The New International Standards for Life Cycle Assessment: ISO 14040 and ISO 14044

Background, Aims and Scope The development of the international standards for life cycle assessment (ISO 14040:1997, ISO 14041:1999, ISO 14042:2000, ISO 14043:2000) was an important step to consolidate procedures and methods of LCA. Their contribution to the general acceptance of LCA by all stakeholders and by the international community was crucial. Currently, the process of the revision of this first generation of LCA standards is close to completion. The paper explains the outline as well as formal and technical changes of the coming new international standards of LCA, i.e. the new ISO 14040 and ISO 14044. Methods The paper refers to life cycle assessment based on the international standards for LCA (ISO 14040:1997, ISO 14041:1999, ISO 14042:2000, ISO 14043:2000). The content relates to the Final Draft International Standard (FDIS) versions of the new ISO 14040 and ISO 14044. Results and Discussion With the publication of the two new standards, ISO 14040 and ISO 14044, the existing four standards ISO 14040:1997, ISO 14041:1999, ISO 14042:2000 and ISO 14043:2000 are technically revised, cancelled and replaced. According to the scope of the revision, the core part of the technical contents remains unchanged. Improved readability and the removal of errors and inconsistencies was the focus of the revision. However, despite the fact that the main technical content was confirmed to be still valid, some relevant formal and technical changes were made. On the technical side these include e.g. the addition of principles for LCA, the addition of an annex about applications, the addition of several definitions (e.g. product, process, etc.), clarifications concerning LCA intended to be used in comparative assertions intended to be disclosed to the public, clarifications concerning the critical review panel, clarifications concerning system boundary, etc. On the formal side, changes include the reduced number of standards, a reduced number of annexes, a reduced number of pages that contain requirements, alignment of definitions and clarification of compliance with the standards. Conclusion The two new standards, ISO 14040 and ISO 14044, reconfirm the validity of the main technical content of the previous standards. Errors and inconsistencies were removed and the readability was improved. The added technical content is in line with the previous requirements and serves mainly as a clarification of the technical content. The unanimous vote on the Draft International Standard versions proved that this was achieved on the basis of the broadest possible international consensus. Recommendation and Outlook Currently the national member bodies undertake the final voting on the FDIS-versions of the standards. Based on the voting results at the previous stages of the documents, a positive result is expected. The publication of the new international standards for life cycle assessment (ISO 14040 and ISO 14044) is expected around mid-2006. For the sake of the international and stakeholder acceptance of LCA, it is recommended that the new standards serve as core reference documents for the users and practitioners of LCA.     

Integrating environmental aspects into product design and development the new ISO TR 14062

Conclusion  It is recommended to transfer the general standard to the company-specific management systems, tools and cultures. Practical experience is necessary to identify its limits in each case. The future development of this Technical Report to a management system standard may not be difficult — and even necessary as shown in the paper. The problem occurs in the variety of opportunities to be implemented. Again, the integration shall be tailored to the existing management systems, in particular ISO 9001/14001. In addition, the design The full version of this paper has been published in Gate to EHS/LCM (DOI: httD://dx.doi.org/10.1065/ehs2003.02.005) (DOI: http://dx.doi.Org/10.1065/ehs2003.03.006) (DOI: http://dx.doi.Org/10.1065/ehs2003.03.007)     

中国生物多样性e-Science平台建设构想

本文结合国际生物多样性信息学发展趋势和生物多样性e-Science相关平台, 在分析我国前期工作成果和相关问题的基础上, 提出了基于服务架构(Service-Oriented Architecture, 简称SOA)和国际空间标准服务ISO 19119的中国生物多样性e-Science平台的三层结构(资源层、服务层和应用层), 并对e-Science平台建设的几个重要方向进行阐述: 组建强有力的协调组织、数据规范化和扩展、海量数据存储和计算、本体构建和语义分析、专题分析和领域建模、服务标准和服务内容以及科学社区的建设, 为我国进行生物多样性e-Science平台建设提供理论依据。     

News from the Biological Stain Commission No. 7

Abstract

In this issue of News from the Biological Stain Commission (BSC), under the heading of Regulatory affairs, the Biological Stain Commission's International Affairs Committee presents information from a meeting held in Berlin by the International Standards Organization ISO/TC 212/WG 1, “Quality and Competence in the Medical Laboratory,” on 11–12 December 2008. After this, we turn again to problems with impure dyes and find that solvent dyes are impure even for non-biological use.     

