The purpose of the Food and Safety Modernization Act (FSMA) Produce Safety Rule (PSR) is to shift food safety regulations from a system that focuses on responding to contaminations to one that focuses on preventing them. The PSR is the first mandatory federal standard for the production of fruits and vegetables in the United States.
While some growers may be exempt or not covered by the PSR, all growers should be prepared to implement food safety practices. Produce safety affects every fruit and vegetable grower, regardless of size or location.
The Tennessee Department of Agriculture (TDA) is participating in a cooperative agreement with the US Food and Drug Administration to advance efforts of food safety on Tennessee farms. A partnership between TDA and Tennessee growers is a key step toward enhancing food safety on our farms.
Does the Produce Safety Rule apply to you?
To be eligible for a qualified exemption, the farm must meet two requirements:
- The farm must have food sales averaging less than $500,000 per year during the previous three years; and
- The farm’s sales to qualified end-users must exceed sales to all others combined during the previous three years.
A qualified end-user is either (a) the consumer of the food or (b) a restaurant or retail food establishment that is located in the same state or the same Indian reservation as the farm or not more than 275 miles away.
When will compliance be required? When will the first inspection happen?
- The first compliance date was January 26, 2019 for the larger farms fully covered by the rule. Inspections of these farms started in June 2019.
- The compliance date for medium sized farms is January 26, 2020
- The compliance date for small farms is January 26, 2021
How will growers and packers know what to expect during an inspection?
- The new rule puts a greater emphasis on documentation (written planning and recordkeeping). These records will be reviewed during an inspection.
- TDA and UT-K Extension are entities that can provide outreach, education and assistance. The Produce Safety Alliance can provide information, training and documentation that will be helpful in successfully implementing the rule.
- TDA is providing “On-Farm Readiness Reviews” for interested growers and packers. The farm operations are looked at as if it was being inspected, but no regulatory action will be taken. It is an opportunity for the farmer to ask questions and the inspector to provide explanations of that they are looking at and why.
- If a grower/stakeholder is interested in more information in regarding the On-Farm Readiness Revies (OFRR) service please email Produce.Safety@tn.gov or call the Food Safety Line at (615) 837-5193.
Who will enforce the rule?
- TDA is carrying out this rule by conducting inspections.
- TDA is looking at and seeking input from stakeholders on being the enforcing agency for Tennessee Farms.
- Coverage and Exemptions Flow Chart — https://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM472499.pdf
- “Rarely Consumed Raw” Produce — https://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM576496.pdf
- New Factsheet on Biological Soil Amendments of Animal Origin: BSAAO Risk Assessment — https://www.fda.gov/Food/FoodScienceResearch/RiskSafetyAssessment/ucm496835.htm
- Water Update — https://producesafetyalliance.cornell.edu/sites/producesafetyalliance.cornell.edu/files/shared/documents/Water-Analysis.pdf
- New Factsheet on Biological Soil Amendments of Animal Origin: Produce Safety Rule — https://www.fda.gov/food/guidanceregulation/fsma/ucm334114.htm
- Before Implementation of the Food Safety Modernization Act's Produce Rule: A Survey of U.S. Produce Growers August, 2018 — https://www.ers.usda.gov/publications/pub-details/?pubid=89720#.W2s3g-nxHcs.email
- USDA and FDA Announce Key Step to Advance Collaborative Efforts to Streamline Produce Safety Requirements for Farmers June 5, 2018 — https://www.usda.gov/media/press-releases/2018/06/05/usda-and-fda-announce-key-step-advance-collaborative-efforts
- Advice for Growers Implementing the Produce Safety Rule — http://vscnews.com/advice-growers-implementing-produce-safety-rule/
Does the Produce Safety Rule Apply to You?
Key Requirements: Fact Sheet
Water Requirement: Background Information
Draft Guidance for Industry
Produce Safety Alliance
Sprout Safety Alliance
Records Required by PSR
If you have any questions please call the Food Safety line at 615-837-5193.
Final Produce Safety Rule
Federal Government Funded Projects*
“This project, publication, program, website, etc. is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award 5U2FFD007410 totaling $986,108 with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.”