Engage In Anticipatory Regulatory Planning

Rank Risks and Engage in Anticipatory Regulatory Planning

BACKGROUND

Agency planning tends to be short-range rather than long-range. There is
almost always a new crisis demanding immediate attention. The budget
cycle is annual. Top agency policymakers often are at the agency for
only two years. All of this gives agencies incentives to develop
short-term rather than long- term plans.

Nonetheless, long-term strategic planning is needed.  Regulatory
agencies have limited resources and limited demands they can make on the
public. They share responsibility with Congress for ensuring that the
nation gets the most for the money it spends on drug safety, the
environment, and other matters. This requires agencies not only to set
strategic goals, but also to determine whether those goals are being
met.

This, in part, is the impetus behind the Government Performance and
Results Act of 1993.[Endnote 1] The Act's implementation should do much
to advance strategic, performance-based planning by the agencies. But
regulatory agencies should take additional steps to plan their future
regulatory agendas (especially those relating to regulation of
environmental, health, and safety risks). The potential targets of
regulations are so many, the implications so large, and regulatory
resources so comparatively limited, that prioritization and long-range
planning is imperative.

Regulatory agencies have begun to take some steps in this direction.
Since 1985, executive agencies have been required to submit their
planned significant regulatory actions to the Office of Management and
Budget (OMB), which has published compilations annually as the
Regulatory Program of the United States.[Endnote 2] Unfortunately,
however, this process was not used as a significant planning document
within the agencies or within the administration as a whole.[Endnote 3]
Moreover, the Program was not published in a timely fashion; for
example, the Program for 1992 was not distributed until February of
1993.[Endnote 4] The new regulatory review executive order will place
greater emphasis on planning and will make the annual regulatory
planning process more meaningful and timely.

The Environmental Protection Agency (EPA) has begun a process that,
although still in its early stages, can provide a model for the other 20
or so agencies that regulate environmental, health, or safety risks,
including the Food and Drug Administration, the Occupational Safety and
Health Administration (OSHA), the Consumer Product Safety Commission,
and the Nuclear Regulatory Commission.[Endnote 5] Its 1987 report,
Unfinished Business, was based on an effort by 75 senior career managers
to compare and rank the relative risks posed by 31 environmental
problems regulated by the agency.[Endnote 6] These rankings, while based
on professional judgments, were limited by incomplete data and the
infancy of risk comparison methodologies. But the effort was a landmark
in that it crossed programmatic lines and also explicitly pointed out
the disparity between the rankings and the resource allocation at
EPA.[Endnote 7] Interestingly, the EPA experts' rankings were almost the
reverse of prevailing public opinion about risk.[Endnote 8]

In 1990, EPA turned to its Science Advisory Board to evaluate Unfinished
Business and the agency's response to it. The Board's special 39-member
Relative Risk Reduction Strategies Committee produced a report, Reducing
Risk, that contained a series of recommendations to the administrator on
how to undertake risk prioritization so that EPA could "target its
environmental protection efforts on the basis of opportunities for the
greatest risk reduction."[Endnote 9]

The Carnegie Commission has applauded Unfinished Business and Reducing
Risk as a "groundbreaking enterprise."[Endnote 10] It has specifically
recommended that "other risk reduction agencies should attempt to
incorporate into their own decisionmaking and institutional culture the
global perspective on risk that these reports and their implementation
embody."[Endnote 11]

As a by-product of its recent focus on risk prioritization, EPA has
devoted increasing attention to the identification of future risk. In
1988, the EPA Science Advisory Board produced a report, Future Risk:
Research Strategies for the 1990s, that catalogued risk reduction
strategies for the future.[Endnote 12] Its first recommendation was that
EPA should shift its regulatory strategy "from end-of-pipe controls to
preventing the generation of pollution."[Endnote 13] Administrator Carol
Browner recently announced her intention to make "pollution prevention
the guiding principle for all our programs at the [EPA]."[Endnote 14]

EPA has also employed its Office of Policy Planning and Evaluation
(OPPE) to plan for the future. OPPE's Office of Strategic Planning and
Environmental Data has a Futures Staff for this purpose.[Endnote 15] The
Office also has recently joined with the Science Advisory Board to
sponsor a new Environmental Futures Committee at the behest of
Administrator Browner.[Endnote 16]

