The power to "re-code" life carries significant ethical and safety responsibilities. Regulatory bodies like the FDA and EMA have established strict guidelines for the handling of recombinant organisms to prevent their accidental release into the environment—a concern known as "Biocontainment." In the laboratory, this is managed through Biosafety Levels (BSL 1-4), while in the field, it involves "Genetic Safeguards" such as engineering organisms that cannot survive without a specific laboratory-provided nutrient.

Ethical debates often center on the concept of "Germline Editing" and the potential for "Genetic Enhancement" rather than just disease treatment. The Recombinant DNA Technology Market industry analysis notes that public perception and varying international regulations (e.g., the strict GMO laws in Europe vs. more permissive ones in the US) significantly influence the commercialization of new rDNA products. To maintain public trust, developers must adhere to "Data Integrity" standards and provide transparent evidence of long-term safety for both human health and ecological stability.