Laxative drug products for over-the-counter human use; psyllium ingredients in granular dosage forms. Final rule

The Food and Drug Administration (FDA) is issuing a final rule establishing that over-the-counter (OTC) laxative drug products in granular dosage form containing the bulk-forming psyllium ingredients (psyllium (hemicellulose), psyllium hydrophilic mucilloid, psyllium seed, psyllium seed (blond), psyllium seed husks, plantago ovata husks, and plantago seed) are not generally recognized as safe and effective (GRASE) and are misbranded. This final rule includes, but is not limited to, any granules that are swallowed dry prior to drinking liquid; dispersed, suspended, or partially dissolved in liquid prior to swallowing; chewed, partially chewed, or unchewed, and then washed down (or swallowed) with liquid; or sprinkled over food. FDA is issuing this final rule after considering reports of esophageal obstruction associated with the use of psyllium laxatives in granular dosage form. These cases continue to occur despite efforts to promote safe use through label warnings and directions. This final rule does not apply to psyllium laxatives in nongranular dosage forms, such as powders, tablets, or wafers. This final rule is part of FDA's ongoing review of OTC drug products.     

A guide to the best technology-transfer practices

In analyzing the best technology-transfer practices of a broad cross-section of goverment agencies, research institutions, and national and industrial laboratories, it was found that different technology-transfer practices should be used at the prospecting, developing, trial, and adoption stages of technology transfer. These results are summarized in a benchmark model that indicates which best practices to use at each stage of the technology-transfer process, and what roles should be played by technology disseminators, developers, sponsors, and implementors during these stages. Rules are suggested for making cost-effectiveness trade-offs among alternative best practices and designing optimal transfer strategies when budgets are limited.     

A simple histochemical technique for the identification of gunshot residue

Alizarin red S (ARS) is a commonly used organic dye useful in the histologic identification of calcium deposits. ARS also forms colored reaction products with other metal ions, including barium and lead, which are present in primer residue. In histochemical studies, ARS is shown to identify primer residues from several manufacturers as well as primer residue deposited in tissue, either experimentally or in close-range gunshot wounds. This can be easily accomplished with routine histologic techniques. ARS does not stain gunpowder residue, tattoo pigment, melanin, graphite, india ink, or anthracotic pigment.     

A study on the standard for forensic anthropologic identification of skull-image superimposition

By means of X-ray photography tests were made of 224 (100 males and 124 females) volunteer Chinese adults of Han nationality to study the related regular patterns of superimposed projection of face landmarks onto the skull. On the basis of these tests, the present article reveals from a forensic anthropology angle the related regular patterns of plane projection of the human face with its skull. Study shows that there exist a strict individual identity and exclusiveness in relation between the human face and skull. The related regularity of displacement of face landmarks appears in projection of the skull with the human head at different photographic positions and angles. On the basis of this discovery, 52 indexes in 4 groups were established as a standard for judging the identification of a skull's body origin by means of skull-image superimposition. Based on forensic anthropology, the technique has raised to a great extent the credibility of unknown skull identification. In the past 8 years, 89 unknown skulls have been identified with their body origins which provided important and accurate evidence for the solution of murders with dismembered bodies, skeletonized bodies, and unidentified dead bodies.     

A theory of identification

This paper analyzes the phenomenon of “identification” by an individual with actors in his environment. It argues that individuals interpret their environment according to “frames,” which they, as recipients of a message, derive by a complex process of interpretation of the communication setting. The paper also argues that individuals identify with actors in their environment, because this identification increases their utility vis-à-vis a “neutral” watching of their environment. The paper applies this approach to a variety of real life examples, in particular to voting.     

A new algorithm for use in computer identification

On 9 May 1987, a Soviet-made IL-62M Polish airliner, LOT Flight 5055, crashed, exploded, and burned, killing the crew and 183 passengers. A forensic science team from the Armed Forces Institute of Pathology, comprised of 6 dental officers, 3 forensic pathologists, and 3 medical photographers, worked in concert with the Polish forensic science team. The small number of antemortem records and the extreme fragmentation of the remains presented a new scenario for computer use. Typically, the Computer-Assisted Postmortem Identification (CAPMI) software is used to compare remains against an antemortem database. Results are listed by the number of tooth-to-tooth matches based on restorative or other characteristics or both. The Polish disaster confounded this approach to some degree, however, and suggested a reconsideration of the theory on which the sort is made, that is, that the cases with maximum number of matches to preexisting dental records would be the most likely identification (ID) match. A hypothesis was constructed that, if searches were accomplished for fragments with a minimum number of mismatches, the correct matches would appear higher in the rank order. Six antemortem records (that had all dental information) were sorted against one hundred and twelve postmortem fragmented records. The resulting report was reordered so that records were listed by minimum number of mismatches. There was significant improvement in rank placement for all of the records. Thus it was accepted that in the situation of highly fragmented remains a different sorting based on the number of mismatches is indicated. Programming changes to make this option available have been implemented in the new version of CAPMI.     

