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S. 981, the "Regulatory Improvement Act of 1998" and Tobacco Control

September 15, 1998

RE: S. 981, the "Regulatory Improvement Act of 1998" and Tobacco Control

Dear Senator:

Our organizations have been in the forefront of the public health community's campaign to halt the tobacco industry's calculated marketing of cigarettes to America's youth. Whether through national tobacco control legislation or a vigorous exercise of FDA's authority to regulate tobacco, it is essential that the federal government take strong measures to protect our children from the unnecessary pain, illness and death caused by smoking.

Despite the August 14 ruling by the Fourth Circuit Court concerning the jurisdiction of the FDA to regulate tobacco products, pending appeal, this agency continues to exercise its authority. We believe that it will continue to do so after the appeals process is complete.

But a new threat to ensuring strong public health protections against tobacco is now before Congress: S. 981, the attractively - but misleadingly - named "Regulatory Improvement Act of 1998." If this bill becomes law it would give Big Tobacco new ways to delay, weaken, or obstruct federal safeguards to protect our children.

When implementing laws or when issuing regulations pursuant to its charge to protect public health, FDA would be required to complete S. 981's extensive, burdensome "one size fits all" regulatory analyses before even making a proposed rule public. Here's how it would work:

1. Risk assessment. The bill would require FDA to conduct an elaborate risk assessment prior to publication of a proposed rule. Completing these risk assessment studies according to S. 981's prescriptive methodology would be a resource-intensive, slow process resulting in months, even years of delay.

2. Net cost-benefit analyses and determination. S. 981 would prevent FDA from expeditiously issuing a regulation that the agency determined would best protect the health of our children. Before even proposing such a rule, it would have to evaluate the costs and benefits of a range of regulatory options, including voluntary options involving no government regulation, and determine which approach was the "most cost-effective" and offered the "greatest net benefits." FDA would have the burden of proof to justify why it selected anything other than this lowest cost option - making a record that could be used (by Big Tobacco) to challenge its decision in court or the political process.

3. "Conflict of interest" review panels. The bill would also mandate the FDA to establish "peer review" panels, which would be convened before the proposed rule saw the light of day to critique the agency's risk assessments and cost-benefit analyses. They could meet behind closed doors, without keeping written minutes of their proceedings. [The bill specifically exempts these panels from the Federal Advisory Committee Act (FACA), with its sunshine in government and balanced membership requirements. The statute permits even those with a direct financial interest in the outcome to participate, since it does not prohibit conflicts of interest.]

S. 981 does not just cover tobacco regulations - its "one size fits all" bureaucratic requirements would be imposed on all health, safety, environmental protection, and civil rights safeguards. But its provisions seem tailor-made for the armies of scientists and other paid experts - some masquerading as "independent" - that have been so skillfully employed by the tobacco industry in the past to blunt or block public health initiatives. Instead of being able to take prompt action to protect our children from a known, serious health hazard, FDA would be bogged down for months or even years in conducting - and then justifying to industry and perhaps reconducting - risk assessments and cost-benefit analyses.

If the agency nonetheless managed to issue a rule that was too strong for the tobacco industry, S. 981 would give them numerous new grounds to challenge the regulation in court. Years of legal uncertainty would then be added to months or years of bureaucratic delay - and if a judge sided with industry, FDA could be forced to go back to the drawing board and begin the rulemaking process from scratch.

What public purpose would be served by requiring FDA regulations to prevent the marketing of tobacco to children to go through these steps? To our knowledge, no case has even been made for subjecting strapped public health agencies like FDA to the new costs, delays and legal uncertainties S. 981 would cause. We hope you will join with us in opposing this unnecessary, damaging legislation.

Sincerely,

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