COMMENT BY: Chemical Manufacturers Association (CMA)
SUBJECT: In favor of proposed revision to OMB Circular A-110
DATE: April 5, 1999

Dear Mr. Charney:

The Chemical Manufacturers Association is pleased to provide these comments on OMB's proposed revisions to OMB Circular A-11O. CMA has a strong interest in the subject of these revisions, for several reasons. First, CMA represents over 90 percent of the domestic productive capacity for basic industrial chemicals. Its members are heavily regulated by the federal government, and many of those regulations are based at least in part on scientific data that are generated by federally-funded research. Equally important, CMA and its members conduct or fund a great deal of research which they have committed, or are already required, to disclose. Earlier this year, CMA announced a three-year, $67 million research Initiative on health and environmental effects of chemicals. CMA will publish the results of this research regardless of its outcome. CMA members also routinely disclose research data under laws like Section 8(e) of the Toxic Substances Control Act. CMA believes that federally funded research should be conducted in a similarly transparent form.

CMA supports the intent of the proposed revisions, although not necessarily their proposed wording. We also recognize that the revisions implicate policy issues of great importance to the scientific community, although these issues are not insurmountable in our view. Thus, while we urge OMB to finalize the revisions, we also urge it to proceed thoughtfully and carefully, taking into account the concerns raised by the scientific community.

Finally, we also call on OMB to implement Congress's instructions, also arising from the FY99 Omnibus Appropriations Act, that OMB issue guidelines on the reliability and dissemination of information.

Publicly-Funded Data That Supports Regulatory Action Should Be Made Public

The proposed revisions, and the legislation that required them, are based on the fundamental premise that government should make available to the public the basis for its regulatory and policy decisions. This principle is at the heart of the Administrative Procedure Act (APA) and related statutes, and is the reason why federal agencies must construct a public docket for every rulemaking. Indeed, the proposed revisions are a logical and appropriate extension of this requirement, since they ensure that data underlying a research report, and not just the report, are available to the public. It Is simply Inconsistent with traditional American principles of democracy, fairness and openness for an agency to base a regulatory or policy decision on research findings when the data underlying that research arc unavailable for public scrutiny.. This is particularly true when the federal government paid for the research in the first place. Looked at another way, the legislation and the proposed revisions address a loophole in the Freedom of Information Act that currently allows the federal government to pay for research and to use its results for policy purposes, but to "park" the data outside of its possession. CMA notes that the proposed revisions effectuate not just administrative law principles, but also basic principles of good science. For example, the National Academy of Sciences states: After publication, scientists expect that data and other research materials will be shared with qualified colleagues upon request. Indeed, a number of federal agencies, journals, and professional societies have established policies requiring the sharing of research materials. Sometimes these materials are too voluminous, unwieldy, or costly to share freely and quickly. But in those fields in which sharing is possible, a scientist who is unwilling to share research materials with qualified colleagues runs the risk of not being trusted or respected.' Many scientific professional organizations have comparable ethics guidelines. Consistently, a recent editorial in Science urged that OMB "realize[] . . the spirit of the legislation," even though the editorial noted numerous concerns regarding the precise wording of the proposal.2 The issue for OMB is how, not whether, to finalize the proposal in a way that balances the public interest in disclosure with other, competing policy goals.

OMB Should Understand and Address Concerns Raised by the Scientific Community

The proposed revisions have engendered a great deal of controversy among federally funded researchers and others, concerned that the proposal would inhibit research in a variety of ways. These concerns have a legitimate basis, and CMA urges OMB to take the time and care necessary to understand them and to craft the revisions in such a way that they are accommodated. This may take some time or outreach beyond this comment period. It may identify shortcomings in the Freedom of Information Act (FOIA) that should be addressed legislatively. Nonetheless, CM.A believes that the objections that have been raised can be accommodated, and are not a basis for indefinitely delaying a final rule.

Critics of the proposal have asserted that it might

o violate privacy obligations or expectations;
o jeopardize intellectual property rights in the United States or abroad;
o open up researchers to harassment by trial lawyers, animal rights activists and other special interests; or simply
o impose undue administrative and financial burdens on researchers.

Thus, OMB is faced with the challenge of balancing the public interest in disclosure with other, competing policy goals. This is a recurring problem in governmental information activities, and one that must be taken seriously.

