“Most likely, the integrated approach is the best option, but we have some concerns,” she said. For one thing, she said that FDA shouldn’t list exempted commodities in the produce safety rule, “etched in regulatory stone.”
Instead, she said the FDA should consider naming exempted commodities in a guidance document, which she said could be more easily updated over time as warranted.
In particular, Klein said the Center for Science in the Public Interest believes some commodities shouldn’t be on the exempted list.
For example, she said kale has traditionally been cooked but new food trends see it being consumed raw. Other items that shouldn’t be exempt, she said, include potatoes and beets. It is not uncommon for beets to be cut up and consumed raw, and Klein said should not be exempt because outbreak data shows they are a significant source of cross contamination down the supply chain..
Other aspects of the produce safety rule that CSPI found wanting include qualified exemption for farmers, she said. Klein said FDA should make clear that inspectors will check records to ensure growers indeed are exempt. “FDA should state outright that failure to have records to confirm you are a qualified exemption creates the presumption you are not qualified,” she said.
Klein said that CSPI believes that growers at the very least should have a written hazard analysis. That’s not required by proposed produce safety rule. She said that requirement would make sure growers would consider hazards that confront their individual operations, and would provide FDA inspectors a roadmap to follow when checking compliance.
Another area where CSPI wants more clarification is the rule’s allowance for alternative methods in place of water testing and standards for use of compost, among other practices. She said the produce safety rule should have defined triggers for the withdrawal on the acceptability of the alternatives. “If the alternative is connected to a hazard or an outbreak, the alternative method should be disallowed,” she said.
The push and pull over the rule will heat up, as industry folks like Joel Nelsen will fight for their respective industries every step of the way to make the rule less burdensome. In other words, game on.