Protecting Health at a Snail's Pace

David Vladeck is director of the Public Citizen Litigation Group, a Washington-based public interest law firm specializing in consumer, public health and constitutional issues

Every day a million American workers are exposed to a metallic substance called hexavalent chromium, which is widely used in industry and known to cause lung cancer. But even though the Occupational Safety and Health Administration acknowledges that its current exposure standard is too weak to protect workers, the agency does not plan to issue new rules until sometime after the turn of the century.

This delay is just one example of a federal rule-making process so encrusted with procedures that health and safety agencies can no longer respond swiftly to serious public health threats.

In 1974, when OSHA issued its first standard covering 14 carcinogenic substances, the rule-making process took nine months. OSHA now takes an average of eight years to issue health standards. Similarly, the Department of Agriculture took four years after the Jack-in-the-Box tragedy in 1993, when four children died from meat tainted by E. coli bacteria, to change its 19th century "poke and sniff" regulatory regime into a modern system for keeping dangerous bacteria out of meat. Meanwhile, environmental rules designed to clean our air and drinking water are hopelessly bogged down in red tape.

Even noncontroversial rules take years. Today's challenge is to unburden the regulatory process so that health and safety agencies--our first and only line of defense against hazards imposed on the public--can do their jobs. Unfortunately, a bill introduced in the Senate by Fred Thompson (R-Tenn.) and Carl Levin (D-Mich.) threatens to further ensnare our health and safety agencies in red tape. It would require time-consuming and expensive peer review panels to oversee the work of federal agencies; subject these agencies to intrusive review by the courts; and, most insidiously, refocus agency inquiries from protecting public health toward saving money for industry.

Each of these proposals is a giant step backward. All create delay. No one defends the glacial pace of rule-making. But the Thompson-Levin bill would add to that delay in several ways. For one thing, existing law requires that agencies notify the public of proposed rules, so that individuals or groups can provide feedback. The bill requires a separate, initial round of public notice on the agency's risk evaluation before the agency can even publish its proposal. This will needlessly prolong the process by as much as a year or more.

Making matters worse, the bill directs agencies to create "peer review" panels to evaluate cost-benefit analyses and risk assessments. Nothing in the bill prevents these panels from being dominated by business representatives, and the bill actually permits these panels to conduct their business in secret by exempting them from the Federal Advisory Committee Act. Even putting aside the conflicts of interest, requiring agencies to submit their analytic work to the merry-go-round of peer review is ill-advised, and it too will cause additional delays.

These delays will cost lives.

We know, for example, that in the absence of regulation, 100,000 children per year were poisoned by iron supplement pills. When the Food and Drug Administration tried to require child-proof containers and warnings, the rule-making took six years. The delay was caused by a regulatory system that deliberately places obstacle after obstacle in the agency's path.

We also know that until warnings were required on products containing aspirin, about 3,500 children per year came down with Reye's syndrome--an often fatal disease linked to giving children aspirin when they have the flu or chicken pox. Reye's syndrome is virtually unheard of today.

Compounding the problem even further is the greatly expanded judicial review mandated by the Senate bill. Until now, agency cost-benefit analyses were not part of the record for judicial review. Not only does the bill change that, it also mandates that the agency's exchanges with the peer review panels be submitted to the court during a rule challenge, heightening the power of the peer reviewers. Allowing industry to base judicial review challenges on an agency's cost-benefit analysis is a troubling development.

Perhaps the worst flaw of the bill is that its emphasis on saving industry money will require agencies to ask the wrong question. When agencies today try to address public health problems, they ask, "How can we best safeguard the public?" Under the Thompson-Levin bill, the question becomes, "How can we safeguard the public health, but at the same time save every compliance dollar we can?" Obviously, the answers to these questions are quite different, and if the bill is enacted into law, the result will be significantly weaker public health protections.

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