As we approach the FSMA Rule compliance dates this September, it’s important for hullers and shellers who are classified as processors, to understand the new requirements. Specifically, most hullers and shellers are classified by FDA as either a Primary Production Farm or Secondary Activities Farm. Regardless, both entities are subject to the Produce Safety Rule.
- A Primary Production Farm is defined as an operation under one management, with locations not necessarily adjacent to each other but which are engaged in growing or harvesting of crops, or any combination of these activities. This kind of farm can pack or hold raw agricultural commodities such as fresh produce and may conduct certain manufacturing/processing activities, such as dehydrating grapes to producing raisins and packaging and labeling unprocessed raisins.
- Secondary Activities Farms are defined as an operation that is not located on the Primary Production Farm, but has dedicated harvesting, packing and/or holding of raw agricultural commodities. Secondary Activities Farms may include many hullers.
Some hullers and shellers will be classified by FDA as food processors, so they should expect to comply with a stricter rule – the Preventive Controls Rule. The compliance dates (“deadlines”) for this regulation have expired for the largest companies, but for the rest, compliance dates will be this September, 2017. However, it’s worth noting that an FDA Guidance Document released August 23, 2016 titled “Compliance Date Extensions and Clarifications for FSMA Final Rules”, grants some facilities that only process raw agricultural commodities, some additional time to comply. This would apply to many hullers and shellers, with the earliest compliance dates being January 2018, versus September, 2016 as originally expected. This allows an additional 16 months’ time to comply based on industry feedback to allow FDA and industry more time to address various concerns.
What is the basic food safety plan for Hullers and Shellers?
The first step for implementing a food safety plan is to designate an individual responsible for FSMA Preventive Controls compliance. It is highly recommended that the individual receives formal training recognized by the FDA. For those subject to the Produce Safety Rule, there is an approved one-day course that Safe Food Alliance offers which includes a section describing recommendations in developing a “Farm Food Safety Plan”.
For those subject to the Preventive Controls Rule, there is a two-and-a-half-day course which Safe Food Alliance also offers as an in depth review of factors FDA expects in a food safety plan under this Rule.
Under either rule the company’s designated person is responsible for planning, implementing and managing the facility’s written food safety plan. An example of the written food safety plan consists of the following:
Good Manufacturing Practices
These are basic rules for employees and visitors which can be customized, but must meet basic regulatory requirements in the Produce Safety Rule or the Preventive Controls Rule. These basic practices also include training of employees to ensure that they are knowledgeable in food safety practices relevant to their jobs. Hullers should have staff members who have attended the relevant FDA approved training course offered by Safe Food Alliance; additionally, all employees must be qualified for their position by appropriate training and knowledge.
For operations under the Produce Safety Rule, a documented risk assessment is optional and can be very basic in its structure if conducted. The rule does require that operations assess their risks, but not that they document them. The focus is to identify key aspects of the operation which might impact food safety and must be controlled – such as water testing, use of manure, and other relevant actions.
For operations under the Preventive Controls Rule, the first step is to conduct a documented risk assessment or hazard identification, which must consider known or reasonably foreseeable biological, chemical, and physical hazards. These hazards could be present because they naturally occur, are unintentionally introduced or intentionally introduced (food fraud, adulteration, etc.).
For operations under the Produce Safety Rule, the expectation is that the operation implements appropriate controls, such as those noted above (water testing, controls on manure use, etc.). There may be documented procedures for these controls, but this is not required. The Produce Safety Rule only requires that records be kept. While documented procedures are not required, they can serve many purposes in helping an operation comply with the regulation.
Documented and implemented Preventive Controls is similar to HACCP but perhaps more basic and are required for operations under the Preventive Controls Rule. They ensure that hazards requiring a preventive control will prevent or minimize the hazards to safe, acceptable levels. Preventive Controls include process controls, food allergen controls, sanitation controls, supply-chain program controls and a recall plan.
Oversight and Management of Controls
Monitoring and Verification: Regardless of whether an operation is under the Produce Safety Rule or the Preventive Controls Rule, it’s important that any key controls put in place are monitored to ensure they’re being implemented and are effective. Monitoring is conducted as appropriate to the type of control to ensure the control is implemented. For those under the Preventive Controls Rule, additional verification is conducted and validation done in order to demonstrate that a control is capable of effectively controlling an identified hazard.
Corrective Actions and Corrections
Under both rules it’s expected that any issues that impact food safety are corrected and that a record of these corrective actions are kept. This may be as simple as re-training an employee who makes a mistake; treating a water source that becomes contaminated; or re-cleaning the operation if the initial cleaning was not effective.
Traceability and Recall
Although the expectation for companies under the Preventive Controls Rule are more detailed in nature, traceability of product is expected to be in place under both rules. The requirement is that a company can trace its products “one step forward and one step back.” For example, what grower or which orchard was each product received from? What customer was each product shipped to? It can be in electronic format, or it can be physical bin tags and bills of lading. Whatever the form of the record, an operation should be able to demonstrate its ability to trace product back to the grower and forward to the processor.
When it comes to food safety, records have always been critical: “If you don’t write it down, it didn’t happen.” Neither the FDA, nor customers can assume an action was taken. Records are necessary to prove that activities are completed as appropriate. For instance, when FDA requires that water be tested, there should be records to show the test results. Does a well need to be treated? If so, a record of that treatment is required. Have employees been trained? Records of that training must also be available.
Contact us for more information
If this information was helpful, Safe Food Alliance is ready to work with its partners on next steps. For more information call (916) 561-5900 or visit our events page for upcoming training or contact us to find out if we can set up a training near you.