Biosafety

In March 2008, the six world leading agro-biotechnology companies, presented a private, international instrument for liability and redress to cover the environmental damage caused by genetically modified organisms.
The proposal was rejected by governments, who instead adopted a binding supplementary liability and redress protocol to the Cartagena Protocol on Biosafety, with no content transfer from the business initiative. Elaborating on this case study, it is explained how powerful business proposals can turn into a policy failure. Business conflicts are identified as one major explanatory factor. The fragmentation of business interests and the lack of business support for the six major firms’ initiative have discredited the role of corporations as regulatory leaders. Business unity is found to be a decisive, necessary condition for the endorsement of corporate proposals by policymakers.

Context: The Institute of Oncology and Radiobiology (INOR) is the leading institution for the diagnosis, treatment and follow-up of cancer in Cuba. The main methods used in cancer treatment are surgery, radiotherapy and chemotherapy. The last one involves the handling of hazardous substances, such as cytostatics, which implies a health risk to persons occupationally exposed to it. There are two sites where a considerable among of cytostatic is handled (Ambulatory Chemotherapy Room (ACR) and the Central Unit of Cytostatic Mixture Preparation (CUCM)). Genotoxicity biomarkers of exposure and effects have been widely used to detect occupational environment hazards.

Aims: To evaluate genotoxicity biomarkers indicative of exposure and effects to cytostatics.

Methods: In this study were tested samples taken from the surfaces of biological safety cabinets located in the Central Unit of Cytostatic Mixture using SOS – Chromotest. We also evaluated samples of oral mucosa exfoliated cells from exposed and control subjects, by micronucleus test.

Results: All subjects were exposed and subjects who administered the mixes in the institution had an increased of DNA damage in comparison with the pharmaceutical staff that prepared it and wear the primary protection barriers properly.

Conclusions: These results underline the efficiency of genotoxicological biomarkers in detecting the exposure levels and the deleterious effect of cytostatics on occupationally exposed personal.

É o primeiro capítulo de um livro sobre biossegurança, voltado para qualquer profissional que se interesse pelo assunto. O livro foi escrito em linguagem coloquial, sem o formalismo tradicional do meio acadêmico e mesclando um texto escrito com vídeos disponíveis no Youtube.

کابینت های ایمنی زیستی ( )BSCsفضاهای کاری محصور با هود تهویه هستند که به منظور نگهداری
میکروارگانیسم های بیماریزا در طی فرآیندهای میکروبیولوژیکی طراحی شده است.
هدف اصلی کابینت های ایمنی زیستی محافظت از پرسنل آزمایشگاه و محیط زیست در برابر میکروارگانیسم
بیماریزا است زیرا ممکن است در هنگام کار با چنین میکروارگانیسم هایی ، آئروسل ها ایجاد شوند. این ها فقط
برای موجودات خاص گروه خطر و برای فرآیندهایی که ممکن است منجر به تشکیل آئروسل شوند استفاده می
شود.

Por sus propias características, el trabajo en el laboratorio presenta una serie de riesgos de origen y consecuencias muy variadas, relacionados básicamente con las instalaciones, los productos que se manipulan (y también con las energías y organismos vivos) y las operaciones que se realizan con ellos. Con respecto a los productos debe tenerse en cuenta que suelen ser muy peligrosos, aunque normalmente se emplean en pequeñas cantidades y de manera discontinua. En consecuencia, la prevención de los riesgos en el laboratorio presenta unas características propias que la diferencian de otras áreas productivas. La organización del laboratorio debe permitir la correcta gestión de la prevención. Partiendo del propio compromiso de la dirección, el laboratorio debe estar adecuadamente jerarquizado para que la aplicación del principio de la seguridad en línea se pueda establecer sin problemas.

