Allen v. Nat'l Institutes of Health

974 F.Supp.2d 18

Klare ALLEN et al., Plaintiffs,

v.NATIONAL INSTITUTES OF HEALTH et al., Defendants.

No. 1:06–cv–10877–PBS.

United States District Court, D. Massachusetts.

Sept. 30, 2013.

Arthur P. Kreiger, Christine Marie Griffin, Mina S. Makarious, Anderson & Kreiger, LLP, Cambridge, MA, Laura Maslow–Armand, Lawyers Committee for Civil Rights Under Law, Mark W. Roberts, McRoberts & Roberts, LLP, for Plaintiffs.

Anton P. Giedt, United States Attorney's Office, Seth D. Jaffe, Foley Hoag LLP, Boston, MA, for Defendants.

MEMORANDUM AND ORDER

SARIS, Chief Judge.

I. INTRODUCTION

This case involves a dispute over whether Defendant National Institutes of Health (“NIH”) should be permitted to fund the new National Emerging Infectious Diseases Laboratories (“BioLab”) at the Boston University Medical Center (“BUMC”) in Boston's South End and Roxbury neighborhoods. If approved, the facility will house Biosafety Level–3 (“BSL–3”) and Biosafety Level–4 (“BSL–4”) laboratories designed to research extremely dangerous pathogens, such as the Ebola virus, for biodefense purposes. Plaintiffs Klare Allen, Melvin King, Joyce King, Carmen Nazario–Vega—residents of the South End and Roxbury—and the Conservation Law Foundation request that the Court enjoin federal funding of the BioLab on the ground that the NIH has failed to comply with the National Environmental Policy Act (“NEPA”), 42 U.S.C. § 4321 et seq. The plaintiffs strongly oppose building the BioLab in their high density urban neighborhood, which they contend would be unsafe and disproportionately affect minority and low-income populations. The Trustees of Boston University (“BU”), who received the NIH grant in support of the BioLab, have intervened. All parties have moved for summary judgment. Plaintiffs have also moved to expand the administrative record.

After hearing and a review of the record, the Court finds that the NIH has met its obligation under NEPA to take a hard look at the environmental consequences of its decision to build the BioLab in Boston. While the community has understandable concerns about the wisdom of locating the facility in a highly populated urban area, the Final Supplementary Risk Assessment (“FSRA”) reports that the risk of infections to the public resulting from accidents or malevolent acts “is extremely low, or beyond reasonably foreseeable,” and the probability of secondary infections is so low that none is likely to occur for any of the pathogens over the proposed 50 year lifetime of the Biolab. See infra p. 32. The report acknowledges that the estimated likelihood of infections or fatalities is “generally slightly greater” at the Boston location than at the two alternative sites (one suburban, one rural). FSRA at 11–24. However, the differences among the three sites “are not substantial.” Id. This conclusion that the BioLab will pose low risk to the public is based, in part, on the security safeguards built into the facility, the low amounts of pathogens that will be present, and the culture of biosafety and training that will be integrated into every day practice at the BioLab.

Significantly, the methodology used in the FSRA for evaluating the risk to the public was scrutinized and approved by two sets of independent experts: the National Research Council, which in the past had been critical of the NIH's methodology, and a Blue Ribbon Panel of experts in infectious disease, epidemiology, and public health.

The NIH emphasizes that the benefits of having the BioLab in Boston include opportunities for efficient medical research collaboration and training with other institutions in Boston and Cambridge to advance critical research on biodefense and infectious diseases.

The Court ALLOWS defendants' motions for summary judgment (Doc. Nos. 83 & 90) and DENIES plaintiffs' motion for summary judgment and permanent injunctive relief (Doc. No. 87).

II. PROCEDURAL HISTORY

In October 2002, the NIH's National Institutes of Allergy and Infectious Disease (“NIAID”) issued a request for proposals to construct a national biocontainment laboratory suitable to perform research on extremely dangerous pathogens. The mission of the NIAID is to play a leading role in the nation's effort to develop diagnostics, vaccines, and therapeutics to combat emerging and re-emerging infectious diseases, including those that can be used as agents of terrorism.

The BUMC proposed building a laboratory on Albany Street in Boston's Roxbury and South End neighborhoods. On September 30, 2003, the NIAID granted BUMC $128 million to construct the BioLab. On December 2, 2005, the NIH issued an Environmental Impact Statement (“EIS”), and on February 2, 2006, approved the decision to fund the construction of the BioLab in Boston.

