International Pesticide Product Registration Requirements

Chapter 23

The Canadian Pesticide Registration System in the Context of International Harmonization

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Daniel Chaput Pest Management Regulatory Agency, Health Canada, Ottawa, Ontario K1A 0C6, Canada

The Pest Management Regulatory Agency (PMRA) of Health Canada is involved in a wide range of international harmonization initiatives both under the North American Free Trade Agreement (NAFTA) and under the Organization for Economic Cooperation and Development (OECD) Pesticides Program. Some of these initiatives, such as, joint reviews, development of common data requirements, and electronic data submission, are briefly described. The development ofjoint residue zone maps covering both Canada and the U.S. and the implementation of OECD GLP are discussed in greater detail.

The Pest Management Regulatory Agency (PMRA) was established in April 1995 in response to the recommendations of the Pesticide Registration Review (PRR) Team. The Multistakeholder Review Team was charged with studying and making recommendations to improve the federal pesticide regulatory system. Administration of the Pest Control Products (PCP) Act was transferred from me Minister of Agriculture and Agri-Food to the Minister of Health, while pest management regulation resources and responsibilities from four government departments were consolidated in the PMRA. PMRA has responsibility for protecting human health and the environment while supporting the competitiveness of agriculture, forestry, other resource sectors and manufacturing. The Agency is also dedicated to integrating the principles of sustainability into Canada's pest management regulatory regime. Recognizing the clear benefits of harmonization, the PMRA is currently participating in harmonization activities which support the development and implementation of common data requirements, common test guidelines, common approaches to risk assessment, as well as common review formats and the format for regulatory decision documents.

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© 1999 A m e r i c a n C h e m i c a l Society

In International Pesticide Product Registration Requirements; Garner, W., et al.; ACS Symposium Series; American Chemical Society: Washington, DC, 1999.


191 At present, the PMRA is pursuing a number of bilateral and trilateral initiatives among the three North American Free Trade Agreement (NAFTA) countries and with a range of other countries through the OECD Pesticides Programme. Some of the initiatives underway within these two forums are summarized in this paper. More details on PMRA harmonization activities are available on the PMRA internet site (http://www.hc-sc.gc.ca/pmra). While certain harmonization projects are specific to NAFTA, others are pursued concurrently in both the NAFTA and the OECD forum. In some cases, a project initiated under NAFTA could later move under the broader OECD umbrella. Harmonization Activities under N A F T A The NAFTA Technical Working Group (TWG) on pesticides is the forum for harmonization activities between regulatory agencies in Canada, the United States and Mexico. The goals of the NAFTA TWG are to: 1) share the work of pesticide regulation; 2) harmonize scientific and policy considerations for pesticide regulation; and 3) reduce trade barriers. Specific activities carried out under NAFTA include: Development of Harmonized Data Requirements. The harmonization of data requirements is one of the cornerstones for efficient joint reviews and worksharing of pesticide evaluations. Data requirements have been harmonized in some areas while significant progress is being achieved in others. Some of the areas in which data requirement harmonization projects are being conducted in consultation with the United States Environmental Protection Agency (EPA) and, in some cases, with other countries include: Product Chemistry Data Requirements. The PMRA published in July 1997 a set of revised product chemistry Regulatory Proposals (7,2) describing the data required to comprehensively characterize technical grade active ingredients and end-use products. These revised documents are harmonized with the US requirements (EPA Product Properties Test Guidelines Series 830). Residue Chemistry Data Requirements. The PMRA published in June 1997 a set of residue chemistry guidelines (5) describing the data required to evaluate and assess the nature and magnitude of the residues in foods, perform dietary exposure assessment and establish maximum residue limits. Also included in these guidelines is specific guidance related to supervised crop residue trials conducted in Canada and/or the U.S. The guidelines describe the Canada/USA residue maps which delineate regions that are unique and which are consistent between the two countries, allowing for the data produced in equivalent zones in either country to be used in support of registration. The Canada/US. residue maps are discussed in more detail in the last section of this paper. Data Requirements for the Registration of Microbial Pest Control Agents and Products. Substantial progress has been achieved on the harmonization of data


