Full opinion text
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 reemerging 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 BioL-ab. 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. 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, bio-safety, and environmental justice. 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 the requirements of the area of research; and support a national response if a biodefense emergency occurs.” FSRA at 1-1. The FSRA responds to the human health issues raised by the public and the Courts: “[T]he analyses [will] determine what, if any, adverse human health effects would occur from an accidental or malevolent release of a pathogen or infected insects/animals from biocontainment. It also [will] determine[] whether there are differences in the effects if the facility were in an area with a lower population density than the Boston site.” Id. The scope of the FSRA includes “qualitative and quantitative analyses of an array of pathogens and events leading to exposure of individuals to pathogens and probabilistic estimates of initial infections, subsequent secondary transmissions, and fatalities.” Id. at 1-15. The FSRA “follows guidelines established by federal agencies for conducting and reporting risk assessments and has been performed by using available scientific data and established methods of analyses.” Id. The report also “acknowledges the uncertainty associated with the data and the appropriate role of judgment (expert opinion) in estimating key parameters required for risk assessment.” Id. Thirteen pathogens were analyzed. A subset of pathogens that could be studied at the BioLab, these 13 pathogens were selected to cover a range of pathogen characteristics, “such as their ability to be spread from person to person ..., the method by which they are spread from one person to the next ..., their ability to cause human disease ... and their ability to cause deaths among those infected....” Id. Each pathogen is designated a BSL level, ranging from 1 to 4. The BSLs are designated by the degree of protection provided to personnel, the environment, and the community. BSL-1 pathogens are the safest to handle and require the most basic level of protections. Id. at 1-10 to 1-11. BSL-4 pathogens are highly fatal and require the most stringent protections. Id. Seven of the pathogens studied were BSL-3 and six were BSL-4. Three questions guided the risk analysis in the FSRA: (1) What could go wrong? That is, what might be the sequence of events that could cause an infectious pathogen to escape the laboratory, set up a chain of transmission, and cause infectious disease in the surrounding community? (2) What are the probabilities of such a sequence of events? (3) What would be the consequences of such a sequence of events? Id. at 1-19. 2. Chapter 2: Facility Design, Operations, and Site Description Chapter 2 describes the facility’s design specifications under federal and state law as well as the operational and security procedures and systems in place designed to mitigate potential risks associated with the release of pathogens due to an accident or malevolent act. In addition to meeting the general requirements for earthquakes and severe weather events, the BSL-4 laboratory is located in the interior of the building, and is structurally isolated from the rest of the building, providing additional protection in the event of an incident which might otherwise compromise the physical integrity of the building. Id. at 2-4, 2-10. The BSL-4 space is separated from the rest of the BioLab using airlock doors that are interlinked to ensure that multiple doors cannot be opened simultaneously. Id. at 2-10. It is under constant negative air pressure (air flows from outside the laboratory space into it), and any air leaving the BSL-4 space must pass through two high-efficiency particulate air (HEPA) filters, which ensures clean air by removing at least 99.97 percent of particles having a diameter of 0.3 micrometer. Id. at 2-8. Other safety measures of the facility include: (1) implementation of a “culture of safety,” a BU safety program including training for laboratory staff, conditioning laboratory privileges on compliance with safety requirements, appointing a Laboratory Safety- Coordinator for the BioLab, and creating a Safety Committee with ongoing responsibility to review all safety procedures; (2) Select Agent clearance: because the pathogens are “select agents” according to the CDC, researchers studying those agents must be adequately screened, trained, and registered with the CDC; (3) the “two-person” rule: for any research involving BSL-3 or BSL-4 pathogens, no research may be conducted unless two researchers are present; and (4) physical security, consisting of barriers, electronic surveillance systems, and intrusion detection systems that form a comprehensive site-wide network of monitored alarms. The network includes security officers, biometric and card access devices, closed circuit television cameras, automatic door locking systems, and access alarms. The BioLab is also surrounded by an 8-foot-high security fence. Id. at 2-3. Chapter 2 also compares the public safety and emergency response capabilities of the Boston site with the proposed Tyngsborough and Peterborough sites. The Boston location has considerably more law enforcement resources to handle an emergency than the other two sites. Boston is the only proposed site that has a dedicated Emergency Operation Center that serves as a centralized location from which large-scale emergency incidents are managed and an Office of Public Health Preparedness, responsible for developing plans to deliver mass prophylactic care in response to disease outbreaks. The chapter concludes, “Heavily populated metropolitan areas, such as Boston, have developed the public safety infrastructure and capabilities necessary to provide services across the spectrum of prevention, preparedness, response, and recovery.” Id. at 2-26. 