Figurines du Paléolithique supérieur en matière minérale plastique cuite d’Afalou Bou Rhummel (Babors, Algérie). Premières analyses par spectroscopie d’absorption Infrarouge

From 1983 to 1993, S. Hachi’s last excavations at the Afalou Bou Rhummel (Algeria) Babors coastal shelter have contextually produced numerous anthropological and zoological, clay figurines, all hand made and cooked, among Iberomaurusian Late Upper Palaeolithic remains. Regarding Maghrebian territories (Morocco, Algeria, Tunisia and Libya), these so peculiar documents are strictly related to 15?000-11?000 BP levels, although deeper archaeological levels are 18?000 BP. Twenty eight small samples (less 1mg) were analysed through infrared absorption spectroscopy (IR) so as to precise, through typical transformation of the major mineral involved: kaolinite, smectites, and amorphous silicates, the final degree of temperature reached after cooking. These documents were all intentionally cooked between 500 and 800 °C. Local clay was obviously picked up for figurine elaboration.     

European Regulations and Their Impact on Tissue Banking

Extensive CoE-EU cooperation ensures coherence and complementarities between the principles of the CoE guides which can be regarded as recommendations on best practice, and the technical requirements of the EU directives which set out legally binding requirements. This means that the same standards now exist throughout European continent. Having a common set of standards facilitates cooperation between different healthcare systems, especially in cases of emergencies, and the export–import issues. Adoption of the same quality management and traceability systems helps to minimise the risks and prevent disease transmissions. It reassures patients who undergo treatments outside of their countries. The tissue establishments need to introduce technical and structural changes to adhere to the new regulations which ultimately results in saving and improving of lives of many patients.This and other EU documents on tissues and cells are also available at     

兽用疫苗管理与控制的国际标准

兽用疫苗是兽医医学产品,需接受像医学产品相同或相似的管理和控制标准,这意味着动物疫苗必须满足复杂的要求,保障产品在预期使用条件下的质量、安全性和免疫效力.在动物医药领域中,欧盟和美国的动物疫苗管理和控制体系发展早,制度完整,为其他国家和地区建立良好的动物疫苗管理与控制标准提供了有价值的参考信息.另外,统一各个国家和地区...     

USDA perspective on environmental enrichment for animals

This article provides a brief historical background of the events and circumstances that led to the 1985 Animal Welfare Act (AWA) amendments. It describes the development of the regulations promulgated by the US Department of Agriculture (USDA) in 1991 as a result of these amendments, the reasoning given for the proposals, and the revisions that were made during the process. Information is included on USDA implementation of the regulations regarding exercise for dogs and environmental enhancement for nonhuman primates. Also mentioned briefly are the requirements for socialization of marine mammals and space requirements for certain other regulated warm-blooded species. These requirements apply to animal dealers (breeders and brokers), exhibitors, commercial transporters, and research facilities. The standards for exercise and environmental enhancement were different from any others previously contained in the AWA regulations, and required more research and understanding of species-specific needs by the regulated community. Finally, this article describes some of the initiatives being undertaken by the research community and USDA-Animal and Plant Health Inspection Services (APHIS)-Animal Care to provide the necessary education and guidance indicated by the violation history data.     

Assessment of Potential Karner Blue Butterfly (Lycaeides melissa samuelis) (Family: Lycanidae) Reintroduction Sites in Ontario, Canada

Although species reintroduction is useful as both an integral part and a performance indicator of habitat restoration, it is not a risk‐free process. Evaluation of potential reintroduction sites is often crucially important in reducing chances of failure. Despite its importance, there is no standard way to do so. This study applied a systematic scheme to evaluate five potential reintroduction sites for the endangered Karner Blue butterfly (Lycaeides melissa samuelis Nabokov) in Ontario, Canada, by looking at both biotic and abiotic aspects. Field data were collected in 2003 from these sites, and three potential founder butterfly sites in the United States. We used data collected from the U.S. sites to determine the minimum standards for ecological requirements of the Karner Blue. Data from the Ontario sites were then compared against these standards. The results show that all five potential reintroduction sites are of lower quality, at least in certain aspects, compared with the three potential founder butterfly sites. This implies that success is not guaranteed if the Karner Blue is reintroduced into these sites under current habitat conditions. Further site restoration is required and should focus on the shortcomings identified for individual sites in this study. The lessons from this study are useful for potential reintroduction site assessment in other restoration projects because they reveal whether the sites are ready for species reintroduction and, if not, how they need to be improved.     

