Federal Focus, Inc.

Agri-Biotech Program

Before the US Food and Drug Administration.
November 30, 1999

I. Good Government Laws

If FDA decides to revise their current policies towards agricultural biotechnology, that revision will have to appear as a proposed regulation in the Federal Register. That proposed regulation is going to be subject to a series of Good Government regulatory authorities including the Paperwork Reduction Act and Executive Order 12866. These authorities were established to ensure that federal policy be based on reason not passion and in this instance are of particular importance because private industry has invested billions of dollars in bio-engineered products.

Under the Paperwork Reduction Act, the Office of Management and Budget - not FDA - is required by law to make a series of judgements about the proposed rule.

One of the most important decisions that OMB will have to make, with FDA's advice, is whether the paperwork requirements of any proposed rule, such as a change in labeling, has practical utility. The standard set by the Act for practical utility is quite specific - and quite different from a right-to-know paradigm. The determination of practical utility must be based on a sufficient record to withstand potential judicial review. In other words, the analytical burden of proof will be on those who want to change the existing three- agency review system.

Under the Executive Order on regulatory planning and review, OMB will have to determine if the proposed regulation conforms to the Administration's regulatory principles. One of those principles is that agency decisions be based on the best reasonable obtainable scientific information. It is clear, that if the FDA is going to change current policy, they will need to compile an impressive scientific record justifying the decision.

II. The Federal Focus Symposium

To assist in the development of federal policy on bioengineered foods, Federal Focus will be holding a symposium on the regulation of agricultural biotechnology on October 24, 2000 at the Georgetown University Conference Center. Prior to the symposium, we will be drafting options papers and other analytic documents. In preparation for the symposium, we will be discussing these papers with key stakeholders, including federal agencies, while they are going through their deliberation process.

The symposium will focus on whether there should be any changes to the current three-agency regulatory regime for agricultural biotechnology. As most people here may know, FDA, USDA, and EPA all have regulatory jurisdiction over various aspects of agricultural biotechnology.

Based on our current state of knowledge, it appears that FDA as well as their colleagues in USDA and EPA are doing a good job. However, our symposium will consider a range of regulatory approaches and options.

To address consumer choice, industry marketing, and labeling for safety, we will look at:

  1. Claims-based labeling of non-GM food products;
  2. Identity preservation for GM and non-GM foodstuffs; and
  3. FDA-mandated labeling of products containing GM ingredients.

To address comprehensiveness of our regulatory system, we will look at two options:

  1. Maintaining the current regulatory regime; and
  2. A GM-specific pre-market review process.

Since any regulatory option is subject to the various Good Government laws, symposium participants will be examining the regulatory options from the paradigm created by these authorities. Use of the regulatory process paradigm will help ensure that our work has practical utility to FDA and other agencies.

We are looking for a good cross-section of stakeholders to attend and participate in this symposium. Stakeholders, public and private, who are interested in the symposium should contact us through our web site: www.fedfocus.org.

III. About Federal Focus

The reason why I started my comments by discussing regulatory requirements is that the objective analysis of regulation, and the underlying substantive record, is what Federal Focus does. Federal Focus, of which I am Chairman, is a tax-exempt 501(c)3 research and educational foundation incorporated in 1986 in the District of Columbia.

We have extensive experience in analyzing science policy issues, particularly as they relate to federal regulation. We have sponsored or co-sponsored a number of symposia, panel presentations and publications on the role of science in public policy.

Our symposia bring together leading experts from government, industry and academia to review and reach consensus, where possible, on crucial science policy issues.

Prior to Federal Focus, I spent a career in the federal government working for five Administrations. I capped my government service by serving as the career head of OMB's regulatory office, the Office of Information and Regulatory Affairs, which has the responsibility for implementing the Paperwork Reduction Act. Basically, my office was in charge of reviewing all proposed federal regulations. My comments are from the perspective of someone who has spent a long time reviewing government regulations.

Before I close, I would like to briefly comment on a front page article on agricultural biotechnology which appeared in the November 3rd New York Times. The article misleadingly implied that USDA and other agencies, including FDA, are not thorough in their regulation of agricultural biotechnology. Although there is not the time to go through every misleading statement in the article, I would like to note that everything we have seen indicates that USDA is actually quite careful about ensuring that approved bioengineered plants do not create so-called superweeds. I hope that this series of FDA meetings, the work by other agencies, and our own symposium preparation process will contribute to a more informed debate on biotechnology policy issues.

Thank you.


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