screen and/or review the additional information submitted to correct the deficiency. For these poor quality submissions, up to 1,912 days may be added to the submission examination process depending on which of the 7 delays are needed by the applicant. Only 6% of the category A submissions registered over the period from 1997-2002 have been ideal submissions. Category A submissions include new active ingredients and companion end use products and/or manufacturing use products, or import maximum residue limits, MRLs, for a new active ingredient, or major new uses (addition of a new use-site category (see response to question d). 94% of the category A submissions registered in this period have had quality problems requiring the use of at least one of the seven delays resulting in additional time being added to the 737 day ideal submission target. PMRA has developed and held training courses and has worked with applicants to assist them in putting together better quality submissions. Through pre-submission consultations and a number of guidelines, the applicant is provided with details of what is required to make a complete submission.
(d) The average length of time to register a pesticide depends on the complexity of each of type of submission. In Canada, for major new active ingredient pesticides, the average time to completion, including the screening and review components, in 2001-02 was 23 months; whereas in the United States, based on the information available from the EPA, in 2001 it was 38 months on average. In 2000-01 the average time to completion in Canada for new active ingredient submissions was 21 months while in the United States in 2000 it was 27 months.
The length of time for each step varies depending on the submission category and subcategory. For category A submissions, which are the most complex and are for new active ingredients or major new uses, there can be eight different sets of performance standards depending on whether the submission is standard or priority or chemical or microbial or reduced risk or a pheromone. For submissions subject to the MOSP, (see response to question c) the typical standard category A submissions registered in 2000-01 had an average verification time of 6 days, first screening time of 49 days, review time of 432 days and first final label verification of 29 days. For 2001-02 the times were 7, 65, 515 and 27 respectively. As part of the MOSP, the final step and end of the review stage for category A submissions is the release of a proposed regulatory decision document, PRDD, for public consultation. For those registered category A submissions that had a public consultation, the public consultation time was always 45 days and the average time for final decision was 32 days. Please note that PRDDs are not currently required by regs but will be required by the new act.
(e) For category A standard submissions, the PMRA targets to complete the review portion of the submission, i.e. after all deficiencies have been addressed by the company, in 18 months (550 days) for traditional chemicals, and 15 months (465 days) for reduced risk chemicals. In 2001- 02 PMRA met its performance target for these submissions. The ideal target length of time for the typical standard category A submission is 7 days for verification, 45 days for screening, 550 days for review, 45 days for public consultation/45 days for final decision, and 45 days for final label verification. For standard category A submissions, subject to the MOSP and excluding deviations, registered/ rejected/withdrawn in 2001-02 that were screened and the review completed, the PMRA met the review performance standard of 550 days on 94% of the submissions.
(f) The new ombudsperson has facilitated increased communication between growers, the PMRA, and Agriculture and Agri-Food Canada to ensure the data requirements for approvals are met and has helped streamline the processing of submissions. In 2002-03 PMRA approved more than 450 minor uses which was more than double that of any of the previous years.