January 14, 2013

FDA's New Produce Safety Rules: Somewhat Less Than Meets the Eye

When I teach my environmental law and food safety law students how to go about ascertaining the meaning of implementing regulations, I tell them to start with the sections of the regulations devoted to definitions and exemptions.  Quite frequently the most hard-fought controversies during the rulemaking process through which the agency promulgated the regulations were over the definitions and exemptions. 

That certainly seems to be true in the case of the long-awaited Food and Drug Administration’s (FDA) proposed “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption,” which the Obama Administration, with much fanfare, issued on January 4.  According to FDA’s analysis of the economic impact of the proposal, almost 80 percent of the country’s produce growers will not have to meet the standards because they are not covered in the definitions or are otherwise exempt.

The proposed rule, which was required by the landmark Food Safety Modernization Act of 2010, would for the first time establish legally enforceable standards for produce farmers.  The standards set out requirements for sanitizing tools and equipment, for ensuring that agricultural water is safe and sanitary, for using animal-based fertilizers (e.g., compost) on food crops, for reducing contamination from domesticated and wild animals, and for training field workers and ensuring that they employ sound hygiene practices.

As my forthcoming book Freedom to Harm recounts, Congress enacted the Food Safety Modernization Act in response to a confluence of crises -- involving thousands of illnesses and many deaths caused by contaminated fresh produce --  brought on by a laissez faire governmental approach to food safety.  FDA now estimates that contaminated produce causes 3.1 million illnesses each year.

The new standards are not especially stringent.  Responding to several serious produce-caused outbreaks in the past several years, large food retailers like Walmart have insisted that the large produce growers with which they do business comply with FDA’s “good agricultural practices” (GAP) guidelines, and they have insisted that growers hire third-party (nongovernmental) inspectors to certify compliance with the GAPs.  In the case of many, perhaps most large growers, the primary impact of the proposed standards would be to update the GAPs and make them mandatory.  FDA’s Deputy Commissioner for Foods and Veterinary Medicine, Michael Taylor, told Food Safety News that if growers are already complying with the GAPs and are getting “serious certifications” they should not have to change many of their practices.

At the same time, the standards will require the laggards to come up to speed.  It is unclear how many laggards there are out there, but we may find out when they begin to howl during the public comment process.  FDA estimates that the proposed standards will reduce the human health burden attributable to contaminated produce by 65 percent.   This suggests that there may be quite a few laggards out there.

To the extent that laggards exist and to the extent that they do not persuade FDA to reduce the stringency of the standards, the regulations should have a beneficial impact on food safety.

Here is where the definitions and exemptions come in.  It turns out that, by FDA’s own estimates, almost 80 percent of produce growers in America are not covered by the regulations or are otherwise exempt. 

To some extent, this is required by the statute –- so much of the substance of the proposed rule was known in advance.  In order to gain enough votes from farm-state senators to pass the food safety bill, the sponsors had to accept an amendment offered by Senator Jon Tester (D-Mont.) that offered a qualified exemption to farms if the average value of their food sales over the past three years was less than $500,000 and if more than 50 percent of their food sales were directly to qualified end-users. Qualified end-users were defined as direct consumers of the food regardless of location, or a restaurant or retail food establishment in the same state or not more than 275 miles from the farm.

In addition, farms are not covered by the regulations if the average annual monetary value of food sold during the previous three-year period was $25,000 or less.

Finally, FDA has exempted produce that is rarely consumed raw, such as beets, brussels sprouts, potatoes, sweet corn, and sweet potatoes.  A farm that only grows such commodities is exempt from the regulations.  This exemption was not compelled by the statute.  It represents FDA’s judgment that some kinds of produce (a long list of which is provided in the proposed regulations) will be cooked to high enough temperatures to kill dangerous microorganisms before they are eaten.

FDA estimates that 149,425 of the country’s 190,000 produce growing farms will be either uncovered or exempt.  That comes to just under 79 percent of all produce growers in the country.

To what extent will these exemptions pose a threat to consumer health?  It is hard to say.

Nearly all packaged “prewashed” produce is grown on large farms that will not come within the exemptions, and much unpackaged produce that consumers purchase in national retail outlets is also grown on nonexempt farms.  All of this produce should be covered by the standards.  But there is a definite trend even in chain grocery stores to feature at least some locally grown produce, and much of it will probably come from uncovered or exempt farms.

What this means as a practical matter is that those of us who prefer to consume locally grown food cannot assume that the produce we purchase was produced in compliance with the new FDA standards.  Yet, although the small farmers who supply local farmers’ markets and grocery stores are not required to comply with the new regulations, they may voluntarily comply.  They should attempt to comply with the substantive provisions of the standards, especially the sanitation, safe water, fertilizer, and animal contamination requirements, even if they cannot afford to comply with all of the recordkeeping requirements. 

The message to consumers is that they should thoroughly wash all locally grown foods that they plan to eat raw and should thoroughly cook all locally grown food that is not eaten raw.

Consumers should also be careful when it comes to foods purchased from large retailers that are not ordinarily consumed raw.  They should assume that potatoes, corn, and the like have not been produced in compliance with the rules, and they should cook them well before eating them and thoroughly wash their hands after handling them.

In short, the new regulations should reduce the incidence of foodborne illnesses, but they will not relieve food preparers of their responsibility to exercise caution in dealing with raw produce.

Thomas McGarity, CPR Member Scholar; Endowed Chair in Admin. Law, University of Texas School of Law. Bio.

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1 As a young entrepreneur and small farmer that grows and sells produce in a "farm state", we take pride in the cleanliness and lack of petro based chemicals on our little family operation. The regulations the FDA has set forth will help with the food borne illnesses that have been in the news lately. The restrictions on who is affected by the coming regulations are a good thing if your in my shoes. If we were to be mandated to spend all the $$$$$ to pay the inspectors that are required, pay all the lab fees required, and invest all the hours that get put into all that mess, we would simply be out of business all together. And as far as the farmers and farms that will be affected. The operations that "pre-wash and package" their produce do fall into the group that will be affected. Fact is; if your SHIPPING produce that you have washed, sorted, and packaged you're doing at least 500K average sales in 3 years, otherwise you wouldn't have to capitol to buy the equipment, pay the workers, and invest all the time it takes to grow, wash, package, and ship your produce across the country.
-- Andrew Wheeler

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