Unresolved Issues
McEntire points out that the Produce Safety rule contains a couple of points that have not yet been resolved, the first having to do with water testing protocols, including the use of antimicrobials in washwater. She explains that many facilities have been using antimicrobials, but questions remain about how much to use and how frequently. “You have to show historical practice works, with evidence from science. You may feel like you’re doing the right thing, but you have to prove it. So there’s been an uptick in research to understand what happens in different situations.”
The FDA is also working with industry groups to reconsider the rules for water testing on farms. The goal is to offer more flexibility on how the goal of clean water can be achieved, since a one-size-fits-all approach does not work for all commodities, environments, or growing conditions. The compliance dates for water testing have been extended due to these ongoing concerns and discussion.
The second unresolved issue has to do with the boundaries between the Produce Safety and Preventive Controls rules. If the packing is done on the farm, the activity falls under the Produce Safety rule; if it’s done by a separate packer, it’s governed by the Preventive Controls rule.
“Functionally, you’re doing the same thing and the risks and hazards are identical,” McEntire contends. “Both rules get you to the same end of food safety, but their approaches are very different.”
Compliance with the Preventive Controls rule allows for subjectivity and flexibility, while the Produce Safety procedures are more prescriptive. “We get the question from our members, ‘If we’re doing the same thing as the guy next door, why are the rules so different?’” McEntire says the industry is working with the FDA to resolve the discrepancy and is optimistic the issue can be resolved by the January 2018 compliance deadline.
Rule #4
Foreign Supplier Verification Program
Primarily affects: Importers
Final rule effective date: January 26, 2016
Compliance deadline rollout: general: May 30, 2017 through July 26, 2017; small businesses: March 19, 2018 through July 29, 2019; very small businesses: March 18, 2019 through July 27, 2020 (importers working with raw produce packing and holding facilities have an additional 16 months to match the Produce Safety deadlines).
Requirements: Places liability on importers to ensure that foreign suppliers comply with either the Preventive Controls for Human Food or the Produce Safety rule.
Exemptions or modified requirements: Importers with less than $1 million in annual food sales, or those working with very small growers with $25,000 or less in annual sales.
