WASHINGTON, D.C. – United Fresh Produce Association submitted comments to the FDA today on two of the proposed rules under the Food Safety and Modernization Act (FSMA), the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Safety Rule) and the Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (Preventive Controls Rule). United’s comments reflect 10 months of review by diverse expert working groups representing numerous member companies throughout the fresh produce supply chain.
“There is nothing more important than advancing food safety in fresh produce, and these proposed rules are an important milestone in that mission,” said United Fresh President & CEO Tom Stenzel. “United Fresh continues to support the public health goals of the FSMA law and is committed to working closely with the FDA to ensure that the regulations can be implemented in the most practical and efficient way possible.”
According to Dr. David Gombas, United Fresh senior vice president of food safety and technology, the association’s nearly 100 pages of comments are intended to give FDA the best real-world information about produce industry practices and how the proposed regulations can help enhance public health, without adding needless burdens that could drive producers and distributors out of business. “We want to ensure FDA establishes food safety provisions that reflect FSMA’s risk-based, scientific approach, recognizing the diversity of fruit and vegetable production,” Gombas said.
In its comments on both the Produce Safety Rule and the Preventive Controls Rule, the association raises several key issues:
One-Size-Fits-All Approach
While FDA has shown a willingness to recognize different risk profiles by proposing exemptions for thermally processed fruits and vegetables and certain commodities rarely consumed raw, FDA fails to take into account the potential for substantive differences in risks inherent in different produce commodities. By applying the same standards to all crops without allowing for commodity differences, FDA unnecessarily adds significant economic burdens on some producers with no impact on risk reduction. United recommends that FDA continue to require growers to manage the risks identified in the Produce Safety Rule, but to move all quantitative metrics into accompanying FDA Guidance documents. This has been a successful approach with the Seafood HACCP Rule, in which one regulation must cover a wide diversity of products.
Irrigation Water Testing Requirements
The Produce Safety Rule proposes specific arbitrary metrics, target organisms and testing intervals for irrigation water, which are not based on sound science and differ from other world regulatory standards. United’s comments communicate to FDA the scientific uncertainty underlying such requirements, and emphasize that the risks and appropriate standards for irrigation water differ significantly across different fruits and vegetables. Therefore, such metrics should be addressed in companion Guidance that can be tailored to specific commodities as needed, and updated when science is better informed.
Alternatives and Variances
FSMA anticipated that differences among commodities, growing regions and practices would require some flexibility in application of appropriate regulatory standards. While FDA attempts to address this need with sections proposing two specific avenues for “Alternatives” and “Variances” to the rule’s requirements, these opportunities are unnecessarily restricted and not likely to be effective as proposed. Alternatives are only offered as options to a few of the requirements for water and soil amendments, but are not available for all of those requirements or for any other risk factors identified (worker hygiene, equipment contact, and animal intrusion). The ability to submit a Variance to the proposed practices is limited to state or foreign governments. United’s comments recommend that both restrictions are unnecessary. Provided that they are supported by sound science, Alternatives should be allowed to requirements for any of the risk factors, and Variances should be accepted from any knowledgeable body such as associations and commodity boards.
Definition of Farm and Farming Activities
The two proposed rules include a new regulatory term, “farm mixed-type facility,” designating operations that would have to comply with both the Produce Safety and Preventive Controls rules. United believes that this designation is overly complicated and not risk-based, and would have severe economic consequences to raw produce handling operations without enhancing public safety. FDA has inadvertently grouped very low risk produce packing and handling facilities together with food processing facilities, which require very different food safety practices. United recommends that packing and holding raw, intact fresh produce is covered adequately by compliance with the Produce Safety rule, regardless of the size of the operation, the owners of the produce handled or the distance from where the produce was grown.
Request for Revised Proposed Rule
United is aware that FDA has already received and will receive many substantive comments to these proposed rules urging significant changes and enhancements. Therefore, United strongly supports the recommendation of the National Association of State Departments of Agriculture that FDA publish a second round of proposed rules so that all stakeholders can review and comment on these changes before they are finalized.
“United appreciates the extensive work that FDA has put into drafting these new proposed regulations, representing the most significant change to food safety law in more than 70 years,” Stenzel said. “That’s why it’s so important that the agency take the time to understand not only our comments but those of all stakeholders. These proposals were a good first step, but can be significantly enhanced to be more effective in protecting public health, while allowing produce growers and distributors to continue providing an abundance of healthy and affordable fresh produce to consumers.”
To read United’s complete comments on the Produce Safety Rule and Preventive Controls Rule, visit the United Fresh website at www.unitedfresh.org/fsma.
Founded in 1904, the United Fresh Produce Association serves companies at the forefront of the global fresh and fresh-cut produce industry, including growers, shippers, fresh-cut processors, wholesalers, distributors, retailers, foodservice operators, industry suppliers and allied associations. From its headquarters in Washington, D.C. and Western Regional office in Salinas, Calif., United Fresh and its members work year-round to make a difference for the produce industry by driving policies that increase consumption of fresh produce, shaping critical legislative and regulatory action, providing scientific and technical leadership in food safety, quality assurance, nutrition and health, and developing educational programs and business opportunities to assist member companies in growing successful businesses. For more information, visit www.unitedfresh.org or call 202-303-3400.
Source: United Fresh Produce Association
