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AAAS 2018 Meeting

Committee chair Dr. Richard Murray and committee members Dr. Steven Bradbury and Dr. Mary Maxon presented at the 2018 AAAS Annual Meeting in Austin, TX on February 18, 2018.

Download the presentation here.

Report

Preparing for Future Products of Biotechnology

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Between 1973 and 2016, the ways to manipulate DNA to endow new characteristics in an organism (that is, biotechnology) have advanced, enabling the development of products that were not previously possible. What will the likely future products of biotechnology be over the next
5–10 years? What scientific capabilities, tools, and/or expertise may be needed by the regulatory agencies to ensure they make efficient and sound evaluations of the likely future products of biotechnology?

Preparing for Future Products of Biotechnology analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making. This report identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of biotechnology are well understood.

Errata

The prepublication version of Preparing for Future Products of Biotechnology, released on March 9, 2017, was provided to the public to facilitate timely access to the report. Although the substance of the report is final, editorial changes were made throughout the text and citations were checked prior to final publication. The following factual and typographical errors in the prepublication version are corrected in the final text.

Page Number in
Prepublication
Report
Error Correction

p. 4, Table S-1

p. 5, Table S-2

p. 42, Figure 2-7

p. 43, Table 2-3

p. 49, Figure 2-8

p. 50, Table 2-4

Unclear term: On Market Correction: A footnote has been added to define “On Market” as equivalent to “in use”; thus, products that have received regulatory approval but are not in use were not considered by the committee to be “On Market.”

p. 4, Table S-1

p. 42, Figure 2-7

p. 43, Table 2-3

Incorrect term: Bioluminescent zebra fish Correction: Fluorescent zebra fish

p. 4, Table S-1

p. 43, Table 2-3

Typographical error: Genomically recorded organisms Correction: Genomically recoded organisms

p. 4, Table S-1

p. 43, Table 2-3

Error: Genome-edited crops marked as “On Market” Correction: Checkmark removed from “On Market” column for genome-edited crops

p. 5, Table S-2

p. 50, Table 2-4

Error: Bioluminescent microbes for home and landscape uses marked as “On Market” Correction: Checkmark removed from “On Market” column for bioluminescent microbes for home and landscape uses

p. 5, Table S-2

p. 50, Table 2-4

Typographical error: Genomically recorded organisms Correction: Genomically recoded organisms

p. 9, Figure S-2

p. 136, Figure 5-2

Error: “Assessment” encompasses “Unregulated” products Correction: “Assessment” redrawn to show that products deemed to be unregulated are not included in that step.
p. 21 Clarification needed in prepublication text: Depending on the familiarity and complexity of the new product, the agency may determine public participation concerning the technology, the benefits of the technology, and its potential implications would be helpful to inform the risk analyses. Revised sentences: Depending on the familiarity and complexity of the new product, the agency may determine in some instances that public participation concerning the technology, the benefits of the technology, and its potential implications would be helpful to inform the risk analyses.
p. 23 Clarification needed in prepublication text: As noted in Figure 1-2 (arrow B), the regulatory agencies may interact with other parties on issues related to implementing the Coordinated Framework. For example, the agencies may work with various global organizations (such as the Organisation for Economic Co-operation and Development) to develop international test guidelines for future biotechnology products. These collaborative efforts expand technical capability and can enhance efficiency in developing risk-analysis methods and also enhance efficiency and effectiveness for U.S. developers intending to export their products. Revised sentences: As noted in Figure 1-2 (arrow B), the regulatory agencies could interact with other parties on issues related to implementing the Coordinated Framework. For example, agencies could work with various global organizations (such as the Organisation for Economic Co-operation and Development) to develop international test guidelines for future biotechnology products. These collaborative efforts could expand technical capability and enhance efficiency in developing risk-analysis methods and also enhance efficiency and effectiveness in evaluating products intended for U.S. import.
p. 26, Figure 2-1 Incorrect figure label: The y-axis label “Basepair/$” is incorrect. Corrected figure label: Y-axis is corrected to ‘U.S. Dollars per Base Pair.”
p. 27 Clarification needed in prepublication text: Recombinant DNA insertions typically involve the transformation of plasmids—the insertion of circular rDNA molecules capable of replicating alongside the host’s genome—or direct insertion into the host’s genome using homologous recombination (the natural ability of cells to exchange DNA between similar DNA molecules of host genes and exogenous DNA). Revised sentence: Recombinant DNA insertions typically involve the transformation of plasmids—the insertion of circular rDNA molecules capable of replicating alongside the host’s genome—or direct insertion into the host’s genome using either the natural ability of cells to exchange DNA or by techniques that create double-stranded breaks in the genome, allowing incorporation of exogenous DNA).
p. 28 Clarification needed in prepublication text: Scientists have re-engineered the CRISPR-Cas9 system so that a single RNA (the guide RNA) can create the Cas9-mediated cut of a target sequence in a genome. Revised sentence: Scientists have re-engineered the CRISPR-Cas9 system so that a single RNA (the guide RNA) can direct the Cas9-mediated cut of a target sequence in a genome.
p. 39, Table 2-2 Updated source needed for Table 2-2 Table 2-2 has been updated with data from U.S. Department of Agriculture–Animal and Plant Health Inspection Service. 2017. Regulatory Impact Analysis & Initial Regulatory Flexibility Analysis, Proposed Rule, APHIS 2015-0057, RIN 0579-AE15; Importation, Interstate Movement, and Environmental Release of Organisms Produced through Genetic Engineering (7 CFR part 340). Available at https://www.regulations.gov/document?D=APHIS-2015-0057-0002.
p. 40 Clarification needed for Footnote 24 prepublication text: See Chapter 3 for more discussion of the roles and responsibilities of the regulatory agencies. Revised Footnote 24: See Chapter 3 for more discussion of the roles and responsibilities of the regulatory agencies and Appendix D for the Federal Food, Drug, and Cosmetic Act definition of food.
p. 44 Error: Drought tolerance in corn (Shi et al., 2017) and more healthful oil quality in soybean (Haun et al., 2014) were being demonstrated through genome editing as well, and canola with herbicide resistance introduce through genome editing was already on the market in the United States.