3. Chapter 3: Pathogen Characteristics Chapter 3 describes the characteristics of the 13 pathogens chosen to be studied, why these pathogens were chosen for analysis, details about their biology, the kinds of infections that each causes and limits of the availability of information for each of the pathogens. The pathogens are summarized below. The seven BSL-3 pathogens are (1) Bacillus anthraeis, a bacterium that causes anthrax; (2) Francisella tularensis, the causative pathogen of tularemia or “rabbit fever”; (3) Yersinia pestis, a bacterium that causes the plague; (4) 1918 H1N1 Influenza Virus, the prototypical pandemic strain of influenza; (5) SARS-associated Coronavirus, which causes severe acute respiratory syndrome (SARS); (6) Rift Valley fever virus (RVFV), an RNA virus in the larger family of viral hemorrhagic fevers; and (7) Andes Virus, the major etiological pathogen of Hantavirus Pulmonary Syndrome (HPS) that occurs in South America. Of these pathogens, Bacillus anthracis, Yersinia pestis, 1918 H1N1 Influenza Virus, and SARS-associated Coronavirus can be spread through airborne transmission and not solely through direct person-to-person or person-to-animal contact. According to the NRC, “some agents handled in BSL-3 facilities may present more serious potential risks than BSL-4 agents.” AR Doc. 647 at 8. “Agents are categorized for BSL-4 containment because they cause deadly disease for which there is no treatment, not because they are highly infectious and cause widespread disease.” Id. at 8-9. The six BSL-4 pathogens are the (1) Ebola virus, causing highly fatal hemorrhagic fever that interferes with the blood’s ability to clot, causes internal bleeding, and damages the body’s vascular system; (2) Marburg virus, closely related to the Ebola virus, also causing highly fatal hemorrhagic fever; (3) Lassa virus, causing a viral hemorrhagic fever; (4) Junin virus, causing the Argentine hemorrhagic fever; (5) Tick-borne Encephalitis virus, causing encephalitis transmitted through the bite of an infected tick; and (6) Nipah virus, causing viral encephalitis. These BSL-4 pathogens are among the most fatal known to mankind. All of them except the Junin virus are transmitted to humans through direct contact with infected animals or other humans. The Junin virus is transmitted to humans by inhaling the virus through the respiratory tract from rodent urine, feces, saliva, and contaminated fomites, which are inanimate substances carrying infectious organisms such as germs or parasites. FSRA at 3-63. The Ebola virus is transmissible as a blood-borne pathogen. AR Doc. 647 at 9. Scientists have hypothesized that the Ebola and Lassa viruses could be spread through airborne transmission; however, current evidence demonstrates that transmission of these viruses is associated with direct contact with infected individuals, rather than spread between humans through airborne transmission. FSRA at 3-50, 3-60; see also AR Doc. 647 at 9 (stating that the Ebola virus “is extremely unlikely to be spread through the routes of transmission”). 4. Chapter 4: Event Sequence Analysis Chapter 4 describes the process of identifying, selecting, and analyzing maximum reasonably foreseeable events that might occur at the BioLab to answer the question: what could go wrong that could cause a pathogen to escape from the laboratory and infect people in the surrounding community? The report considers more than 300 potential incidents. Because many of these incidents are similar to others, common incidents were consolidated and narrowed down into 34 categories of incident types. The 34 categories include aircraft crash, animal bite, centrifuge release, fire, flooding inside the laboratory, inadequate pathogen accountability, loss of power, malevolent act, earthquake, tornado, needles-tick, spill, and transportation mishap. FSRA at 4-9. Likely frequencies were assigned to each category along with a description of the potential exposure of laboratory workers, other facility workers, and members of the public. Id. at 4-8 to 4-11. The 34 event types are further grouped into five scenarios that purport to represent all potential event types because the risks associated with these five scenarios provide the upper bounds for the risks posed by similar events. The five scenarios are: (1) a centrifuge release, in which a centrifuge tube breaks and a pathogen is released into the air; (2) a needlestick, in which a lab worker breaks his skin with a needle so that the pathogen enters his body; (3) an earthquake, including the maximum reasonably foreseeable event that would cause total collapse of the BioLab building and release all of pathogens; (4) an aircraft crash into the BioL-ab; and (5) malevolent acts, such as a terrorist attack. The analysis indicated that an earthquake, aircraft crash, and malevolent act could cause the greatest harm, with high exposure of pathogens to laboratory and facility workers and “moderate” exposure to the public. At the same time, the report calculates that the probability of an earthquake or aircraft crash strong enough to cause a dangerous pathogen release is only once in 10,000 to 1 million years. Id. at 4-31, 4-48. Aerosolized pathogen particles could be dispersed beyond 300 meters, but concentrations would be extremely low beyond three kilometers. The centrifuge release would cause moderate exposure to laboratory workers but no exposure to other facility workers or the public. Similarly, the needlestick would cause low exposure to laboratory workers but no exposure to other facility workers or the public. The probability of a centrifuge release or needlestick is once in 1 to 100 years. The likelihood of an undetected and unreported needlestick decreases to once in 100 to 10,000 years. The analysis also determined that the probabilities of these incidents would be the same at all three sites, except for an airplane crash, which is more likely to occur at the Boston site because of its proximity to Logan Airport. According to United States Department of Energy guidance, the likelihood of a malevolent act (like terrorism) is “unknowable” and therefore the frequency of the event cannot be measured. While it is too speculative to calculate the risk of a malevolent act, Chapter 6 and the sealed threat assessment analyze various factors that could make a terrorist attack more likely or less likely at the three sites. See infra pp. 28-30. Appendix D summarizes the reports of Dr. Karl Johnson who found, for the five BSL-4 facilities he reviewed from 1970 to 2009, “no infections occurred during 700,-000 worker hours of facility operation.” Id. at D-5. In