New FDA Strategy Document for FSMA, Food Safety Modernization ACT

[author: Lee Smith]

The USDA has issued a new “strategy” document that outlines the agency’s direction with regard to implementing the Food Safety Modernization Act (“FSMA”).  The document is intended to “to guide the next phase of FSMA implementation by outlining broadly the drivers of change in FDA’s approach to food safety and the operational strategy for implementing that change.” The strategy includes agency internal changes as well as purporting to be a guide to the rules regarding food and feed facilities, produce safety and the new food import system.

The Appendix of the strategy ccontains the FDA Guiding Principles which are mostly set out below:

Inspection and Surveillance 

FDA 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. 

• 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
• Collecting data on compliance rates to evaluate program performance and plan future efforts

Administrative Compliance Tools 

FSMA’s public health prevention focus and new administrative enforcement tools mean that FDA’s primary tools for correcting preventive control deficiencies and resolving problems that put consumers at risk will be administrative compliance actions, rather than court enforcement cases, including:

• 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
• 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

Judicial Enforcement Tools  

Enforcement includes judicial actions when necessary to complement non-judicial compliance actions and address matters for which there is no adequate administrative remedy, such as:

• 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
• Criminal prosecution for falsifying records, lying to FDA, knowingly putting consumers at risk, or in other appropriate cases

Guiding Principles for Implementation of Produce Safety Standards

Effective implementation and oversight of produce safety standards poses distinct challenges for FDA due to the scale and diversity of the produce sector, the large number of produce farms, and their lack of familiarity with FDA regulatory oversight. Moreover, Congress envisioned a different role for FDA on produce farms compared to food facilities, as reflected in the lack of an inspection frequency mandate in FSMA for farms, the directive to coordinate education and enforcement activities with state and local officials , and the mandate to USDA to provide technical assistance grants to support implementation, especially for entities such as small growers.

Another reality shaping FDA’s approach to produce safety is that 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.

For this reason, 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.

In keeping with this broad vision for FSMA implementation, FDA will focus its efforts on:        

• Deploying a cadre of produce safety experts in headquarters and the field with the depth and breadth of capacity to develop the guidance needed to support implementation and provide technical support to government and industry parties working to foster compliance
• Actively supporting education and technical assistance for growers, primarily through collaboration with other public and private parties
• Supporting public and private parties involved in audits and other accountability functions with technical assistance and other collaborative support
• Conducting targeted on-farm surveys and inspections to understand current practices and identify gaps in compliance
• Taking administrative compliance and enforcement action when needed to correct problems that put consumers at risk
• Responding to produce outbreaks effectively to lessen impact on public health
• Conducting in-depth environmental assessments where appropriate to identify root causes of outbreaks associated with produce and inform future prevention efforts

Guiding Principles for Implementation of FSMA’s New Import System

FSMA provides FDA with a multi-faceted new tool kit for import oversight that is intended to ensure that imported foods are produced using modern preventive measures that achieve the same level of food safety protection as FSMA’s new preventive control and produce safety standards. FDA will use the new tool kit to build a prevention-oriented import system that provides much-heightened assurances about the safety of imported food.

Rather than relying primarily on FDA detecting and stopping food safety problems at the border, the new system relies primarily on importers providing documented assurances that their foreign suppliers have taken proper steps to prevent problems. To complement FDA’s oversight of importers, FSMA directs FDA to strengthen private audit systems, increase its overseas presence, and work in partnership with foreign governments to strengthen and capitalize on their capacity to help ensure the safety of food destined for the United States, all in keeping with the collaboration and leveraging elements of our operational strategy for FSMA implementation.

FDA will use all elements of the FSMA tool kit to provide the heightened assurances of food safety called for by Congress and expected by consumers in a manner that makes efficient use of FDA’s resources and leverages the resources and efforts of others.

Key features of FDA’s import implementation effort will include:

• Developing the skills, capacity, and processes to audit foreign supplier verification programs and hold importers accountable for effectively managing their supply chains in accordance with FSMA
• Reconfiguring current import screening and field exam activities to complement oversight of FSMA’s  foreign supplier verification requirement and ensure that FDA is making strategic, risk-based use of its import oversight resources
• Implementing the voluntary qualified importer program and other measures to expedite entries for good performers and thereby allow more resources to be directed toward high-risk imports
• Developing the skills, capacity, and processes to audit accrediting bodies and accredited third-party certifiers, with the goal of enhancing the rigor, objectivity, and transparency of private audits and their contribution to assuring the safety of imported food
• Developing the skills, capacity, and processes to conduct comparability assessments of foreign government regulatory systems as the basis for relying, where justified, on foreign oversight, minimizing duplication of effort, and improving risk-based resource allocation
• Building data integration and analysis systems and harnessing all available sources of relevant information to strengthen risk-based targeting of resources