Revision: Drought tolerance in corn (Shi et al., 2017) and more healthful oil quality in soybean (Haun et al., 2014) were being demonstrated through genome editing as well.28

28At the time the committee was writing its report, a canola variety with herbicide resistance had been commercialized by the company Cibus, which described the variety as developed using genome editing (Gocal, 2015). The resistance arose from a single nucleotide mutation in the BnAHAS1C gene selected for during an oligonucleotide-mediated genome-editing approach. However, Canadian regulatory documents note that, although the variety was developed using a genome-editing approach, Cibus “hypothesized that the single nucleotide mutation was the result of spontaneous somaclonal variation” rather than directly from the oligonucleotide-mediated editing. See Novel Food Information–Cibus Canola Event 5715 (Imidazolinone and Sulfonylurea Herbicide Tolerant). Available at http://www.hc-sc.gc.ca/fn-an/gmf-agm/appro/canola-5715-eng.php.

 

Gocal, G. 2015. Non-transgenic trait development in crop plants using oligo-directed mutagenesis: Cibus’ Rapid Trait Development System. Pp. 97–106 in NABC Report 26 New DNA-Editing Approaches: Methods, Applications, & Policy for Agriculture, A. Eaglesham and R.W.F. Hardy, eds. Ithaca, NY: North American Agricultural Biotechnology Council.

