Future Biotechnology Products and Opportunities to Enhance the Capabilities of the Biotechnology Regulatory System

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1 Future Biotechnology Products and Opportunities to Enhance the Capabilities of the Biotechnology Regulatory System June 2016

2 Synthetic Biology at Modular Genetics

3 The Future of Chemical Manufacturing and Markets Current Manufacturing Process: Negative effects include CO2, other greenhouse gas emissions and deforestation Petroleum Palm Oil Refining Process Deforestation 50,000 new chemical products $1 trillion market opportunity Modular s Manufacturing Process: Two-thirds of all organic chemicals can be made from renewable feedstocks Agricultural Residue Fermentation

4 Surfactant Manufacturing Today Polar or charged group Surfactants Oily Chain Chemical Processes Petroleum Palm oil Polar The raw materials are not renewable Chemical processes are hazardous (ethoxylation, chlorination) Certain surfactants are environmental toxins (e.g., alkylphenol ethoxylates) Contaminated with carcinogen (e.g., 1,4 dioxane, nitrosoureas)

5 Future of Surfactant Manufacturing Polar or charged group Surfactants Oily Chain Chemical Processes Synthesized by Bacillus subtilis from cellulosic sugar Polar The raw materials are renewable cellulosic sugar No Chemical processes are used fermentation only Biodegradable composed of fatty acids and amino acids or amino alcohols Potential for contamination with carcinogens eliminated (e.g., 1,4 dioxane, nitrosoureas)

6 Green Purification Yields Protein-Free Surfactant

7 Cradle-to-Cradle Approach to Regulation Temperature Process Reagents Solvents Waste Is Product similar or identical to chemical found in Nature? Is engineered organism present in the product? Is DNA from engineered organism present in the product? Organic Chemistry o C Ethoxylation, chlorination Phosgene gas, ethylene, petroleum, palm oil Alcohols and glycols 1,4 dioxane No No No Organic Chemistry o C Fermentation Carbohydrate (e.g., xylose) Water CO 2 and water Yes No No

8 Chemicals, Fuels, Materials and Devices Often a functional replacement of existing product. However, the new product has an improved health, safety and sustainability profile Eventually these manufacturing methods will result in significant carbon capture, and this should be encouraged as a long-term goal. Oils Hydrocarbon fuels Many small molecules (e.g., ethanolamine) In vivo Any substance that can be produced without killing a living system In vitro Any substance that can be produced under conditions where enzymes function The future will be determined by: The market Technical feasibility The regulatory landscape Future Products

9 Regulatory Issues for the U.S Behave responsibly and show leadership Implement the best system and actively encourage others to adopt it. Many countries do not have a program in place for chemical safety and are considering adopting REACH (but with country-specific modifications). Regulatory issues are a barrier to global product launch (U.S. vs Europe vs U.S. We need a uniform global system) Establish a simple, rapid and inexpensive regulatory system Ideally it will be a global system ( We are a global company ) Does it really cost $1 million to register 1 product under REACH? If so, 50,000 new product = $50 billion in Europe alone Ensures that, from a regulatory perspective, companies choose the U.S. as the first place to deploy new green technology. Regulation should not stifle innovation We hate the current product, but Never develop anything new Devote the majority of regulatory activity to difficult cases and establish a simple, open and cooperative system that enables us to transition to the green economy rapidly Implement a cradle-to-cradle regulatory philosophy with regard to choosing how we manufacture..

10 Total cost of REACH compliance per substance $80,000 file:///c:/users/kjarr_000/downloads/chemical%20market.pdf $85,000 $130,000 $325, $680,000 $1 million Anecdotal The numbers I have heard are around $1M for a product including all the testing and data gathering but of course there is a range according to how hazardous it is. I suspect the $1M is pessimistic and weights internal costs highly.

11 Examples of Issues to Manage 1. Beginning with the Asilomar Conference in 1975, those trained to use the technology have been trained to use it safely. This is an industry where, traditionally, standard practice has been synonymous with safe practice. We need to ensure that new users of the technology adopt the traditional safety culture. 2. Increased use of new organisms that do not have a history of safe use. 3. Changes to international law that could impact growth of the industry. 4. Intentional release, including gene drives. 5. Unintended release (e.g., algae grown in open ponds). 6. Functional foods and probiotics for health and to replace antibiotics (*engineered live organisms). 7. Moving pathways for production of drugs (heroine) into organisms that are easy to grow in the lab or at home (yeast). 8. Introduction of genes that encode bioluminescene proteins into plants that might become weedy. 9. Transmission of genes, such as genes for bioluminescene proteins, into animals to create novel pets (glowing cats). 10.Transmission of viruses from pigs to humans as we grow organs in pigs. 11.Cloning of human beings

12 Examples of Issues to Manage II 11.Enhanced human performance through engineering of somatic cells (enhanced muscle function as an example, or make more erthropoietin to make more red blood cells). 12.Somatic engineering to change human brain function (memory, mood, behavior). 13.Improving the utility of living organisms (both somatic modification and germline modification). Increased performance of domestic animals and modification for improved behavior. 14.Engineering to modify senescence and increase life span. 15.Biological weapons. Globally, we need to agree we will not develop them and consequences must be severe for individuals or nations that seek to develop them.