What Do You Need to Know About FDA’s New FSMA rules?

Sophia Kruszewski, Policy Specialist, National Sustainable Agriculture Coalition
Publish Date: 
Winter 2016
Vol. XI No. 1

The U.S. Food and Drug Administration (FDA) recently finalized two major rules - known informally as the “Produce Rule” and the Preventive Controls or “Facilities Rule” - under the Food Safety Modernization Act (FSMA). These rules were the subject of significant grassroots advocacy from the sustainable agriculture community during the drafting or “rulemaking” stage, which resulted in a number of important changes in the final rules. As we enter FSMA’s implementation phase, this article lays out some of the main issues in the rules for farmers.

The information below is only an overview, intended to alert you to the rules’ key issues and point you toward more information specific to your operation. Both NSAC and OSU will have resources available to help you navigate the rules in more detail, and more information will be coming from USDA, FDA, and others to help farmers understand and adapt to new requirements.

What is the Produce Rule?
The Produce Rule sets standards for “covered farms” that are growing, harvesting, packing, and holding “covered produce.” Not all farms will be subject to the new Produce Rule; some will be exempt from all requirements, some may be eligible for modified requirements, and all covered farms have at least two years (if not three or four) to come into compliance.

Exempt Farms
A “covered farm” has more than $25,000 in gross annual produce sales, averaged across a rolling three-year period and adjusted for inflation. So, farms with $25,000 or less in annual gross produce sales (based on a rolling average of three years’ worth of sales and adjusted for inflation), are exempt from the rule. This is often called the “de minimis” exemption. Produce means fruits and vegetables, and includes mushrooms, sprouts, peanuts, tree nuts, and herbs. Food grains primarily grown and processed for use as meal, flour, baked goods, cereals or oils (e.g. barley, dent- or flint-corn, sorghum, oats, rice, rye, wheat, flax seed, rapeseed) are not considered produce. Produce is “covered” by the rule if it is usually consumed raw. FDA has developed a non-exhaustive list of covered produce, and an exhaustive list of produce “rarely consumed raw” and therefore not covered by the rule. In general, you should assume your produce is covered unless you only grow produce on the “rarely consumed raw” list (see the list links in the Resource section). If you only grow produce on FDA’s “rarely consumed raw” list, then this rule doesn’t apply to you, because it isn’t considered “covered” produce. If you only grow grain, this rule doesn’t apply to you because grain isn’t “produce.” If, however, you grow both grains and covered produce, or both covered and not-covered produce, then these requirements would apply to your covered produce.

In addition to the de minimis exemption and the exemption for produce rarely consumed raw, there are also exemptions for produce that is:

1. Grown only for personal or on-farm consumption;
2. Not a raw agricultural product (e.g. as been processed – in which case the Facilities Rule may apply); or
3. Destined for commercial processing.

However, certain assurances and disclosures are required if claiming the exemption for commercial processing.

So, if you grow, harvest, pack, or hold produce usually consumed raw and not destined for commercial processing, and you exceed the $25,000 produce sales threshold, then you are not exempt. However, you may not have to comply with the full Produce Rule if you are “qualified exempt” as explained below.

Qualified Exempt Farms
Farms that exceed $25,000 in produce sales may be eligible for modified requirements as “qualified exempt” farms depending on their size and market channels. To qualify, you must have:1. Less than $500,000 in all food sales (not just produce) based on an average of the previous three years and adjusted for inflation; and2. Sales to “qualified end users” exceeding sales to all other purchasers.

A qualified end user is the consumer (an individual, not a business), or a restaurant or retail food establishment located either in the same state or same tribal reservation, or not more than 275 miles from the farm. So you can do some wholesale, as long as those sales don’t exceed your direct sales.

If you meet these criteria, then you’re eligible for modified requirements, which include maintaining records of your status (how much you sell, who you sell it to) and providing your farm’s name and complete business address on a label or sign at the point of sale.

Qualified exempt farms should also be familiar with the process by which FDA might withdraw or reinstate a qualified exemption.

Covered Farms
Farms exceeding $25,000 in produce sales that are not qualified exempt are “covered farms” and must comply with the full Produce Rule, which includes standards for: employee qualifications and training; worker health and hygiene; water used during growing, harvesting, packing, and holding; biological soil amendments of animal origin (like manure and compost); wild and domesticated animals; equipment and buildings; and post-harvest activities, like packing and holding.

Before getting into detail, it’s important to note that the rules tend to explain what the standard is, but they don’t necessarily explain

How to meet the standard. The “how” may vary from farm to farm, and the rules attempt to provide flexibility for farms to do what’s appropriate for their operation. More detailed information will be coming later from FDA through guidance documents to explain what is intended and required under various components of the rule. Some existing training programs may also be able to fill in the detail needed to understand exactly what to do. These training programs are likely to be modified – and new training projects likely to be developed –

to explain the new FSMA requirements in manners tailored to a wide variety of agricultural operations. Look to your local sustainable agriculture association or University Extension for more information on food safety training.

This article only focuses on a few key requirements related to training, agricultural water, and biological soil amendments.

Training Requirements
There are specific training requirements for farm employees and supervisors, including that at least one “supervisor or responsible party” for your farm take a food safety training course at least equivalent to an FDA-recognized standardized curriculum. FDA is currently working with the Produce Safety Alliance (PSA) to develop a standardized curriculum; however, you are not required to take the PSA training course as long as the training you take covers the FSMA requirements. FDA also plans to support the development of standardized curricula tailored toward local foods producers and Tribal producers. Therefore, you may wish to wait on taking a “FSMA training” until more options become available in the coming months and years better suited to your operation.

