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Although still in the phase 1 rulemaking stage of implementing the Food Safety Modernization Act (FSMA), the Food and Drug Administration is planning for moving forward with “phase 2” which will involve training and compliance activities.

FDA Deputy Director for Regulatory Affairs, Roberta Wagner, discussed the agency’s current thinking about how it will tackle the next implementation phase, in an August 26 webinar sponsored by the Food Safety Preventive Controls Alliance (FSPCA). FSPCA is a collaborative program of the Illinois Institute of Technology, industry, academic and government stakeholders which is developing a core curriculum, training and outreach programs for companies producing human and animal food in compliance with FSMA’s preventive control provisions.

A similar presentation, sponsored by the Produce Safety Alliance (PSA), was made in early July by Kathy Gombas, who has the lead role for FSMA change management in FDA’s Center for Food Safety and Applied Nutrition (CFSAN). PSA is a collaborative project between Cornell University, USDA and FDA that will provide training and education on current best practices and guidance, and on the regulatory requirements for produce.

In Phase 2, FDA will be investing in regulatory training to promote consistent inspections. Because not every inspector will be an expert in the products being inspected in every establishment, inspectors will have access to subject matter experts in FDA headquarters who can answer questions that arise. The inspectors will be assessing a company’s “food safety culture” which will determine what approach the agency will take with that facility, using a risk-based approach, the FDA officials explained

FDA plans to facilitate industry implementation of preventive practices by expanding its oversight toolkit to encourage voluntary compliance. This expanded toolkit will include:

  • Commodity and sector-specific guidance;
  • Education, outreach and technical assistance;
  • Regulatory incentives for compliance.

So, a company’s food safety culture will guide FDA’s regulatory approach, using targeted, risk-based inspection models. In addition, the agency will be conducting more sampling, although the sampling will focus on fewer commodities, the agency says.

FDA expects to “educate before regulating,” providing technical assistance and considering work performed by public-private partners. For produce, for example, it plans to conduct targeted on-farm surveys and inspections and to “deploy a cadre of specialized produce safety experts for on-farm activities, to encourage voluntary compliance.”

For Phase 2, the agency has created a steering committee that oversees three workgroups: on Preventive Controls in Food and Feed Facilities, Produce Safety Standards, and Import Oversight. In addition, it plans to set up a Regulator Technical Assistance Call Center, to allow for inquiries and responses while inspectors are at the inspection sites.

The agency also plans to continue stakeholder engagement and to work with multiple partners to foster industry understanding of final rules/guidance and to facilitate high rates of voluntary compliance.

The FSPCA is developing a training curriculum consistent with FSMA. This curriculum will be publicly available when the final preventive controls rule is published. The Produce Safety Alliance is also developing a training curriculum and expects to be in the train-the-trainer phase in the fall or early winter.

Training and education are key to the success of FSMA, not only for the regulated industry but for the FDA regulators who are charged with inspections and enforcement of the sweeping new rules. There is concern within the food industry that the FDA will not be prepared when the final rules take effect leading to inconsistent interpretation and enforcement of the law. Just as the industry is required to employ “qualified individuals” to oversee food safety plans, it has been suggested that the FDA require inspectors to be “qualified” through formal training before performing compliance activities under FSMA.

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