We previously reported that beginning May 11, 2016, California’s Office of Environmental Health Hazard Assessment (OEHHA) will start requiring warnings for consumer products containing BPA under the Safe Drinking Water and Toxic Enforcement Act of 1986 (also known as Proposition 65).  On March 17, 2016, OEHHA published two notices related to the BPA warning requirements. In the first notice, OEHHA proposes to establish a Proposition 65 Maximum Allowable Dose Level (MADL) or safe harbor level for BPA of 3 micrograms (μg) per day for dermal exposure from solid materials.  Comments on the dermal safe harbor level are due on May 16, 2016.

Separately, OEHHA proposes an emergency regulation to allow the temporary use of a standard point-of-sale warning message for BPA exposures from canned and bottled foods and beverages.  This would relieve manufacturers of the duty to provide warnings on product packaging for those products that must be labeled by May 11th. While a deadline for comments on the proposed warning message was not provided, under California’s Government Code section 11349.6, interested persons only have five calendar days to submit comments. As such, comments on the point-of-sale warning message are due on March 22, 2016.

This post summarizes the key components of the two notices. Click here to read more.

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Photo of Martin Hahn Martin Hahn

Partner, Washington, DC

Martin Hahn uses his background in food technology and his comprehensive understanding of the laws governing the food industry to navigate clients through the myriad regulatory and business issues impacting the industry from farm to table. He recognizes the demands placed on his clients and finds innovative and creative solutions, particularly when responding to observations raised by regulators  during inspections. Whether the issue involves obtaining the authorization of a new food or dietary ingredient, complying with manufacturing requirements, labeling or advertising, product recalls, or enforcement, Martin serves as an effective advisor and advocate.

Martin’s career has touched on almost every issue impacting the food industry. He has a comprehensive understanding of the laws affecting the labeling and advertising of foods, dietary supplements, infant formulas, medical foods, and foods for special dietary use. He helps clients anticipate new trends and develop the data that is needed to distinguish their products from others on the market. With his understanding of science and technology in the food industry, Martin provides assistance in obtaining regulatory authorizations to market new food ingredients, food packaging materials, and dietary ingredients. He also assists clients in responding to proposed regulations and draft guidance, as well as, tracks and keeps his clients apprised of the latest trends in class action law suits and helps clients anticipate new regulatory initiatives.

Martin grew up on a farm and worked in food processing plants before going to law school. His hands-on experience in the field and degree in food technology allow him to better understand the challenges his clients face in complying with the laws impacting food manufacturing. He understands Hazard Analysis Critical Control Point (HACCP) and the regulations under the Food Safety Modernization Act (FSMA).

Photo of Elizabeth Fawell Elizabeth Fawell

Partner, Washington, DC

Elizabeth Fawell navigates the detailed, and often complex, regulatory issues confronting food companies and helps them understand both the rules and various risks involved so that they can make informed business decisions. Elizabeth works with every segment of the food industry, including manufacturers, distributors, retailers, restaurants, and food service operators; and their trade associations.  Elizabeth’s work on behalf of food industry clients with the Food Safety Modernization Act (FSMA) since its inception and her understanding of Hazard Analysis Critical Control Point (HACCP) systems provides her with the experience and perspective needed as she counsels clients on how to comply with new requirements under the law. Elizabeth is a Preventive Controls Qualified Individual (PCQI) and has completed the FSPCA PCQI training.

Elizabeth knows how laws, regulations, and guidance documents are developed, interpreted, and enforced. Her extensive knowledge enables clients to prevent and respond to enforcement actions such as Warning Letters, Import Alerts, and agency investigations. She helps clients in determining whether an RFR is necessary and whether a recall is warranted. If so, she helps manage the recall to minimize business impacts. Elizabeth provides real-time advice during factory inspections, helps clients prepare 483 responses, and drafts inspection manuals. She also assists clients in lawfully and creatively promoting their products; such as the development of labels, claims, and website and promotional campaigns. Elizabeth also supports clients in advertising disputes and with responses to FTC and Attorney General investigations.

Elizabeth helps clients stay informed of and ahead of public policy issues and develops strategies for effective advocacy before regulators. She also counsels clients on compliance with Consumer Product Safety Commission (CPSC) safety standards, testing and certification requirements, and reporting obligations.

Elizabeth is a member of the Food and Dietary Supplements Committee of the Food and Drug Law Institute.

Photo of Xin Tao Xin Tao

Senior Associate, Washington, DC

With a working knowledge of regulatory requirements and a strong understanding of life science, Xin Tao works closely with clients in the food and drug industry to navigate the evolving federal and state regulatory environments and develop innovative regulatory strategies to commercialize products made with emerging technologies.  Xin’s background in life science (biochemistry and biophysics) assists him in his science-based food and drug law practices. Xin advises clients on food and drug law with a particular focus on novel food and dietary ingredients, biotechnology, FDA cGMP compliance, ingredient labeling, and California’s Proposition 65.  Xin’s unique ability in understanding and interpreting the complex scientific issues as they relate to the governing regulatory requirements helps clients with all phases of the product development, manufacturing, and marketing.  He is also increasingly expanding his expertise of USDA’s organic regulatory regime as it pertains to his clients.

Xin has helped numerous food, dietary supplement, and pharmaceutical companies evaluate the need for marketing approval from the U.S. Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and the Environmental Protection Agency (EPA). He also pursues clearance or pre-market approval (e.g., food additive petition, GRAS notice, NDI notification) when necessary and responds to FDA enforcement activities including Warning Letters and Import Alerts. Xin has advised numerous companies on issues relating to the advertising and promoting of products including the Federal Trade Commission (FTC)’s claim substantiation standards . Xin also has vast experience with FDA and USDA due diligence investigations for companies subject to takeover or merger activity.

Xin is very actively involved in a number of organizations that serve Chinese legal and life science professionals in the Washington region, including the Sino-American Pharmaceutical Professionals Association and Washington DC Chinese Legal Association.  Xin is a frequent speaker and contributor to industry publications both in the U.S. and China.  He is adept at assisting both Chinese food and drug companies doing business in the U.S. and U.S. clients doing business in China.

During law school, Xin worked as a regulatory food scientist and also served as an executive editor of the Georgetown Environmental Law Review.