2009
”’Health & Human Services & U.S. Department of Agriculture, Co-Chairs”’, “Report of the Trans-Federal Task Force on Optimizing Biosafety and Biocontainment Oversight,” July 2009.[http://www.hhs.gov/aspr/omsph/biosafetytaskforce/index.html]
*”At the October 4 , 2007, House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations hearing entitled ‘Germs, Viruses, and Secrets: The Silent Proliferation of Bio-Laboratories in the United States.’ the Department of Health and Human Services (HHS) announced the formation of the Trans-Federal Task Force on Optimizing Biosafety Oversight 9the ‘Task Force’).” p. 4.
*”The purpose of the Task Force is to propose options and recommendations to improve bioafety and biocontainment oversight of research activities at high and maximum containment research laboratories in the United States through a comprehensive review of mechanisms by which individual research 9local0 institutions and the Federal Government can ensure safe working conditions.” p. 156.
*”The Task Force envisions effective, comprehensive, local (institutional) and Federal oversight that protects laboratory workers, public health agriculture, and the environment, without hindering the progress of science.” p. 156.
*”there are four areas of concern, which include lapses in biosafety, lack of timely reporting of incidents, and lack of Federal oversight for research involving pathogens that are neither select agents nor recombinant DNA agents.” p. 4.
*”The issues of biosafety and personnel reliability, although related to laboratory biosafety and biocontainment, are not the focus of this report but are being addressed by a Federal Working Group established by Executive Order 13486, ”Strengthening Laboratory Biosecurity in the United States”.” p. 5.
<div class=”boilerplate” id=”controversial” style=”background-color: #dddddd; width: 100%; margin: 0 auto; padding: 7px; text-align: left;”>*”Recommendations 1.1: Identify or establish a Federal entity to coordinate biosafety and biocontainemtn activities, and to ensure comprehensive and effective Federal oversight for all high and maximum containment research facilities and activities in all sectors. …” p. 10.
*”… 2.2: Support the development of an accreditation system for biosafety/biocontainment management programs at high and maximum containment research institutions.” p. 10.
*N.B. “The term ‘high and maximum containment’ is used in this report to describe biosafety level 3 (BSL-3) and BSL-4 laboratories and equivalent containment facilities…” p. 4.
“3.1: Establish national, position-specific training standards and core competencies in biosafety and biocontainemnt for all research, managerial, and support personnel at high and maximum containment research laboratories in all sectors.” p.11
“4.1: Establish: (1) a new voluntary, non-punitive incident reporting system for high and maximum containment research laboratories…””
*”5.1: Develop comprehensive biocontainment guidelines comparable to those of the BMBL to cover research, including high and maximum containment research, on plant, livestock, and other agriculturally significant pests and pathogens.” p. 11.
*”6.1: Require … proper installation of and preventive and ongoing maintenance programs for biosafety and biocontainment infrastructure and equipment.” p. 12.
*”7.1: Develop and maintain a robust program of applied biosafety and biocontainemnt research to create additional and update exisiting evidence-based practices and technologies.” p. 12.
*”8.1: Develop comprehensive strategies to improve public communication, outreach, and transparency about biosafety and biocontainment issues and activities at high and maximum containment research facilities.” p. 12.</div>
*[[Lab Safety]], [[Oversight]], [[Law]]
”’Wilson, Duff”’, “Research Uproar at a Cancer Clinic: Errors at Illinois Center May Signal Failings at Similar Hospitals,” B1 & B7, NYT, Oct. 23, 2009.
*”an outside audit that had found ‘major deficiencies’ in 12 of 29 experiments being overseen by that doctor, potentially endangering patients or skewing the studies’ results.”
*”And if Carle’s problems turn out to any indication, the community centers may not always be adhering to the rigorous protocols of research medicine that the national Cancer Institute expects them to follow. That could call into question the scientific evidence that the community research program amasses.”
*”But some experts in community medicine say that many of the local programs simply fly under the federal government’s radar.”
*[[Misconduct]], [[Oversight]]
”’Moss, Michael”’, “Companies Strike Deal on testing for E. COli,” NYT, A23, Oct. 8, 2009.
