Who needs to be compliant under the FSMA Produce Rule on January 26th, 2018?
Before jumping into the extended compliance dates, you must first understand the depth of FSMA Produce Rule. The FSMA Produce Rules lays out many actions that farms are responsible for implementing. It’s critical to understand what the FSMA Produce Rule means, and it’s just as critical to know what sorts of farms need to comply, if you would like to learn more head over to our Is Your Farm Covered by the FSMA Produce Rule blog.
The FDA is extending compliance dates for facilities that only pack and/or hold raw agricultural commodities that are produce and/or nut hulls and shells. Compliance dates for facilities that are covered by the two Preventive Controls rules for human and animal food, including CGMPs, and are solely engaged in packing and/or holding produce raw agricultural commodities (for example, some packing houses) are extended to align with the compliance dates for farms conducting similar activities under the Produce Safety rule. This extension includes facilities that hull, shell, pack and/or hold nuts; the earliest compliance date is January 26, 2018.
Certain facilities that would qualify as secondary activities farms except for the ownership of the facility also have extended compliance dates. The FDA is extending the compliance dates for operations that would be secondary activities farms except that they do not meet the ownership criterion in the definition of a secondary activities farm. 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. FDA is considering future rule making to modify the definition of a farm in order to address ownership issues; the earliest compliance date is January 26, 2018.
Compliance dates for facilities that color raw agricultural commodities are being extended for 16 months to align with the Produce Safety rule. Currently coloring is considered a manufacturing/processing activity that requires food facility registration and is subject to the CGMP and Preventive Controls for Human Food rule. FDA is considering future rule making to modify the definition of a farm in order to address “coloring” activities; the earliest compliance date is January 26, 2018.
Why is extra time allowed for smaller farms to come into compliance with the requirements?
The FDA has staggered the compliance dates, based on the size of farms, to provide additional time for small and very small farms to come into compliance with the requirements, and is providing extended time for almost all farms to meet certain water requirements in Subpart E. Because of their history of outbreaks, operations growing sprouts have less time to come into compliance than other farms and do not get additional time to come into compliance with any of the water requirements. Farms with an average annual value of produce sold of $25,000 or less during the previous three year period are not covered by the rule.
Other Compliance Dates:
Compliance dates for covered activities, except for those involving sprouts, after the effective date of the final rule are:
- Very small businesses, those with more than $25,000 but no more than $250,000 in average annual produce sales during the previous three year period: four years
- Small businesses, those with more than $250,000 but no more than $500,000 in average annual produce sales during the previous three year period: three years
- All other farms: two years
- The compliance dates for certain aspects of the water quality standards, and related testing and record keeping provisions, allow an additional two years beyond each of these compliance dates for the rest of the final rule*
Agricultural Water Requirements:
- *Note: On September 12, 2017, FDA issued a proposed rule that, if finalized, would extend the compliance dates for the agricultural water requirements by an additional two to four years (for produce other than sprouts).
- The new agricultural water compliance date the FDA is proposing:
- The largest farms is January 26, 2022.
- Small farms and very small farms would have until January 26, 2023 and January 26, 2024.
Compliance dates for modified requirements for farms eligible for a qualified exemption are:
- For labeling requirement (if applicable): January 1, 2020
- For retention of records supporting eligibility for a qualified exemption: Effective date of the final rule
- For all other modified requirements:
- Very small businesses, four years after the effective date of the final rule
- Small businesses, three years after the effective date of the final rule
Compliance dates for covered activities involving sprouts after the effective date of the final rule are:
- Very small businesses: three years
- Small businesses: two years
- All other farms: one year
For more information, see Compliance Date Extensions and Clarifications for FSMA Final Rules.