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FDA Food Safety Strategy Includes Import Oversight, Compliance Incentives

Wednesday, May 07, 2014
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration released May 2 a document outlining an operational strategy for implementing the changes in the FDA’s approach to food safety that were mandated and empowered by the Food Safety Modernization Act. This document also includes guiding principles for how this strategy can be implemented with respect to food and feed facilities, produce safety standards and import oversight. It will guide the work of teams responsible for developing the specific strategies, capacity building, training and operational plans needed to implement FSMA in these areas. It also provides the basis for dialogue with FDA’s government partners and other stakeholders concerning implementation of the FSMA rules.

Operational Strategy Elements

- FDA’s primary focus will be reducing the risk of foodborne illness by fostering broad, consistent industry implementation of modern preventive practices.

- FDA will focus its industry oversight efforts on using a broad array of tools to ensure that firms are consistently implementing effective prevention systems that protect food safety within their operations and through their supply chains. While this will include developing legally sufficient evidence to prove specific rule violations when judicial enforcement is the right remedy, FDA will focus primarily on assessing whether systems are working effectively to prevent problems and on taking immediate action to protect public health through voluntary corrective action or a range of administrative remedies. 

- FDA will work to create an integrated global food safety network that includes partner agencies (federal, state, local, tribal, territorial and foreign), international organizations, the food industry, growers, academic experts and consumers.

- FDA will build robust data integration and analysis systems and information sharing mechanisms to support active operational partnership and foster mutual reliance with trusted partners.

- FDA will use an expanded oversight tool kit that includes both traditional and new tools, such as commodity- and sector-specific guidance on implementation of prevention-oriented standards; education and outreach to industry to ensure expectations and requirements are understood; technical assistance to facilitate compliance (especially by small and mid-size operators); regulatory incentives for compliance such as less frequent or intense inspection for good performers; reliable third-party audits to verify compliance; public education, transparency and publicity to promote compliance and prevention; and modernized approaches to inspection and enforcement.

- FDA will expand the skills and capacities of its scientific, technical and operational staff, change its internal operational practices to enable quick decisions and immediate action when needed to protect public health, work more closely with partner agencies to coordinate compliance and enforcement efforts, change its resource planning and deployment to ensure resources are used optimally in a flexible, risk-based, and efficient manner, and improve the quality and quantity of data used to fully evaluate and make the most informed, risk-based decisions.

Guiding Principles for Implementing the Strategy

Food and Feed Facilities

- Implementation of FSMA’s preventive controls mandate in food and feed facilities will build on FDA’s experience implementing Hazard Analysis Critical Control Point in seafood and juice processing operations, specifically FDA’s familiar roles in issuing rules and guidance and conducting inspections to assess and enforce compliance. Implementation of preventive controls must differ, however, due to the much larger number and diversity of covered facilities, FSMA’s new records access and administrative enforcement tools, and FDA’s commitment to the expanded tool kit for strategic and risk-based industry oversight outlined in the operational strategy.   

- 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. Among other things, FDA will provide 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.

- FDA’s primary tools for correcting preventive control deficiencies and resolving problems that put consumers at risk will be administrative compliance actions, including voluntary correction of problems at the facility level, voluntary correction achieved at the district level, administrative detention of product if needed, voluntary and mandatory recalls, and administrative suspension of registration when other measures have failed or are inadequate to achieve correction of significant deficiencies that put consumers at risk.

- Enforcement also includes judicial actions when necessary, including seizures to back up administrative detentions, injunctions 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.

Produce Safety Standards

- 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.

- FDA will focus its efforts on deploying a cadre of produce safety experts in headquarters and the field 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, 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, responding to produce outbreaks effectively, and conducting in-depth environmental assessments to identify root causes of outbreaks.


Import System

Key features of FDA’s effort to implement a prevention-oriented import system include the following.

- 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 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

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