2015 Meeting - EPA Workshop for Public Input on Considerations for Risk Assessment of Genetically Engineered Algae

EPA's Office of Pollution Prevention and Toxics hosted a public meeting entitled, "Workshop for Public Comment on Considerations for Risk Assessment of Genetically Engineered Algae" on September 30, 2015. The objective of this workshop was to receive public input and comments on EPA's data needs to support risk assessments of biotechnology products subject to oversight under the Toxic Substances Control Act that make use of genetically engineered algae and cyanobacteria.

EPA will use information discussed during the workshop to inform an update to an EPA guidance document entitled "Points to Consider in The Preparation of TSCA Biotechnology Submissions for Microorganisms".

2015 Meeting Final Summary Report

View the Final Summary Report

2015 Meeting Workshop Presentations

2015 Meeting Federal Register Notice

2015 Meeting Final Agenda

Time Event  Duration
7:00-8:00 am  Registration   1 hour
8:00-8:05 am  Welcome   5 min
8:05-8:20 am  Keynote Speaker (Jeff Morris)   15 min
8:20-8:45 am  Presentation #1: Toxic Substances Control Act Oversight of New Organisms (Mark Segal)   25 min
8:45-9:15 am  Comments/Discussion on Presentation #1   30 min
9:15-9:30 am  Presentation #2: Considerations for Risk Assessment of Genetically Engineered Algae (Gwen McClung)   15 min
9:30-10:00 am  Comments/Discussion on Presentation #2 and Charge Questions 1-3   30 min
10:00-10:15 am  BREAK   15 min
10:15-10:45 am  Comments/Discussion on Presentation #2 and Charge Questions 1-3 (continued)   30 min
10:45-11:00 am  Presentation #3: Considerations for Risk Assessment of Genetically Engineered Microorganisms (Carolina Peñalva-Arana)   15 min
11:00-11:30 am  Comment/Discussion on Presentation #3 and Charge Questions 4-6   30 min
11:30-11:50 am  Comments/Discussion on Relevant Topics not Covered Previously (Charge Question 7)   20 min
11:50 am-Noon  Closing Remarks   10 min
Noon  Adjourn

2015 Meeting Draft Charge Questions

    Draft Charge Questions for Presentation #2 on Commercial-Scale Algae Production

    Effects Considerations

  1. Besides toxins and the potential for harmful algal blooms (HABs), what other effects may be associated with the commercial-scale production of algae? (e.g., invasiveness, horizontal gene transfer, ecological effects, effects on aquatic food webs, etc.)
    1. What types of data can be collected and should we request/gather in order to evaluate these potential effects?
    2. How can these effects be best detected/monitored? How can these effects be best measured?
  2. What algal data are available to help determine the potential effects posed by commerical-scale algal production?
    1. Are data available about natural occurring or wild-type algae, when found or grown in high concentrations in uncontained systems, that can be used to evaluate the effects of engineered algae grown at commercial-scale?

    Exposure Considerations

  3. What potential exposures do different containment systems pose that should be considered during a risk assessment?
    1. How can a submitter demonstrate a containment system is secure?

    Draft Charge Questions for Presentation #3 on Advanced Genetic Engineering

  4. How can the predicted function of a genetically engineered construct be shown to be limited to the purpose for which it was designed?
    1. How can a construct based on a gene known to encode multiple functions (i.e., under different conditions or in other species) be shown to be contained?
  5. With genetically engineered microorganisms, what biological containment methods are best employed? (e.g., xenonucleic acids, altered codon usage, noncanonical amino acids, etc.)
    1. Should data requirements be different for these organisms? If so, why?
    2. What information should be included on the construct used to develop a new microorganism using synthetic biology techniques?
    3. What information can be used to confirm that a biological containment method is fail-proof?
  6. What differences exist and should be considered when assessing the risk of RNA versus DNA modifications?
  7. Draft Charge Question for Concluding Session

  8. What questions have we not asked that are relevant to our task? Have we missed any relevant issues?