[Actual problems of biosafety].

Actual problems of biosafety are presented. Examination of biosafety as a subsystem of life safety of humans allows to attract methodical apparatus developed by taking into account general terms of safety theory applied to problems of ensuring biosafety. As an actual goal implementation of technologies of risk analysis in evaluation of potentially dangerous biological objects and territories of Russian Federation is determined. Analysis of legislation and normative-methodical documentation in the field of ensuring biological safety during work with pathogenic biological agents revealed a number of problems of technical, organizational and scientific nature. Proposals for their solution are given.

Can microbes be patented?

Native microorganisms in their original form cannot be patented. However, microbes like yeasts, bacteria, protozoa, unicellular algae, fungi, actinomycetes and viruses can be patented if they have been genetically modified. The process and the product obtained can also be patented.

Destruction of microbial collections in response to select agent and toxin list regulations.

In this study we have followed up on anecdotal and hearsay evidence that microbial collections were destroyed in the United States following the imposition of the regulations associated with the Select Agents and Toxins List, to validate or refute that information. Using a questionnaire, we documented 13 episodes of microbial collection destruction involving viral, bacterial, and fungal strains, which we believe is almost certainly an underestimate of the number of collections destroyed. In every case, the motivation for the destruction of the collection was a desire to avoid the perceived burdens of the regulatory environment associated with operating under the Select Agent Regulations. Some institutions that destroyed isolates considered, and in some cases tried, transferring their collections to registered institutions prior to collection destruction but desisted when confronted with transport regulations. Destruction of microbial collections represents a loss of strains and biological diversity available for biomedical research and future mechanistic, forensic, and epidemiologic investigations. Given the rapid evolution of microbial strains, the destruction of archival collections is a potentially irretrievable loss that was an unintended consequence of regulations to protect society against the nefarious use of biological agents. Furthermore, unregistered institutions continue to destroy newly acquired clinical isolates, thus preventing the establishment of new repository collections. We recommend that government agencies develop plans to ensure that microbial collections are preserved when considering future additions to microbial threat lists under which the possession of certain microbes is criminalized.

[ISO 15189 accreditation in clinical microbiology laboratory: general concepts and the status in our laboratory]. / Klinik mikrobiyoloji laboratuvarinda ISO 15189 akreditasyonu: Genel bilgiler ve laboratuvarimizdaki durum.

One important trend in the laboratory profession and quality management is the global convergence of laboratory operations. The goal of an accredited medical laboratory is to continue "offering useful laboratory service for diagnosis and treatment of the patients and also aid to the health of the nation". An accredited clinical laboratory is managed by a quality control system, it is competent technically and the laboratory service meets the needs of all its patients and physicians by taking the responsibility of all the medical tests and therapies. For this purpose, ISO 15189 international standard has been prepared by 2003. ISO 15189 standard is originated from the arrangement of ISO 17025 and ISO 9001:2000 standards. Many countries such as England, Germany, France, Canada and Australia have preferred ISO 15189 as their own laboratory accreditation programme, meeting all the requirements of their medical laboratories. The accreditation performance of a clinical microbiology laboratory is mainly based on five essential points; preanalytical, analytical, postanalytical, quality control programmes (internal, external, interlaboratory) and audits (internal, external). In this review article, general concepts on ISO 15189 accreditation standards for the clinical microbiology laboratories have been summarized and the status of a private laboratory (Acibadem LabMed, Istanbul) in Turkey has been discussed.

The patenting of novel biotech products.

Patent laws covering NCEs are well established in most developed countries. For such entities to be patentable, they must be novel, inventive and have some practical use. Furthermore, the patent applications must describe how to make the entities, and provide data to support the patent claims. The same criteria are being applied by Patent Offices to the patenting of the new generation of biotech products: genes, proteins, microorganisms, transgenic plants and transgenic animals. This feature review focuses on the patenting of these novel products.

Transportation of reagents, reference materials and samples: the international perspective.

The International Regulations for the transport of infectious substances, which could include reagents, reference material and samples, are based on the 13th revision of the United Nations Model Regulations and are the standard for transport of infectious substances by all means of transportation. The 13th revision, effective January 2005 and further amended in March and July 2005, made major improvements in these shipping regulations. They specifically exempt certain substances, including those that have been neutralized or inactivated to destroy any pathogens and samples from "normal" animals. Infectious substances are divided into Category A, which includes primarily cultures of the more pathogenic agents and Category B, which includes all other substances that do not meet the Category A criteria. Tissue specimens, submitted for diagnosis, are included in Category B. Category A shipments must have a Dangerous Goods Certificate and meet other requirements; Category B shipments do not. The National requirements, such as import permits, and certain airline restrictions must also be met.

Constraints on transportation of reagents, reference materials and samples, difficulties and possible solutions: a user's perspective.

The air transportation of infectious materials is regulated by international air transport associations and based on United Nations Model regulations which have become more practical in addressing animal disease agents. However, individual countries' import and interstate requirements determine what materials can be imported and transported, and this approval process can be long, resulting in delays in organism confirmation, use of international OIE and other reference laboratories, and acquisition of reference materials, proficiency test panels, and reagents for performing necessary testing. Delays can be prevented for permits that are required for the routine work performed by a laboratory through the use of comprehensive and annually renewed permits. This process, however, does not address new and exotic agents where time is critical to an effective emergency response. This paper suggests actions by both the OIE and regulatory authorities which can assist in streamlining and expediting the permit process.