More Money Needed to Fully Implement Food Safety Overhaul, FDA Says
The Food and Drug Administration has submitted to Congress a report on progress made and challenges faced in implementing the Food Safety Modernization Act. While the report indicates that the FDA has been hard at work to comply with FSMA mandates, it also states that the agency will need an additional $400-450 million “to make FSMA a fully successful initiative.” Congress added $100 million in the FDA budgets for fiscal years 2011 and 2012, which the report calls “a meaningful start.”
Among the issues discussed in the report are the following.
Standard Setting and Guidance. The FDA states that developing and implementing new prevention standards is its most critical activity in the initial phase of its implementation of FSMA because these standards will be the foundation upon which a new food safety system will be built. The three areas of focus are preventive control standards requiring food processors to identify potential hazards associated with their processes and prevent those hazards from occurring, specific risk-based standards for safe production and harvesting of produce that take account of the diversity of sizes and operations, and importer verification of the safety of foods from foreign suppliers.
In January, the FDA proposed the first two regulations that set science-based standards for preventing foodborne illness. In the near future it must also establish standards for the safe transportation of food and to prevent the intentional adulteration of food. The FDA states that in all areas of standard setting under FSMA it is “committed to adopting standards that provide flexibility in achieving the goal of prevention based on current knowledge of hazards and interventions, and that can accommodate new knowledge about how to improve food safety that will continue to emerge.”
Imports. The FDA states that it must implement “an entirely new paradigm for import oversight to succeed in ensuring the safety of food coming into the United States.” Imported food now comprises 15% of the total U.S. food supply, and food is imported from more than 110,000 manufacturers in more than 150 countries, “many of which are less developed nations without robust regulatory systems in place.” FSMA provides new authorities to the FDA in this area, including the authority to hold importers accountable for verifying that their foreign suppliers have adequate preventive controls in place to ensure that imported foods are as safe as those produced domestically.
The FDA notes that over the past decade it has taken significant steps to improve its oversight of imported food, including implementing a new risk-based analytics system (PREDICT) to improve screening and targeting at the border, establishing foreign offices in China, India, Latin America, Europe, the Middle East and Africa, and taking steps to develop joint planning and standard setting with other nations (e.g., a pilot comparability arrangement that has been negotiated with New Zealand).
FDA is now “well along” with a series of efforts under FSMA that will further transform the regulation of imports, including developing the Foreign Supplier Verification Program and creating a program through which accredited third parties can certify that foreign food facilities comply with U.S. food safety standards. However, “enforcement will be complicated and resource-intensive” and the FDA will need additional investments for “recruiting and training a cadre of staff to audit the Foreign Supplier Verification Program, to oversee the Voluntary Qualified Importer Program and the third-party accreditation process, and to develop the information systems that will support effective risk-based decision making.” The agency will also have to “make faster progress in capacity building and developing cooperative relationships with foreign counterparts,” “work with coalition partners to identify critical data elements needed to inform risk models and standardize the reporting of this information to allow for the seamless and automated flow of data,” “provide advanced training to current analytics experts as well as bring in new employees with significant analytical talent and experience,” and “make major improvements in its ability to allocate its resources based on risk,” including by expanding its investment in systems recognition arrangements with foreign governments.
Inspections and Compliance. FSMA requires (a) all domestic high-risk food firms to be inspected at least once in the first five years and at least once every three years thereafter, (b) all domestic non-high risk food firms to be inspected at least once in the first seven years and at least once every five years thereafter, and (c) at least 600 foreign food facility inspections in the first year, a number that is to be doubled every year through 2016, when no fewer than 19,200 inspections will be required.
The FDA expects to meet the first requirement within three years and in FY 2012 reached 1,200 foreign inspections. However, no significant increase in the latter number is expected in the foreseeable future because reaching the 2016 goal for foreign inspections “would require hundreds of millions of dollars in new funding, which the agency cannot realistically expect to receive.” Instead, the FDA believes that money would be better spent implementing the FSMA tool kit for imports, which will include the Foreign Supplier Verification Program, the Voluntary Qualified Importer Program, and expanded use of foreign inspection information.
The FDA states that implementing the modernized inspection and compliance program needed to implement FSMA will require a range of investments in training, capacity and infrastructure, including (a) a more data-driven, risk-based prioritization system for inspection and compliance activities, (b) enhanced, interoperable internal/external data systems, (c) training for FDA and state inspectors in preventive controls and the new systems and prevention-oriented approach to inspections and compliance, (d) stronger and more timely technical support for inspectors from FDA’s food safety experts, which requires expanding expert capacity at FDA headquarters and in the field, and (e) new information technology tools for inspectors, such as handheld inspection recording devices and “intelligent questionnaires” to shorten and promote consistency in the conduct of food facility inspections and inspection report writing.