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Comments on OMB Proposed Revisions

Comments Of Public Citizen On The Office Of Management And Budget's Proposed Revision Of OMB Circular A-110, "Uniform Administrative Requirements For Grants And Agreement With Institutions Of Higher Education, Hospitals, And Other Non-Profit Organizations

Links to Relevant OMB Documents   

OMB Request for Comments on Clarifying Changes to Proposed Revision to OMB Circular A-110

Proposed Revision to OMB Circular A-110, "Uniform Administrative Requirements for Grants and Agreements with Institutions of Higher Education, Hospitals, and Non-Profit Organizations"

OMB Circular A-110

Public Citizen submits these comments in response to the Office of Management and Budget's ("OMB's") request for comments on clarifying changes to OMB's proposed amendment of Circular A-110 to implement Public Law 105-277. Pub. L. 105-277 directs OMB to amend Section __.36 of OMB Circular A-110 "to require Federal awarding agencies to ensure that all data produced under an award will be made available to the public through the procedures established under the Freedom of Information Act." OMB published its proposed revision to Section __.36 for comment on February 4, 1999, 64 Fed. Reg. 5684, and published "proposed clarifying definitions," on August 11, 1999. 64 Fed. Reg. 43,786. These comments respond to OMB's proposed "clarifying" changes.

Interests of Public Citizen

Public Citizen is a non-profit public interest membership organization with over 150,000 supporters nationwide. Since its founding by Ralph Nader in 1971, Public Citizen has fought in Congress, federal agencies, and the courts for sound government policies on issues such as drug safety, automotive safety, nuclear energy, workplace hazards, and many other issues that require reliance on scientific studies. Public Citizen also conducts extensive advocacy and education programs on campaign finance reform, international trade regulation, and health care policy, and these programs frequently require detailed examination of economic, demographic, financial or other research data. Public Citizen has regularly used the Freedom of Information Act ("FOIA") to request records related to its advocacy and education efforts, and it has represented FOIA requesters in approximately 300 lawsuits challenging government secrecy. Public Citizen submits these comments to encourage OMB to improve public access to records of research funded with federal funds, as required by Pub. L. 105-277, and to urge the OMB not to impose limitations on access that are not supported by the statutory language and would not be workable in practice.

Comments on Proposed "Clarifying Changes"

At the outset, we note that OMB's proposal to implement Pub. L. 105-277 is based on the premise that OMB has discretion to limit the data that will be made available to the public under Circular A-110 in ways that are not supported by the language of Pub. L. 105-277. The statutory language directs OMB to amend Circular A-110 to ensure public access to "all data produced under an award" Pub. L. 105-277 (italics added). The statute does not give OMB the authority to limit the revisions in the Circular so that they do not cover "all data" or establish procedures for access that differ from those "established under the" FOIA. However, in OMB's proposed revision and clarifying amendments, OMB has significantly departed from the statutory language by providing that agencies' obligation to obtain awardee records for public access is limited to "data relating to published research findings produced under an award that were used by the Federal Government in developing a regulation." 64 Fed. Reg. 43,791/3. This proposed language is based on snippets from congressional floor statements concerning the relevant statutory provision, 64 Fed. Reg. 5684/2, and OMB's belief that it may use "its discretion to balance the need for public access to research data with protections of the research process." 64 Fed. Reg. 43,786/c.2.

We question the validity of these limitations, and we believe that, if OMB adopts the type of restrictions that it proposes, the revision to Section __.36 is likely to be challenged and found to be unlawful. Moreover, grantees will be uncertain about whether they may rely on the limitations in Section __.36 because there will be a substantial cloud on their validity. Agencies generally do not have authority to impose limitations or conditions that are not supported by the statutory text, even if the limitations are supported by policy considerations. See, e.g., Federal Reserve Board v. Dimension Financial Corp., 474 U.S. 361, 374 (1986); American Petroleum Inst. v. United States Environmental Protection Agency, 52 F.3d 1113, 1119 (D.C. Cir. 1995); Ethyl Corp. v. EPA, 51 F.3d 1053, 1059 (D.C. Cir. 1995). The limitations on the scope of Section __.36 that OMB has proposed -- particularly the limitations in the proposed "clarifying definitions" -- may be legally invalid because Congress has not given OMB the discretion to impose restrictions that are not in the statutory language.

