FSMA: A Serious Law with Serious Flaws (The Joy of Regulation, Part II)

A few weeks ago, our post The Joy of Regulation: Part I offered a general primer on regulation in the United States. It focused on how an agency like the FDA gained so much power to write, enforce, and adjudicate food safety regulations. With the Food Safety Modernization Act (FSMA) rules about to be finalized, we’re bringing you two more pieces, today and tomorrow, on the topic.

Today’s post is a deep dive into how one of the FSMA rules (the so-called Produce Rule) will affect vegetable and berry farms, their markets, and the future of many small farms. Please consider sharing your input with the FDA–the public comment period is only open one more week, until December 15. Additional resources and submission instructions are at the bottom of this post.

Clouds of Fury

A brief history of FSMA: In a rare show of bipartisan agreement (who’s against food safety?) the Food Safety Modernization Act was passed by Congress in 2010 and signed into law in 2011. The law put the Food and Drug Administration (FDA) in charge of writing the rules (see our last post on this topic to learn more about why this is the case) that will guide implementation of the law. The law requires comprehensive, science-based standards and preventive controls across the food supply, with specific attention to farms that grow fresh produce.

Usually, laws that regulate farms are the province of the USDA, so FDA has had to get up to speed on agricultural practices. As part of their public input process, they visited farms, processors, and food hubs in different parts of the country, including NH and VT, in the summer of 2013. These visits, and the thousands of comments that FDA got in response to the first draft of the rules, led them to make some significant changes, including improvements, to the second draft of the rules. While I appreciate FDA’s willingness to respond to feedback there is still a long way to go if FSMA is to represent a rational approach to improving food safety for farmers and their customers. Here’s why:

1) The Produce Rule will create confusion and unfairness in the marketplace
Not all farms will have to comply with FSMA, which means some farms will have to bear the cost of compliance, and others will not. There are two definitions that describe which farms won’t have to deal with FSMA directly.

First, farms that sell $25,000 or less of produce annually are ‘excluded’ from the law. In other words, if you sell annually $25,000 or less of any fruits or vegetables, the law does not apply to you.

Second, there is the ‘exemption’ for some farms under the Tester-Hagen amendment, which was added to the law in an effort to protect small farms and local markets from the cost of complying with FSMA. It says that farms selling less than $500,000 of food annually, of which at least half is sold directly to consumers or retail food establishments within 275 miles, are exempt from FSMA (except for some labeling requirements, etc.). The definition of ‘food’ in this case is based on an earlier law and it includes all human food (including chewing gum!) and all animal food, too, such as hay.

Third, the proposed FSMA rules do not regulate every kind of fruit and vegetable crop, only so-called ‘covered produce,’ which is typically consumed raw. FDA’s reasoning is that many crops have a ‘kill step’ when they are cooked so there is not enough risk to make them worth regulating on the farm. Potatoes, squash, sweet corn, or tomatoes for tomato paste are examples of crops not covered by FSMA.

Here’s where the confusion comes in: There are three different definitions to measure sales of produce used in the same law. Adding to the confusion is a separate food safety program that will continue even after FSMA is implemented: Good Agricultural Practices, or GAPS. The GAPS guidelines were written by USDA in 1998; GAPS is a voluntary program, not a law. However, many supermarket chains require GAPS or a similar program for growers they buy from. Getting GAP certified requires passing a food safety audit.

Putting this information together, here’s an example of what will happen:

Let’s say I am a part-time strawberry grower selling only to a wholesale distributor. If my farm has annual sales over $25,000 (above the ‘exclusion’ from FSMA), I will have to follow the same rules as a strawberry farm with $25 million in sales, whether it is up the road, or across the country. The difference of course is my net income will be just a few thousand dollars, so compliance will be a huge burden on my business, whereas it will be a small part of operating costs for a large farm.


Across the street from me is another strawberry farm, and they sell over $200,000 of wholesale berries to the very same distributor that I sell to, but they don’t have to comply with the entirety of the Produce Rule. That’s because they also have $250,000 in retail sales to direct markets, so they are largely exempt from FSMA under the Tester-Hagen amendment.

Up the road, my friend grows and sells just over $25,000 of potatoes. I’ve convinced her to put in some strawberries to supplement her income with sales to my distributor. She expects to sell just a few thousand dollars of wholesale berries, but that means she would have to comply with FSMA. Even though the potatoes are not ‘covered’ by the Produce Rule, the $25,000 exclusion threshold is based on annual sales of all produce. Needless to say, those berries will be ripped out; otherwise the farmer will have to comply with a complex set of rules in order to add a small amount of income.

Another nearby farm grows mostly sweet corn and pumpkins. Much of their produce is sold to a local grocer that requires GAPS (Good Agricultural Practices) food safety certification, even though this farm does not have to comply with FSMA because those are not ‘covered’ crops.  The farm advertises their food safety certification but when asked, they must explain to customers that they do not actually comply with the food safety law.

The scenarios above highlight the fact that application of the Produce Rule will cause confusion among consumers, buyers, and farmers. Further, the rule will create a huge barrier to entry, and survival, for small growers serving wholesale markets like distributors and institutions.

An entirely different approach.  If one recognizes that all farms are going to have to engage with food safety to survive in the marketplace, it would make more sense for the Produce Rule to specify that all commercial produce farms must have food safety plans, but to allow a scale-appropriate process for small farms. Farms that are exempt or excluded from FSMA should be covered by simpler, scale-appropriate rules developed at the state level. Customers, attorneys, and insurance companies are eventually going to demand some evidence of food safety practices from all producers.

