Chapter 1
Overview Richard Turle
Downloaded by 80.82.77.83 on January 21, 2018 | http://pubs.acs.org Publication Date: June 16, 1999 | doi: 10.1021/bk-1999-0724.ch001
Environmental Technology Centre, Environment Canada, Ottawa K1A 0H3, Canada
The quest for quality of analytical measurements, just to take one field of scientific endeavor used in the development of pesticides, has long been the aim of analytical chemistry. Irrespective of the nature of the material being analyzed, analytical chemists have tried to produce quality results. Indeed, to ensure quality results, bodies such as The Association of Official Analytical Chemists were established in the last century to apply standardized test methods in the hope that accuracy would follow. Eventually, the terms accuracy and precision when applied to a numerical value obtainedfromanalysis defined the quality of the result. Modern instrumentation and the application of computers and statistical software have made the production of apparently accurate and precise results a seemingly easy thing to do. Yet today we are still on a continued quest for improving the quality of analytical results and associated data. Certainly, in the area of pesticide registration, the quest continues unabated, and it is not just the analytical chemist who is concerned. It is the toxicologist, thefieldand animal scientist, the regulator, and the environmentalist who also are concerned with the quality of the data. Why? The answer lies in the need for the public to be assured that the products that they use are safe. Safe is a big word in the context o f pesticide registration. Safe can be defined as safe in terms o f specificity o f effect, safe against harmful effects for the transporter, applicator or bystander; safe against health effects for the consumer o f the target organism , whether it be a direct or incidental application; and finally, safe for the environment in that a healthy ecosystem will remain after application and the pest has been eliminated.
Given that pesticides,
designed to kill something,
unlike pharmaceutical products, are
this indeed a tall order. The responsibility for ensuring a
pesticide is safe falls in most countries to a form o f regulating body.
Such regulating
bodies have the responsibility to make a judgment on the validity o f scientific data generated by pesticide producers.
In Canada, this is now the Pest Management
Regulatory Agency that reports to the federal Minister o f Health. In the U S A , it is the Environmental
Protection
Agency
which
administers
the
Federal
Insecticide,
Fungicide and Rodenticide Act. In Mexico, the responsibility falls to the Departments
© 1999 A m e r i c a n C h e m i c a l Society
Garner et al.; International Pesticide Product Registration Requirements ACS Symposium Series; American Chemical Society: Washington, DC, 1999.
1
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2 of Agriculture and Health. Other OECD member countries have similar agencies for pesticide registration. Just to complicate a technically complex problem, pesticides are often developed in one country, manufactured in a second, and then shipped to a third before final use. Obviously, any system to ensure safety of pesticides must recognize these realities of a global economy. Is the publicrightto be concerned with safety? Undoubtedly, yes! Ever since Rachel Carson's far-seeing book, "The Silent Spring" (7), described the effects of organochlorine pesticides, there has been an increasing awareness that it has not been acceptable for a pesticide manufacturer, user or regulating body to say a pesticide is safe without a considerable quantity of data being generated to prove it. Producing such data is expensive and time consuming. The registration process is costly, and without registration, a pesticide is without commercial value or benefit to the farmer. Given these economic and sometimes conflicting pressures, it is essential that systems exist to ensure that all of the scientific data used for registration, whether produced in the laboratory or in the field, have been acquired under known and verifiable conditions with every aspect documented. Such systems must be inherently strong enough to ensure that errors, incompetence or outright fraud are discovered and corrected before registration is allowed. For such reasons, scientific data gathered for the purposes of pesticide registration must be of known quality and will have had to have been gathered under a quality management system. Generally, two systems have been developed to ensure that scientific measurements and test results are accurate. These two systems, while not incompatible in a single laboratory, have different aims and are driven by different needs. The most common one in use today is based on ISO Guide 25 (2). This is a technical standard for a quality system which is used by many countries to allow laboratories to gain accreditation. This assures both clients of laboratories and regulating bodies, which may receive their data, that the laboratory has a quality system in place, with written test methods and standard operating procedures, which is managed by a quality assurance officer. The certificate of accreditation, given by a national accrediting organization, is given only after a site inspection conducted by qualified auditors. Inherently, such accreditation is most suitable where statistical quality assurance can be applied. In other words, it best applies to situations where there are many samples for each test. It is the most common quality system used by laboratories which have to confirm that products in trade meet established standards. Accredited laboratories are used by regulatory bodies in many countries, post registration, to ensure that food does not contain unacceptable levels of pesticides. No attempt is made in such accredited laboratories to ensure that all data can be subject to a later audit or reconstruction. Good Laboratory Practice Standards (GLPS) is another quality management system that has been applied to both laboratory and field testing for pesticide registration, as well as to the pharmaceuticals, chemical substances, and food additives registration processes. The driving force behind GLPS as a quality system is to ensure the regulators that all of the data produced are accurate and that, if required, it is possible to reconstruct the results from the raw data. Inherently, this system works best when applied to a situation of having many tests applied to one substance. In
Garner et al.; International Pesticide Product Registration Requirements ACS Symposium Series; American Chemical Society: Washington, DC, 1999.
