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Requirements for facilities transferring or receiving select agents. Final rule.

CDC administers regulations that govern the transfer of certain biological agents and toxins ("select agents"). These regulations require entities that transfer or receive select agents to register with CDC and comply with biosafety standards contained in the Third Edition of the CDC/NIH publication "Biosafety in Microbiological and Biomedical Laboratories ("BMBL")." On October 28,1999, CDC published a Notice of Proposed Rulemaking ("NPRM") seeking both to revise the biosafety standards facilities must follow when handling select agents and to provide new biosecurity standards for such facilities. These new standards are contained in the Fourth Edition of BMBL, which the NPRM proposed to incorporate by reference, thereby replacing the Third Edition. No comments were received in response to this proposal. CDC is therefore amending its regulations to incorporate the Fourth Edition.

Centers for Disease Control and Prevention, U.S.↗

[The Vancouver regulations and publishing in biomedical journals].

The paper deals with structure, importance and advantage as well as the path of development of the Uniform requirements for manuscripts submitted to biomedical journals (Vancouver style) from 1978, when they were established and firstly published, through changes and amendments up to their last--fourth edition. Authorship, abstract, key words and literature citation are fields dealt with in detail with appropriate discussions. The 16 year long existence of the Vancouver style, a great number of journals with high impact factor which conform to its requirements, as well as its advantages presented in the paper, should be a sufficient reason for scientists, explorers and editors of biomedical journals to conform to the requirements if they have not conformed to them yet.

Guidelines as Topic↗

Mortality in broiler chicks on feed amended with Fusarium proliferatum culture material or with purified fumonisin B1 and moniliformin.

Two hundred twenty-eight male chicks (Columbia x New Hampshire) were given feed amended with autoclaved culture material (CM) of Fusarium proliferatum Containing fumonisin B1 (FB1), fumonisin B2 (FB2) and moniliformin in 3 separate feeding trials. Purified FB1 and moniliformin were given separately and in combination in a fourth feeding trial. Birds were given amended rations at day 1 (Trial 1 and 4), day 7 (Trial 2), and day 21 (Trial 3) and their respective ration was given for 28 days (Trial 1), 21 days (Trial 2), 7 days (Trial 3), and 14 days (Trial 4). FB1 concentrations were 546, 193, and 61 ppm; FB2 were 98, 38 and 14 ppm; and moniliformin were 367, 193, and 66 ppm in the first 3 feeding trial regimens. Chicks in Trial 4 were given dietary concentrations of purified FB1 at 274 and 125 ppm, and moniliformin at 154 and 27 ppm. FB1 and moniliformin, both alone and in combination, produced dose-responsive clinical signs, reduced weight gains and mortality in chicks. Age of birds given amended feeds had little difference in the clinical response; however, those given the rations from days 7 or 21 were slightly less susceptible than those given rations beginning at 1 day of age. Additive effects were noted when the toxins were given in combination. When toxins were given separately, adverse effects took longer to occur. A system to monitor pattern and rate of defecation (RD) was developed for assessing the chicks' approach to feed, water and heat source as illness progressed. Our results indicate that chicks fed corn heavily infected with F. proliferatum under field conditions could suffer acute death similar to that described for 'spiking mortality syndrome' during the first 3 weeks of age.

Animal Feed↗

Impact of dietary allelochemicals on gypsy moth (Lymantria dispar) caterpillars: importance of midgut alkalinity.

Midgut pH of gypsy moth larvae was depressed artificially with buffered diet to examine the impact of alkalinity on the caterpillars' ability to tolerate a dietary polyphenol and a quinone. A 2x3 factorial design was used, with 2 levels of succinate buffer and 3 dietary amendments (tannic acid, juglone, or control). Development was monitored during the third and fourth instars, with consumption, food passage rates, midgut pH, and midgut redox potential (Eh) measured in the fourth instar. Diet buffering successfully depressed midgut pH to hypothetically suboptimal acidic levels without reductions in survivorship, but it did reduce larval growth and impede development. Buffering dramatically reduced survivorship of fourth instar larvae eating diets containing tannic acid or juglone. Growth increased on unbuffered diet amended with tannic acid, but not with juglone. Caterpillars passed food through the gut more slowly when feeding on buffered tannic acid diet or on unbuffered juglone diet. These results indicate that maintenance of midgut alkalinity is critical to tolerance of dietary tannic acid and juglone, and that these allelochemicals have very different activities in the caterpillar gut.

