For pesticide risk assessments, EPA typically focuses its assessments on the active ingredients, whereas the Services contend that all the other chemicals or whole products need to be considered. The following sections describe in further detail the types of mixtures potentially involved, their components, and difficulties encountered in incorporating them into an exposure analysis.
Pesticide Formulations and Tank Mixtures
Pesticide formulations typically contain chemicals other than the active ingredients that often do not have a direct effect on the target species. The term inert is used to designate a chemical that is not classified as an active ingredient. Some inerts can be toxic, and EPA has proposed the term other ingredients rather than inerts (EPA 2012g). Nonetheless, inert is engrained as a term in the pesticide literature and is commonly used—for example, the EPA Inert Ingredient Assessment Branch, which was established in 2005. For brevity, the following discussion uses the term inert but recognizes that inerts might be biologically active and potentially hazardous.
The term adjuvant is closely related. Adjuvants differ from inerts only in that adjuvants are added to a tank mixture in the field at the time that the pesticide is applied rather than when it is formulated. Tank-mixture adjuvants—such as surfactants, compatibility agents, antifoaming agents, spray colorants (dyes), and drift-control agents—are added to a tank mixture to aid or modify the action of a pesticide or the physical characteristics of the mixture (Ferrell et al. 2008).
Inerts and adjuvants are an extremely broad array of chemicals, including carriers, stabilizers, sticking agents, and other materials added to facilitate handling or application. Mixtures of different pesticide formulations or pesticide formulations in combination with various adjuvants are typically applied to save time and labor and to reduce equipment and application costs. Such a mixture might also control a variety of pests or enhance the control of one or a few pests.
EPA is responsible for the regulation of inerts and adjuvants in pesticide formulations. EPA (52 Fed. Reg. 13305 ) developed four classes (lists) of inerts on the basis of the available toxicity information: toxic (List 1), potentially toxic (List 2), unclassifiable (List 3), and nontoxic (List 4). List 4 was subdivided into two categories: List 4A contained inerts on which there was sufficient information to warrant a minimal concern, and List 4B contained inerts the use patterns of which and toxicity data on which indicated that their use as inerts was not likely to pose a risk. Although EPA no longer actively maintains the lists, references to that classification system are in the older literature; moreover, EPA documents, such as the current Label Review Manual (EPA 2010), still refer to the lists of inerts.
After a review of the toxicity data that supported food tolerances for pesticide inerts, EPA (71 Fed. Reg. 45415) revoked food tolerances for over 100 inerts; that is, these inerts can no longer be used in pesticides that are applied to food commodities. Thus, no List 1 inerts are now allowed in food-use