This helpful article from the Almond Board of California includes information about extended compliance dates available to some huller/shellers that would align their Preventive Controls Rule with their Produce Safety Rule, starting in 2018.
Most growers will need to comply with the Food Safety Modernization Act (FSMA) over the next few years (see our last blog). Thankfully, while the FDA establishes standards to follow, they have not mandated specific documents or procedures. This gives farmers the flexibility to design their own Produce Safety Manual.
For some growers, this may mean strengthening their existing Good Agricultural Practices (GAP). This articles highlights those areas to help farmers come into compliance with FSMA.
As a reminder, Primary Production Farms (traditional growers) and Secondary Activities Farm (traditional co-op huller/shellers) should have a Produce Safety Plan in place by the following dates based on crop value:
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
Note: Agricultural Water and Soil Amendments are excluded from the four food safety areas mentioned below. Deadlines for these standards have been pushed back at least two years from initial compliance dates.
Employee Qualification and Training
FSMA contains several requirements to build food safety into the daily job duties of supervisors and workers. This begins with at least one supervisor or responsible party successfully completing food safety training. In addition, there should be in place:
- Job-specific requirements for supervisors and workers. These should verify individuals are qualified upon-hire to perform their job. In addition, there should be ongoing training to keep workers current on best practices for their role.
- Training specific to food hygiene and food safety related to an individual’s job.
- Hygiene programs unique to a Farm’s operation, such as restroom locations, sanitation zones and requirements, hand washing and drying procedures, etc.
Growers may want to ensure documents are in place that describe specific training programs given, how often, and an example of the training materials. It may also be helpful to create, use and retain original sign-in sheets (English and Spanish) to validate training took place with verification step.
Once qualified to perform their duties in a manner that helps maintain food safety, FSMA then provides guidance on awareness and training in three, additional areas of hygiene. Specific to protecting covered products and food-contact surfaces from contamination, there should be policies in place to address:
- Specific personal hygiene practices, such as cleanliness standards and dress, removal of hand jewelry and other belongings, eating and drinking rules, etc.
- Managing sick persons on the worksite.
- Visitor contamination prevention.
Building, Tools and Equipment
The portion of FSMA regulations applying to building, tools and equipment are designed to prevent these sources – and the inadequate sanitation of them – from contaminating covered produce. To minimize these chances, growers should document by location a workflow showing how product makes its way through their operation. This will note the buildings, tools and equipment that will come in contact with the crop. For each of these areas, consider describing the steps taken to ensure:
- Equipment is designed, installed and stored to allow for adequate cleaning and maintenance; and
- Inspected, maintained, and cleaned when appropriate and as frequent as necessary to protect against contamination.
To help show compliance with these measure, growers may wish to develop and use a daily cleaning logs. These reports should record actual dates, times and steps taken when cleaning and sanitizing equipment and transport containers. The logs should be signed and dated by the operator, and verified and signed by a quality supervisor.
A Produce Safety Plan may also want to address these additional topics noted in the regulations:
- How potentially contaminated produce is identified and removed from the workflow.
- Steps taken to prevent against contamination from known, or reasonably foreseeable, hazards.
- The use of packaging, storage and shipping materials are adequate for their intended use and unlikely to support the growth or transfer of microbes.
Domesticated and Wild Animals
If there is a reasonable chance of intrusion by grazing, working, wild or domesticated animals, growers may want to document this likelihood and steps taken to prevent and monitor the situation. To help ensure compliance, consider creating or downloading a simple, site-identified inspection checklist. Be sure to maintain original, signed copies. Consider at least an annual, formal survey of the farming operations and how animal intrusion is being reduced. This portion of the Plan may include:
- Who is doing the inspections and how often.
- The preventive steps taken to control contamination from animals, such as the removing traps and dead animals in a timely manner, cleaning procedures for droppings, roof and other scheduled maintenance, etc.
- Corrective action steps. If there becomes evidence of animal intrusion, what steps will be taken to immediately correct the situation and update the plan to prevent future occurrences.
As mentioned, compliance with the Produce Safety Rule may be achieved by using existing GAP documents. In that or any case, there are additional recordkeeping requirements to keep in mind. For the Produce Safety Manual double-check that:
- Names and physical addresses of specific locations are on the paperwork.
- Actual values and observations are reported. No rounding, strikethroughs or N/As.
- An adequate description exists for traceability of covered produce through the operations, such as product type, lot number, source orchard, or other identifiers.
- Location of the Growing and/or Post-Harvest zones. An FDA inspection may pay more attention to these areas during inspection.
Records may be print or electronic, so long as they are reasonably the same. For electronic records, this means files should be accessible for daily use, allow for signature capture, kept secure, and allow for verification. There is a two year retention requirement from the date the record was created. Records should also be retrievable within 24 hours of request for official review.
A best practice may be to maintain one Produce Safety Manual in one location. It may reference other documents stored on property, such as in Human Resources or on the production floor. Employees should be trained about where the manual is located, how it relates to their job, and how they are empowered to create a Food Safety First culture.
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).