p. 44 Clarification needed in prepublication text: RNAi technology had already been used to reduce browning the flesh of apples and potatoes (NASEM, 2016b), and these products had cleared U.S. regulatory requirements. Scientists were using RNAi to create virus resistance in cassava, a staple crop in many African countries (Taylor et al., 2012). RNAi was also being used as a way different from rDNA to introduce insect resistance into corn; this product was deregulated by USDA–APHIS in 2015. Revision: RNAi technology had already been used to introduce traits, including the reduction of browning in the flesh of apples and potatoes (NASEM, 2016b), and such products had cleared U.S. regulatory requirements. Scientists were using RNAi to create virus resistance in cassava, a staple crop in many African countries (Taylor et al., 2012). RNAi was also being used as a way different from rDNA-mediated toxin expression to introduce insect resistance into corn; this product was deregulated by USDA–APHIS in 2015.
p. 45 Incorrect term: Engineered bioluminescent zebra fish have been on the market since 2003. Correction: Engineered fluorescent zebra fish have been on the market since 2003.
p. 49, Figure 2-8 Error: Bioluminescent microbes for home and landscape uses marked as “On Market” Correction: Bioluminescent microbes for home and landscape uses shown as “Under Development” and “Early-Stage Concept.”
p. 74, Table 3-2,
New Animal Drug,
Premarket Risk
Assessment column
Clarification needed in prepublication text: New animal drugs cannot be marketed until FDA affirmatively approves them. The burden of proof is on the manufacturer to show that the drug is safe and effective for the animal and—for drugs used in animals used as food—that the drug will not place humans at risk by leaving residues in edible tissues. Revision: New animal drugs cannot be marketed until FDA affirmatively approves them. The burden of proof is on the manufacturer to show that the drug is safe and effective for the animal and—for drugs used in food-producing animals—that food products derived from treated animals are safe for consumption.
p. 74, Table 3-2,
New Animal Drug,
Post-market Risk
Assessment column
Clarification needed in prepublication text: FDA performs inspections and encourages veterinarians and animal owners to report emerging safety problems with approved animal drugs. Revision: FDA performs inspections and requires reporting of certain safety problems by sponsors and manufacturers as well as encouraging reporting by veterinarians and animal owners of safety problems with approved animal drugs.
p. 75 Clarification needed in prepublication text: Future biotechnology products may include an additional array of new products that may not fit within existing policies. Examples would be synthesized foodstuffs produced directly in industrial and fermentation facilities without the intermediation of plants or animals (such as egg-white protein produced from GE yeast) or cultured food products like yogurt containing GE microorganisms. This discussion examines the flexibility of FDA’s statutes to cope with such products. Revision: Future biotechnology products may include an additional array of new products, for example, synthesized foodstuffs produced directly in industrial and fermentation facilities without the intermediation of plants or animals (such as egg-white protein produced from GE yeast) or cultured food products like yogurt containing GE microorganisms. Some of these future foodstuffs may fit within FDA’s existing policies, but other may present challenges. This discussion examines the flexibility of FDA’s statutes to cope with such products.
p. 78 Incorrect and missing agencies: The trends identified in Chapter 2 present challenges and counsel a need to ensure that FDA’s Center for Food Science and Applied Nutrition receives adequate resources for the task ahead. Correction: The trends identified in Chapter 2 present challenges and counsel a need to ensure that FDA’s Center for Food Safety and Applied Nutrition and Center for Veterinary Medicine receive adequate resources for the task ahead.
p. 78 Clarification needed in prepublication text: FDA’s new animal drug risk assessment considers a drug’s safety and effectiveness to the animal and, in the case of animals used for food, whether the change creates risks to humans through residues or other impacts on the animal’s edible tissues. Revision: FDA’s new animal drug risk assessment considers a drug’s safety and effectiveness to the animal and, in the case of food-producing animals, whether food derived from the animal is safe for consumption.
p. 78 Clarification needed in prepublication text: Biotechnology-altered animals of the future may include nonfood animals, such as pets or species brought back from extinction. In addition to environmental risks, these animals may pose consumer-safety risks. For example, a biotechnology-altered pet could have altered susceptibility to zoonotic diseases or aggressive traits that pose injury risks to humans. FDA’s new animal drug authorities do not allow the agency to address these risks. Revision: Biotechnology-altered animals of the future may include nonfood animals, such as pets or species brought back from extinction. In addition to environmental risks, these animals may pose consumer-safety risks. For example, a biotechnology-altered pet could have altered susceptibility to zoonotic diseases or aggressive traits that pose injury risks to humans. According to the FDCA, the term safe, as used in the new animal drug provisions, “has reference to the health of man or animal.” While this is sometimes conceived as an authority merely to ensure the safety of foods derived from food-producing animals, it actually carries a broader authority to consider human-safety impacts of new animal drugs. Thus, if an alteration to an animal results in human risks that go beyond food-safety risks, FDA has authority to take these other risks into account as part of a user-safety evaluation.
p. 85, Table 3-3, USDA–APHIS Authority column Clarification needed in prepublication text: Products are regulated by USDA–APHIS while under experimentation and can subsequently be deregulated for commercial release. Revision: Products are regulated by USDA–APHIS while under experimentation and can subsequently be deregulated for unconfined release, which for many types of products is a necessary practical step for commercial use.
p. 87 Clarification needed in prepublication text: As of 2016, USDA authority over GE insects has been exercised under the PPA but no under the AHPA. Revision: As of 2016, USDA authority over GE insects that are plant pests has been exercised under the PPA but the AHPA authority has not been exercised over GE insects that are animal pests.
p. 88 Incorrect sentence: Because of the use of a plant pest to transform an organism has been a key feature in the authority grant to USDA–APHIS to oversee products of biotechnology, the agency typically has not regulated biotechnology plants that are not engineered using a plant-pest vector or those plants that do not contain any plant-pest DNA. Correction: Because the use of a plant pest to transform an organism has been a key feature of the regulations used by USDA–APHIS since 1987 to oversee products of biotechnology, the agency typically has not regulated biotechnology plants that are not engineered using a plant-pest vector or those plants that do not contain any plant-pest DNA.
p. 88 Clarification needed in prepublication text: As of 2016, USDA–APHIS had considered several cases of crops engineered with genome-editing technology to cause directed insertions or deletions of one to several bases with no evidence that the genetic sequences used to introduce deletions contained any material from a plant pest. Revision: As of 2016, USDA–APHIS had considered several cases of crops engineered with genome-editing technology to cause directed insertions or deletions of one to several bases.
p. 90 Clarification needed in prepublication text: Under the proposal, GE crops and plants submitted to USDA–APHIS would be considered regulated articles only if the agency had not evaluated previously the plant-pest risk or noxious-weed risk posed by the submitted trait–crop combination or if the trait–crop combination has received DNA from a donor organism in a taxon known to contain plant pests and the introduced DNA was sufficient to produce a plant-disease property in the trait–crop combination. Revision: Under this proposal, GE crops and plants would be subject to a mandatory regulatory status evaluation by USDA–APHIS only if the agency had not evaluated previously the plant-pest risk or noxious-week risk posed by the submitted trait–crop combination or if the trait–crop combination has received DNA from a donor organism in a taxon known to contain plant pests and the introduced DNA was sufficient to produce a plant-disease property in the trait–crop combination.
p. 91, Box 3-4 Clarification needed in prepublication text: When NEPA is triggered, product developers must submit an environmental assessment to USDA–APHIS before the permit can be granted or the product regulated. Revision: When NEPA is triggered, USDA–APHIS must determine its appropriate response under NEPA regulations before a permit can be granted or the product deregulated.
p. 91, Box 3-4 Clarification needed in prepublication text: For FDA’s oversight of biotechnology-altered animals, NEPA can be triggered when the agency considers a field trial (which the agency sees as analogous to clinical trials of an “investigational new animal drug”) and again when the animal is approved for commercial use. Revision: For FDA’s oversight of biotechnology-altered animals, NEPA can be triggered for major federal actions, which include FDA’s approval of an investigational new animal drug application (for example, an application to commence a field trial) and FDA’s approval of a new animal drug application to commence commercial use.
p. 92, Box 3-4 Incorrect sentence: The Oxitec mosquitoes (engineered to produce sterile offspring) were the first biotechnology-altered animals to undergo a NEPA assessment for a field release, although the GE salmon also received a NEPA analysis for transport of the food into the United States. Correction: The Oxitec mosquitoes (engineered to produce sterile offspring) were the first biotechnology-altered animals to undergo a NEPA assessment for a field release.
p. 92, Box 3-4 Incorrect sentence: It reviewed a zebra fish genetically engineered to glow before the agency put in place its GE animal policy in 2009; the agency determined it would not regulate the zebra fish because the fish would not be sold as food. Correction: It reviewed a zebra fish genetically engineered to fluoresce before the agency put in place its GE animal policy in 2009; the agency decided not to enforce the approval requirement for the zebra fish based on an evaluation of risk factors, including whether it posed a human, animal, or environmental risk.
p. 92, Box 3-4 Missing source Source added: SOURCE: Based on a white paper prepared for the committee by S. Carter, Science Policy Consulting, 2016, which is available upon request from the National Academies’ Public Access Records Office at PARO@nas.edu.
p. 93, Box 3-5 Incorrect statement: With respect to biotechnology products, the regulatory agencies have limited experience with the ESA. USDA–APHIs has generally made a “no effect” determination in its decisions, and so has limited experience with the ESA and consultation with FWS and NMFS. Similarly, EPA and FDA have found “no effect” for all of their biotechnology products. Revision: With respect to biotechnology products, the regulatory agencies have limited experience undertaking ESA Section 7(a)(2) consultations. At the time the committee was writing its report, EPA, FDA, and USDA–APHIS have typically made “no effect” determinations for their regulatory actions.
p. 93, Box 3-5

Clarification needed in prepublication text: However, FWS has not been intimately involved in the regulation of GE animals, and FWS personnel have criticized FDA’s environmental assessments and decision-making processes for GE animals like the AquAdvantage Salmon (as summarized in Earthjustice and CFS, 2013).