addition, he surveyed three BSL-3 laboratories of the National Institute of Allergy and Infectious Diseases from 1982 to 2003 and found that only one clinical infection and four asymptomatic infections had occurred for 3.2 million worker hours of operation during those years. Id. The Johnson reports are viewed as having “the best data available for use in estimating frequency of infections in BSL-3 and BSL-4 facilities.” Id. at D-6. The BSL-4 facilities surveyed represent the extent of the BSL-4 operation in the United States. However, the Johnson reports do not reflect all the BSL-3 facilities, which number in the hundreds. The FSRA summarizes: Airborne dispersion calculations for the [Maximum Reasonably Foreseeable] earthquake show that individual members of the public beyond the NEIDL exclusion fence (i.e., at least 30 m from the facility) would receive an average exposure that is smaller than any dose proven to cause infection in humans or animals via inhalation, with the possible exception of [Rift Valley Fever Virus]. While this is an extremely severe event that includes the loss of all biocontainment features and results in the maximum credible release amount, the public exposure estimates are still small due to the small quantities of pathogen in the laboratory, the limited potential for release of this inventory, and the dilution of any release in the atmosphere. Id. at 4-51. 5. Chapter 5: Transportation Analysis Chapter 5 addresses potential risks associated with transporting pathogens to and from the BioLab. A traffic accident involving these shipments, in which packages containing pathogens might be damaged, may pose a risk to the surrounding community due to the risk of exposing members of the public to infectious materials. Because BSL-3 and BSL-^1 pathogens are classified as Category A Infectious Substances under U.S. Department of Transportation regulations, they must be triple-packed, which includes a leak-proof primary receptacle, a leakproof secondary packaging, and a rigid outer packaging of adequate strength for its capacity, mass, and intended use. Id. at 5-2. Because of the strength of the packaging used to transport these pathogens and the nature and amount of pathogens being transported, the report concludes that the likelihood of a public infection resulting from a transportation-related release is less than once in 1 million years. Id. at 5-28. Crash-related injuries and fatalities would be far more likely to occur. The report states that three sites would have the same probability because “the protocols followed for pathogen shipments would be similar for all sites.” Id. 6. Chapter 6: Threat Assessment Methodology Overview Chapter 6 summarizes the procedures used and the conclusions reached in performing the threat assessment for the BioLab. It addresses the likelihood of malevolent acts, threats to the public that stem from deliberate efforts to expose personnel at the BioLab or members of the public to the pathogens studied there. Because of the sensitive nature of the threat assessment, it is considered a “Controlled Document” under the provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. Therefore, only an overview of the findings is described in the report. The threat assessment analyzes the threats to and vulnerabilities of the security systems in place at the BioLab, and examines the security and police personnel and procedures, electronic systems, BioL-ab policy and procedures, and facility design and construction. It attempts to identify and evaluate threats at each of the three sites, determine the likelihood of those threats occurring, assess the potential consequences associated with the impact if those threats occurred, and provide effective mitigation measures to ensure secure operations against the identified threats. Id. at 6-1 to 6-2. In order to determine the types of threats at each site, the assessment analyzed crime statistics, determined the local threat environment by conducting interviews with federal, state, and local law enforcement agencies, collected and evaluated threat intelligence, and determined the target attractiveness (i.e., how suitable the target would be to a malevolent actor’s primary goal). Id. at 6-4 to 6-5. The threat assessment identifies 11 scenarios of potential threats, ranging from a disgruntled employee surreptitiously removing and releasing a pathogen to an extremist group blowing up the BioLab with an improvised explosive device (“IED”). Id. at 6-11 to 6-12. According to Department of Energy guidance, it is too speculative to analyze the consequences of malevolent acts “because the potential number of scenarios is limitless.” Id. at O-163. For example, the report describes the hypothetical scenario of a terrorist removing a pathogen from the facility and using a nebulizer and fans in a highly populated area to deliver high exposure levels to a large number of people. Because the release could be attempted at any location of the terrorist’s choosing, the report states that “the potential consequences of such a release ... would be speculative and is beyond the scope of this [report] to attempt to characterize the consequences of this type of scenario.” Id. at 6-17 to 6-18. Therefore, the threat assessment recommends that the consequences for malevolent acts “could be discussed by comparison to the consequences of a severe accident.” Id. at O-163. The consequences resulting from the malevolent act scenarios (including the use of an IED to damage the containment boundary and the HVAC systems, including the HEPA filters), were analyzed in comparison to maximum reasonably foreseeable earthquake consequences. The threat assessment concludes that all malevolent acts scenarios would necessarily be less consequential than an earthquake that would result in the complete collapse of the facility and a total loss of pathogens “because the inventory is less, the release fraction is less, and the release may be discharged [above ground level],” diluting the pathogen release and reducing the harm to the public. Id. at O-238; AR. Doc. 770 at 6-17. The NIH filed under seal and ex parte the threat assessment, dated October 26, 2010. Because of its confidentiality, plaintiffs did not have an opportunity to review or challenge it. Among other things, the Tetra