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Public response to infectious disease research: the UC Davis experience.

This summary of the experience of the University of California, Davis, in public communications describes the course of applying for funds to build a National Biocontainment Laboratory. Opponents of the project put forward a wide range of arguments falling into two main areas: (1) the safety of the facility and the perceived risk of release of biological agents by accident, theft, or terrorist acts; and (2) concerns that the laboratories would be used for military or secret research beyond the control of the university. The communications strategy in support of the proposal used a number of different tools, including public workshops, direct mail, web sites, and proactive media relations. Communicating in this type of environment is challenging and requires long-term commitments of time and effort, as well as efficient cooperation across departments within the university and externally with local, county, and regional governments, agencies, elected officials, and community members.

California↗

Administrative issues related to infectious disease research in the age of bioterrorism.

The recent unprecedented growth in infectious disease research funding and infrastructure has resulted in part from an outgrowth of concern about newly emerging and re-emerging diseases and the progressive development of antibiotic-resistant pathogens. However, the most compelling impetus is the suspected and demonstrated capability and will of unknown individuals, groups, or states to use biological agents and/or toxins as weapons. Although the actual number of known victims and fatalities from bioterrorism in the United States has been miniscule compared with many other daily hazards, biological agents have the potential to cause human mass casualties, severely damage segments of our economy or agricultural infrastructure, poison or compromise our food or water supply, and, perhaps most damaging, disrupt our society physically and psychologically. The significant institutional commitment necessary to participate in infectious disease research is described, with a focus on programs that involve research with pathogens thought to have potential for use by bioterrorists. Administrative considerations are described, and include obtaining necessary research funding to offset high operating costs; complying with "select agent" regulations, security screening of employees; building or renovating a biocontainment facility; finding skilled professional and technical manpower; providing adequate physical security in a threat environment; conducting targeted training; overcoming potential internal and external dissent; developing and/or providing sufficient occupational health and safety programs; achieving and maintaining compliance standards in a fluid regulatory environment; mitigating potentially hazardous working conditions; understanding personal and institutional liability; and reassuring and dealing with a concerned, skeptical, or even hostile public.

Animals↗

Recombinant DNA risk assessment studies in humans: efficacy of poorly mobilizable plasmids in biologic containment.

Recombinant DNA risk assessment studies quantitated the mobilizability of "safe" plasmid pBR325, in comparison with readily mobilizable plasmid pJBK5 (chloramphenicol and tetracycline resistant). Of 15 volunteers who became colonized after ingestion of 5 X 10(10) Escherichia coli HS-4, a normal human flora strain containing pJBK5 and daily oral tetracycline, nine manifested transfer of pJBK5 to normal flora by means of triparental mating. In contrast, none of 12 other volunteers cocolonized with HS-4 bearing "safe" pBR325 and normal flora showed transfer (P = 0.001), despite ingestion of tetracycline. To accomplish transfer directly, E coli HS-4 containing both pBR325 and a derepressed, conjugative plasmid (F-amp) was fed to two groups of volunteers. Transfer of pBR325 to normal flora occurred in 13 of 18 volunteers taking daily tetracycline but in none of eight who did not (P less than 0.002). Nor were transconjugants detected, despite tetracycline ingestion, in five volunteers who ingested and excreted E coli K12 (pBR325 plus F-amp).

Adult↗

Handling small arbovirus vectors safely during biosafety level 3 containment: Culicoides variipennis sonorensis (Diptera:Ceratopogonidae) and exotic bluetongue viruses.

Equipment and procedures are described for biosafety level 3 (BL-3) containment work with small, zoophilic arthropods. BL-3 classified pathogens always must be manipulated in biological safety cabinets. Procedures, including physical barriers and handling methods, that prevent the escape of potentially virus-infected insects are discussed, and the use of a monitoring system for insect security is explained. The inability to recover escaped minute, flying insects poses a major difference from similar work with larger insects, such as mosquitoes. Methods were developed for the safe and secure handling of Culicoides variipennis sonorensis Wirth & Jones infected with exotic bluetongue viruses during BL-3 containment.

Animals↗

Sequence analysis of cloned cDNA encoding part of an immunoglobulin heavy chain.

The recombinant plasmid pH21-1 consists of mouse-derived complementary DNA (cDNA) in the E. coli plasmid pMB9. The mouse insertion has been completely sequenced, and encodes the CH3 domain and half the CH2 domain of the immunoglobulin gamma1 heavy chain. The predicted amino acid sequence differs at several positions from that previously published for this protein. The pattern of codon usage resembles that in some other eukaryotic messenger RNAs. A computer program has been used to predict the optimum secondary structure for the mRNA encoding the CH3 domain and the inter-domain junction.

Animals↗

The persistence of engineered Agrobacterium tumefaciens in agroinfected plants.

