The Food Safety Modernization Act (FSMA), signed into law in January 2011, was the largest overhaul of the nation’s food safety laws in over 70 years. The law added a number of important provisions that increase federal regulation for various players in the food system and increased the U.S. Food and Drug Administration’s (FDA) authority to regulate the food system. For example, FSMA gave FDA the authority to require food companies to recall food under certain circumstances (mandatory recall authority) and expanded FDA’s authority to include oversight of specific on-farm agricultural practices. FSMA instructed FDA to write a number of regulations, two of which were released in January. These two proposed rules may significantly affect farmers and food processors, particularly small- and mid-size producers and processors. One rule sets out standards for produce safety and creates new requirements for certain on-farm practices (which have never been regulated before); the second rule sets out measures designed to prevent food safety problems at facilities that process food.
What the Regulations Propose
The Produce Safety Rule (PSR) [see footnote 1] applies to farms that grow, harvest, and hold fresh produce that is often consumed raw [see footnote 2]. If a farm is subject to the PSR, the farm will have to comply with new requirements in the following areas: worker training and health and hygiene; agricultural water; biological soil amendments; domesticated and wild animals; and equipment, tools, and buildings.
There are a couple of exemptions from the PSR. First, if over the past three years the farm’s food sales average less than $25,000, the farm is not required to comply with the rule at all. The rationale is that these very small farms do not significantly contribute to the food supply and, therefore, do not pose a major threat to the public’s health.
Second, if the farm’s food sales average less than $500,000 and more than half of the farm’s sales are direct to consumer (or to another “qualified end-user” that is defined in the PSR), the farm falls under the “qualified exempt” category. These qualified exempt farms do not have to comply with most portions of the PSR; however, “qualified exempt” farms are still obliged to meet a few requirements. This qualified exemption may be taken away under certain circumstances; if this exemption is taken away, the farm must come into compliance with all provisions of the PSR. This second exemption comes from the Tester-Hagan Amendment, which was an important win for direct-to-consumer farm and food operations. It is critical that FDA implement the amendment correctly to uphold the intent of the amendment; as discussed below, your voices are needed to accomplish this goal.
The Preventive Controls Rule (PCR) [see footnote 3] applies to facilities that manufacture and process food. If a facility is subject to the PCR, the facility must follow the updated current good manufacturing practices and must create a food safety plan for its operation (called the Hazard Analysis and Risk-Based Preventive Controls (HARP-C) plan). This HARP-C plan basically requires facilities to identify places in their manufacturing and processing activities that might pose a food safety risk, create a plan to prevent those risks, monitor the processes, fix any problems, and keep records of their manufacturing and processing activities.
There are modified requirements and exemptions from the PCR for certain facilities. First, there is a “qualified facility” exemption that scales back some of the requirements certain facilities must meet. A facility will qualify for this exemption if the facility’s annual food sales over the past three years average less than $500,000 and more than half of its sales are direct to consumer (or to another “qualified end-user” that is defined in the PCR). Facilities that qualify for this exemption must comply with the current good manufacturing practices and must create a modified food safety plan. Again, this exemption may be taken away under certain circumstances, and if it is taken away, the facility must come into compliance with all provisions of the PCR.
The second exemption applies to certain operations that are both farms and facilities. These “farm mixed-type facilities” conduct both farming activities and facility activities. Farm mixed-type facilities are subject to both the PSR and the PCR (unless they qualify for an exemption). For example, farms that harvest and pack their own produce fall squarely within the PSR; however, if a farm packs produce from another farm, it will fall under the PCR (because packing and holding produce from another farm is considered a manufacturing/processing activity). The farm mixed-type facility is a complex new entity and it is not always clear when an activity will be considered a farm activity and when it will be considered a facility activity.
FDA has created an exemption from the PCR for certain farm mixed-type facilities: if the farm mixed-type facility is a small or very small business [see footnote 4] and conducts only low-risk activities on the farm (listed in the proposed rule, such as chopping peanuts, making jam, and waxing intact fruits and vegetables), the farm is exempt from the PCR. Additionally, CSAs, farmers markets, and roadside stands should be exempt from the PCR but FDA has failed to make that specific clarification even though it is required by FSMA.
The Main Issues of Concern
These two new proposed rules raise a number of concerns; three of those concerns are discussed below, including recommendations on how to address those concerns. Although many small- and mid-sized operations (both farms and facilities) will qualify for modified requirements under the direct-to-consumer exemption, these qualified exempt operations have the most to lose if their exemptions are withdrawn and they become subject to either rule.
➢ First, according to the proposed rules, FDA can take away an exemption based on two circumstances. An exemption can be taken away if there is a foodborne illness outbreak directly linked to the operation. An exemption can also be taken away if there is information that suggests there is a significant risk of foodborne illness contamination in the operation. In our opinion, the types of situations that might trigger a withdrawal under the second circumstance are not very clear; FDA should be required to justify, with specific scientific information, that an exemption should be taken away due to the risk of a foodborne illness outbreak.
