Back to main page of the Summary of Environmental Law in North America database
chapter: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
No federal environmental statute specifically regulates biotechnology or, more specifically, the release of biogenetically engineered organisms. Several agencies, including the Environmental Protection Agency (EPA), Food and Drug Administration (FDA), and U.S. Department of Agriculture (USDA), could have jurisdiction over different aspects of biotechnology under more generally applicable laws.
U.S. Environmental Protection Agency
In a 1986 policy statement, EPA determined that biogenetically engineered products were included among the regulated substances under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), 7 U.S.C. secs. 136-136y; and for data-gathering purposes under the Toxic Substances Control Act (TSCA), 15 U.S.C. secs. 2601-2629. EPA also announced the creation of a science advisory committee to "provide peer review of specific product submissions under TSCA, FIFRA and other EPA statutes and scientific oversight of the Agency's biotechnology programs." Statement of Policy: Microbial Products Subject to the Federal Insecticide, Fungicide and Rodenticide Act and the Toxic Substances Control Act, 51 Fed. Reg. 23,313 (1986); Subcommittee on Investigations and Oversight, House Committee on Science and Technology, Report on Issues in the Federal Regulation of Biotechnology: from Research to Release, 99th Cong., 2nd Sess. (1986). See also Section 11: Chemical Substances and Products. In addition, under certain circumstances, bioengineered organisms might meet general standards under the Clean Air Act, the Clean Water Act, the Resources Conservation and Recovery Act, or the National Environmental Policy Act (NEPA). See Foundation on Economic Trends v. Heckler, 756 F.2d 143 (DC Cir. 1985) (applying NEPA to biogenetically engineered organisms).
Food and Drug Administration
The Federal Food, Drug, and Cosmetic Act (FFDCA) may require some biogenetically engineered products to be labeled if they contain an allergen or change the nutritional content of the food. The FDA might also require a premarket review of any product that contains substances not naturally found in the food. Regulation of biotechnology by the FDA will be limited, however, because the FDA is not interested in the process by which a food is developed. Moreover, biogenetic engineering does not typically change the chemical structure of the food, so it has not been regulated as a food additive under the FFDCA. See 21 U.S.C. sec. 348.
U.S. Department of Agriculture
The USDA administers several programs aimed at fighting exotic or foreign species of plants, bacteria, and other pests that could harm domestic agriculture. These provisions can generally be applied to the introduction of biogenetically engineered organisms. See Plant Quarantine Act, 7 U.S.C. secs. 151-164, 166, 167; Federal Plant Pest Act, 7 U.S.C. secs. 150aa-150jj; Virus-Serum Toxin Act, 7 U.S.C., 21 U.S.C. secs. 151-159; and, Federal Noxious Weed Act, 7 U.S.C. secs. 2801-2813. Under the Plant Pest Act, USDA requires notification at least 30 days in advance of any release of a biogenetically altered organism that could harm domestic agriculture. All releases are allowed unless USDA determines that a release is potentially dangerous to domestic agriculture, in which case a permit might be required. The permitting process includes a 60-day notice and comment period for the public. 7 C.F.R. pt. 340.
Stem Cell Research
On August 9, 2001, the President announced for the first time that funds would be used for human embryonic stem cell research. See Stem Cell Research Report for Congress.
Although there are many critics of biotechnology food products, there is very little regulation of food biotechnology that differs from the regulation of conventional food products. See CRS Report: Food Biotechnology in the United States.
The Clean Air Act established an Office of Noise Abatement and Control within the EPA; its primary authority is to evaluate the effects of noise on human health and the environment. 42 U.S.C. sec. 7641.
