In this article, we made a summary of farm exemptions. Remember to personally check on the official site to clarify any doubt you might have: https://collaboration.fda.gov/tefcv13/
Exemptions reach:
- Produce that is rarely consumed raw
- Produce that is not a raw agricultural commodity
- Produce for personal consumption
- Produce for consumption on the same farm it was produced or on a farm under the same management
- Farms that on yearly average don’t produce more than $25.000 of their market value, adjusted for inflation using 2020 as the baseline year for calculating adjustment
- Egg producers with less than 3000 chickens
- Farms whose more than half of annual production value are sold to end users and whose total monetary value of sales is less than $500,000.
- Produce that is packed and sold to end users in the same farm. Packaging must maintain integrity, prevent contamination, and contain name, address, and phone number of the farm where it was produced.
In addition, is also eligible for exemption produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance, treating with a validated process to eliminate spore-forming microorganisms, and processing such as refining, distilling, or otherwise manufacturing/processing produce into products such as sugar, oil, spirits, wine, beer or similar products. However, they must follow the three conditions below:
1- Disclose in documents accompanying the food that the food is “not processed to adequately reduce the presence of microorganisms of public health significance”
2- Either:
- Annually obtain written assurance from customers, who perform the processing, that they have established and are following procedures that adequately reduce the presence of microorganisms of public health significance; or
- Annually obtain written assurance from your customers that an entity in the distribution chain, subsequent to them, will perform commercial processing that adequately reduce the presence of microorganisms of public health significance. In addition, customers must:
- Disclose in documents accompanying the food that the food is “not processed to adequately reduce the presence of microorganisms of public health significance”; and
- Will only sell to another entity that agrees, in writing, it will either:
(A) Follow procedures that adequately reduce the presence of microorganisms of public health significance; or
(B) Obtain a similar written assurance from its customer that the produce will receive commercial processing, and that there will be disclosure in documents accompanying the food that the food is “not processed to adequately reduce the presence of microorganisms of public health significance”; and
3- Establish and maintain documentation containing disclosures, an annual written assurances obtained from customers, the name and location of your farm, actual values and observations obtained during monitoring, an adequate description of covered produce applicable to the record, and the location of a growing area or other area applicable to the record, the date and time of the activity documented
We have studied the regulation and we are ready to help you navigate this challenge. If you are not sure whether you are reached by this new rule, contact us. Get prepared on time, don’t wait till last minute.
For more information and details about Farm Exemptions visit the FDA official link: https://collaboration.fda.gov/tefcv13/