Several plant species, including tomato (Lycopersicon esculentum), Gynura aurantiaca, avocado (Persea americana), and grapefruit (Citrus paradisi) grafted on Troyer citrange (Poncirus trifoliata x C. sinensis) were "agro-infected" with Agrobacterium tumefaciens strain LBA-4404, carrying a mini-Ti plasmid with a dimeric cDNA of citrus exocortis viroid (CEVd). Extracts prepared from tissues of the agroinfected plants 38-90 days after inoculation were plated on selective media and found to contain large amounts of the engineered bacteria. These observations suggest the need for more stringent quarantine measures when handling A. tumefaciens cells harboring constructs for "agroinoculation" with plant viruses or viroids.

Agrobacterium tumefaciens↗

Biosafety considerations for autopsy.

An autopsy may subject prosectors and others to a wide variety of infectious agents, including bloodborne and aerosolized pathogens such as human immunodeficiency virus, hepatitis B and C viruses, and Mycobacterium tuberculosis. Other hazards include toxic chemicals (e.g., formalin, cyanide, and organophosphates) and radiation from radionuclides used for patient therapy and diagnosis. These risks can be substantially mitigated through proper assessment, personal protective equipment, appropriate autopsy procedures, and facility design.

Autopsy↗

The epidemiology of HIV transmission among paid plasma donors, Mexico City, Mexico.

Screening of blood product donations for antibody to HIV began in Mexico in May 1986. From June to October 1986, the HIV cumulative seroprevalence increased from 6.3 to 9.2% in a commercial plasma collection center. Of the 281 people who donated the antibody-positive units, 62 (22.1%) had documented seroconversion during these 5 months. An epidemiologic study of 54 seropositive and 58 seronegative donors was carried out. The HIV serologic status did not change in any of these donors after repeat testing. Only 13.0% of the seropositives and 15.5% of the seronegatives had any of the known risk factors for AIDS. There was a direct relationship between frequency of plasma donation and the risk of being seropositive. A survey of employees disclosed the frequent re-use of disposable blood collection equipment. We conclude that HIV transmission had probably occurred in this plasma collection center.

Adult↗

Handling, storage, treatment, and disposal of mixed wastes at medical facilities and academic institutions.

Mixed waste includes hazardous/ toxic chemicals and radioactive materials mixed together. Most mixed wastes are difficult and costly to work with safely. Meeting the legal and regulatory requirements to generate, use, store, treat, and dispose of mixed waste can also be costly and difficult. The regulations that govern mixed waste, from creation to final disposition, are extensive and complex to implement. Complete and documented compliance with the applicable regulations is essential to demonstrate that personnel and environment safety has been assured. Noncompliance with the multitude of government's requirements for mixed waste can lead to serious repercussions. Noncompliance may cause serious harm to individuals and the environment, fines and penalties against a facility, and/or suspension of a facility's operations. Each facility that generates, uses, or possesses mixed waste must employ adequate expertise to assure full regulatory compliance. This paper introduces the large scope and variety of mixed waste and the current and potential methods to treat and ultimately dispose of, or recycle, mixed waste. Alternatives for regulatory compliance are also discussed and effective means to control mixed waste are presented. The paper is based on my Master's Thesis (Hageman 2001).

Academic Medical Centers↗

Environmental and body contamination through aerosols produced by high-speed cutters in lumbar spine surgery.

STUDY DESIGN: A cadaver study to evaluate contamination in the operating room through the use of a high-speed bone cutter. OBJECTIVES: To determine the grade of contamination of animate and inanimate objects through an aerosol intraoperatively, produced by a high-speed cutter during lumbar laminectomy. SUMMARY OF BACKGROUND: In spinal surgery, high-speed cutters are used that produce an aerosol consisting of a mixture of irrigation solution, blood, and tissue debris. Such aerosols can be contaminated with potential pathogens. The surgical personnel and the environment are therefore exposed to a contamination risk. METHODS: Laminectomies at three points (L2-L4) were performed on a human cadaver using a high-speed cutting device. The aerosol produced by the irrigation solution was contaminated with Staphylococcus aureus ATCC 12600. To detect the contamination of the environment and of the surgical team, surveillance cultures were used. RESULTS: By air sampling, staphylococci were detected in the operating room at an extension of 5 by 7 m. The surgical team showed extensive face and body contamination with S. aureus. Despite protection by a barrier drape, similar contamination was observed on both the cadaver's head and the anesthesiologist. CONCLUSIONS: The use of high-speed cutters in spinal surgery produces an aerosol that can be contaminated with blood-borne pathogens from infected patients. This aerosol is spread over the whole surgical room and contaminates the room and all personnel present. It is therefore critical to ensure that effective infection control measures are performed, not only by the surgeons but by everyone present in the operating room. The room itself must be sufficiently disinfected after such procedures.

Aerosols↗