FSMA Produce Safety and Preventive Controls Regulations: How Do They Apply?
The 2011 U.S. Food Safety Modernization Act (FSMA) mandates science based approaches to evaluating food safety risks on produce farms and in food processing facilities. Among the eight regulations issued under the law in 2015 and 2016, two will be discussed in this article; “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption" (Produce Safety Rule) and “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food" (Preventive Controls Rule). In this article, we'll go over the basics for each of these rules and provide some information on how they may or may not affect the mushroom industry.
The Produce Safety Rule
This regulation is particularly significant because, for the first time, Congress granted authority to the U.S. Food and Drug Administration (FDA) to develop and enforce farm food safety standards for commercial growers, harvesters, and packers of fruits, vegetables, mushrooms, and sprouts. Only produce that FDA has deemed as likely to be eaten raw and that are grown on farms with greater than $25,000 in produce sales (adjusted annually for inflation) are covered. Practices, policies, control measures, and in some instances, microbial metrics are mandated for reducing food safety risks in several key areas. After reviewing of the FDA requirements, it is apparent that the industry-driven standards established in the Mushroom Good Agriculture Practices (MGAP) program meet or exceed most of the requirements in the Produce Safety Rule. However, some mushroom growers may be indirectly affected by the Preventive Controls Rule (described later in this article) if their wholesale packer or processor buyers are required, under that regulation, to develop supply chain food safety standards for the mushrooms they purchase.
Agricultural water
Good Agricultural Practices (GAP) generally require that any water used for irrigation and post-harvest washing should be appropriately safe for its intended use. The Produce Safety Rule only applies to pre- or post-harvest water that is intended to or likely to contact the crop or crop-contact surfaces. Since mushrooms are typically irrigated with spray methods, the quality of the water used for this purpose is regulated.
FDA initially required growers to periodically monitor the quality of pre- and postharvest agricultural water through microbiological testing. However, in 2024, FDA revised its requirements for evaluating the safety of agricultural water. Testing pre-harvest agricultural water for generic E. coli concentration is no longer required, although it is a regulatory option for some situations and can be helpful in identifying trends. FDA’s new approach is that water test results are not to be used as the sole factor when making use decisions for pre-harvest agricultural water. Instead, the new ruling places more emphasis on considering factors such the location and nature of the water source, how it is applied, and surrounding the environment. A pre-harvest agricultural water assessment must now to be at least once a year. Already, the industry standard is to use water obtained from wells for crop irrigation. Postharvest water standards are no detectable levels of E. coli are allowed. As an additional safeguard, many growers treat their agricultural water with a sanitizer to avoid any possibility for E. coli to occur. Compliance dates start April 07, 2025, for farms that sell more than $500,000 total food per year (three-year rolling average) and are staggered by business size class, as in other parts of the Produce Safety Rule. FDA indicates there may be updates to this revision as they obtain more data.
Raw and composted animal manure
FDA's main concern is when raw or incompletely composted animal manure that may contain human pathogens is applied to soil in a manner that can cause crop contamination. The Produce Safety Rule (21 CFR Part 112) requires that biological soil amendments of animal origin, such as raw manure, may not come into contact with PSR-covered crops unless they are treated using a physical, chemical, or biological process validated to ensure pathogen reductions to acceptable levels. The common use of poultry manure in Agaricus bisporus mushroom substrate formulations is therefore regulated under the Produce Safety Rule.
Fortunately, research carried out at Penn State (Weil et al. 2013, LaBorde 2013) has demonstrated complete elimination of L. monocytogenes, E. coli O157:H7, and Salmonella spp. during a standard 6-day phase 2 composting process that includes a pasteurization step of at least 140°F for 2 hours. After reviewing the results of this study, FDA has indicated that phase 2 composting serves as an example of a validated controlled physical process that meets the most stringent microbial standard established in the FDA Produce Safety Rule. They further state that the finished substrate may be used without any requirement for microbial testing or application interval restrictions. Growers must maintain composting temperature and time records for each batch as well as provide documentation that the finished compost is handled, conveyed, and stored in a manner that prevents it from becoming a source of contamination. For compost purchased from third parties, growers must obtain documentation from the supplier (such as a Certificate of Conformance) at least annually that attests to their using a scientifically validated process, and that it has been handled, conveyed, and stored in a manner and location that minimizes the risk of contamination.