Emergency Health Services Informational and Educational Programs: Development and Present Status

The development and present status of the Emergency Health Services (EHS) national and educational programs are discussed. Instituted in 1951 for medical and dental practitioners at a military school at Camp Borden, professional civilian indoctrination was later assumed by EHS at Canadian Emergency Measures College (CEMC). The federally sponsored courses there are now specialized; provincial EHS authorities undertake general indoctrination. Courses for graduates in pharmacy and nursing are also offered at CEMC. Hospital Disaster Institutes have been held across the country since 1954; Public Health Disaster Institutes, since 1966. Schools of Hygiene include the subject in graduate programs. Some years ago, three medical faculties introduced undergraduate teaching in mass casualty care; now, encouraged by the Association of Canadian Medical Colleges, a larger number are doing so. Several faculties of Dentistry, all faculties of Pharmacy, and 132 of 177 nursing schools teach apposite aspects. Professional journals have published many articles on this subject; this, for example, is the fourth Emergency Health Services Symposium presented by The Canadian Medical Association Journal.     

Regulatory Issues for Genetic Testing in Clinical Practice

Whereas deliver of health care is nationally based with great differences in ways of service provision and financing between countries, and thus not subject to international regulations, genetic testing has become more exposed to international regulations and conventions. This is due to an interest of protecting the individual for abuse by inappropriate use of genetic information, but also to the fact that a specimen from a person aimed for a medical (clinical genetic) test is considered as "tradable goods", and thus also subject to other non-medical associated regulations. There is a substantial transborder flow of samples for genetic testing thus requiring internationally accepted quality standards. Therefore, laboratories acting on an international market need to follow certain rules and regulations, also applicable to obtain high-quality standards nationally. Further, genetic testing for rare disorders is often provided by a limited number of non-commercial laboratories and associated with research programs for the individual disorders. International surveys have revealed that there is a general lack of high standards for quality assurance. This article is aimed to give an introduction and overview of regulations, conventions, and quality standards applicable for the laboratory who is seeking to improve there quality performance.     

U.S. laws, regulations, and policies important to managers of nonhuman primate colonies

The various animal welfare laws, regulations, policies, accreditation standards, and welfare groups have an obvious impact on the activities of managers of nonhuman primate colonies. Federal organizations such as the Department of Health and Human Services, Department of Interior, the Department of Agriculture, the Department of Transportation, and the Justice Department regulate many aspects of animal management. Pertinent guidance is available through scientific organizations such as the American Association for Accreditation of Laboratory Animal Care and the National Academy of Sciences. Finally, the recommendations of responsible animal welfare organizations should also receive careful consideration.     

Alternatives of Informed Consent for Storage and Use of Human Biological Material for Research Purposes: Brazilian Regulation

Informed consent is recognized as a primary ethical requirement to conduct research involving humans. In the investigations with the use of human biological material, informed consent (IC) assumes a differentiated condition on account of the many future possibilities. This work presents suitable alternatives for IC regarding the storage and use of human biological material in research, according to new Brazilian regulations. Both norms – Resolution 441/11 of the National Health Council, approved on 12 May 2011, and Ordinance 2.201 (NATIONAL GUIDELINES FOR BIOREPOSITORIES AND BIOBANKS OF HUMAN BIOLOGICAL MATERIAL FOR RESEARCH PURPOSE) of the Brazil Ministry of Health, approved on 14 September 2011 – state that the consent of subjects for the collection, storage and use of samples stored in Biobanks is necessarily established by means of a Free and Informed Consent Form (ICF). In order to obtain individual and formal statements, this form should contain the following two mutually exclusive options: an explanation about the use of the stored material in each research study, and the need for new consent or the waiver thereof when the material is used for a new study. On the other hand, ICF suitable for Biorepositories must be exclusive and related to specific research. Although Brazilian and international regulations identify the main aspects to be included in the IC, efforts are still necessary to improve the consent process, so that the document will become a bond of trust between subject and researcher.     

