The Toxics Substances Control Act (TSCA) (15 U.S.C. ยงยง2601 et seq. [2000]) is the only federal law that impacts bioremediation activities independently from the proposed use of the bioremediation activity. TSCA was enacted by Congress in 1976 in order to create a system to track industrial chemicals used in or imported into the United States. Chemicals that potentially pose an unreasonable environmental or human health risk may be banned from manufacturing or importation. Once-common chemicals that are currendy banned under TSCA include asbestos compounds and poly-chlorinated biphenyl oils.

In 1984, the U.S. EPA issued a proposed policy statement that defined "new chemical substances" under TSCA to include living organisms and microorganisms (9b). This policy statement was officially adopted in 1986. Over the next 11 years, the EPA went through a rulemaking process to formally implement the policies and issued the final rule regarding approval of microorganisms in 1997 (9c). Under the Microbial Products of Biotechnology Rule, the EPA has set up a screening program for "new" microorganisms used commercially for such purposes as production of industrial enzymes and other specialty chemicals, agricultural practices (e.g., biofertilizers), and breakdown of chemical pollutants in the environment. New microorganisms are those microorganisms formed by combining genetic material from organisms in different genera (intergeneric). Microorganisms that are not intergeneric would not be considered new and would not be subj ect to TSA requirements.

Persons intending to use intergeneric microorganisms for commercial purposes in the United States must submit a Microbial Commercial Activity Notice (MCAN) to the EPA at least 90 days before such use. Within that 90-day period, the EPA is to review the submission in order to determine whether the microorganism presents an unreasonable risk to human health or the environment. Upon approval, or upon expiration of the MCAN review period, the submitter may begin manufacture or import of the microorganism. Expiration of the review period without ap proval does not constitute approval or certification of the new microorganism and does not mean that the EPA may not take regulatory action against the microorganism in the future.

The rule also addresses intergeneric microorganisms used in research and development for commercial purposes. It creates a mechanism for reporting on testing of new microorganisms in the environment called a TSCA Experimental Release Application (TERA). A TERA would be submitted to the EPA at least 60 days prior to initiation of such field trials.

The rule contains certain exemptions, including those for research and development activities and test marketing and general exemptions for certain specific microorganisms.

State Regulations

It is not possible to identify all the state regulations that could potentially impact a bioremediation project. The fact that a federal environmental program is in place does not limit the ability of a state to impose additional and more restrictive requirements. As an example, under the CWA, it is specifically stated that "Except as expressly provided in this chapter, nothing in this chapter shall (1) preclude or deny the right of any State or political subdivision thereof or interstate agency to adopt or enforce (A) any standard or limitation respecting discharges of pollutants, or (B) any requirement respecting control or abatement of pollution ..." (33 U.S.C. 1370 [2000]). The only limitation is that the state requirements can be no less stringent that those enacted in the CWA.

In addition to retaining the right to impose additional or more stringent regulations in those areas where the federal government has enacted legislation, the states are free to impose regulation in other environmental areas. Most states have a variety of environmental regulations that either predate the federal regulation in that area or were enacted in order to address a problem or concern unique to the citizens of that state. These regulations may or may not impact a proposed bioremediation activity, but each project must be evaluated to ensure that it complies with all state regulations, in addition to the federal regulations.

Regulatory and Liability Concerns Associated with Bioremediation Activities

The use of bioremediation treatment technologies in place of more conventional physical or chemical treatment technologies raises significant regulatory and compliance issues, depending upon the application selected. There are also significant risk and liability issues associated with use of this technology that might not be present with the use of more conventional technologies. It is important to be aware of this during the evaluation phase of any project.

Most environmental regulations have compliance standards. For example, discharges to the waters of the United States are required to comply with effluent limitations based upon either water quality or technology-based standards. Remediation activities under CERCLA will be based upon either compliance with standards, such as the maximum contaminant levels, or compliance with some risk standard based upon harm. If the project or system is not able to meet the limitation or standard, the facility will either be in violation or, in the case of a remediation, will not be approved as a remediation mechanism.

Because of the compliance requirements, a treatment is typically chosen to ensure, with a high degree of confidence, that the technology will meet the necessary limit or standard. Selection of a process that cannot provide that degree of confidence may increase the costs and liability to the company. That is why many companies typically select the option that provides the highest degree of certainty and the lowest degree of future risk, even if the initial costs may be higher.

As an example, suppose a facility has an area of contaminated soil. The company could choose to excavate the soil and send it to an approved landfill. As an alternative, the company could attempt an in situ remediation. Excava tion and disposal would remove all material from the site and essentially guarantee no future liability issues. The results from a bioremediation project are not as clear-cut. There are a variety of potential outcomes. The treatment may not work, and the material would still be on-site. The treatment might work but might not reduce pollutant levels enough to end liability, or the biological degradation products might create a secondary source of liability. If the main goal of the project is to ensure an end to all future liability for that contamination, a company might select excavation and disposal even if the up-front costs are significantly less for bioremediation.

In many cases, the decision to implement a bioremediation project will be more of a corporate decision than a technical or legal decision. The affected party will have to make a determination among its possible options, based upon the best available information regarding expected effectiveness, cost and benefits, regulatory framework, and politics and public opinion, whether to implement a conventional treatment-remediation technology or a more innovative technology, such as bioremediation.

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