In accordance with global trend, Nigeria and the rest of Africa are gradually embracing the genetically modified organisms. As well, Nigeria is coming to terms with the reality and ubiquity of applications of agro-biotechnology, including its prospects both for economic advancement and for diverse associated risks. Hitherto, majority of farmers in Nigeria were organic farmers by default, a status that is now undergoing rapid transition to conventional farming not only as a result of agro-biotechnology but also as a result of recent remarkable improvements over access to agro-chemical inputs. As Nigeria embraces agro-biotechnology and transitions into conventional agriculture, organic farming status will assume a new importance as a niche. To embrace the challenge and leverage on the opportunities of Nigeria's agricultural transition, organic farming stakeholders would need to actively penetrate the presently fluid legal regulatory space to secure organic-farming friendly policy in the country.

In September 2006, a WTO dispute settlement panel issued its long-awaited decision in favor of the United States in the dispute between the U.S. and the European Union over genetically modified organisms (GMOs). The ruling was based on narrow procedural grounds, and did not resolve the controversy over the safety of GMOs, over the right of countries to regulate GMOs more stringently than conventional products, or over the consistency of the EU's GMO regulatory regime with WTO requirements. The debate over GMOs continues unabated. Unfortunately, the high profile dispute between the U.S. and the EU has eclipsed the important debate in the developing world over the socioeconomic implications of this technology. While scientific uncertainty continues to impede efforts to reach consensus on the human health and environmental impacts of GMOs, the socioeconomic perils of biotechnology in developing countries are becoming increasingly evident. Regrettably, the trade and environmental agreements governing the transboundary movement of GMOs privilege science as the arbiter of trade disputes to the exclusion of other forms of normative discourse. With limited exceptions, socioeconomic considerations may not be used to justify GMO trade restrictions. Using environmental justice as an analytical framework, this article examines the unique risks and benefits of biotechnology for developing countries, and places the debate over biotechnology in the context of the historic and ongoing controversy between developed and developing countries over the rules governing trade in conventional agricultural products. It concludes by proposing alternative regulatory strategies designed to ensure that international trade law promotes rather than frustrates environmental protection, the human right to food, and the promotion of sustainable economic development.

This Project aims to realize an Environmental and Social Development Plan through an Environmental Assessment Study. This study is for the building of a Biosafety Lab in Kamboinse. Throughout the implementation of the project, there will be both positive and negative impacts on the different components of the environment. Large quantities of dust, smoke and exhaust gases, and other suspended solids that may exceed the discharge standards will be observed. The soil will undergo degradation through its upper layer, and this could increase water and wind erosion of soils. The negative impacts will be felt on the quality of surface water which will experience a certain turbidity due to the deposition of suspended solids. The project site has low vegetation cover, however, excavation and land clearing will cause the destruction of the scarce tree individuals, shrubs and grass cover. For terrestrial wildlife, the work will have no significant impact, it should be noted, however, the destr...

Opinion in Africa over the use of genetically modified crops
for food has been divided, honed by more than a decade of
arguments in Europe and elsewhere. Fortunately, the perceived
image of a passive Africa in this game is changing rapidly with
clear positions on how to harness modern biotechnology.
This article examines the status of biosafety regulation
across Africa, pertinent challenges and the extent to which
regulation fosters or constrains the development of
agricultural biotechnology.

No Brasil, entre 2008 e 2009, 16 tipos de sementes transgênicas foram liberados, o consumo de agrotóxicos passou a ser o mais elevado do mundo e a concentração fundiária aumentou. Esses dados revelam alguns dos impactos decorrentes do avanço do modelo do agronegócio, mas não permitem que se evidenciem os processos de resistência organizados pela sociedade civil. E foi justamente no contexto dessa dinâmica continuada de resistência e construção de alternativas que AS-PTA e Terra de Direitos organizaram o Seminário sobre Proteção da Agrobiodiversidade e Direito dos Agricultores, cujo conteúdo e propostas estão apresentados neste livro. A realização do evento contou com o apoio do Ministério do Meio Ambiente, do Governo do Paraná, da Fundação Heinrich Böll e do Núcleo de Estudos Agrários e Desenvolvimento Rural do Ministério do Desenvolvimento Agrário.