*”Costco said Wednesday that they had struck a new accord on testing for the pathogen E. Coli.”
*”some of the largest slaughterhouses have resisted the added scrutiny for fear that one grinder’s discovery of E. coli will lead to expanded recalls of beef sent to other grinders.”
*”‘The U.S.D.A. is supposed ti be protecting public health and at the same time be promotig agricultural products, and my view is that those two things don’t mix,’ said Representative Rosa DeLauro.”
[[E. coli]], [[Oversight]], [[Public Health]]
”’Harris, Gardiner”’, “E. Coli Kills 2 And Sickens Many Others; Focus on Beef,” NYT, A12, Nov. 3, 2009.
*”The New hampshire resident who died of it contracted hemolytic uremic syndrome, a disease that attacks red blood cells and can cause kidney failure. The New Yorker who died was an adult from Albany County who had several underlying health problems.”
*”Donna Rosenbaum, executive director of Safe Tables Our Priority, a food safety organization said … ‘contamination problems are not found by any checks on the products by companies. They’re found when people get sick, and that’s a failure in the system.”
*[[E. coli]], [[Oversight]], [[Public Health]]
”’Moss, Michael”’, “E. Coli Outbreak Traced to Company That Halted Testing of Ground beef,” NYT, A14, Nov. 13, 2009.
*”it was linked to an outbreak that has killed two people and sickened an estimated 500 others.”
*”E. Coli outbreaks in ground beef, which have now reached 18 since 2007, that the beef trimmings commonly used to make ground beef are more susceptable to contamination because the pathogen thrives in cattle feces that can get smeared on the surfaces of whole cuts of meat.”
*”But while slaughterhouses seek ti limit such contamination, and conduct their own testing for the pathogen, they have resisted independent testing by grinders for fear that it would cause expanded recalls.”
*”The United States Department of Agriculture, which banned the deadly E. Coli strain known as 0157:H7 in 1994, has encouraged — but does not require — meat companies to test their products for the pathogen. In the absence of such a rule, meat companies have adopted varied practices.”
*[[E. coli]], [[U.S. Dept. of Agriculture]], [[Oversight]], [[Public Health]]
== 2010 ==
”’Doyle, Michael”’, “Agriculture Department chemist successfully fights guilt-by-association,” January 19, 2010, Mc Clatchy, Suits & Sentences Blog, available at [http://blogs.mcclatchydc.com/law/2010/01/agriculture-department-chemist-successfully-fights-guiltbyassociation.html] Last checked august 11, 2012.
*”Going about his everyday business in a Midwestern office of the Food Safety and Inspection Service, Poett applied to obtain certain toxic chemicals. But in August 2006, the FBI informed Poett’s supervisors that he was deemed to be a ‘restricted person’ who ‘has involvement with an organization that engages in domestic or international terrorism or international crimes of violence.’”
*”Poett filed Freedom of Information Act requests to get to the bottom of it all. As Poett ultimately determined, the FBI’s career-crimping determination stemmed from his past, passing involvement with a group called the Irish Northern Aid Committee in America, also known as Noraid. Way back in 1992, Poett had written the British ambassador to the United States, saying he regretted the possibility that ‘the funds others and I have solicited may have fallen into the wrong hands’ and adding that he would ‘pray for the peaceful resolution between the British and Irish People.’”
*” Kollar-Kotelly noted Monday that the government determined that ‘the FBI no longer reasonably suspects Plaintiff of knowing involvement with an organization that engages in domestic or international terrorism or with any other organization that engages in intentional crimes of violence and that Plaintiff is now eligible for access to select agents or toxins.’”
*[[Scientist]], [[Select agent]], [[Agriculture]], [[Northern Ireland]], [[Oversight]], [[State Department]], [[Law Enforcement]], [[Law]]
”’Ziff, Deborah”’; ”’Seely, Ron”’, “UW-Madison professor barred from lab for potentially dangerous experiments,” May 11, 2010, Wisconsin State Journal,[http://host.madison.com/wsj/news/local/education/university/article_bc095ae8-5d4a-11df-8e83-001cc4c03286.html] last checked 10/30/2011.