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requirements for these types of products especially in the areas of characterization and healthriskassessment. Further harmonization is currently underway through the OECD pesticides programme. A PMRA Regulatory Proposal describing these requirements is scheduled for publication in late 1998. Joint Reviews of Pesticide Data Submissions between Canada and the U.S. A key component in supporting the various harmonization activities is the practical experience obtained through an expanding programme ofjoint reviews between Canada and the U.S. and work sharing with a broader range of countries. This provides invaluable experience in refining the terminology, the level of detail, and really understanding the significance of any apparent differences in the interpretation of data. The PMRA and the EPA have established a process for the Joint Review of chemical products that meet the EPA criteria of "reduced-risk" and products containing either microbials or semiochemicals (including pheromones). Candidates eligible for Joint Review must contain a new active ingredient with use patterns common to both countries and be supported by complete data bases. During the course of a Joint Review, the PMRA and EPA together may request additional information or data. It is anticipated that the Joint Review programme will increase the efficiency of the registration process, increase access to pest management tools in both countries and facilitate the registration of alternative pest control products with a reduction in review time but not in safety standards. The targeted time frame for the evaluation of a Joint Review is in the order of twelve months as opposed to eighteen months for a standard submission. Joint reviews of a chemical, a pheromone and a microbial pesticide have been initiated. Since this Joint Review initiative is a first for both Agencies and for industry, a number of adjustments are being made as it proceeds in order to streamline the process to the extent possible. Harmonization Activities under the OECD Pesticides Programme The OECD's Pesticide Programme is one of ten subprogrammes of the OECD's Environmental Health and Safety (EHS) Programme. The purpose of the EHS Programme is to help countries manage the risks of chemicals as efficiently and effectively as possible while enjoying the many benefits they provide. The PMRA represents Canadian interests in the OECD Pesticide Programme. Canada has taken, and continues to take, an active role in many projects within the OECD Pesticide Programme. These include: Harmonization of Guidance Documents for Industry Data Submissions (Dossiers) and Country Data Review Reports (Monographs). The goal of this project is twofold: i) Through harmonized data requirements, to develop a common data submission (dossier) acceptable to all OECD countries; and ii) To develop a common format and content for individual study reviews and final Monographs prepared by countries.



193 The preparation of a single dossier acceptable to OECD countries will increase the efficiency of national regulatory processes by facilitating work sharing among countries and could result in substantial savings to industry. In addition, information exchange among countries will be facilitated with the adoption of common review formats. A meeting among representatives of national governments and industry was held in January 1997 to initiate discussion on the development of an OECD document based on that prepared for use in the European Union (EU). Along the lines of common data submission and as a result of the OECD forum activities, the PMRA introduced in 1996 a requirement for the provision of comprehensive data summaries in registration submissions involving major new uses and new active ingredients. The PMRA is using the approach adopted by the EU while at the same time working with the OECD to make the EU format acceptable to all OECD countries. This requirement for a summary is intended to speed up the review process by providing decision makers in the PMRA with a clear, comprehensive summary of the characteristics of the product, its risks and value. Electronic Data Submission. Canada, through the PMRA, has taken the lead in forming an international group to coordinate a harmonized approach for an electronic capability. The formation of the Global Regulatory Information Technology (GRIT) group was announced at the November 4, 1996, OECD Pesticide Forum meeting. Participants include the pesticide Agencies from the United States, Canada, Germany, United Kingdom, Australia, European Union member states, plus representation from the OECD Pesticide Forum secretariat, the European Crop Protection Association, the American Crop Protection Association and Canadian industry. The development of a compatible electronic submission and review process will increase efficiencies throughout the regulatory process. It is a logical next step from the work to develop common submission formats and data review reports. GRIT will consider developments and will make strategic plans for electronic data submission while ensuring good cooperation at the international level. Interpretation of Data. A more consistent approach to the interpretation of data between countries is paramount to allow reviews and work to be shared among all jurisdictions. To this end, there are several projects related to the development of guidance on the interpretation of study results including: • • •