Biological safety cabinets (BSC) are devices that are widely used by microbiologists and pharmacists when handling biohazardous materials. A safe working environment shall be achieved while using such devices. However, the safety of the BSC operators is compromised as these devices are very sensitive to the air pattern surrounding them. Isolating the interior area of the BSC from the surroundings using an air curtain at the front of the BSC was simulated using a 3D numerical model. The air used as an air curtain was drawn from the breathing zone of the operator to decrease the probability of any contaminant escape from the inside of the device towards the face of the operator. This numerical study was done simulating the dimensions, air velocities, air pressures of an actual 4-foot BSC class II type A2. The air curtain modification was added to the numerical model to compare the safety performance enhancement before and after adding the air curtain. To calculate the performance enhancement in the numerical study 1x10^5 particles were discharged from the supply HEPA filter and were traced at the breathing zone of the operator where the BSC after modification showed 16.32 % decrease in the number of the traced particles

This report is the outcome of an EFSA procurement (OC/EFSA/GMO/2015/02) which aims at reviewing relevant scientific information on RNA interference (RNAi) that could serve as baseline information for the environmental risk assessment of RNAi-based genetically modified (GM) plants. The report is based on a systematic literature search on the use of RNAi molecules in arthropods, nematodes, annelids and molluscs with dsRNA, siRNA and miRNA applied primarily through feeding and soaking (oral ingestion). The numbers of retrieved publications covering these areas are reported, along with the species name, life stages tested, the target gene and its function, details of the test substances and their concentrations used, methods of delivery and effects. Separate sections discuss the available information on: (1) the uptake and systematic spread of RNAi activity, including a description of the various components involved in this process; (2) the mechanisms of dsRNA-, siRNA-and miRNA-elicited gene silencing and the different factors involved in RNAi efficiency; (3) routes of exposure of the biotic and abiotic environment to dsRNA, siRNA and miRNA from GM plants; (4) the environmental fate of dsRNA, siRNA and miRNA; and (5) the various factors that may limit non-target effects including exposure, factors influencing the silencing efficiency of dsRNA, siRNA and miRNA, possible unintended and off-target effects, and their mechanisms. Finally, an overview of the species of arthropods, nematodes, annelids and molluscs for which genomic data are available is also presented. The report identifies some of the challenges involved in developing plants with RNAi systems which affect invertebrate gene expression. The report also concludes that, currently, knowledge on issues such as exposure, specificity, offtarget effects, sequence similarities and bioinformatics is very limited, as only a few RNAi expressing plants which specifically target invertebrate species have been developed and comprehensively studied.

