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Regulating Traditional and Antimicrobial (biocidal) Pesticides Internationally: a Complex System of Laws and Regulations

Copyright 2007 by Ibex Global LLC, all rights reserved.

Pesticide products are not only used for crops any more. Traditional pesticides are used against all manner of pests, from dustmites to fabric-eating moths, while antimicrobial (or biocidal) pesticides are used against viruses, bacteria, and fungi and can be incorporated into various non-traditional media, from clothing to plastics to paint. The systems of laws and regulations that determine how these products are sold and marketed are likewise complex and vary widely around the world.

Often, global companies will find that their pesticide products are regulated based on the kinds of claims made. For example, in both the United States of America and the Australia and New Zealand markets, products that contain substances otherwise classified as pesticides are exempt from regulation, provided that the products only make product protection claims (e.g., “preserves wood”) and the substances themselves have been approved as pesticides under the right set of circumstances. Examples of such rules are the Federal Insecticide, Fungicide, and Rodencide Act (“FIFRA”) of 1972, 7 U.S.C §§ 135 et seq., and FIFRA regulations at 40 C.F.R. Parts 150-178, in the US administered by the US Environmental Protection Agency (“EPA”) and the NICNAS system in Australia. To make claims beyond these product protection claims, registrations and approvals are required.

By contrast, the European Union’s Biocidial Products Directive,** effective September 2006, requires extensive registration of all pesticides for almost all uses, regardless of whether they have been incorporated into products or not and regardless of whether only product preservation claims are made. Exceptions to this rule are certain cosmetic uses and uses in medical devices, which are exempt from the Biocidal Products Directive.

Regulatory agencies like the US Food & Drug Administration (“FDA”), the UK’s Medicines and Hospital Regulatory Authority (“MHRA”), and the Australian tend to view their jurisdiction as beginning whenever a therapeutic, physiological, medical, or food-related claim is made for a product. At that point, the product may be classified as either a pharmaceutical (drug), a medical device, a combination thereof, or a food-contact item.

It is important to understand where the dividing lines are and the wording of particular claims for products in order to understand how a product will be regulated and what approvals, licenses, or registrations will be required for that product. Often, companies will the route of creativity, crafting product claims and marketing materials carefully, in order to ensure that their products fall into one regulatory category rather than another. The ultimate goal is always to be able to make the broadest claims possible in light of what the product’s technology will support and what regulatory restrictions will allow. To do so, companies often choose a combination of short-term compliance and medium- or even long-term regulatory approvals, in order to plan for present and future growth, respectively, and to gain a market edge over competitors via difficult-to-obtain regulatory approvals and licenses.

In addition to the issue of regulating pesticides once they are on the market, there are a number of issues regarding shipping, both internationally and under domestic laws and regulations that require study to ensure seamless entry to local markets.

For more information, contact the Ibex Global team at info@ibexglobal.net or visit us as www.ibexglobal.net or www.ibexglobal.co.il.

* This document is not intended to provide legal-regulatory advice but merely as a general overview of the subject matter. For specific issues and products, consultation with a regulatory expert is advisable.

** Directive 98/8/EC.

About the Author

Tom Page teaches international and comparative environmental and public health law and regulation at the Hebrew University of Jerusalem Faculty of Law. He also serves as global regulatory affairs director for a multinational high-tech company and as a consultant to Ibex Global Environmental & Medical Technology Consulting LLC.

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