Tech threat assessment team used various methodologies in its analysis of the comparable risks at the three sites, which are used by the Department of Defense for offensive target analysis based on military objectives. One methodology is designed “to determine the most likely terrorist targets.” Threat Assessment at 48. In a comparison of terrorist scenarios for the three sites, the Boston location scored the highest because of two criteria: population and proximity. Other methodologies were also used to evaluate target “attractiveness”, for example by looking at other potential targets within three to five miles of the site and by looking at the accessibility, vulnerability and recognizability of a site from a criminal’s point of view. Id. at 78-82. After examining the baseline physical and operational security, the threat assessment concluded that the “systems being employed at the exterior of the [BioLab] provide a well defined perimeter and make this area a difficult environment for a malevolent act to be successfully carried out by an outsider.” Id. at 102. Interior security systems were also described. The Tetra Tech team developed the 11 “worst case” scenarios involving internal and external breaches of security by terrorists, extremists, criminals, malicious employees, and persons with psychopathic tendencies. Overall, the report ranked the threat from insiders (those working at the facility) as higher than the threats from other malevolent actors. Id. at 156. The report explained that the first and primary response force for the vast majority of the scenarios were the protective service officers, and the onsite security features remain the same for each comparative location. Id. at 157. Significantly, the threat assessment identified and recommended additional, upgraded measures to mitigate the effects of deliberate actions by terrorists and other malevolent actors to destroy, incapacitate, or exploit the facility’s mission, pathogens, and technology, which for obvious reasons I do not describe. With the recommended mitigation features, the threat assessment concluded that “no matter where the [BioLab] is located amongst the comparable sites, the risk from a malevolent act is essentially the same, regardless of the differences associated with the current and projected threat spectrums at the three sites.” Id. at 158. On September 4, 2013, the Court issued an order requesting a supplemental filing regarding the status of the recommended mitigation features. In response, defendants filed the affidavits of Thomas G. Robbins, the Executive Director of Public Safety of Boston University, Kevin Tuohey, the Executive Director for Research Compliance of Boston University, and Allred P. Johnson, Director of Research Services, NIH, who also serves as NIH’s Chief Security Officer and the Designated Agency Safety and Health Official. In these affidavits, defendants provide evidence that the mitigation recommendations in the threat assessment have been or will be addressed prior to the initiation of the NEIDL’s operations. The defendants also provide evidence that the threat assessment is consistent with information gleaned by law enforcement after the Boston Marathon bombings. 7. Chapter 7: Potential for Released Pathogens to Become Established in the Environment Chapter 7 considers whether, if any of the 13 pathogens were released from the BioLab, either by accident or malevolent act, a pathogen could become established in the environment in the New England area (in animals, insects, soil, or water). The analysis showed that four BSL-3 pathogens — Francisella tularensis, Yersinia pestis, 1918 H1N1 Influenza Virus, and Rift Valley fever virus — could become established in the environment if released from any of the three locations. Id. at 7-13 to 7-17. However, because the “intensively urbanized nature of the [Boston site] supports smaller populations of [disease-carrying animals],” it would be more difficult for these pathogens to become established in the local environment in Boston as compared to the rural and suburban sites. Id. at 7-22. One BSL-4 pathogen, Tick-borne Encephalitis Virus, could also become established, but this is unlikely to occur. The virus would have to adapt to a new host, since the tick which carries it is not endemic to New England. Id. at 7-17 to 7-22. 8. Chapter 8: Health Effects — Initial Exposure Chapters 8 and 9 address what could happen if any of the 13 pathogens were released either inside the BioLab or outside in the community. In order to determine the probability of infection and death to laboratory workers, facility workers, and the public under a variety of scenarios, the report utilizes a methodology based on a review of the available literature and mathematical modeling exercises with both qualitative and quantitative components. Because information in the literature and sufficient quantitative data are not available for all pathogens, NIH convened an additional expert panel, using the modified Delphi methodology, to fill in the missing gaps. Id. at H-2. Chapter 8 looks at the likelihood of an infection or fatality occurring as the result of direct exposure to the pathogens from an accident inside the BioLab. The report analyzes the extent to which the scenarios causing the exposure of pathogens described in Chapter 4 — centrifuge release, needlestick, and maximum reasonably foreseeable earthquake — would result in infections or fatalities. The first step is to analyze the probabilities of how likely it is for an infection to occur after exposure to different amounts of each pathogen through the respiratory route, called the dose response assessment. As a result of the dose response assessments and modeling, the report concludes the following: A laboratory worker would become infected about once per 100 to 10,000 years as a result of an undetected and unreported needlestick, and would die about once per 200 to 1 million years. Id. at 8-10 to 8-14. A laboratory worker would become infected about once every 100 to 10,000 years as a result of a BSL-3 pathogen centrifuge release, and would die once every 5,000 to more than 2 million years, with the Rift Valley fever virus having the highest probability. Id. at 8-20. Regarding the maximum reasonably foreseeable earthquake scenario, resulting in the complete destruction of the building and release of all pathogens, the highest probability of infection to the public is associated with the Rift Valley fever virus at once per 100,000 years, then the Ebola virus at once per 6 million years, and all other pathogens at once per 10 million years. Id. at 8-25 to 8-32. With regard to medically vulnerable subpopulations— children under five years old, adults over 65 years old, people with diabetes, people with HIV/AIDS, and pregnant women— there is no significant increase of risk to these populations at any of the three sites. Id. at 8-42 to 8-43. 