By Stephen F. Sundlof, D.V.M., Ph.D. and Edward A. Steele
WASHINGTON — The Food Safety Modernization Act (FSMA) is the most sweeping reform of the U.S. Food and Drug Administration’s (FDA) food-safety authority in more than 70 years. It gives FDA expansive new powers to regulate the food industry and requires substantial changes in the way manufacturers and importers must produce, document, and verify their products comply with the new law.
Although FMSA was signed into law on January 4, 2011, its impact on the food industry has yet to be felt because the regulations needed to implement the law have not been published. This has caused uncertainty and concern within the food industry.
But many insiders predict some of the most important proposed regulations will issue soon after the November 6, 2012 presidential election. Among these regulations are the requirement for preventive controls to minimize food-safety problems, and verification that foreign suppliers have produced food in accordance with the new food-safety law.
The preventive controls regulations will require food facilities to:
· Identify and evaluate the hazards that could affect food manufactured, processed, packed, or held by such facility
· Identify and implement preventive controls to avert or minimize any such hazards
· Monitor the performance of those controls and verify they are working
· Establish procedures for corrective actions should preventive controls fail
· Maintain records of such monitoring
· Re-evaluate hazards every three years
· Provide FDA with a written food-safety plan and related records during an inspection
Once the preventive controls regulations are issued, firms will have only a short period of time to implement the new requirements. Facilities inspected by FDA and found to be without proper preventive controls can be prohibited from operating until adequate preventive controls are in place. Even if a firm has implemented adequate preventive control in its facilities, it must ensure its ingredient suppliers have taken similar measures or face potential shortages and market disruptions.
Foreign Supplier Verification Program
Of particular concern is a new requirement that importers must verify their foreign suppliers produce food at the same level of public health protection as required by domestic producers. Essentially, importers must be able to demonstrate imported food was produced under the same or equivalent conditions mandated in the Food Drug and Cosmetic Act, including the new provisions such as preventive controls.
Importers can verify the supplier complies with the Foreign Supplier Verification Program (FSVP) by monitoring records for shipments, lot-by-lot certifications of compliance, annual on-site inspections, checking the hazard analysis and risk-based preventive control plans, and periodically sampling and testing shipments.
In addition, FDA can require that certain imported foods and ingredients it has determined pose a safety risk must be accompanied by an Import Certification. In determining whether an import certificate is required, FDA can consider the known safety risks associated with the food; the known food-safety risks associated with the country, territory, or region of origin of the food; or whether the food-safety programs, systems, and standards in the country of origin of the food are inadequate to ensure the article of food is as safe as a similar food that is produced in the United States.
The certifying official can be an agency or a representative of the government of the country from which the food originated, or an independent third party accredited to provide such certification or assurance. Sourcing products from countries with weak food-safety laws and inspection programs may prove to be difficult, and it is likely many products that currently enter freely into the U.S. will not be able to meet the rigorous demands that would qualify them for the certification program. Food companies should evaluate their supply chains to ensure any imported products will comply with the FSVP or import certification requirements before the new regulations take effect, or risk market disruptions.
For most FDA-registered food facilities, the pending FSMA regulations will require significant changes to their processes and systems. Fortunately, help is available in the form of training, education and expert consultation. However, the changes required will take time so companies should not wait until the last minute to begin the transformation process.
Editor's Note: The authors will explore these issues further on Tuesday, Nov. 6 during SupplySide West in Las Vegas.
Dr. Stephen Sundlof was the Director of the FDA Center for Veterinary Medicine from 1994-2008 and the Director of the FDA Center for Food Safety and Applied Nutrition from 2008-2009. He is currently an Expert Consultant with EAS Consulting Group, LLC. EAS specializes in FDA regulatory consulting, training and auditing matters. Mr. Edward Steele had a 30-year career with FDA before becoming a consultant to the industries regulated by FDA. He held various management positions at the Center for Food Safety and Applied Nutrition, including Director of Compliance Programs, Office of Compliance; Director of Executive Operations Staff, Office of the Center Director; and Division Director, Office of Seafood. He was the Vice President of AAC Consulting Group/Kendle International before founding EAS Consulting Group, LLC in 2006 where he is currently the Chairman & CEO.
Mr. Edward Steele had a 30-year career with FDA before becoming a consultant to the industries regulated by FDA. He held various management positions at the Center for Food Safety and Applied Nutrition, including Director of Compliance Programs, Office of Compliance; Director of Executive Operations Staff, Office of the Center Director; and Division Director, Office of Seafood. He was the Vice President of AAC Consulting Group/Kendle International before founding EAS Consulting Group, LLC in 2006 where he is currently the Chairman & CEO.