Another agency now engaged in risk prioritization is the Research and
Special Programs Administration in the Department of Transportation,
which regulates the safety of gas, offshore, and hazardous liquid
pipelines. About 20 to 25 pipeline-related risks will be ranked as high,
medium, or low as part of this initiative.[Endnote 17]

NEED FOR CHANGE

As the Carnegie Commission report declared, "the fundamental problem in
regulatory decision making at the agency level, as at the presidential
and interagency levels, is how to set priorities. It is a great
challenge for science-based regulatory agencies to compare and rank
individual risks and families of risks within the universe they
regulate."[Endnote 18]

The scope of agencies' regulatory mandates far exceeds their rulemaking
resources. For example, OSHA, which must issue health and safety
standards for thousands of chemicals, carcinogens, and other dangers in
most of our nation's workplaces, only has sufficient resources to pursue
15 to 20 rulemaking efforts at any given time.[Endnote 19] Hence the
dire need for prioritization. Prioritization by agencies will also help
inform Congress about agency resource needs and may help Congress
reorder its own thinking while also informing regulated parties about
the agency's likely future agenda.

Risk prioritization can help agencies distinguish between regulatory
targets that demand immediate attention and those that allow for mid- or
long-range corrections. But in this fast-changing technological world,
regulatory agencies must also begin to anticipate future problems before
it is too late or before an expensive regulatory scheme must be imposed.

For example, EPA is finding solutions now to the potential problem posed
by the lithium in batteries used to power electric motor
vehicles.[Endnote 21] OSHA, for another example, might have better
anticipated the workplace stresses and injuries caused by the
computerized office (e.g., non-ergonomic chairs, video display terminal
exposure, and carpal tunnel syndrome).

It is a truism to say that tomorrow's regulatory problems will likely
differ markedly from today's.  Changes in risk prioritizing must be
anticipated from numerous sources. New knowledge about the hazards of
existing technologies (e.g., chlorofluorocarbons or CFCs) and exposures
(e.g., radon) is always being developed. Solutions to one problem may
cause another (e.g., increased indoor pollution in offices with
improperly designed energy efficient programs).  Changes in behavior
(e.g., increased use of lawn-care pesticides), introduction of new
technologies (e.g., biotechnology), side effects of government
intervention (e.g., floodplain management), or changes in societal
concerns (e.g., greater concern about costs or fairness of solutions)
all bear on future risk regulation. These sorts of changes must be
anticipated to the greatest feasible extent.[Endnote 22]
 In short, regulatory agencies cannot simply be reactive. They must
develop ways of, and devote resources to, anticipating the need for new
research or regulatory initiatives--and possibly for new or adjusted
statutory mandates to forestall or remedy those problems.

Cross-References To Other Npr Accompanying Reports

Department of Transportation, DOT01: Measure Transportation Safety; and
DOT11: Improve Intermodal Transportation Policy Coordination and
Management.

Environmental Protection Agency, EPA03: Shift EPA's Emphasis Toward
Pollution Prevention and Away from Pollution Control; and EPA07:
Establish Measurable Goals, Performance Standards and Strategic Planning
within EPA.

Federal Emergency Management Agency, FEMA02: Develop a More Anticipatory
Customer-Driven Response to Catastrophic Disasters.

Mission-Driven, Results-Oriented Budgeting, BGT02:  Effectively
Implement the Government Performance and Results Act of 1993.

Creating Quality Leadership and Management, QUAL02:  Improve Government
Performance Through Strategic and Quality Management.

Endnotes

1. Pub. L. 103-62 (1993). The Act authorizes 10 three-year pilot
projects to test program performance measures and requires Congress to
vote in 1997 on mandatory government-wide implementation of five-year
strategic planning, annual program goal-setting, and annual program
performance reporting beginning in fiscal year 1998.

2. E.O. No. 12498, Federal Register 1036 (1985).

3. Discussions with regulatory officials from various agencies convened
at Department of Transportation, May 13, 1993, Elliott, Donald, "TQMing
OMB: Or Why Regulatory Review under Executive Order 12291 Works So
Poorly and What President Clinton Can Do About It," draft, August 17,
1993, p. 24, Law and Contemporary Problems (Durham, North Carolina:
forthcoming 1994).

