The Devil in the Details

By Brad Sullivan

It is an honor to be writing the first submission to LeafyGreens.com. It is ironic that I am writing this so soon after the regulations for the Food Safety Modernization Act (FSMA), adopted January 4, 2011, were released, because the genesis of this site started at a food safety conference I spoke at in February 2011. I spoke about the difficulty of growers complying with multiple—and possibly conflicting—processor requirements and federal/state environmental, water quality and food safety regulations.

When I was finished, I got the chance to hear FDA Deputy Commissioner of Foods, Michael Taylor, speak about the considerations that were going into FSMA from the Tester Amendment, exempting “small” (producers selling less than $500,000 per year) operations, and how the “devil would be in the details”, i.e., the regulations.

Now, after a year-long delay (supposedly brought on by the timing of last year’s elections), we finally have the details. The regulations clarify the expanded powers granted to regulatory agencies under FSMA to order recalls, regulate imported foodstuffs, create standards on water, soil amendment, worker health and hygiene, sanitation, animal intrusion, trace-backs, set out audit and inspection standards, and create flexible safety standards for various commodities given differences in their cultivation/harvest practices, geography and the commodity itself.

Encouraging the Good

On first read, the FSMA regulations seem to be an attempt to encourage “good” individuals to remain so. By that I mean the legislation and regulations do not echo the scientifically and technologically impossible standards of the civil litigation system, requiring perfection and 100% safety, nor do they require the industry to attain ever-increasing standards (as with gas mileage for cars, decreasing pollution discharges, or a utility company’s use of renewable energy). Instead, they attempt to balance what the agencies can do to lessen the number and impacts of major food outbreaks with consumer expectations of 100% food safety.

Much of this effect would be achieved through record keeping requirements, along with audits and inspections—measures that some in the industry adopted years ago. Many of the companies I have worked with are already doing more than will be required under the regulations or FSMA.

Most growers and processors take their responsibility to produce healthy, wholesome products very seriously. Some of these persons have taken extraordinary steps to improve the safety of their products. These individuals will not be much impacted by the regulations as they already are in compliance, but can now hopefully be assured that others in their industry will be forced to follow their lead.

Start With What Works

Certain interests will likely be disappointed by the regulations, as they were by FSMA itself. They have voiced their opinions that these rules do not “go far enough.” To them I point out the continuing research conducted by academia and industry to understand and define the scope of threats to our food supply. As this knowledge base increases, the proposed regulations can be built upon to reflect effective, science-based—rather than anecdotal—food safety rules and regulations.

For now, requiring good trace-back records, availability of facilities and equipment for inspection, increased record-keeping and standards for auditors, water, workers, and wildlife—along with new enforcement powers—are a good start, and should be reassuring to American consumers. Though some critics see steps not taken or programs not continued as back-sliding on the part of the Department of Agriculture or the Food and Drug Administration, I think the agencies did their job in balancing political considerations while drafting the regulations based on science and existing technologies.

I welcome the adherence on the part of the agencies to science-based improvements instead of “common sense.” Intuitively, if some number of pre-production tests is a good idea then two times as many tests sounds even better, right? (Similar logic could be applied to finished product testing, buffer areas, ingredient tests, contact times, chlorine levels, etc.)

In this case, our “common sense” would steer us wrong. Simply increasing the quantity of control measures without a sound strategy for targeting those measures achieves little else than a waste of resources that could be better spent on effective, science-based efforts. The FSMA regulations appear to be mindful of this consideration.

The new regulations attempt to recognize that products grown in wholly different regions may differ in their requirements. A peach from California’s Central Valley may be grown differently from those grown in Georgia or Chile. These differences typically arise based on climate, seasons and scale of operation. Under FSMA’s regulations, the agencies can now address these differences, using an ever-expanding base of scientific research as their guide.

Join the Conversation

Comments to the regulations for “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food”, (Docket Number: FDA-2011-N-0920) and “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” (Docket Number: FDA-2011-N-0921) are due by May 16, 2013. What this means to you is that the Final Rule will be required within one year of the closure of comment period, with regulations becoming effective 60 days thereafter. By July 2014, some form of these regulations will become the administrative law for food producers in the US.

As with the Tester Amendment, we should not let hopes for the “perfect” get in the way of the “good.” The details will leave much to be desired if the standards against which they are judged are perfection on pathogen elimination to consumer advocates, or cost-effectiveness, clarity and shifting burdens to the parties most able to affect changes. Over the coming months we will be meeting and speaking with clients as potential comments are formulated. It is during this comment period that we can all participate.

I hope that readers of this article will consider participating in this process, either by submitting comments of their own or contacting us at LeafyGreens. I will personally read and consider any input you may have as I work to prepare the comments I will be assisting in over the coming months.

Read the regulations here, ask questions of colleagues, professionals or farm groups, and please participate and join with others in commenting on those proposed regulations that may affect you.

Contact the author at: Brad@lg-attorneys.com

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Categories: Editorial