P. L. PRATT (1); (1) MillerCoors LLC, Golden, CO, U.S.A.

Regulations and Guidelines
Wednesday, June 4 - 1:00 p.m.-2:45 p.m.
Level 4, Red Lacquer Ballroom

The Food Safety Modernization Act (FSMA) was approved by the United States Congress in December 2010 and passed into law in January 2011. It aims to ensure that the U.S. food supply is safe by shifting the focus of the Food and Drug Administration (FDA) from responding to food adulteration to proactively preventing foodborne illnesses. FSMA enforces requirements on both domestic and foreign food entities across the entire domestic food supply chain. It broadens the FDA’s authority to not only regulate food facilities but require the implementation and execution of comprehensive, science-based preventive controls. Although the U.S. brewing industry is under the jurisdiction of the Alcohol and Tobacco, Tax and Trade Bureau (TTB) and fermented beverages are considered to be low risk products, the industry should not be complacent in its approach to implementing effective food safety programs. In point of fact, six of the seven recently published FSMA proposed rules apply to the brewing industry. These six proposed rules are 1) produce safety; 2) current good manufacturing practices and hazard analysis and risk-based preventive controls for human food; 3) foreign supplier verification programs (FSVP) for importers of food for humans and animals; 4) current good manufacturing practice and hazard analysis and risk-based preventive controls for food for animals; 5) focused mitigation strategies to protect food against intentional adulteration; and 6) sanitary transportation of human and animal food. This paper examines the emerging roles of these six FSMA proposed rules and assesses the consequences of these rules, as they are currently written, on the brewing industry.

Patricia L. Pratt received her Ph.D. degree in biochemistry and microbiology from Heriot-Watt University, Edinburgh, Scotland. Her brewing career commenced in 1993 at Heineken International, where she held numerous leadership positions. She is currently employed with MillerCoors LLC, Golden, CO, in the Corporate Brewing, Research, Innovation and Quality Division. One of her responsibilities includes food safety and regulatory compliance. She serves as a member of the Advisory Board for Brewery Analytes Proficiency Scheme (BAPS) U.K. and MBAA Food Safety Committee.

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