Salt Institute v. Thompson, CIV.A. 04-359GBL.

• Decision Date: 15 November 2004
• Docket Number: No. CIV.A. 04-359GBL.,CIV.A. 04-359GBL.
• Court: U.S. District Court — Eastern District of Virginia
• Parties: SALT INSTITUTE and the Chamber of Commerce of the United States of America, Plaintiffs, v. Tommy G. THOMPSON, Secretary, U.S. Department of Health and Human Services, Defendant.

345 F.Supp.2d 589

SALT INSTITUTE and the Chamber of Commerce of the United States of America, Plaintiffs, v. Tommy G. THOMPSON, Secretary, U.S. Department of Health and Human Services, Defendant.

No. CIV.A. 04-359GBL.

United States District Court, E.D. Virginia. Alexandria Division.

November 15, 2004.

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Reed D. Rubinstein, Esquire, Mark E. Solomons, Esquire, Greenberg Traurig, Washington, DC., for Plaintiff.

Dennis Carl Barghaan, Jr., Esquire, Assistant United States Attorney, United States Attorney's Office, Alexandria, VA, Edward H. White, Esquire, Trial Attorney, United States Department of Justice, Civil Division, Federal Programs Branch, Washington, DC, Elizabeth J. Shapiro, Esquire, Assistant Branch Director, Thomas R. Lee, Esquire, Deputy Assistant Attorney General, Paul J. McNulty, Esquire, United States Attorney — EDVA, Peter D. Keisler, Assistant Attorney General, for Defendant.

MEMORANDUM ORDER

LEE, District Judge.

THIS MATTER is before the Court on Defendant's Motion to Dismiss pursuant to Federal Rules of Civil Procedure 12(b)(1) and 12(b)(6). This case involves Plaintiffs Salt Institute and Chamber of Commerce of the United States of America's allegations that the National Heart, Lung and Blood Institute ("NHLBI") violated the Information Quality Act ("IQA") and the Shelby Amendment by failing to disclose the data and methods underlying the Dietary Approaches to Stop Hypertension-Sodium Trial conducted by an NHLBI grant recipient, the DASH-Sodium Collaborative Research Group. 44 U.S.C § 3516, note (2000); 64 Fed.Reg. 54926 (Oct. 8, 1999). Plaintiffs also allege that NHLBI violated the IQA by reporting the results of the DASH-Sodium Trial on its website and in medical journal articles and by recommending that people limit their sodium intake to moderately low levels. The issues before the Court are:

(1) whether Plaintiffs' claims should be dismissed because Plaintiffs lack standing to pursue their claims in federal court due to an absence of an injury in fact,

(2) whether Plaintiffs' claims should be dismissed because no private right of action arises under the IQA,

(3) whether Plaintiffs fail to state a claim that NHLBI, violated the Shelby Amendment by failing to implement procedures through which the public could obtain the DASH-Sodium Trial data under the Freedom of Information Act ("FOIA").

I. BACKGROUND

The plaintiffs in this case are the Salt Institute, a trade association of companies that "produce and market salt for food and other uses," and the Chamber of Commerce of the United States of America ("Chamber"), a business federation which includes "companies that use, market, and/or sell food products containing salt," First Am. Compl. ¶¶ 7,8. Plaintiffs seek declaratory and injunctive relief from this Court on their claims that the NHLBI, which is one part of the National Institutes of Health ("NIH"), an agency of the Department of Health and Human Services ("HHS"), violated the IQA and the Shelby Amendment. Plaintiffs assert that NHLBI violated the IQA and the Shelby Amendment by failing to disclose the data and methods underlying the Dietary Approaches to Stop Hypertension-Sodium Trial ("DASH-Sodium Trial") conducted by an NHLBI grant recipient-the DASH-Sodium Collaborative Research Group. The Salt Institute and the Chamber also allege that NHLBI violated the IQA by reporting the results of the DASH-Sodium Trial on its website and in medical journal articles and by recommending that people limit their sodium intake to moderately low levels.

A. The Information Quality Act ("IQA")

The IQA is located in Section 515 of the Treasury and General Government Appropriations Act for Fiscal Year 2001 and directs the Office of Management and Budget ("OMB") to issue guidelines that provide "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 ..." Pub.L. No. 106-554, § 1(a)(3) [Title V, § 515] (Dec. 21, 2000) (published at 44 U.S.C. § 3516 note). The IQA also directs OMB to include three specific requirements in its guidelines: (1) that federal agencies develop their own information quality guidelines, (2) administrative mechanisms for affected persons to seek correction of information that does not comply with OMB's guidelines, and (3) that federal agencies report periodically to OMB on the number and nature of complaints they receive regarding the accuracy of the information they disseminate. § 515(B)(2). Neither the Act itself nor its very limited legislative history provide a mechanism for judicial review of information quality or any avenue for judicial relief.