Journal Article↗

A cladistic analysis of the tribe Labiostrongylinea Beveridge, 1983 (Nematoda: Cloacinidae) parasitic in macropodoid marsupials (Marsupialia: Macropodoidea), with a redescription of Parazoniolaimus collaris Johnston & Mawson, 1939.

Morphological characters of both adult and juvenile representatives of the genera comprising the Labiostrongylinea (Strongylida: Cloacinidae: Cloacininae) were examined to prepare an amended description of Paralabiostrongylus bicollaris, a redescription of Parazoniolaimus collaris and a cladistic analysis of the tribe. A cluster of Wallabinema spp., with a fleshy collar on which amphids and deirids are borne, was used as the outgroup for the analysis. The 50% consensus tree, bootstrapped through 1000 replicates, derived from the cladistic analysis had a basal polytomy of Dorcopsinema and Paralabiostrongylus; and a crown polytomy of Labiosimplex, Labiomultiplex, Parazoniolaimus, Labiostrongylus and Potorostrongylus. This analysis provided reasonable evidence for considering all 7 clades as being of generic status and amended diagnoses were prepared. The morphology of the cephalic end of fourth stage juveniles, cephalic papillae and amphids lying posterior to the lips, gave support to the contentions that a fleshy collar is a plesiomorphic character and that Dorcopsinema is the most primitive genus within the group. There was, however, insufficient support from morphological data to provide a robust resolution of generic relationships. Host and biogeographical data were indicative of Paralabiostrongylus and Labiosimplex having been derived from ancestral Dorcopsinema, then Labiostrongylus, Labiomultiplex and Parazoniolaimus derived from ancestral Labiosimplex, and Potorostrongylus from ancestral Labiomultiplex. Additional data, derived from molecular sequencing, is needed to help resolve the relationships within the tribe.

Animals↗

The fourth dimension. Management of the postmodern clinical laboratory.

The clinical laboratory has undergone historic changes over the past decade. The Clinical Laboratory Improvement Amendments of 1988 are the regulatory acknowledgement of the technological revolution that has occurred. Challenged to meet increasingly diverse medical needs while facing cost restraints, managerial leadership will replace technical leadership in the clinical laboratory. Ignored for half a century by most American industries, total quality management has been invoked as the embodiment of systems engineering and group decision making in the postmodern clinical laboratory. The matrix organization, workload recording, and productivity measuring are cost-effective applications of total quality management in the clinical laboratory.

Clinical Medicine↗

[International health regulations--evaluation and trends].

The current International Health Regulations (IHR) were adopted by the Twenty-second World Health Assembly in 1969 and amended in 1973 and 1981. They are a revised and consolidated version of the International Sanitary Regulations which were adopted by the Fourth World Health Assembly in 1951, themselves based on the previous International Sanitary Conventions. The purpose of the IHR is to ensure maximum security against the international spread of diseases with a minimum interference to world traffic. Over the years the IHR included cholera, yellow fever, plague, smallpox, typhus and relapsing fever, and then dropped the last three as a result of the global eradication of smallpox and the decline of typhus and relapsing fever as international threats. The IHR have played and still play an important part with respect to the diseases for which they were drawn up. The international spread of yellow fever has been contained by the application of a highly effective vaccine to travellers, and of plague by the inspection of ships and aircrafts for rats, and improvements in the design of air and sea cargo carriers to make them increasingly uninhabitable for rats. The role of the IHR was questioned as far as smallpox and cholera are concerned by arguing that smallpox was eradicated by rigorous national local vaccination programmes and cholera must be defeated by improved environmental sanitation. However, one must not lose sight of the fact that an important element of the IHR is the obligation to notify cases of the diseases listed, together with as much epidemiological information as possible, in order to permit other countries to take appropriate action.(ABSTRACT TRUNCATED AT 250 WORDS)

Communicable Disease Control↗

Persistence and fate of polychlorinated biphenyls (PCBs) in sewage sludge-amended agricultural soils.

