The U.S. Food and Drug Administration (FDA) has just wrapped up its second public comment period on proposed regulations to implement the Food Safety Modernization Act (FSMA). The issue of FSMA has been covered many times in Wise Traditions and WAPF action alerts, starting back in 2010 when the bill was debated in Congress and during the intense fight for the Tester-Hagan amendment to protect small-scale, direct-marketing producers.
As with the majority of modern laws, the fights didn’t end when the bill was passed; rather, they just got more complicated as the administrative agency (in this case, FDA) went into rulemaking mode. Over the last two years of the rulemaking process, we have delved deeply into esoteric details and urged WAPF members to take action multiple times.
Before we wade into the latest round of painful details in the second half of this article, though, let’s step back just a little to understand the effects of FSMA on farmers and food producers. While FSMA has many pieces, the bulk of the attention is on two major rules: Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption (the Produce Rule) and Hazard Analysis and Risk-Based Preventive Controls for Human Food (the HARPC rule).
Please note that this article is based on the rules as currently proposed. There are certain to be at least some changes when FDA issues the final rules, which may affect the scope and applicability of the rules. In addition, this article is not legal advice. Every farm and food business is different, and your obligations under FSMA will depend on the specifics of your operation, as well as the requirements contained in the final rule.
WHO IS SUBJECT TO THE PRODUCE RULE?
The Produce Rule is FDA’s venture into an unfamiliar world for the agency: the world of growing crops in soil and open air, rather than labs and test tubes. The agency’s proposed rule would regulate almost every aspect of growing crops, including equipment, worker training, water for irrigation and washing produce, manure and compost use, grazing livestock or using working animals in produce fields, record keeping and more. Who will be subject to this rule?
The Produce Rule applies if:
1. You harvest, pack, or hold fruits, vegetables, nuts, mushrooms, or sprouts for sale (the rule does not apply to people raising food for themselves or that is not for sale), and
2. Any of the produce that you grow and sell is usually consumed raw (produce such as artichokes, asparagus, lentils, potatoes, sweet corn, turnips, and winter squash are not covered).
If you meet both conditions, then you fall within the scope of the Produce Rule. The next question is whether you are exempt, either entirely or partially.
If you sell less than twenty-five thousand dollars worth of produce on an annual basis, you are completely exempt. There is also a “qualified exemption” under the Tester-Hagan amendment that requires two conditions 1) you sell less than five hundred thousand dollars annually in sales of all food, and 2) you sell more than half of that directly to either (a) individual consumers or (b) retailers and restaurants that are either in-state or within two hundred seventy-five miles of your farm. If you meet both conditions, you have a qualified exemption.
Under the Tester-Hagan exemption, you must place a label on the food or a sign at the point of sale with your name and the complete address of the farm. Moreover, FDA is able to revoke the qualified exemption if there is a foodborne illness investigation that is “directly linked” to the exempt farm or if there are “conditions or conduct” that are “material” to the safety of the food produced at the exempt farm. The process for revoking the exemption is one of the major issues in the proposed rules, as discussed more in the final section of this article.
For produce that will be processed in a way that kills potential pathogens, such as through canning, you are subject to a few requirements such as recordkeeping, but not the substantive requirements on how the produce is raised for that produce. If you raise a mix of produce, some of which will be processed and some of which will be eaten fresh, then the full rule applies to the produce that you raise for fresh eating.
WHO IS SUBJECT TO THE HARPC RULE?
While the applicability of the Produce Rule is confusing, the situation with the HARPC Rule is even more convoluted because it is the result of FSMA layered on top of pre-existing law. The HARPC rule applies to “facilities,” a term that was initially defined in the Bioterrorism Act of 2002. In the Bioterrorism Act, Congress required any “facility engaged in manufacturing, processing, packing, or holding food for consumption in the United States” to register with FDA.
The Bioterrorism Act specified that farms were excluded from coverage, but the FDA’s implementing regulations very narrowly defined “farms.” Farms could grow, harvest and pack their own crops, but packing another farm’s produce (such as with a multi-farm CSA), was considered a facility’s activity. And any type of processing, even as slight as cutting up greens for a salad mix, would also turn a “farm” into a “facility” that had to register.