A post-processing technique for cranial CT image identification

Objective: A major challenge in radiographic identification is the inconsistent orientation between clinical (ante-mortem, AM) and post-mortem (PM) radiographs. The objectivity and accuracy of radiological identification would be greatly enhanced by post-processing techniques that allow quantitative comparison of PM CT data in the same orientation as the AM CT data. Methods: We applied a post-processing technique to reposition a multislice computed tomography (MSCT) scan for spatial registration with a CT radiograph from the same patient. A second set of MSCT images from different individuals served as the non-matched control group. The consistency in radiographic positioning eliminated subjectivity in the comparison and identification process because the radiograph superposition provided objective evidence that confirmed the identification with fine detail. Results: A quantitative comparison with statistical validation was achieved by measuring a set of 14 landmarks from the images. Discrimination of identity based on logistic regression analysis of the earlier CT patient scans (the AM group) versus subsequent MSCT scans (the PM group) was objective and reliable. Conclusion: This quantitative comparison depends less on subjective judgment and the experience of the examiner, and so may meet legal standards.     

A multi-enzyme electrophoretic system for the identification of seminal fluid from postmortem specimens

The screening of autopsy specimens, vaginal, buccal, and rectal swabs, for the presence of seminal fluid in rape homicide investigations utilizing classical techniques can lead to erroneous results. In the absence of spermatozoa, techniques are needed which can help to identify seminal fluid. This report illustrates the use of a multi-enzyme electrophoretic approach identifying seminal acid phosphatase (SAP) and lactic acid dehydrogenase (LDH-X) as an initial screening procedure. Subsequent analyses for the presence of acid and alkaline phosphatase (semiquantitative) yield information which can help identify false-positive SAP's. Additionally, salivary amylase can be tentatively identified using the same multi-enzyme procedure which informs the investigator of possible salivary contamination of the sample and possible erroneous PGM results. Statistics utilizing the multi-enzyme approach in case work are also presented.     

A method for group identification of hair infected with Microsporum

A method for identifying the group appurtenance of biological objects from subjects suffering from various diseases is developed. The method can be used in examination of putrefactive objects (blood, secretions, hair, etc.) and in cases when the group appurtenance cannot be identified by other methods.     

A short note on the identification of mitragynine

The leaves of Mitragyna speciosa are used as a substitute for opium. Criminal penalties for possession of mitragynine in this country are assigned for possession of defined quantities of mitragynine and its identification as Mitragyna speciosa by thin-layer chromatography and gas chromatography.     

A validation study of mRNA markers for skin cell identification

The objectives of this study were to develop and optimize a multiplex of three skin specific gene markers; loricrin (LOR), corneodesmosin (CDSN) and keratin 9 (KRT9) and 1 house-keeping marker, β-actin (ACTB) using an endpoint PCR assay to analyze expression data from a range of relevant samples. Marker specificity and suitability were evaluated for their inclusion in future forensic casework. The presence of the three skin mRNA markers was successfully confirmed from swabs of human skin obtained from 20 individuals at each of 6 different body sites (forehead, neck, arm, palm, leg and sole). Significant variation was observed in the relative expression of the three genes across the body sites, with some individuals consistently failing to express one or more of the targets. Inter-individual variation was also evident. Accordingly, these markers must be used with caution in the identification of skin in forensic samples.     