Four metal enriched sewage sludges containing different concentrations of polychlorinated biphenyls (PCBs) were applied to two field soils in the UK in 1968. Samples of the sludges, sludge-amended soils and soils from untreated control plots were stored and analysed retrospectively. Sludge concentrations ranged from 1 to 7 mg SigmaPCB kg(-1). The pattern of PCBs was similar in three of the four sludges, with congeners 14, 18, 28 and 52 present at the highest concentrations. The fourth sludge contained higher amounts of congeners 149, 153, 138 and 180. SigmaPCB concentrations in control plot soil have declined over the last 20 years, indicating a reduction in atmospheric deposition inputs of PCBs to the soil. SigmaPCB concentrations also declined on the sludge-amended plots, reaching control plot concentrations (30-60 microg SigmaPCB kg(-1)) in the late-1980s. Half-lives ranged from < 1 to 8.5 years for congeners 18, 28 and SigmaPCB. Biodegradation and/or the formation of reversibly sorbed soil PCB residues could not account for the losses observed. Volatilisation is implicated as the most important loss process on both the control and sludge-amended plots. Using the fugacity approach, congener concentrations in soils at Luddington were predicted still to have not reached equilibrium with the air. Further losses to the atmosphere are likely.

Journal Article↗

Factors contributing to the loss of ethanologenicity of Escherichia coli B recombinants pL0I297 and KO11.

To be economic and to be compatible with modern continuous bioconversion systems, it is imperative that the process organism exhibits an extremely high degree of stability. In the case of ethanol production from lignocellulosic biomass, functional stability of the potential process biocatalyst can be assessed in terms of the capacity to sustain high-performance fermentation during the continuous fermentation of biomass-derived sugars. This investigation employed glucose- or xylose-limited chemostat culture to examine the functional stability of two patented, genetically engineered E. coli-namely E. coli B (ATCC 11303) carrying the Zymomonas genes for pyruvate decarboxylase and alcohol dehydrogenase II on a multicopy plasmid pLOI297 and a chromosomal pet integrant of strain 11303, designated as strain KO11. Both recombinants carry markers for antibiotic resistance and have been reported to exhibit genetic stability in the absence of antibiotic selection. Chemostats were fed with Luria broth (LB) (with 25 g/L sugar) at a dilution rate of 0.14 and 0.07/h when the feed medium was glucose-LB and xylose-LB, respectively. They pH was controlled at 6.3. With glucose, both recombinants exhibited a rapid loss of ethanologenicity even when selection pressure was imposed by the inclusion of antibiotics in the feed medium. With strain KO11, increasing the concentration of chloramphenicol from 40 to 300 mg/L, resulted in a retardation in the rate of loss of ethanologenicity, but it did not prevent it. Under xylose limitation, the plasmid-bearing recombinant appeared to be stabilized by antibiotics, but this did not reflect genetic stability, since the slower-growing revertant was washed out at a dilution rate of 0.07/h. With both recombinants, interpretation of functional stability with xylose was complicated by the inherent ethanologenicity associated with the host culture. Based on an average cost for large bulk quantities of antibiotics at $55/kg and an amendment level of 40 g/m3, the estimated economic impact regarding the potential requirement for operational stabilization by antibiotics in a plant operating in batch mode varied from a maximum of 29 cents/gal of E95 ethanol for antibiotic amendment of all fermentation media to a minimum of 0.45 cents/gal where antibiotics were used exclusively for the preparation of the inocula for every fourth batch fermentation cycle. The high degree of instability observed in these continuous fermentations does not auger well for the proposed potential industrial utility of these patented, genetically engineered constructs for the production of fuel ethanol from biomass and wastes.

Anti-Bacterial Agents↗

Scanning and transmission electron microscopic study of recovered porcine aortic valved conduits.

Four explanted porcine aortic valved conduits were examined using scanning and transmission electron microscopy. Sources of obstruction such as neointima or "peel" and calcification were observed. In one sample the neointima was found to possess an unusually large expanse of squamous cells partially lining the luminal surface. This lining much resembled a normal endothelium, which is not an expected feature of neointima. Cells, presumably of host origin, were noted upon the leaflet surfaces. They did not seem as well organized as those found on the neointima. Calcification did not seem greatly advanced but was clearly apparent. Certain treatments proposed by others to curtail calcification are discussed and amended herein. SEM examination of three of these conduits provided good evidence of lining cells on only the inflow surface of the leaflet. The fourth conduit, however, showed cells on both inflow and outflow surfaces. These cells possessed certain characteristics of cells from leaflets of the other three conduits, but questions remain as to the precise identification of all of these lining cells. TEM examination provided cytological evidence of macrophage-like cells lining the inflow surface of a leaflet.