In addition to excluding farms (narrowly defined) from the definition of facilities, the Bioterrorism Act also excluded “retail food establishments.” FDA defined the term as “an establishment that sells food products directly to consumers as its primary function,” specifically if “the annual monetary value of sales of food products directly to consumers exceeds the annual monetary value of sales of food products to all other buyers.” The term “consumers” did not include businesses, just individuals.
Logically, most people would read the definition of “retail food establishments” to include farms or food businesses that sell the majority of their food directly to consumers at places such as farmers’ markets or roadside farm stands. But thanks to the structure of the Bioterrorism Act, that wasn’t the case.
The Bioterrorism Act was focused on physical locations of “facilities.” For example, Kraft foods would not simply do a single registration, but would register each individual location of each manufacturing plant. So if a business processes food at one location and sells at another— such as someone who makes jams in their kitchen and then sells it at the local farmers market—the pre-FSMA law was unclear as to whether or not they would be a retail food establishment, and FDA had made conflicting statements over whether such operations were instead “facilities” that had to register.
One of the less-publicized aspects of the Tester-Hagan amendment was a provision directing FDA to clarify that farmers’ markets, community-supported agriculture (CSA) programs, and other direct-to-consumer sales platforms came under the definition of a retail food establishment and, therefore, were not facilities and did not have to register with FDA. While the Congressional directive was very clear, FDA still has failed to amend this definition, which is confusing and cause for worry.
The FDA has made some minor changes to the definition of a “farm” in the HARPC rule, expanding it to allow for packing produce from other farms and dehydrating uncut produce (such as raisins or herbs).
What does this mean? If you meet the definition of a farm or a retail food establishment, then you are not a facility, you do not have to register with the FDA under the 2002 Bioterrorism Act, and the HARPC rule doesn’t affect you. If you are a “facility,” however, you not only have to register with the FDA under the 2002 Bioterrorism Act, but you will also have to undergo the extensive HARPC requirements under FSMA, unless one of the exemptions applies.
The main exemption to the HARPC rule comes from the Tester-Hagan amendment. As with the Produce Rule, producers who gross less than five hundred thousand dollars annually and sell more than half directly to consumers or to local retailers or restaurants, have a “qualified exemption.” The Tester-Hagan amendment also directed FDA to define “very small businesses” that would have this same qualified exemption. To be honest, little attention was paid to this provision because many of us assumed that FDA would set the bar so low that this additional exemption would be of little use. However, when the FDA issued its first set of proposed rules, it specifically requested comments as to what the cutoff should be. WAPF urged a one million dollars gross annual sales test, and the FDA has accepted that recommendation! Thus, anyone who sells less than one millon dollars annually of human food—whether or not those are through direct sales—will have a qualified exemption to the HARPC rule if the FDA stays with its current proposal.
Facilities with qualified exemptions must:
1. Provide documentation showing that they fall within the exemption;
2. Either provide documentation that they comply with state and/or local food safety laws or create a simplified HARPC plan;
3. Have a label on the food or a sign at the point of sale with your name and the complete address of the farm. As with the Tester-Hagan exemption for the Produce Rule, the FDA can revoke the exemption on a qualified facility on a case-by-case basis.
THE SUBSTANTIVE ISSUES WITH THE PROPOSED RULES
For those farmers and food producers who will be subject to new requirements under one or both of these rules, what are the concerns?
The most general concern comes from the risk of arbitrary and unfair enforcement. It is almost certain that FDA will not receive enough funding to fully implement all the inspections and actions called for under FSMA. While a rational assessment of the risk would dictate that the agency focus its limited resources on the large, high-risk operations that dominate the conventional food market, FDA’s track record indicates that the agency is all too likely to target operations that are raising or processing food using non-conventional methods. The extensive and often ambiguous requirements in both proposed rules leave plenty of room for alleged violations that are in the eye of the beholder, namely the local FDA inspector.
Many of WAPF’s comments on the proposed rules focused on the ambiguities and potential avenues for abuse. In particular, the provisions that govern FDA’s ability to revoke a producer’s Tester-Hagan exemption are very problematic. As proposed by FDA, a local inspector can simply allege that revocation “is necessary to protect the public health and prevent or mitigate a foodborne illness outbreak based on conditions or conduct associated with the qualified [farm or facility] that are material to the safety of the food manufactured, processed, packed, or held at such [farm or facility].” The agency would then notify the producer of this finding, without being required to specify what the alleged problems are, and the producer would have only ten days to respond.
