Straight Talk from legal advisors Elizabeth Fawell and Maile Hermida of Hogan Lovells U.S. LLP
Get your FSMA Facts straight from the experts. Almond Board of California has engaged a consulting firm whose lawyers have worked with FSMA since its beginning. In this FSMA Files column, they help clear up some of the uncertainty around the many compliance dates of FSMA.
Question: I’m confused about which compliance obligations were triggered in September 2017 and which will take effect in January 2018. Can you clarify?
Straight Talk
September 2017
September 18, 2017 was the compliance date for several requirements under the Preventive Controls rule, including:
- Compliance with Preventive Controls for Human Food regulations for “small businesses” (fewer than 500 full-time equivalent [FTE] employees).
- Compliance with Preventive Controls for Animal Food rule for larger businesses.
- Compliance with modified GMP requirements for small businesses (when applicable).
January 2018
January 26, 2018 is the initial compliance date for the Produce Safety rule, applying to farms with more than $500,000 in annual produce sales.
- Please note that you may choose to file a written disclosure to be exempt from the Produce Safety rule. Learn more about your options at almonds.com/growers/fsma.
January 26, 2018 is also the compliance date for large-business brownskin almond facilities that only size, sort, grade and pack almonds and/or large business facilities that hull/shell almonds but are not technically considered a “farm.”
This fact sheet will help you determine if your operation qualifies as a “farm.”
Explanation: Each FSMA rule has its own set of compliance dates. These dates vary based on the size of the operation, as defined under each rule, and in some cases, also vary based on the type of activities performed at the operation.
For Preventive Controls for Human Food, “large businesses” (more than 500 FTE employees) were required to comply last year (September 2016). The “small businesses” subject to this rule were required to comply this September. Only those companies that meet the definition of a “very small business” (less than $1 million in food sales plus the value of food held without sale) are not required to comply until September 2018.
It’s also important to know that the FDA has delayed the Preventive Controls for Human Food compliance date for (1) certain brownskin almond facilities and (2) certain facilities that almost, but don’t quite, meet the definition of a secondary activities farm. These facilities are not required to comply with the Preventive Controls for Human Food rule until the applicable Produce Safety rule compliance date for their size business. If the facility is part of a company with more than 500 FTE employees, then their compliance date is in January 2018.
The last tricky factor to consider for the Preventive Controls for Human Food compliance dates is that the supplier verification provisions under Subpart G have compliance dates based on your supplier’s own compliance date with applicable FSMA rules. The general principle here is that once your own Preventive Controls compliance date has arrived, you’re required to conduct supplier verification for any supplier for which it is six months after their compliance date. For example, a “small business” would need to conduct supplier verification for a “large business” as of September 18, 2017, but would not need to conduct supplier verification of a “small business” until March 19, 2018.
Compliance with the Preventive Controls for Animal Food rule also began September 18, 2017. This compliance involves the preventive controls requirements for large businesses and compliance with the GMP requirements for small businesses. Note, however, that the FDA recently announced its routine regulatory inspections will not assess compliance with the rule’s preventive controls requirements until the fall of 2018 but will instead focus on compliance with GMP requirements. Bear in mind that many almond operations will not be covered by the Preventive Controls for Animal Food rule based on the scope of their operations.
January 26, 2018 is the first compliance date for the Produce Safety rule. Farms with less than $500,000 in annual produce sales have later compliance dates. As noted above, this also is the Preventive Controls for Human Food compliance date for (1) certain large-business brownskin almond facilities and (2) facilities that are similar to, but don’t meet the definition of, a secondary activities farm.
The chart below summarizes the facilities that have compliance dates arriving in September and January. The Almond Board also has prepared more comprehensive charts that summarize all of the compliance dates for each of the FSMA rules. They are available at
almonds.com/growers/fsma and
almonds.com/processors/fsma.
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Type of Operation
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Rule
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Explanation or Notes
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September 18, 2017
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Facility that is part of a small business (<500 FTE employees)
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Preventive Controls for Human Food
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This also is the compliance date for these businesses to implement a supply chain program for their larger suppliers (with over 500 FTE employees)
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Preventive Controls for Animal Food (if applicable)
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GMP requirements only
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Facility that is part of a large business (>500 FTE employees)
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Preventive Controls for Animal Food (if applicable)
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Preventive Controls requirements (GMP compliance date was September 2016.)
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January 26, 2018
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Farm with >$500,000 annual sales
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Produce Safety
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Farms have additional time to comply with certain water-related requirements
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“Facilities solely engaged in packing and/or holding activities conducted on produce RACs and/or nut hulls and shells” that are part of a large business (>500 FTE employees)
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Preventive Controls for Human Food
Preventive Controls for Animal Food – GMPs only (if applicable)
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This covers almond brownskin facilities that only size, sort, grade, or pack almonds, as well as facilities that only hull and shell almonds, as long as the facility does not engage in manufacturing or processing activities (i.e., chopping, grinding, mixing, roasting, pasteurizing, salting)
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For facilities that meet the definition of “secondary activities farms” except for the ownership criterion and are part of a large business (>500 FTE employees)
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Preventive Controls for Human Food
Preventive Controls for Animal Food – GMPs only (if applicable)
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Facilities that meet the definition of “secondary activities farms” except for the ownership criterion can take advantage of an extension for compliance with the PC rule if: (1) the operation is not located on the primary production farm; (2) the operation is devoted to harvesting, packing and/or holding of RACs (including operations that hull, shell and/or dry nuts without additional manufacturing); and (3) the operation is under common ownership with the primary production farm that grows, harvests and/or raises the majority of the RACs harvested, packed and/or held by the operation
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Please keep your questions coming! You can send them to Tim Birmingham at
tbirmingham@almondboard.com with the subject line “FSMA Files.”
This column was prepared by Elizabeth Fawell and Maile Hermida, who are lawyers with Hogan Lovells U.S. LLP in Washington, D.C. The FSMA Files column is provided for informational purposes only and does not constitute legal advice.
