Archive for August 8, 2008

This story highlands the miscommunication by DHS concerning the proposed facility.

We don’t believe there would be any scenarios requiring evacuation,” Mr. Verrico said. “Pathogens at the lab would be in such minuscule quantities that any scenario that would cause the cells to become airborne … the cells would be so dispersed they would not infect people. We won’t have to evacuate. Chances of ever having to do that are practically nonexistent,” he said.

The NBAF will have a cGMP Laboratory for vaccine production, is 30- 50L a minuscule amount of agent? And they do not see any scenarios requring evalution specifically at Plum Island or other site? (Page 3-26/27 DEIS, Page 2-216 Table 3.8.9-1 — National Park Service Potential Strategies and Considerations for FMD Response (NPS 2001)


Plum report questioned
Local residents voice safety concerns about new lab operations
 North Fork residents are questioning findings in the Department of Homeland Security’s NBAF Draft Environmental Impact Statement. The EIS is part of the site selection process that’s put Plum Island in the running for a proposed Biosafety Level 4 research lab. The new facility will investigate exotic-pathogen foreign animal diseases posing significant threats to the United States. As a BSL-4 lab, it would be equipped to handle diseases that can be transmitted from animals to humans.

The current research center on the 840-acre island 1 1/2 miles east of Orient Point is a BSL-3 lab facility; it studies and works with diseases that cannot infect humans. Federal scientists have been conducting research into foot-and-mouth disease at the site for more than 50 years.

DHS, which took over operation of Plum Island from the Department of Agriculture in 2003, says it welcomes the questions. The Aug. 12 DHS forum in Greenport is “designed to help catch problems and point out errors in the EIS document,” according to a DHS spokesman.

“This is a draft document,” said DHS media officer John Verrico. “The purpose of the meetings being held in all six proposed locations is to get comments from the public about the proposal, the document, and to find answers to people’s EIS questions.”

Community questions focus on concern for public safety and quality of life both during construction and after operation of the new facility begins in 2014.

The number one issue for Orient resident Debbie O’Kane is safety. “There is a serious level of risk associated with this facility,” Ms. O’Kane said. “Unless there is a definite evacuation plan, they should not build a BSL-4 lab on Plum Island.”

There is no mention of evacuation plans in the draft EIS.

“Any evacuation plan for an area is whatever [evacuation] plans are already in place for any purpose [such as a hurricane],” Mr. Verrico explained. “We don’t modify an area’s evacuation plan; we don’t know the local details.”

Suffolk County has an evacuation plan for the North Fork, according to Joe Williams, director of Suffolk County’s Fire, Rescue and Emergency Services. He says he expects most people will self-evacuate by car and local police will keep traffic moving, which he concedes will be a challenge, given there are only two major east/west roads.

For those who can’t evacuate on their own, the county has agreements with private bus companies. Evacuees will be picked up at all county bus stops by clearly marked vehicles and taken to a shelter at Riverhead High School, says Mr. Williams. The school can accommodate 700 people.

“We don’t believe there would be any scenarios requiring evacuation,” Mr. Verrico said. “Pathogens at the lab would be in such minuscule quantities that any scenario that would cause the cells to become airborne … the cells would be so dispersed they would not infect people. We won’t have to evacuate. Chances of ever having to do that are practically nonexistent,” he said.

But Bob DeLuca, who chairs the Group for the East End, doesn’t agree with DHS. He said, “You cannot have a BSL-4 facility without an integrated emergency management plan.” He worries if there should be an “escape” of a pathogen, no matter how small, local people might panic. He asks whether local, state, and federal authorities are prepared to handle that “panic” sort of emergency. “This is a real issue for local emergency management services. They need to be prepared to respond and they need to be prepared to work with Homeland Security.”

Another section of the EIS states the federal Environmental Protection Agency must determine if groundwater will be affected as withdrawals triple, from 17 to 54 million gallons per year.

It also states there are three remediation sites (possibly containing hazardous or toxic waste) within the footprint of the proposed lab. The EIS says these would be investigated prior to any site being chosen, but it is unclear how the results of this investigation will affect site selection.

Other questions about the draft EIS:

* The importance of construction and operations costs in the decision process. (Plum Island will be the most expensive to build and operate.);

* How energy costs will be factored in. (Plum Island will run on oil, all other facilities will use lower-cost natural gas.);

* How many contractors and workers will commute/live in Connecticut versus New York;

* Whether there is community support for the new facility.

Sen. Hillary Clinton and Rep. Tim Bishop are opposed to Plum Island for the BSL-4 lab, as is Southold Supervisor Scott Russell, County Legislator Ed Romaine and County Executive Steve Levy.

Mr. Bishop and Ms. Clinton have both said DHS officials have “assured” them that the NBAF will not be built on the island.

“I oppose putting the new NBAF on Plum Island, and value DHS’s assurances the Island is not a suitable location for BSL-4 research,” Mr. Bishop said.

An informational meeting and opportunity for public comment is scheduled for Aug. 12, 6-10 p.m. at Greenport School.


 More language from the DEIS concerning the cGMP moddule 

cGMP module is needed for small-scale vaccine and reagent production. For large-scale manufacturing an industry partner would be needed. The cGMP module would allow for production and testing of two vaccine candidates at any given time. Modular components (BSL-2) would include a viral production room, a vaccine sterile assembly and fill room, a vaccine lyophilization area, and a diagnostic reagent production room. (Page 2-3 DEIS)“the largest scale envisioned for manufacturing needs in this facility is 30L – 50L. The Sterile Fill and Assembly function will support the capability to apply the agent into a delivery system for use in the study model. The primary current application for vaccines is direct injection; however, other delivery forms may be considered in the future (ingestion – solid dose, aerosol, transdermal). It is assumed that the QC Testing component to meet cGMP requirements will be supported by dedicated space and equipment located within the laboratory blocks at the NBAF”.

Restricted personnel access and full gowning procedures will be required for classified manufacturing areas. The facility is assumed to be utilized 24 hours per day, based on a year-round production schedule (365 days), with periodic shutdowns for maintenance and validation. A BSL-2 biocontainment facility is envisioned for the majority of manufacturing and support space with a BSL-3 Enhanced Viral Production Area. The ability to respond to a national emergency for zoonotic-type diseases is anticipated, which will require BSL-4 biocontainment and cGMP. For the initial program, however, BSL-4 vaccine capability will not be provided. (Page 3-27)


The Butner Town Council at last night’s monthly council meeting voted unanimously against hosting the proposed National Bio- Agro Defense Facility in Butner. Present at the meeting was Rep. Doug Berger and town manager Tommy Morrow. The council stated that they would be informing the consortium and DHS of their decision. Citing several concerns relating to the facility and unanswered questions concerning the Draft Environmental Impact Statement.

Their decision to oppose the facility comes on the heels of earlier announcements from Congressman Brad Miller and state Rep. Doug Berger. Both have gone on record saying they could not support the NBAF. The City of Raleigh voted unanimously on Aug. 6th to oppose the facility.

The Department of Homeland Security is currently holding DEIS meetings in other states, Athens, Georgia is the only state besides N.C. with organized opposition to the NBAF. The Athens meeting will be held on Aug. 14th.

DHS will be accepting comments until August 25 on the proposed NBAF,  with the final site selection to be announced sometime in October.

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