Under the proposed rules, the agency can choose whether or not to provide a hearing before it makes its final determination. And once the FDA makes a final decision to revoke the exemption, the farmer or facility would then have only sixty or one hundred twenty days (depending on which rule) to come into full compliance with the extensive, expensive FSMA requirements. In practical terms, almost any small producer targeted in this way would go out of business. While FDA is unlikely to use this power often, even a few cases of arbitrary revocations could create a severe chilling effect on producers all over the country.
For those producers who are not exempt under the Tester-Hagan provision, one of the biggest problems is the proposal for irrigation water standards. The FDA is continuing with its original proposal that irrigation water must meet the EPA’s standards for water for recreational use. This simply makes no sense. The recreational water standard was developed to prevent gastrointestinal illness in swimmers and does not account for the fact that microorganisms die off rapidly in the interval between irrigation and harvest (as opposed to a swimmer swallowing the water directly). Moreover, the recreational water standard is based on testing for generic E. coli, but the presence of generic E. coli does not mean that pathogens are present; and, conversely, the absence of generic E. coli does not mean that the water is free from pathogens. Thus, setting the standard for irrigation water to test at a low level of generic E. coli imposes major costs on farmers without necessarily protecting food safety.
No one knows how implementing this standard would affect American produce farming, but evidence suggests that a very significant percentage of surface waters would fail the test, forcing farmers to switch to groundwater (if that is even an option in their area), bear significant cost to treat their water chemically, or simply go out of business.
In response to the comments in the first round which raised these points, the FDA included a provision in the new proposed rules that allows farmers to use water that exceeds this standard based on a logarithm formula calculating die-off. But the provision is so confusing that even FDA officials appear to be unable to explain how it would actually work in practice.
The proposed rules contain many other opportunities for arbitrary and unfair enforcement. For example, the Produce Rule requires that farmers wait an “adequate” time in between grazing livestock in a field and harvesting the crop from that field—but what does that mean? Similarly, although the FDA has now clarified that a farmer is not required to take actions that would violate the Endangered Species Act by destroying wildlife habitat, it is unclear what steps will be required for farmers to prove to the inspectors that they are preventing contamination of their crops by wild animal excrement.
It is worth noting one major improvement in this second round of proposed rules, namely the sections dealing with “biological soil amendments” in the Produce Rule. The first version of the proposed rules would have required that farmers wait nine months after applying manure to a field before they could harvest their crop; even applications of fully treated compost called for a forty-five-day waiting period. This would have been devastating to organic and sustainable farmers. In response to the outcry in the first public comment period, the FDA now proposes that a farmer can apply compost and harvest the crop without any waiting period. For manure (which, under FDA’s definitions, includes things like static composts, vermicompost, and many compost teas), the FDA plans to conduct research over the next few years to assess the risk and then set standards based on those studies. This is a significant victory, and shows that the agency will at least sometimes listen when enough people speak up.
Not all the changes were for the better, however. The FDA also made changes to the HARPC Rule that make it far more expensive and burdensome. The FDA has added a requirement for a “supplier verification program,” that requires facilities to implement a program for raw materials and ingredients that it receives from farms or other businesses and that have a “significant hazard.” The receiving facility would have to conduct either an on-site audit, sampling and testing of the ingredients, or a review of the supplier’s records. The new proposed rule also requires collection and testing of samples from the environment “if contamination of a ready-to-eat food with an environmental pathogen is a significant hazard.” Despite the use of the words “significant hazard,” the provision is broad and ambiguous enough that it could easily be used to justify multi-day testing of every nook and cranny of a facility, as we have already seen happen with some cheese makers.
WAPF, along with many other organizations and thousands of individuals, have submitted comments to FDA on these and other problems in the proposed rules. The FDA will now review the comments and issue final rules sometime in 2015. The process will not truly end then, however. Issues such as enforcement, the studies on the use of manure and other biological amendments, and protecting the integrity of the Tester-Hagan exemptions will need to be addressed as we move forward, if we are to ensure the ability of farmers and artisan food producers to provide food for our country.
This article appeared in Wise Traditions in Food, Farming and the Healing Arts, the quarterly journal of the Weston A. Price Foundation, Winter 2014🖨️ Print post