Agricultural Water
In addition to general requirements regarding monitoring and maintaining the quality of your water supply and distribution systems, the rule sets specific microbial water quality standards and testing requirements for two categories of water:(1) Water used in harvest and post-harvest activities, and sprout irrigation water; and(2) Water used during growing that is likely or in-tended to contact covered produce. This means the standard doesn’t apply to irrigation methods where the water isn’t intended or likely to contact produce (i.e.drip irrigation of tomatoes).

For harvest and post-harvest water, the microbial standard is no detectable generic E. coli per 100mL, and untreated surface water cannot be used for these purposes.

For irrigation water, the standard is much more complicated. The big take-away is that you can still use water that exceeds the microbial standard as long as you wait a period of time (in days) to allow for the natural reduction in generic E. coli to bring you within the threshold. You calculate the necessary number of days by determining your water quality profile and applying what’s called a “die-off rate.”

FDA has provided a die-off rate of 0.5 log reduction per day, which assumes a roughly 67% reduction in generic E. coli on the surface of the crop each day due to natural causes (e.g. sunlight, moisture, temperature). You do not have to test to verify that the die-off rate is accurate, as long as you keep records of your calculation and the length of time you waited between irrigation and harvest.

However, if it would take more than 4 days for the microbial die-off to bring you below the microbial standard, then you cannot irrigate covered produce with that water unless you switch to an irrigation method where the water is unlikely to contact the harvestable portion of the crop, or you treat the water.

If this confuses you, you aren’t alone. It’s a complicated concept, and FDA intends to provide guidance and tools to help farmers calculate the water quality profile and the appropriate number of days that they need to wait between the end of irrigation and harvest.

Testing Frequencies
Testing requirements follow a three-tiered approach:(1) Start by calculating your baseline water quality profile based on a certain number of samples (4 for groundwater, 20 for surface water – collected over a period of 2-4 years). That profile tells you if you exceed the threshold, and whether you need to take some action before using that water (i.e. wait a number of days between irrigation and harvest; switch irrigation methods; or treat the water);(2) Take annual samples (1 for groundwater, 5 for surface water) to verify your baseline.(3) Use the 5 new samples and the previous three years’ 15 samples on a rolling basis to recalculate the baseline and determine if any changes in use are needed.

Again, it’s complicated. But all farms have at least 4 years to come into compliance with these requirements, giving time for additional information, training, and technical assistance to become available, including research that may support alternative standards and testing frequencies based on regional variations or other factors.

When do you need to be in compliance?
As mentioned above, all farms have at least two years to come into compliance, and smaller operations have as many as three or four years. These are all based on gross annual produce sales, based on a rolling three-year average:(1) No more than $250,000 (“very small business”): four years – January 2020.(2) No more than $500,000 (“small business”): three years – January 2019.(3) More than $500,000: two years – January 2018.

For the water standard requirements related to taking samples and calculating your water profile, you have two additional years to comply.

Biological Soil Amendments of Animal Origin
The rule establishes handling, storage, transportation, and application requirements for animal manure – raw or composted – or other animal-based amendments (like fish emulsion).

A major change in the final rule is that the compost application standards are now essentially aligned with the National Organic Program (NOP) requirements: no restrictions, as long as the manure has been properly composted. For untreated manure applied in a manner where there is some potential for contact after application, FDA deferred finalizing the application interval while they conduct research and a risk assessment to justify an appropriate application interval; they will re-propose that interval sometime in the next 5-10 years. This decision resulted from significant comments from farmers and others regarding potential conflict with the NOP, and the lack of a robust scientific justification, for the originally proposed 9-month application interval. As FDA develops this interval, certified organic farmers are expected to continue following the NOP standards regarding the application of raw manure (90-120 days, depending on the application method), and others may also choose to follow the same standard as a prudent interim measure.

Many growers are probably already satisfying many of these requirements. The biggest change is likely the water testing and the recordkeeping requirements. In addition to the sales records needed to justify your status, there are record requirements for many of the rule’s standards. Now is a good time to start thinking about or seeking information on good systems for keeping track of your records in the least burdensome way.

Preventive Controls Rule for Facilities
As mentioned above, the Facilities Rule may also apply to some farms in certain circumstances, whether or not they are also subject to the Produce Rule. Whether the Facilities Rule applies to you is largely determined by FDA’s definition of “farm.” This definition includes both primary production farms and secondary activities farms (like a farmer cooperative aggregating produce for distribution not located on a farm), and some limited processing activities, like drying herbs or packaging/labeling products.

If you meet FDA’s definition of “farm,” then this rule doesn’t apply to you. If you do not – you are chopping or peeling produce; milling flour; making jam – then you may be considered a “farm mixed-type facility” that is required to register with FDA as a facility and is subject to the rule. However, you could still be exempt as a “retail food establishment” if the majority of your sales are direct to consumers through farm stands, CSAs, farmer markets, or other direct marketing platforms.

Even if you are not exempt as a farm or a retail food establishment, you may not have to follow the full requirements if you have less than $1 million in food sales and/or are only doing on-farm value-added processing considered “low risk” (e.g. making maple syrup, milling flour).

FDA is currently working on a guidance document focused on which activities fit within the “farm” definition and which do not to aid farmers in understanding whether this rule applies to them. NSAC also has a flow chart that walks farmers through questions to determine whether this rule (or the Produce Rule) applies.

Now what?
Remember: you have time to figure out whether and to what extent these rules apply to you. The goal of this overview is to give you an idea of what’s required, and what additional questions you need answered. I’m sure there are still many. NSAC, FDA, USDA, OSU and others will be providing information and resources for training and technical assistance in the coming months, so stay tuned, stay engaged, and check out the FSMA

FSMA Resources