*”A UW-Madison professor who studies an infectious disease lost his laboratory privileges for five years after conducting unauthorized experiments with a potentially dangerous drug-resistant germ.”
*”One person who worked in professor Gary Splitter’s lab got brucellosis but university officials don’t know if that individual, who has since recovered, caught the strain used in the unauthorized experiments.”
*”Brucellosis is a disease that is usually found in farm animals but can spread to humans and cause flu-like symptoms or worse.”
*”The 2007 experiments, which the National Institutes of Health calls a ‘major action violation,’ in part prompted the university to beef up its biological safety oversight. The university was also fined $40,000.”
*”Splitter, a tenured professor in the School of Veterinary Medicine, won’t be allowed to work in a lab for five years because of the violation.”
*”Splitter said he was not aware of the unauthorized experiments, which he said were conducted by graduate students in his lab, and that the university did not properly educate researchers about guidelines for working with antibiotic-resistant strains.”
*”His lab created antibiotic-resistant strains of brucellosis and inserted them into mice in 2007 and possibly earlier, university officials said, without approval from local or federal agencies. The concern is that if someone contracted the antibiotic-resistant version of the disease created in the lab, treatment might have been more difficult.”
*”The university learned of the stock of antibiotic-resistant strains after a round of university-wide lab inspections by the Centers for Disease Control and Prevention. They began investigating Splitter’s lab in early 2008.
*”University officials said evidence gathered during the investigation contradicted Splitter’s claim that he was unaware of the work being done by his students.”
*”Splitter said part of the problem was understaffing in the university’s bio-safety program, which is charged with training scientists about regulations. At the time of the experiments, he said, there were only two people employed in the program and neither were trained biologists.”
*”In the past year, UW-Madison has hired five biological safety officers and a new director, said Bill Mellon, associate dean for research policy.”
*[[Brucellosis]], [[Lab Safety]], [[Misconduct]], [[Oversight]], [[CDC]], [[Academia]], [[Drug Resistance]], [[Scientist]]
”’Basken, Paul”’, “Scientist, Banned From Lab, Blames U. of Wisconsin for Biosafety Lapse,” May 19, 2010, Chronicle of Higher Education[http://www.chroniclecareers.com/article/Scientist-Banned-From-Lab/65632/], last checked 10/30/2011.
*”University of Wisconsin officials suspended a professor’s laboratory privileges over unapproved tests involving an infectious disease, and said they’ve sent a strong message about accountability for hazardous materials.”
*”The five-year ban on hands-on lab work “does not restrict other people from submitting grants; it doesn’t restrict me from being an investigator on a grant; it doesn’t restrict me from working with others on grants or on science,” Dr. Splitter, a tenured professor of pathobiological sciences and a veterinarian, told The Chronicle.”
*”The case, which dates back to a routine inspection of Dr. Splitter’s lab by federal officials nearly three years ago, has garnered national attention in the past week as an example of concerns that the government may not be doing enough to guard against accidental or intentional spreads of pandemic disease.”
*”In the case of Dr. Splitter, the work involved the pursuit of a vaccine for brucellosis, a disease that humans contract from farm animals. Its effects are usually limited to chronic flu-like symptoms, though complications make it fatal in about 3 percent of cases. The disease infects about 500,000 people a year, mostly in developing countries, where the months-long process of treatment with antibiotics can be prohibitive.”
*”Ensuing investigations, which involved interviews of Dr. Splitter’s graduate students by federal inspectors and a nine-month closure of his lab, led to an agreement with federal officials last October in which the university paid the $40,000 fine. The university disclosed this month its decision to suspend Dr. Splitter’s laboratory privileges for a five-year period, ending in 2013. (He has not been allowed in his lab since 2008 because of the investigation, so the university is counting those years as part of his suspension.)”
*”William S. Mellon, associate dean for research policy at the University of Wisconsin at Madison Graduate School, said the university acted to penalize Dr. Splitter after concluding that Dr. Splitter was aware that new federal rules imposed after the September 11, 2001, attacks on the United States required him to seek specific government approval for his work with antibiotic-resistant genes.”