Analysis of the potential for a comprehensive approach towards LCA and EMS in Japan

Sustainable development can only be achieved if industry adoptsboth product related and organisation related environmental management tools, such as Life Cycle Assessment (LCA) and Environmental Management Systems (EMS). In Japan, EMS (ISO 14001) is more widely applied than LCA (ISO 14040). Therefore,one means by which Japanese industries could be motivated to adopt and use LCA is to relate LCA-activities to the policies and instruments of ISO 14001. The potential of such a comprehensive approach was analysed by a survey of 270 Japanese enterprises (response rate 45%). The results indicate that 19% of the responding representatives had responsibilities for both LCA and EMS, while the remaining only work in one of both fields. A statement in the company’s/ plant’s Environmental Policy of ISO 14001, stating that LCA is to be used as part of the EMS, was found in 42% of all companies. A surprising number (39%) either already use, or plan to use, LCA and EMS as combinated/integrated tools. A strong argument for the establishment of a comprehensive approach can be seen in the perception of the usefulness of LCA, which was rated significantly higher in companies that acknowledged the complementary potential of LCA and EMS.     

Selective multinationality how environmental management helps high-tech SMES identify high-growth,low-risk markets

Background  Small and medium sized enterprises in developed regions, as well as larger ‘Southern’ firms are more exposed to risk in regards to allocation decisions. This includes expenditures on fixed assets, R&D and environmental management, as well as the choice of suitable markets for the product or service at hand. For either type of firm, the consequences of not selecting, or timing, suitable markets can lead to bankruptcy. Objectives  This paper examines means for SMEs to expand internationally given the current fiscal climate, and rapid advances in certain enabling technologies. The goal is to identify a set of criteria which smaller firms can use to globalize which reduce risk and increase access to capital. Methods  Case studies are presented of a European Start-Up as well as a century-old Latin American firm, both in the water-treatment sector. The similarities in the risk-reward profiles are used to identify some key strategic guidelines for enterprises wishing to be, selectively, multinational. Results and Discussion  Selective multinationality is an immediate plan for international expansion which identifies the most appropriate markets, independent of their proximity to the firm’s production base or headquarters. At the base of selective multinationality, is the goal to impose the firm’s product in regions of high growth, high selling price and low risk of price dumping. Therefore, this requires theto resist the temptation to expand to markets based on merely geographical proximity. The globalization strategy should be established, along with environmental management, from the outset of the creation of the firm. It will be shown, herein, to be a key driver in the valuation of High Tech industrial SMEs, in particular those with high risk-high reward tradeoffs. Selective multinationality can best be implemented if the firm in question has a technology which addresses unmet needs in niche markets, where there is an expanding customer base focusing on client relationships and cost effectiveness, and where the multinationals enter from outside the sector via resellers. It will be demonstrated to be effective for startups from developed regions, as well as SMEs from developing/emerging countries, to both of whom the consequences of sub-optimal resource allocation can risk the future of the firm itself. Therefore, SMEs can, with appropriate planning and the integration of marketing and environmental strategies, become, selectively, global firms, with better credit access and sales growth, concomitant with lower risks. The High Tech industrial SME will succeed better if, from the outset, they behave like the organization they want to become, with globalization a key element of strategy, from the business plan foreword. Two case studies are presented, one documenting the water sector and die other the cost savings possible by integrating environmental management into die firm’s strategy.     

Application of life cycle assessment in environmental labelling

The present state of worldwide discussions of how to apply LCA in environmental labelling, taking into account the current ISO 14 020 and ISO 14 024 works, is described. There is a consensus to use LCA as a tool for more scientific environmental labelling. The examples presented verify some practical possibilities to realise this approach. As a background to different stages of practical labelling, results from LCA studies are already used in the German “Blue Angel” scheme, e.g. for the definition of the scope in one product category, for the priorisation of specific life cycle phases and criteria, as a basis to establish a scoring system or to emphasise the importance of information on how to use environmentally sound products. Practical examples are presented in detail for hand-drying systems, paper products, milk packages, household equipment, televisions and detergents. Some future perspectives are mentioned. Presentation at “The Second International Conference on EcoBalance - The New Stage of LCA as a Common Language”, Nov. 18, 19 and 20, 1996 Tsukuba, Japan     

Orcein,a traditional stain revealed: some introductory remarks

In the three earlier editions of News from the Biological Stain Commission (BSC), under the heading of “Regulatory affairs,” the BSC's International Affairs Committee reported on the work of Technical Committee 212, Clinical Laboratory Testing and in Vitro Diagnostic Test Systems of the International Standards Organization (ISO/TC 212) and its working groups, WG 1, WG 2 and WG 3. In this issue of News from the BSC, H.O. Lyon provides information from the annual meeting of ISO/TC 212 that took place June 2–4, 2008 in Vancouver, British Columbia, Canada. In addition, under the heading of “Certification,” J.A. Kiernan examines the certification procedure for thionine used by the BSC laboratory in Rochester, NY.     

