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Daniel Rubenstein is a member of Keller and Heckman’s Food and Drug Practice Group. Mr. Rubenstein assists companies, organizations and trade associations in establishing compliance with regulatory requirements for food packaging materials and food ingredients throughout the United States, European Union (EU), Asia and South America (MERCOSUR).
Leveraging his background and experience as an Industrial Engineer, Mr. Rubenstein appreciates both the technical and legal aspects of the challenges faced by industry in navigating the complex regulatory systems in place across the world. In this regard, Mr. Rubenstein has assisted clients in establishing a suitable U.S. Food and Drug Administration (FDA) status, and exemption from premarket review, for a variety of food-contact materials, and has successfully filed numerous Food Contact Notifications (FCNs) with FDA for new and innovative polymers, additives, and processing aids used in the manufacture of food-contact articles. In addition, Mr. Rubenstein advises clients regarding the suitable status of food-contact materials under the EU Framework Regulation, and the Plastics Regulation (EU) No. 10/2011.
Mr. Rubenstein also assists clients with a variety of animal feed assessments, and frequently supports Keller and Heckman’s scientific staff in the preparation of self-determined Generally Recognized as Safe (GRAS) positions for various substances used as processing aids in water treatment and ethanol production facilities that may carry-over as a component of distiller's dried grains with solubles (DDGS) used as feed for livestock.
As a former supply chain analyst for a Pittsburgh, Pennsylvania-based medical device manufacturer, Mr. Rubenstein has experience in process optimization, inventory control, facility layout and good manufacturing practice (GMP) in FDA-regulated facilities. Mr. Rubenstein uses this experience to assist clients in developing strategies to prevent and, when necessary, respond to contamination and “accidental additive” situations that arise during the manufacturing and transportation of food-contact materials. Mr. Rubenstein also proactively advises clients regarding quality control and internal auditing strategies, and conducts in-depth analyses of manufacturing processes and Standard Operating Procedures (SOPs) for FDA-compliance purposes.
Mr. Rubenstein has previously been featured in the American Bar Association's The Health Lawyer, as well as the University of Maryland's Journal of Health Care Law and Policy. Mr. Rubenstein’s publications have also been awarded by the Washington Bar Association and the Maryland State Bar Association. Mr. Rubenstein is a member of the Institute of Industrial and Systems Engineers (IISE) and the Maryland Program for Mediator Excellence (MPME).
American Bar Association Maryland State Bar Association Maryland Program for Mediator ExcellenceInst. of Industrial and Systems Engineers
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