*”It appears, Mr. Mellon said, that Dr. Splitter—who has spent 32 years at the University of Wisconsin and is one of only about five experts worldwide working on a vaccine for brucellosis—simply never accepted the new requirements imposed on researchers. “Those are hard transitions to make—I understand that,” Mr. Mellon said.”
*”Investigations, both by federal officials and by outside analysts hired by the university, found the campus’s Institutional Biosafety Committee ‘was an organization in disarray,’ Dr. Splitter said.”
*”Mr. Mellon said he recognized that the case highlighted some shortcomings in the university’s operations and that the university has responded, hiring five new biological-safety officers and a new director for the operation. He said it’s ‘silly,’ however, for Dr. Splitter to deny his own responsibility.”
*”One of the graduate students, discussing the case with The Chronicle on the condition he not be identified, said the case pointed out the confusion over regulations and the hassles that await him if he decides to continue working with hazardous agents.”
*”The university’s penalty against Dr. Splitter became public the same week the Proceedings of the National Academy of Sciences published an analysis suggesting that the more restrictive biosafety laws imposed after the 2001 attacks had led to far fewer published studies in the field and accelerated the rate of researchers turning to other fields of study.”
*[[Brucellosis]], [[Lab Safety]], [[Misconduct]], [[Oversight]], [[CDC]], [[Academia]], [[Drug Resistance]], [[Scientist]]
”’Gregg, Kelsey”’, “Unauthorized Brucellosis Experiments, University of Wisconsin-Madison,” Posted May 21, 2010, Federation of American Scientists, Biosecurity Blog, [http://www.fas.org/blog/bio/2010/05/unauthorized-brucellosis-experiments-university-of-wisconsin-madison/]. Last checked 10/30/11.
*” Professor of pathobiological sciences, Gary Splitter, DVM, PhD, was suspended from laboratory work above BSL-1 until 2013 because unauthorized work was conducted with an antibiotic-resistant strain of Brucella, a select agent, by his graduate student in 2007.”
*”Brucella bacteria can cause the disease brucellosis, which presents as a prolonged non-specific febrile illness in humans accompanied by chills, sweats, headache, fatigue, myalgias (muscle pain), arthralgias (joint pain), and anorexia.”
*” This unauthorized research is even more egregious because it was with an antibiotic-resistant select agent, making this research of dual use concern.”
*” Dr. Splitter claims that the incident was the result of an understaffed biosafety committee and ‘The University of Wisconsin fail[ing] to provide the right education.’ Dr. Splitter, while culpable, may be right that this incident ‘… was a major meltdown by the university.’ Put together, the unauthorized work and a past case of brucellosis acquired in Dr. Splitter’s laboratory, indicate personal and systemic failures to educate laboratory personal about biosafety level procedures and regulations. This incident highlights the need for continued efforts to educate students and scientists alike about research of concern and general laboratory biosafety.”
*[[Brucellosis]], [[Misconduct]], [[BSL]], [[Dual use]], [[Oversight]], [[Select agent]]
”’Carey, Benedict”’, “Studies Halted at Brain Lab Over Impure Injections,” NYT, July 16, 2010, [http://www.nytimes.com/2010/07/17/health/17columbia.html?_r=1&hp] Checked July 17, 2010.
*”Columbia University has quietly suspended research at a nationally prominent brain-imaging center and reassigned its top managers after federal investigators found that it had routinely injected mental patients with drugs that contained potentially dangerous impurities.”
*”The investigations found that the center — regarded by experts as the nation’s leader in the use of positron emission tomography, or PET, for psychiatric research — repeatedly violated Food and Drug Administration regulations over a four-year period.”
*”F.D.A. investigators returned in January 2010 and found that many of the center’s lab’s practices had not changed, and cited a long list of specific violations, including one instance in which the staff hid impurities from auditors by falsifying documents.”
*”‘They raided the place like it was a crime scene, seizing hard drives,’ said one former lab worker, who requested anonymity because he feared reprisals from the university.”
