ASTM International is the global leader in voluntary technical standards. If you’ve ever worn a bicycle helmet, for example, you’ve probably seen the ASTM label on the back. If you have ever flown on a jet, the fuel that kept you up in the air had to meet an ASTM standard. The standards ASTM members develop are intended to enhance the safety of and improve the quality of consumer and industrial products.
At first thought, microbes may seem an odd nomination for an ASTM standard. But considering the pace of growth experienced by the industrial biotechnology industry, which serves a wide range of industries from food and beverage to fine chemicals and materials, we should perhaps be more surprised that ASTM standards for industrial microbes haven’t been called for sooner.
A working group initiated in 2016 under ASTM International’s industrial biotechnology subcommittee for best practices (known as E62.02) took on the important task of standardizing the way we classify the industrial microbes that are the basis of the bioeconomy. The standard, which outlines four classification fields representing genotype class, biosafety risk grouping, mode/intent of use, and the extent of genome sequence information, was approved by ASTM main committee E62 earlier this month. We recently caught up with DuPont Senior Principal Scientist and ASTM E62 Vice-chair Joseph McAuliffe, also a member of the standards working group, to discuss the new classification standard, what it means for consumers, and why synthetic biology companies should care (hint: it’s important for supporting a growing, healthy bioeconomy).
Why should synthetic biology companies care about a clear classification system for industrial microbes?
There are two main reasons. The status quo (i.e., “GMO or not”) is too simplistic and fails to capture the diversity of products that are close to market or already commercialized. This has in turn created regulatory and customer perception hurdles for many new products. The second reason is that there is a rapid diversification of the types of product concept emerging from synthetic biology companies, many of which are designed for human use or directly in the environment. ASTM technical committee E62 believes that a clear classification system will help guide the regulatory frameworks that will need to be put in place to deal with these new products, prevent confusion about new products and reassure customers and the public alike that the industry is acting in a responsible manner.
What kinds of problems arise due to unclear classification?
One example is the approach taken in the EU, whereby the process used to create an engineered microorganism can determine how it is classified – this creates a traceability issue, as there is the risk that otherwise genetically similar strains would need to be classified differently, depending on how they were made. Case in point: the USDA and the EU are at odds as to how to regulate gene edited organisms.
How did the effort to develop a new standard come about?
When ASTM technical committee E62 was created in 2014, we sought to bring technical clarity to an issue that we thought was inhibiting the growth of the industrial biotechnology industry. A clear classification for microbe-based products would not only improve inter-industry communication and commerce, but provide a robust framework to navigate the continued expansion of the industry as new tools and applications are proposed. In 2016 we put a working group together to develop a detailed proposal.
Who were the key participants in the Subcommittee for Best Practices in Industrial Biotechnology?
Our task group consisted of several individuals with industry, academic, and regulatory experience. The team included David Dodds (Dodds and Associates), Jim Zahn (DuPont Tate & Lyle Bioproducts), Keira Havens, Vince Sewalt (DuPont Nutrition and Biosciences), Alice Chen (DuPont Nutrition and Biosciences). The working group received significant support from William Armiger, E62 Chair (BioChemInsights, Inc.), Teresa Clark (ENSO Plastics) and Pat Picariello, the ASTM Staff Manager responsible for overseeing E62 and several other ASTM technical committees.
How have we been classifying organisms until now, and how will this new standard change that?
There are many ways that microorganisms have been classified, the most familiar being the Linnean Taxonomic classification (Genus/species) that dates back centuries. Genomic homology is now widely used and there is an active debate about the value of traditional taxonomy versus this newer approach. Then there are more specific classifications for biosafety, strain lineage, method of construction, etc. All of these systems are in addition to the overly broad categories of GMO and non-GMO, which have particular relevance to industry and consumer applications.
The bottom line is that there was no simple system designed to capture the information industry needs to place their technology in a readily understood context until our system was developed.
Describe how the system might work in practice?
The system could be applied in several ways. In the short term we hope it helps people communicate more accurately – between companies and VCs, between companies and their customers, and to the general public. The system has four independent fields that represent different aspects of industrial microbes. For example, Genotype class (Field 1) and Biosafety (Field 2) are rather different and should be considered separately from each other to best determine how to safely handle or regulate a given microbial product. Field 3 (Mode of use and Primary Application) gives an idea of what the product is to be used for and in what manner – information that is often hard to determine through alternative classifications and has obvious application to regulation. Field 4 (DNA sequencing) describes genomic sequence information and reflects the extent to which the genome of a microbial strain has been characterized.
Long-term it is possible that this effort provides a framework that can be improved upon and adopted by regulatory agencies determining how to regulate a given microbial product. The system is a summary of the properties of a microbe and its intended application, which should enable regulators to ask far more detailed and specific questions to determine whether and how a given strain should be regulated. Ultimately, we hope that this system will provide a robust framework for legislators and regulators as they craft policy both protects the public and allow for innovation needed for the industrial biotechnology industry to grow.
How do you anticipate this could be used to improve or expedite commerce?
The standard removes ambiguity and provides accuracy in the description of a microorganism used to make a product. We hope that it will be used to help industry communicate their products more effectively to both partners and the public they interact with it. One hope is that we can move past the GMO/non-GMO dichotomy to deeper questions about application, risk, and benefit. For example, a strain designed for open use or human consumption requires different considerations relative to one used in a contained facility. Similarly, we may want to ensure that organisms making chemicals harmful to humans but useful for industry are evaluated by different criteria than those that make less hazardous materials. Right now, it can be difficult to navigate these questions. Our new system is designed to pack as much information as possible into a conceptually simple format.
What benefit will this ultimately have for consumers?
This standard will allow consumers to access more information about application, risk, and benefit than they currently have, in an objective standard format. The goal is to bring the industry and consumers to the same table with a common language that allows them to determine which organisms best suit their needs. Overall, we hope that people will welcome more insight into the nature and intended use for microbial products as they diversify.
To learn more about the classification standard, and participate in future review and development of the standard, click here.0