This post is part one in a two-part series.
The final Food Safety Modernization Act (FSMA) rule for produce safety, formally known as the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption rule, is probably one of the more technical rules within FSMA. This rule not only applies safety standards to produce for the very first time, but now there’s a dense amount of technical detail.
To help us better understand the Produce Safety rule, we enlisted the help of Marc Sanchez, regulatory attorney at FDA Atty, to break it down for us in our June FSMA Club webinar.
This article aims to take a very high-level view of the rule and help you get some sense of what the goal of the rule is, how it’s meant to function, and help you begin to understand how to develop a strategy for compliance that’s unique to the produce you grow, leaving those technical details for you to solve as you go through and apply the rule.
Does this rule even apply to your operation? As the formal title of this rule suggests, FDA is applying this particular rule to produce, which can also be referred to as Raw-Agricultural-Commodities—foods in their raw or natural state and obviously for human consumption. Additionally, this rule is going to apply whether the produce is imported or grown/harvested domestically.
Covered under the Rule:
- Domestic and imported produce
- Produce for human consumption
Excluded from the Rule:
- Personal on-farm consumption
- Not Raw-Agricultural-Commodities (RACs)
- Specified produce “rarely consumed raw” (e.g. pumpkin, navy beans, coffee beans, etc.)
- Farms with sales under $25,000 per year
- There is a calculation in the rule that looks at the annual average value of produce sold over the previous three-year period
Even though these exemptions seem like an easy way to say the rule doesn’t apply to you, you really need to look into the details of the exemptions to ensure you’re correct in your reasoning, not only to claim exemption the first time around, but to continuously ensure that exemption is still being met as time passes.
Definition of a Farm Clarified
One thing you’ll notice with this rule is the amount of discussion around farms, which the FDA addressed with a harmonized definition between this rule and the other FSMA rules. We discussed the differences between a primary production farm and a secondary activities farm in a previous post, but these same definitions apply to this rule as well.
There is a great flowchart the FDA created titled Coverage and Exemptions/Exclusions Flowchart, which helps to capture the information listed under the exclusions and exemptions in a visual format that is easy to follow and understand.
One of the keys to determining coverage under the definition of a farm is to look at activities. The official title of the rule basically captures the activities included within the rule: growing, harvesting, packing, and holding. These are the activities the FDA expects a farm to conduct, but there are some limited amounts of activities a farm can do in addition to what it’s currently doing that don’t push past the farm idea. For example, you can do a limited amount of dehydrating and packing.
Certain activities, however, do start to go outside of what the FDA expects a farm to be doing. A couple of examples of these include pitting plums and making bean chips. It’s a big spectrum, but you can see that simple things like pitting and chopping can even put you outside this rule and into compliance requirements for another FSMA rule.
Qualified Exemptions and Flexibility
Qualified exemptions and flexibility under this rule are going to have the same caveat as the farm definitions. These exemptions are technical and are going to require a review of the rule and an application of the rule.
These exemptions include:
- Full Exemption: Produce that will receive commercial processing (kill step or other process to minimize hazards)
- This is produce that’s never really meant to get to the consumer
The rule requires written assurances that the company receiving the produce will initiate the kill step and minimize hazards. It also requires disclosure in that the produce has not been processed to reduce the presence of microorganisms and requires documentation of this as well.
- Qualified Exemption: Modifies requirements rather than excludes facilities from coverage
- Annual food sales under $500,000
- Majority of food sales to “qualified end users”
An example of a qualified end user can be restaurants that are located within 275 miles from the farm. This is an exemption that modifies requirements, but doesn’t exclude the requirements and there are instances where the FDA can revoke the modification status in the interest of public health.
- Flexibility: State, tribe, foreign government may petition for variances and farms may petition for alternatives if scientific information demonstrates same level of protection
Standards for Produce Safety
This is the heart of the Produce Safety rule with the real focus on microbial contamination. This rule is interesting because it’s narrow and diverse. It’s narrow in that for the first time with FSMA, the FDA is focusing on produce as opposed to all food that the FDA regulates. But this narrow field of produce is also incredibly broad. So even though this rule is focused on produce, there is a whole range of produce grown and a whole set of different activities for each.
