Pesticide Formulation and Adjuvant Technology

Chester L. Foy, David W. Pritchard

• Publisher: CRC Press
• Year: 2018
• ISBN:
  9781351425322
• Edition: 1
• Topic: Naturwissenschaften
• Subtopic: Chemie

Pesticide Formulation and Adjuvant Technology brings together experts from industry, academia, regulatory offices, and the legal profession to provide a complete and international reference on agrichemical formulations and modern adjuvant technology.
Global specialists discuss key topics, from scientific and technical issues to regulatory and legal aspects, including:

Chapter 1

The Regulation of Inert Ingredients in the United States

Tina E. Levine

CONTENTS

I.	Background
II.	The Inert Strategy
III.	New Inert Ingredients
IV.	Trends and Issues in the Next Decade
References

I. BACKGROUND

The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)^6,7,8,9 requires that all pesticide products sold or distributed in commerce be registered by the Environmental Protection Agency (EPA). Prior to the establishment of the EPA, the Department of Agriculture (USDA) registered pesticides under FIFRA. Although the EPA registers pesticide products, most of the data requirements and regulatory activities under FIFRA have traditionally focused on the active ingredient.

In addition to its mandate under FIFRA, EPA has authority to regulate pesticide products under the Federal Food, Drug, and Cosmetic Act (FFDCA).^8,9 Section 408 of FFDCA authorizes the EPA to establish tolerances or safe levels of pesticide residues in raw agricultural commodities; Section 409 similarly authorizes EPA to promulgate food additive regulations for pesticide residues in processed foods. Prior to the establishment of the EPA, the Food and Drug Administration (FDA) had the responsibility for establishing tolerances and food additive regulations for pesticide residues.

In 1961, the FDA published a notice in the Federal Register¹ stating that USDA had determined that each component of registered pesticide products, including the inert ingredients, were pesticide chemicals and thus subject to the requirement of tolerances or exemption under FFDCA. Several years later, in 1969, the FDA established a policy regarding data requirements and review procedures for clearance of pesticide inert ingredients used on food.²

This guidance provided the basic framework for the regulation of inert ingredients in the United States until 1987.

In 1987, the EPA announced the Inert Strategy.⁴ This strategy was designed to reduce the potential of adverse effects from chemicals used as inert ingredients contained in pesticide products and to make sure all inert ingredients were supported by valid data. EPA divided the extant inert ingredients into four toxicity categories. List 1 contains “Inerts of Toxicological Concern”, chemicals that have been found to produce cancer, adverse reproductive effects, developmental toxicity, other chronic effects, ecological effects, or that have the potential for bioaccumulation (Table 1). In general, chemicals were placed on the list based upon a well-documented peer review, such as a bioassay from the National Toxicology Program or International Agency for Research on Cancer (IARC) review.

Table 1
List 1 - Inerts of Toxicological Concern

CAS No.	Chemical Name
62-53-3	Aniline
1332-21-4	Asbestos fiber
1332-21-9	1,4-Benzenediol
7440-43-9	Cadmium compounds
56-23-5	Carbon tetrachloride
67-66-3	Chloroform
106-46-7	p-Dichlorobenzene
103-23-2	Di-(2-ethylhexyl)adipate
78-87-5	1,2-Dichloropropane
117-87-8	Di-ethylhexylphthalate
66-12-2	Dimethylformamide
123-91-1	Dioxane
106-89-8	Epichlorohydrin
110-80-5	2-Ethoxyethanol
111-15-9	Ethanol ethoxyacetate
107-06-2	Ethylene dichloride
109-86-4	Ethylene glycol monomethyl ether
140-88-5	Ethyl acrylate
110-54-3	n-Hexane
302-01-2	Hydrazine
78-59-1	Isophorone
7439-92-1	Lead compounds
568-64-2	Malachite green
591-78-6	Methyl n-butyl ketone
74-87-3	Methyl chloride
75-09-2	Methylene chloride
25154-52-3	Nonylphenol
127-18-4	Perchloroethylene
108-95-2	Phenol
90-43-7	o-Phenylphenol
75-56-9	Propylene oxide
8003-34-5	Pyrethrins
81-88-9	Rhodamine B
10588-01-9	Sodium dichromate
26471-62-5	Toluene diisocyanate
79-00-5	1,1,2-Trichloroethane
56-35-9	Tributyl tin oxide
79-01-6	Trichloroethylene
1330-78-5	Tri-orthocresylphosphate (TOCP)
78-30-8	Tri-orthocresylphosphate (TOCP)

List 2 covers “Inerts With a High Priority for Testing” that are generally closely related by structure or chemical class to compounds on List 1 (Table 2). Many of the chemicals on this list had been targeted for testing under the Toxic Substances Control Act (TSCA).^7,8,9 List 3 covers “Inerts of Unknown Toxicity”. The chemicals in this group are those that do not fit into any of the other three groups. List 4 comprises the “Minimal Risk Inerts”. These chemicals are generally regarded as safe. In 1989, List 4 was subdivided into 4A and 4B.^6,7,8,9 List 4A covers those substances judged to be of minimal risk based on their inherent nature, such as food substances like corn cobs and cookie crumb...