Factors affecting the recovery of Campylobacter spp. from retail packs of raw, fresh chicken using ISO 10272-1:2006

Aims:  This study sought to determine the most effective protocol for the detection of Campylobacter spp. in retail packs of fresh, raw chicken based on ISO 10272-1:2006.
Methods and Results:  Three sample preparation protocols were studied; two based on excision and one combining excision with a rinse of the remaining sample. Enrichment cultures were incubated both in closed bottles and microaerobically, and sub-cultured at 24 and 48 h. Packs of chicken (110) were analysed and only two yielded no Campylobacter spp. Subculturing enrichment broths at 24 h gave the same prevalence as at 48 h, P  >   0·4 but microaerobic incubation yielded approximately 50% more positive samples than did incubation in closed bottles. Sampling based on excision plus rinsing gave the highest Campylobacter prevalence (92·7%).
Conclusions:  To isolate Campylobacter spp. from retail packs of chicken, enrichment cultures must be incubated in a microaerobic atmosphere and sub-cultured at 24 h and, possibly, 48 h. Sampling packs by excision plus rinsing maximized recoveries.
Significance and Impact of the Study:  ISO 10272-1:2006 permits the use of inefficient protocols which markedly underestimate the true prevalence of Campylobacter spp. in retail, fresh chicken. Equivalent results could be obtained 24 h earlier, with consequent savings. Its revision is essential.     

以内部审核促进医院质量管理持续改进

目的 分析医院质量管理体系运行情况,促进医院质量管理持续改进。方法 通过内部审核,发现不合格项并对其进行统计分析,找出影响医院质量管理的主要问题,采取相应的改进措施。结果 2003—2008年医院共组织内部审核7次,发出不合格项118项,通过采取纠正措施和预防措施,并制定医院质量管理工作重点,不合格项目逐年减少。 结论 医院质量管理体系的运行符合ISO9001标准的要求,是适宜的、有效的。内部审核促进了医院质量管理持续改进。     

The Critical Review Process According to ISO 14040-43: An Analysis of the Standards and Experiences Gained in their Application (5 pp)

Background The critical review is an important, though not always well understood and correctly applied element of Life Cycle Assessment studies. It is the intention of this paper to analyse the relevant standards and to present personal experiences in conducting critical reviews.Results and Discussion A peer review for LCA-studies was first proposed in the SETAC guidelines ‘A Code of Practice’ (1993). The ISO standard 14040 (1997) describes three types of ‘Critical review’ which are optional in general, but mandatory ‘for LCA studies used to make a comparative assertion that is disclosed to the public’. For this purpose, the most comprehensive form according to section 7.3.3, the panel method, has to be (‘shall’ in ISO terminology) be used. From personal experience, this method is found to be the most frequently performed in practice (60%), the average panel size being three experts. Large panels with more than 4 experts are rare.Recommendation Personal experience leads to supporting the recommendation by SETAC of the accompanying or ‘interactive’ critical review, which should be preferred, over the review ‘a posteriori’, which offers considerable risks in regards to the duration and costs of an LCA study. ISO 14040, on the other hand, does not recommend one or the other way of performing the critical review.     

Experiences and thoughts about life cycle assessment in the automotive industry in Japan

Experiences with-Life Cycle Assessment (LCA) in the Japanese Automotive Industry and the author’s thoughts on how to apply LCA for automobiles are described. In this paper, LCA applications are categorized into three types:

Apeironpro, software for life cycle assessment (LCA) and environmental performance evaluation (EPE)