*”The office under fire, the Kreitchman PET Center, on West 168th Street in Manhattan, has attracted millions of dollars in research funds from the federal government and pharmaceutical companies to study drug actions and the biology of brain disorders, among other things.”
*”The agency regulates the allowable radiation levels and the purity of the drugs. If a drug contains too many impurities — unknown chemicals that may or may not be related to the tracer itself — then its effects in the body are unpredictable.”
*”‘There could be a patient safety issue, for one,” said Dr. Barry Siegel, chairman of the radioactive drug research committee at Washington University in St. Louis. “And there could be a scientific validity issue. If you’re exposing people to radiation and getting garbage data, then that becomes an ethical problem.'”
*”The report highlighted an equation that the lab routinely used, resulting in injections that exceeded the limit for acceptable impurities. The lab did not adequately check ‘the identity, strength and purity of each active ingredient prior to release’ for injection into patients, the report said. Agency investigators also found a forged document, a hard copy record that had been altered to hide a drug impurity that showed up clearly in the computer records.”
*”Former employees, speaking on the condition of anonymity because they worked in the imaging field or hoped to, said those practices were not only commonplace but also condoned. They described a center under such pressure to produce studies that it papered over and hid impurities in drugs to stretch its resources and went ahead with business as usual despite F.D.A. warnings.”
*[[Misconduct]], [[Ethics]], [[Personnel Reliability]], [[Oversight]], [[Law Enforcement]]
”’Bita, Natasha”’, “Checks by the TGA reveal 98 per cent of drug labs have problems,” The Australian,[http://www.theaustralian.com.au/news/nation/checks-by-the-tga-reveal-98-per-cent-of-drug-labs-have-problems/story-e6frg6nf-1225893662606] July 19, 2010.
*” Deficiencies have been uncovered at 98 per cent of the pharmaceutical laboratories audited by the drugs regulator in the past year.”
*”The federal government’s Therapeutic Goods Administration yesterday revealed that only three of the 139 labs it audited last financial year were problem-free.”
*”But the TGA is now investigating the cause of discolouration affecting some multi-dose vials of Panvax — a problem it became aware of only after the FDA blew the whistle during its own audit of CSL in April. The TGA has proclaimed Panvax to be safe, even though it still does not know the cause of the discolouration.”
*”The TGA is conducting a separate inquiry into CSL’s seasonal flu shot — a world-first combination of swine and seasonal flu strains in a single vaccine.”
*[[Vaccination]], [[Oversight]], [[Lab Safety]], [[Australia]]
”’Jordan, Bryant”’, “Airmen Given Expired Anthrax Vaccines,” Military.com, NEWS, [http://www.military.com/news/article/airmen-given-expired-anthrax-vaccines.html], October 28, 2010, Last Checked November 3, 2010.
*”All Air Force medical facilities stopped vaccinating against anthrax on Oct. 26 after officials determined that many treatment centers administered expired vaccines earlier in the same month.”
*”In a memo issued Oct. 26, Air Force Brig. Gen. Mark Ediger, commander of the Air Force Medical Operations Agency in San Antonio, said the stand-down would remain in place until treatment centers can confirm the vaccine stock they have is current. But Ediger also said that confirmation that corrective actions had been taken were to be sent to the AFMOA by close of business Oct. 27, according to a copy of the memo obtained by Military.com.”
*”The only exceptions to the stand-down will be for personnel slated to deploy prior to Oct. 29 if the center can confirm that its vaccine supply is current, the memo states. If the available vaccine has passed its expiration date, the medical centers must follow waiver procedures set up by the Air Force Central Command Surgeon General’s office.”
*”Also before anthrax vaccines may be routinely administered again, the medical centers will have to verify that everyone who handles them completes a review of the proper instructions on vaccine expiration, administration and documentation, the memo states.”
*”Though it is still unclear how many Airmen may have been treated with an expired dose, the Anthrax Vaccine Immunization Program, or AVIP, requires troops assigned to high-threat areas to be inoculated against a potential infection.”
*[[Anthrax]], [[Vaccination]], [[Oversight]]
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