9. Chapter 9: Secondary Transmission Chapter 9 considers the likelihood of an infected laboratory worker or member of the public being able to transmit the pathogen to other members of the public and potentially causing a dangerous outbreak. All 13 pathogens were analyzed qualitatively and four of the pathogens that can be transmitted directly from person-to-person contact — -Yersinia pestis, 1918 H1N1 influenza virus, SARS-associated coronavirus, and Ebola virus — were analyzed quantitatively as well. Id. at 9-2. The report concludes that the probability of secondary infections is so low that none is likely to occur for any of the pathogens over the proposed 50-year life of the BioL-ab. Of the BSL-3 pathogens, Yersinia pestis, 1918 H1N1 influenza virus, and SARS-associated coronavirus pose the highest risk for secondary transmission. Id. at 11-9. The Ebola virus represents the highest transmission risk among BSL-4 pathogens. Id. at 11-11. The pathogen with the highest likelihood of the public being infected through secondary transmission is the 1918 H1N1 influenza virus at once in 550 to 16,000 years. Id. at 9-6. For the total number of infections and fatalities, the report states that there is no statistically significant difference among the three sites. “The reason that the overall results from the suburban and rural sites are so similar to the urban site results is that there is a high estimated rate of commuting to and from the towns at those sites, so that a significant portion of transmissions occur among nonresidents and are not subject to local population constraints or to the estimates for decreased contact rates that were based on residents only.” Id. at 9-15. When comparing local residents at each site, “[tjhere tends to be a lower estimated chance of each consequence ... at the suburban and rural sites compared to the urban site because of commuting and contact rate differences, although uncertainty ranges overlap in most cases. The differences suggest that a more substantial portion of the risk from an undeteeted/unreported laboratory worker infection at the suburban and rural sites would be borne by nonresidents, particularly areas with a strong connection with the local area via commuting.” Id. For each medically vulnerable subpopulation, the estimated likelihood of infections and fatalities was not substantially different among sites. Id. at 9-15 to 9-16. 10. Chapter 10: Environmental Justice Chapter 10 addresses NIH’s compliance with Executive Order 12,898, Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations, which “directs federal agencies to develop environmental justice strategies to address disproportionately high and adverse human health or environmental effects of their programs on minority and low-income populations, and to focus federal attention on the environmental and human health conditions of minority and low-income populations with the goal of achieving environmental protection for all communities.” Id. at 10-1. The order is also intended “to promote nondiscrimination in federal programs that affect human health and the environment and provide minority and low-income communities’ access to public information and public participation in matters relating to human health and the environment.” Id. at 10-1 to 10-2. The report analyzes how the BioLab would affect low-income and minority populations at the three locations. It first compares the percentage of low-income and minority populations within a 10-ki-lometer (6-mile) radius from the center of each site to ensure that all potential areas that could be affected by a release of pathogens are considered. At the Boston location, 51 percent of census tracts have a minority population greater than the national average, while 53 percent have a poverty level greater than the national average. Id. at 10-13. For the Tyngsborough suburban location, these numbers are 22 percent for the minority population and 24 percent for the poverty level. Id. at 10-15. For the Peterborough rural location, they are 0 percent for both the minority population and the poverty level. Id. at 10-17. The report acknowledges that low-income and minority populations would likely be more affected by a pathogen release at the Boston site compared to the other two locations because of its higher percentages of both minorities and low-income persons. It also states that “[t]here are reports of higher rates of infectious diseases such as HIV/AIDS, syphilis, hepatitis, and tuberculosis among racial and ethnic minorities----Thus, health disparities along with chronic diseases have the potential to contribute to increased susceptibility to any of the pathogens being studied in this [report].” Id. at 10-23. However, the report concludes that the risk of direct pathogen exposure to the low-income and minority populations within a 2-kilometer radius of the Boston location is extremely low. In the event of a maximum reasonably foreseeable release earthquake, the “public would receive an average exposure that is unlikely to cause infection,” with the possible exception of the Rift Valley fever virus where the frequency is still very low. Id. at 10-20. With regard to secondary transmissions, “the potential for exposure extends well beyond the 10-km (6-mi) radius used for the demographic study, and those at greatest risk will be the [infected person’s] social contacts.” Id. at 10-20. The extent to which individuals living closer to the Boston site “would bear the risk estimated under secondary transmission scenarios is not obvious, due to the unpredictability of where transmissions would occur among people traveling in and out of the local area.” Id. at 10-21. Therefore, “the analysis did not determine that people in close proximity to the [Boston location] were at greater risk than people in the larger vicinity located farther away.” Id. at 10-22. 