Background, Aims and Scope  In the world there are more than thirty LCA software products, but they do not have inventories or an evaluation method either with regional applicability, especially for Colombia. A special software for Life Cycle Assessment and the Environmental Performance Evaluation has been developed, which considers the environmental impacts generated by products during their life cycle and processes involving productive activities. It accounts with inventories applicable to Colombia, for processes and services like electrical energy production, transport and waste disposition. The Ecoscarcity evaluation method was adapted to Colombia with national legislation and agreements for polluting reduction signed by country and the EPI (Environmental Points of Impact) was established for 353 substances. Methods  The software allows users to use the methodology which corresponds to the standard ISO 14030 and 14040 directives. The database uses the SPOLD international format. For ApeironPro software, database information used from monitoring air emissions and effluents on factories in the region were realized by the Environmental Research Group from Pontificia Bolivariana University and secondary type information has been obtained starting from studies realized by environmental organizations and factories in the country which are interested in the management of quality environmental indicators. The antiquity of the information was restricted from the last 5 years, 1998 to 2003, in order to possess temporal representativity. The Ecoscarcity method uses information of the Environmental Ministry and Environmental Institutes of Colombia for the actual current load (F), and target norm for total load (F_k), using information with national legislation and agreements for polluting reduction signed by the respective countries. The software was designed in Web ambience with the database in MySQL, while the programming language was JAVA from Sun Microsystem. Results  The software has inventories for energy (electricity from coal, natural gas, fuel oil, hydroelectricity) transport (mean air, truck, motor bus), processes (plastics, rubber, sugar, paints production, detergent production, combustion in heaters, foundry of copper, iron, gold), waste disposal (incineration and landfill). Discussion  The Ecoscarcity method was analyzed for seven impact categories: climate change, acidification, stratospheric ozone depletion, photo-oxidant formation, eutrophication, ecotoxicity and depletion of abiotic resources (coal, oil, natural gas, copper, nickel). Conclusions  For Colombia, the highest environmental impact is associated with the ozone layer depletion (235.7 Ecopoints/g) while the lowest is associated with depletion of coal (8.6 × 10⁻⁷ Ecopoints/g), although this is reasonable since Colombia is the tenth largest producer of coal in the world. Recommendations and Perspectives  Latin America and Colombia need more inventories for their processes and to identify the more significant environmental impacts of their industries. This work is an initial step in the research about Life Cycle Assessment and can also improve the work in ecolabels for Colombia.     

The tissue bank at the Instituto Nacional de Investigaciones Nucleares: ISO 9001:2000 certification of its quality management system

Tissue banking is a complex operation concerned with the organisation and coordination of all the steps, that is, from donor selection up to storage and distribution of the final products for therapeutic, diagnostic, instruction and research purposes. An appropriate quality framework should be established in order to cover all the specific methodology as well as the general aspects of quality management, such as research and development, design, instruction and training, specific documentation, traceability, corrective action, client satisfaction, and the like. Such a framework can be obtained by developing a quality management system (QMS) in accordance with a suitable international standard: ISO 9001:2000. This paper presents the implementation process of the tissue bank QMS at the Instituto Nacional de Investigaciones Nucleares in Mexico. Objective: The objective of the paper is to share the experience gained by the tissue bank personnel [radiosterilised tissue bank (BTR)] at the Instituto Nacional de Investigaciones Nucleares (ININ, National Institute of Nuclear Research), during implementation of the ISO 9001:2000 certification process. At present, the quality management system (QMS) of ININ also complies with the Mexican standard NMX-CC-9001:2000. The scope of this QMS is Research, Development and Processing of Biological Tissues Sterilised by Gamma Radiation, among others.     

