- Submit Annual Self-Certification
- Qualified Exempt Definition & Requirements
- Commercial Processing Exempt Definition & Requirements
- Resources
- Education & Technical Assistance
- About the Produce Safety Rule
- Rule Updates for Exempt Farms
Submit Annual Self-Certification
Farms may use this form to self-certify their eligibility for the qualified exempt status for the applicable calendar year.
Qualified Exempt Definition
A produce farm is eligible for qualified exempt status under the Produce Safety Rule when:
-
The farm’s average annual food sales over the previous three-year period (adjusted for inflation using 2011 as a baseline) are less than $500,000.
AND
-
More than 50% of the farm’s average annual food sales over the previous three-year period were to qualified end-users, which include the consumer of the food (when the consumer is not a business) or a retail food establishment, such as a restaurant, grocery store, or food co-op, located in Vermont or within 275 miles of the farm. 21 CFR § 112.5.
The $500,000 inflation adjusted cut-off is updated annually by FDA.
Qualified exempt farms should submit an annual self-certification to the Agency as proof of eligibility. Qualified exempt farms are not required to undergo routine inspections but must follow the modified requirements listed below.
Qualified Exempt Requirements
-
Records must be kept that document that the farm satisfies the qualified exempt criteria (see Annual Self-Certification form). Records must be kept for as long as necessary to support the farm’s status during the applicable calendar year. 21 CFR § 112.7.
-
The name and complete business address of the farm where produce was grown must be prominently and conspicuously displayed on product labels and/or at the point of purchase, such as on a label, poster, sign, placard, or electronic notice if sold online. 21 CFR § 112.6.
Commercial Processing Exempt Definition
A farm’s produce is eligible for the commercial processing exemption when:
-
Produce is sold for commercial processing that adequately reduces the presence of microorganisms of public health significance. Examples include processing in accordance with the requirements of 21 CFR part 113, 114, or 120, treating with a validated process to eliminate spore-forming microorganisms (such as processing to produce tomato paste or shelf-stable tomatoes), and processing such as refining, distilling, or otherwise manufacturing/processing produce into products such as sugar, oil, spirits, wine, beer or similar products. 21 CFR § 112.2(b).
Farms with produce eligible for the commercial processing exemption must follow the modified requirements listed below.
Commercial Processing Exempt Requirements
-
Disclosure: Farms must disclose in documents accompanying produce eligible for the commercial processing exemption that the food is “not processed to adequately reduce the presence of microorganisms of public health significance.” 21 CFR § 112.2(b)(2).
-
Written Assurance: Farms must annually obtain written assurance from the customer that performs the commercial processing that the customer has established and is following procedures (identified in the written assurance) that adequately reduce the presence of microorganisms of public health significance. 21 CFR § 112.2(b)(3). This requirement is currently under enforcement discretion. See Updates below.
Resources
Access produce safety resources to enhance produce safety practices on your farm and to assist with regulatory compliance.
Education & Technical Assistance Available
An Agency subject matter expert can provide one-on-one educational and technical assistance on regulatory requirements and produce safety best practices.
About the Produce Safety Rule
The Produce Safety Rule establishes science-based minimum food safety standards for the safe growing, harvesting, packing, and holding of fruits and vegetables. The Rule was adopted in Vermont statutes under 6 VSA Chapter 66.
The compliance date for qualified exempt farms to begin retaining records in support of eligibility for the qualified exemption went into effect in January 2016. The compliance date for qualified exempt labeling requirements went into effect in January 2020.
Rule Updates for Exempt Farms
-
May 2020: FDA announced a temporary policy that provided flexibility in the eligibility criteria for the qualified exemption. Under this policy, the FDA does not intend to enforce the criteria regarding the portion of sales made to qualified end-users for farms that met the criteria based on sales that were made in years prior to the Covid-19 pandemic, but no longer meet the criteria in due to market disruptions caused by Covid-19.
-
January 2018: FDA announced an enforcement discretion policy for certain provisions of the Produce Safety Rule. Under this policy farms are not requirement to obtain written assurances under the commercial processing exemption