Comment period passes for supplemental FSMA rules
The December 15 deadline for comments on the Food Safety Modernization Act supplemental language for the produce safety and preventive control rules has expired, with produce organizations submitting their official views on the changes to FDA.
“Our main priority is to assure that when these regulations are finalized and implemented they will best serve public health and our industry’s food safety needs,” said Jim Gorny, vice president of food safety and technology for the Produce Marketing Association (PMA). “These proposed FSMA rules will have profound business implications on every aspect of the global produce supply chain – they have to be right.”
PMA’s submission noted the groundbreaking nature of how FDA will become more involved — and more proactive — in preventing safety risks involved with the growing, harvesting, packing and holding of produce. The PMA comments then addressed three additional overarching concerns.
- Enforced standards versus flexibility: The prescriptiveness of the proposed rules was described as “particularly disconcerting to numerous produce industry sectors because any deviation from FDA prescribed preventive controls would be considered a prohibited act.” Another area of concern is how FDA is interpreting the term “enforceable standards” to mean “qualitative standards.” In some cases, said PMA, “it is not currently possible to set risk-based and science-based quantitative preventive control standards for some on-farm microbial hazards due to lack of technical information about the risks posed by some on-farm microbial hazards and the efficacy of various known preventive controls.”
- Efficacy of proposed regulation provisions: How will FDA determine the effectiveness of the proposed preventive controls provisions? Rather than relying only on measurements of improved public health outcomes, FDA should also consider any reduction of adulterated produce and a reduction in foodborne illnesses. “If FDA does not take this hybrid approach of broad requirements in the implementing regulation coupled with situation-specific guidance, FDA risks imposing standards on the produce industry that do not enhance produce safety in specific provision areas or saddling the industry with burdensome provisions that may only marginally enhance produce safety,” according to PMA.
- Produce and preventive controls rule coverage: PMA recommends that FDA align two of the five proposed FSMA rules — the preventive controls and produce safety rules — to strengthen enforcement and streamline the process. “There is very serious produce industry concern that the regulatory lines of coverage between the produce safety rule and preventive controls for human foods rule are not workable for agriculture and do not reflect the realities of produce production and handling,” PMA said.
The PMA website has a comments section where the organization’s comments can be read in their entirety.
The California Leafy Greens Marketing Agreement (LGMA) said that changes to the originally-proposed version of the produce rule “reflect much of the earlier input provided by the LGMA and others throughout the produce industry.” In the latest round of comments, LGMA focused on four concerns.
- Water testing: The supplemental water rules were “much improved” over the previous version, LGMA said, particularly the removal of the 7-day testing requirement for surface waters. There is room for additional improvement. LGMA is recommending that FDA ask growers “to use water testing and monitoring procedures that are similar to those required under the LGMA Metrics. First, because we believe this system allows producers to stay on top of water quality changes so they can be addressed in real time. And, second, the system is something that many producers are already used to doing. This system is working well for leafy greens producers as well as other commodity groups.”
- Farm definition: The rule’s definition of “harvest” would mean that some common leafy green practices (such as field coring) would be considered harvesting rather than processing, and thus subject to the provisions of the produce rule. LGMA said the proposed language in the supplemental rule was “a huge improvement over the original version,” but that some “clean-up” is needed in the language.
- Soil amendments: LGMA expressed concern about the relaxation of regulations related to the use of compost and raw manure, particularly the elimination of use-to-harvest intervals. “The LGMA metrics do not allow for the use of non-composed manure in leafy greens farming operations, and we are recommending that, at the very least, the kind of harvest intervals originally included in the rule be reinstated.”
- Small farm exemptions: LGMA said it remains opposed on principle to exemptions from federal food safety laws. “Based on our experience, we believe that all farmers can and should implement basic food safety practices on their farms, and that the rules should not exempt anyone from the obligation to do so. Unfortunately, the new rules actually expand the number of farms that will now be exempt under FSMA,” LGMA said.
Visit LGMA’s website for full comments on the revised produce rule and the revised preventive controls rule.
After FDA reviews all comments, it is expected to revise the proposal and issue a final rule, including timelines for implementation. The final rules are expected by September 2015.
