The O’Jays, the Philadelphia soul group, had once had a hit song called “992 arguments.” The Food and Drug Administration’s produce safety rule docket beats that in spades.
Thirty six thousand, three hundred and forty three. That’s how many comments that the FDA has received (as of July 30) on the monumental proposed regulation titled “Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption.”
According to the terms of a settlement between FDA and the Center for Food Safety and the Center or Environmental Health, the agency is supposed to issue its final rule for the produce safety rule by Oct. 31. Before that — sometime this summer — the agency was expected to issue a revised draft regulation.
Well, the clock is ticking, and there are 36,343 ways to Oct. 31 that will make that deadline a real challenge for the FDA.
For your review, here are a few links to comments on the produce safety rule:
The definition of a raw agricultural commodity (RAC) and a Farm are intertwined, so much so that a RAC produced on a farm might no longer be a RAC due simply because it was carried 100 feet to another farm. This creates a confusing, illogical circle and does nothing to increase food safety quality on that RAC. Instead, a RAC should officially transform when it’s been changed by processing (at which time it would become part of the Preventive Control Rule). Otherwise, it should remain a RAC and a part of the Produce Rule, regardless of who owns it, until it is appropriately changed by processing.
We urge FDA to reconsider standards that take into account the relative risks and comparative benefits associated with individual commodities. FDA should initially propose regulations for only those commodities with a history of microbial contamination. If these regulations can be successfully implemented and enforced, it may be appropriate at that point to consider whether there is a net public health benefit to be gained from expanding regulations to cover other commodities.
FDA must maintain and fully implement Tester-Hagan provisions
The Tester-Hagan amendments were a statutory recognition that treating unlike things alike would not necessarily result in better safety. Farm direct is the most traceable and transparent system, and these farmers are looking their customers in the eye and serving the same food to their own families. So it’s not just the number of handlers or “touches,” but the high accountability of the farm direct marketing channel that justifies the Tester-Hagan provisions.
Without those provisions, a more likely outcome would be much less domestically grown food – especially from the growing farm-direct sector, which is also our best hope to attract and retain young and beginning farmers. It is plenty hard for these people to get started in farming as things stand today.
FDA should require, where appropriate, environmental testing in packing houses. The 2011 outbreak of illnesses linked to Listeria-contaminated cantaloupes, which infected 146 people from infancy to age 96 years and resulted in 30 deaths and one miscarriage, illustrates the need for better food safety standards in packing houses.
FDA should revise its list of commodities that are “rarely consumed raw” and so therefore would be exempt from produce safety standards. The list currently includes items that are consumed raw, such as kale, asparagus, figs, beets, and brussels sprouts. If FDA decides to retain this proposed exemption, the agency should exclude items that are eaten raw. Further, it should consider listing exempted items in a guidance document rather than in code so that the list of commodities could be more easily revised to reflect future changes in consumer eating habits.
The agency should carefully consider the implications of defining “small business” for the purpose of granting exemptions from produce safety standards. All produce growers should produce safe products, regardless of their size.
FDA should minimize compliance periods for the proposed rule. FSMA implementation is already delayed, and foodborne illness outbreaks continue to occur. The agency should consider offering enhanced technical assistance instead to help growers comply with new safety standards as soon as possible.
TK: From covered commodities to the Tester provisions to product and water testing, the definition of a farm and more, there are plenty of opinions about how should FDA should finalize the produce safety rule. Thirty six thousand, three hundred and forty three(and counting), to be precise.
The last stanza of The O’Jays “992 arguments” lamented a failed love affair. “Maybe we just weren’t meant for each other” won’t be the last verse of the FDA produce safety rule. The agency has the unenviable job of making the final produce safety rule something that growers can, if not love, at least learn to live with.