Background
EPA and state enforcement policies present as many problems as EPA regulations for the higher education community. Current enforcement is frequently variable, capricious and poorly targeted with respect to higher education. Even while focusing on regulatory reform, it is important to remember that current enforcement problems, unless changed, will continue to plague even the best regulations.
Variable—Enforcement of RCRA rules is highly variable from EPA region to region and from state to state within each region. In some cases state-to-state variability results from differences in rules because states are allowed to adopt regulations more strict than the federal rules. Unfortunately, however, most variability appears to result from differences in interpretation of the same rules, sometimes by different inspectors within the same state.
Capricious—EPA and state inspectors are widely considered to be inconsistent in interpretation of RCRA rules. Fines appear to vary widely and without apparent pattern. A significant minority of inspectors blow up minor details of compliance into major events. EPA news releases often place paperwork errors on the same level as items that have direct potential for environmental harm.
Poorly targeted—EPA relies heavily on fines, news releases and “supplemental environmental projects” to punish noncompliance and aims these penalties directly at the central administration of the institution. Perhaps these methods are effective when applied to industry but they hit the wrong targets when applied to higher education. EPA is widely noted for complaining that higher education does not comply with its regulations and by implication—and sometimes by near-direct statement—that the higher education sector is a group of irresponsible scofflaws. This disregards the fact that higher education is highly compliant with NIH, CDC and NRC rules and guidelines, as well as with the requirements of many accreditation agencies that have no formal enforcement powers at all.
What is the difference between EPA and everyone else?
Peer review—While EPA targets the central administration with its penalties, the successful agencies and organizations use peer review supported by influence over funding decisions. For example, the NIH recombinant DNA guidelines are guidelines, not regulations. The guidelines require each campus to establish an Institutional Biosafety Committee to review all research protocols that fall under the guidelines. Most observers regard compliance with the recombinant DNA guidelines to be excellent. The Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC), a non-governmental organization, uses a similar approach with similar success. Organizations that accredit academic programs are also non-governmental and achieve similar results. In all of these examples, there is a background threat of funding suspension, but that penalty is practically never needed.
In the regulatory arena, the Nuclear Regulatory Commission (NRC) uses peer review through Radiation Safety Committees, in this case backed up with civil and criminal penalties, with high effectiveness in the higher education community.
In a final example, after a death in a gene therapy trial in 1999, research institutions responded very rapidly to NIH findings of need for change. In less than a year, the institutions strengthened the peer review Institutional Review Boards and added compliance support staff. Although there was a clear threat of funding suspension in this case, there were no fines.
The contrasts between NRC and EPA are especially informative because both agencies have complex regulations with potential civil and criminal penalties but NRC finds excellent compliance on college and university campuses. First, NRC requires a peer review process in institutions that are major users of radioactive materials. The Radiation Safety Committee oversees use of radioactive materials, reviews and approves research and other use protocols. The committee also sets related institutional policy.
Enforcement policy—The second component of compliance success is an enforcement policy with a well thought out program of incentives and penalties for self-identification, mandatory reporting and rapid correction of non-compliance. The process for determining fines is very clear, as shown in a diagram from the NRC Enforcement Manual. [1]
The third component of NRC compliance success is a strong emphasis on end results, i.e. protection of workers, the general public and the environment, with lesser emphasis on intermediate process steps. This performance orientation began in the 1990s and is clearly enunciated in a 1998 Commission document as well as in the current enforcement policy. [2], [3]
In contrast, EPA enforcement manuals focus on regulatory compliance and advise inspectors to be aware of shifting enforcement priorities. [4], [5]
The Occupational Safety and Health Administration (OSHA) shares the same inspection and enforcement model used by EPA. However, OSHA does not apply to public institutions in 29 states that have not signed enforcement agreements with the agency. In addition, OSHA usually directs enforcement at service areas that have a more centralized management structure. Therefore, OSHA problems have been fewer and less visible.
Summary
Higher education and research institutions have an excellent history of compliance with government regulations and guidance from non-governmental organizations. Most agencies and organizations promote compliance through peer review models that fit well with academic administration in universities.
Regulatory reform activities, while important and much-needed, should not obscure the fact that EPA could achieve better results with less pain by moving toward the NRC enforcement model.
