Understanding the Food Safety Modernization Act
Marc C. Sanchez, Food Attorney
Since its passage last January the Food Safety Modernization Act (FSMA) slowly rolled out. Some provisions are already in effect, others come in the New Year, and the full Act will be in place in another two years. FSMA applies to a broad range of people in the food industry – including farmers. Here is a summary of what provisions are currently in effect and which can be expected to come into force over the next year.
FSMA applies broadly within the food industry with only one narrow exemption. There is a general exception for farmers. A farmer or facility may be exempt from some provisions of FSMA if they sell less than $500,000 gross sales (this includes any subsidiaries or affiliates) and more than half of the product sold is sold to ‘qualified end users,’ defined as consumers and restaurants or retailers either in-state or within 275 miles of the farm or facility. The FDA has authority to withdraw an exemption from a farm or facility associated with a foodborne illness outbreak.
It is also important to note that FSMA does not apply to meat, poultry or eggs. Those areas remain under the Meat Inspection Act and the review of the USDA.
What’s Already in Effect
The full implementation of FSMA will take three years, but some provisions took effect immediately. Most notably the FDA was given mandatory recall authority. Prior to this, with the exception of infant formula, the FDA has had to rely on food manufacturers and distributors to recall food voluntarily. Other notable provisions include increased inspections frequency, expanded records access, and export certification.
FSMA will likely increase the number of 483s and Warning Letters issued. The FDA issued a record number of 483 Inspectional Observations in 2010 with over 10,000 for the year. Increased inspections will include any factory, warehouse, or establishment that manufactures, processes, packs or holds food. Expect FSMA only to increase the number of 483s issued.
Facility registration took effect in the spring of 2010. FSMA requires all facilities to register with the FDA and update their registration every two years on even numbered years. This provision also gives FDA authority to suspend a facility’s registration if food is found to present a reasonable probability of causing serious adverse health consequences or death.
The registration and increased inspections will work hand-in-hand. The new legislation mandates the FDA target inspection resources to “high-risk” facilities, based on the known safety risks of the food, the compliance history of the facility, the rigor and effectiveness of the facility’s hazard analysis and risk-based preventive controls, and if the food or facility has meet certification requirements for imported food. This means past compliance performance and current practices will be under review.
In the fall the FDA issued new rules on fees as required under FSMA. FSMA gives the FDA authority to collect fees from the responsible party to cover reinspection-related costs from domestic registered facilities when the FDA conducts a follow-up inspection to determine that a previously identified noncompliance has been addressed. This provides an incentive to ensure compliance with FSMA during the first inspection in order to avoid additional fees.
Other fees also took effect this fall. The FDA can assess a fee for failure to initiate a recall as ordered, not conducting the recall in a manner specified, and/or not providing the FDA with requested documentation/information. A fee that will take shape this winter affects the reinspection for imports. There are at least four situations for which the FDA would assess fees for reinspections on imports.
The Year Ahead
There are several provisions that will take effect in the spring and summer of 2012. By the spring all registered facilities will be required to conduct a hazard analysis, implement preventive controls and develop a food safety plan to document the monitoring, correction, and verification of preventive controls. The food safety plan and all related documents must be made available to FDA during inspections. As part of its food safety plan, a facility may be required to document sanitation procedures, a recall plan, a food allergen control program, supplier verification activities, and environmental sampling testing.
Overall FSMA raises the standards required in hazard analysis plan and likely will require more frequent and more sophisticated environmental and finished product testing. Failure to submit a food safety plan to the FDA may place a facility on the ‘high-risk facility’ list.
The preventive controls requirements only apply to registered facilities. Under the current definition, farms, restaurants, and retail facilities are exempt from the registration requirement. A different definition of farm, however, applies to qualify for this exemption. It will be important for owners to consult the regulations to ensure their facility is exempt from the preventative controls requirements.
There are other definitions still taking shape under FSMA. The FDA must still develop regulations defining what constitutes ‘on-farm packing’, ‘holding, manufacturing,’ and ‘processing.’ Some facilities that are only engaged in specific types of on-farm manufacturing, processing, packing or holding activities that are determined to be low-risk may be exempt or subject to modified preventive controls requirements. FSMA is a complex area to navigate, but a proper understanding is vital to avoid penalties and reinspection costs.
Also in the spring the FDA will provide an update on protection against intentional adulteration. The FDA is conducting an assessment and will determine where mitigation strategies are necessary for protection against intentional adulteration. At the end of that assessment, likely in the late spring, the FDA will issue regulations that outline appropriate mitigation strategies at vulnerable points in the supply chain for food at high risk of intentional adulteration.
Early in the Nee Year the FDA will also publish a list of high-risk foods. The list is still tentative, but there is speculation that peanuts will be on the list because it is a common allergen. The FDA will develop regulations for additional record-keeping requirements for high-risk foods by next fall.
Farms will be exempt from the new recordkeeping requirements for high risk food if certain criteria provided for in the statute are met. FSMA provides FDA authority to request that farms identify immediate recipients, other than consumers, during an active investigation or when deemed necessary to protect public health. FSMA compliance requires an in-depth look at farm operations and regulatory requirements to ensure compliance and understand regulatory obligations.
Traceability, as will be explored in more detail, below will begin pilot programs this winter. Using the information gathered during the pilot, FDA is directed to create a product tracing system.
Also in the New Year look for produce safety standards. FSMA mandates the FDA establish standards for the safe production and harvesting of produce where the agency has determined that standards would minimize the risk of serious adverse health consequences. Look for a proposed rule on the minimum standards and an updated Good Agricultural Practices (GAP) early in the New Year. The standards should include science-based minimum standards related to soil amendments, hygiene, packaging, temperature controls, and animals in the growing area, water, and intentional and unintentional hazards.
Some provisions are set on an annual timetable. For example, at least every two years, the FDA is required to review and evaluate relevant data to determine which foodborne contaminates pose the greatest risk. Based on that review the FDA is directed to issue guidance documents and action levels. Registered facilities will need to verify that their preventive controls are adequate and effective to mitigate the hazards identified.
This is by no means an exhaustive review of FSMA. The legislation makes sweeping changes that affects every sector of the food chain. It’s important to take time to review the legislation and understand how it impacts operations.