Salt Institute v. ThompsonSalt Institute v. Thompson
MEMORANDUM ORDER
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.
(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) (рublished 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
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/Guide-lines/NIHinfo2.shtml (last revised Nov. 12, 2003). The HHS guidelines include both department-wide and agency-speсific 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 disseminаtion. Id. at § V.l.
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 decidе any appeals within 60 days. Id.
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 Freedоm 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 award that were used by the Federal Government in developing an agency action that has the forcé and effect of law, the Federal awarding agency shall request, and the recipient shall provide, within a reasonable time, the research data so that they can be made available to the public through the procedures established under FOIA.
Id. at 14407. The revised circular applies only to data that is published and used by the Federal agency in support of an action that has the force and effect of law. Id. Additiоnally, the circular is applicable only to data first produced under new or competing continuing grants awarded after April 17, 2000, the regulation’s effective date. See 64 Fed.R,eg. 54926. .
C. DASH-Sodium Trial
In recent years, scientists supported and funded by Defendant have conducted studies focusing on the relationship between diet quality and blood pressure: The first clinical study, conducted in 1997, was called the Dietary Approaches to Stop Hypertension (“DASH study”). The results of the DASH study were published in the New England Journal of Medicine in 1997, and the study findings indicated that a diet rich in fruits, vegetables, and low-fat dairy products, coupled with reduced saturated and total fat intake, could reduce blood pressure (“DASH diet”). The DASH diet did not severely restrict dietary salt intake. See Compl. ¶ 17; L.J. Appel, T.J. Moor, E. Obarzanelk, et al., A Clinical Trial of the Effects of Dietary Patterns on Blood Pressure, 336 NEW ENG. J. MED. 1117 (1997).
In 2000, as a follow-up to an earlier clinical study on the effects of a healthy diet on blood pressure, researcher's examined the effects of different levels of dietary sodium on the blood pressure rates of persons eating a healthy diet and persons eating a typical diet. The study was performed by the DASH-Sodium Collaborative Research Group (hereinafter “Group”), a large group of research scientists from hospitals and universities around the country that received a grant
The DASH study involved 412 participants who were randomly assigned to еat a typical U.S. diet or the DASH diet. On January 4, 2001, the DASH-Sodium Collaborative Research Group published its findings in the New England Journal of Medicine. See Compl. ¶ 19; Frank M. Sacks, MD et al., Effects of Blood Pressure on Reduced Dietary Sodium and the Dietary Approaches to Stop Hypertension Diet, 344 NEW ENG. J. MED. 3, 5 (January 4, 2001). The Group concluded that lower levels of blood pressure corresponded to lower levels of sodium intake in all participants. Id. The Group later performed a more detailed subgroup analysis of the DASH-Sodium Trial Data and published its results in the December 18, 2001 edition of the Annals of Internal Medicine. William M. Vollmer, PhD, Frank M. Sacks, MD, et al., Effects of Diet and Sodium Intake on Blood Pressure: Subgroup Analysis of the DASH-Sodium Trial, 135 ANNALS OF INTERNAL MEDICINE 1019, 1025-26 (December 18, 2001) In this article, the research scientists confirmed and еxtended their earlier findings and concluded that decreases in blood pressure associated with reduced sodium intake were present in all subgroups. See Def.’s Mem. Supp. Def. Mot. Dis. at 11 [hereinafter “Defs Mot. Dismiss”]; Id.
After the results of the DASH-Sodium Trial had been published in these peer reviewed medical journals, NHLBI reported the conclusions of the Group in various website press releases and publications. See Def.’s Mot. to Dismiss at 12.
D. Administrative Proceedings Related to Plaintiffs’ Request for Data Disclosure and Information Correction
On May 14, 2003, Plaintiffs filed an IQA petition with the NHLBI asking the it to make publicly available all the data and methods on which it relied in the DASH-Sodium Trial. Compl. Ex. 1. Plaintiffs complained about various statements contained in six NHLBI-related documents discussing the results of the DASH-Sodium Trial and the effect of salt intake on blood pressure. Plaintiffs asserted that the information in the six documents “directly states and otherwise suggests that reduced sodium consumption will result in lower blood pressure in all individuals.” First Am. Compl., Ex. 1 at 2. Plaintiffs stated, “[t]his petition seeks correction of information disseminated by NHLBI ...” Plaintiffs, however, also noted that they did “not at this time request or recommend that the challenged information be removed from public view.” Id. at 15. Instead, Plaintiffs limited their request for relief to the disclosure of the DASH-Sodium Trial Data, including mean blood pressures, standard deviations, and sample sizes for the relevant subgroups on each of the three levels of sodium intake for both the control and the DASH diet. See First Am. Compl. ¶ 33; Id. at 14-15.