Allowing a two-tiered system of food safety oversight (rather than farms having to comply, or not) will allow all farms to provide their markets with a reasonable level of food safety assurance, while at the same time reducing risk. This is especially important to Vermont growers, the vast majority of which will be exempt from FSMA under the Tester amendment. (The 2012 Census of Agriculture found about 800 Vermont farms sell vegetables but only 50 farms had vegetable sales over $250,000.)

To make such a tiered system fair, the differential treatment of wholesale and retail growers has to be fixed. I propose that farms with less than $250,000 in sales of all produce should be answerable to state agriculture agency programs. These programs will modify FSMA rules to fit the capacity of small farms. That level of produce sales is roughly comparable to the Tester-Hagen exemption based on $500,000 in sales of all food. (Ideally, Congress will go back and change this definition to only include fresh produce.)

I have every confidence that Cooperative Extension and state Agencies of Agriculture can develop small-scale food safety certification systems that fit the farms they work with, following the general principles of the FSMA produce rule and GAPS. In fact, Vermont, Massachusetts, and Rhode Island all have or are developing local, practical, programs to help their relatively small farmers remain competitive in the marketplace while also reducing risk.

2. Randomly testing surface water is not likely to improve food safety.
The FSMA rules regulate ‘agricultural water’ which is used for overhead irrigation or spraying crops. Water that does not touch the edible part of a crop is not regulated. The biggest challenge with the proposed rule is the requirement to test surface water (from streams and rivers) for generic E. coli levels to determine if it is safe to use. The level of E. coli in these waters is constantly changing, due to the influence of wildlife, livestock, and rainfall. It also takes a week or more to get test results back from a lab, so by the time a farmer gets an E. coli assessment it is no longer accurate.

The first draft of the rules required testing surface water every week during the season, a costly process for growers. The water testing in the revised Produce Rule requires testing 20 times over 2 years, and 5 times a year after that, and then asks growers to use a complicated statistical analysis to see if the water can be used. The revision is still based on a flawed assumption and a lack of science. Put simply, we do not know how to accurately characterize a flowing body of water for food safety risks. Testing generic E. coli repeatedly, perhaps months before application of surface water to a crop, will waste time and money and will also create a false sense of security. It is akin to saying that if cloudy weather is a food safety risk, farmers should measure the cloud cover 20 times over two years to establish their baseline risk. The resulting calculation is not likely to reflect the actual risk of cloudiness, nor whether it will be cloudy at harvest.

An alternative approach is to require practices that are known to promote microbial die-off on crops. These include waiting to harvest after applying agricultural water, washing produce, and/or storing produce.  The revised rule proposes using die-off rates to compensate for water that exceeds the E. coli standard, but not enough detail is provided. On-farm research conducted by UVM faculty shows that washing produce is very effective for reducing E. coli, and research should also be done on microbial die-off in storage, which FDA mentions. The final rule should require only minimal testing of surface water, to keep an eye out for extreme contamination, and focus on practices that kill microbes before the crop is sold. These include waiting several-days after overhead irrigation, or cleaning the crop, either with multiple rinses, some specific time under a flowing rinse, or use of an approved sanitizer in the wash water.


3. Not regulating raw manure at all is risky and confusing.
The first draft of the Produce Rule got a lot of push-back on its requirement to wait 9 months after applying manure until harvesting produce. This is a long time to wait and practically speaking few vegetable farmers could use manure as a source of soil fertility given their crop rotations. However, the revised rule withdrew any requirement to wait after applying manure, saying that more science is needed. Although it makes sense to delay creation of a new standard for manure management until there is sufficient data, it makes no sense to not require any wait between application of manure and harvest. Manure is known to pose a risk to food safety, and pathogens it may contain are known to die off over time after field application. Buyers will not tolerate the idea that manure may have been recently applied to crops, and farmers will be confused by a rule that requires ongoing testing of water for E.coli yet allows a farmer to spread manure at any time.

An alternative approach is to require the common sense standard that is already widely accepted by growers and buyers. That is, the 90 or 120-day waiting period after manure application until harvest, depending on whether the edible part of a crop touches the ground or not. This is required by the National Organic Standards; GAPS is similar, with 120 days for all crops. As more data is developed, a different waiting period could be proposed.

4. Creating obstacles based on location of farm activities or cooperative ownership will harm local food systems.
The proposed rule triggers stricter standards for farmers that conduct certain farm activities ‘not in one general location’ (i.e. off-the-farm), or not controlled by one entity (i.e. food hubs or informal collaboration). Sorting, mixing, removing stems and husks, washing, packaging, and labeling are all considered farm activities under the Produce Rule. However, if they take place off the farm, or if they are done by enterprises that are jointly-controlled by multiple farms, these situations would trigger the Preventative Controls rule (because the farms would now be ‘facilities’) and require more intense food safety procedures.

An alternative would be to recognize that farms often have several physical locations for their activities, and this should not change a farm into a ‘facility’ under the rule. Farmers also often work together in to conduct farm activities, and this should not be penalized. Rather, the extent of processing should be the threshold for going from a farm to a facility. In other words, chopping, peeling, slicing, and other true ‘food processing’ activities warrant more rigorous regulation than the activities used to prepare raw crops for sale.

If you’re confused and frustrated after reading this, you’re not alone. But don’t let that keep you from letting the FDA know what you think about any of the issues that seem important to you. If you first want to know more about the details of the revised Produce Rule, check out this summary.

How to share your input with the FDA
The deadline for comments is next Monday, December 15, 2014.

Clouds of Fury by Paul Moody via Flickr (CC BY-NC 2.0), cropped for formatting
Strawberries by JustyCinMD via Flickr (CC BY 2.0), cropped for formatting
Lettuce by Emma Cooper via Flickr (CC BY-NC 2.0), cropped for formatting

Posted in: Economic, Environmental, Health.