A molecular genetic approach for forensic animal species identification

This study investigated potential markers within chromosomal, mitochondrial DNA (mtDNA) and ribosomal RNA (rRNA) with the aim of developing a DNA based method to allow differentiation between animal species. Such discrimination tests may have important applications in the forensic science, agriculture, quarantine and customs fields. DNA samples from five different animal individuals within the same species for 10 species of animal (including human) were analysed. DNA extraction and quantitation followed by PCR amplification and GeneScan visualisation formed the basis of the experimental analysis. Five gene markers from three different types of genes were investigated. These included genomic markers for the beta-actin and TP53 tumor suppressor gene. Mitochondrial DNA markers, designed by Bataille et al. [Forensic Sci. Int. 99 (1999) 165], examined the Cytochrome b gene and Hypervariable Displacement Loop (D-Loop) region. Finally, a ribosomal RNA marker for the 28S rRNA gene optimised by Naito et al. [J. Forensic Sci. 37 (1992) 396] was used as a possible marker for speciation. Results showed a difference of only several base pairs between all species for the beta-actin and 28S markers, with the exception of Sus scrofa (pig) beta-actin fragment length, which produced a significantly smaller fragment. Multiplexing of Cytochrome b and D-Loop markers gave limited species information, although positive discrimination of human DNA was evident. The most specific and discriminatory results were shown using the TP53 gene since this marker produced greatest fragment size differences between animal species studied. Sample differentiation for all species was possible following TP53 amplification, suggesting that this gene could be used as a potential animal species identifier.     

A guide to the EEOC's final regulations on the Americans with Disabilities Act

The Equal Employment Opportunity Commission (EEOC) recently issued its final regulations on the Americans with Disabilities Act (ADA). Although the regulations offer some guidance for employers on how to comply with the Act, they fail to provide specific answers to the many complicated compliance questions that will surely arise. Further, the regulations are almost totally silent on certain critical issues related to insurance, workers' compensation, and potential conflicts between ADA obligations and terms of collective bargaining agreements. The EEOC has essentially left the resolution of many important ADA questions to case-by-case determination and the litigation process.     

A novel method for the identification of saliva by detecting oral streptococci using PCR

We have used DNA amplification methods to detect common oral bacterial strains to test for the presence of saliva in forensic samples. Streptococcus salivarius and Streptococcus mutans were detected in various forms of saliva samples, whereas these streptococci were not detected in semen, urine, vaginal fluid, or on skin surfaces. Therefore, we demonstrated that these streptococci are promising new marker for the forensic identification of saliva. Our data indicated that S. salivarius is more reliable than S. mutans as an indicator of saliva presence, because the detection rates for S. salivarius and S. mutans by this method were 100% and 90%, respectively. Furthermore, S. salivarius was detected in all saliva stain samples, whereas S. mutans was only identified in 60% of the stains. Finally, using this method we were able to successfully detect S. salivarius and S. mutans in mock forensic samples. We therefore suggested that this method is useful for the identification of saliva in forensic science.     

A PCR multiplex and database for forensic DNA identification of dogs

Animal-derived trace evidence is a common finding at crime scenes and may provide an important link between victim(s) and suspect(s). A database of 558 dogs of pure and mixed breeds is described and analyzed with two PCR multiplexes of 17 microsatellites. Summary statistics (number of alleles, expected and observed heterozygosity and power of exclusion) are compared between breeds. Marked population substructure in dog breeds indicates significant inbreeding, and the use of a conservative theta value is recommended in likelihood calculations for determining the significance of a DNA match. Evidence is presented that the informativeness of the canine microsatellites, despite inbreeding, is comparable to the human CODIS loci. Two cases utilizing canine DNA typing, State of Washington v. Kenneth Leuluaialii and George Tuilefano and Crown v. Daniel McGowan, illustrate the potential of canine microsatellite markers for forensic investigations.     

A global study of forensically significant calliphorids: implications for identification

A proliferation of molecular studies of the forensically significant Calliphoridae in the last decade has seen molecule-based identification of immature and damaged specimens become a routine complement to traditional morphological identification as a preliminary to the accurate estimation of post-mortem intervals (PMI), which depends on the use of species-specific developmental data. Published molecular studies have tended to focus on generating data for geographically localised communities of species of importance, which has limited the consideration of intraspecific variation in species of global distribution. This study used phylogenetic analysis to assess the species status of 27 forensically important calliphorid species based on 1167 base pairs of the COI gene of 119 specimens from 22 countries, and confirmed the utility of the COI gene in identifying most species. The species Lucilia cuprina, Chrysomya megacephala, Ch. saffranea, Ch. albifrontalis and Calliphora stygia were unable to be monophyletically resolved based on these data. Identification of phylogenetically young species will require a faster-evolving molecular marker, but most species could be unambiguously characterised by sampling relatively few conspecific individuals if they were from distant localities. Intraspecific geographical variation was observed within Ch. rufifacies and L. cuprina, and is discussed with reference to unrecognised species.