Natalie Rainer, J.D., M.P.H. is a Partner and a Member of K&L Gates LLP's Health Care and FDA practice. She focuses her practice primarily in the food and beverage industry. Natalie practices food and drug law, advising clients on regulatory requirements for foods, dietary supplements, cosmetics, and food and drug packaging in jurisdictions around the world, including North America, Latin America, Europe, Asia, and the Middle East.

Natalie has in-depth experience in evaluating the regulatory status of food additives, color additives, and food contact materials. She counsels companies on advertising and labeling requirements, including claim substantiation, nutrition labeling, menu labeling, and environmental claims. She also provides guidance regarding compliance with U.S. Department of Agriculture (USDA) regulations, including the Bioengineered Labeling rules, organic rules, and regulations related to additives in meat and poultry products. 

Natalie holds a J.D. from Georgetown University, an M.P.H. degree from the Johns Hopkins University Bloomberg School of Public Health, and a B.A. degree from the University of California–Berkeley.

Peter Coneski, Ph.D. is a Senior Scientific Advisor in K&L Gates LLP's Health Care and FDA practice. He provides technical assistance in evaluating the regulatory compliance of food additives and food contact materials in the U.S. and other jurisdictions. He also develops strategic testing plans and protocols for analytical data acquisition that support industry filings to regulatory agencies globally. In addition to his work related to food additives and food packaging materials, Peter advises clients on global sustainability initiatives, Extended Producer Responsibility schemes, and compliance with emerging legislations impacting companies operating in a global marketplace. 

Peter also has an extensive research background, authoring numerous peer-reviewed publications and holding several patents related to his work. He was granted an American Society for Engineering Education Postdoctoral Fellowship at the U.S. Naval Research Laboratory, where he focused on the development and characterization of novel, high-performance polymeric and composite materials. While earning his Ph.D., he developed absorbable and persistent polymer with enhanced biocompatibility for use as implantable biomaterials.  

Peter holds a Ph.D. and a master's degree from the University of North Carolina at Chapel Hill, and a B.S. degree from Clarkson University.

In this episode of Food Safety Matters, we speak with Ms. Rainer and Dr. Coneski [30:07] about:

• The growing understanding of the health effects of dietary exposure to chemicals migrating from packaging to food
• How concerns about chemical contaminants and environmental contaminants are shaping food safety policy and regulations
• Technical challenges producers face when attempting to reduce chemical usage in food packaging
• Impacts on the sustainability and composability of packaging stemming from producers’ efforts to adapt to regulatory developments and shifting attitudes about chemicals in packaging
• How the federal government is reacting to emerging Extended Producer Responsibility (EPR) programs that vary by state
• The challenge that producers face in assuring the quality and safety of packaged food while maintaining compliance with regulations and adhering to various state EPR requirements
• The wave of state legislative efforts to regulate food chemicals following the California Food Safety Act, and how an emerging patchwork of state regulations could impact processors’ ability to meet regulatory requirements for all markets
• Whether the U.S. Food and Drug Administration’s (FDA’s) enhanced, systematic process for the post-market safety assessment of chemicals in food could lead to better state-federal cooperation on food chemical regulation
• Thoughts on the prioritization of food chemical safety under FDA’s reorganized Human Foods Program and whether it will be successful in the near-term and long-term, in light of the new presidential administration.

News and Resources

News

FDA, CDC Ordered to Temporarily Pause All External Communications, Obtain Trump Admin Approval [4:32]

USDA Inspector General Phyllis Fong Dismissed by Trump Administration [6:41]

Dr. Sara Brenner Appointed FDA Acting Commissioner as Trump Nominee Awaits Senate Confirmation [7:31]

Scientists Seek to Develop Improved Tests for Norovirus, Hepatitis A on Berries, Leafy Greens [16:47]

FAO/WHO Developing Risk Assessment Models for Listeria in Four Food Commodity Groups [20:37]

EU Regulation Limits PFAS in Food Packaging, Bans Single-Use Plastic Packaging for Produce [25:07]

Resources

The Association of Food and Drug Officials (AFDO) Furlough

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