On August 19, 2003, NHLBI responded by letter to Plaintiffs’ petition and noted that since Plaintiffs were not seeking a correction of any disseminated information but instead were seeking access to data generated by Federal grantees, the request should be made under FOIA, not through an IQA petition.
See
First Am. Compl., Ex. 2 at 2. The letter further stated that the agency would forward Plaintiffs’ request for data to the appropriate FOIA officials.
See id.
NHLBI also noted that the challenged information satisfied NIH’s information quality standards and that the information was subjected to extensive review under NHLBI’s procedures for publication. The NHLBI explained that the Group already honored
On September 3, 2003, the NHLBI sent Plaintiffs a letter advising them that it was treating their petition as a FOIA request. It then denied Plaintiffs’ petition because the NHLBI did not have the requested data. The letter stated that the grants for the DASH studies “were Cooperative Agreements which did not require the investigators to share their data with the National Institutes of Health.” See First Am. Compl., Ex. 3 at 1. NHLBI also stated that it would not forward a request for access to third-party investigations unless thе request was for data covered by the Shelby Amendment, as implemented in OMB’s revised Circular A-100. It further stated that the Shelby Amendment applies only to data that is (1) first produced under a new or competing grant awarded after April 17, 2000; and (2) cited publicly and officially by the Federal Government in support of an agency action that has the force and effect of law. First Am. Compl., Ex. 3 at 2. NHLBI indicated that the DASH-Sodium grants were competitively awarded in February 1997 and were extended for five subsequent years through non-competitive continuing grants, thus making the Shelby Amendment inapplicable to the DASH-Sodium Trial data. Id. at 2.
On September 22, 2003, Plaintiffs appealed the NHLBI’s refusal to corrеct or disclose the data. See First Am. Compl., Ex. 4. Plaintiffs reiterated both their request for access to the DASH-Sodium Trial data and their complaints regarding the various statements made by NHLBI regarding sodium intake and the results of the DASH-Sodium Trial. See id. In January 2004, the Institute listed the Sodium Trial on the “Limited Access Data Set” (“LADS”) website. The LADS website provides researchers with limited and tightly controlled access to raw data sets. Plaintiffs allege that the Institute placed the raw data in LADS to frustrate Plaintiffs’ efforts to gain access to all of the data. Compl. ¶ 38.
On February 11, 2004, NHLBI denied Plaintiffs’ appeal. See First Am. Compl., Ex. 5. NHLBI advised the Plaintiffs that they could request the data from the DASH-Sodium Collaborative Research Group and explained that a public access data set of the DASH-Sodium Trial was available through the Internet. See id. at 2. NHLBI also reiterated its conclusion that the statements regarding sodium intake in the challenged documents satisfied the information quality guidelines. Plaintiffs filed their initial complaint on March 31, 2004. They filed their First Amended Complaint on June 10, 2004.
On July 15, 2004, the Dash-Sodium Trial investigators published the specific data requested by Plaintiffs in an article in The American Journal of Cardiology, known as the “Bray Paper.”
See
G.A. Bray et. al.,
A Further Subgroup Analysis of the Effects of the DASH Diet and Three Dietary Sodium Levels on Blood Pressure: Results of the DASH-Sodium Trial, 94 J. CARDIOLOGY
222, 223-25 (July 15, 2004); Reply Mem. Supp. Def.’s Mot. Dismiss. Ex. 1. The Defendants have submitted to the Court the Bray Paper along with a declaration of Nancy L. Geller, Director of Biostatistics Research in the Division of Epidemiology and Clinical Applications of the NHLBI at the NIH, asserting in summary, “[i]t appears to me that the data Plaintiffs requested, and more, is available in the Subgroup Analysis [Bray] paper.” Geller Declaration ¶ 11. Plaintiffs, however, assert that the Bray Paper does not provide the data requested. Pls. Sur-Resp. to Def.’s Reply Supp. Mot. Dismiss
II. DISCUSSION
A. Standard of Review
A Federal Rule of Civil Procedure 12(b)(6) motion should not be granted unless it appears beyond a doubt that the plaintiff can prove no set of facts in support of his claim that would entitle him to relief. FED. R. CIV. P. 12(b)(6);
Conley v. Gibson,
B. Analysis
1. Plaintiffs Lack Standing
Plaintiffs Salt Institute and Chamber of Commerce lack standing to pursue their claims in federal court.
