The first key compliance date for the Preventive Controls Rule, one of the main provisions of the Food Safety Modernization Act (FSMA), is just around the corner. This rule, which will largely impact food processors and manufacturers, and may impact some farms engaged in value-added processing and related activities, will require compliance for many businesses on September 19, 2016. Though some businesses may not need to comply until later dates because of a staggered compliance schedule based on the size of the business as defined by the rule.
While this rule will still require compliance as previously planned in most cases, FDA recently released compliance date extensions and clarifications for specific issues in four of the seven major FSMA rules. Two of the four rules for which there are updates include the Preventive Controls Rule and the Produce Safety Rule, both of which will impact many farmers and processors in New England.
FDA announced it is “extending the compliance dates 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.” The agency’s most concise explanation of the compliance date extensions can be found here. A more thorough accounting of the updates are offered below.
Again, not all compliance dates are being extended; only a specific set of dates have been altered. The following information will explain changes most relevant to farmers and processors in New England.
Compliance date extensions for facilities that only pack and/or hold raw agricultural commodities that are produce and/or nut hulls and shells
Compliance dates have been extended for facilities that are covered by the Preventive Controls Rule for Human Food (and also Animal Food), including Current Good Manufacturing Practices (CGMPs), and are solely engaged in packing and/or holding raw agricultural commodities. For example, some packing houses and food hubs may be impacted by this extension. This extension also includes facilities that hull, shell, pack and/or hold nuts.
Note that this extension only applies to operations solely packing and/or holding raw agricultural commodities. Thus, operations involved in manufacturing and/or processing activities are not covered by the extension.
Summary of the revised compliance dates:
- Very small businesses (less than $1 million in food sales): January 27, 2020
- Small businesses ($1 million or more in sales but fewer than 500 employees): January 28, 2019
- All other operations: January 26, 2018
Compliance date extensions for facilities that would have qualified as “secondary activities farms” due to close affiliation with “primary production farms,” but do not satisfy the ownership requirement
Understanding this extension first requires defining the terms primary production farm and secondary activities farm, which are terms used in the Preventive Controls Rule.
In this rule, FDA has a special definition of “farm”; an operation is a farm, and thus exempt from the Preventive Controls Rule (or, more specifically, exempt from registering with FDA as a “facility,” and thus exempt from the rule), if it satisfies the definition of either primary production farm or secondary activities farm.
Primary production farms are what you would imagine: entities devoted to growing of crops, the harvesting of crops, the raising of animals (including seafood), or any combination of these activities. They may also pack and hold these products, and even engage in limited manufacturing or processing activities, as long as these activities do not change the raw agricultural product into a processed product (for example, these farms can dry/dehydrate grapes to produce raisins, but cannot slice apples and then dry/dehydrate them – the latter is a processed product). Primary production farms must also be under one management, in one general (but not necessarily contiguous) physical location.
A secondary activities farm is an entity located off of or away from a primary production farm, but that otherwise can conduct all the same activities as farms (i.e. pack and hold raw agricultural commodities and conduct limited subset of processing activities).
Primary production farms and secondary activities farms are both exempt from registering as facilities under the Preventive Controls Rule. But, for an entity to actually meet the definition of secondary activities farm, the majority of the raw agricultural commodities packed and held must come from a primary production farm, or group of primary production arms, that have a majority ownership interest in the secondary activities farm. It is potential problems with this ownership provision that has spurred extension of compliance dates.
FDA recognizes that this “farm” definition is confusing and may not sufficiently capture the various ownership structures that exist in practice. Thus it is both (a) extending the compliance timeline for operations that would qualify as secondary activities farms except that they do not meet the ownership requirement and (b) it has issued draft guidance for public comment on the issue, which may result in a revision of the “farm” definition.
For example, some operations that might otherwise qualify as secondary activities farms own the primary production farm, rather than being owned by the primary production farm as currently required. Or they are not owned by (and do not own) the primary production farm but are majority owned by the same entity as the primary production farm.
The extension is applicable only to an operation satisfying all of the following requirements: (1) the operation is not located on a primary production farm; (2) the operation is devoted to harvesting, packing, and/or holding of raw agricultural commodities; and (3) the operation is under common ownership with the primary production farm(s) that grows, harvests, and/or raises the majority of the RACs harvested packed, and/or held by the operation.
