It’s Not Who You Are. It’s Who the FDA Says You Are.
The Food Safety Modernization Act (FSMA) has arrived. Depending on your almond operation, the Compliance Date may be rolling out in just a few months or may be past due. That’s why it’s important to understand which of the FSMA rule(s) apply to you – based on the FDA definitions for your business.
Produce Safety Rule
Called “Primary Production Farms” in the regulations, traditional growers are relatively easy to spot. Falling under the Produce Safety Rule, these producers Grow, Harvest, Hull, Shell and Handle almonds in one general location and under one ownership. Compliance dates start in 2018 depending on crop value (see below).
Also under the Produce Safety Rule are “Secondary Activities Farms” – similar to traditional co-ops. These are operations that Hull, Shell, and/or Handle almonds grown by the primary production farm, including brownskin almond handlers. The caveat is these operations must be under majority ownership by the traditional farm and the majority of product run through the facility must be from the common ownership farm.
Jan. 26, 2018 – Greater than $500,000 in crop value*
Jan. 28, 2019 — $250,000 – $500,000 in crop value
Jan. 27, 2020 — $25,000 – $250,000 in crop value
*Legislation specifically reads, “…average annual monetary value of produce sold during the previous 3-years period….” Trade associations change “monetary value” to “crop value” to make specific to the almond industry.
Farms are fully exempt from FSMA if the crop value is under $25,000. Additional exemptions exist for produce grown only for personal or on-farm consumption.
Direct Marketing Modified Requirements
With Farmer’s Markets in mind, producers can comply with the Produce Safety rule IF they generate less than $500,000 in ALL food sales (not just produce) AND more than 50% of sales is direct to consumers. If this applies to your operation, you should start keeping adequate records now to document your qualified exemption. This documentation should be reviewed and verified annually.
If you are required to comply with the Full Produce Safety Rule, the guidelines generally require meeting Good Agricultural Practices (GAP) already in place related to:
- Agricultural water
- Biological soil amendments
- Worker hygiene
- Employee training
- Building, tools and equipment
- Domesticated and wild animals
Preventive Controls Rule
This portion of the legislation is also known as the Facilities Rule since it typically applies to a Food Facility already required to register with the FDA. It is also known under its full name: Current Good Manufacturing Process, Hazard Analysis and Risk-Based Preventive Controls for Human Food (HARPC).
Preventive Controls may apply to your operations if you are not a Primary Production or Secondary Activities Farm, and engage in Hulling/Shelling, Sizing, Sorting, Processing or Manufacturing activities (e.g. if you roast, chop, grind or coat almonds).
Compliance is based on the size of your operations, defined by revenue and headcount:
Sept. 19, 2016 – 500 or more full-time equivalent (FTE) employees, and $1 million or greater in total annual sales of human food.
Sept. 18, 2017 – Less than 500 FTE employees, and $1 million or greater in total annual sales of human food.
Sept. 17, 2018 – Less than 500 FTE employees, and less than $1 million in total annual sales of human food.
If you are required to comply with the full Preventive Controls rule, you will need to have a Food Safety Plan prepared by a Preventive Controls Qualified Individual (PCQI). The Food Safety Plan must include the following elements. In addition, you will need to document its implementation in records kept and made available to the FDA upon request for review and copying:
- A hazard analysis
- Preventive controls
- Monitoring procedures
- Corrective action procedures
- Verification procedures
- A supply chain program, if appropriate
- A recall plan
Future blog posts will also be dedicated to explaining key elements of a standard Food Safety Plan.
Additional Rules under FSMA
The Food Safety Modernization Act overhauled many portions of the FDA legislative landscape. Below is a snapshot of the other portions of the regulations that may apply to you:
- Foreign Supplier Verification Program – started May 30, 2017 for ALL sized importers and consignees who have explicit responsibility to verify their foreign suppliers have adequate preventive controls in place to ensure the food coming into the U.S. meets food safety standards comparable to those in the U.S.
- Sanitary Food Transportation of Human and Animal Food – With a division point at $27.5 million in annual receipts for an April 6, 2017 or an April 6, 2018 compliance date, this rule puts into practice many of the Good Transportation Practices (GTPs) already in use around food transportation and establishes requirements for vehicles and transportation equipment, records, training and waivers.
- Mitigation Strategies for Protection of Food Against Intentional Adulteration – begins rolling out to large businesses starting July 26, 2019
- Initial capitalization indicates words defined in the legislation.
- Partial source: Almond Board of California, FSMA is Coming! What You Need to Know for Produce Safety Compliance (Document #2017IR0068), and FSMA Has Arrived! What You Need to Know For Preventive Controls Compliance (Document #2017IR0069).