Environmental Protection Agency – Early Career: Assessment Tools for Biotechnology Products

Proposal Deadline: July 15, 2020 at 11:59:59 pm Eastern Time

Synopsis of Program:

The United States Environmental Protection Agency (EPA), as part of its Science to Achieve Results (STAR) program, is seeking applications proposing research to support the development of improved science-based human health and environmental risk assessments of new biotechnology products, including those developed through synthetic biology, genome editing, and metabolic engineering.

Applicants should address at least one of the three research areas, including at least one subtopic, described below. Applications may respond to one research area or integrate across two or three research areas.

  • Long-term stability, persistence, efficacy, and reliability of microbial biocontainment strategies, microbial synthetic genetic constructs, or microbial genetic restriction technologies:
    • a. Long-term stability, persistence, and reliability of synbio microbial biocontainment strategies (e.g., xenonucleic acids, noncanonical amino acids, recoded microorganisms) for synbio microorganisms. For the purposes of this RFA, biocontainment methodologies are those that prevent unintended proliferation of genetically modified organisms in the environment.
    • b. Stability and persistence of synthetic genetic constructs in microbes (e.g., are synthetic transgenes eliminated from viral, bacterial, algal or fungal genomes over time?). For the purposes of this RFA, “synthetic genetic constructs” are defined as new biological entities, not directly derived from extant organisms, such as enzymes, genetic circuits, and cells or the redesign of existing biological systems for useful purposes.
    • c. Efficacy of genetic restriction technologies or orthogonal gene constructs in precluding horizontal gene transfer from synthetic microorganisms. Horizontal gene transfer is a process in which organisms exchange genetic material with other species. For the purposes of this RFA, “genetic restriction technologies” are defined as methods that impede transgene movement. Particularly with self-replicating microbial systems, re-engineered cells may produce undesired consequences if they escape or overwhelm their intended host environment.
  • Ecological effects/impacts of synbio organisms or by-products that are released into the environment:
    • a. Survival, persistence, and unintended ecological effects of synbio microorganisms, plants and animals.
    • b. Unintended environmental effects/potential impacts of synthetic microorganisms, plants and animals such as: bacteriophages, plant viruses, entomopathogens, bacterial or fungal colonizers, (e.g., rhizobia, other nitrogen-fixing bacteria, mycorrhizae), higher plants, mosquitoes, or rodents.
  • Risks to human health from novel biomolecules produced using metabolic or genetic pathways by organisms used as manufacturing bioreactors. Much work regarding toxicity and allergenicity of new protein domains relies on bioinformatics that use existing databases of known toxins and allergens. These databases, or the literature, do not apply to biomolecules made by synbio organisms. Methods and models are needed to determine potential physiological responses, such as:
    • a. Adverse responses, including protein toxicity/allergenicity, biosynthetically produced proteins, atypical nucleotides, or noncanonical amino acids (i.e., nonstandard amino acids and possibly other ligands),
    • b. Predictive toxicity motif detection in instances where noncanonical amino acids are incorporated into peptides/proteins,
    • c. Synbio microorganism colonization of the human microbiome.

More information, including the RFP, can be found on grants.gov.

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