The primary federal statute for controlling noise pollution is the Noise Control Act of 1972(NCA). 42 U.S.C. secs. 4901-4918. Under the NCA, EPA was authorized to set noise emission performance standards for: construction, transportation, electric, or electronic equipment; any motor or engine; railroad carriers, 42 U.S.C. sec. 4916; 40 C.F.R. sec. 201.1; 49 C.F.R. pt. 210; and, motor vehicle carriers, 42 U.S.C. sec. 4917; 40 C.F.R. sec. 202.10; 49 C.F.R. sec. 325.1. The standards must protect public health and welfare, taking into account the magnitude and conditions of use of such product, the best available technology, and the cost of compliance. 42 U.S.C. sec. 4905; 40 C.F.R. pts. 204, 205. EPA can also require labeling of any product that could emit dangerous levels of noise, 42 U.S.C. sec. 4907; 40 C.F.R. pt. 211, and certify as "low noise-emission" any product that emits substantially less noise than the standard, 42 U.S.C. sec. 4914. These standards also apply to imports. 42 U.S.C. sec. 4908. The NCA has its own provisions for: enforcement, 42 U.S.C. sec. 4910; judicial review, 42 U.S.C. sec. 4915; and, citizen suits, 42 U.S.C. sec. 4911. The Transportation Department enforces the noise standards set for railroads and motor vehicles. States can regulate the use, operation, or movement of any product, but they can only issue noise-emission standards that are identical to the federal standards.
Congress has passed several amendments to TSCA that govern certain specific indoor air pollutants, notably asbestos, radon, and lead. TSCA requires the inspection, containment, and removal of asbestos from schools. 15 U.S.C. sec. 2643. TSCA expresses the long-term goal that indoor concentrations of radon equal ambient concentrations and attempts to achieve this goal through a series of educational and training efforts, development of model construction guidelines, and technical assistance and grant programs. 15 U.S.C. secs. 2661-2671. State legislation is becoming increasingly common; such legislation typically requires investigating whether radon is present and warning potential buyers of the property. The federal regulations take a similar approach to reducing hazards posed by lead-based paint and lead-contaminated soil. The federal program includes training and education, certifications for persons involved in removing lead-based paints, and a program to identify lead hazards. 15 U.S.C. secs. 2681-2692.
The Federal Occupational Safety and Health Act (OSH Act) requires employees to maintain a safe and healthy workplace free of recognized hazards likely to cause death or serious injury. 29 U.S.C. secs. 651-678; 29 C.F.R. pts. 1900 to 1990. The OSH Act created the Occupational Safety and Health Administration (OSHA) within the Department of Labor, and charged it with primary responsibility for safeguarding workplace health and safety. OSHA is responsible for setting health and safety standards and for implementing the Hazard Communication Standard discussed below. In addition, the OSH Act and its implementing regulations provide for a comprehensive set of record keeping and reporting requirements, as well as specific provisions authorizing inspections and enforcement actions.
Occupational Safety and Health Standards
Each employer has a general obligation to provide "employment and a place of employment which are free from recognized hazards that are causing or are likely to cause death or serious physical harm." 29 U.S.C. sec. 654(a)(1). This general clause provides a minimum standard where no specific standard has been enacted. OSHA is authorized to issue specific workplace standards for toxic materials or harmful physical agents if exposure poses a significant health risk. The standards must be based on the best scientific evidence and must be economically feasible. 29 U.S.C. sec. 655(b)(5). Pursuant to this authority, OSHA has established permissible exposure limits (PEL's) for hundreds of chemicals. Each PEL is an eight-hour, time-weighted average exposure limit. See 29 C.F.R. sec. 1910.1000, Z Tables. OSHA has established additional requirements for: asbestos, 29 C.F.R. sec. 1910.1001; benzene; cotton dust; formaldehyde, 29 C.F.R. sec. 1910.1048; lead, 29 C.F.R. sec. 1910.1025; and, vinyl chloride, 29 C.F.R. sec. 1910.1017.