➢ Second, even before FDA starts the process of taking away an exemption, FDA should give the qualified exempt operation a “warning letter” so that the operation can have the opportunity to fix the identified issues. FDA already uses warning letters to give facilities that manufacture and process food a chance to fix the problem(s) before FDA takes more serious legal action, and a similar process should be implemented under the PSR and PCR.
➢ Third, as the rules are currently proposed, once an exemption is taken away, there is no process through which an operation can regain its exempt status. As is noted by FDA, the cost of compliance with the rules is quite high. If a farm is subject to the rule (or is required to come into compliance with the rule), the FDA estimates annual compliance for small farms will be $12,972 [see footnote 5]. Farms that qualify under the Tester-Hagan Amendment will incur some compliance costs as well, although not as high as the cost of full compliance. FDA needs to ensure that farmers and facility operators are not subject to unjustified withdrawal proceedings and, if they do go through the process, FDA should establish a process that qualified exempt operations can use to regain their exempt status.
Suggested Comments to FDA
When a federal agency proposes a new regulation, it must provide the public with a copy of the proposed rule and a certain period of time within which to submit comments to the federal agency. These comments can provide support, express concern or disagreement, and/or suggest changes to the proposed rule. The federal agency will then review the comments and, in the final rule, address the comments of substance that were submitted. The federal government must take into account the number of comments it gets on a certain topic, which means the more comments that are submitted, the better!
In a recent article on Food Safety News, Jenny Scott, senior advisor in FDA’s Office of Food Safety, said that “[FDA] really want[s] to hear about specific situations and concerns and how people would be impacted by the proposed rule" [see footnote 6]. Farmers and food processors, particularly small operations that sell directly to consumers, will be impacted by this rule and therefore should submit written comments to FDA sharing their opinions and comments about the two proposed rules. It is critical that your voices are heard in D.C.
The comments on the Produce Safety Rule and the Preventive Controls Rule are due to FDA by November 15, 2013. Although provisions overlap in the two proposed rules, comments must be submitted separately for the Produce Safety Rule and for the Preventive Controls Rule.
For more information on the proposed rules, the issues of concerns and recommendations, and how you can get involved, visit the National Sustainable Agriculture Coalition’s Food Safety Modernization Act website: http://sustainableagriculture.net/fsma/. NSAC has numerous resources, including email updates, and can help you write your comments to submit to FDA.
2. The non-exhaustive list includes “almonds, apples, apricots, aprium, asian pear, avocados, babaco, bamboo shoots, bananas, Belgian endive, blackberries, blueberries, broccoli, cabbage, cantaloupe, carambola, carrots, cauliflower, celery, cherries, citrus (such as Clementine, grapefruit, lemons, limes, mandarin, oranges, tangerines, tangors, and uniq fruit), cucumbers, curly endive, garlic, grapes, green beans, guava, herbs (such as basil, chives, cilantro, mint, oregano, and parsley), honeydew, kiwifruit, lettuce, mangos, other melons (such as canary, crenshaw and persian), mushrooms, nectarine, onions, papaya, passion fruit, peaches, pears, peas, peppers (such as bell and hot), pineapple, plums, plumcot, radish, raspberries, red currant, scallions, snow peas, spinach, sprouts (such as alfalfa and mung bean), strawberries, summer squash (such as patty pan, yellow and zucchini), tomatoes, walnuts, watercress, and watermelon.” Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, 78 Fed. Reg. 3504, 3629 (Sub. A § 112.1(b)) (proposed Jan. 16, 2013) (to be codified at 21 C.F.R. pts. 16, 112), available at http://www.gpo.gov/fdsys/pkg/FR-2013-01-16/pdf/2013-00123.pdf 3629.
4. “Small business” is defined as a business with less than 500 employees. The FDA is proposing to define “very small business” as one with average annual sales of $250k, $500k, or $1 million. FDA is seeking comment on this issue.
5. U.S. DEP’T OF HEALTH & HUMAN SERV., FOOD & DRUG ADMIN., ANALYSIS OF ECONOMIC IMPACTS‒STANDARDS FOR THE GROWING, HARVESTING, PACKING, AND HOLDING OF PRODUCE FOR HUMAN CONSUMPTION 294-95 (2012), available at http://www.fda.gov/downloads/Food/FoodSafety/FSMA/UCM334116.pdf.
6. Cookson Beecher, Proposed Rule for Food Processors Alarms Some, Confuses Many, July 29, 2013, FOOD SAFETY NEWS, http://www.foodsafetynews.com/2013/07/proposed-rule-for-food-processors-alarms-some-confuses-many/#.UgT9PNKsh8F.