Downloaded by 80.82.77.83 on January 21, 2018 | http://pubs.acs.org Publication Date: June 16, 1999 | doi: 10.1021/bk-1999-0724.ch001
3 many ways, and indeed, in some laboratories, the two systems require the same kind of information: test method procedures, sample handing procedures, etc. Another unique feature for GLP is that a study director is required. It is this person's responsibility to ensure studies are conducted to the GLP requirements for the purpose intended. It is a mandatory requirements that there is a quality assurance officer, and that there is sufficient control of documentation to ensure that any study can be fully reconstructed. Both the study director and the QA officer mutually rely on each other to ensure that only effective data are produced. The scope of the required documentation is far beyond that required by ISO Guide 25. For example, if the test report indicates that pesticide residue studies were conducted on 1000 mice, there should be records to indicate that at least 1000 mice were purchased and that their taxonomy was confirmed by a veterinarian. How do these two quality systems relate to the demands of pesticide product registration requirements? Most countries requiring registration of pesticides require data submitted to have been prepared according to one of the forms of GLP in use today. These are the OECD (5) and American forms of GLP, as mandated by the USFDA and the USEPA. Both have the same intent and eventually may be harmonized into one system. Increasingly, developing countries are also making GLP a requirement for pesticide registration. In some countries, the use of ISO Guide 25 in laboratories is being recognized as an acceptable form of quality system for post registration studies in assessing actual application rates, application concentrations, and food chain residues. The codification of quality systems, such as GLP or ISO Guide 25, does not remain static. Issues, such as verifying the accuracy of computer systems in data capture and data interpretation and retrieval, are in a state of flux. The application of GLP to field studies, where there is far less control over environmental conditions than in a laboratory, has been an area of debate among the GLP practitioners and pesticide companies and regulators. The GLP issues in the field relate to recording application conditions, weather conditions and other factors that might affect the results. The cost of pesticide regulation and the cost of producing information to obtain a registration increasingly has led to recognition that there needs to be some form of international harmonization between the various registration systems. As a direct consequence, there is a need to ensure that the GLP systems also are harmonized among themselves so there is complete recognition internationally for any one country's test data. Further, there is a debate among quality assurance practitioners that there should be an examination of quality systems, such as ISO Guide 25 and GLP, to identify commonalities so that only one accreditation is required for laboratories working under both systems. The obstacles to achieve this are formidable; however, such achievement would result in efficiency within laboratories accredited for both systems. In this symposium volume, various details of the quality systems are presented as they are applied by different countries to these issues, as well as to other aspects of the increasing number of requirements for pesticide registration.
Garner et al.; International Pesticide Product Registration Requirements ACS Symposium Series; American Chemical Society: Washington, DC, 1999.
4 Literature Cited 1. 2.
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3.
Rachel Carson, Silent Spring, Houghton Mifflen, Boston, Mass., 1962. ISO Guide 25: 1990, General Requirements for the Competence of Calibrat Laboratories. The OECD Principles of Good Laboratory Practices, Environment Monograph No. 45; Organization for Economic Cooperation and Development, Paris, 1992.
Garner et al.; International Pesticide Product Registration Requirements ACS Symposium Series; American Chemical Society: Washington, DC, 1999.
