'one size fits all approach', one of the concerns

United Fresh submits comments to FDA about foreign supplier rule

United Fresh submitted comments to the FDA last week 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 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 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 United raises several key issues:

One-Size-Fits-All Approach
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.

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.

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.

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.

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.

If you have questions, please contact
Dr. David Gombas
United Fresh
+1 202-303-3411
Email: dgombas@unitedfresh.org
Robert Guenther
United Fresh
+1 202-303-3409
Email: rguenther@unitedfresh.org


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