- What is the Produce Safety Rule and why is it needed? The Produce Safety Rule is part of the Food Safety Modernization Act. It focuses on agricultural water, domestic and wild animals, biological soil amendments of animal origin, cleaning and sanitization of equipment, tools, and buildings, and worker health and hygiene.
The goal of the Produce Safety Rule is to reduce foodborne outbreaks from consuming fresh produce.
- How do I know if my farm needs to comply with the Produce Safety Rule? Not all farms have to follow the requirements of the Produce Safety Rule. Very small farms and farms that sell to specific types of buyers may qualify for an exclusion or an exemption. Certain crops are also not covered by the Produce Safety Rule.
You can visit ODA’s decision tool to check your farm’s status or contact the Produce Safety Team at firstname.lastname@example.org or 503-986-4620.
- When does my farm need to comply with the Produce Safety Rule? All of the requirements under the rule are in effect, with the exception of the Agricultural Water portion (Subpart E). Thus, all farms subject to the Produce Safety Rule now must be following the requirements.
FDA will be updating the water portion of the rule (Subpart E) in 2021, so this section is currently on hold. This means farms do not have to take water samples according to the rule until this section is finalized by FDA.
- What do I need to do to be compliant with the Produce Safety Rule?The rule requires employee training, record keeping, equipment cleaning and sanitizing, risk assessment, and monitoring activities. Farms that are subject to the rule will also have a routine FDA-led inspection.
Covered farms are required to have at least one responsible party complete training on the rule. The best first step is to attend a Produce Safety Alliance Training.
- What kind of technical assistance is available?ODA works with growers on a confidential basis to assist them with understanding how the Produce Safety rule applies on their farm. Technical assistance is voluntary, free and can be in-person, over the phone, or online. Contact the Produce Safety Team at email@example.com or at 503-986-4620 to find out more.
- How is the Produce Safety Rule different from a USDA Good Agricultural Practices Audit? The Produce Safety Rule is a federal regulatory program. This means, if your facility is subject to the rule, there is no opting out. If a farm does a USDA Good Agricultural Practices (GAP) audit and is also subject to the Produce Safety Rule, the farm must follow the requirements of both.
There are many third-party food safety audits beyond the USDA GAP audit. Even if your farm is participating in another audit like a PRIMUS, GlobalGAP, USDA Harmonized GAP, etc. you are required to follow the Produce Safety Rule and the other audit standards.
Produce Safety Rule Inspection
USDA GAP Audit
No cost at this time
FDA Regulatory Investigator. ODA has not taken on the regulatory part of this rule.
Auditor from ODA, USDA or other accredited body.
Once an inspection has occurred, the return time is currently unknown.
|Notification of visit||Pre-announced||After a grower has requested the audit service, the audit is scheduled. There are instances where unannounced audits occur, depending on harvest window.|
|Scoring||None||Points-based: 80% score needed on all audit parts to meet the criteria.|
|Certification||None issued||Certificate issued by USDA if criteria are met.|
|General summary||The rule covers: |
- Agricultural water
- Biological soil amendments of animal origin
- Domesticated and wild animals
- Equipment, tools, buildings and sanitation
A farm is not required to have a farm food safety plan but it is a recommended best practice.
|A food safety plan must be written and in place.|
*Table is not a complete representation of all differences or similarities.