In the continuing series on the industry impacts of the Food Safety Modernization Act (FSMA), Dr. David Acheson focuses on the new requirements for foreign producers, new accountability for those importing food to the U.S., and the new tools available to FDA.
With FSMA reflecting and responding to the shift toward a global food supply, some of the most sweeping changes are related to imported foods, as FDA puts major new emphasis in this area.
On June 20, FDA revealed its strategy for imports, the “Pathway to Global Product Safety and Quality.” The plan outlines its strategy for addressing the increased complexity of the global supply chain. FDA emphasizes that under both the new import strategy and FSMA, importers will be held accountable for the safety of their products. FSMA requires that, for the first time, importers verify that the food they bring into the U.S. was produced in a manner consistent with U.S. laws and regulations. FDA acknowledges that it will need assistance through partnerships and coalitions to ensure information sharing and adequate oversight of the global supply chain.
Some may think this is not that new; that importers have always been required to assure imported foods met the requirements of the FD&C Act. While that is true, one key difference is verification—what will really drive change and potentially increase risk for importers and foreign firms who don’t understand the new requirements.
Foreign Grower/Producer Responsibility. Foreign food growers and producers wishing to export food to the U.S. will have to prove that they have produced the food in compliance with U.S. laws and regulations. Foreign growers will need to be in compliance with new produce safety standards that FDA will issue. FDA is required to publish a proposed rule by January 2012 that includes minimum standards for soil amendments, hygiene, packaging, temperature controls, animals in the growing area, and water.
Foreign producers will need to be in compliance with the HACCP provision. They will be required to have a food safety plan that outlines the hazards identified and preventive controls implemented, and document monitoring activities, corrective actions, and verification activities. FDA is also required to develop a regulation on appropriate mitigation strategies to protect against intentional adulteration. To the extent required by the Act, foreign facilities will need to implement mitigation strategies.
Because the Act also mandates increased FDA inspections, foreign food facilities will likely see inspectors on a more routine basis. But FDA does not have the resources to meet the foreign inspection mandate itself, so it will rely on partnerships with foreign governments and other U.S. government agencies for assistance.
Foreign growers and producers must be in compliance with all the new requirements, or they will not be able to export to the U.S. Foreign firms will face additional scrutiny (from regulators, importers, and third parties) to ensure they are meeting the new requirements. Failure to meet these will inhibit access to the U.S. market and erode consumer confidence in a brand.
Foreign growers and processors can prepare by becoming familiar with the new requirements, assessing their current programs, and working proactively to address any gaps before the requirements come into effect.
Importer Accountability. FSMA places increased accountability on the importer for ensuring that food imported to the U.S. is not adulterated or misbranded. Under the legislation, FDA is required to develop model standards and recognize a body to accredit third party certification bodies. Third party certification will be a crucial tool for importers as the new requirements come into effect.
The legislation creates a supplier verification program (to be in effect by January 2013) that will require the importer to verify that all imported product has been produced in compliance with U.S. laws and regulations. Third party certification will likely play a critical role in providing importers with assurance that facilities have conducted a hazard analysis, implemented preventive controls, documented their processes in the food safety plan, and are producing food that is not adulterated or misbranded. The supplier verification program reflects a significant shift of the burden of food safety to importers.
FSMA also authorizes FDA to create the Voluntary Qualified Importer Program (VQIP) incentive programs for importers who are able to demonstrate compliance. VQIP will provide expedited entry review for participating importers. Importer eligibility will be based on several factors, including the safety risks of the food, the regulatory capacity of the country of export, the importer’s compliance with supplier verification and preventive controls requirements, and the potential risk for intentional adulteration in the product. The program will require that food offered for import under the program be accompanied with a certificate. Third party certification will be a critical component of the VQIP process. FDA is authorized to charge a user fee to importers wishing to participate in the program, with the cost of participation yet to be determined. In his FY 2012 budget, President Obama requested authorization for FDA to collect $70,000,000 in user fees from the VQIP program.
These new programs will have a significant impact on importers and their customers. Importers must take responsibility for verifying the safety of food that they import into the country and must be able to have confidence in third party certification bodies to assist with certification of facilities and products. Importers can prepare by becoming familiar with the new requirements, evaluating their current programs, and developing strategies to address any potential gaps. Taking a proactive approach to food safety will position both producers and importers to be able to take advantage of VQIP and gain expedited access to U.S. markets.
New FDA Tools and Authorities. FSMA provides FDA with several new tools and authorities that will have an impact on importers. Upon the signing of the legislation, FDA was given the authority to require a mandatory recall if a firm fails to cooperate with a voluntary recall. FDA has already issued a new regulation on prior notice, requiring that refusal of a product from any other country be noted on a prior notice submission. The Agency has also issued a regulation that lowers the bar for using administrative detention authorities. As of July 4, 2011, FDA has the authority to revoke any facility’s registration status if it is determined to be producing food in a manner that presents a risk of causing serious adverse health consequences or death to humans or animals.
The legislation gives FDA authority to require import certifications for certain foods to certify that food has been processed in compliance with U.S. laws and regulations. Requirements for certification will be based on the known risks associated with the food or country, region, or territory of origin. To date, FDA has not utilized this authority.
In addition to new enforcement tools, FSMA gives FDA expanded authority to partner with other regulatory and public health agencies worldwide to help promote the safety of the food supply. FDA has finite resources, and given the current fiscal situation, will likely continue to face resource challenges. As a result, implementation of FSMA and oversight of the global supply chain will require partnerships and leveraging of all available resources. FDA is looking to utilize foreign governments, other U.S. government agencies, and private third parties to gain more information about the global food supply and support its oversight activities.
The new legislation requires the establishment of a third party certification program in which FDA uses external audits by recognized private entities or government bodies, to determine the compliance of foreign facilities with U.S. laws and regulations for importer-verification programs and VQIP eligibility. To provide certifications for FDA, private entities and foreign governments must meet established criteria demonstrating a sufficient food safety program that provides oversight comparable to that of FDA. FDA has stated it will build off its 2009 Guidance for Voluntary Third Party Certification of Food and Feed in developing the new program.
FSMA enables FDA to expand its laboratory capacity though accreditation of private labs that meet model standards it sets forth. By July 2013, all regulatory samples must be analyzed by an accredited laboratory. This will have the most immediate impact on laboratories undertaking testing for products on import alert, but may well expand in time to other regulatory testing.
As shown in the figure on page 12, FSMA creates a new structure for oversight of imported food that will change the way growers, producers, importers and regulatory officials interact and oversee the safety of the global supply chain.
Conclusion. With the implementation of the new legislation in the next year or two, there will be changes in the food safety landscape across the entire global supply chain. It is important that producers, importers, foreign governments, and private third party auditors and laboratories stay informed on the implementation of the new law and stay ahead of changes to ensure their positions as food safety leaders. By monitoring FDA updates, Federal Register notifications, and industry groups, companies will be able to identify opportunities to provide input and engage in the rule making process. The new legislation won’t change the food safety landscape overnight, but there is a unique opportunity for industry leaders to share best practices with FDA, participate in shaping the new regulations and guidance, and position themselves to have the solutions to the needs created by the new requirements.
Dr. David Acheson is Managing Director, Food and Import Safety Practice, at Leavitt Partners (www. leavittpartners.com). From 2002-2009, Dr. Acheson was with the U.S. Food and Drug Administration (FDA) in a variety of positions culminating as Associate Commissioner for Foods, prior to which he was active as an internist and in academia, with a specialization in foodborne illness. Dr. Acheson can be reached at firstname.lastname@example.org.