FDA will hold a “National Kick-Off Meeting on Implementation of the Food Safety Modernization Act (FSMA)” on April 23-24, 2015, in Washington, D.C.
The agency has sent out a save-the-date notice to subscribers to its FSMA webpage, but the notice contains few details. FDA says that meeting specifics, including registration information, will be made available in March via a Federal Register notice and an announcement on FDA’s FSMA webpage.
We have learned that the public meeting will include opening presentations by the FDA implementation teams for the major pending FSMA rulemakings (including Preventive Controls, Produce Safety, Foreign Supplier Verification Programs, and Intentional Adulteration), as well as breakout sessions during which FDA will seek input from stakeholders.
Despite the use of the word “kick-off” in the meeting title, don’t worry that you somehow missed publication of the FSMA final rules and that FDA is about to “kick-off” implementation. That is not the case. FDA has not issued any of the 7 foundational FSMA final rules. The agency remains under the following court-ordered deadlines for publication of the final rules:
August 30, 2015
- Preventive Controls for Human Food
- Preventive Controls for Animal Food
October 31, 2015
- Produce Safety
- Foreign Supplier Verification Programs
- Accreditation of Third Party Auditors
March 31, 2016
- Sanitary Transportation of Food
May 31, 2016
- Intentional Adulteration
Although we won’t know the compliance dates until FDA actually publishes the final rules, it is likely that the earliest date that any businesses would need to comply with any of the final rules would be August 2016. To help you make plans, a rough compliance timeline appears below.
FDA’s decision to hold such a public meeting while it is still drafting the final rules is interesting. It suggests that the agency is finding certain issues challenging and is willing to present its current thinking and seek feedback before proceeding with the final rules.
Projected Timeline for Compliance with FSMA Final Rules*
2016
August
- All businesses (except for small and very small businesses) must comply with Preventive Controls for Human Food rule
- All businesses (except for small and very small businesses) must comply with Preventive Controls for Animal Food rule
2017
March
- Businesses (except small businesses) must comply with Sanitary Transportation of Food rule
April
- Importers must comply with FSVP rule (However, if the imported food is subject to the Preventive Controls for Human Food rule or the Preventive Controls for Animal Food rule, the importer must comply with the FSVP rule 6 months after the date that its foreign supplier is required to comply with the relevant preventive controls rule. If the imported food is a raw agricultural commodity (RAC) that is subject to the Produce Safety rule, the importer must comply with the FSVP rule 18 months after the date of publication of the FSVP rule or 6 months after the foreign supplier is required to comply with the Produce Safety rule, whichever is later. If the imported food is a RAC that is not subject to the Produce Safety rule, the importer must comply with the FSVP rule 18 months after the date of publication of the FSVP rule or 6 months after the effective date of the Produce Safety rule, whichever is later.)
July
- Businesses (except small and very small businesses) must comply with Intentional Adulteration rule
August
- Small businesses must comply with Preventive Controls for Human Food rule
- Small businesses must comply with Preventive Controls for Animal Food rule
December
- Farms (except for small and very small farms) must comply with Produce Safety rule (However, such farms have an additional two years to comply with the water quality testing, monitoring and recordkeeping provisions of the rule.)
2018
March
- Small businesses must comply with Sanitary Transportation of Food rule
July
- Small businesses must comply with Intentional Adulteration rule
August
- Very small businesses must comply with Preventive Controls for Human Food rule
- Very small businesses must comply with Preventive Controls for Animal Food rule
December
- Small farms must comply with Produce Safety rule (However, small farms have an additional two years to comply with the water quality testing, monitoring and recordkeeping provisions of the rule.)
2019
July
- Very small businesses must comply with Intentional Adulteration rule
December
- Very small farms must comply with Produce Safety rule (However, very small farms have an additional two years to comply with the water quality testing, monitoring and recordkeeping provisions of the rule.)
*This timeline contains projections or estimates of FSMA compliance dates based on the following assumptions: (1) FDA will publish the final rules on or around the court-ordered deadlines listed above; and (2) the final rules will contain the same compliance dates as the proposed rules. This timeline may need to be updated as each final rule is issued.