In addition, we believe that, even if OMB has the authority to impose the type of limitations that it has proposed in the clarifying definitions, it should not do so. As we explain more fully below, the limitations are not supported by sound policy considerations and are impractical. The "clarifying definitions" are likely to obstruct public access to data that should be available for public scrutiny, and impose unnecessary burdens on the agencies and grantees required to determine whether data falls within the clarifying definitions.

1. Research Data. OMB proposes to define "research data" as "the recorded factual material commonly accepted in the scientific community as necessary to validate researching findings, but not any of the following: preliminary analyses, drafts of scientific papers, plans for future research, peer reviews, or communications with colleagues." Moreover, under the proposed definition, "research data" would exclude "(A) trade secrets, commercial information, materials necessary to be held confidential by a researcher until publication of their results in a peer-reviewed journal, or information which may be copyrighted or patented; and (B) personnel and medical files and similar files the disclosure or which would constitute a clearly unwarranted invasion of personal privacy, such as information that could be used to identify a particular research subject in a research study."

We have no objection to defining "research data" as the material commonly used to validate research findings and to exclude physical objects such as laboratory samples. However, the exclusions for trade secrets, commercial information and personnel or medical files should not be incorporated into the definition of "research data." Instead, research data that arguably contains such information should be sent to the awarding agency and the awarding agency, not the awardee, should determine whether the data falls within these exceptions, just as the agency would in processing an agency record for release under the FOIA.

We believe that three considerations demonstrate that OMB should not adopt these portions of the proposed clarifying definition. First, in order to comply with the statute's mandate that the data be "made available to the public through the procedures established under the Freedom of Information Act," Pub. L. 105-277, the agency must make the determination whether the data falls within exemptions in 5 U.S.C. § 552(b) of the FOIA, just as it does with ordinary agency records. Awardees are not equipped to make such a determination. Moreover, awardees have every incentive to find that data is not included in the "data" that must be provided to the agency under Section __.38, and if the data is not provided to the awarding agency, FOIA requesters may be left without an effective remedy for obtaining access to the data.

In addition, the provisions that OMB has proposed will inevitably lead to disputes over whether an awardee withholding data is applying the correct standards for "commercial information" or personnel files. These terms are terms of art under the FOIA, and the courts have given these terms complex and subtle definitions. See Department of State v. Ray, 502 U.S. 164 (1991; Critical Mass Energy Project v. NRC, 975 F.2d 871 (D.C. Cir.1992) (en banc), cert. denied, 507 U.S. 984 (1993); National Parks & Conservation Ass'n v. Morton, 498 F.2d 765 (D.C. Cir. 1974). Allowing awardees to assert that data is not "research data" because the awardee believes that it falls within one or more of these provisions invites unnecessary disputes and will hinder public access.

Second, the agency has an affirmative duty under the FOIA to determine that all segregable information is released. See Trans-Pacific Policing Agreement v. U.S. Customs, 177 F. 3d 1022 (D.C. Cir. 1999) (agency has responsibility to make segregability determination even if requester does not request it). The agency cannot make this determination if the awardee does not deliver the data to the agency for review.

Third, we see no justification for OMB's proposal to exclude "information which may be copyrighted or patented" from the definition of research data. This exclusion is not based on any exemption in the FOIA, and the possibility that information may be copyrighted or patented does not warrant denying a requester access to the material under the FOIA in all cases. Allowing a FOIA requester to inspect records does not infringe on patent or copyright rights.

Moreover, the phrase "information which may be copyrighted or patented" is extraordinarily broad and vague. Does this include data for which the awardee has not applied for any copyright or patent, but for which the awardee might submit an application at some indefinite time in the future? Does this phrase include data for which the awardee could not apply for a copyright or patent, but for which some other individual or entity may seek a copyright or a patent? To qualify for exemption on the grounds that the information "may be copyrighted," is it sufficient that the information is fixed in a "tangible medium of expression" as required by the copyright statute, 17 U.S.C. § 102(a), or must the information meet all the conditions for a valid copyright? See Feist Publications v. Rural Telephone Serv. Co., 499 U.S. 340, 345-46 (1991) (work must demonstrate originality to qualify for copyright protection). Similarly, who decides whether information is exempt because it "may be patented," even though no patent application is pending? Indeed, the phrase "information which may be copyrighted or patented" is so vague that neither awardees nor agencies will not be able to determine what is covered and what is not. Consequently, this provision will not provide any meaningful reassurance to awardees, but will foster disputes concerning the application of this phrase.

Accordingly, we urge OMB to delete both subparts (A) and (B) of the proposed definition of "research data."