 

Revision: However, FWS has not been intimately involved in the regulation of GE animals, and FWS personnel have criticized FDA’s environmental assessments and decision-making processes for the AquAdvantage Salmon (as summarized in Earthjustice and CFS, 2013).

 

p. 94, Box 3-5 Missing source Source added: SOURCE: Based on a white paper prepared for the committee by S. Carter, Science Policy Consulting, 2016, which is available upon request from the National Academies’ Public Access Records Office at PARO@nas.edu.
p. 96 Clarification needed in prepublication text: Jurisdiction redundancy also exists; for example, all three agencies receive composition and agronomic performance data for GE crops. Revision: Jurisdiction redundancy also exists; for example, all three agencies can receive composition and agronomic performance data for GE crops.
p. 106 Clarification needed in prepublication text: There may be regulatory gaps associated with these types of products. For example, if USDA determines that a product is not regulated by virtue of the mechanism used to insert the genetic modification or the source of the genetic material, then the agency may have no authority to do a National Environmental Policy Assessment. Revision: There may also be regulatory gaps associated with these types of products. For example, if USDA determines that a product is not regulated by virtue of the mechanism used to insert the genetic modification or the source of the genetic material, and that product may be a plant pest or weedy species, there would not be oversight when oversight is warranted.
p. 116, Figure 4-5 Incorrect data Correction: Figure 4-5 has been updated with correct data.
p. 123, Figure 4-8 Incorrect data in “Control of organismal traits” Correction: Figure 4-8 has been updated with correct data for that area of research.
p. 180, Glossary Incorrect definition: Definition of trait limited to only plants. Correction: The definition of trait has been revised.
p. 196 Incorrect term and meaning: animal feed Correction: The term animal feed has been replaced with animal food and the meaning has been revised.

Find a Speaker

Below are the invited speakers who made presentations to the committee. They are listed in alphabetical order along with the meeting title and date of their presentation.

