FSMA's Produce Safety Rule
On this page:
- What is the Produce Safety Rule?
- Implementation of the Produce Safety Rule
The Produce Safety Rule (21 CFR Part 112) is one of 7 parts of the Food Safety Modernization Act (FSMA). It establishes minimum food safety standards for operations growing, harvesting, packing, and holding covered produce.
In many states, including Maine, there has never been jurisdiction for food safety on produce farms before the Produce Safety Rule. That meant that if birds were nesting right over the stored veggie boxes and getting droppings on them, there wasn’t much that could be done about it.
The Produce Safety Rule is based on certain consumer health and produce safety fundamentals:
- Microbiological pathogens can make people sick.
- Pathogens are more likely to make vulnerable people sick, including the young, the elderly, the pregnant, and the immunocompromised.
- Pathogens are commonly found in animal and human feces.
- Pathogens most commonly contaminate food via:
- Food contact surfaces, including equipment and tools
- Biological soil amendments of animal origin
Most of the requirements of the Produce Safety Rule are basic practices already common in many parts of the food system. There are requirements about worker health & hygiene, training for workers, sanitation of equipment and tools, packaging used for produce, and managing risks from water, animals, and manures. They are built on the consumer health and produce safety fundamentals above.
Please Note: There is one subpart of the Produce Safety Rule devoted to Agricultural Water. Implementation of the entire Agricultural Water subpart has been delayed while it is under review. The FDA will not be enforcing the water regulations while they review the available science and assess how better to address water concerns across national variations in growing conditions, crops, and seasonality. For delayed water compliance dates please see the Inspection section below.
Our primary source document is the full text of the Produce Safety Rule:
- 21 CFR Part 112: Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption
The FDA has also provided a draft guidance for industry expanding on the regulations and how they apply:
- Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption: Draft Guidance for Industry
Here at Maine’s DACF, we have also prepared some plain English resources explaining the basic requirements of the Produce Safety Rule:
- FSMA Facts (PDF) - Provides an overview of the Produce Safety Rule
- FSMA Records & Documentation Requirements (PDF) – Lists all the records required for Produce Safety Rule compliance in Maine.
Because these regulations are new to an entire farming sector, implementation of the Produce Safety has been intentionally designed to be educational in nature.
The FDA has structured the implementation of the Produce Safety Rule to build in time for farms to learn and adapt. They’ve done this by:
- Funding states to provide education & outreach.
- Partnering with states to do the boots-on-the-ground inspections.
- Staggering compliance dates by farm size to give farms time to get ready.
- Making initial inspections educational in nature, with only egregious conditions triggering official compliance action.
- Developing collaborative partnerships to provide resources and technical advice to farmers.
The FDA has provided funding and resources to do outreach, education, and compliance inspections in each state through federal cooperative agreements. They are working with all the states, territories, and tribal governments to "educate before and while we regulate."
In Maine, the Department of Agriculture, Conservation & Forestry is responsible for implementing the Produce Safety Rule in its entirety. We have been tasked with:
- Trying to REACH every farm in Maine to help figure out which will be affected by the Produce Safety Rule.
- Providing TRAINING in produce safety in conjunction with diverse education partners both in industry and at the University of Maine Cooperative Extension.
- Doing ON-FARM EDUCATIONAL VISITS to answer real-world questions and help farms assess their readiness to meet food safety standards.
- Doing INSPECTIONS for regulatory compliance for farms that are covered by the Produce Safety Rule.
In all of these, we take a measured approach to discuss any issues openly and reasonably with the grower, and to work together to find solutions to food safety challenges.
The Department of Agriculture, Conservation & Forestry has been tasked with trying to reach every one of Maine’s farms to figure out who is likely to be affected by the Produce Safety Rule and to get them any help they may need.
Maine has between 7,600 – 8,200 farms, according to the US Ag Censuses. Our farms are doing everything from tapping maple trees to raising livestock, planting grain, growing Christmas trees, carding wool and fur, cultivating shellfish, milking animals, cutting hay, and growing fruits, vegetables, and berries.
True to Maine’s independent, live-and-let-live nature, the DACF doesn’t require registration just to farm produce. This means we’re still reaching out to connect to Maine’s produce farms. While we continue our effort to help everyone navigate this new regulation, you can help us by filling out your farm's information, even if you're not growing produce.
Sharing this information with the DACF is voluntary, and is not required by any regulation. Any farm information submitted voluntarily is held under State and Federal confidentiality policies, and will not be shared with other farmers, businesses, or service providers.
As part of our outreach efforts, we also meet with organizations and community groups around the state to answer questions and provide basic information about the Produce Safety Rule. We work with groups to offer sessions tailored to specific crops & sectors, types of farming practices, or stages of farm development. We are happy to collaborate to meet needs at a grassroots level.
In addition to presentations, community sessions, and resources in our Library of Resources, we also partner with the University of Maine Cooperative Extension to offer two other education opportunities:
On-Farm Readiness Reviews
On-Farm Readiness Reviews are FREE, non-regulatory farm visits where we walk around the farm and take stock of your farm’s food safety status together. They are educational in nature, and a great chance to ask Produce Safety Rule questions and troubleshoot any tricky challenges in a real world environment.
