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Pesticide Formulation and Adjuvant Technology
Chester L. Foy, David W. Pritchard
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eBook - ePub
Pesticide Formulation and Adjuvant Technology
Chester L. Foy, David W. Pritchard
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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:
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Information
Chapter 1 | The Regulation of Inert Ingredients in the United States |
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.
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...