Adolescent↗

Medical devices; performance standards for dental and mammographic X-ray devices; amendment--FDA. Proposed rule.

The Food and Drug Administration (FDA) is proposing to exempt panoramic dental x-ray units from the requirement that they be manufactured with exposure timers which automatically reset to zero upon premature termination of an exposure. Removing the automatic timer reset requirement will not compromise the quality of the radiographic image and will protect patients from being subjected to unnecessary radiation due to repeat radiographs. FDA also proposes five changes to align the performance standard with the equipment requirements issued under the Mammography Quality Standards Act of 1992 (MQSA). First, the agency proposes to remove any reference to the use of equipment not specifically designed for mammography from the performance requirements for mammography equipment. Second, FDA proposes that the mammographic field alignment requirements restrict the irradiation beam to less than 2 percent of the source-image receptor distance (SID) beyond the image receptor edges. Third, it is proposed that the definition of an image receptor support device be amended to specify that it must provide a primary protective barrier for any orientation of the x-ray tube and image receptor support device assembly. Fourth, it is proposed that the useful beam must be confined to the dimensions of the primary barrier provided by the image receptor support device (except on the chest wall side). Fifth, it is proposed that exposures not be permitted without the primary barrier in place.

Equipment Safety↗

Comparative pathologic changes in broiler chicks on feed amended with Fusarium proliferatum culture material or purified fumonisin B1 and moniliformin.

Feed amended with autoclaved culture material (CM) of Fusarium proliferatum containing fumonisin B1 (FB1) (61-546 ppm), fumonisin B2 (FB2) (14-98 ppm) and moniliformin (66-367 ppm) was given to 228 male chicks in three separate feeding trials. In a fourth feeding trial, purified FB1 (125 and 274 ppm) and moniliformin (27 and 154 ppm) were given separately and in combination (137 and 77 ppm, respectively). Chicks that died during the trial periods, survivors and controls were subjected to postmortem examination. Specimens (liver, kidney, pancreas, lung, brain, intestine, testis, bursa of Fabricius, heart and skeletal muscle) were examined grossly and preserved for subsequent histopathologic and ultrastructural examination. Prominent gross lesions in affected birds fed diets amended with CM or purified FB1 and moniliformin included ascites, hydropericardium, hepatopathy, nephropathy, cardiomyopathy, pneumonitis, gizzard ulceration, and enlarged bursa of Fabricius filled with caseous material. The various concentrations of FB1 and moniliformin in the amended rations produced well-defined dose-response lesions in all groups in all four trials. Histopathologic changes included hemorrhage, leucocytic infiltration, fatty change or infiltration, individual cell necrosis and fibrosis in liver, kidneys, lungs, heart, intestines, gizzard, bursa of Fabricius and pancreas. Edema and hemorrhage were prominent in brains of treated birds. Ultrastructural changes included cytoplasmic and nuclear enlargement of cells in affected liver, lungs, kidneys, heart and pancreas. There were thickened membranes of the smooth endoplasmic reticulum, dilation of the rough endoplasmic reticulum with loss of ribosomes and vacuolated or deformed mitochondria.

Animal Feed↗

Income Tax (Amendment) Act 1988 (No. 1 of 1988), 21 January 1988.

This Singapore Act does the following, among other things: 1) authorizes the deduction from income taxes of the delivery and hospitalization expenses incurred with respect to the birth of a legitimate fourth child, up to $3000; 2) authorizes a deduction of payments made to a person's or that person's parent's retirement fund, up to $6000; 3) grants a rebate of $20,000 against tax payable to a person who has a third legitimate child, spread over up to five years, with an additional rebate against tax payable of 15% of her income for a married woman electing to be charged in her own name; and 4) sets deductions from taxable income at $750 for the first, second, and third child; and $300 for the fourth and fifth child, if born before 1 August 1973. In addition to these deductions, a married woman electing to be charged in her own name and having achieved certain educational qualifications is authorized to deduct 5% of her earned income for her first child up to $10,000, 10% for her second child up to $10,000, and 15% for her third child up to $10,000. For a fourth child born after 1 January 1987, she may deduct $750 and 15% of her earned income up to $10,000. In a message to Singapore citizens to mark the new year, the Prime Minister of Singapore urged citizens not to use lunar signs to plan the birth of their children. He stated, "Have your babies any year, including the snake year." See International Herald Tribune, 10 February 1989.

