ENVI Committee Report
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16. INTERNATIONAL HARMONIZATION
16.1 The PMRA is currently working with its counterparts in other countries to harmonize the processes used to regulate pest control products. The aims of harmonization include standardization of the type and scope of studies required to register a pesticide, the protocol followed in carrying out these required studies, the format and presentation of the submissions provided in support of a registration application, and the methods used to evaluate submissions and prepare reports.
16.2 Most notably, the PMRA is pursuing a wide range of initiatives with the United States and Mexico through the Technical Working Group on Pesticides, established under the North American Free Trade Agreement (the NAFTA TWG). The NAFTA TWG met for the first time in March 1996; its aim is to create a more consistent basis for pesticide registration by the year 2002. Targets for harmonizing pesticide regulatory processes in the NAFTA countries include:
- developing common data submissions for manufacturers;
- providing greater co-ordination of approval processes for pesticides;
- eliminating trade problems related to differences in maximum residue limits;
- developing a common labelling system; and
- providing concurrent access to products.
16.3 Harmonization initiatives are also being pursued through the Organization for Economic Co-operation and Development (OECD) Pesticides Forum. Current efforts of the OECD Pesticides Forum are focused on developing a common format for industry data submissions and country review reports, a compatible electronic data submission and review process, common data sets and evaluation criteria, common data requirements for pheromones and microbials, comprehensive summary requirements, test guidelines and effective risk reduction initiatives.283
16.4 Many witnesses expressed support for the PMRA's harmonization initiatives. Dr. Kelly Martin of the Canadian Association of Physicians for the Environment, for example, saw great merit in harmonization because it called for information sharing and tended generally to push Canada upward in risk assessment. She remarked:
| To me harmonization has great merit. It is sharing information. Why are we re-inventing the wheel? I think harmonization in fact is pushing us in risk assessment upward. I think, in general, it probably pushes us upward. [...] Of course Americans will always have a bigger weight. So if we think we want something greater than they have, it will take a lot of political will to do that. I think harmonization is the route to go, with some focus on what research we actually need and want. They are moving faster towards that than we are, so it could be quite helpful.284 |
16.5 Denise Dewar of the Crop Protection Institute also stated that in her experience, international harmonization had pushed the bar higher.285 On the other hand, Barbara McElgunn of the Learning Disabilities Association of Canada informed the Committee that, in at least one instance, the Canadian standard had been lowered due to harmonization. She indicated that the PMRA had changed the maximum residue limit (MRL) for chlorpyrifos from 0.1 parts per million to 1.0 parts per million to harmonize with the US.286
16.6 While many witnesses endorsed harmonization, a majority of them had serious concerns that Canadian standards might be lowered in the process. Some standards might be eliminated altogether. For example, there are current discussions within the Economic Advisory Council to possibly eliminate the requirement for the PMRA to conduct "efficacy reviews" since such reviews are not generally required in the US.
16.7 The World Wildlife Fund told the Committee that the NAFTA process was dominating pesticide related initiatives in Canada. Stating that harmonization was being offered as the way to gain efficiencies, conduct cheaper re-evaluations, get lower-risk pesticides on the market and resolve so-called trade irritants, this organization felt that although work-sharing and avoiding duplication were commendable objectives, registering pesticides more quickly and cheaply and avoiding differences simply because they might impede trade were less worthy. It recommended that the PMRA be given a clear, health and environment driven negotiating position.287 The Canadian Environment Law Association and the Ontario College of Family Physicians, for their part, were particularly concerned about the possible lowering of Canada's maximum residue limit (MRL) standards through harmonization. They recommended that the PMRA ensure that the negotiation of MRLs with our trading partners be effected under a transparent process and that the strength of Canada's MRLs not be compromised.288
16.8 The Committee agrees with these recommendations. Throughout this report we have stressed the importance of ensuring that protection of human health and the environment is given top priority. We have also emphasized the importance of having an open and transparent process. These fundamental principles must drive the harmonization process, not be subordinated by it. The Committee strongly opposes any initiative that might lower Canadian standards on the grounds of expediency. It is imperative that our standards not be relaxed. We must ensure that only the most protective standards are applied.
| The Committee recommends that a clause be added in the operative sections of the new Pest Control Act requiring that protection of human health and the environment according to the precautionary principle be the sole objective of any action to harmonize Canadian standards with those of other countries, and that such standards not be weakened in any way. |
| The Committee recommends that the harmonization process be fully transparent by requiring that all harmonization negotiations and actions be reported on the Pest Management Regulatory Agency's electronic public registry of information. |
283 Pest Management Regulatory Agency, Web site, The information on international harmonization was drawn from a fact sheet prepared by the PMRA, entitled Fact Sheet on International Harmonization of Pesticide Regulation, November 1999.
284 Evidence, Meeting No. 11, December 1,1999.
285 Evidence, Meeting No. 9, November 25, 1999.
286 Evidence, Meeting No. 4, November 16, 1999.
287 World Wildlife Fund, Brief to the Committee.
288 Canadian Environment Law Association and Ontario College of Family Physicians, Brief to the Committee.