August 31, 2016
This fall, many food and farm operations subject to the Food and Drug Administration’s (FDA) Food Safety Modernization Act (FMA) Preventive Controls Rule were expected to be coming into compliance with the new food safety requirements for food facilities. However, with significant confusion persisting, particularly over whether a farm is or is not a facility that must register with FDA, some of the compliance dates have now been extended for certain farms and food facilities.
According to FDA, these extensions are necessary “to address concerns about the practicality of compliance with certain provisions, consider changes to the regulatory text, and better align compliance dates across the rules.”
Compliance dates have been extended for more than just the Preventive Controls Rule. Of particular importance for the sustainable agriculture community, FDA has extended compliance deadlines for:
Such operations are now held to the same compliance timelines as farms covered by the Produce Rule for similar activities:
Remember that these extended dates do not apply if the operation is doing any manufacturing or processing of the produce.
FDA’s definition of “farm” establishes two types of farms that are exempt from registration (and therefore from the Preventive Controls Rule requirements): primary production farms, and secondary activities farms. Secondary activities farms can be located off-farm and conduct all the same activities as farms (i.e. pack and hold raw agricultural commodities – or “RACs” — and some limited processing activities). Like primary production farms, secondary activities farms are also exempt from registering as long as the majority of the RACs packed and held come from primary production farms that have a majority ownership interest in the secondary activities farm.
If that seems confusing to you, you aren’t alone. FDA has received numerous questions regarding the many kinds of ownership scenarios that do not fit neatly into this definition.
To address the confusion, FDA has issued draft guidance for public comment on the issue, and is considering undertaking a focused rulemaking to add more clarity to the “farm” definition and address this ownership issue.
In the meantime, FDA is extending the compliance timeline for operations that would be secondary activities farms, but they don’t meet the majority ownership requirement.
To qualify for the extension, you therefore must satisfy the following requirements:
According to FDA, examples of common ownership include:
These are just a few examples of situations where there is no majority ownership of the secondary activities farm by the primary production farm(s) – though there is a close relationship between them – and therefore they are not exempt from registering with FDA or from compliance with the Preventive Controls Rule. There may be other scenarios that would qualify for the extended compliance timelines due to the common ownership between the primary production and secondary activities farm.
The final rule also contains additional detail on how covered farms can take water samples to meet the Produce Rule’s testing requirements. This is not a new compliance date, but rather a clarification of the originally-established staggered timeline that gave farmers extra time to come into compliance with new water testing requirements. As a reminder, this part of the rule requires covered farms to establish a “microbial water quality profile” based on a series of water samples, and then adjust their practices accordingly (for more information on these aspects of the Produce Rule, please see our Special Report: Understanding FDA’s FSMA Rule for Produce Farms).
As it stands, the compliance date to establish the baseline water quality profile is two years after a covered farm’s general compliance timeline, and must be based on at least 20 samples collected over no less than two and no more than four years.
These compliance timelines are as follows:
However, in the new rule, FDA clarifies that farms do not have to have all 20 samples collected by the extended compliance date, because farms can take up to four years to collect the necessary samples.
For example, a farm could take 5 samples each year over four years to establish its baseline. It could also take 10 samples each year for two years; or 6 samples in one year and seven in each of the next two years, etc. But for the purpose of this example, let’s say the farm is taking the maximum allowable time to collect its samples. So, a large farm could start collecting samples in its first year of compliance (2018) and then would not have to calculate its microbial water quality baseline profile until 2021, after all 20 samples have been taken. If it’s a small farm under the same scenario, then they would start collecting samples in 2019 and the microbial water quality profile wouldn’t be calculated until 2022. If the farm is very small, then it would start in 2020 and it would be 2023 by the time the microbial water quality criteria is calculated.
Under this rule, therefore, there is presumably additional time – particularly for small and very small farms – to collect water samples, allowing farmers to wait until more information and resources are available to assist them in doing so.
You can learn more about how the extended compliance dates impact operations covered by the Foreign Supplier Verification Program and the Animal Food Preventive Controls Rule here.
FDA also recently issued two draft guidance documents for public comment on the Preventive Controls Rule: one that provides additional detail and interpretation of food safety requirements (aka HARPC) for food processors, and another that looks at the “farm” definition (which determines which operations must register with FDA and are therefore subject to the Preventive Controls Rule). NSAC is currently analyzing these draft guidance documents, and will provide more detail soon.
For more information on whether and how the FSMA rules apply to farms and food businesses, check out our new Special Reports.