Asia↗

The continuing impact of treatment of eye disease on optometric practice in Missouri.

BACKGROUND: This study is a follow-up to a study performed in 1991 to determine the continuing impact of the use by optometrists in Missouri of therapeutic agents (TPA) to treat eye diseases. METHODS: Sixty-four percent of the Missouri optometrists certified to use therapeutic pharmaceutical agents responded to a 1995 questionnaire. RESULTS: More than 90 percent of those responding prescribe all categories of topical agents, while oral agents are used at lower percentages. Almost two-thirds of optometrists are registered with the Drug Enforcement Administration to prescribe controlled substances. The median number of therapeutic prescriptions written per year was 240, an increase of 67 percent from the previous study. More than half of the respondents now receive in-office detailing by drug company representatives. A small percent of optometrists have hospital clinical privileges and about one-fourth have privileges in nursing homes. CONCLUSIONS: The percentage of TPA-certified optometrists residing and practicing in Missouri has risen from one-half to slightly more than three-fourths of practitioners in a 4-year time period. This increase, coupled with the demonstrated increase in therapeutic prescriptions written, enhanced exposure to in-office detailing, and recent amendment of the optometry law to include the management of glaucoma bodes well for the delivery of primary eye care to citizens of the state.

Drug Prescriptions↗

Use of a left ventricular assist device in an outpatient setting.

The vented electric Heartmate LVAD (VE-LVAD) (Thermo Cardiosystems, Inc., Woburn, MA) is a reliable, fully portable system that allows selected patients with end-stage cardiomyopathy to undergo outpatient treatment while waiting for heart transplantation. This implantable, pusher-plate LVAD is actuated by an electric motor located within the pump housing. The patient wears external batteries and a system controller, which power and control the LVAD motor through a percutaneous lead. Since May 1991, four men have been supported with the VE-LVAD. They ranged in age from 33 to 50 years (mean, 44.3 years); two had idiopathic cardiomyopathy, and two had ischemic cardiomyopathy. Of the four patients, three underwent support of 196, 219, and 504 days; support in the fourth patient is ongoing at more than 90 days. All four patients were fully rehabilitated to New York Heart Association Class I status. Because they were well and fully mobile, the protocol was amended to allow these patients to leave the hospital in a four phase program that begins with 16 hr day passes and leads to hospital discharge. When patients leave the hospital, they are accompanied by trained family members or friends. The patients who have participated in the program have performed routine activities, attended social events, and spent the night at home. The VE-LVAD system seems safe and appropriate for the outpatient setting in selected patients. Patients have been able to manage the system without assistance from medical or engineering personnel. This initial positive experience with outpatient LVAD treatment demonstrates the potential for providing long-term cardiac support with this type of implantable technology.

Activities of Daily Living↗

Importance of algal biomass to growth and development of Anopheles gambiae larvae.

We conducted experiments to investigate the importance of algal food resources for larval growth and adult emergence of Anopheles gambiae Giles s.s. in simulated larval habitats in Kenya, and in greenhouse and laboratory microcosms in the United States. In the first experiment, we used shading to reduce algal biomass, and because algal production and larval development might be a function of underlying soil nutrients, we crossed sun-shade treatments with soils of two distinct types collected near larval habitats. Shading reduced pupation rates and total adult biomass of An. gambiae by approximately 50%. Soil type had no significant effect on mosquito production, but it did significantly affect concentrations of phosphorus and chlorophyll a in the surface microlayer. In a subsequent experiment conducted in the greenhouse to reduce temperature differences found between the shaded and sunlit treatments, <1% of larvae in the shaded treatments reached the pupal stage. There was a marked reduction of chlorophyll a levels as a function of shading and larval density. In a third experiment, larvae receiving material harvested from sunlit surface microlayers performed as well as those receiving liver powder, whereas those receiving surface microlayer from shaded habitats suffered >90% mortality and failed to pupate. In a fourth experiment, glucose was added to shaded microcosms to stimulate bacterial activity in the absence of algae. Bacterial growth rates were 2 to 3 times higher, and larval development was enhanced in glucose-amended treatments. However, pupation rates and adult weights in glucose-amended shaded microcosms were still poor compared with those in nonamended sunlit microcosms. Overall, these results demonstrate the importance of algal biomass in the surface microlayers of larval habitats to development and adult production of An. gambiae.