1
In order to satisfy the three-part test for standing under Article III of the U.S. Constitution, the plaintiff must show: (1) it suffered an “injury in fact” that is (a) concrete and particularized, (b) actual or imminent, not conjectural or hypothetical; (2) the injury is fairly traceable to the challenged action of the defendant, and (3) it is likely, as opposed to merely speculative, that the injury will be redressed by a favorable decision.
See Lujan v. Defenders of Wildlife,
a. Injury in Fact
i. Concrete and Particularized Injury
Plaintiffs fail to allege that they have suffered a concrete and particularized injury, and at most, assert no more than a generalized grievance shared by members of the public at large.
See, e.g., Taubman Realty Group Ltd. P’ship v. Mineta,
ii. Actual and Imminent
Plaintiffs might contend that they are injured by NHLBI’s dissemination of the results of the DASH-Sodium Trial because this information might cause consumers to reduce their consumption of salt, thus decreasing the Plaintiffs’ constituent members’ sales. Even assuming
arguendo
that Plaintiffs had included this theory in their complaint, which they did not, such an injury is based on the hypothetical actions of third parties and is too speculative to constitute the type of “certainly impending” injury necessary to have standing under Article III.
See Whitmore v. Arkansas,
b. Injury is Not Traceable to NHLBI’s Actions
Plaintiffs fail to allege that their purported injury is fairly traceable to the challenged conduct of NHLBI and not attributable to some independent third party not before the Court. Plaintiffs must establish that there is a causal connection between the injury and the alleged violations of the law.
See, e.g., Friends for Ferrell Parkway,
The published results of the DASH-Sodium Trial themselves are more likely the cause of any injury allegedly suffered by the Plaintiffs rather than NHLBI’s mere dissemination of Dash-Sodium Trial results. The conclusions of the independent scientists who conducted the DASH-Sodium Trial were reported in articles in both the January 4, 2001 issue of the New England Journal of Medicine and the December 18, 2001 issue of the Annals of Internal Medicine. Plaintiffs are not, however, seeking a correction or any other relief regarding the published results of the DASH-Sodium Trial. Furthermore, the DASH-Sodium Trial scientists are third parties not presently before the court. Plaintiffs have failed to establish that NHLBI’s withholding of the data is the cause of their purported injury.
c. Redressability
Plaintiffs purported injuries would not be redressed even if they received their desired remedies of access to the DASH-Sodium Trial data and amendment of NHLBI’s statements and recommendations regarding salt intake. In determining whether a plaintiff has a sufficient injury to establish standing, courts ask whether a ruling favorablе to the plaintiff would eliminate the harm to him.
See, e.g., Friends for Ferrell Parkway,
d. Organizational Standing
Plaintiffs do not have organizational standing. An organization has standing to challenge government action that causes injury to the organization itself.
Hunt v. Washington State Apple Adver.,
(i) An injury in fact has ocсurred to the members of the organization that would give individual members a right to sue on their own behalf;
(ii) The injury to the members is related to the organization’s purpose; and
(iii) Neither the nature of the claim nor the relief requested requires participation of the individual members in the lawsuit.
Id. at
343,
Plaintiffs have not properly alleged an injury in fact because they have not alleged that their members have suffered a concrete and particularized injury that would give them the right to sue on their own behalf. Therefore, Plaintiffs have not properly alleged organizational standing. Plaintiffs lack the requisite legal standing to assert their claims in federal court.
2. Judicial Reviеw of NHLBI’s Actions Regarding the DASH-Sodium Trial
Generally, there are two possible avenues for judicial review of federal agency action: (1) a substantive statute may provide a private right of action for judicial review of an agency action or (2) the provisions of the Administrative Procedure Act may provide for judicial review.