2. Published. As noted above, the proposed revision of Section __.36 provides that agencies' obligation to obtain data from awardees applies to "data relating to published research findings produced under an award that were used by the Federal Government in developing a regulation." OMB has proposed to further limit the data covered by defining "published" as either when "(A) Research findings are published in a peer-reviewed scientific or technical journal; or (B) A Federal agency publicly and officially cites to the research findings in support of a regulation." 64 Fed. Reg. 43,789/3.

We oppose this definition because it is inconsistent with the statute and will potentially deny public access to data used by the Federal Government in developing policy and rules. The legislative history, as OMB itself acknowledges, indicates that the purpose of the legislation is to provide the public with access to data "used by the Federal government in developing policy and rules." 64 Fed. Reg. 5684/2 (citing 144 Cong. Rec. S12134 (October 9, 1998) (Statement of Sen. Lott). OMB's proposed requirement that the data be "publicly and officially" cited in support of a regulation, however, excludes much of this data. Specifically, this requirement excludes data that is used by the Federal Government in developing policies that are not embodied in "regulations." It also excludes data that is used by the Federal government, but is not "publicly and officially" cited when it is used.

There is no sound policy basis for making these distinctions. Public access to data used by the government should not depend on whether the agency chose to cite the data in its "official" announcement of the rule. The decision whether to cite the data in the official announcement is often arbitrary, and access to data that was not cited may be crucial to evaluating the basis of the policy. Moreover, whether data is covered by this provision should not depend on whether the government calls the rule for which the data was used a "policy" or a "regulation." As we discuss further below, these labels are often misused and have little bearing on whether the government's action has important public policy implications. In addition, the limitations introduced by the definition of "publish" are clearly contrary to the statutory test, which states that the Director of OMB should require awarding agencies "to ensure that all data produced under an award" will be made available. Pub. Law 105-277 (emphasis added).

OMB's objective of preventing the premature release of data can be achieved without artificially limiting the research data that is subject to public access in a way that is contrary to the statutory language by restricting the timing of release of data that is subject to Section __.38, without excluding the data from this Section in its entirety.

Accordingly, we urge OMB not to adopt the proposed definition of "published," and, instead, to add language that would allow agencies to postpone release of the data until publication of research findings or the agency action in which the data is used.1 Such a provision would protect the interest of the public in obtaining "the information needed to validate Federally-funded research findings, and would give researchers protection against being "forced to release their research prematurely." 64 Fed. Reg. 43,789/3.

3. Used by the Federal Government in developing a regulation. OMB has also proposed replacing the proposed language in Section __.38 that would require that data be used by the Federal Government "in developing policy or rules" with a more restrictive requirement that data be used "in developing a regulation" for which notice and comment is required under 5 U.S.C. § 553. 64 Fed. Reg. 43,789-91. Apart from the fact that this restriction does not appear to be authorized by the statute, we believe that it would be unwise for OMB to adopt this provision.

OMB's notice states that it is adopting this provision because it believes that (i) it will be easy to determine when an agency has publicly and officially cited data in support of a "regulation" and (ii) because there is "lesser public interest in obtaining the underlying research data when the agency is not taking action" pursuant to 5 U.S.C. § 553. 64 Fed. Reg. 43,791. Both of these conclusions are erroneous.

First, limiting Section __.38 to data cited in "developing a regulation" under 5 U.S.C. § 553 will not provide certainty for awardees or make the Circular easy to administer because it is often uncertain whether a particular agency statement of position is a "regulation" subject to 5 U.S.C. 553, or is a policy statement, or a interpretive rule. Indeed, the courts have described the distinction between substantive rules subject to Section 553, and policy statements and interpretive rules that are not subject to this statute as "blurred" and "baffling." Community Nutrition Institute v. Young, 818 F.2d 943, 946 (D.C. Cir. 1987) (citing cases); see also Noel v. Chapman, 508 F.2d 1023, 1030 (2d Cir. 1975) (stating that difference between Section 553 rule and general statement of policy is "enshrouded in considerable smog."); American Hospital Association v. Bowen, 834 F.2d 1037, 1045 (D.C. Cir. 1987) (distinguishing between interpretive rules and rules subject to Section 553 notice and comment is an "extraordinarily case-specific endeavor"). An agency's decision to label an action a policy statement rather than a rule subject to notice and comment is not determinative. Indeed, it is given little weight by the courts, and agency decisions are frequently set-aside because the agency treated a substantive rule as a "policy" or interpretive rule. See, e.g., Chamber of Commerce v. Occupational Safety and Health Administration, 636 F.2d 464, 468-69 (D.C. Cir. 1980).2