Domestic and wild animals
FDA is concerned about the possibility that intrusion of wild and domestic animals into fields could result in fecal contamination of produce. This is not a significant issue for mushrooms because they are grown indoors and are thus protected from animal intrusion.
Worker health and hygiene practices
Requirements in this category include taking measures to prevent contamination of produce and food-contact surfaces by ill or infected persons; requiring produce handlers to follow hygienic practices, such as hand washing after using the restroom; providing an adequate number of properly supplied toilet and hand-washing facilities; and taking measures to prevent visitors from becoming a source of contamination. These are already addressed in MGAP standards and mushroom growers who follow them should have no problems with the FDA standards.
Growing, harvesting, and post-harvest practices
This section describes standards for preventing environmental contamination of produce and food contact surfaces from inadequately cleaned and sanitized toilet and hand-washing facilities, production equipment, tools, packing containers, and buildings. The necessity for regular cleaning and sanitizing of food and non-food contact surfaces is emphasized. This may be new to some produce growers, but mushroom growers who diligently follow MGAP or other audit standards should be well prepared to meet these FDA standards.
Training requirements
Training is required at two levels. Growers are responsible for making sure that farm workers who handle produce, as well as their supervisors, are trained on the importance of health and hygiene and that they have obtained training, education, or have the experience necessary to perform their currently assigned duties. This could include in-house training or attendance at industry food safety training workshops or seminars. Worker training materials available from the American Mushroom Institute (AMI) are an excellent choice for meeting this standard. In addition to this requirement, at least one supervisor or responsible party must have successfully completed food safety training using a standardized FDA-approved curriculum. Penn State Extension regularly offers certification training using the curriculum developed by the Produce Safety Alliance. Application of the PSR to the mushroom industry is discussed and sessions are offered in Spanish.
Exemptions
The rule provides an exemption for produce that will be commercially processed in a manner that can reduce harmful microorganisms to safe levels. This would apply to mushrooms intended for canning or for freezing provided the processor provides evidence that adequate reductions occur. Other exemptions are available for farms with food sales greater than $25,000 but no more than $500,000 (adjusted each year for inflation) as long as the majority of sales are to either (a) the consumer of the food or (b) a restaurant or retail food establishment that is located in the same state as the farm or not more than 275 miles away. Given the marketing structure of the mushroom industry in the United States, this exemption category is not likely to be available to most growers of fresh mushrooms.
The Preventive Controls for Human Food Rule
All facilities that manufacture/process, pack, or hold foods for human consumption are covered under this rule. Raw agricultural commodities, including mushrooms, are considered processed if they have been washed, cut (not including trimming inedible parts during harvesting), packaged (including under modified atmosphere), thermally processed (including canning), frozen, or dried. Packing is defined as placing food into containers other than that which the consumer receives at the grocery store.
FDA considers on- and off-farm packing operations where at least half of the packed produce is grown and harvested on a farm under the same ownership as fitting within their definition of a “farm". These types of operations are not covered under the Preventive Controls Rule (although they may be covered under the Produce Safety Rule). However, off-farm packing houses where more than half of the packed produce is grown on farms under different ownership are covered under the Preventive Controls Rule. This distinction means that many off-farm mushroom packers who source product from multiple farms that they do not own can expect to be covered under this rule. As indicated by the full title of the rule, there are two main sections, Good Manufacturing Practices (GMP) and Hazard Analysis and Risk-Based Preventive Controls. We'll go over a brief description of each.