Presenter Affiliation Event Date
Todd Anderson Department of Energy Committee Meeting 2 June 1, 2016
Adam Arkin Lawrence Berkeley National Laboratory Committee Meeting 3 June 27, 2016
David Babson DOE BETO Committee Meeting 3 June 27, 2016
Robbie Barbero White House Office of Science & Technology Policy Committee Meeting  1 April 18, 2016
Lynn Bergeson Bergeson & Campbell PC Webinar: An Overview of the TSCA Updates August 2, 2016
David Berry Flagship Ventures Committee Meeting 3 June 27, 2016
Tom Burkett BUGSS Committee Meeting 2 June 2, 2016
Kristen C. Nelson University of Minnesota Webinar: Re-Envisioning Risk Assessment July 22, 2016
Lionel Clarke UK Synthetic Biology Leadership Council Committee Meeting 2 June 1, 2016
Craig Criddle Stanford University Committee Meeting 3 June 27, 2016
John Cumbers Synbiobeta Committee Meeting 2 June 1, 2016
Christopher DaCunha Universal Biomining Committee Meeting 2 June 1, 2016
Bruce Dannenberg Phytonix Committee Meeting 3 June 27, 2016
Isha Datar New Harvest Committee Meeting 3 June 27, 2016
Ron Davis Stanford University Committee Meeting 3 June 27, 2016
Diane DiEuliis National Defense University Webinar: Safeguarding the Bioeconomy July 21, 2016
Jed Eberly US Army Engineer Research & Development Center Webinar: Assessing the Environmental Impact of Synthetic Biology August 1, 2016
Rebecca Edelstein US Environmental Protection Agency Committee Meeting  1 April 18, 2016
Norman Ellstrand UC-Riverside Committee Meeting 2 June 2, 2016
Juan Enriquez Excel Venture Management Committee Meeting 2 June 1, 2016
Kevin Esvelt Massachusetts Institute of Technology Webinar: Gene Drives July 28, 2016
Antony Evans Taxa Committee Meeting 3 June 27, 2016
Lisa Ferguson US Department of Agriculture Committee Meeting  1 April 18, 2016
Justin Gallivan Defense Advanced Research Projects Agency (DARPA) Webinar: Defense and Intelligence Agency Funding July 25, 2016
Theresa Good National Science Foundation Committee Meeting 2 June 1, 2016
Doug Gurian-Sherman Center for Food Safety Committee Meeting 2 June 2, 2016
Karl Handelsman Codon Capital Committee Meeting 3 June 27, 2016
David Hanselman Synthetic Genomics, Inc. Committee Meeting 2 June 2, 2016
David Hanselman International Gene Synthesis Consortium Committee Meeting 2 June 2, 2016
Michael Hansen Consumers Union Committee Meeting 3 June 27, 2016
Rachel Haurwitz Caribou Biosciences, Inc. Committee Meeting 2 June 1, 2016
Keith Hayes CSIRO, Australia Committee Meeting 2 June 2, 2016
Elizabeth Heitman Vanderbilt University Medical Center Webinar: Gene Drives July 28, 2016
Stephan Herrera Evolva Committee Meeting 2 June 2, 2016
Andrew Hessel Autodesk Committee Meeting 3 June 27, 2016
Nathan Hillson Joint BioEnergy Institute Committee Meeting 2 June 1, 2016
Nathan Hillson Joint BioEnergy Institute Committee Meeting 2 June 2, 2016
Alicia Jackson Drawbridge Health Committee Meeting 3 June 27, 2016
Gregory Jaffe Center for Science in the Public Interest Committee Meeting 2 June 2, 2016
Kevin Jarrell Modular Genetics Committee Meeting 3 June 27, 2016
Dan Jenkins Monsanto Committee Meeting 2 June 1, 2016
Ellen Jorgensen GenSpace Committee Meeting 2 June 2, 2016
John Julias Intelligence Advanced Research Projects Activity (IARPA) Webinar: Defense and Intelligence Agency Funding July 25, 2016
Anne Kapuscinski Dartmouth University Committee Meeting 3 June 27, 2016
Todd Kuiken Wilson Center Committee Meeting 2 June 2, 2016
Gigi Kwik Gronvall University of Pittsburgh Medical Center-Center for Health Security Webinar: Safeguarding the Bioeconomy July 21, 2016
Wayne Landis Western Washington University Committee Meeting 3 June 27, 2016
Peter Licari Terravia Committee Meeting 3 June 27, 2016
Steve Mashuda Earth Justice Webinar: Re-Envisioning Risk Assessment July 22, 2016
Terry Medley DuPont Committee Meeting 2 June 2, 2016
Zahra Meghani University of Rhode Island Webinar: Re-Envisioning Risk Assessment July 22, 2016
Kevin Munnelly Gen9 Committee Meeting 2 June 1, 2016
Tichafa Munyikwa Syngenta Webinar: Re-Envisioning Risk Assessment July 22, 2016
Ritu Nalubola US Food and Drug Administration Committee Meeting  1 April 18, 2016
Bill Peck Twist Bioscience Committee Meeting 2 June 1, 2016
Pablo Rabinowicz Department of Energy Committee Meeting 2 June 1, 2016
Kent Redford Archipelago Consulting Webinar: Synthetic Nature and the Future of Conservation August 2, 2016
Thomas Reed Intrexon Committee Meeting 2 June 1, 2016
Ortwin Renn University of Stuttgart Committee Meeting 2 June 1, 2016
Randy Rettberg iGEM Committee Meeting 2 June 2, 2016
John Ryals Metabolon Webinar: Screening Tools July 29, 2016
Dan Schlenk University of California, Riverside Webinar: Screening Tools July 29, 2016
Vincent Sewalt Dupont Committee Meeting 3 June 27, 2016
Ron Shigeta Indie Bio Committee Meeting 3 June 27, 2016
Rachel Smolker Biofuelwatch/Global Justice Ecology Project Committee Meeting 3 June 27, 2016
Brynne Stanton Gingko Bioworks Committee Meeting 2 June 1, 2016
Steven Strauss Oregon State University Committee Meeting 3 June 27, 2016
Craig Taylor Alloy Ventures Committee Meeting 3 June 27, 2016
Shengdar Tsai Harvard University Committee Meeting 2 June 2, 2016
John Turner US Department of Agriculture Committee Meeting  1 April 18, 2016
Chris Warner US Army Engineer Research & Development Center Webinar: Assessing the Environmental Impact of Synthetic Biology August 1, 2016
Patrick Westfall Zymergen Committee Meeting 3 June 27, 2016
Fern Wickson GenOk Centre for Biosafety Committee Meeting 3 June 27, 2016
Chris Wozniak US Environmental Protection Agency Committee Meeting  1 April 18, 2016
John Yates The Scripps Research Institute Webinar: Screening Tools July 29, 2016
Edward You Federal Bureau of Investigation-Weapons of Mass Destruction Directorate Webinar: Safeguarding the Bioeconomy July 21, 2016

 

 

Testing embeds

Committee

Click a name to read a committee member’s bio.  For The National Academies of Sciences, Engineering, and Medicine policies on committee composition and conflicts of interest, click here.  To view the official membership listing on the Academies Current Projects System, click here.

Richard Murray, ChairCalifornia Institute of Technology

Dr. Richard Murray is Thomas E. and Doris Everhart Professor of Control and Dynamical Systems and Bioengineering at California Institute of Technology. He received his B.S. degree in Electrical Engineering from California Institute of Technology in 1985 and his M.S. and Ph.D. degrees in Electrical Engineering and Computer Sciences from the University of California, Berkeley, in 1988 and 1991, respectively. Professor Murray’s research is in the application of feedback and control to mechanical, information, and biological systems. Current projects include integration of control, communications, and computer science in multi-agent systems, information dynamics in networked feedback systems, analysis of insect flight control systems, and biological circuit design. Professor Murray has recently developed a new course at Caltech that is aimed at teaching the principles and tools of control to a broader audience of scientists and engineers, with particular emphasis on applications in biology and computer science. Dr. Murray is co-founder and board member of Synvitrobio, a start-up biotechnology company focused on commercialization of cell-free synthesis methods.

