Dr. Emily Monosson is a toxicologist with a B.S. from Union College, and an M.S. and Ph.D. from Cornell University. She works part-time as a consultant, writer, teacher and researcher while navigating the ups and downs of balancing a career in science and caring for her two children.
- Federal Food, Drug and Cosmetic Act
- Food quality protection act
- Arsenic in Drinking water
- The Water Quality-Based Approach To Pollution Control
- WHole effluent toxicity
- Chemical Regulation: Options for Enhancing the Effectiveness of the Toxic Substances Control Act
- Science and the politics of toxic chemical regulations: US and European contrasts
Introduction
The need for government attention to and regulation of chemicals increased as the chemical and Industrial Revolution progressed, and as the human-chemical relationship intensified. As will become clear in this article, the great majority of chemical control laws, from limits on pesticide residues (up until very recently) to ‘allowable’ concentrations of chemicals in surface or drinking waters, have focused on control of individual chemicals. Several of the chemical control laws are reviewed below (Figure 1).
Federal Food Drug and Cosmetic Act
Prior to the late 19th-early 20th centuries in the United States, there were virtually no controls on food additives, drug efficacy, or the safety of either. One of the earliest laws concerning chemical or drug use and development was the Drug Importation Act of 1848. Apparently short-lived, this early law was enacted to protect the public from impure, degraded, or ineffective drugs that were produced elsewhere in the world and exported to the U.S. (Figure 1). With the development and sale of unregulated ‘remedies’ and all sorts of food preservation schemes (refrigerators as we know them were not developed until the last quarter of the 19th century), it soon became clear that some kind of regulation was necessary for consistent consumer protection. Concerns about adulteration, including use of preservatives in foods, spurred some of the early human studies on the health effects of adulterants. Under the direction of Dr. Harvey Wiley, the second chief chemist of the U.S. Department of Agriculture (USDA) Division of Chemistry, preservatives were tested by his now infamous “poison squad,” a group of USDA employees who apparently volunteered to ingest to test the toxicity of several commonly used food preservatives of the day (formaldehyde and sulphites, for example, were amongst the first to be explored). These studies resulted in the creation of such early food and drug control laws as the Food and Drug Act of 1906. Our current Federal Food Drug and Cosmetic Act (FFDCA) authorizes assessments of the safety of new drugs, food additives, and colors; and it specifies tolerance levels for pesticides and other chemicals that may occur in foods.
Not surprisingly, from the earliest tests conducted by Wiley to many current toxicity tests required of new food additives, chemicals are tested and regulated on a single-chemical basis. Pesticide tolerances for a particular fruit or vegetable, for example, include consideration of the reference dose (RfD) for the pesticide (as an individual chemical), and consumption rates, maximum pesticide residues found during experimental exposures, and other uses and residue levels on other crops. Concern for multiple or mixed, pesticide residues in foods, however, has prompted the FFDCA recently to act in concert with the U.S. Environmental Protection Agency (EPA) to address the issue of chemical mixture exposure in foods.
Federal Insecticide, Fungicide and Rodenticide Act
Prior to the 1970’s the early Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) under the U.S. Department of Agriculture (USDA) was geared essentially towards protecting consumers from ineffective products. It really was not until amendments to the law in the 1970s that FIFRA was re-directed to consider the environmental fate and toxic effects of these chemicals and to protecting consumers and the environment from these products. The changes in FIFRA gave a boost to the newly emerging field of environmental toxicology. Nonetheless, fulfilling the regulatory requirements to evaluate adverse environmental effects of individual pesticides, and building upon the existing body of toxicology, environmental toxicologists focused, once again, on the evaluation of single chemicals.
Recent amendments made to both FIFRA and the FFDCA by the way of the Food Quality Protection Act (FQPA), have been hailed as groundbreaking approaches to pesticide regulation, for their departure from regulation based upon single chemicals. The FQPA is changing the way pesticide residues are regulated by setting ‘health-based’ standards for ALL pesticides in foods. ‘All’ in this case means combined residues from several different pesticides, or, chemical mixtures. The importance of this amendment, with respect to chemical mixtures should not be underestimated. This is one of the first attempts to regulate the permitting of individual chemicals based on their potential for combined toxicity. It will require development of innovative and reliable techniques to address combined toxicity. Although we will discuss the methodology used to determine new pesticide limits later, we should point out that this combined approach for now is limited to similarly acting pesticides. Currently, the FQPA does not address pesticide mixtures that act through different mechanisms. For example, several different organophosphate pesticides may occur in combination along with arsenic. The mixtures assessment will consider the combination of organophosphates, but nonetheless will assess arsenic separately. The rational for only extending combined toxicity to similarly acting pesticides should become clear as we discuss the toxicological tools available for such work.