11. Chapter 11: Risk Characterization Chapter 11 provides the overall conclusions of the report. In summary, the FSRA concludes that the risk of infections or deaths resulting from accidents or malevolent acts at the BioLab are generally very low to only remotely possible. This is largely due to the safeguards and training at the facility and the low amounts of pathogens used. The report states that based on experience at other BSL-3 and BSL-4 laboratories, “laboratory workers may be exposed to pathogens and [laboratory associated infections] are a real possibility” because of the likelihood of a needlestick or centrifuge release. Id. at 11-14. “The greatest potential risk identified in the analysis is to the people conducting research in the laboratories.” Id. at 16. “Infections caused by 12 of the 13 pathogens are unlikely to occur in the lifetime of the facility (estimated to be 50 years); only Rift Valley Fever Virus infection has a reasonable chance of causing infection in a lab worker.” Id. Comparing risks to the general public at the three locations, the report acknowledges that there are slightly smaller risks at the suburban and rural sites compared to the Boston site. The estimated likelihood of infections and fatalities resulting from secondary transmission among the public is “slightly greater” at the urban site because residents’ contacts on average are fewer in the suburban (15 percent lower) and rural (50 percent lower) sites, and the populations are lower. Id. at 11-24. However, the difference was not substantial. Id. The report also acknowledges that the urban site has a relatively greater risk of a fatality from direct exposure to the Rift Valley fever virus following an earthquake because of Boston’s higher population density. Id. at 11-25. However, regarding the overall risk to the public, the Reader’s Guide to the FSRA concludes: “The risk to the general public is extremely low, or beyond reasonably foreseeable.” Id. at 17. Regarding secondary transmissions, which pose a greater risk to the public, the Reader’s Guide concludes that even infections from a release of 1918 H1N1 influenza and SARS, which are the most likely to occur, “might occur over 500-5,000 years of operation, far beyond the facility lifetime of 50 years.” Reader’s Guide at 17. C. Public Input In addition to receiving comments from the NRC Committee and BRP experts, the NIH also solicited input from the public when drafting the FSRA. From 2008 to 2010, the BRP held seven meetings (four located in Boston) aimed at informing the public as well as receiving questions and comments from the public. In these meetings, Boston community members asked questions about and provided comments on the proposed work plan recommended by the BRP, environmental justice issues and how to effectively engage communities, planning and oversight of biocontainment laboratories, the report’s design and methodology, the proposed approach to quantitative modeling, and initial and secondary infection rates. Id. at 10-11. On April 19, 2012, the NIH also held a 3-hour public hearing in Boston to receive comments on the final draft of the FSRA. D. Conclusions of the Experts The BRP and NRC Committee spent considerable time reviewing and critiquing the report to ensure it adequately addressed the risks of permitting research of BSL-3 and BSL-4 pathogens at the Boston site. Over the four years it took to draft the FSRA, the BRP met nine times, held 25 teleconferences, met with the NRC Committee six times, and conveyed its findings to the NIH in four meetings with the NIH Advisory Committee to the Director of NIH. In reviewing the final report, the BRP concluded that: This study is unprecedented in its scope, breadth and complexity, and utilized widely accepted validated methods. The scenarios described in the risk assessment used real live data and experience to the maximum extent possible. With that in mind the Blue Ribbon Panel believes that this is the most scientifically sound rigorously conducted study that is possible at this point. AR. Doc. 371 at 11-12. Since its initial letter in 2007 finding the first draft of the FSRA to be “not sound and credible,” the NRC Committee issued updated letter reports in 2008, April 2010, September 2010, and December 2011. The NRC Committee remained critical of the FSRA’s methodology throughout the drafting process. For example, the September 2010 letter concluded that the NRC Committee “could not endorse as scientifically and technically sound the illustrative analyses presented.” AR. Doc. 650 at 7. At that time, the committee found that the “the analyses presented did not represent a thorough assessment of the public health concerns.” Id. However, in its final December 2011 letter, the NRC Committee concluded that the NIH responded to many of its concerns and stated: The [FSRA] is now closer to reaching its goal of being “scientifically and technically sound” and, in general, addresses the concerns raised in the original NRC review of the “DSRASSA” document in 2007. While there are many approaches to preparing a risk assessment and in some aspects the Committee would have used approaches other than those found in this draft, this is no reason to fault the document. It is clear that NIH and the Blue Ribbon Panel have gone to unprecedented lengths to improve the risk assessment for the [BioLab] and have made substantial advances____ It is the Committee’s view that no further advice from this group would be useful nor should it be required. Id. at 14. IY. DISCUSSION A. Standard of Review Plaintiffs allege that the NIH violated NEPA and the Administrative Procedures Act (“APA”) by issuing its decision allowing funding of the BioLab in the current Boston location. NEPA provides: [A]ll agencies of the Federal Government shall ... (C) include in every recommendation or report on proposals for legislation and other major Federal actions significantly affecting the quality of the human environment, a detailed statement by the responsible official on — (i) the environmental impact of the proposed action, (ii) any adverse environmental affects which cannot be avoided should the proposal be implemented, [and] (iii) alternatives to the proposed action.... 