The NIH Guidelines has specific requirements involving recombinant/synthetic nucleic acid molecules involving animals. This information can be found in Appendix Q.
Appendix Q specifies containment and confinement practices for research involving whole animals, both those in which the animal's genome has been altered by stable introduction of recombinant/synthetic nucleic acid molecules or into the germ-line (transgenic animals) and experiments involving viable recombinant or synthetic nucleic acid molecule-modified microorganisms tested on whole animals.
Appendix Q supersedes Appendix G (Physical Containment) when research animals are of a size or have growth requirements that preclude the use of containment for laboratory animals. The animals covered in Appendix Q are those species normally categorized as animals including but not limited to cattle, swine, sheep, goats, horses, and poultry.
Some animals may require other types of containment (see Appendix Q-III-D, Footnotes and References for Appendix Q). Other research with non-laboratory animals, which may not appropriately be conducted under conditions described in Appendix Q, may be conducted safely by applying practices routinely used for controlled culture of these biota.
For example, in BSL-1 aquatic systems, equivalent conditions could be met by utilizing tanks that provide adequate physical means to avoid the escape of the aquatic species, its gametes, and introduced exogenous genetic material. A mechanism would also be in place to prevent escape of the organisms or their gametes into the supply or discharge system of the container (e.g., tank, aquarium, etc.) Acceptable barriers include appropriate filtration, irradiation, heat treatment, chemical treatment, etc. Moreover, the top of the rearing container shall be covered to avoid escape of the organism and its gametes. In the event of tank rupture, leakage, or overflow, the construction of the room containing these tanks should prevent the organisms and gametes from entering the building's drains before the organism and its gametes have been inactivated.
Field research involving the animals covered in Appendix Q may require additional federal approvals by the USDA, EPA or FDA.