FDA's New Food Safety Law - What Does It Mean for Everyone in the Global Food Chain?

Why Should You Attend:

On January 4, 2011, President Obama signed into law new food safety legislation entitled the FDA Food Safety Modernization Act (FSMA). The new law is intended to ensure the U.S food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it.

This law has many new things and takes a proactive approach rather than reactive and has 3 major categories. Improve capacity to prevent food safety problems, detect and respond to food safety problem and improve the safety of imported food.

Attend this webinar to understand how the 3 objectives of this law will affect food companies and those in the global food supply chain and how compliance with the new law can be achieved by understanding:

• How to prevent food safety problems
• How to respond to and handle food safety problems internally
• How to expedite the entry of imported food and how to assure FDA of the safety of imported food
• And in the event of a recall, how to work with the FDA

Areas Covered in the Webinar:

• Recordkeeping requirement
• Hazard analysis and risk-based preventive controls
• Performance standards
• Standards for produce
• Sanitary transportation of food
• Port shopping
• Targeting of inspection resources
• Laboratory accreditation
• Surveillance
• Foreign supplier verification
• Voluntary qualified importer program
• Inspection of foreign facilities
• Accreditation of third party auditors

Who Will Benefit:

• Food Manufacturers and Processors
• Produce Growers
• Importers
• Foreign Manufacturers and Processors
• Food Storage personnel
• Consultants to the Food Industry
• Food Science Persons
• Laboratory Analysts Associated with Food Analyses
• Food Retailers
• Food Scientists (Food Chemistry and Food Microbiologists)
• Suppliers to the Food Industry

Instructor Profile:

Sandra N. Whetstone is a former US Food and Drug Administration (FDA) executive with more than 35 years of experience as a US Food and Drug official and is a recognized expert in US Food and Drug Law, the Public Health Service Act and related statues. Her primary area of expertise is in the practical application of the US Food, Drug and Cosmetic Act, promulgating regulations under the acts, developing and implementing compliance programs for the FDA regulated industries, and developing enforcement strategies for effective compliance and consumer protection covering the full range of products under FDA’s jurisdiction.

In her most recent position as Director of the Division of Compliance Management and Operations, Office of Enforcement, Office of Regulatory Affairs, U.S. Food and Drug Administration, she provided strategic and policy leadership to a division staff with oversight over all of the Agency’s regulatory and administrative actions involving: pharmaceuticals (humans and veterinary), biologics, medical devices, food, including dietary supplements, and cosmetics. Ms. Whetstone was in the approval chain for all of the Agency’s compliance programs and policy documents. She directed the Agency’s recall operations and led a major reengineering of the Agency’s recall procedures. She has conducted numerous seminars for the industry as well as the states and other governments. She developed and conducted internal professional training for agency personnel to ensure consistent application of the laws and relevant scientific and technical standards.

Mrs. Whetstone spent the first part of her FDA career in the FDA’s Bureau of Foods (predecessor to the Center for Food safety and Applied Nutrition) where she served as an analytical chemist prior to moving into the area of regulatory affairs as a compliance officer. Her food experience includes serving as Director of the Program and Enforcement Branch in the Office of Seafood in FDAs Center for Food safety and Applied Nutrition, where she had oversight of the Agency’s seafood program including the Cooperative Shellfish Program. Ms. Whetstone's international experience regarding food import issues is extensive. She has conducted numerous visits to major food producing nations and trained commercial producers and government agencies on U.S. market requirements and regulatory standards. She directed and coordinated the development of numerous compliance programs for all segments of the food industry. She also represented the agency in many national and international forums.

Topic Background:

The new food safety legislation entitled the FDA Food Safety Modernization Act (FSMA) was signed in to law by President Obama on January 4, 2011. The new law is intended to ensure the U.S food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it.

The FDA Food Safety Modernization Act is an historic piece of legislation. First, it has been more than 70 years since the US food safety regime was overhauled top to bottom. Second, the new law calls for profound changes such as:

• Prevention of foodborne illness, not reaction to problems, is now the guiding principle of the new food safety law- with the primary responsibility for prevention resting squarely on the shoulders of food producers and processors.
• For the first time ever, FDA has an inspection mandate and new legal powers to ensure companies are meeting their prevention duties and to stop potentially unsafe food from entering the US market, not just removing it after the fact.
• Congress has made efficient, risk-based use of resources and partnership among government food safety agencies a part of the law.
• New importer accountability requirements are now a part of the law
• For the first time ever, FDA will have mandatory recall authority for all food products.

This law has three major categories which need to be followed by all food companies:

• Improving capacity to prevent food safety problems. The following areas will be covered: Records management and retention, registration of food facilities, hazard analysis and risk-based preventive controls, performance standards, protection against intentional adulteration, authority to collect fees, sanitary transportation of food, food allergy and anaphylaxis management and new dietary ingredients.
• Improving capacity to detect and respond to food safety problems. The following areas will be covered: Targeting of inspections for domestic and foreign facilities, and ports of entry; laboratory accreditation for analyses of foods; enhanced tracking and tracing of food and recordkeeping; surveillance; mandatory recall authority; administration detention of food; decontamination and disposal standards and plans; enhancing food safety and the reportable food registry.
• Improving the safety of imported food. Following areas will be covered: Foreign supplier verification requirements; voluntary qualified importer program; authority to require import certification for food; Prior notice requirements for imported food shipments; inspection of foreign food facilities; accreditation of third-party auditors and foreign offices of the Food and Drug Administration.

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