Biotechnology in the United States
Biotechnology in Environmental Law
The use of science and technology to modify species, establish them in new locations where their characteristics are advantageous to humans, and alter them genetically for specific purposes.
For thousands of years, humans have altered the genetic makeup of organisms through selective breeding. But now, newer technologies such as gene splicing, gene fusion, and DNA recombination can accelerate changes and even create entirely new genetically engineered microorganisms called designer bugs. They have many applications in agriculture, pharmaceutical and chemical manufacturing, and environmental cleanup.
Although genetic engineering is a relatively new form of biotechnology, the Environmental Protection Agency (EPA) has already taken an interest in it. It is not alone. Several other agencies have an interest in genetic engineering as well. The Food and Drug Administration, the Federal Department of Agriculture, and the National Institutes of Health cooperate to deal with this evolving science. The Office of Science and Technology Policy (OSTP), an organization that works closely with the president, has also influenced regulatory practices.
In 1986, the federal agencies concerned with biotechnology issued a cooperative statement that outlined how they interacted, where their authority originated, and what they would regulate. Guidance and policy statements, interpretations of jurisdiction, and discussions of the issues have been the basis of the early regulations. Rules for development of new microorganisms have not yet been established. Though both the Department of Agriculture and the EPA focus on these issues, the discussion here will focus on the EPA.
The EPA uses two primary laws as the basis of its regulations: the Toxic Substances Control Act (TSCA) and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). TSCA covers new chemical substances and those determined by the EPA to have a significant new use. FIFRA sets procedures for licensing of pesticides and gives the EPA authority to gather information about them. In addition, other environmental statutes could be used to address particular concerns, such as the Clean Air Act, the Clean Water Act, the Resource Conservation and Recovery Act, and the Comprehensive Environmental Response, Compensation, and Liability Act. However, these statutes have not yet been at the forefront of environmental review of this issue.
FIFRA jurisdiction is perhaps easier to see than TSCA jurisdiction. Since many of the organisms being developed function as pesticides, FIFRA applies without stretching definitions. When the EPA began using FIFRA to regulate genetically engineered microbes, it issued guidance, along with an information packet.
A person who wanted to obtain an experimental use permit would notify the EPA, supply it with the information requested and supplementary information upon demand. If the permit is granted, testing may go forward. Testing means, in most situations, that the microbial pesticide will be released into the environment to prove its worth.
The Office of Science and Technology Policy published a policy statement to establish criteria for federal agencies to follow when deciding what type of discretionary jurisdiction to exercise. Tension between the desire for scientific advance and protection of the environment is apparent in the statement. Basically, the OSTP, in conjunction with former Vice President Dan Quayle and the Council on Competitiveness, determined that a risk based analysis should be used, and the analysis must not be unreasonable. The focus is to be the product, its characteristics and risks, not the process that created it. For example, if the product is to be used as an insecticide, the proper review would be done by the EPA under the Federal Insecticide, Fungicide, and Rodenticide Act. If, on the other hand, the product is to be used as a food additive or substitute, the Food and Drug Administration would review it. Performance based standards instead of design standards are to be used in considering the permit application. The focus is whether the product achieves its purpose, and not how it was created. Regulatory review is to be minimized to the extent possible. However, public health and welfare are to be protected.
In February 1993, the EPA issued proposed rules for FIFRA that followed the policy statement. It decided, after requiring experimental use permits (EUPs) for genetically altered microbial pesticides, that many should be exempt from notification and EUP components of FIFRA. The EPA believes the history of registered microbial pesticides has demonstrated they are safe in small-scale testing projects. Therefore, the need for a permit will be determined based on risks, but will usually not be required if EPA rules are followed.
The EPA uses TSCA as a catchall for microbes that are not pesticides and do not fall under other TSCA exemptions. Although TSCA is limited to regulation of chemical substances, the EPA has seized jurisdiction of genetically engineered organisms by breaking down organic substances into their smallest component: the identifiable molecule, which is technically a chemical substance. To date, this interpretation of the EPA’s right to regulate under TSCA has not been tested.
Under TSCA, the agency gets a notice called a premanufacturing notification (PMN) before the organism or chemical is manufactured. Information must accompany the PMN if it is available. The EPA can request more data and testing; it may also want additional information about the environment into which it is to be released. The procedure gives the EPA an opportunity to prescreen the substance. See also cleanup technologies; water pollution control technology.
Based on “Environment and the Law. A Dictionary”.
Biotechnology in State Statute Topics
Introduction to Biotechnology
The purpose of Biotechnology is to provide a broad appreciation of the Biotechnology legal topic. Select from the list of U.S. legal topics for information (other than Biotechnology).
Resources
Further Reading
- Information about Biotechnology in the Gale Encyclopedia of American Law.