The OSHA Hazard Communication Standard
OSHA's Hazard Communication Standard (HCS) ensures that employees receive usable and readily accessible information concerning workplace hazards. Initial responsibility lies on chemical manufacturers, importers, or distributors to determine the hazards presented by their products, and to provide appropriate container labels and material safety data sheets (MSDSs) along with their shipments. The HCS requires employers to label containers of hazardous chemicals in the workplace, to provide MSDSs for each hazardous chemical to which an employee might be exposed, and to offer employee information and training programs. The HCS applies to over 50,000 chemicals that are flammable, explosive, toxic, or carcinogenic. There is no comprehensive list of OSHA hazardous chemicals. 29 C.F.R. sec. 1910.1200.
Hazardous Waste Operations and Emergency Response Rules
These regulations apply to certain cleanup operations of RCRA hazardous wastes and all industrial workplaces where there is a potential need for an emergency response. An emergency response is defined as a response, involving employees outside of the immediate release area, or non-employees, to an occurrence which is likely to result in an uncontrolled release of a hazardous substance. Each facility must train at least one employee to recognize whether a hazardous substance release creates a safety or health hazard. Employers must certify that their employees are adequately trained and that the specific training requirements are met. 29 C.F.R. sec. 1910.120.
Other Federal Statutes
TSCA, FIFRA, and the Clean Air Act (CAA), also provide specific protection for employees. Under TSCA section 8(c), any manufacturer or processor of a chemical substance must retain records of any significant adverse reaction to health or the environment alleged to have been caused by the chemical substance or mixture. Records relating to adverse effects on the health of employees must be retained for 30 years, while records of all other adverse effects must be retained for 5 years. 15 U.S.C. sec. 2607; 40 C.F.R. pt. 717. Chemical manufacturers must also develop a hazard communication program for certain significant new uses of chemicals. 40 C.F.R. sec. 721.72. Under FIFRA, EPA has established minimum worker protection standards for agricultural workers in fields treated with pesticides. 40 C.F.R. pt. 170. Under the 1990 CAA Amendments, the Secretary of Labor promulgated a chemical process safety standard designed to protect employees from accidental releases of "highly hazardous chemicals." The regulations cover hazard assessment, safety procedures and information, training, and investigative procedures for accidents.
Several states also have statutes and regulations aimed at protecting the occupational health and safety of their workers.
The federal government uses a broad range of economic instruments to protect the environment, including fees, taxes, and tax deductions.
User and Permit Fees
There are a wide range of federal fees designed to recover the reasonable agency costs associated with a specific activity. For example, the CAA authorizes fees for certifying, monitoring, and testing motor vehicle compliance, 42 U.S.C. sec. 7552.
The federal government has imposed several taxes designed to discourage environmentally damaging activities, including: a petroleum tax; a tax on certain chemicals manufactured or sold, and certain imported substances; a tax on any ozone depleting chemicals sold, used, or imported in the United States, 26 U.S.C. secs. 4681-4682; an excise tax on inefficient automobiles; and, a coal excavation tax.
Tax on Petroleum
The federal government imposes a tax on all crude oil received at a U.S. refinery, any domestic crude oil used or exported from the United States, and any petroleum products entering the United States for consumption, use, or warehousing. 26 U.S.C. secs. 4611-4612.
Tax on Certain Chemicals and Imported Substances
The federal government imposes a per ton tax on certain listed chemicals. 26 U.S.C. secs. 4661-4662. A similar tax is imposed on certain listed substances sold or used by an importer. 26 U.S.C. secs. 4671-4672. Revenue goes to the Hazardous Substance Superfund, described in Section 13.
Ozone Depleting Chemicals Tax
The Ozone Depleting Chemicals (ODC) tax, 26 U.S.C. secs. 4681-4682, is levied on any listed ODC used or sold in the United States by the manufacturer, producer, or importer. The tax is levied in proportion to the chemical's impact on ozone depletion.
Excise Tax on Inefficient Vehicles
The Energy Tax Act of 1978, 26 U.S.C. secs. 4064, imposed an excise tax on automobiles that get less than 22.5 miles per gallon. The tax is based on the calculated fuel economy of the model type. A General Agreement on Tariffs and Trade (GATT) panel found that applying such a measure to imported cars does violate trade rules. See Section 22: Transportation.
