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
2 March 2005 MaterialsOverview of Today
2 March 2005 MaterialsThemes for TodayWhy are these changes taking place?
2 March 2005 MaterialsShipping/Mailing Research Materials
“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.”
2 March 2005 MaterialsLaws for the Transport of Hazardous Material...
2 March 2005 MaterialsPreparing Hazardous Materials for Shipment...
If you prepare or package a shipment, you must receive additional function-specific training in:
2 March 2005 MaterialsNo Vial In Pocket
Monday, September 13, 2004 Materials
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.
2 March 2005 MaterialsU.S. Export Control Laws
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
2 March 2005 MaterialsU.S. Export Control Laws and Agencies
2 March 2005 MaterialsImplications of Export Laws
2 March 2005 MaterialsITAR Licensing Requirements for Shipping Controlled Equipment Out of the U.S.
2 March 2005 MaterialsEAR Licensing Requirements for Shipping Controlled Equipment Out of the U.S.
2 March 2005 MaterialsOFAC Prohibitions for Shipping Controlled Equipment Out of the U.S.
2 March 2005 MaterialsFundamental Research Exclusion
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 MaterialsEAR Fundamental Research Exclusion
2 March 2005 MaterialsEAR Fundamental Research Exclusion, continued.
Shipment of controlled materials, samples or other commodities outside of the U.S. is never excluded.
2 March 2005 MaterialsThe “Deemed Export” Concept
2 March 2005 MaterialsThe “Deemed Export” Concept
2 March 2005
= “Deemed Export”
2 March 2005 MaterialsEAR Fundamental Research ExclusionIs destroyed if the University accepts any contract clause that:
2 March 2005 MaterialsRed Flags for Export Control Laws
2 March 2005 MaterialsIf Export Control Red Flags Exit
2 March 2005 MaterialsEAR Penalties
2 March 2005 MaterialsTrouble on the Horizon
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.”
2 March 2005 Materials2002 Public Health Security and Bioterrorism Preparedness and Response Act
HHS-USDA Overlap Materials
Botulinum neurotoxin producing species of Clostridium
Venezuelan Equine Encephalitis virus
2 March 2005Examples of Regulated Select Agents
2 March 2005 MaterialsImplementation of Biological Registry Requirements at UNC
2 March 2005 MaterialsWhat Constitutes Bona Fide Research?
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.”
2 March 2005 MaterialsWelcome 42 CFR 73 Requirements
2 March 2005 MaterialsSafety Plans
2 March 2005 Materials73.11(b) Security Plan Requirements
2 March 2005 MaterialsSecurity Costsfor one building, one <1,000 sq. ft. lab
Stolen cards Materials
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!
2 March 2005 MaterialsSecurity Improvements
“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
2 March 2005 Materials73.11(b) Security Plan Requirements, cont.
2 March 2005 MaterialsSelect Agent Tracking System“to account for all vials…origin and destination”
2 March 2005 MaterialsPhysical Inventory Issues
2 March 2005 MaterialsOther Typical Stepsfor Select Agent Security
2 March 2005 MaterialsEHS Access Approval Check Off
2 March 2005 MaterialsNIH Bioterrorism Research Funding
2 March 2005 MaterialsControversial Paper: IL4-Mousepox
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.
2 March 2005 MaterialsControversial Paper: Synthetic Polio Virus
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.
2 March 2005 MaterialsNRC Report on Dual Use Research
Report of the National Research Council of the National Academies:
“Biotechnology Research in an Age of Terrorism: Confronting the Dual Use Dilemma” (October 2003)
Gerald Fink, Committee Chair
2 March 2005 MaterialsNational Science Advisory Board for Biosecurity (NSABB) Charge
2 March 2005 MaterialsExperiments That Currently Require Institutional Biosafety Committee (IBC) Approval
2 March 2005 MaterialsNew Experiments of Concern
Saturday, February 5, 2005 MaterialsBy 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.”
2 March 2005 MaterialsMedical Surveillance For Biosafety Level 3 Laboratoriesprior to laboratory work
2 March 2005 MaterialsU.S. Nuclear Regulatory Commission
June 21, 2004 MaterialsBy JEFFRY SELINGOThe Chronicle of Higher Education
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…
2 March 2005 MaterialsTop RCRA Compliance ProblemsSatellite Accumulation Area
2 March 2005 MaterialsSatellite Accumulation Area Solution Number One:Remember the ThreeL’s
2 March 2005 MaterialsStorage Without a Permit Solution Number Two:Promptly Remove Your Waste
2 March 2005 MaterialsEHS’ Role in Research Compliance at UNC
2 March 2005 MaterialsUNC Internal Processing FormQuestion: Does the proposal involve research with any of the following materials?
If yes, contact EHS for required approvals.
2 March 2005 MaterialsUNC Laboratory Safety PlanA Laboratory Safety Plan is required for all research in UNC laboratories
2 March 2005 MaterialsOther Laboratory Safety Plan Approvals Prior to the Start of Research at UNC
2 March 2005 MaterialsOther EHS Research Approvals
2 March 2005 MaterialsPersonnel Requirements for UNC Research