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How Do GAP Certifications Compare to FSMA’s Produce Safety Rule?

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This presentation provides a general comparison between Good agricultural practices (GAP) that produce operations have been undergoing for the past decade and the requirements set by FSMA’s Produce Safety Rule.

The information covered in this presentation is also summarized below for your convenience.

GAP and GMP Certifications FSMA- Produce Safety Rule

All the Good agricultural practices (GAPs) and Good Manufacturing Practice (GMPs) audits that produce farms have undergone up to this point have been buyer-driven. After successfully passing an audit, the farm receives a GAP and/or GMP Certification.

For the past two decades, farms selling primarily wholesale have been required to pass a third party audit annually in order to sell to a specific outlet.

GAP Audits often include a field and harvest crew audit. Good manufacturing Practices (GMP) or Good handling practices (GHP) audits cover packinghouses and if any produce is processed the facility is often required to determine if it requires a HACCP plan.

Depending on the audit, some may only cover growing and harvesting activities in the field. While others cover all activities performed at a farm.

The Produce Safety Rule is a federal law that requires segments of the industry to grow, harvest, pack and hold produce in such a way that minimizes the risk of causing food borne illness. The PS Rule has set the requirements for a regulatory program that is based on inspections, not audits. An audit will not replace an inspection. For more information, read what to expect of a regulatory inspection? 

The practices outlined in the PS Rule must be research based and are based on Good Agricultural Practices (GAPs).

During an inspection, all activities that apply to growing, harvesting, packing or holding activities will be assessed.

The PS Rule came into effect starting in 2017 for sprout growers and 2018 for all other operations. (See compliance dates for the PS Rule). Farm inspections started in NC in 2019.

There are numerous companies that offer auditing services; each one has a slightly different scheme (guidance documents, auditing guidelines and fees). Examples of companies include: Primus labs, QCS and USDA. The Food and Drug Administration (FDA) and the North Carolina Department of Agriculture & Consumer Services/Food and Drug Protection Division regulate the PS Rule in NC. FDA has published the practices outlined in PS Rule.
If a grower currently sells to different buyers the farm may have to conduct audits with different companies. FDA and NCDA&CS/Food and Drug Protection Division inspectors will conduct inspections. The frequency of the inspections is not outlined in the Rule.
The grower pays for the cost of the audits. Cost share is available to offset some of the costs in NC. Regular inspections are not expected to be fee based.
An audit is only conducted after a grower has requested the service, set a date and paid the fees. The fees are non-refundable if the farm fails the audit. Inspections will be announced but can happen at any point in time.
Audits have changed the way many farms operate. Many farms have adopted a food safety culture, but audits are only a snapshot of what happened on the day of the audit at the farm and/or packinghouse. It will be much easier for a farm that is already following a food safety plan and passing audits to comply with the PS Rule. Records to comply with the PS Rule do not need to be duplicated, just supplemented with additional requirements.

Audits can cover the whole operation: adjacent areas, wildlife intrusion, employee hygiene, compliance with city, state and federal laws regarding labor laws, compliance with all pesticide laws and applications, fertilizer (synthetic and organic) applications and laws, harvest practices, water testing and inspection of the water sources, tool inventory, all chemicals used in the operation, maintenance of equipment, pest control, harvest practices, inventory of all the materials supplied, post harvest handling, safe transport, trace back and recall protocols, pre audits by the farm, records and training for all employees that handle the crop. Depending on the audit, there may be more or less requirements.

To conduct an audit for GAP Certification, a farm must have a food safety plan.

The PS Rule covers the following:

–    Training

–    Agricultural water

–    Biological soil amendments of animal origin

–    Domesticated and wild animals

–    Equipment, tools, building and sanitation

–    Sprouts

The rule does not cover aspects of the operation that are already being regulated by other agencies (such as pesticide and fertilizer laws).

The rule does not require a farm to have a food safety plan.

Audits require growers to prove they have attended training annually and to train their employees as needed.

The Rule requires all farms that grow covered produce and do not meet the guidelines to be exempt or qualified exempt to have a supervisor or representative for the farm attend a Produce Safety Alliance Grower training. This is a one-time requirement.

Training requirements for employees are very similar in the PS Rule and audits.

Any crop can be audited, as long as the grower requests it.

The PS Rule covers crops that are considered raw agricultural commodities (RACs) and that will not receive commercial processing.

The PS Rule provides exemptions and qualified exemptions, so not all operations have to comply with the rule in its entirety. Become familiar with the exemptions and the requirements for these farms if your farm is eligible as there are some record keeping and labeling requirements that will still apply.

In the event of a food safety outbreak, all documents used to build a food safety plan are legally binding, regardless of the fact that FDA does not regulate audits. In the event of a food safety outbreak, all records must be provided to FDA within 24 hours of a formal request made by the agency to any operation that is being investigated for a possible food safety outbreak.