Richard M. Amasino, University of Wisconsin, Madison

Richard M. Amasino is a professor with the Department of Biochemistry at the University of Wisconsin–Madison. His work focuses on how plants perceive seasonal cues such as changing day-length and temperature and how they use such cues to determine when to initiate flowering. His most recent focus has been on understanding the biochemical pathway through which perception of winter cold leads to flowering in the spring–a process known as vernalization. Dr. Amasino is also a member of the Great Lakes Bioenergy Research Center, which is one of the three bioenergy research centers established by the U.S. Department of Energy. His work with the center involves studying the biochemical basis of plant biomass accumulation as well as directing the education and outreach program of the center. Dr. Amasino is a Howard Hughes Medical Institute (HHMI) professor, a member of the U.S. National Academy of Sciences, and a fellow of the American Association for the Advancement of Science. His teaching and research have resulted in several national and international awards, including the Alexander von Humboldt Foundation Award in 1999. He has served both as president and chair of the board of trustees of the American Society of Plant Biologists. Dr. Amasino received his BS in biology from Pennsylvania State University and his MS and PhD in biology/biochemistry from Indiana University.

Steven P. Bradbury, Iowa State University

In August of 2015, Dr. Bradbury was appointed as a professor of environmental toxicology in the Departments of Natural Resource Ecology and Management and Entomology. He is also a faculty member in Iowa State University’s Toxicology Program. From July 2014 through July 2015, Dr. Bradbury served as a visiting professor in the Department of Entomology. Dr. Bradbury is contributing to research, teaching and extension in university-wide toxicology, environmental, agriculture and natural resource science and policy programs. Areas of emphasis include pesticide resistance management; pollination services and monarch butterfly conservation; and sustainable agriculture, including the role of integrated pest management within nested layers of governance. Dr. Bradbury retired from the U.S. Environmental Protection Agency in 2014. During his last 4 years at EPA he was the Director of the Office of Pesticide Programs. In this role he led evaluation of new and existing pesticides, including biotechnology products; integration of federal pesticide registration decisions within related national, state and stakeholder-initiated programs; and addressed management options for emerging, high impact pests, pesticide resistance, and water quality, endangered species and pollinator protection. Prior to joining OPP in 2002, Dr. Bradbury had over 15 years of experience in EPA’s Office of Research and Development leading efforts to advance human health and ecological risk assessments in support of water quality, pesticide and industrial chemical programs. Dr. Bradbury has a BS in Molecular Biology from the University of Wisconsin-Madison and a MS in Entomology (Insecticide Toxicology) and a PhD in Toxicology and Entomology from Iowa State University. He has published over 70 peer-reviewed journal articles and book chapters and has an extensive record of invited presentations at international and national scientific conferences. In 2014, Dr. Bradbury received the Henry A. Wallace Award for Outstanding Leadership to National and International Agriculture from the College of Agriculture and Life Sciences, Iowa State University.

Barbara Evans, University of Houston Law Center

Dr. Barbara Evans joined the University of Houston Law Center in 2007. She is George Butler Research Professor and Director of the Center for Biotechnology and Law at UHLC and is an affiliated member of the Center for Medical Ethics and Health Policy at Baylor College of Medicine. She was named a Greenwall Foundation Faculty Scholar in Bioethics for the period 2010-2014 and conducts an active research agenda including projects funded by the National Institutes of Health and Food and Drug Administration. Her research interests include governance, privacy, and financing issues with large health information networks and tissue repositories; regulatory and judicial uses of evidence from large-scale observational studies; and legal barriers to clinical translation of pharmacogenomics. Earlier in her career, she was a partner in the international regulatory practice of a large New York law firm and subsequently advised clients on U.S. privacy, research, and medical device regulatory matters. Prior to joining the University of Houston Law Center, she was a Research Professor of Medicine and Director of the Program in Pharmacogenomics, Ethics, and Public Policy at the Indiana University School of Medicine/Center for Bioethics. She holds an electrical engineering degree from the University of Texas at Austin; M.S. and Ph.D. degrees from Stanford University; a J.D. from Yale Law School; and she completed a post-doctoral Fellowship in Clinical Ethics at the M.D. Anderson Cancer Center.

Steven L. Evans, Dow AgroSciences

Dr. Steve Evans is currently a Fellow at Dow AgroSciences in Seeds Discovery R&D. He received his B.A. and B.S. degrees in chemistry and microbiology from the University of Mississippi and a Ph.D. in microbial physiology from the University of Mississippi Medical School. He was an NIH postdoctoral fellow at the University of California, Berkeley, and subsequently with the U.S.D.A. in Peoria, Illinois. In 1988 he joined Mycogen Corp., now Dow AgroSciences, where he has been involved in the development of natural and recombinant biopesticides, including several crop traits from the Mycogen pipeline. At the U.S.D.A. and subsequently in industry roles, Evans blends high-resolution chemical analysis with enzymology to research agricultural applications of biotechnology. Evans continues to identify and acquire differentiating biotechnology capabilities. Evans is chair emeritus of the Industrial Advisory Board of the SynBERC synthetic biology consortium and co-chair of the BIO Organization IES synthetic biology sub team.

Farren Isaacs, Yale University

Dr. Isaacs is an Assistant Professor of Molecular, Cellular and Developmental Biology at Yale University. He received a B.S.E. degree in Bioengineering from the University of Pennsylvania and obtained his PhD from the Biomedical Engineering Department and Bioinformatics Program at Boston University. In his PhD he integrated theory and experiment to study gene regulatory network dynamics and then pioneered the design and development of synthetic RNA components capable of probing and programming cellular function. He then was a research fellow in the Department of Genetics at Harvard Medical School working on genome engineering technologies with George Church. At Harvard, he developed enabling technologies for genome engineering, including MAGE (Multiple Automated Genome Engineering) and CAGE (Conjugative Assembly Genome Engineering). His research is focused on developing foundational genomic and biomolecular engineering technologies with the goal of developing new genetic codes, and engineered cells that serve as factories for chemical, drug and biofuel production. He has recently been named a “rising young star of science” by Genome Technology Magazine, a Beckman Young Investigator by the Arnold and Mabel Beckman Foundation, and recipient of a Young Professor award from DuPont. Dr. Isaacs is also co-founder and CTA of enEvolv, a start-up biotechnology firm aimed at commercializing the MAGE technology he co-invented.

