The Role of IR-4 in The Herbicide Registration Process for Specialty Food Crops

Abstract

The Interregional Research Project Number 4 (IR-4) Specialty Food Crops Program is a publicly-funded program initiated in 1963 to develop and submit regulatory data to support registration of pest control products for specialty crops. In the early to mid 1990s, nearly 45% of the IR-4 residue projects supported new herbicide registrations for fruits and vegetables with the other 55% devoted to fungicides, insecticides, and nematacides. In 2005, the number of residue projects conducted by IR-4 to support herbicide fruit and vegetable registrations was less than 30%. The three main factors that have contributed to this decline are: fewer herbicides available for registration; product liability concerns; and an increased focus on new, safer, and Reduced Risk Pesticides for insect and disease control. It has been a number of years since a new herbicide has been developed for a major crop that could be extended to specialty food crops. Many of the current IR-4 herbicide projects are with products that have been on the market for 20 or more years. Product liability is a concern because of the high value of many specialty crops relative to the potential market opportunity. In many cases, the registrant requires product performance data before IR-4 can proceed with a residue project. With limited funds for developing these data, many new projects never proceed to the regulatory stage. Although registrants can seek indemnification for some of these uses, it is a complicated often state-specific process. IR-4 has been successful in a number of areas, including the registration of a large numbers of uses through reduced data extrapolations for products such as glyphosate and carfentrazone-ethyl. Additionally, IR-4 submitted the first successful petition establishing an exemption of tolerance for a conventional herbicide (imazamox). Future IR-4 initiatives include collaboration with industry, growers, and academia to develop new herbicide technologies such as plant breeding or transgenic crops and generation of appropriate data to extend those products to specialty food crops. IR-4 will also assist in registering products that can be used on crops that have been selected (or developed through biotechnological approaches) to be tolerant to existing herbicides. Registrants should strongly consider developing herbicides for specialty food crops, with IR-4's assistance, as a means to expand markets and also as a means to extend data protection of their products, as allowed under the Food Quality Protection Act.