FSMA Produce Safety and Preventive Controls Regulations: How Do They Apply?

This article reviews the basics for Produce Safety and Preventive Controls and provides some information on how they may affect the mushroom industry.
FSMA Produce Safety and Preventive Controls Regulations: How Do They Apply? - Articles


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 8 regulations issued under the law in 2015 and 2016, 2 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). There still is some uncertainty about the content and impact of these two regulations. In this article, we’ll go over the basics for each 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 are covered. Practices, policies, control measures, and in some instances, microbial metrics are mandated for reducing food safety risks in several key areas which will be described below. 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. However, 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 will be regulated. FDA requires that crop-contact water samples contain no more than a geometric mean of 126 cells of generic E. coli per 100 mL with a statistical threshold value (STV) of no more than 410 CFU E. coli per 100 mL of water. A geometric mean is an average obtained from bacterial population counts that have been converted to logarithmic values. The STV essentially means that no more than 10% of your samples may contain more than 410 E. coli CFU per100 mL. Postharvest water standards are clearer; no detectable levels of E. coli are allowed. This is nothing new for mushroom growers since surface water (e.g. ponds, rivers, creeks), which can often contain high levels of E. coli, is not permitted under MGAP standards. Lower risk well or municipal water containing no E. coli is already the industry standard for irrigation and cleaning. As an additional safeguard, many growers treat their agricultural water with a sanitizer to avoid any possibility for E. coli to occur.

FDA has established minimum testing frequencies for untreated agricultural water. You must initially develop a baseline water quality profile consisting of at least 4 samples taken over 1 year. If, after that first year, your water is within the GM and STV E. coli limits, you only have to take one sample each year to update your water quality profile. If annual testing shows your water is not in compliance with the standard, you must develop a new 4 sample baseline water quality profile as described above. Growers who continuously treat their well water with an EPA approved sanitizer are not required to establish a baseline water quality profile. However, they must periodically monitor sanitizer levels to assure that the treated water is consistently safe. There are no testing or treatment requirements for water obtained from a public municipal water source.

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. Composting processes that reach uniformly high temperatures is one way for farmers to eliminate risks associated with the use of manure based soil amendments, although few have actually done the research necessary to validate the efficacy of these methods. Mushroom substrate prepared from ingredients that include raw animal manure is regulated under the Produce Safety Rule.

Fortunately, research carried out at Penn State (Weil et al. 2013, LaBorde 2013) has already 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 are, however, required to 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 rest room; 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. FDA has signaled that an approved food safety curriculum will be available in fall of 2016 and Penn State Extension will be offering certification courses. However, much of the content may not be applicable to the unique practices required for growing mushrooms and we are awaiting guidance from FDA on how this curriculum can be adapted to specific commodities.


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 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.

Compliance dates

Phase-in periods for compliance with the Produce Safety Rule are based on 3 year average annual produce sales within FDA defined categories. The starting time for the phase-in periods started on November 27, 2015, the date the regulation was published in the Federal Register. Very small businesses with annual sales greater than $25,000 but no more than $250,000 have 4 years to begin compliance (January 2019). Small businesses with average annual produce sales greater than $250,000 but no more than $500,000 had 3 years (January 2018). All other businesses had 2 years (January 2017) to comply. An additional two years beyond each of these compliance dates is allowed for enforcement of agricultural water standards.

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 a 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.

Adapted from an image in “Preventive Controls for Human Food Participation Manual. First edition. 2015. Food Safety Preventive Controls Alliance.

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 a 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. At least one responsible person must have the knowledge necessary to prepare the food safety plan, develop the hazard analysis, validate the preventive controls, review records, and conduct a reanalysis of the food safety plan (or oversee these activities). This qualification can be met by attending an FDA approved training curriculum or otherwise obtain the required knowledge through job experience. Penn State Extension has several individuals who have received certification as qualified lead trainers and Preventive Controls workshops are offered regularly.


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.

Compliance dates

The starting time for compliance with the rule starts earlier than that for the Produce Rule, and the phase in periods are shorter. To date, the deadline for all food businesses has passed and all mushroom packing and slicing operations should not delay in making preparations for meeting applicable requirements in the Preventive Controls Rule.

It is probably apparent to you now that these regulations are not at all simple. But each company should make sure they understand what is expected of them and when enforcement begins. FDA has plans to develop fact sheets to clarify some of the complex requirements and Penn State Extension will provide regular updates at mushroom training events and conferences. Watch for further information updates at FDA’s FSMA website or visit the Penn State Food Safety and Quality website.


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.