Martha Krebs, Pennsylvania State University

Martha Krebs is senior scientist in Pennsylvania State University’s College of Engineering and principal investigator and director of the Consortium for Building Energy Innovation at The Navy Yard in Philadelphia. In her most recent previous position, Krebs worked with University of California, Davis faculty and staff to leverage and expand research programs through federal, state and private partnerships. In that role she also has served as science advisor for the California Energy Commission. Before joining UC Davis, she was the Commission’s deputy executive director for research and development (R&D). From 1993 to 2000, Krebs served as assistant secretary and director of the Office of Science at the Department of Energy, responsible for the basic research program that supports the department’s energy, environmental and national security missions. She also advised the Secretary of Energy on the department’s R&D portfolio and the institutional health of its National Laboratories. From 1983 to 1993, Krebs served as an associate director for Planning and Development at the Department of Energy’s Lawrence Berkeley National Laboratory, where she was responsible for strategic planning for research and facilities, technology transfer, and science education and outreach. From 1977 to 1983, she served on the House Committee on Science first as a professional staff member and then as subcommittee staff director, responsible for authorizing the department’s non-nuclear energy technologies and energy science programs. Krebs received her bachelor’s degree and doctorate in physics from the Catholic University of America. She is a fellow of the American Physical Society, the American Association for the Advancement of Science and the Association of Women in Science.

Jennifer Kuzma, North Carolina State University

Jennifer Kuzma is the Goodnight-NCGSK Foundation Distinguished Professor in Social Sciences and co-director of the Genetic Engineering and Society Center at NC State University. Prior to this position she was a faculty member in science and technology policy at the Humphrey School of Public Affairs, University of Minnesota (2003-2013); study director at the National Academies of Science in Washington DC for genetic engineering and bioterrorism (1999-2003); and a AAAS Risk Policy Fellow at the U.S. Dept. of Agriculture (1997-1999). She has over 100 scholarly publications on emerging technologies and governance; and has been studying genetic engineering and its societal aspects for over 25 years. She discovered that bacteria product isoprene, a precursor to natural rubber, during from her Ph.D. work in biochemistry, and her postdoctoral work in plant molecular biology resulted in a publication in the journal Science. She has held several leadership positions, including the Society for Risk Analysis Council & Secretary, Chair of the Gordon Conference on S&T Policy, the FDA Blood Products Advisory Committee, and the UN WHO-FAO Expert Group for Nanotechnologies in Food and Agriculture. In 2014, she received the Society for Risk Analysis Sigma Xi Distinguished Lecturer Award for recognition of her outstanding contributions to the field of risk analysis. She has been called upon in national media for her expertise on genetic engineering policy issues, including recently in the Washington Post, Scientific American, New York Times, 2015 World’s Fair exhibit, Nature, and National Public Radio.

Mary Maxon, Lawrence Berkeley National Laboratory

Dr. Mary Maxon is the Biosciences Area Principal Deputy at Lawrence Berkeley National Laboratory where she is responsible for developing strategies for the use of biosciences to address national-scale challenges in energy and environment. Previously, she was Assistant Director for Biological Research at the White House Office of Science and Technology Policy (OSTP) in the Executive Office of the President where she developed the National Bioeconomy Blueprint. Before moving to OSTP, Dr. Maxon ran the Marine Microbiology Initiative at the Gordon and Betty Moore Foundation, which supports the application of molecular approaches and comprehensive models to detect and validate environmentally-induced changes in marine microbial ecosystems. Prior to that, Dr. Maxon served as Deputy Vice Chair at the California Institute for Regenerative Medicine, where she drafted the intellectual property policies for California stem cell grantees in the non-profit and for-profit research sectors. Previously, she was Associate Director and Anti-infective Program Leader for Cytokinetics, a biotechnology company in South San Francisco and team leader at Microbia, Inc., based in Cambridge, Massachusetts, where she contributed to the discovery and development of the Precision Engineering technology for production of commercial products using metabolic engineering. Dr. Maxon received her Ph.D. from the University of California, Berkeley in Molecular Cell Biology, and did postdoctoral research in biochemistry and genetics at the University of California, San Francisco.

Raul F. Medina, Texas A&M University

Dr. Raul F. Medina’s research interests center around the role that ecological factors play in the population genetics of arthropods. Dr. Medina is particularly interested in the incorporation of evolutionary ecology considerations into pest control practices. His laboratory is currently assessing how species interactions at macroscopic (e.g., host-parasite associations) and microscopic (e.g., arthropod microbiomes) levels may affect genetic variation of agricultural pests and arthropod vectors of human disease. Dr. Medina is currently exploring if the same principles governing insect herbivores’ adaptation to their hosts translate in arthropod parasites of animals. Dr. Medina completed his Bachelor in Biology in Lima, Peru at the Universidad Nacional Agraria La Molina. He then obtained a Graduate Certificate in conservation biology from the University of Missouri in Saint Louis. He received his Master and PhD from the University of Maryland working on predation of forest caterpillars and on hymenopteran parasitoid population genetics respectively. Soon after his PhD Dr. Medina started working at Texas A&M where he is currently an Associate Professor.

David Rejeski, Woodrow Wilson Center for International Scholars

*As of 8/12/2016, Mr. Rejeski is a global fellow with the Woodrow Wilson Center.

