FSMA Conference Part 3: Regulating Farm Production: From Zero to Sixty

[Ed. Note: On Friday, the Petrie-Flom Center, the Food Law and Policy Clinic (a division of the Center for Health Law and Policy Innovation), the Food Law Lab, and the Harvard Food Law Society (with support from the Top University Strategic Alliance and the Dean’s Office at Harvard Law School) co-sponsored a conference at HLS called “New Directions for Food Safety: The Food Safety Modernization Act and Beyond.”  This week, we will be sharing a series of blog posts from the event, and video will follow shortly.]

By Jason St. John, JD candidate, Harvard Law School

The third conference session, “Regulating Farm Production: From 0 to 60,” was moderated by Robert Greenwald, Director of the Center for Health Law Policy and Innovation at Harvard Law School. To make the presentations more cohesive, the presenters divided each of their fifteen-minute presentations into two seven-minute presentations. The panel discussed the FDA’s proposed Produce Safety rule under the Food Safety Modernization Act (FSMA), the rule’s focus on produce and growing of food, and the large question of whether FSMA makes our food safer.

First to speak was Dennis Stearns, Professor from Practice at the Seattle University School of Law, who gave a history of FSMA’s origins. Although the traditional story is that FSMA came from the search for more scientific food regulations, historically, major changes in food regulation happen because of a sense of crisis. The crisis that precipitated FSMA was the 2005 and 2006 E. coli outbreaks in bagged lettuce and spinach.

The trace-back after the second E. coli outbreak revealed serious problems at the field where the spinach was being grown, including feces from wild animals, contaminated water, and other hazards. However, this obscured the fact that there was not much empirical evidence on food hazards generally. The facts provided about the hazardous field provided the basis for subsequent regulation, which focused on the growing of food as opposed to processing. Stearns concluded by suggesting that the processing of the food, rather than production, carries the greatest risks.

Next to speak was Alli Condra, Clinical Fellow in the Food Law and Policy Clinic at Harvard Law School, who spoke about the details of the proposed Produce Safety rule. The rule is limited to certain farms, and only applies to some products of those farms. For example, foods that are rarely consumed raw, like potatoes, or foods that will undergo a “kill step” in further processing, like canned green beans, are not covered under the proposed rule. Farms that have annual revenues less than $25,000 are not covered. In addition, farms that have less than $500,000 in annual sales may be eligible for a qualified exemption, if more than one half of sales go to consumers or to retail units that sell directly to consumers, such as restaurants.

Margot Pollans, Resnick Program for Food Law and Policy Teaching Fellow at the UCLA School of Law, spoke next, on the problem of the mixed-type facility. Under the Produce Safety rule, the smallest amount of food processing turns a farm into a mixed-type facility, subjecting the farm to new rules. If a farm holds any food made or grown on a different farm it is treated as a mixed-type facility. This means that almost any community supported agriculture (CSA) program will result in the farm being treated as a mixed-type facility, because in CSAs farms often trade food to meet customer demand. Secondly, almost any value-added activity, such as production of jams, maple syrup, or honey, turns a farm into a mixed-type facility. This is particularly serious for small and mid-size farms as those activities can be very profitable, but due to the cost of compliance to new rules they may abandon those activities.

Fourth, Condra spoke about ways in which the rules do not reflect real-world operation of farms. For example, in estimating costs of compliance, the FDA assumed that small farms operated for only three months each year, but most small farms operate for longer than that, and so the FDA underestimated costs to small farmers. In a hypothetical case, a small farm may have $490,000 annual dairy sales, and then, due to an ancillary vegetable farm that creates another $15,000 in value, the farm is subject to the Produce Safety rule, thanks to the strict cut-off at $500,000. Condra ended by asking the most important question; how much safer will our food be due to these regulations?

Then Pollans spoke again, to discuss the poor incentives that the Produce Safety rule offers for sustainability. Specifically, she focused on two examples, fertilizers and ecosystem services. Under the proposed rule, if a farmer were to use biological soil amendments instead of synthetic fertilizer, the farmer would need to apply the fertilizer months before harvest, sometimes up to nine months before harvest. This is not feasible, and so farms are encouraged to use synthetic fertilizers that take much more energy to produce and are worse for the environment. Use of synthetic fertilizers also reduces the amount of microbes in the soil, which actually makes food less safe. Secondly, the proposed rule creates a preference for confinement of domestic animals on the farm, and a preference for shutting out wild animals. The steps farmers will need to take to isolate their farms will reduce the ecosystem services provided to the farm from the surrounding area, such as water purification.

Finally, Stearns spoke about the concerns of industrial agriculture. If anything goes wrong in a large processing plant, a major illness outbreak could occur. With non-industrial agriculture, the farms are reaching fewer consumers, and so there is a smaller chance for a significant bacterial outbreak. Stearns reminded everyone of the E. coli outbreaks in 2005 and 2006, and of the fact that the processing plants involved in that outbreak did not live up to their Hazard Analysis and Critical Control Point (HACCP) standards. However, nothing in the current proposed rule addresses the likelihood of a processing facility adhering to its HACCP standards. Lastly, FSMA gives the FDA many more responsibilities but does not increase its resources. Perhaps, Stearns concluded, the lack of resources will mean that the inspections under the Produce Safety rule will focus on industrial agriculture, and ignore small and mid-size farms.

After the presenters spoke, there was a question and answer session. One person asked if farms would simply ignore the new regulations, given the cost of compliance? Pollans responded by saying that we will likely see farmers assuming that there will not be enforcement of these regulations, but in the long term, this is a bad outcome for all involved.

One farmer made the comment that the three questions he always receives from his customers are whether there are GMOs in the food, if there are non-sterile bacteria, or if pesticides were used in the food, and the Produce Safety rule, for all it does, does not address these questions.

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