November 22, 2000

Hon. Carol Browner
Administrator
U. S. Environmental Protection Agency
1200 Pennsylvania Ave., NW
Washington, DC 20460

Dear Administrator Browner:

For the last two years, EPA’s Office of Pesticide Programs has been considering development of a new policy on the acceptability of human volunteer test data in connection with pesticide reviews. It is our understanding that the Agency expects to issue a proposed policy for public comment in the not-too-distant future, and that a draft of that proposed policy will undergo inter-agency review.

I am writing to point out that if EPA proceeds with proposal of a new rule on human volunteer testing, it must –

1. consult with other interested Federal agencies, including all those represented on the Human Subjects Research Subcommittee of the Committee on Science of the National Science and Technology Council to maintain consistency under the terms and principles of the Common Rule on human testing and to avoid conflicts;

2. communicate to OMB’s Office of Information and Regulatory Affairs ("OIRA") that it considers the proposed rule on human testing to be a "significant regulatory action" under E.O. 12866, and submit the proposal to OIRA for review;

3. provide OIRA with the documentation concerning authority and justification for the rule, its impacts, and assessment of feasible alternatives, in accordance with the E.O. 12866 requirements for review of significant regulatory actions; and

4. submit any final rule to Congress under the Congressional Review Act as a "major rule".

A detailed discussion of the need for these actions is provided below.

Inter-agency review of this matter is both appropriate and necessary under the unique circumstances of this "Common Rule" issue and under Executive Order 12866, as CRE as previously pointed out in October 2 letters to Acting Assistant Administrator Wayland and Dr. Greg Koski, who has been tasked with leading both the new DHHS Office of Human Research Protections and the inter-agency Human Subjects Research Subcommittee under the the Committee on Science of the National Science and Technology Council. (These letters, along with a CRE white paper on the issue, are available on the CRE website at www.thecre.com.) It is clear that any new rule which EPA might propose that would limit acceptance of human volunteer test data would likely be effectively a modification of the substance and principles embodied in the Common Rule, and therefore must be addressed in that context as an inter-agency coordination and consistency matter. As previously noted, such a rulemaking proposal would also raise novel legal issues concerning use of the best available scientific information under FIFRA, and concerning the legal authority of EPA, or any Federal agency, to interfere with informed, voluntary human activity on perceived ethical grounds.

Applicability of the "significant regulatory action" provisions of E.O. 12866

Such a rulemaking proposal would come within the terms of Executive Order 12866 ("Regulatory Planning and Review") as a "rule" subject to the regulatory principles of the Order, and as a "significant regulatory action" subject to review by the Office of Information and Regulatory Affairs of the White House Office of Management and Budget.

Under E.O. 12866 sec. 3 a proposed human volunteer testing policy would be both a "rule" and a "regulatory action" because it would prescribe policy that would have the force and effect of law on pesticide registrants. Such a regulatory action would be a "significant regulatory action" because it could –

-- "adversely affect in a material way . . . a sector of the economy [agriculture and agricultural chemicals] . . . [and] public health or safety [due to failure to utilize the best available scientific data];

-- "[c]reate a serious inconsistency or otherwise interfere with an action taken or planned by another agency" [i.e., the Common Rule and its underlying principles, adopted by 16 other Federal agencies] ; and

[r]aise novel legal or policy issues arising out of legal mandates [e.g., FIFRA and the legislation originally authorizing promulgation of the Common Rule by HHS] . . . or the principles set forth in this Executive Order [e.g., need to modify existing regulations to address an identifiable problem; use of best reasonably obtainable scientific information concerning the need for, and consequences of, a proposed regulation; and consistency among Federal agencies].

Since such a rulemaking would be a "significant regulatory action" under the Order, EPA must notify OMB’s Office of Information and Regulatory Affairs that the proposed rule should be reviewed as a "significant regulatory action".

Information that must be provided to OMB for a "significant regulatory action"

Under the Executive Order provisions concerning OIRA review of "significant regulatory actions", EPA must provide to OIRA at least the following information for use in its review:

An explanation of the problem being addressed, the need for the rule to address that problem, and how the proposed rule would fill that need;

an assessment of costs and benefits showing that the benefits justify the costs;

an explanation of how the rulemaking is consistent with a statutory mandate;

an assessment of any anticipated adverse effects on human health or safety;

an assessment of potentially effective and reasonably feasible alternatives; and

an assessment of how the rulemaking is consistent with applicable law, the principles of the Executive Order, and does not conflict with the policies or actions of other Federal agencies.

We also wish to call to the Agency’s attention not only that this rulemaking is subject to OIRA review under E.O. 12866; but also that, if and when it is to be promulgated as a final rule, it must be submitted to Congressional and GAO review under the Congressional Review Act ( "CRA", 5 U.S.C. § 801-08). Any such statement of policy would be considered a "rule" within the definition of that term in the Administrative Procedure Act (5 U.S.C. § 551) and within the definition of "rule" in the CRA (5 U.S.C. § 804). It appears that if and when such a rule is submitted under the CRA prior to promulgation, it would also be considered a "major rule", and would have to be evaluated for compliance with all applicable law and Executive Order 12866.

Conclusion

We expect that EPA and the other concerned agencies will carefully consider the need for, validity of, and ramifications of such a proposed policy, along with its legal basis. As we have previously noted in our white paper on the subject, we believe that EPA lacks legal authority to interfere in voluntary human testing except to the extent Congress has provided guidance in FIFRA, and that suppression of valid scientific data, obtained under established ethical principles, in agency regulatory proceedings, would be illegal and subject to legal remedy.

We submit that EPA must take the following actions if it is to proceed with proposing and promulgating a new policy on human volunteer testing:

1. Consult with the other Common Rule Federal agencies in order to develop a policy which is consistent with the Common Rule and avoids conflicts.

2. Notify OIRA that the policy statement is a "significant regulatory action" under E.O. 12866 and submit the proposed rule to OIRA for review.

3. Supply OIRA with the justifications and analyses required for review of significant regulatory actions under E.O. 12866.

4. Submit any proposed final rule to Congress as a "major rule" under the Congressional Review Act.

Thank you for your careful consideration of this matter.

Respectfully,

Jim J. Tozzi,
CRE Advisory Board Member