To request an On-Farm Readiness Review, contact us at 207-764-2100:
Produce Safety Alliance (PSA) Grower Training
Farms that are fully covered under the Produce Safety Rule are required to have at least one supervisor or responsible party successfully complete a food safety training recognized as adequate by the FDA. Right now, the training recognized as adequate by the FDA is the Produce Safety Alliance (PSA) Grower Training.
- In-person classes: Maine has previously offered these PSA Grower Trainings at subsidized rates through the University of Maine Cooperative Extension. Currently there are no upcoming sessions scheduled in person.
- Online Classes: Grower trainings are currently being offered online as well as in-person. Find an upcoming PSA Grower Training offered by UMaine Cooperative Extension or other groups nationwide.
In Maine, Produce Safety Rule inspections are performed by our Maine Department of Agriculture, Conservation & Forestry inspectors operating under FDA authority. We are credentialed by the FDA to do this work and we follow their protocols.
Compliance and inspection dates are staggered by farm size. The purpose of this is to start with the farms that are statistically more likely to reach more of our vulnerable eaters due to their scale of product reach.
We began inspections of Large Farms in 2019 and will continue to phase in inspections by farm size as each compliance inspection date arrives. A fully covered farm is required to comply with all the requirements of the Produce Safety Rule over a year prior to their inspection dates.
See COVERAGE STATUS to learn more about different coverage statuses, exemptions, and requirements.
COVERED FARM SIZE
PRODUCE SAFETY RULE COMPLIANCE
WATER SUBPART COMPLIANCE
January 26, 2018
January 26, 2022
January 28, 2019
January 26, 2023
VERY SMALL FARMS
January 27, 2020
January 26, 2024
The FDA has established inspection protocols designed to make the inspection rollout educational in nature. All initial inspections will be considered educational, and only egregious conditions that pose an imminent health hazard will trigger compliance actions. Because we operate under FDA authority, we work closely with the FDA’s Office of Compliance on compliance and enforcement when there are egregious conditions.
For everything else that is less than egregious, we can keep that conversation of issues between you and the Maine team. We’ll discuss any less than egregious issues together and ask you to share how you plan to address those risks presented. When we come back for your next routine inspection, we will then require action to address any significant issues.
Start of Inspection
At the beginning of the inspection, we will show you our FDA credentials and issue you the FDA form 482 – Notice of Inspection. We’ve created an example here filled out for a hypothetical farm:
During the Inspection
Initial inspections for the Produce Safety Rule are pre-scheduled. We’ll meet you at the pre-arranged time and place and together we’ll go through a standard inspection. During an inspection we’ll:
- Start with an opening meeting to cover some basics and adjust our inspection plan.
- Review required records or documents.
- Talk with your responsible parties about your operations.
- Visit your growing areas and observe harvest activities.
- Visit your storage areas for produce, soil amendments, packaging, and food contact surfaces.
- Observe your crew doing routine handling activities.
- Interview some of your workers.
- Inspect toilet and hand-washing facilities.
- Finish with a closing meeting.
Throughout the inspection we’ll share and discuss any observations or issues of concern along the way, and we'll listen to what you share with us about your operation. We’ll revisit the observations or issues with you during the closing meeting before we finish up our paperwork.
Close of Inspection
At the close of the inspection, we’ll issue the FDA form 4056 – Produce Farm Inspection Observations. The FDA 4056 is used to record observations of significant concern during the inspection. We’ve created some examples here for different scenarios:
- FDA 4056 Example - for an initial inspection with no egregious conditions (PDF)
- FDA 4056 Example - for an initial inspection with egregious conditions (PDF)
- FDA 4056 Example - for a routine inspection in Year 2 (PDF)
After the Inspection
After we return to the office, we complete an FDA Produce Farm Inspection Report Summary. This is a more descriptive report that includes significant issues, discussion items, any corrective actions offered, and some specific information about the farm. While that form is not released for public view, we’ve created a few scenarios to give you an idea of what the language of those written observations look like:
We send every farm a copy of their Produce Farm Inspection Report Summary so you have the same information to work from as we do.
- Straight Talk on FSMA Inspections (PDF) - Find out more about our inspection processes, reports, and more in this presentation.
- Top 5 Inspection Issues Infographic from 2019 Inspection Season (PDF)
- FSMA Ask Me Anything: Produce Safety Rule Hot Topics & Questions (PDF)
- FAQs about Inspections (PDF) part of our Library of Resources.
We can help folks prepare for inspections, and we strongly encourage any farm that thinks they may be due for inspection to reach out and talk to us. We’ll prioritize you for On-Farm Readiness Reviews, connect you to resources, and guide you through the process. We try to be as transparent as possible about how this all works. Contact us at 207-764-2100
For more information on the Produce Safety Rule continue exploring this website
- Coverage Status - Who is subject to the Produce Safety Rule and what applies to your farm
- Library of Resources - Helpful links and documents from around the nation.
- Maine's FSMA Team - Your resource team for produce safety in Maine and the Northeast.
Reach out to our team any time for help navigating the FSMA regulations. We are happy to support Maine’s food safety culture every way we can!