Second, and more importantly, there is great public interest in access to data that is used by the Federal Government in developing policy statements and other "rules" that are not subject to notice and comment under 5 U.S.C. § 553. Even if an agency action does not qualify as a "substantive rule," it may have important legal consequences because it guides how a federal authorities exercise their discretion in adjudicating disputes, awarding permits, setting rates, or making other decisions. For example, policy statements that are not subject to notice and comment rule making have been used to establish federal policies on civil rights issues,3 enforcement of mine safety standards,4 and environmental cleanup decisions.5 The public interest in access to the data that federal officials used in developing such policies is often just as important, or more important, than access to the data used to develop substantive rules.

Indeed, Section __.38's exclusive focus on data used in "developing a regulation," ignores the public interest in data that is used by the Federal government in deciding not to adopt a regulation or other policy, or to delay adopting a regulation or policy. If an agency terminates a rule making or decides not to initiate a rule making, public disclosure of scientific data that was used by the agency in making this decision is just as important to evaluating the agency's conduct as data that relates to a regulation that is issued. Cf. Motor Vehicle Manufactures Ass'n v. State Farm Mutual Automobile Ins. Co., 463 U.S. 29 (1983) (agency decision to rescind rule is subject to the same standard of review as agency issuance of regulation).

4. Proposed Monetary Impact Threshold. OMB's notice also requests comment on whether the new provisions of Section __.38 should be limited to regulations that meet "a $100 million impact threshold." 64 Fed. Reg. 43,791/1. In particular, OMB asks for examples of regulations that do not meet the $100 million threshold, but the benefit of providing the public with access to the research data used by the government is sufficient to "justify burdens on, or risks to, the traditional scientific process." Id.

We believe that such monetary threshold is not authorized by the statute. Moreover, we believe that it would be unwise and detrimental to public access for OMB to adopt such a limitation. The balancing of public interest against the "burdens on, or risks to, the traditional scientific process" presented by OMB's request for comments does not make sense in this context. First, the statutory language does not authorize OMB to engage in such a balancing or impose monetary thresholds on the federally-funded data that must be made available under this provision. Second, whatever "burdens" may be placed on the traditional scientific process by public access, there is no reason to think that these burdens will be related to the monetary impact of the regulation for which data is used. To the contrary, the "burden" or "risk" will be related to whether there is a "tradition" of secrecy and commercial exploitation of data in the particular scientific field that collects the data needed for the policy or rule at issue. The degree to which researchers share data and information varies widely from one scientific discipline to another, and the monetary impact of the federal action may be wholly unrelated to the commercial value of research data used by federal authorities taking the action. Consequently, the monetary threshold that OMB is considering would not effectively advance the interests in public access or promoting scientific research.


For the reasons stated above, the OMB should not adopt the "clarifying definitions" for Section __.38 of Circular A-110 that are set forth in the agency's August 11, 1999, Federal Register notice. 
Respectfully submitted,
Michael Tankersley
1600 20th Street, NW
Washington, DC 20009
(202) 588-1000
Attorney for Public Citizen



1. For example, the following sentence might be added to Section __.38:

If it is anticipated that awardee data that has been requested under the FOIA will be used in published research, absent special circumstances, the awarding agencies shall not make the data available to the public until research findings are published in a peer-reviewed scientific or technical journal, or a Federal agency issues a decision in which the data was used, whichever is earlier.

2. Indeed, the language chosen by OMB is likely to add to the confusion. OMB's proposal uses the word "regulation" to refer to rules "for which notice and comment is required under 5 U.S.C. § 553." 64 Fed. Reg. at 43,790, 43791. However, the term "regulation" is not used in 5 U.S.C. § 553 or Public Law 105-277, and the courts have used the terms "substantive rule" or "legislative rule" to refer to agency actions that are subject to the notice and comment requirements.

3. See, e.g., Metro Broadcasting, Inc. v. FCC, 497 U.S. 547 (1990) (policy for promoting minority ownership of radio and television stations).

4. Brock v. Cathedral Bluffs Shale Oil Co., 796 F.2d 533, 538-39 (D.C. Cir. 1986) (Labor Department enforcement policy).

5. Fertilizer Institute v. United States Environmental Protection Agency, 935 F.2d 1303, 1307 (D.C. Cir. 1991).

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