Adjuvants for Agrichemicals

Chester L. Foy

• Publisher: CRC Press
• Year: 2018
• Print ISBN: 9781315890401
• eBook ISBN: 9781351086400
• Topic: Biological Sciences
• Subtopic: Botany
• Index: Biological Sciences

Based on a conference, this book is intended to promote a better understanding of the effects of adjuvants on pesticide penetration, translocation, photodegradation and stability, spray deposition and dissipation, and the fate of herbicides in the environment.

Section II

Regulation and Importance; Environmental Effects; Spray Deposition and Dissipation; Soil Adjuvants; Organosilicone Surfactants, Oils, and Emulsifiers

Chapter 20

REGULATION OF PESTICIDES AND INERT INGREDIENTS IN PESTICIDE PRODUCTS

Edwin F. Tinsworth

The Environmental Protection Agency (EPA) regulates pesticides under two statutes: the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug and Cosmetic Act (FFDCA). Recent amendments to FIFRA, proposed amendments to FFDCA and continuing debate in Congress regarding food safety make discussions of registration, reregistration, and special review as they relate to both active and inert ingredients in agrichemicals timely. The following is a summary of the EPA’s authority to regulate pesticides and adjuvants; the three programs — registration, reregistration, and special review — that are the backbone of pesticide programs at the EPA; and what the future may hold in terms of these processes.

FIFRA requires that all pesticide products sold or distributed in commerce be registered by the EPA. It further requires that the EPA determine that the product, when used according to directions, will not pose unreasonable risk to human health or the environment, taking into account the risks and benefits of the chemical’s use. In addition, FIFRA requires the EPA to reregister existing pesticides.

Under the FFDCA, the EPA is authorized to establish tolerances of pesticide residues on raw agricultural commodities (RACs) and food additive regulations for pesticide residues in processed foods.

Prior to the establishment of the EPA, the Food and Drug Administration (FDA) was responsible for establishing tolerances and food additive regulations. In 1961, the FDA published a notice that each component of a registered pesticide product, including inert ingredients, was a pesticide chemical and subject to the requirements of tolerances under the FFDCA. In 1969, they established a policy requiring that certain minimal toxicity data be provided on inert ingredients and stating that the need for data depicting the residues of the inert ingredients in or on RACs and processed food would be dependent on the substance’s toxicity. The FDA policy also provided for a less formal clearance process of inerts that were deemed to be generally recognized as safe (GRAS).

The definition established by the FDA clearly indicates that the EPA may set tolerances and food additive regulations for inert ingredients in pesticides. Further, regulations under FIFRA which set forth the data generally required to assess a pesticide’s risk also state that the EPA can require data on inert ingredients in pesticide products. Additionally, the EPA’s authority to require data extends to end use-formulated products plus any recommended vehicles and adjuvants not part of the product, but mixed with the product at the time of its use.

Despite the fact that the EPA can regulate adjuvants under existing and past authority, little testing has been required to date. About 50% of the approximately 1200 existing inert ingredients used in pesticide products have been cleared for use under the FFDCA. Over 100 of these have been deemed GRAS by the FDA in the past. Until recently, most regulatory actions and data requirements under FIFRA for food-use and non-food-use pesticides have focused on the potential risks posed by the pesticide active ingredients in formulated products. The basic exception is that the EPA requires product chemistry and acute toxicity testing on the formulated, or end-use product, thereby characterizing the acute risks of the combination of active and inert ingredients that make up that product.

When the EPA registers a pesticide, the burden of proof that the pesticide will not result in unreasonable adverse effects lies with the prospective registrant of the pesticide. In order to prove that the pesticide meets this statutory standard, data must be developed to characterize acute, subchronic, and chronic toxicity, reproductive effects, oncogenicity, teratogenicity, metabolism, and mutagenicity. Product chemistry data showing the chemical’s fate in the environment, data regarding potential ecological effects, and residue chemistry data are also required to support registration. In most cases, these data are required to be conducted on the active ingredients contained in the product. Prior to registration of the formulated product, acute toxicity and product chemistry data must also be submitted for the product as formulated. As part of the information submitted to support registration, the prospective registrant must disclose to the EPA all ingredients in the pesticide, including inert ingredients, and the percentages at which they will occur in the product. Until 1987, however, the EPA focused little attention on that percentage of the product comprised of inert ingredients.

In addition to registering pesticides, the EPA was directed by amendments to FIFRA in 1972 to reregister existing pesticides, some of which were registered as long ago as 1947. Approximately 40,000 products containing one or more of over 800 active ingredients were to be reviewed to determine whether the existing database was adequate to support registration by current standards. To accomplish this objective, the EPA developed the registration standards process. That process begins with a review of the existing database for a given active ingredient, and results in a determination of the validity of the existing data, identification of gaps in the database, whether tolerances are set appropriately, and preliminary determinations of risk if these can be ascertained from the existing data. Based on the available data, the EPA develops a regulatory position regarding the continued registration of the chemical. The EPA’s position can include requirements to modify labeling or manufacturing processes, restrict the chemical to use by certified pesticide applicators, or recommend the chemical for a special review. The registration standard documen...

Table of contents

• Cover
• Half Title
• Title Page
• Copyright Page
• Table of Contents
• Section I. A Bibliographic Survey: Physiological Action; Effects on Pesticide Penetration, Translocation, Photodegradation, and Stability
• Section II. Regulation and Importance; Environmental Effects; Spray Deposition and Dissipation; Soil Adjuvants; Organosilicone Surfactants, Oils, and Emulsifiers
• Section III. Rationale for Use; Concerns within the Pesticide Industry; Evaluation Methodology; Efficacy with Herbicides and Growth Regulators; Enhancement of Disease and Insect Control
• Appendix. Formulations and Applications of Adjuvants for Agrichemicals: A Selected Bibliography of World Literature in English
• Index