Regional Mgmt. Corp. Inc. v. Legal Serv. Corp.
a. Private Right of Action Under the Information Quality Act
There is no private right of action under the IQA and an agеncy’s decision to deny a party’s information quality complaint is not reviewable by this Court. For a plaintiff to enforce the provisions of a federal law in court, Congress must first have afforded the party a private right of action.
See Alexander v. Sandoval,
b. Administrative Procedure Act Judicial Review
The presumption of APA judicial review only applies only if two underlying
i. Final Agency Action
The NHLBI’s actions in this case do not constitute a final agency action necessary for judicial review under the APA. A final agency action is “one by which rights or obligations have been determined, or from which legal consequences will flow.”
Bennett v. Spear,
ii. Agency Discretion
Judicial review is also precluded because the informal agency decisions concerning NHLBI’s statements and recommendations regarding the DASH-Sodium Trial were matters “committed to agency disсretion by law.” There is a strong presumption of reviewability under the APA.
Abbott Labs. v. Gardner,
Neither the IQA nor the OMB Guidelines provide judicially manageable standards that would allow meaningful judicial review to determine whether an agency properly exercised its discretion in deciding a request to correct a prior communication. In fact, the guidelines provide that “[a]gencies, in making their determination of whether or not to correct information, may reject claims made in bad faith or without justification, and are required to undertake only the degree of correction that they conclude is appropriate for the nature and timeliness of the information involved.” 67 Fed.Reg. at 8458. Courts have determined that regulations containing similar language granted sufficient discretion to agencies to preclude
c. APA and Shelby Amendment
Plaintiffs lack standing to assert that NHLBI violated the Shelby Amendment. Plaintiffs allege that NHLBI violated the Shelby Amendment, Pub.L. No. 105-277, 1998 HR 4328, which directs ÓMB to amend its Circular A-110 to require federal agencies to give the public access to all data generated by federally funded studies. See First Am. Compl. ¶¶ 55-61. Plaintiffs claim that NHLBI exceeded its statutory discretion by granting public access only to data from new studies funded after April 17, 2000, that was cited publicly and officially in support of agency action with the force of law. See id. ¶ 58. Plaintiffs generally allege that they are “adversely affected and aggrieved by this final agency action, and have no other adequate remedy at law.” Compl. ¶ 61. As with their claims under the IQA, Plaintiffs lack standing because they have not alleged an injury that is sufficiently particularized and concrete to satisfy the constitutional requirements for standing.
Furthermore, Plaintiffs fail to state a claim bеcause OMB, not NHLBI, is responsible for implementing the Shelby Amendment. In their claim, Plaintiffs assert that NHLBI exceeded its statutory discretion under the Shelby Amendment and “restricted public access only to data from new studies funded after April 17, 2000 that was cited publicly and officially in support of an agency action with the force of law.” First Am. Compl. ¶ 58. Contrary to Plaintiffs’ assertion, OMB, not NHLBI, restricted access to grantee data in the manner described pursuant to its authority under the Shelby Amendment. The Shelby Amendment directs OMB, not NHLBI, to amend OMB Circular A-110 to require federal agencies to make data produced by federal grant recipients available to the public under FOIA procеdures. Omnibus Consolidated and Emergency Supplemental Appropriations Act, 1999, Pub.L. No. 105-277, 1998 HR 4328 (1998). OMB implemented the Shelby Amendment and NHLBI merely applied the terms of OMB’s revised Circular A-110. Accordingly, Plaintiffs’ claim that NHLBI violated the Shelby Amendment fails to state a claim on which relief can be granted.
III. CONCLUSION
The Defendants Motion to Dismiss is granted because the Plaintiffs lack standing to sue, there is no private right of action under the Information Quality Act, and the NHLBI’s actions regarding the DASH-Sodium Trial data are not subject to judicial review under the Administrative Procedure Act.
.For .the foregoing reasons, it is hereby
ORDERED that Defendant’s Motion to Dismiss is GRANTED.
The Clerk is directed to forward a copy of this Order to counsel.
Notes
. Because Plaintiffs allege that the Bray Paper does not provide them with all the information they requested, their claim is not moot. Nevertheless, Plaintiffs claims are dismissed because they lack standing.