FDA offers some insights into its strategy for implementing the next phase of the Food Safety Modernization Act (FSMA) in a guidance document posted on the agency’s website May 2. A key element of the agency’s operational strategy will be to rely heavily on the industry to implement preventive measures.
The agency says the industry needs to work in a continuous improvement mode and to manage operations and supply chains “in a manner that provides documented assurances that appropriate preventive measures are being implemented as a matter of routine practice every day.”
I would especially draw your attention to the appendix to the guidance, which details some of the ways the agency plans to implement FSMA’s provisions. FDA will vary its strategy for different types of food facilities. For food and animal feed facilities, for example, the agency says it will significantly expand its inspection and surveillance tools to include a wider range of inspection, sampling, testing, and other data collection activities conducted through its own field force and through collaboration with partner agencies and the food industry.
For these facilities, inspection and surveillance will include:
- Efficiently screening firms for food safety performance to guide risk-based inspection priority, frequency, depth, and approach;
- Providing firms incentives for compliance through enhanced presence in and targeted scrutiny of high-risk firms and products and reduced scrutiny of firms with records of demonstrated good performance;
- Assessing the compliance of individual firms through a range of inspection and sampling techniques used in a strategic, risk-based way to maximize coverage of priority sectors and firms;
- Making in-depth assessments of individual firms when needed to increase the incentive for compliance and determine the need for compliance or enforcement actions
- Collecting data to inform understanding and analysis of sector-wide hazards, practices, and preventive control deficiencies; and
- Collecting data on compliance rates to evaluate program performance and plan future efforts
The agency says its primary compliance tools will be administrative actions rather than court enforcement cases. The administrative actions will include:
- Voluntary correction of problems at the facility level, achieved immediately during the course of an inspection through communication with firm management by investigators and, as needed, Center technical staff;
- Voluntary correction achieved at the District level through deficiency letters, issued within days after an inspection with Center back up, to document significant safety-related deficiencies and request correction within a specified period, with immediate inspection follow up to verify correction;
- Administrative detention of product if needed to provide immediate public health protection or for other appropriate purposes;
- Voluntary and mandatory recalls to remove potentially hazardous food from the market; and
- Administrative suspension of registration when other administrative compliance measures have failed or are inadequate to achieve correction of significant deficiencies that put consumers at risk.
FDA’s judicial enforcement tools will include:
- Seizure actions that are needed to back up administrative detentions;
- Injunction actions when suspension of registration or other measures are inadequate to prevent future non-compliance; and
- Criminal prosecution for falsifying records, lying to FDA, knowingly putting consumers at risk, or in other appropriate cases.
A Different Approach for Produce
Implementation of FSMA’s produce safety standards will require a different approach, the agency says. Because of the scale and diversity of the produced sector, “there is no reasonable expectation FDA will have the resources to make routine on-farm inspection a major source of accountability for compliance with produce safety standards.”
So, the agency explains, “FDA’s implementation of produce safety standards will entail a broad, collaborative effort to foster awareness and compliance through guidance, education, and technical assistance, coupled with accountability for compliance from multiple public and private sources, including FDA and partner agencies, USDA audits, marketing agreements, and private audits required by commercial purchasers.”
A Strategy for Imports
For imported foods, the agency will rely primarily on “importers providing documented assurances that their foreign suppliers have taken proper steps to prevent problems.” The agency plans to build its skills and capacity and to focus on auditing foreign supplier verification programs and on holding importers accountable for managing their supply chains.
According to the Congressional Budget Office, FDA needed $1.4 billion through 2015 to fulfill FSMA requirements. But the agency’s budget for FSMA received only modest increases since the legislation’s enactment.
As examples, the Foreign Supplier Verification Program will require new staff and skills to audit and verify the adequacy of the importer’s verification plan; conduct more foreign inspections; work more on food safety with foreign governments to leverage their efforts; and improve the agency’s data and import systems to facilitate prompt entry of foods that meet U.S. safety standards.
FDA’s strategy relies on partnerships with state departments of agriculture, other state partners, and local, territorial, and tribal authorities to deliver the education, training and technical assistance, as well as compliance oversight, needed to ensure the rules are implemented properly. However, additional resources are required to build the capacity of these partners and provide the needed assistance to growers, especially small and mid-size operators.
This cannot be done unless FDA finds additional resources to build the capacity of its partners and provide the needed assistance to growers, especially small and mid-size operators. The current appropriations are insufficient to take advantage of these opportunities and meet the objectives of FSMA.