Understanding Produce Safety Rule Inspections
Produce Safety Rule Inspections under the Food Safety Modernization Act allow Colorado Department of Agriculture (CDA) credentialed inspectors to observe activities related to growing, harvesting, packing and holding covered produce, on covered farms throughout Colorado, to ensure compliance with the Produce Safety Rule (PSR). The first Produce Safety Inspection a farm receives will be educational and focused on ensuring growers understand how the PSR applies to their farm.
- All regular inspections will be announced and scheduled in advance by CDA during the growing season, including a pre-inspection call to discuss whether the farm is covered by the PSR.
- Unannounced inspections may occur for cause (such as a prior, unresolved produce safety issue; a follow-up inspection; the grower does not respond to communications from CDA; and/or response to a complaint, recall or foodborne illness outbreak investigation).
- There is no fee for an inspection.
- Inspections are conducted by CDA inspectors who are credentialed by FDA.
- On the scheduled date, a CDA inspector will arrive at the farm; show his/her FDA credentials; describe the type of inspection that will occur; and issue a Notice of Inspection (Form 482).
- During the inspection, inspectors will:
- Walk around the farm, observe covered activities taking place on the farm at the time of the inspection and document their observations on Form 4056.
- Ask questions/discuss food safety activities/practices related to the standards of the Produce Safety Rule to determine if the standards are being met:
- Worker health and hygiene
- Biological soil amendments of animal origin
- Pre-harvest, harvest and post-harvest activities
- Domesticated animals and wildlife
- Pre- and post-harvest sanitation
- Agricultural water – Good Agricultural Practices relating to water
- Request and review the following records:
- Worker training
- Compost treatment (if applicable)
- Cleaning and sanitizing tools and equipment
- At the end of the inspection:
- Inspector has a closeout meeting with grower.
- Grower receives Produce Farm Inspection Form (From 4056).
- After the inspection:
- The Colorado Department of Agriculture will send the grower a completed Produce Farm Inspection Report Summary, which details areas of improvement discussed during the inspection.
Tips for a Successful Produce Safety Rule Inspection
- Know when their farm may be subject to inspection. This table provides PSR compliance dates and start dates for inspections, by farm size:
(based on average annual produce sales and adjusted for inflation)
|FDA Compliance Date for Covered Produce||On-Farm Inspections Begin|
|All other businesses:
|January 26, 2018||Growing season 2019|
$275,276 – $550,551
|January 28, 2019||Growing season 2020|
|Very small businesses:
$27,528 – $275,276
|January 27, 2020||Growing season 2021|
|Under $27,528||Exempt from PSR||None required|
- Communicate promptly with the Colorado Department of Agriculture regarding their inspection date and time to ensure proper scheduling (answer calls and check voicemail and email regularly).
- Prepare for their PSR inspection by:
- attending a Produce Safety Alliance Grower Training course,
- reviewing PSR regulatory and guidance documents,
- reviewing their food safety practices and organize supporting documents, and
- requesting an On-Farm Readiness Review.
- Designate a person who is knowledgeable about the farm’s food safety practices to accompany the inspector around the farm during the inspection. Inform employees of the inspection date and time.
- Review Form 4056 after the inspection and understand any additional follow-up required for compliance.
- Ask questions before, during and after the inspection.
- Consult coproducesafety.org and the resources listed below for additional information.
- FDA Produce Safety Inspection webpage: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/produce-safety-inspections
- FDA Form 4056: https://www.fda.gov/media/124867/download
- FDA Draft Guidance (provides examples and recommendations for subparts of the PSR): https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-standards-growing-harvesting-packing-and-holding-produce-human-consumption
There are many resources on this website, however, you can also download a factsheet with resources specific to Produce Safety Rule compliance following inspection.