The Holidays Come Early? FDA Revises Draft Food Safety Rules


CLF, sustainable agriculture organizations, and farmers and food businesses across the country can finally open the gift FDA presented just before the holidays last year. As explained, thanks to tens of thousands of comments, FDA announced last December that it would revise the most onerous provisions of two Food Safety Modernization Act (FSMA) rules — the Produce Safety Rule and the Preventive Controls Rule. The Produce Safety Rule sets standards for how farms grow produce. The Preventive Controls Rule regulates facilities that process raw produce. As originally drafted, these rules threatened thousands of small and medium-size farms that supply New England with fresh, locally and sustainably grown produce. Last Friday, FDA released the revised proposed rules.

So, did we get what we wanted? We still need to review the revisions in detail, but at first blush, the supplemental rules look promising. Here’s a quick summary of several key changes:

Produce Safety Rule

Agricultural Water

  • Old draft. Many farms would have had to test irrigation water every seven days. The rule encouraged chemical, antimicrobial pesticide treatment of water.
  • New draft. The testing interval is more flexible, likely reducing the need for chemical treatment.

Biological Soil Amendments

  • Old draft. In many cases, farms that apply raw manure to fertilize crops were required to wait nine months between applying the raw manure and harvesting the produce. This standard would have led to increased use of synthetic fertilizers.
  • New draft. The nine-month waiting period has been removed.
  • Old draft. Farms had to wait 45 days between applying composted manure and harvesting crops.
  • New draft. The waiting period is zero days.

Wild Animal Intrusion

  • Old draft. To keep animals from entering cropland, farms were incentivized to destroy vegetative buffers around fields and streams. Destroying these buffers would have removed important pollinator and other species habitat and increased nutrient loading into watersheds.
  • New draft. It states explicitly that farms are not required to exclude animals from growing areas, destroy animal habitat, or clear farm borders.

What Is Covered

  • Old draft. The exclusion for farms with annual sales of $25,000 or less and the definition of a “very small business” and a “small business” were based on all food sales. This discouraged farms from diversifying beyond produce because doing so would place them at risk from exceeding the annual sales cap.
  • New draft. The exclusion and the definitions are now based on sales of produce only, allowing more very small farms in New England to qualify.
  • Old draft. Farms eligible for the qualified exemption from the rule were afforded little to no due process before FDA could withdraw the exemption and farms had no ability to regain the exemption once withdrawn.
  • New draft. FDA has put in place a process for farms to respond to a withdrawal notice before losing the exemption and an opportunity to reinstate the exemption if it has been withdrawn.

Preventive Controls Rule

  • Old draft. If a farm packs or holds raw produce from a farm under different ownership, it would have had to comply not only with the Produce Safety Rule but also with the Preventive Controls Rule. This cramped definition of a farm would have disincentivized many New England farmers from working cooperatively or diversifying their operations.
  • New draft. Farms that pack or hold raw produce from other farms are subject to the Produce Safety Rule only.

We’ll dig deeper into the supplemental rules, but commend FDA on issuing the new proposals. Many of the revisions appear to be what CLF and other groups recommended. FDA will officially publish these supplemental rules for comment on September 29. Then, the public will have 75 days to comment.

In the meantime, you can read the supplemental rules here and here. Get up to speed with more background information. Read CLF’s comment on the first proposed Produce Safety Rule here and our comment on the first proposed Preventive Controls Rule here. Once the comment period officially begins, it’s up to all of us to ensure that FDA gets the final regulations right. Stay tuned for more information and further action in the weeks and months ahead.

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The views and opinions expressed on this blog do not necessarily represent the opinions or positions of Conservation Law Foundation, our boards, or our supporters.