4. Regulatory Program of the United States Government (April 1,
1992-March 31, 1993), officially transmitted to Congress on January 15,
1993, but not available to agencies or to the public until February.

5. Other risk regulatory agencies include the Animal and Plant Health
Inspection Service, the Food Safety and Inspection Service, and the
Forest Service (Department of Agriculture); National Oceanic and
Atmospheric Administration (Department of Commerce); Army Corps of
Engineers (Department of Defense), Office of Surface Mining, and the
Fish and Wildlife Service (Department of Interior); Mine Safety and
Health Administration (Department of Labor); and Coast Guard, the
Federal Aviation Administration, the National Highway Traffic Safety
Administration, and the Research and Special Programs Administration
(DOT).

6. Environmental Protection Agency, Unfinished Business: A Comparative
Assessment of Environmental Problems (Washington, D.C., 1987).

7. Of course, to a large extent, EPA's budgetary priorities are set by
legislation. See Environmental Protection Agency, Reducing Risks
(Appendix B.4), SAB-EC-90-021B (Washington, D.C., 1990).

8. For example, while the public ranked nuclear accident radiation and
industrial pollution of waterways as among the highest risks, EPA
experts ranked them among the lowest. Conversely, the public was not
very concerned about radon and indoor air pollution, which were ranked
as high risks by the EPA experts. See Breyer, Stephen, Breaking the
Vicious Circle: Toward Effective Risk Regulation (Harvard University
Press 1993), Chart 7, "Rating Risks --How the Public and EPA Rate Health
Risks Associated with Environmental Problems," derived from Russell,
"What, Me Worry?" American Health 47 (June 1990). This problem may be
affected by the media's perception of risk as well. See "Stories on
Cancer's Causes Are Said to Be Misfocused: Media Overplay Minor
Environmental Threats to Health, Experts Contend," Washington Post (July
27, 1993), p. A6.

9. Environmental Protection Agency, Reducing Risks:  Setting Priorities
and Strategies for Environmental Protection, SAB-EC-90-021 (Washington,
DC, 1990), p.  6.

10. Carnegie Commission on Science, Technology and Government (Carnegie
Commission), Risk and the Environment: Improving Regulatory Decision
Making (Washington, D.C., 1993), p. 81.

11. See also the favorable review "Developing a Mindset for Risk
Prioritization," American Industrial Health Council Quarterly (Fall
1990), p. 3.

12. Environmental Protection Agency, Future Risk:  Research Strategies
for the 1990s, SAB-EC-88-040 (Washington, D. C., 1988).

13. Ibid., at pp. 5, 8-9.

14. Carol M. Browner, Administrator, Environmental Protection Agency,
Memorandum to EPA employees, "Pollution Prevention Policy Statement: New
Directions for Environmental Protections," June 15, 1993, p. 1.

15. Interview with David Rejelski, Futures Staff Chief, Office of
Strategic Planning and Environmental Data, Office of Policy, Planning
and Evaluation, EPA, June 24, 1993.

16. The Charter of the new committee will be to conduct a short-term
(five-year horizon) and long- term (20-year horizon) "scan of future
developments that will affect environmental quality and the Nation's
ability to protect the environment." The final report is scheduled for
September 1994.  Interview with Donald G. Barnes, Director, Science
Advisory Board, July 7, 1993; Environmental Protection Agency, Draft
Charter, Science Advisory Board, Environmental Futures Project
(undated).

17. Telephone interview with Judith S. Kaleta, Chief Counsel, Research
and Special Programs Administration (RSPA); RSPA FY 1994 Budget
Submission, pp. 145-149 (detailing its "Risk-Based Prioritization
Plan").

18. Carnegie Commission, p. 73.

19. Shapiro, Sidney A., and Thomas McGarity, "Reorienting OSHA:
Regulatory Alternatives and Legislative Reforms," Yale Journal on
Regulation, vol. 6, no. 1 (Winter 1989), p. 14, n. 85.

20. Interview with David Rejelski.

21. Because of increasingly strict air quality rules in California,
electric vehicles are expected to become more prevalent there in the
next decade.

22. The foregoing paragraph is adapted from Andrews, Richard,
"Long-Range Planning in Environmental, Health, and Safety Regulatory
Agencies," (draft background paper for Carnegie Commission, supra note
10, prepared May 4, 1991), pp. 6-7.