1. OMB Guidelines

The OMB published final guidelines on implementing the IQA on February 22, 2002. See 67 Fed.Reg. 8452 (Feb. 22, 2002). The Guidelines require federal agencies to undertake four principal responsibilities: (1) to "adopt specific standards of quality that are appropriate for the various categories of information they disseminate;" (2) to "develop a process for reviewing the quality ... of information before it is disseminated;" (3) to "establish administrative mechanisms allowing affected persons to seek and obtain, where appropriate, timely correction of information maintained and disseminated by the agency that does not comply with OMB or agency guidelines;" and (4) to provide OMB with reports regarding the agencies' information quality guidelines and any information quality complaints they receive. 67 Fed Reg. at 8458-59. Furthermore, the OMB guidelines encourage agencies that are responsible for disseminating influential scientific, financial, or statistical information to provide a "high degree of transparency about data and methods to facilitate reproducibility of such information by qualified third parties." Id. at 8460.

The OMB guidelines also address administrative correction mechanisms and require agencies to "specify appropriate time periods for agency decisions on whether and how to correct information" and to "establish an administrative appeal process to review the agency's initial decision." Id. at 8459. OMB states that the agencies should correct information only "where appropriate" and that "these administrative mechanisms shall be flexible" and "appropriate to the nature and timeliness of the disseminated information." Id. Agencies maintain significant discretion in ensuring the quality of the information of the information they disseminate.

2. HHS Guidelines

On October 1, 2002, pursuant to the IQA and the OMB guidelines, HHS implemented its own "Guidelines for Ensuring the Integrity of Information Disseminated by HHS agencies." U.S. DEPT. OF HEALTH AND HUMAN SERVICES, GUIDELINES FOR ENSURING THE INTEGRITY OF INFORMATION DISSEMINATED TO THE PUBLIC, available at http:// www.aspe.hhs.gov/infoquality/Guidelines/NIHinfo2.shtml (last revised Nov. 12, 2003). The HHS guidelines include both department-wide and agency-specific guidelines, including the guidelines of the NIH. HHS indicates that it generally favors public access to the data underlying agency-sponsored scientific studies when the data is available. Id. Such public disclosure of data, however, may not always be permissible, due for example, to confidentiality requirements, proprietary restrictions, or resource availability. Id. The NIH guidelines state that generally "grantees own the data generated by or resulting from a grant-supported project." Id. at § II.2 and n. 1. Consequently, although data sharing is encouraged, NIH recognizes that it may be limited by confidentiality concerns and other factors that preclude data dissemination. Id. at § V.1.

The HHS guidelines also establish a process for information correction requests and appeals. Id. at § VI. HHS reminds complainants that they bear the burden of proof to establish the need for and the type of correction sought. Id. A correction request must include specific reasons for asserting that the information at issue violates OMB, HHS, or agency-specific guidelines and "specific recommendations for correcting the information." Id. The agency aims to respond to correction requests within 60 days of receipt, and a party may appeal the agency's decision within 30 days after that. The agency aims to decide any appeals within 60 days. Id.

B. The Shelby Amendment

In 1998, Congress added two sentences to the Fiscal Year 1999 Omnibus Consolidated Emergency Supplemental Appropriations Act that are designed to require federal agencies to make available to the public research data produced by federal grantees under FOIA in certain circumstances. Termed the Shelby Amendment, the entire provision provides:

...Provided further, That the Director of OMB amends 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: Provided further, That if the agency obtaining the data does so solely at the request of a private party, the agency may authorize a reasonable user fee equaling the incremental cost of obtaining data.

FY 1999 Omnibus Appropriations Act (144 CONG. REC. H11178 (daily ed. Oct. 19, 1998)). OMB, after publishing two proposed revisions and receiving over 12,000 comments, published the final revision of Circular A-110 in October of 1999, 64 Fed.Reg. 54926 (October 8, 1999), which became effective April 17, 2000. See Uniform Administrative Requirements for Grants and Agreements with Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations, 65 Fed.Reg. 14406 (March 16, 2000). OMB's final revision, in pertinent part, provides the following:

...in response to a Freedom of Information Act (FOIA) request for research data relating to published research findings produced under an...