42 U.S.C. § 4332. NEPA does not dictate whether a government agency may fund a project like the BioLab. Instead, “it simply prescribes the necessary process for preventing uninformed — rather than unwise — agency action.” Robertson v. Methow Valley Citizens Council, 490 U.S. 332, 333, 109 S.Ct. 1835, 104 L.Ed.2d 351 (1989). NEPA’s procedural requirements are meant to “ensure both that an agency has information to make its decision and that the public receives information so it might also play a role in the issue.” Dep’t of Transportation v. Public Citizen, 541 U.S. 752, 768, 124 S.Ct. 2204, 159 L.Ed.2d 60 (2004); see also 40 C.F.R. § 1500.1(c) (“The NEPA process is intended to help public officials make decisions that are based on an understanding of environmental consequences, and take actions that protect, restore, and enhance the environment.”). “NEPA does not prevent agencies from then deciding that the benefits of a proposed action outweigh the potential environmental harms: NEPA guarantees process, not specific outcomes.” Town of Winthrop v. FAA, 535 F.3d 1, 4 (1st Cir.2008). “Judicial review of a federal agency’s compliance with NEPA is governed by [the APA].” Airport Impact Relief, Inc. v. Wykle, 192 F.3d 197, 202 (1st Cir.1999). “[T]he reviewing court shall hold unlawful and set aside agency action, findings, and conclusions found to be ‘arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.’ ” Id. (quoting 5 U.S.C. § 706(2)(A)). “While this is a highly deferential standard of review, it is not a rubber stamp.” Id. at 203; see also Citizens Awareness Network v. U.S. NRC, 59 F.3d 284, 290 (1st Cir.1995) (“[Deference is especially marked in technical or scientific matters within the agency’s area of expertise.”). “The reviewing court must undertake a thorough, probing, in-depth review and a searching and careful inquiry into the record. Only by carefully reviewing the record and satisfying itself that the agency has made a rational decision can the court ensure that agency decisions are founded on a reasoned evaluation of the relevant factors.” Wykle, 192 F.3d at 202 (internal quotations omitted). “NEPA requires an agency to take a ‘hard look’ at environmental consequences.” Beyond Nuclear v. U.S. NRC, 704 F.3d 12, 19 (1st Cir.2013). Summary judgment is an appropriate procedure for resolving a challenge to a federal agency’s administrative decision when review is based upon the administrative record. If the Court finds “the agency’s determination procedurally adequate, summary judgment in [the agency’s] favor [is] appropriate unless [the non-moving party has] raised a genuine issue of material fact as to whether its substantive decision was arbitrary and capricious or an abuse of discretion.” Concerned Citizens on I-190 v. Secretary of Transportation, 641 F.2d 1, 7 (1st Cir.1981). “[T]he real question is not whether the facts [can establish some dispute], but rather, whether the administrative record, now closed, reflects a sufficient dispute concerning the factual predicate on which [the agency] relied ... to support a finding that the agency acted arbitrarily or capriciously.” Commonwealth of Massachusetts v. Sec’y of Agric., 984 F.2d 514, 525 (1st Cir.1993). B. Plaintiffs’ Challenges to the FSRA Plaintiffs allege that the FSRA fails to adhere to NEPA’s requirements in a number of respects. The Court addresses each of their arguments below. 1. Statement of Purpose Plaintiffs contend that the NIH has violated NEPA by relying on an outdated statement of purpose and need for building the BioLab. A statement of purpose and need must “briefly specify the underlying purpose and need to which the agency is responding in proposing the alternatives including the proposed action.” 40 C.F.R. § 1502.13. “Courts review purpose and need statements for reasonableness giving the agency considerable discretion to define a project’s purpose and need.” Alaska Survival v. Surface Transp. Bd., 705 F.3d 1073, 1084 (9th Cir.2013). “A purpose and need statement will fail if it unreasonably narrows the agency’s consideration of alternatives so that the outcome is preordained.” Id. “Where an action is taken pursuant to a specific statute, the statutory objectives of the project serve as a guide by which to determine the reasonableness of objectives outlined in an [Environmental Impact Statement].” Id. at 1084-85. Plaintiffs argue that the NIH’s statement of purpose and need relies on an outdated 2002 report indicating that there was an “insufficient amount of [BSL]-3 and BSL-4 laboratory space ... [to] protect the United States from further bioterrorist attacks.” FSRA at 1-4. Plaintiffs provided the NIH with an Alternative Vision document they prepared in 2010 suggesting that modern research techniques limit the need for live pathogen research. See id. at O-100. Others opposing the BioLab have noted the proliferation of bio-safety laboratory space in the United States since 2002. Id. at O-89, O-236. The NIH’s decision to construct the BioLab was part of its response to a Congressional mandate in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. In the aftermath of the September 11th terrorist attacks and “ongoing threats from new and emerging pathogens” — including anthrax letter attacks in 2001 and SARS and bird flu scares in 2002 — Congress mandated “a major expansion of research on such biological agents with an emphasis on the development of vaccines, therapeutics, and diagnostics to address these public health threats.” AR. Doc. 804 at 1. Over the past decade, the continuing need to construct BSL-3 and BSL-4 laboratory space has been supported by the NIH’s National Institutes of Allergy and Infectious Disease, the Institute of Medicine of the National Academy of Sciences, and the NRC Committee. See FSRA at 1-4, 1-7; AR. Doc. 650 at 6 (NRC Committee “acknowled[ing] and emphasizing] the need for biocontainment laboratories, including BSL-4 laboratories”). Plaintiffs’ claim fails because the NIH has adequately and reasonably demonstrated the continuing need to build the BioLab pursuant to Congressional mandate. Its decision is entitled to deference. See Alaska Survival, 705 F.3d at 1086. 