The rule focuses on the growing, harvesting, packing and holding of produce and is very similar to the requirements of USDA Good Agricultural Practices (GAP) certification. This is the first time there have been federal governmental regulations in this area.
Are there any exemptions of who will be covered by this rule?
Note that it is everyone’s responsibility to sell safe, unadulterated food. However, the produce safety rule itself will not apply to the following:
- Growers selling <$25,000/ year in produce sales (on average over previous 3 years)
- Those selling produce that is rarely consumed raw (such as potatoes). However, if the same grower also produces other products, those may be covered
- Produce used for personal/ on-farm consumption
- Produce intended for commercial processing with a “kill step” (i.e. tomatoes to be canned)
- Growers who, on average over the past 3 years, meet the following only need to meet certain modified requirements*:
- < $500,000 annual food sales AND
- A majority of food (by value) is sold directly to a “qualified end user”
- A “qualified end user” is either:
- The consumer of the food OR
- A restaurant or retail food establishment that is located:
- In the same state as the farm that produced the food; OR
- Not more than 275 miles from the farm
*The modified requirements include disclosing the name and address of the farm and maintaining records to prove that you meet this qualified exemption (who you are selling to and how much).
All other produce growers will be covered by the rule. In addition, if there is a food borne disease outbreak associated with your farm, you will no longer be exempt from the rule.
NOTE: Any processing of produce beyond washing and normal harvesting (such as chopping, peeling, or roasting) would be covered by the Preventive Controls rule, although some exemptions apply to that rule also.
Produce Safety Rule General Information
- Produce Rule Fact Sheet – Kansas State University
- Soil Amendments Fact Sheet – Kansas State University
- Soil Amendments Fact Sheet – Food and Drug Administration
- Am I Covered? – Food and Drug Administration
- Compliance Dates – Produce Safety Alliance
- Key Requirements – Food and Drug Administration
- Small Farm Guidance Guide – Food and Drug Administration
- Farm Food Safety Decision Tree – Cornell University
- Agricultural Water for Production Decision Tree – Cornell University
- Water Testing Methods – Food and Drug Administration
- Understanding FSMA Water Standards – Produce Safety Alliance
- GM/STV Excel Tool – Western Center for Food Safety
- GM/STV Online Calculator – University of Arizona
Templates for Record Requirements
- Cleaning and Sanitizing Record – Kansas State University
- Annual Water Inspection – Kansas State University
- Water Treatment Log – Kansas State University
- Worker Attendance Sheet – Kansas State University
- Commercial Processor Verification Letter – Kansas State University
- FSMA Full Exemption Worksheet – Kansas State University
- FSMA Qualified Exemption Worksheet – Kansas State University
- Pre-Plant Assessment (optional) – Kansas State University
- Training Handout (optional) – Kansas State University
- Pre Harvest A (optional) – Kansas State University
- Pre Harvest B (optional) – Kansas State University
- Records Required – Produce Safety Alliance
What are the main differences between FSMA and GAPs?
USDA GAP certification (or other food safety certifications such as Primus) are not required by governmental regulations, but may be required by a buyer. Please refer to the comparison of GAPs and FSMA. Please note that this is our current understanding of the situation and that more details will be included in future clarifications from FDA.
- EVERY producer that is covered by FSMA will need to attend a certified one day FSMA training (regardless if you have GAP or other certifications, have been to other trainings, etc).
- FSMA does NOT require a full on-farm food safety plan or an audit/inspection; rather those covered by FSMA will need to follow the food safety practices and testing required by FSMA. More information on exact methods of enforcement of FSMA will be forthcoming in the future.
- We understand that GAPs will be updated to basically match FSMA requirements; therefore, if you pass a GAPs audit, you should also be compliant with FSMA (but you still need FSMA training)
- FSMA requires no detectable generic E. coli in water that will directly contact produce after harvest, for handwashing, and when growing sprouts; water applied to growing produce must have a geometric mean of <126 CFU generic E. coli/ 100 mL water.
|Good Agricultural Practices (GAPS) certification||Food Safety Modernization Act (FSMA) Produce Safety rule|
|Required by?||Some Buyers||Federal governmental regulations|
|What does it cover?||Basic on-farm produce safety: water, soil amendments, animals, personnel, equipment, worker training, record keeping; expected to eventually be revised for consistency with FSMA requirements||Same foundational principles and content areas as GAPs, though specifics differ. In particular, at time of publication, the approach to water quality differed substantially and some requirements related to manure application were deferred to a future date.|
|Administered by?||USDA or 3rd party||FDA- will likely work with state departments of ag and/or health|
|Can I get an exemption?||Only required if your buyer requires it||There are some exemptions, which can be revoked if linked to food borne disease outbreak|
|Training requirements?||“One formal food safety workshop” is required, although there is no specific workshop required||If covered, need to attend standardized FSMA Produce Safety Rule training|
|Documented on-farm food safety plan required?||Yes- more information on writing an on-farm food safety plan is available here||No, though components of a food safety plan would aid meeting some requirements|
|Audit/inspection frequency?||Audited every year that you are certified||Farm may be inspected by governmental regulator; frequency currently unknown|
|What happens if you fail audit/inspection?||You can make corrections and get audited again||Unknown at this time|
Additional Resources on FSMA
- Produce Safety Alliance – Cornell University
- Preventive Controls for Human Food – University of Wisconsin
- North Central Region FSMA Center – Iowa State University
- FSMA Technical Assistance Network – Food and Drug Administration
- Produce Inspections – Regulators Virtual Produce Tour
Funding for this website and the listed workshops are made possible in part by grant KS5895 from the FDA. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the FDA.
Source: Food Safety Modernization Act