On May 18, 2006, the plaintiffs filed a complaint against the NIH, alleging that the EIS violated NEPA. On June 29, 2006, the plaintiffs moved for a preliminary injunction to enjoin federal funding of the BioLab. On August 2, 2006, in parallel litigation in state court, the Massachusetts Superior Court ruled that a separate environmental report prepared by University Associates, an affiliate of BU, was inadequate under the Massachusetts Environmental Policy Act (“MEPA”), Mass. Gen. Laws ch. 30 §§ 61–62H. See Ten Residents of Boston v. Boston Redevelopment Authority, 2006 WL 2440043, at *19 (Mass.Super.2006). The Court found that the report violated MEPA because it “failed to consider any ‘worst case’ scenario that involved the risk of contagion arising from the accidental or malevolent release of a contagious pathogen, and ... failed to analyze whether that ‘worst case’ scenario would be materially less catastrophic if the Biolab were located in a feasible alternative location in a less densely populated area.” Id. at *18.

As a result of the state court decision, University Associates was required to amend its report. On September 13, 2006, defendants in this case filed notice of their intention to perform additional risk assessments taking into account the public health consequences of the accidental release of dangerous pathogens; an alternatives analysis to determine whether siting the facility in a less-populated area would result in materially different public health consequences in the event of a pathogen release; and additional measures to identify and assess other risks associated with the BioLab. See Doc. No. 27. On October 20, 2006, this Court deferred a decision on plaintiffs' motion for a preliminary injunction until the NIH finished its supplemental report. See Doc. No. 36.

The supplemental report, entitled the “Final Supplementary Risk Assessment” (“FSRA”), was issued on July 6, 2012. On January 2, 2013, the NIH issued its decision approving the FSRA to fund the BioLab in Boston. The parties subsequently filed cross-motions for summary judgment.

III. FACTUAL BACKGROUND

A. The Experts

Soon after the order staying the development of the BioLab, the NIH began the process of amending the initial EIS by commissioning a team of expert independent scientists and engineers from the National Research Council (“NRC”) of the National Academy of Sciences. The NRC is a private non-profit society of distinguished scholars established by an Act of Congress in 1863.

In July 2007, the NIH issued a draft report to respond to the concerns regarding the EIS. A committee of 11 experts from the NRC conducted a technical review of the draft report.¹ On November 21, 2007, the NRC Committee issued a letter on the draft report and concluded that the draft “is not sound and credible.” The Committee stated that the draft “has not adequately identified and thoroughly developed worst case scenarios [and] does not contain the appropriate level of information to compare the risks associated with alternative locations.” AR Doc. 647 at 2.

In response, the NIH appointed a second set of experts, the Blue Ribbon Panel (“BRP”), in February 2008 to provide independent and scientifically based advice to the NIH regarding the scope of further risk assessments and site suitability analyses needed for the BioLab. The BRP was made up of 16 nationally recognized experts in infectious diseases, public health and epidemiology, risk assessment, modeling, risk communications, biodefense, biosafety, and environmental justice.² The NIH also requested the NRC Committee to reconvene and provide independent review of the supplementary risk assessment.

B. The FSRA

The NIH hired the environmental consulting firm Tetra Tech, Inc. to prepare the FSRA. With the BRP and NRC's input, Tetra Tech and the NIH spent the next four years developing the supplementary risk assessment that resulted in the issuance of the FSRA in July 2012. The FSRA is a 2,700–page report that evaluates the risks of release and exposure to the public of 13 different pathogens expected to be handled at the BioLab's Boston location under multiple release scenarios including terrorist attacks, laboratory accidents, transportation accidents, and natural disasters such as an earthquake. These analyses are also applied to two different alternative sites in Tyngsborough, Massachusetts (the suburban site) and Peterborough, New Hampshire (the rural site). In addition, the report includes a sealed threat assessment for malevolent acts and addresses the impact of the BioLab's Boston location on low-income, minority, and medically vulnerable populations. The following is a chapter-by-chapter summary of the FSRA's analysis of the BioLab.

1. Chapter 1: Introduction

The FSRA begins by stating that the purpose of the BioLab is “to provide safe and secure laboratories dedicated to the study of disease-causing microorganisms (pathogens) to research the pathogenesis of emerging infectious diseases ...; develop vaccines, therapeutics, and diagnostics for the pathogens; develop animal models for the comparative study of the pathogens; perform preclinical and clinical research in humans; train scientists and related support personnel in...