The narrow scope, however, allows the FDA to bring in some more technical standards to be applied based on the harvesting method, the packing method, and so forth. There are six core areas, but in this post, we’ll focus on agricultural water and biological soil amendments of animal origin. Our second post will cover the rest.
When you look at the framework of this rule, it should look familiar in the sense that FDA is looking at a farm the way it would a manufacturing facility. Like with a manufacturing facility, you’re going to take the same compliance mindset and determine where the microbial contamination can occur and determine the necessary steps you can take to mitigate these risks.
Standards for Safe and Sanitary Water
One of the places the FDA focuses on, and one that’s not very well-liked is agricultural water. There were a lot of comments on both the initial proposed rule and the revised proposed rule.
The purpose, however, is to make sure that the water you’re using is free from fecal contamination, and in some cases, you’re going to be looking at treated water and untreated water that maybe needs to be treated. This standard addresses both of those and what’s it’s asking the farm to do is:
- Identify the hazard associated with watering
- Predict those foreseeable hazards that could come into contact with the produce or food contact surfaces
However, how you use that water depends on how it needs to be handled. If you’re using the water for growing, it needs to follow one standard. If you’re using it for other activities (anything from washing produce to washing hands), that’s going to set a different standard or stringency.
This is where the math comes in. If you’re looking at water for growing, there’s a statistical standard the FDA is looking at for the threshold of E. coli that can be permitted in the growing water. But if you’re talking about water that is being used to wash the produce or wash the hands, the FDA states that there can be no detectable generic E. coli present.
So this part of the rule is setting testing requirements, frequency, and establishing steps to follow if water does not meet the set testing requirements, which includes treating the water if needed. So you’re building a microbial water quality profile for the water in your control within your operation and giving it a different weight if it’s used for growing versus if it’s used for other purposes.
Standards for Treated and Untreated Soil Amendments
The FDA identifies two components to this particular standard. One is raw manure with requirements around contact with produce and also the interval between applications and harvest. One model to use when looking at intervals for application is the USDA Natural Organic Program (NOP) standard which the FDA recommends to help minimize the risk of contamination. This program uses a 90-day and 120-day interval rule depending on whether the crop is in contact with the soil or not.
With this component, the FDA is wanting to set microbial standards in composting methods that are also validated to ensure the microbial standards are met. There’s some flexibility when determining what composting method can be used, but you then have to demonstrate that the chosen method is safe. If you’d like feedback regarding a particular composting method you use, make sure to check the comments section of the published rule to see if the FDA addresses your method directly.
Additionally, the storage, handling, and location is still a part of having biological soil amendments on the farm, and making sure that it’s stored properly, handled properly, and not leading to cross contamination.
Let’s Talk About Sprouts
Sprouts are interesting because they singled out, which is unique within these FSMA rules, but it’s rightly singled out. Sprouts are predominantly, if not solely, eaten raw and they are highly associated with outbreaks. The FDA provides some frequency of outbreaks within the rule (43 outbreaks between 1996 and 2014, roughly three outbreaks a year).
The core requirements for sprouts basically focus on testing and minimizing the presence of Listeria as well as other microbials. One of the key components in this is to have a written sampling plan and a corrective action plan on spent irrigation water.
The FDA has determined that if you’re looking at the spent irrigation water, you’re going to be able to determine if Listeria is present in the growing process and could potentially end up on the sprouts themselves.
One of the very unique features of this particular standard is the express hold and release requirement. FDA states that you cannot release or sell any sprout unless you’ve held it, tested the irrigation spent water, and received negative results. You don’t see this type of requirement anywhere else within FSMA, and that speaks volumes to the concern the FDA has with sprouts based on its past.
If you’d like more information on the Produce Safety rule, take a look at our on-demand webinar, Produce Safety: An In-Depth Analysis (Part 1)!