Good Manufacturing Practices (GMP)
GMPs are not new to food processors. They are a broad set of sanitation standards, first issued nearly 50 years ago, for worker health, hygiene, facilities, and equipment design, and prevention of cross-contamination. All non-farm facilities that process, pack, or hold food must comply with GMP standards. In the Preventive Controls rule, GMPs have been updated to take into consideration advancements in processing technology and the emergence of previously unrecognized food safety hazards, such as food allergens. FDA now requires documented proof that workers who are responsible for identifying sanitation failures or food contamination should have a basic level of competency necessary for producing safe food.
Hazards and Risk-Based Preventive Controls
This section pertains to requirements for establishing and implementing a written preventive controls food safety system. A diagram that summarizes FDA's point of view of what constitutes an overall food safety system and what is included in a preventive controls food safety plan is shown in Figure 1. Their approach has much in common with the traditional Hazards Analysis Critical Control Point (HACCP) approach. A preventive controls plan must include a written hazard analysis that identifies any significant potential biological, chemical, and physical hazards that require process controls in the food safety plan. Lower risk hazards not designated as significant can be controlled outside of the preventive controls framework and under prerequisite or GMP programs. Like HACCP, monitoring, corrective actions, and verification procedures are part of a preventive controls plan. However, FDA's new approach to identifying and controlling potential hazards is broader than what you may have learned in a HACCP course. In addition to controlling significant hazards at process control steps (CCPs), you are required to establish preventive controls for food allergens, sanitation practices, and incoming materials and ingredients as supply-chain controls where appropriate.
Figure 1. The Preventive Food Safety System.
FDA states that environmental microbial monitoring generally would be required if contamination of a ready-to-eat food with an environmental pathogen, such as Listeria monocytogenes, is a hazard requiring preventive control. Given the increasing numbers of fresh produce recalls and outbreaks in the last several years, it is likely that most fresh produce packing and slicing facilities, including fresh mushroom packing and processing facilities, will be required to have a Listeria monocytogenes environmental monitoring program and to develop sanitation preventive controls that reduce the possibility for food-contact surface contamination to occur.
Training requirements
Similar to the Produce Safety Rule, training is required at two levels. All food handlers and supervisors are required to receive GMP training that includes the basic principles of employee health and hygiene. Each covered facility is required to have a preventive controls qualified individual (PCQI) in place to evaluate foreseeable hazards; identify and implement appropriate process, allergen, sanitation, and supply chain controls; and oversee monitoring, verification, and record-keeping activities. To become a PCQI, an individual must be able to demonstrate expertise in risk-based food safety management through on-the-job experience or by attending an FDA-recognized training course, such as that developed by the Food Safety Preventive Controls Alliance (FSPCA). Penn State Extension offers regular FSPCA Preventive Controls workshops throughout Pennsylvania each year.
Exemptions
Although all must comply with GMP standards, not everyone covered under the Preventive Controls Rule has to develop and implement a preventive controls food safety plan. Only facilities with average yearly food sales of less than $1,000,000 in food sales plus the value of inventory are not subject to all parts of the rule. However, those qualifying for an exemption must show evidence that they have identified potential hazards associated with their food products and have implemented preventive controls to address those hazards. Similar modified requirements are available for facilities with less than $500,000 in total annual food sales and, more than half of sales to certain local direct end users (e.g. consumers, grocery stores, and food service establishments). It seems likely, though, that most mushroom packing and processing facilities will not be eligible for these exemptions. And even if they were, wholesale buyers are not likely to settle for anything less than the standards established in current federal regulations.
For information on other FSMA regulations and updates as well as upcoming training opportunities, visit the Penn State Extension FSMA website.
References
Food and Drug Administration (FDA). 2015. Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food. 21 CFR Part 117. September 17, 2015.
Food and Drug Administration (FDA). 2015. Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption. 21 CFR Part 112. November 27, 2015.
LaBorde LF. 2013. Impact of FDA Produce Safety Standards on Mushroom Substrate Composting. Mushroom News. 61(9):10-13. September 2013.
Weil JD, Cutter CN, Beelman RB, LaBorde LF. 2013. Inactivation of human pathogens during phase II composting of manure-based mushroom growth substrate. Journal of Food Protection, 76:1393–1400.
Originally printed in Mushroom News Magazine, September 2016. Updated August 2024.