At bottom, many of the objections that have been raised reflect two fundamental policy considerations: privacy and competitive interest. CMA strongly supports the legitimacy of these goals, as they protect our members' vital interests:

Privacy. To promote the health and safety of their employees, CMA members often collect data on that topic, which they maintain in confidence to protect those employees' privacy rights. CMA believes that where such privately-funded research data are used in support of governmental policy decisions, they should not be disclosed where or to the extent that they would infringe on the privacy rights of employees or others.

Competitive Interest. Our members are engaged in highly competitive businesses, and protection of their confidential business information (CBI) is vitally important to them. Often, data that were generated by private funds are used by the government to support regulatory decisions (e.g., data on industrial process characteristics may be used to develop "achievable" technology-based emissions limits). While these data should normally be made public for the reasons discussed earlier, the government traditionally " and appropriately " does not do so where or to the extent that the data legitimately represent confidential business information.

Fortunately, the Freedom of Information Act currently contains exclusions that enable the government to withhold "personal and medical files and similar files the disclosure of which would constitute a clearly unwarranted invasion of personal privacy,"4 as well as confidential "trade secrets and commercial or financial information."5 Information concerning pending patent applications is also protected.' CMA believes that these exclusions are adequate to accommodate the concerns that have been raised regarding privacy and CBI. (Although, to the extent that OMB concludes they are not, CMA urges OMB to convey that conclusion to Congress.) OMB might also consider clarifying that private entities that are research partners of the federal government be given notice of a FOIA request for their data and an opportunity to explain why they believe the data might be covered by a FOIA exemption.

The other concerns that have been raised center around more practical questions regarding burden and intrusion on into the scientific process: how long must researchers keep data? Are field notes data? Of particular importance we support the notion that researchers should not be required to release data until the earlier of three events occurs:

o the findings they support have been published in a scientific Journal after formal peer-review (where that is the researcher's intention);
o the findings they support have otherwise been made public by the researcher without some sort of qualification that they should not yet be relied upon by any governmental entity or
o the commencement of a comment period or similar limited window of opportunity to have input on the governmental action that is based on the research.

These practical concerns are legitimate and not necessarily simple to resolve. We are confident, however, that they are tractable and that ultimately OMB can satisfactorily address them. We note that several federal agencies, most notably NSF, NASA and the FDA, have data sharing requirements. Their experience should be informative.

OMB Should Issue Guidance on Reliability and Dissemination of Information

The Conference Report on the FY99 Omnibus Appropriations Act states that it "incorporates some of the language. . . set forth in House Report 105-592. . . and [the language in th[is] report] should be complied with unless specifically addressed in the [Conference Report]." The House Report in turn urges. . .OMB.. . to develop, with public and Federal agency involvement, rules providing policy and procedural guidance to Federal agencies for ensuring and maximizing the quality, objectivity, utility, and integrity of Information (including statistical information) disseminated by Federal agencies, and information disseminated by non-Federal entities with financial support from the Federal government.... The OMB rules shall also cover the sharing of, and access to, the aforementioned data and information, by members of the public. Such OMB rules shall require Federal agencies to develop. . . with public participation their own rules consistent with the OMB rules. The OMB and Agency rules shall contain administrative mechanisms allowing affected persons to petition for correction of information which does not comply with such rules.

The OMB rules are due September 30 of this year and the agency rules a year later.

While OMB has proposed the Circular A-110 revisions in response to another aspect of the Omnibus Appropriations Act, OMB has made no public statement regarding this aspect of the law. CMA is puzzled and troubled by this silence, because the topic is one of increasing importance. Very rapidly, the federal government is supplementing its traditional regulatory activities with novel information activities that have the same regulatory goals and effects.

There is no question that such activities are intended to, and do, influence behaviors. However, while traditional regulatory activities must comply with the APA and other requirements, information activities are subject to no constraints whatsoever. An entity injured by an erroneous statement in an agency web site has no recourse, indeed, no means even to see that the error is corrected. While some agencies, such as EPA, have begun to recognize this issue and are making progress toward addressing it, a set of government-wide standards would be very beneficial, as would the dialogue that would be generated by their development. CM:\ calls on OMB at least to clarify its intentions regarding this Congressional direction.

If you have any questions regarding these comments, please contact me.

Sincerely,

James W. Conrad, Jr.
Senior Counsel