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by Theo Vermeire, Head of Department Nanotechnology, Occupational Health and Transport Safety Centre for Safety of Substances and Products, RIVM, The Netherlands. Chair of the Scientific Committees Working Group on the SynBio Opinions

by Theo Vermeire, Head of Department Nanotechnology, Occupational Health and Transport Safety Centre for Safety of Substances and Products, RIVM, The Netherlands. Chair of the Scientific Committees Working Group on the SynBio Opinions

SCENIHR, SCHER and SCCS Opinions on Synthetic Biology

Synthetic biology (SynBio) has already delivered important products to the market such as yeast-synthesized artemisinin and biodegradable plastics produced from sugars. There is a potential for substantial contributions to medicine, materials, chemistry, food, nutrition, energy, sustainability, waste treatment, and safety. Yet, like for many new and emerging technologies, there is controversy leading to fierce debates on SynBio’s potential for societal benefit, or risks.

The UN Convention on Biological Diversity held its 12th Conference of the Parties (COP 12) October, 6-17, 2015 in Pyeongchang, Republic of Korea. In a special session on SynBio, the Parties were urged “to take a precautionary approach ….when addressing threats of significant reduction or loss of biological diversity posed by organisms, components and products resulting from synthetic biology”. The COP urged Parties to approve organisms resulting from SynBio techniques for field trials only after appropriate risk assessments are carried out. This recommendation was an important goal for the EU, ensuring a good balance between the potential of SynBio and the need for precaution on the issue. The EU had a middle position and provided an important scientific contribution to the development of definitions through a joint preliminary Opinion from its Scientific Committees SCENIHR, SCHER and SCCS.

This first Opinion, adopted by the SCs on September 26, 2014, answered questions from the European Commission on the scope and definition of SynBio. In late December 2014, the European Commission Scientific Committees issued a draft second opinion on whether existing risk assessment methods are adequate for SynBio. Early 2015, it will be followed by a third opinion on research priorities for risk assessment. These three opinions, which are written by an interdisciplinary Working Group of 20 experts from Europe and the United States, could significantly contribute to develop a European and global SynBio policy. Although security issues concerning SynBio are important, the terms of reference pertain exclusively to safety and, thus, security issues are not being addressed in any of the three Opinions.

The first opinion lays the foundation for the two other opinions with an overview of the main scientific developments, concepts, tools and research areas in SynBio. Additionally, a summary of relevant regulatory aspects in the European Union, in other countries such as the USA, Canada, South America, China, and at the United Nations is included. It stresses that SynBio is currently encompassed within genetic modification as defined in the European Directives 2001/18/EC and 2009/41/EC and will likely remain so in the foreseeable future. The definition reads: ‘SynBio is the application of science, technology and engineering to facilitate and accelerate the design, manufacture and/or modification of genetic materials in living organisms.’ The opinion proposes an ‘operational’ definition based on present knowledge and understanding of the field of SynBio. It is acknowledged that it is difficult to accurately define the relationship between genetic modification and SynBio on the basis of quantifiable and currently measurable inclusion and exclusion criteria. Thus, in addition to the definition, a list of specific criteria was considered reflecting that SynBio covers any organism, system, material, product, or application resulting from introduction, assembly, or alteration of the genetic material in a living organism.

This definition has the advantage that it does not exclude the relevant and large body of risk assessment and safety guidelines developed over the past 40 years for GM work.  Additionally, the present definition allows for the rapidly advancing nature of GM technologies and important nuance that supports the need for on-going updates of risk assessment methods, which will be addressed in Opinion II. However, the definition presently excludes two research areas commonly mentioned in the context of SynBio, bionanoscience (non-living nanomaterials made from the components of living organisms) and protocell research (efforts to synthesize living organisms from non-living materials), because they have not yet produced living systems. Nonetheless, bionanoscience and protocell research could one day produce living organisms, and thus are considered in the second opinion on risk assessment methodologies.

Opinion II will focus on risk assessment methodologies for the relatively new research areas of genetic parts libraries, designer cell chassis, DNA synthesis, genome editing, and xenobiology (engineering with non-canonical alternatives to DNA and RNA). The questions focus on the implications of likely developments in SynBio on human and non-human animal health and the environment and on determining whether existing health and environmental risk assessment practices of the EU for GMOs are adequate for SynBio. Additionally, the Scientific Committees were asked to provide suggestions for revised risk assessment methods and risk mitigation procedures including safety locks for a period up to approximately 10 years from now.

I would like to conclude that pressures for innovation and economic growth are high, but a parallel activity is needed to minimize health and environmental risks. These three opinions of the Scientific Committees are expected to contribute significantly to responsible research, development and innovation with regard to SynBio.

Stiff joints, aching bones, painful movement – modern man has come up with solutions to alleviate some of the problems of old age. Metal-on-Metal joint prosthesis, a specific category of hip implants used for total hip arthroplasty and for hip resurfacing arthroplasty, may solve many dysfunctions of the hip joint, but are there risks involved?

In response to a number of concerns related to Metal-on-Metal implants, the European Commission gave the Scientific Committee on Emerging Newly Identified Health Risks the mandate to produce an opinion on “the safety of Metal-on-Metal joint replacements with a particular focus on hip implants”.

In its final opinion published in September, the Scientific Committee concluded that all types of Metal-on-Metal  hip arthroplasties  (surgical procedures that restore the function of a joint) release metals which, once in the body fluids and tissues, may lead to local and/or systemic adverse health effects. Large-diameter implants were found to pose the greatest risk.

Because of the potential health risk posed by Metal-on-Metal hip implants, the decision to use them should be made on an individual basis, weighing the pros and cons for each patient by considering relevant factors such as age, gender, body size, physical fitness and lifestyle. Some high-risk patient groups, like small-boned and pregnant women, should not be considered as candidates for Metal-on-Metal hip arthroplasty, and when it is chosen as the best option for other patients, the implantation should only be performed by very qualified surgeons to reduce the risks.

The Scientific Committee on Emerging Newly Identified Health Risks endorses the strategy outlined in the European Consensus Statement, which recommends systematic follow-up, including clinical and radiographic investigation, for all patients and all Metal-on-Metal implants.

Read the full opinion here: MB)

In light of the expected increase in the application of nanotechnologies to medical devices, the Scientific Committee on Emerging Newly Identified Health Risks was requested to provide a Guidance on the risk assessment of medical devices containing nanomaterials.

Nanomaterials are generally materials of which a single unit is between 1 and 1000 nanometers in size, at least in one dimension, but are usually defined as those between 1—100 nm, or less than one nanoscale in size. 

The Scientific Committee concluded that the potential risk due to the use of nanomaterials in medical devices is mainly associated with the possibility of free nanoparticles from the device being released in to the body, and the duration of exposure. The potential release depends on whether the nanomaterials are used as free nanomaterials, nanomaterials fixed on surfaces or nanomaterials embedded in a matrix.

In addition to particle release and potential effects of these particles, possible local effects at the site of application should also be considered. Importantly, wear-and-tear of a medical device may result in the generation of nanosized particles even when the medical device does not contain nanomaterials.

In the future, as knowledge of the properties of nanomaterials improves, it may be possible to predict the nature, distribution, tissue levels and potential persistence of the particles but this is unlikely to be possible at present.

Read the Guidance here: MB)