Tools and methodologies to support more sustainable biofuel feedstock production

Increasingly, government regulations, voluntary standards, and company guidelines require that biofuel production complies with sustainability criteria. For some stakeholders, however, compliance with these criteria may seem complex, costly, or unfeasible. What exiting tools, then, might facilitate compliance with a variety of biofuel-related sustainability criteria? This paper presents four existing tools and methodologies that can help stakeholders assess (and mitigate) potential risks associated with feedstock production, and can thus facilitate compliance with requirements under different requirement systems. These include the Integrated Biodiversity Assessment Tool (IBAT), the ARtificial Intelligence for Ecosystem Services (ARIES) tool, the Responsible Cultivation Areas (RCA) methodology, and the related Biofuels + Forest Carbon (Biofuel + FC) methodology.     

New laws mean MDs must keep up to date on living-will and related legislation.

Lawyer Karen Capen discusses the legal aspects of documents such as living wills, advance directives and "proxies for personal care." Most provinces are enacting legislation to govern such directives, and physicians should keep abreast of new legislation and regulations in their jurisdiction.     

Variability of dry mass as a fundamental biological property demonstrated for the case of Vaccinia virions.

The dry mass of individual vaccinia virions, as an example of a presumably uniform biological population, prepared in different lost at the Institute for Tropical Hygiene in Hamburg, was tested for variability by quantitative electron microscopy. A value of 5.26 X 10(-15) g for the median weight of the particle was calculated from 7,300 determinations. By assessing the variability of polystyrene latex spheres, which were used as mass standards, we demonstrated that the variability of dry mass of vaccinia virions is fivefold greater than the variability (standard) introduced by the method for determining mass. It was concluded that while genetic control in a presumably homozygous virion is strict with respect to quality, quantity of viral components (other than DNA) varies in fashion that can be aptly described by a log-normal distribution. It is recognized that this observation is empirically supported by the paradigm that any composite biological entity is subject to quantitative variability, the more so the heavier the individual representatives of a species are. In addition, the effects that extractions and staining have on the dry mass of vaccinia are reported, as well as is the median for the dry mass of other strains of pox viruses.     

Process optimization for biodiesel production from mahua (Madhuca indica) oil using response surface methodology

A central composite rotatable design was used to study the effect of methanol quantity, acid concentration and reaction time on the reduction of free fatty acids content of mahua oil during its pretreatment for making biodiesel. All the three variables significantly affected the acid value of the product, methanol being the most effective followed by reaction time and acid catalyst concentration. Using response surface methodology, a quadratic polynomial equation was obtained for acid value by multiple regression analysis. Verification experiments confirmed the validity of the predicted model. The optimum combinations for reducing the acid level of mahua oil to less than 1% after pretreatment was 0.32 v/v methanol-to-oil ratio, 1.24% v/v H2SO4 catalyst and 1.26 h reaction time at 60 degrees C. After the pretreatment of mahua oil, transesterification reaction was carried out with 0.25 v/v methanol-to-oil ratio (6:1 molar ratio) and 0.7% w/v KOH as an alkaline catalyst to produce biodiesel. The fuel properties of mahua biodiesel so obtained complied the requirements of both the American and European standards for biodiesel.     

Ethical problems with the mental health evaluation standards of care for adult gender variant prospective patients

The World Professional Association for Transgender Health's "Standards of Care: The Hormonal and Surgical Sex Reassignment of Gender Dysphoric Persons" (SOC) set forth standards clinicians must meet to ensure ethical care of adequate quality. The SOC also set requirements gender variant prospective patients must meet to receive medical interventions to change their sexual characteristics to those more typical for the sex to which they were not assigned at birth. One such requirement is that mental health professionals must ascertain that prospective patients have met the SOC's eligibility and readiness criteria. This article raises two objections to this requirement: ethically obligatory considerations of the overall balance of potential harms and benefits tell against it, and it violates the principle of respect for autonomy. This requirement treats gender variant prospective patients who request medical intervention as different in kind, not merely degree, from other patient populations, as it constructs the very request as a phenomenon of incapacity. This is ethically indefensible in and of itself, but it is especially pernicious in a sociocultural and political context that already denies gender variant people full moral status.     

Selective apoptosis-inducing activity of crinum-type Amaryllidaceae alkaloids

The selective apoptosis-inducing activity of Amaryllidaceae alkaloids belonging to the crinane-type is reported. A mini-library of natural and synthetic crinane alkaloids was assembled. Biological screening indicated crinamine 4 and haemanthamine 9 to be potent inducers of apoptosis in tumour cells at micromolar concentrations. Structure-activity relationships demonstrated the requirement for both an alpha-C2 bridge and a free hydroxyl at the C-11 position as pharmacophoric requirements for this activity.     

