FFVA demands clarity on the Food Safety Modernization Act

FFVA has responded to the FDA’s call for comments on two rules proposed under the Food Safety Modernization Act – the Produce Rule and the Preventive Controls Rule.

In its comments submitted in November, FFVA pointed out problems in both proposed rules stemming from inaccurate assumptions and a lack of clarity, leading to proposals that would unnecessarily burden growers and food handlers.

“Much in the way of added expense will be thrust upon growers, as overall compliance costs for FSMA will be significant,” said Mike Aerts, FFVA director of membership and marketing, who drafted the comments with input from FFVA producer members.

FFVA thoroughly reviewed the rules and worked with members and other industry groups to develop a sound response for submission to FDA. Multiple producer member companies were involved in developing comments to ensure all commodity perspectives were represented and communicated accurately.

“There are issues that need clarification and further discussion, especially where some of the mitigation measures are based on inappropriate assumptions,” the comments state.

About 7,000 comments were reported to have been submitted. Many agriculture groups, including FFVA, anticipate significant revisions in the rules based on comments and have called on the FDA to publish the proposed rules again for additional comment once they have been revised.

The Produce Rule

The Produce Rule, formally known as Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption, prompted FFVA to emphasize that the safety of commodities grown in Florida has always been the driving issue for producer member companies.  The comments point out that Florida growers have followed the majority of the rule’s recommended practices for many years.

The comments explain that generalizations cannot be made in many areas, and some of FDA’s definitions are problematic. For example, the comments state that FDA’s declaration that “a farm mixed-type facility that washes covered produce not grown on that farm or another farm under the same ownership for distribution into commerce would be engaging in an activity outside the farm definition” does not make sense.  FFVA countered that fresh produce operations cannot be categorized by ownership and physical location, explaining the complexities resulting from leased land and other factors.

FFVA also questioned cost figures presented by FDA, saying that the agency cited outdated numbers. “For example, the $574 million in benefits appears to be an estimate that can’t be validated. The labor rates that the agency cited as a part of the calculations were already 10 years old,” the comments state. “Costs are much higher than what FDA is estimating…. and may actually be six-fold what FDA estimates. The cost/benefit impact assessment should be revised with more accuracy.”

Other problems are apparent with FDA’s definitions of terms such as “facility,” “commonly consumed,” “rarely consumed raw” and even “produce.”  FFVA also called for more clarity with regard to the terms “agricultural water” and “growing season.”

In addition, several pages of the association’s comments address the challenges associated with FDA’s proposed requirements for surface water testing.

Read FFVA’s comments on the Produce Rule here.

The Preventive Controls Rule

The comments also addressed concerns over the Preventive Controls Rule, known officially as the Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food.

View the Preventive Controls Rule here.

The general consensus was that the proposed standards must be targeted where they will make a practical difference. The comments reiterated many of the calls for clarity included in the comments regarding the Produce Rule.

FFVA offered a list of suggestions regarding language in the Preventive Controls proposed rule. A major concern was the definition of “facility” vs. “farm.” The comments urged that terms such as “facility” and “plant” be clarified, as well as “holding” and “storage.” They also assert that decomposition or spoilage is not a food safety issue and should not be included in a food safety act.

FFVA also suggested that FDA’s definition of a pest is far from being inclusive enough. “Animals and insects are but a small percentage of organisms that must be dealt with from a pest management standpoint,” the comments said.

FFVA also opposed the idea of exempting certain facilities simply because of their size or if they sell directly to consumers. “FSMA was intended to provide public assurance that FDA is providing the appropriate regulatory oversight of all fruits and vegetables. … We likewise oppose exemptions for certain farms simply because of size or amount of sales,” FFVA said.

The comments included a list of concerns regarding personnel, plants and grounds, sanitation and more.

In both sets of comments, FFVA acknowledged the need for a Produce Rule and a Preventive Controls Rule, but said the proposed rules need more refining. It emphasized the burden of additional costs for producers to comply with the rules. “Overall compliance costs for FSMA will be significant, and a major difficulty is that growers will have to absorb the costs of implementing these regulations. These additional FSMA costs cannot be passed on from producers to customers.”

“Much in the way of added expense will be thrust upon growers, as overall compliance costs for FSMA will be significant,” said Mike Aerts, FFVA director of membership and marketing, who drafted the comments.

FFVA urged FDA to publish the rules again for a second round of comments once they are revised based on comments the agency receives.

“Given the complexity of the Rule(s) and its potential impact on the industry, it is essential that the agency get it right,” FFVA said. “This is a phenomenal opportunity for FDA to allow the incorporation of sound science and information to dictate what is in the best interest of our nation’s fruit and vegetable producers and consumers.”


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