First, the statistics. At the time that President Obama signed the Food Safety Modernization Act (FSMA) into law in 2011, the United States imported about 15-20 percent of its domestic food supply, and as many as 70 percent of the food importers were small companies. Since FSMA was passed, the amount of food imported on an annual basis has increased more than 10 percent.
At the same time, numbers developed by the Centers for Disease Control and Prevention and cited by the Food and Drug Administration (FDA) indicate that 48 million people (one in six) get sick each year from foodborne illnesses and that 128,000 are hospitalized and 3,000 die from such illnesses. FDA believes that many of these cases of illness and death are preventable.
When one combines these illness numbers with the expanding market for food imports, the concern for safety becomes more pronounced. Current import rules generally only require that a foreign facility, where food is manufactured, processed, packed or held, be registered with FDA, that prior notice of the food import be provided to import officials, and that the product otherwise comply with U.S. laws, such as labeling laws. A gap can be created, though, where there is difficulty in effecting the monitoring and inspection of foreign facilities.
Accordingly, FSMA requires FDA to create several new food import programs. These include a verification program for importers to ensure that foreign suppliers have sufficient controls, a third-party certification program for foreign facilities to ensure compliance with U.S. laws, and a voluntary program to provide for expedited review and entry of food imports. In 2013, FDA began implementation of a Foreign Supplier Verification Program for importers and a rule on the accreditation of third-party auditors. Finalization of these programs is expected this year.
FDA has spent the summer further fleshing out the programs it is creating to implement FSMA’s import requirements.
In June, FDA published draft guidance on the Voluntary Qualified Importer Program. This voluntary program will create an expedited import review process for qualifying food importers. To qualify, importers will need to establish a quality assurance program that demonstrates a “high level of control over the safety and security of supply chains.” Foreign facilities where the food to be imported is manufactured, processed, packed or held must be accredited pursuant to the third-party certification program also being developed. Importers will also need to show that they have at least three years of experience importing food products and that there is no history of noncompliance with food safety regulations by either the importer or other entities in the supply chain. Importers pay a fee to participate and, in return, FDA will expedite entry into the U.S. for all foods included in the approved application.
In July, FDA proposed a rule creating user fees for the accreditation of third-party auditors. The accreditation program, originally proposed by FDA in 2013, is a program whereby FDA will recognize accreditation bodies, which will, in turn, accredit third-party auditors who are qualified to conduct food safety audits and issue food and facility certifications. The certifications issued by accredited auditors and certifying bodies then will be used by FDA to assist FDA in deciding whether to admit imported food into the country.
The fee proposal outlined by FDA in July provides for fees to be paid by accreditation bodies, as well as third-party auditors and certification bodies, when applying for and maintaining their relevant status with FDA. The fees are based on FDA’s analysis of costs and manpower associated with the review of various status determinations and range from about $35,000 for initial recognition of an accreditation body or direct accreditation of a third-party auditor or certifying body down to an annual fee of about $2,000 for a third-party auditor or certifying body accredited by an accreditation body (in addition to fees paid to the accreditation body).
Also in July, FDA issued a draft guidance document that establishes model standards on the qualifications for third-party auditors and certification bodies, which can include foreign governments or private companies that would conduct food safety audits of relevant facilities. This document was guided by, but will take precedence over, ISO/IEC standard 17021 on the requirements for bodies providing audit and certification management systems. Standards established by the rule include those relating to the education, training and competence of personnel, availability of resources and equipment to conduct audits, the ability to communicate with regulated companies and regulatory authorities, and the ability to identify and avoid conflicts of interest. The guidance even allows accreditation bodies to analyze the management capabilities and “skills, personal attributes and behaviors” of audit agents and managers. Auditors will then be required to submit reports of audited facilities to FDA and to the accreditation body.
So, after considering all of these new processes and controls, the question remains: Will our food supply be safer? FDA certainly thinks so. For instance, FDA has stated that “[p]articipation in the third-party accreditation program will facilitate food safety protections, benefit trade, improve efficiency of FDA oversight of imported foods, and increase efficiency and reduce costs for importers with a high level of control over the safety and security of their supply chains.”
The proposed import rules are consistent with FSMA’s heightened focus on prevention through identifying and correcting food safety risks throughout the supply chain. This increased scrutiny of process risks will have obvious positive impacts on food safety and hopefully help lead to increased transparency in the supply chain process. There are outstanding questions, though, regarding how the FSMA obligations will increase food costs on the consumer and how they will open up the chain of liability when something goes wrong. It is clear that these rules will impact agreements food companies have with their suppliers and customers, but the legal world is still trying to ascertain exactly what those impacts look like.
One thing that is for certain is that it will be years before these programs are fully implemented and incorporated into the business practices of food companies around the world. There is no question that there will be increased controls on food production and distribution, as well as increased opportunity to demonstrate and verify safe production and distribution practices. Just as important, there will also be increased opportunity under FSMA to hold food companies accountable. Hopefully, five years from now, I’ll be writing another article about how the new FSMA import programs have resulted in a significant decrease in those illness statistics with which I opened this one.
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