Summary of the revised compliance dates:
- Very Small Businesses (less than $1 million in food sales): January 27, 2020
- Small Businesses ($1 million or more in sales but fewer than 500 employees): January 28, 2019
- Other businesses: January 26, 2018
Clarifications, including the compliance timeline, regarding agricultural water testing (specifically for testing of untreated surface water) for covered farms in the Produce Safety Rule
The FDA is clarifying that farms subject to the Produce Safety rule have discretion in both (a) how many samples they take for their initial agricultural water survey to establish a microbial water quality profile (MWQP) (provided the total is 20 or more samples) for untreated surface water and (b) the time period over which these samples are taken (provided the samples are taken at least over a two year period, and no more than a four year period).
- Untreated surface water is emphasized here because the Produce Safety Rule also requires testing for untreated groundwater. However, the FDA update only pertains to untreated surface water testing.
- There are no new compliance dates regarding to the water quality survey in the Produce Safety Rule. FDA is simply clarifying the rule and the timeline.
The FDA has clarified the rule largely by offering examples.
The following example applies to farms subject to the Produce Rule that are not small or very small farms. For small and very small farms, the example holds, except the relevant dates are all 1 and 2 years later, respectively.
Farms that are not small or very small farms must begin testing untreated surface water no later than January 26, 2018. Technically, the farm needs to be in compliance with the rule’s microbial quality criteria two years later, so by January 27, 2020. But, because the farm can take samples for up to four years, as explained above, the farm does not actually have to complete its initial survey by January 27, 2020; it can continue sampling further into the future and will not be considered in violation of the rule.
FDA provides the following further examples for farms that are not small or very small businesses:
- Beginning in 2018, conducting an initial survey consisting of taking 10 samples per year over 2 years (10 in 2018 and 10 in 2019) for a total of 20 samples; calculating the MWQP for the first time upon completing the 20-sample data set (e.g., at the end of 2019, early 2020); and applying any necessary corrective actions as soon as practicable and no later than the following year (e.g., in 2020-2021);
- Beginning in 2018, conducting an initial survey consisting of taking 5 samples per year over 4 years (5 in 2018, 5 in 2019, 5 in 2020, and 5 in 2021) for a total of 20 samples; calculating the MWQP for the first time upon completing the 20-sample data set (e.g., at the end of 2021, early 2022); and applying any necessary corrective actions as soon as practicable and no later than the following year (e.g., in 2022-2023); or
- Beginning in 2018, conducting an initial survey consisting of taking 10 samples per year over 4 years (10 in 2018, 10 in 2019, 10 in 2020, and 10 in 2021) for a total of 40 samples; calculating the MWQP for the first time upon completing the 40-sample data set (e.g., at the end of 2021, early 2022); and applying any necessary corrective actions as soon as practicable and no later than the following year (e.g., in 2022-2023).
Compliance date extensions for certain provisions concerning written customer assurances
In some of the rules, including the Preventive Controls Rule and Produce Safety Rule, there is recognition that in some cases, it is not possible for an entity to control a hazard. Instead, the entity’s customer must control the hazard. These are called “customer provisions.”
In these provisions, a farmer, manufacturer, or processor must disclose in documents accompanying the food that leaves their farm or facility that the food is not processed to control the hazard. The farmer, manufacturer, or processor must also obtain written assurance from the customer that the customer will manufacture the food in accordance with applicable food safety requirements (or, the customer must place in writing that it will only in turn sell the product to another entity that will meet applicable standards).
Entities needing to comply with customer provisions have been given an additional two years to comply while FDA “considers the best approach to address feasibility concerns.”
Compliance dates for these requirements are different for reach rule. The earliest compliance date is now September 19, 2018 for large human food facilities.
Summary of the revised compliance dates for the Preventive Controls Rule for Human Food:
- Small Businesses (a business, including any subsidiaries and affiliates, employing fewer than 500 full-time equivalent employees): September 18, 2019
- Other businesses (neither small or very small): September 19, 2018
Summary of the revised compliance for the Produce Safety Rule:
- Very small businesses (more than $25,000 but no more than $250,000 in average nanual produce sales during the previous three year period): January 26, 2022
- Small businesses (more than $250,000 but no more than $500,000 in average annual produce sales during the previous three year period): January 26, 2021
- All other operations: January 27, 2020
FDA released other compliance date extensions and clarifications not mentioned above, including for the Foreign Supplier Verification Program and the Animal Food Preventive Controls Rule. If these apply to your business, you can learn more here.
Furthermore, FDA issued two draft guidance documents for public comment on the Preventive Controls Rule for Human Food.
- Draft guidance designed to help you comply with the following requirements: written food safety plan, hazard analysis, preventive controls, monitoring, corrective actions, verification, and associated records.
- Draft guidance designed to help you to determine whether the activities that you perform are within the “farm” definition.