Pesticides are arguably the most heavily regulated of all chemical substances. While the benefits of pesticide use are well known and documented, there are nonetheless extensive laws and regulations now in place in many countries to ensure that pesticides are used in a responsible way. These laws and regulations require extensive testing and data generation before a pesticide can be marketed.
In the United States, the Federal Insecticide, Fungicide, and Rodenticide Act and the Federal Food, Drug, and Cosmetic Act are the basic laws that describe how pesticides and antimicrobial substances are to be regulated and used while ensuring that human health and the environment are adequately protected and that the nation’s food and drinking water supplies are safe and wholesome. Similar pesticide laws and regulatory frameworks exist in the EU, Canada, Australia, Japan, and most other developed countries. Developing countries are also instituting similar regulations.
In general, under these laws, before making safety and registration decisions, regulatory authorities must often review the results of numerous scientific tests designed to describe the environmental fate and transport, as well as the hazard potential, of a given pesticide to humans, wildlife, and plants. Several of the countries have developed and issued specific and detailed guidelines for conducting studies that are to be used to determine pesticide safety. Some of these study guidelines are similar to those used in related industries, such as industrial chemicals, food additives, and pharmaceutical products. In most countries, there are also more general test reporting standards, known as Good Laboratory Practices (GLPs), that ensure that regulatory studies are conducted in a consistent and repeatable way from country to country, and that accurate records of the testing are maintained.
The regulatory and scientific consultants at Exponent are well-versed in all of the pesticide laws and regulations, as well as pesticide study test guidelines and methodology, and GLPs issued by the various regulatory authorities.
In addition, our scientists have extensive experience in the design, direction, and execution of such studies, including market-basket surveys, and occupational and residential exposure studies, as well as studies of product chemistry, toxicology, ecotoxicology, environmental fate, and residue chemistry. The range of studies with which Exponent scientists are experienced include standard laboratory and field studies, as well as specialized and site-specific laboratory and field studies. In addition, Exponent has scientists trained in managing efficacy studies to support pesticide use on field and horticultural crops, certain veterinary uses, and efficacy of antimicrobial products.
Exponent has extensive knowledge of and experience with many of the prominent contract research organizations (CROs) around the world. This knowledge allows us to help clients obtain study proposals and cost estimates, and ultimately to get studies initiated and completed in a cost-effective and timely fashion.
Finally, Exponent routinely provides study monitoring services to those clients who prefer more of a turnkey approach. In this scenario, Exponent can discuss the regulatory needs with the client, assist the client in determining the exact study requirements, make contact with CROs, help develop and finalize the study protocol, discuss any special issues with the appropriate regulatory authorities, monitor the progress of the study(ies), and submit it/them in the proper context to the authorities, and then follow up if there are post-submission questions or issues to be managed.