UPDATE 07-07-2017: The next compliance date is in March 2018. Importers should spend this time developing the programs as it takes time to work with Foreign Suppliers to build a robust FSVP program.
FDA recently published a Federal Register notice announcing delays for the implementation of certain FSMA rules. This delay affects only a small portion of the industry (among others, customer assurance and facilities coloring agricultural commodities), and the vast majority of the FSMA rules go into effect as regularly scheduled – some as soon as September 16, 2016.
“Review the federal register notice closely to double-check that your company indeed is covered under the new extensions – otherwise, you may unwittingly violate the law.” [1] Below we briefly review some of the delayed FSMA provisions.[2]
The First Delay: the “Customer Assurance” Provision
FSMA’s customer assurance provision allows manufacturers to ship foods with uncontrolled hazards to a subsequent party for further processing, provided that (1) the manufacturer/processor discloses to the subsequent processor any uncontrolled hazard, and (2) the subsequent processor provides a written assurance that it will control the hazard. This is significant, as FDA’s final rules for cGMP/HARPC generally require manufacturers and processors to identify and control potential hazards in a food supply/manufacturing chain at all times.
However, industry expressed concern about the rule’s practicality, given that some industry members could be overwhelmed by the requirement for thousands of customer assurance letters. FDA accepted this argument, and decided to extend the compliance date for another two years to consider feasibility concerns. The same applies to facilities manufacturing or receiving animal foods. Readers should note that the manufacturer/processor’s disclosure requirement still remains in place and is not delayed by this rule.
Revised deadlines:
- September 18, 2019 for small businesses
- September 19, 2018 for all other facilities subject to the requirement
In addition, this delay also changes the compliance dates for the customer assurance obligations in FSVP and the produce safety regulations.
Revised deadline for FSVP:
- May 28, 2019 for importers
Revised deadlines for Produce Safety Regulations:
- January 26, 2021 for very small businesses (sprouts)
- January 26, 2022 for very small businesses (other commodities)
- January 27, 2020 for small businesses (sprouts)
- January 26, 2021 for small businesses (other commodities)
- January 28, 2019 for all other businesses (sprouts)
- January 27, 2020 for all other businesses (other commodities)
The Second Delay: Packagers or Holders of Produce RACs
The current regulations exempt “farms” from §117’s requirements, while still subjecting off-farm facilities solely engaged in packing or holding produce Raw Agricultural Commodities (RACs) to the same requirements (the original compliance date was September 18, 2016). Industry claimed that “secondary activities” farms[3] (exempt from §117 but subject to produce safety regulations) and off-farm facilities (subject to §117) that solely package, pack, and hold produce RACs should be treated the same, since they engage in similar activities.
FDA heeded the industry’s concern, and extended the compliance dates by approximately 16 months to match the dates for off-farm facilities with the dates for facilities subject to produce safety regulations.
Revised deadlines:
- January 27, 2020 for very small businesses
- January 28, 2019 for small businesses
- January 27, 2018 for all other businesses
The Third Delay: Some “Secondary Activities” Farms
The third delay affects facilities that would qualify as secondary activities farms except for the ownership requirement. The new delay applies to those facilities engaged in the same functions as a secondary activities farm, but not meeting the ownership requirement. These facilities currently need to comply with §117 instead of the produce safety regulations, because they are technically not secondary activities farms.
FDA determined that its definition of the ownership structure was not sufficiently flexible after reviewing the comments, and announced a delay of 16 months for operations that would be secondary activities farms if not for the ownership requirement. However, the operation would need to meet the following requirements –a) it cannot be located on the primary production farm, 2) it must be devoted to harvesting, packing, or holding, and 3) the ownership must be under common ownership with the primary production farm producing the majority of the secondary activities farm’s RACs.
Revised deadlines:
- January 27, 2020 for very small businesses
- January 28, 2019 for small businesses
- January 26, 2018 for all other businesses
Lastly, this delay extends §117 compliance dates for facilities that do not qualify as farms because they are engaged in coloring RACs. Under the current rules, a RAC-coloring facilities is not a “farm” as defined in FSMA, and is therefore not exempt from §117. Despite this, FDA decided to delay the compliance date for these operations because RAC-coloring does not transform RACs into processed food. The agency may revise the definition of a “farm” in the future to include RAC-coloring and to reflect its developing views.
Revised deadlines:
- January 27, 2020 for very small businesses
- January 28, 2019 for small businesses
- January 26, 2018 for all other businesses
Double-Check your Compliance Dates
As we discussed, most of the compliance dates remain the same and any change affects only a small portion of the industry. Even the extensions affecting a broad range of companies – i.e., customer assurance provision extension – only have limited effect because the rest of the FSMA compliance obligations remain the same. Before relaxing your FSMA compliance effort, check carefully to see whether this truly delays the FSMA compliance date for your business. As always, we invite you to come to us with any questions.
For more information regarding FSMA please watch our video: Overview of FSMA (FDA’s Food Safety Modernization Act)
[1] Benjamin L. England, Esq.
[2] While not discussed in this blog, FDA also extended the compliance dates for facilities solely engaged in the ginning of cotton, those importing food contact substances subject to FSVP, cGMP requirements for facilities producing grade A milk and milk products, as well as clarifying the compliance dates for the produce safety regulations’ agricultural water testing requirements.
[3] A farm located away from the primary production farm’s premise, devoted to harvesting, packing, or holding of RACs, while being majority-owned by the primary production farm.