Repeat Dose Toxicity Data Review Guidance (US/Canadian/Australian project) Guidance for Summarizing Results from Field Dissipation Studies (UK proposal) Aquatic Dissipation Data Review Guidance (Canadian/US proposal)

Good Laboratory Practices (GLP). The PMRA, in line with its goal to pursue international cooperation, is committed to implement the OECD GLP Principles for pest control products in a timely manner. PMRA activities in this area are discussed in more details in the next section.


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The Introduction of OECD Principles of Good Laboratory Practices (GLP) Good Laboratory Practice (GLP) is defined by the OECD as a quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported (4). The purpose of GLP is to promote the development of quality test data which forms the basis for the mutual acceptance of data among countries. To date, Canada has no formal GLP regulatory program in place despite some attempts to introduce GLP requirements in the area of drugs several years ago. In 1988, the promulgation of the Canadian Environmental Protection Act (CEPA) created the basis for a GLP program for industrial chemical New Substance Notification Regulations (NSNR), but it has not historically been enforced. An informal voluntary compliance monitoring program is currently in place in this area pending the development of GLP regulations. The PMRA, in support of its international harmonization initiatives, intends to implement GLP for pest control products in a timely manner. To this end, the Agency published in 1996 a GLP consultation paper (5) outlining a proposed approach for establishing GLP requirements for pest control products and for monitoring GLP compliance. The emerging PMRA GLP program is being developed after careful consideration of the comments received on the 1996 proposal. The Canadian Context The preamble of the OECD document "Revised Guide for Compliance Monitoring Procedures for Good Laboratory Practices" (5) states that "Member countries will adopt GLP principles and establish compliance monitoring procedures according to national legaland administrative practices... Thus, itwould appear evident that the OECD recognizes and accepts that there can be some degree of variability in the application of GLP depending on the national context. This conclusion is supported by the variety of approaches to GLP implementation and monitoring currently in place in OECD member countries. Some of the key elements of the Canadian context which influenced the PMRA approach to GLP include: JJ

i)

Although GLP is not formally implemented in Canada, it is already an industry standard given the structure of the pesticide industry originating mostly from the US and / or Europe where GLP has been in place for many years;

ii)

GLP laboratory capacity currently exists in Canada as a number of test facilities have been submitting pesticide GLP compliant studies to EPA for a number of years. However, in the absence of a Canadian GLP compliance monitoring program and given the scope of the EPA program, this claim has not been systematically verified by an independent body;

iii)

The Canadian government, as many others world-wide, is in the "right-sizing" mode, redefining priorities and encouraging alternative program delivery approaches in light of reduced resource levels; and

iv)

The PMRA is currently implementing a cost recovery regime. In International Pesticide Product Registration Requirements; Garner, W., et al.; ACS Symposium Series; American Chemical Society: Washington, DC, 1999.