Animal Feed↗

Management of mine spoil for crop productivity with lignite fly ash and biological amendments.

Long-term field trials using lignite fly ash (LFA) were carried out in rice crops during the period 1996-2000 at Mine I, Neyveli Lignite Corporation, Tamil Nadu. LFA, being alkaline and endowed with an excellent pozzolanic nature, silt loam texture, and plant nutrients, has the potential to improve the texture, fertility, and crop productivity of mine spoil. The rice crops were the first, third, fifth, and sixth crops in rotation. The other crops, such as green gram (second) and sun hemp (fourth), were grown as green manure. For experimental trials, LFA was applied at various dosages (0, 5, 10, 20, 50, 100, and 200 t/ha), with and without press mud (10 t/ha), before cultivation of the first crop. Repeat applications of LFA were made at the same dosages in treatments of up to 50 t/ha (with and without press mud) before cultivation of the third and fifth crops. Press mud, a lightweight organic waste product from the sugar industry, was used as an organic amendment and source of plant nutrients. Also, a recommended dosage of chemical fertilizer, along with gypsum, humic acid, and biofertilizer as supplementing agents, was applied in all the treatments, including control. With one-time and repeat applications of LFA, from 5 to 20 t/ha (with and without press mud), the crop yield (grain and straw) increased significantly (p < 0.05), in the range from 3.0 to 42.0% over the corresponding control. The maximum yield was obtained with repeat applications of 20 t/ha of LFA with press mud in the third crop. The press mud enhanced the yield in the range of 1.5-10.2% with various dosages of LFA. The optimum dosage of LFA was 20 t/ha for both one-time and repeat applications. Repeat applications of LFA at lower dosages of up to 20 t/ha were more effective in increasing the yield than the corresponding one-time applications of up to 20 t/ha and repeat applications at 50 t/ha. One-time and repeat applications of LFA of up to 20 t/ha (with and without press mud), apart from increasing the yield, evinced improvement in the texture and fertility of mine spoil and the nutrient content of crop produce. Furthermore, some increase in the content of trace and heavy metals and the level of gamma-emitters in the mine spoil and crop produce was observed, but well within the permissible limits. The residual effect of LFA on succeeding crops was also encouraging in terms of eco-friendliness. Beyond 20 t/ha of LFA, the crop yield decreased significantly (p < 0.05), as a result of the formation of hardpan in the mine spoil and possibly the higher concentration of soluble salts in the LFA. However, the adverse effects of soluble salts were annulled progressively during the cultivation of succeeding crops. A plausible mechanism for the improved fertility of mine spoil and the carryover or uptake of toxic trace and heavy metals and gamma-emitters in mine spoil and crop produce is also discussed.

Agriculture↗

Banning tobacco billboards: The case for municipal action.

In 1994, Baltimore, Md, became the first city to generally prohibit billboards from displaying alcohol and tobacco advertisements. The owner of most of Baltimore's billboards, Penn Advertising, sued, but the federal district court rejected the billboard company's complaint and ruled that the First Amendment had not been violated and that the federal cigarette labeling acts had not preempted the ability of Baltimore to regulate and prohibit billboard cigarette advertising. In the fall of 1995, the federal district court's judgment was unanimously affirmed by the Fourth Circuit Court of Appeals in Richmond, Va. This article analyzes the constitutional and preemption issues and concludes that states and municipalities are on firm legal ground when they restrict the location or placement of publicly visible cigarette advertisements without attempting to regulate the advertisement's content or message. States and municipalities command broad authority to protect children and to shield the public from intrusive forms of advertisement that inflict their messages on a captive audience. A billboard ban thus offers local communities a legal avenue to help curb the rising tide of juvenile smoking without raising taxes, creating bureaucracy or angering smokers.

Advertising↗