Assistance is given regarding the regulation by FDA, USDA and EPA of plants, animals, microorganisms, insects, fish and other organisms that are genetically altered through the use of conventional or modern genetic methods. Modern methods can include recombinant DNA, cell fusion and somatic cell nuclear transfer (SCNT) techniques involved in cloning. Help in evaluating the regulatory status of organisms developed through the use of these and other methods is also available. The organisms can be subject to regulation by FDA, USDA or EPA depending on the purpose of the changes and the genetic methods involved. Counsel is further given on the extent of EPA regulation under FIFRA or TSCA, and related registration, PMN, EUP, notification, MCAN, TERA, and tolerance or tolerance exemption requirements; or where USDA is involved, on regulation under the FPPA involving experimentation with or commercialization of plants or insects or other organisms that may be plant pests or noxious weeds in accordance with USDA's notification, permit, deregulation, and reporting requirements, including providing advice on NEPA assessment considerations and on responding to NEPA product challenges.

Assistance is provided in the area of animal biologics, including advice on their experimental authorization and commercial licensure requirements; on transgenic food plants for human food or animal feed use and FDA's consultation procedures; on transgenic plants or animals for the production of human pharmaceuticals; and on cloned or transgenic animals and their regulation under the new animal drug provisions of the FFDCA and under the Federal Animal Health Protection Act by USDA.

A significant part of the practice also focuses on adventitious presence issues associated with early field testing or with the commercialization of transgenic crops; or, otherwise, with product liability and governmental regulatory issues associated with the "escape" into the environment of transgenes from altered organisms. Advice on biotechnology coexistence issues with conventional or organic agriculture, including regarding the concepts of "zero tolerance" or de minimis presence, is also part of the practice.