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New Research Compliance Issues for Biological and Hazardous Materials. Peter A. Reinhardt, Director Dept. of Environment, Health & Safety. Overview of Today. Shipment/mailing of research materials, sample and specimens Department of Commerce Export rules Select Agent requirements
Peter A. Reinhardt, Director
Dept. of Environment, Health & Safety
“Violations contrary to the U.S. Code of Federal Regulations (CFR) 49, if substantiated, may result in the assessment of a civil penalty of up to $27,500 per violation, and deliberate violations may result in criminal prosecution of up to $500,000 and 5 years in prison.”
Professor at U. of Delaware Pleads Guilty in Case Involving Smuggled Poultry Virus
A popular professor of microbiology at the University of Delaware pleaded guilty last week to criminal charges related to the smuggling of a poultry virus from Saudi Arabia.
If the federal judge presiding over the case accepts a plea agreement reached with the U.S. attorney for Maine, the professor, John K.
Rosenberger, will serve six months of home detention, be on probation for two years, and pay a fine of up to $250,000.
Mr. Rosenberger, a former chairman
of the department of animal and food sciences at Delaware\'s College of Agriculture and Resources, is known for his work on avian disease. He pleaded guilty in the U.S. District Court in Bangor, Me., to aiding and abetting the receipt and concealment of a smuggled virus -- in this case, a type of avian influenza that can devastate commercial flocks -- in his university laboratory.
George T. Dilworth, an assistant U.S. attorney in Maine, said there are no bioterrorism connections in the case. However, he said, before the September 11 terrorist attacks, people were too cavalier about violating regulations on the importing of viruses from other countries. "We now understand why these rules are as strict as they are," he said.
Regulate the distribution to foreign nationals and foreign countries of strategically important products, services and information for reasons of foreign policy and national security
Credits: Erica Kropp and Anne Bowden, University of Maryland College Park
Robert Hardy, Council on Government Relations
Applies to information resulting from basic and applied research in science and engineering conducted at an accredited institution of higher education (EAR) or higher learning (ITAR) located in the U.S. that is not restricted for proprietary reasons or specific national security reasons (EAR) or subject to specific U.S.G. access and dissemination controls (ITAR) See 15 CFR 734.8(a) and 22 CFR 120.11(a)(8).
2 March 2005
= “Deemed Export”
In March 2004, the Department of Commerce’s Inspector General issued a report on the status of EAR compliance, and stated that: “Technology related to controlled equipment—regardless of how use is defined—is subject to the deemed export provisions (and the requirement to license foreign nationals having access to that equipment) even if the research being conducted with that equipment is fundamental.”
Botulinum neurotoxin producing species of Clostridium
Venezuelan Equine Encephalitis virus
2 March 2005Examples of Regulated Select Agents
SEC. 817 of the USA Patriot Act:(Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism)
“Whoever knowingly possesses any biological agent, toxin, or delivery system of a type or in a quantity that, under the circumstances, is not reasonably justified by a prophylactic, protective, bona fide research, or other peaceful purpose, shall be fined under this title, imprisoned not more than 10 years, or both.”
Are visitors issued cards? Is the card system used to record all area access?
Piggybacking/tailgating–following someone inside
Revolving door–entering upon someone’s exit
Blocking doors open
“Innocent” piggybacking—entry by multiple cardholders following a single swipe (no record of cardholders who don’t swipe)
2 March 2005Card System Failures
Security training is required!
“When we have a free path, we go forward. If we meet an obstacle, we go around it. If the object cannot be overcome, we retreat. When the enemy is unprepared, we surprise him. If he is alert, we leave him alone.”—Baader-Meinhoff Gang, infamous German urban terrorist organization
Ronald J. Jackson and colleagues at Australia\'s Commonwealth Science and Industrial Research Organization and Australian National University
Journal of Virology, February 2001
In trying to develop a mouse contraceptive to control pest populations, the researchers inserted a gene for an immune-system molecule called interleukin-4 into the mousepox virus. Instead of rendering mice infertile, the engineered virus was far more deadly than the natural strain, killing even mice that had been vaccinated against mousepox.
Eckard Wimmer and researchers at the State University of New York at Stony Brook
Science, August 9, 2002 (online edition, July 11)
Used the genetic sequence of poliovirus to order pieces of DNA from a company. By patching the pieces together and putting the complete DNA chain into a soup of cellular molecules, the team created poliovirus particles capable of paralyzing and killing mice.
Saturday, February 5, 2005By Alice Dembner and Stephen Smith, The Boston Globe
BU Scientists Missed Bacteria-illness Link Chief Of Research On Tularemia Quits
Boston University scientists ran tests in August that showed two laboratory workers had been exposed to tularemia, but they did not connect the results to their illnesses three months earlier because they were convinced that they were working with a weakened strain of the bacteria that could not cause disease, BU officials said yesterday.
A top university administrator and the state\'s leading infectious disease official said that the test results should have
spurred the researchers to investigate more thoroughly. But it was not until two months later, weeks after a third worker fell ill, that the researchers determined that the bacteria they were working with were probably contaminated with the active, disease-causing form.
Also yesterday, BU said Dr. Peter Rice, who headed the campus\'s tularemia research, had resigned all his positions at the university and at Boston Medical Center. BU had placed him on leave and removed him as head of infectious diseases at BMC, saying he had allowed safety lapses in his lab. Rice has worked at BU for about 30 years.
Rice\'s lawyer said the infections were not caused by safety lapses, but "by the unknown presence of a virulent organism. in the lab.”
Settlement with EPA Will Cost Fitchburg State College $205,000
Boston Fitchburg State College will pay $50,000 in fines and spend $155,000 on two environmental projects as part of a settlement with the U.S. Environmental Protection Agency over hazardous-waste violations on its campus, in Massachusetts.
Last year the EPA proposed fining Fitchburg State $358,000 for improperly storing laboratory chemicals that could have exploded or released toxic vapors near two active classrooms. Inspectors
also found numerous containers of unknown materials and improperly marked wastes, some of which were stored unsafely. After the EPA inspection, some 6,500 pounds of hazardous wastes were shipped off the campus. Some of the material was so dangerous that crews had to use a robot to collect it.
"The problems at Fitchburg State College were severe and put students and staff at risk," Robert W. Varney, regional administrator for the EPA\'s New England office, said in a written statement on Friday.
Besides the fine, the college also agreed to have independent environmental audits of its facilities conducted annually for three years and to put in place a formal environmental…
If yes, contact EHS for required approvals.