Biosafety is a set of actions focused on preventing, minimizing and eliminating risks associated with research, production, teaching, use, technology development and services related to genetically modified organisms (GMOs) with the aims of protecting human and animal health and environmental preservation.
Transgenic organisms, or GMOs, are organisms in which genetic material has been altered by recombinant DNA technology. Biotechnology allows the insertion of one or more genes into the genome of an organism from a different organism or species (e.g., animals, plants, viruses, bacteria); the expression of the introduced gene results in a new feature in the phenotype of the modified organism. A shortened definition of genes is that they are DNA sequences that contain the necessary information to affect phenotypic expression in an
organism, such as the shape of a seed or resistance to a specific pest. The information encoded by the gene is expressed through two principal steps: transcription, in which the coding region of the DNA is copied into single-stranded RNA; and translation, in which the amino acid sequence encoded by mRNA is assembled and translated into protein. Thus, for
the creation of a GMO, it is necessary to introduce the gene responsible for a particular trait into the genome of the target organism through recombinant DNA techniques.
Several products derived from recombinant DNA technology are commercially available worldwide. GMO products already on the market include human insulin, somatropin and transgenic varieties of crops, such as maize, soybeans, cotton and common beans. The United States, Brazil and Argentina are among the principal countries engaged in the
commercial production and marketing of GMOs (James, 2010).
The emergence of genetic engineering in the early 1970s in California, USA, with the isolation, introduction, and expression of the insulin gene in Escherichia coli provoked a strong reaction from the scientific community all over the world, which led to the Asilomar Conference in 1974. At that time, the scientific community proposed a moratorium on
genetic engineering. They argued that rules and safeguards should be established to ensure Transgenic Plants – Advances and Limitations
428 the use of genetic e ngineering techniques without risking human life and the environment.
In a relatively short period of time, biosafety regulations were developed for the appropriate use of these technologies in the laboratory. After over 35 years of research on and commercial use of biotechnology, there have yet to be any reports about the adverse effects of the use of genetic engineering on human and animal health or the environment.
Therefore, to ensure the appropriate generation and utilization of this technology, biosafety regulations and monitoring mechanisms have been developed in different countries around the world. Several field tests with transgenic varieties have been performed in the USA,
Argentina, Bolivia and Chile since 1991. However, in Brazil, these tests only began in 1997.

The newly discovered coronavirus (Severe acute respiratory syndrome coronavirus-2, SARS-CoV-2) is the causative agent of the ongoing pandemic. Broad arrangement has been done to minimize virus spreading among population and to control the worldwide outbreak. Expanded biosafety measure specifically with respect to the work require using SARS-CoV-2 in laboratory (lab.) and a special consideration should be taken to protect researcher and lab. worker during handling of specimens. Therefore, the aim of this review is to help the scientists, researchers, lab. staff and biosafety specialists to respond to the current coronavirus disease (COVID-19) through discussion of effective biosafety practices that can prevent laboratory acquired infections and to lessen the spread of infection into community and environment. Al-Shuwaikh AM, Al-Shwaikh RM, Hanna DB.

Este trabalho procura contar a forma como se deu a entrada das sementes transgênicas no Brasil e sua posterior institucionalização. E, a partir do caso brasileiro, avalia se essa tecnologia tem condições de contribuir, como anunciado por seus proponentes, para o enfrentamento de questões como a insegurança alimentar, o aquecimento global e o esgotamento de recursos naturais. Além disso, apresenta a forma como o discurso científico foi utilizado para legitimar interesses comerciais maiores e remonta o passo a passo da disputa política pela definição de uma nova legislação para o tema, identificando seus principais atores, argumentos e interesses em jogo. Considerando que esse debate nunca esteve reduzido a cientistas de um lado e leigos do outro, este trabalho também expõe os argumentos científicos que justificam posturas precaucionárias. E, nesse sentido, aponta efeitos adversos do uso da tecnologia que foram antecipadamente apontados, mas descartados pelos setores comprometidos com sua rápida adoção. Do mesmo modo, o caso da liberação comercial da primeira variedade de milho transgênico no Brasil é usado para evidenciar que a aprovação desses produtos, apesar de decidida por um conjunto de doutores, se deu de forma contrária à boa prática científica. O trabalho procura ainda interpretar os movimentos estratégicos de nível internacional, sem os quais as sementes transgênicas não teriam sido difundidas no Brasil e em outros países a ponto de praticamente substituir a produção convencional em poucos anos. Por movimentos estratégicos entende-se: fusões entre as divisões de químicos, sementes e fármacos de grandes empresas multinacionais; concentração empresarial do mercado de sementes; uniformização global de padrões para a propriedade intelectual sobre inovações biotecnológicas e para a proteção de cultivares; e aprovações de legislações nacionais transferindo a comitês técnicos atribuições normativas e poderes decisórios. Um dos capítulos é destinado a confrontar a base científica da engenharia genética com os conhecimentos atuais no campo da própria genética. Essa investigação resgatou a história das ideias sobre genes desde os primórdios da genética até os dias atuais, no intuito de compreender as raízes tanto do otimismo quanto do pessimismo em torno da técnica. A revisão da bibliografia da área permitiu identificar que a manutenção de um entendimento defasado sobre o papel e o funcionamento dos genes é necessária para a preservação do mercado das sementes transgênicas e de seus agrotóxicos associados. Por fim, baseado nos resultados práticos decorridos quase vinte anos da adoção dessas sementes, conclui-se que as principais promessas associadas ao seu uso não foram cumpridas. Ademais, aponta-se novo problema trazido com a tecnologia: a contaminação genética das demais sementes não geneticamente modificadas. A disseminação de genes modificados sobre sementes crioulas, nativas, parentes silvestres e afins ameaça o uso presente e futuro desses recursos que são base da alimentação humana. Os diferentes sistemas agrícolas que permitiram a manutenção até hoje desse acervo genético diversificado e localmente adaptado são apontados como alternativa sustentável e credível ao modelo de agricultura proposto pela indústria das sementes transgênicas.