Life cycle assessment in the telecommunication industry: A review

Background, Goal and Scope Today, after the technologically and commercially successful breakthrough of electronic telecommunication facilities, rapid and globally untrammelled information exchange has become an indispensable service in daily life. Associated with the tremendous growth in electronic telecommunication hardware (GSMAssociation 2005), however, was and continues to be an increasing awareness of the environmental effects related to both the operation and the production, as well as the End-of-Life (EoL) treatment of such communication equipment. Environmental concerns, for example, have resulted in various governmental regulations such as the WEEE-(CEC 2003b) and the RoHS-directives (CEC 2003a). To analyse, interpret and improve the environmental performance of electronic telecommunication equipment, life cycle assessment (LCA) is increasingly recognised as one promising analytical tool. Based on a thorough review of the scientific work and by discussing industrial views, this paper is intended to determine the key milestones achieved, to analyse the current research situation and to outline the key challenges concerning LCA and electronic telecommunication industries. Method Starting with a brief reflection of the LCA approach, the particularities in context with telecommunication products1 are discussed. Exemplary for various stakeholders participating in the supply chain of telecommunication means recent industry perspectives are also presented. Results In the core section of the proposed paper, the pertinent scientific literature on LCA and electronic telecommunication means is reviewed and the most impressive achievements are documented. Particular attention is dedicated to subcomponents of individual electronic telecommunication devices (e.g. Printed Wiring Board Assemblies (PWBA) of mobile phones), components of mobile communication networks (e.g. Base Transceiver Stations (BTS)) and entire networks concentrating on product comparisons, inventory approaches, impact assessment method development, result interpretations and presentation, and usability of LCA in decision-making. Discussion From the reviewed scientific literature and industry views, it was found that telecommunication products, in general, represent complex objects requiring a well thought-out performance of the LCA tool. It has been shown that today there is a lack of stakeholder involvement resulting in LCA studies which only partly fulfil the expectations of the contractors. In this spirit it was recognised, at present, that most of the LCA studies on telecommunication equipment result in bulky and stakeholder unspecific compilations of findings impossible to be used in rapid decision-making. This aspect may explain why LCA so far is not or only partly integrated into decision-making of globally integrated industries, such as in telecommunication industries. Conclusions In summary, it can be stated that LCA represents a promising alternative to analyse, to interpret and essentially to adjust the environmental performance of electronic telecommunication products. The review showed that there is a need to focus research efforts in order to arrive at sound improvements of the LCA methodology. Perspectives The conclusions from the presented review suggest concentrating in particular on further development of the LCA methodology with respect to efficiency, effectivity and flexibility. This challenge is associated with the need for LCA to be understood as a process rather than a discontinuously applicable tool, attending industrial processes, in essence to contribute to improved environmental performances of products. In this context, particular attention should be paid to proper stakeholder involvement and continuous exchange of concentrated information relevant for the respective stakeholder.     

Validation of DNA and RNA real-time assays for food analysis using the hilA gene of Salmonella enterica serovars

In Europe, alternative methods for the detection of food-borne pathogens can be used instead of the standard ISO/CEN reference protocol, if validated according to the protocol outlined in ISO 16140, 2003. In this study, the performance of two novel methods for the detection of Salmonella sp. using real-time PCR technology in tandem with an adapted two-step enrichment protocol were assessed and validated against a reference culture method, ISO 6579, 2004. The DNA and RNA real-time PCR assays amplified a 270 bp region of the hilA gene of Salmonella enterica serovars, and incorporated an internal amplification control (IAC) which was co-amplified with the hilA gene to monitor potential PCR inhibitors and ensure successful amplification. The inclusivity and exclusivity of the hilA primer set was examined for both the DNA and RNA methods and detected the 30 S. enterica serovars but not the 30 non-salmonellae strains. The inoculation of meat carcass swabs with five different S. enterica serovars at five different inocula, indicated both PCR methods were able to detect between 1 and 10 CFU per carcass swab. The real-time DNA PCR assay performed as well as the traditional cultural method in detecting Salmonella sp. in artificially contaminated salad, chocolate, fish and cheese samples. The relative accuracy, relative sensitivity and relative specificity of the DNA PCR real-time method were determined to be 98.5, 98.1 and 100%, respectively. The DNA method was further validated in a collaborative inter-laboratory trial according to ISO 16140, 2003. The validated methods provide an accurate means for the rapid detection and tracking of S. enterica serovars giving equivalent results to the standard method within three days, thus providing an alternative testing method to the reference microbiological method. The real-time PCR methodology not only offers significant time-saving advantages compared to traditional methods, it can also be applied to a wide range of samples types.     

Validation and Substantiation of 25 kGy as Sterilization Dose for Lyophilized Human Amnion Membrane

The validation and substantiation of sterilization dose for lyophilized human amnion membrane by gamma irradiation delivered by Co⁶⁰ source were investigated. The validation experiments were conducted according to ISO 13409 method B. A total of 120 human amnion membranes were collected. Of these, 10 membranes were used for estimation of bioburden and 20 membranes were used for the individual sterility test at verification dose. The average bioburden per product unit with sample item portion (SIP = 1) for lyophilized human amnion membrane was 572 cfu. The verification dose experiments were done at dose of 8.1 kGy and the results of sterility tests showed that human amnion membrane got one positive. Consequently, the sterilization dose of 25 kGy was confirmed and substantiated.     

News from the Biological Stain Commission No. 5

In this fifth issue of News from the Biological Stain Commission (BSC), under the heading of Regulatory Affairs, the BSC's International Affairs Committee provides more information from the meeting of the International Standards Organization ISO/TC 212 Committee that took place on June 2–4, 2008 at Vancouver, Canada. In addition, we give an update on the current situation regarding the supplies of hematoxylin.