195 Overview of the Emerging Canadian GLP Program for Pesticides. The requirement for all health and safety studies submitted to the PMRA to be GLP compliant will be established through the publication of a Regulatory Directive; a tool used by the PMRA to provide more details and/or interpret the Pest Control Products Act and Regulations governing the regulation of pesticides in Canada. As per the approach used in certain European countries, the requirement for GLP compliant studies will be introduced gradually, by study types, to help ensure an orderly implementation. For example, the principles will initially be applied to crop residue studies (including field trials) in support of the U.S./Canada joint residue zone maps which are discussed in the next section of this paper. A GLP compliance monitoring authority (CMA) will be established as per OECD requirements. The CMA will be responsible for the administration of a GLP compliance programme and for discharging other related functions such as publishing documents detailing programme operation, ensuring that an adequate number of trained inspectors is available and maintaining records of GLP compliance status of inspected test facilities. Steps are being taken to recognize the Standards Council of Canada (SCC) as a domestic compliance monitoring authority (CMA) for pest control products. The SCC Conformity Assessment Division currently administers a national laboratory accreditation program which includes over 200 laboratories accredited to ISO/IEC Guide 25. It is likely that a number of these labs would also be involved in the GLP programme for pesticides. In these cases, efforts will be made to streamline the assessment activities in light of the commonalities between OECD GLP Principles and the ISO Guide 25 accreditation while preserving program integrity and identity. In order to avoid duplication and minimize operational cost, the compliance monitoring program will build on the existing SCC administrative infrastructue to the extent possible. The technical expertise required to carry out inspections will be drawn from staff in government agencies as is the current practice with other SCC programs. The programme will be based upon OECD GLP requirements. A GLP compliance inspection would involve an on-site inspection in conjunction with an audit of one or more ongoing or completed studies. An inspection report would be prepared and forwarded to a SCC review panel for a decision on certification. The SCC would issue a certificate once the certification is approved by the panel. This formal recognition of a test facility GLP status would address international requirements and broaden market acceptance of the laboratory and their data. This approach was recognized in a 1994 OECD GLP Panel statement (7) which acknowledged that such quasi-accreditation programs are valid if based upon OECD GLP Principles, as opposed to ISO Guide 25, and include government oversight. A similar approach is currently in place in Australia, New Zealand, Ireland, Norway and Sweden, where the National Accreditation body (NAB) is also the compliance monitoring authority. In other countries the NAB is involved in GLP compliance monitoring by acting as a delivery arm for the compliance monitoring authority (e.g.,


196 France) or an agreement exists between the NAB and the GLP CMA concerning the mutual acceptance of common element inspection data (e.g., Belgium). After the initial implementation phase, the program will gradually become selfsustaining and function on a fee for service basis between the test facilities and the SCC as is the practice with the Council's current programmes.


Multiple Quality Assurance Systems in Analytical Chemistry Laboratories - A Viewpoint Quality assurance is certainly not a new concept in analytical chemistry. However, the increasing demand for legally enforceable and decision-oriented data and the need for international acceptability of this information has led to the formalization of quality assurance systems. These systems are codified m guides or standards and include, ISO Guide 25 (EN 45001 in EU countries), Good Laboratory Practices (GLP) and the ISO 9000 series of standards. Significant success has been achieved in ensuring the international acceptability of these standards; however, the applicable standard varies with the stage of the product life cycle. For example, GLP typically applies at the development stage (pre-market testing) where data are being generated for registration purposes while ISO Guide 25 would typically apply in routine post-registration regulatory (e.g. residue monitoring) or quality control activities. An increasing number of analytical laboratories are involved in both pre- and post- registration testing activities, which result in these facilities being confronted with the need to cope with two or more of these standards. This can result in a significant burden for a laboratory as it involves separate audits and inspections, often by different organizations which typically operate on a fee for service basis. There are two distinct, although related, issues to consider in this regard; the introduction of a unified approach to monitoring adherence to the individual quality standards and the potential for integrating the standards into a single uniform document. Although the latter scenario would be desirable, it is recognized that the greatest shortterm potential for harmonization rests with the issue of integrated compliance monitoring. These issues have been recognized internationally where there is a growing trend to more or less formally link the monitoring activities of the NAB with those of the GLP CMA. Even the possibility of combining the standards has already been discussed in some forums due to the appreciation that while the vehicle differs, their quality focus is consistent. These endeavours are supported by a growing number of parties with a vested interest in the issue, for example: EURACHEM (a network of European national laboratories which have an interest or responsibility for chemical analysis and related quality issues) "... would like to see and is willing to contribute to ... greater harmonisation of the terminology and requirements of ISO/IEC Guide 25, ISO 9000 series, GLP and other quality management systems leading to only one assessment" (

International Pesticide Product Registration Requirements

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