Select agent regulations

In recent years, there has been an increase in research with biological agents, particularly those that pose a potential for use by terrorists. In this environment, laws have been enacted and regulations developed to ensure the appropriate use of specified "select agents and toxins" for legitimate research. Within this regulatory environment, it has been necessary for institutions and investigators to adapt to an entirely new set of requirements to begin or continue to work with these pathogens. Registration and approval for use of select agents and toxins, security and safety requirements, and daunting record-keeping requirements are only some of the regulatory challenges that researchers face in working with these agents. A brief overview of recent regulations is presented, as well as where to obtain additional information on regulations, standards, and guidelines related to work with select agents and toxins.     

Basic principles of developing national standards for antibiotics

The main principles in preparation of national standards of the antibiotics manufacture in the USSR are compared with those of the World Health Organization. The characteristics of preparing standards of mono- and multicomponent antibiotics, as well as the requirements for optimal packing of the standards are presented.     

Head and neck cancer in the UK: what is expected of cytopathology?

Objective:  This review highlights the role of cytopathology in cancer management within UK Head and Neck Cancer Networks and informs on the issues raised by recent UK Department of Health documents and other UK professional guidance. UK guidance requires the formal involvement of cytopathologists within multidisciplinary cancer teams, with medical and non-medical cytopathology staff setting up and running rapid access lump clinics, and support for image-guided fine needle aspiration cytology (FNAC) services. UK guidance also makes recommendations for training, resources and quality control. This review also highlights the resource gap between best practice evidence-based guidance for head and neck (HN) cancer services and existing UK provision for cytopathology, as evidenced by lack of availability of experienced staff and adequacy of training and quality control (QC). Finally, it stresses the importance in the UK of the Royal College of Pathologists' guidance, which defines the need for training, the experience needed for new consultants, the requirements for audit and QC. The implications for the additional resources required for HN cancer cytopathology services are discussed. Recent professional guidance specifying the provision of HN cancer services in the UK includes a cytopathology service for cancer networks, such as rapid access FNAC clinics. Although these clinics already operate in some institutions, there are many institutions where they do not and where the provision of cytopathology services would have to be restructured. This would need the support of local cancer networks and their acceptance of the detailed requirements for cytopathology, including resources, training and QC. The standards are not defined locally, as Strategic Health Authorities and Primary Care Trusts have been instructed by the Department of Health to support, invest and implement them.     

Current state of Health Canada regulation for cellular and gene therapy products: potential cures on the horizon

We provide an overview of the regulatory framework, pathways and underlying regulatory authority for cell, gene and tissue-engineered therapies in Canada. Canada's regulatory approach uses three sets of regulations, namely, the Cells, Tissues and Organs Regulations, the Food and Drug Regulations and the Medical Devices Regulations. We provide an overview of each these sets of regulations as they apply to clinical investigation to post-market product lifecycle stages. Information is provided on the current sources of relevant Health Canada guidance documents. We highlight several regional success stories including Prochymal, a cell therapy product that achieved Canadian regulatory approval using the conditional marketing approval system. We also examine the perceived gaps in the Canadian regulations and how those gaps are being addressed by interactions between the government, stakeholders and international bodies. We conclude that the risk-benefit approach used by Health Canada for regulatory approval processes is sufficiently flexible to enable to development of novel cell and gene therapy products in Canada, yet stringent enough to protect patient safety.     

Survey of safety and health care in British medical laboratories.

A retrospective postal survey of 24 000 medical laboratory workers in England, Wales, and Scotland showed highly variable standards of safety and health care. Pre-employment health screening was offered to two-thirds of employees, the physicians being the least likely to be examined (15%). Scottish laboratories provided better safety control than English and Welsh laboratories, while Public Health Service Laboratories had a better record than National Health Service establishments. Mouth pipetting is still practised in 65% of English and Welsh laboratories, and the use of protective clothing is rarely compulsory. The servicing of safety cabinets is often inadequate. Known and suspected carcinogens are still apparently used in a few laboratories (2-10%). In view of the wide variation in standards among laboratories, urgent consideration should be given to establishing regulations for codes of safe practice rather than relying merely on recommendations as at present.