Reclamation Fees and Fund
Under the Surface Mining Control and Reclamation Act of 1977 (SMCRA), Pub. L. No. 95-87, 91 Stat. 445 (codified as amended in scattered sections of 30 U.S.C.), all coal mine operators must pay a reclamation fee. 30 U.S.C. sec. 1232(a). Proceeds may be used for reclamation and restoration of land and water resources adversely affected by past coal mining, among other things. 30 U.S.C. sec. 1231.
The federal tax system allows deductions that provide both positive and negative environmental incentives.
Under the Internal Revenue Code (IRC), a taxpayer may deduct the value of qualified charitable contributions from taxable income. 26 U.S.C. sec. 170. Partly because of this tax break, individual donations are a major source of revenues for many nonprofit, nongovernmental organizations, including environmental organizations.
The charitable contribution provisions of the IRC include a deduction for the contribution of land to a conservation organization. This provision encourages the donation of conservation easements to land trusts and other public interest organizations. 26 U.S.C. sec. 170(h). An easement is a legal right to control certain uses of a piece of land; a conservation easement gives the holder of the easement the right to restrict or forbid future development on a parcel of land, even though the original owner may continue to make some use of the property. The land trusts can either transfer the land to a government agency or manage the land in accordance with the purpose of the charitable donation. In some states, particularly Oregon, similar concepts are being extended from land to water rights.
The federal government's procurement policies are mostly determined by the separate agencies, but a few executive orders and statutory provisions have placed specific, environmentally related restrictions. Most notably, the Solid Waste Disposal Act requires the federal government to issue procurement guidelines that would require the federal government to purchase those items composed of the highest percentage of recovered materials, unless such materials are not readily available, are available only at unreasonably high prices, or fail to meet the necessary performance standards. 42 U.S.C. sec. 6962(c). The government is also required to issue an affirmative procurement program aimed at assuring that items composed of recovered materials will be purchased to the maximum extent practicable. 42 U.S.C. sec. 6962(i). See Federal Acquisition, Recycling, and Waste Prevention, Exec.Order 12,873, 29 Wkly. Comp. Pres. Doc. 2115 (Oct. 20, 1993).
Several other environmental statutes also restrict federal government procurement contracts. For example, all government agencies are generally supposed to promote the purposes and policies of the Clean Air Act through purchasing decisions. All federal agencies are also prohibited from entering into any procurement contract with any person convicted of a criminal violation of the CAA if the contract would be performed at the facility that gave rise to the violation and the condition giving rise to the conviction has not been corrected. 42 U.S.C.sec. 7606. The federal government is supposed to give preference to certified low-noise emission products, 42 U.S.C. sec. 4914(e). For example, the Clean Water Act, 33 U.S.C. sec. 1368, prohibits any federal agency from contracting with any person convicted of a crime under the CWA until such time as the situation giving rise to the crime has been fixed.
The Resource Conservation and Recovery Act (RCRA), 42 U.S.C. secs. 6901-6992k, regulates underground storage tanks (UST's) containing petroleum or CERCLA hazardous substances. 42 U.S.C. secs. 6991-6991i. The UST program applies to all tanks that are at least ten percent underground and have a capacity of greater than 110 gallons. Each owner of a regulated UST in operation at sometime after January 1, 1974, must register the tank with the appropriate state or local authority. The registration includes information regarding the age, size, type, location, and use of the tanks. New UST's must meet certain new design and performance standards, and existing UST's must be upgraded to meet the same standards by 1998. 40 C.F.R. secs.280.20-280.21. Additional regulations cover release detection and reporting, spill and overfill procedures, testing, record keeping, corrective action, closure, and financial assurance. EPA may issue an administrative order to compel owners or operators of UST's containing petroleum to carry out corrective action, or, in certain circumstances, may take corrective action first and seek recovery of response costs.