This paper argues that although many transgenic crops are still in their early states of adoption and even more are being tested and developed, emerging trends show significant societal benefits through positive economic impact (especially by raising farm incomes), fostering food security, and promoting environment sustainability. Agricultural biotechnology has the potential to increase production on existing arable land; reduce losses related to pests, disease, and drought; increase access to food through higher farm incomes; raise nutrition levels; and promote sustainable agriculture. The pipeline includes crops with potential benefits such as enhanced photosynthesis, stress tolerance, aluminum tolerance, salinity tolerance, pest and disease resistance, nitrogen use efficiency, phosphate use efficiency, and nitrogen fixation.

Safe-by-Design is an engineering concept for risk management. Recent rapid developments in biotechnology are possible with techniques that allow doing genetic engineering faster and with more precision. These developments cause new opportunities to arise such as eradicating diseases, breeding healthier livestock and cleaning soils. Questions on new risks of biotechnology follow these new opportunities. This report investigates and explains the opportunities and challenges offered by the concept of Safe-by-Design for managing these risks of biotechnology. Among the techniques used in biotechnology, this report focuses on the ones used for genetic engineering. This report was commissioned by the Dutch Ministry of Infrastructure and Water Management. You can cite this report as “Robaey, Zoë. 2018. Dealing with risks of biotechnology: understanding the potential of Safe-by-Design. Report commissioned by the Dutch Ministry of Infrastructure and Water Management.”

The General Safety Test is an animal test for the detection of extraneous toxic contaminants and one which is sometimes undertaken for biological products intended for administration to humans. In the European Pharmacopoeia, the test is referred to as the ‘Abnormal Toxicity Test’; whereas in the United States Pharmacopeia, the test is the ‘General Safety Test’. Aside from some relatively minor differences relating to the size of the animals used, the numbers required, and with the interpretation of animals that appear ‘distressed’, the two compendial tests are essentially the same.

This paper examines one important aspect of the current organization of scientific and technological research – namely, the system of patenting and licensing and its role in structuring the production and dissemination of knowledge. The primary justification of patenting in science and technology is consequentialist in nature. On this account, patenting incentivizes research and thereby promotes the development of scientific and technological knowledge, which in turn facilitates social progress. Some have disputed this argument, on the grounds that patenting actually inhibits the development of knowledge. In this paper, I make a stronger argument; in some areas of research in the US – in particular, research on GM seeds – patents and patent licenses can be, and are in fact being, used to prohibit some research. I discuss three potential solutions to this problem: voluntary agreements, eliminating patents, and a research exemption. I argue against eliminating patents, and I show that while voluntary agreements and a research exemption could be helpful, they do not sufficiently address the problems of access that are discussed here. More extensive changes in the organization of research are necessary. In addition to developing an argument about patenting and licensing, this paper illustrates a promising approach to social epistemology.