Galen D. Rende
Galen Rende counsels domestic and international clients on food and drug regulations, with an emphasis on food packaging and other types of food contact materials. He assists clients in establishing clearances under U.S. Food and Drug Administration (FDA) regulations as well as comparable regulating agencies in other countries around the world. He advises clients on a wide range of regulatory issues including good manufacturing practices, chemical risk assessment processes, and testing requirements.
Prior to joining Keller and Heckman, Galen worked at the American Chemistry Council (ACC) where he provided legal research and analytical support on emerging issues involving globally-manufactured chemistries, including EPA enforcement of the Toxic Substances Control Act (TSCA), Integrated Risk Information System (IRIS) Assessments, International Agency for Research on Cancer (IARC) Monographs, and legal claims brought by individuals and state Attorneys General.
Galen also worked as a Law Clerk for the Department of Justice, Environmental and Natural Resources Division, where he drafted pleadings, motions, and legal memoranda in actions brought under the Administrative Procedure Act (APA), National Environmental Policy Act (NEPA), and the Just Compensation Clause of the Fifth Amendment to the United States Constitution.
While in law school, Galen served on the executive board of the Maryland Moot Court Board and was a Staff Editor for the Maryland Law Review.
- Provided counsel and support in obtaining Food Contact Notifications (FCNs) for food contact substances from the U.S. Food and Drug Administration
- Assisted clients in the recycled plastics industry in obtaining letters of no objection (LNO) for their recycling processes from U.S. and Canadian regulatory bodies
- Performed regulatory review of food-contact materials to assess compliance with European Union and Chinese food-contact laws and regulations
- American Bar Association