Mr. Rejeski directs the Science and Technology Innovation Program (STIP) at the Woodrow Wilson Center, a non-partisan policy research institute in Washington DC. STIP focuses on emerging technologies and the critical choices innovation presents to public policy. Work includes synthetic biology (http://www.synbioproject.org), nanotechnology (http://www.nanotechproject.org), citizen science (http://wilsoncommonslab.org/), additive manufacturing, converging technologies, and the application of computer games to public policy challenges. He is presently a Guest Researcher at the International Institute of Applied Systems Analysis (IIASA) in Austria, a Visiting Scholar at the Environmental Law Institute, and was a Visiting Fellow at Yale University’s School of Forestry and Environmental Studies. Between 1994 and 2000, he worked at the White House Council on Environmental Quality (CEQ) and the Office of Science and Technology Policy (OSTP) on a variety of technology, R&D, and policy initiatives, including the development and implementation of the National Environmental Technology Strategy, the Greening of the White House, and the Education for Sustainability Initiative. Before moving to OSTP, he was head of the Future Studies Unit at the Environmental Protection Agency. He spent four years in Hamburg, Germany working for the Environmental Agency, Department of Public Health, and Department of Urban Renewal and, in the late 1970’s, founded and co-directed a non-profit involved in energy conservation and renewable energy technologies. He sits on the advisory boards of a number of organizations, including the UK Open Plant Project, the NSF-funded Synthetic Biology Engineering Research Center (SynBERC), DARPA’s ‘Living Foundries’ Program, the Center for Environmental Policy at American University, and the Journal of Industrial Ecology. He has also served on NSF’s Advisory Committee for Environmental Research and Education; EPA’s Science Advisory Board and Board of Scientific Counselors; the Committee on Science, Engineering and Public Policy of the American Association for the Advancement of Science (AAAS); the Board on Global Science and Technology of the National Academies of Sciences, Engineering and Medicine; and Games for Change. He has graduate degrees in public administration and environmental design from Harvard University and Yale University and a degree in industrial design from the Rhode Island School of Design.

Jeffrey Wolt, Iowa State University

Dr. Wolt is currently professor in the programs of Agronomy, Environmental Science, and Toxicology at Iowa State University. He started his academic career studying biology at Case Western Reserve University and completed his BS in bio-agricultural science at Colorado State University. He received his MS and PhD in agriculture from Auburn University with emphasis in environmental soil chemistry. His expertise includes soil solution chemistry, environmental chemistry, biogeochemistry, ecotoxicology, and risk assessment. Prior to coming to Iowa State, he held academic appointments with the University of Tennessee, the University of Hawaii, and Purdue University. He also worked as an environmental chemist and risk analyst with Dow Chemical. Dr. Wolt’s current research interests include biotechnology safety analysis applied to risk management and science policy decision-making; environmental and ecotoxicological risk assessment; soil and environmental chemistry applied to exposure assessment, efficacy, environmental monitoring, environmental toxicology, and environmental fate of xenobiotics and genetically modified agricultural products; and applied soil solution chemistry. He also works with regulators and scientists throughout the world to formulate and promote harmonized approaches for assessing the safety of genetically-engineered plants. His lab group works on the environmental fate of plant products introduced into agroecosystems.

*Committee composition has changed as of 8/31/2016 due to the resignation of Richard Johnson.

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The National Academies of Sciences, Engineering, and Medicine’s Committee on Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System Committee will be accepting input via SurveyGizmo throughout the course of the study. The input is intended to help ensure that the committee hears about important issues from interested parties. All submissions made to SurveyGizmo may be reviewed by members of the Committee. By submitting input, you agree that all input received by the Committee via SurveyGizmo, including your name and e-mail address (if included in the input) will be included in the Public Access File created for the Committee and may be quoted in whole or in part in the Committee’s report with attribution. SurveyGizmo and Widgix, LLC is not affiliated in any way with, or endorsed by, the National Academies of Sciences, Engineering, and Medicine, and your submission to the SurveyGizmo website is subject to SurveyGizmo’s terms of use.

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About Us

The National Academies of Sciences, Engineering, and Medicine

The National Academies of Sciences, Engineering, and Medicine provides independent, objective advice to improve government decision making and public policy and to increase public understanding in matters involving science, engineering, technology, and health.

Reports from the Academies are unique, authoritative expert evaluations. Each report is produced by a committee of experts selected by the Academies to address a particular statement of task.  Committees are balanced to represent various points of view, and committee members are screened for conflict of interest. Committee members serve without pay and deliberate free of outside influence.

Efforts are made to engage the public early on in studies so that all viewpoints are made known to the committee.  Watch this website for information about public meetings.

Learn more about the Academies study process.

Study Statement of Task

An ad hoc committee of the National Academies of Sciences, Engineering, and Medicine will produce a report designed to answer the questions “What will the likely future products of biotechnology be over the next 5-10 years? What scientific capabilities, tools, and/or expertise may be needed by the regulatory agencies to ensure they make efficient and sound evaluations of the likely future products of biotechnology?”

The committee will:

    • Describe the major advances and the potential new types of biotechnology products likely to emerge over the next 5-10 years.
    • Describe the existing risk analysis system for biotechnology products including, but perhaps not limited to, risk analyses developed and used by EPA, USDA, and FDA, and describe each agency’s authorities as they pertain to the products of biotechnology.
    • Determine whether potential future products could pose different types of risks relative to existing products and organisms. Where appropriate, identify areas in which the risks or lack of risks relating to the products of biotechnology are well understood.
    • Indicate what scientific capabilities, tools, and expertise may be useful to the regulatory agencies to support oversight of potential future products of biotechnology.

Human drugs and medical devices will not be included in the purview of the study per a sponsor’s request.