2. Alternatives to the Boston location Plaintiffs contend that the FSRA does not adequately analyze the proposed alternatives to the Boston location, namely the suburban Tyngsborough and rural Peterborough sites. “The duty under NEPA is to study all alternatives that appear reasonable and appropriate for study at the time of drafting the EIS.” Beyond Nuclear, 704 F.3d at 20 (internal quotations omitted). “[T]he consideration of alternatives is ‘the heart of the environmental impact statement.’ ” Dubois v. U.S. Dep’t of Agric., 102 F.3d 1273, 1286 (1st Cir.1996) (quoting 40 C.F.R. § 1502.14). “The EIS [should] ‘rigorously explore and objectively evaluate all reasonable alternatives, and for alternatives which were eliminated from detailed study, briefly discuss the reasons for their having been eliminated.’ ” Id. (quoting 40 C.F.R. § 1502.14(a)). “[T]he decisionmaker [must] be provided with a detailed and careful analysis of the relative environmental merits and demerits of the proposed action and possible alternatives.” Id. at 1286-87 (internal quotations omitted). The First Circuit has characterized this requirement as “the linchpin of the entire impact statement.” Id. at 1287 (internal quotations omitted). “The discussion of environmental effects of alternatives need not be exhaustive. What is required is information sufficient to permit a reasoned choice of alternatives as far as environmental aspects are concerned.” Id. (internal quotations omitted); see also Seacoast Anti-Pollution League v. Nuclear Regulatory Comm’n, 598 F.2d 1221, 1232 (1st Cir.1979) (“Alternative sites cannot be studied Ad infinitum, and the fact that a sampling of sites has been found not to be superior affords some basis for believing that other sites will fare no better.”). a. Alternatives Analysis Assumptions In this ease, the original EIS “failed to consider alternative locations for the Biol-ab.” Allen v. Boston Redevelopment Auth., 450 Mass. 242, 259, 877 N.E.2d 904 (2007). The FSRA attempts to fix the problem by adding analysis of the suburban Tyngsborough and rural Peterborough sites. The plaintiffs maintain that the alternatives analysis is based on unsupported assumptions that favor a predetermined choice of the Boston location. i. Structure of the BioLab Plaintiffs first criticize the FSRA’s assumption that the proposed laboratories in Tyngsborough and Peterborough would have the identical structure as the Boston BioLab. Plaintiffs contend that given the greater space available at the other locations (210 acres in Tyngsborough and 700 acres in Peterborough), a BSL-4 laboratory could be built on those sites with different dimensions that could alter the risks associated with secondary transmissions or malevolent attacks. Defendants respond that the NIH’s decision to assume the other sites had the same structure was reasonable because regardless of where the facility was located, it needed to conform to “the same high standards of bio-safety containment protection, earthquake resistence, and external force protection.” FSRA at O-102. Moreover, to adequately compare the risks at the three sites, “the alternatives [needed to] be developed to a comparable level” as the Boston site. Id. Finally, the FSRA adds that even if alternate designs were proposed for the other two locations, it “would not significantly alter the results” of the risk analysis. Id. at O-230. Specifically, the centrifuge release and needlestick scenarios would not be affected by a different structure because they only concern operations inside the facility. The MRF earthquake scenario would also not be affected because it assumes a total release of all pathogens which would not change due to the size or structure of the building. See id. Plaintiffs have not explained how a change in the structure of the BioLab would make a substantial difference. ii. Commuting Methods Plaintiffs also contend that the FSRA does not take into account the higher risk of secondary transmission of pathogens based on the commuting methods to the Boston site as opposed to the rural and suburban sites. They argue that because many workers will commute to Boston using public transportation, the likelihood of an infected lab worker transmitting a disease to the public would be greater if he traveled to and from the Boston location by bus or subway than if he were commuting by car to the rural and suburban sites. This argument has greater force. The NRC Committee’s 2007 letter finding the draft supplementary risk assessment “not sound and credible” specifically criticized the draft’s assumptions that “[t]ravel to and from the facility [would] be by privately operated vehicle for all three locations” and “use of public transportation (trains or buses) is unlikely in the case of the South End of Boston inner city location.” AR. Doc. 647 at 14. The 2007 letter stated that lab workers would likely have more contacts with the public at the Boston site because of the use of public transportation, which would affect the secondary transmission analysis. The NRC suggested that the NIH analyze whether there would be “a higher potential for aerosol transmission of disease in such crowded microenvironments where aerosol transmission between humans may be very important as a mechanism for the spread of contagious diseases.” Id. The NIH acknowledges that it did not quantitatively consider how public transportation may affect secondary transmissions of pathogens. The FSRA states: “Use of public transportation was not specifically addressed because assessment of potential links between public transit ridership and risk of acquiring infection is an open area of research and no clear correlations were found in the literature that could be used to support any further adjustments in assumed site-specific contact rates.” FSRA at O-123; see id. at L-18 (“The formulation of quantitative models to address [issues including public transportation] is an open area of research, and at present there are no well established or validated methods for estimating the effects of these characteristics on rates of transmission for specific sites or populations.”). While the NIH concluded that public transportation data could not be incorporated into a quantitative analysis of the rate of secondary transmissions because of the lack of reliable scientific literature, the FSRA does address the risks associate