Implicit Price Deflators for Gross Domestic Product (GDP)

Several FSMA rules have provisions in which a value is adjusted for inflation and averaged over 3 years. We provide the values based on Price Deflators for Gross Domestic Product (GDP) and the average for the most recent 3 years for the applicable rules below. The GDP deflator is not a static number, and changes monthly. We intend to update the values at the beginning of April each year.

If you choose to use the information below to determine whether your facility, farm, or other operation (depending on the relevant FSMA rule) had average annual sales/revenue below the most recent adjusted cut-off, you would:

1. 1. Determine your annual sales and/or revenue information (depending on the FSMA rule) for each of these years: 2019, 2020, and 2021;
2. Calculate your average annual sales/revenue for those three years;
3. Compare your three-year average to the value posted in the column titled “Average 3 Year Value for 2019 – 2021.”

Preventive Controls for Human Food

Qualified Facility: Definition 1: Very Small Business - a facility averaging less than $1 million (adjusted for inflation) in annual sales per year during the 3-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed, or held without sale.

Qualified Facility: Definition 2: Average annual monetary value of all food sold during the 3-year period preceding the applicable calendar year was less than $500,000, adjusted for inflation and sales to qualified end-users during such period exceeded the average annual monetary value of the food sold by such facility to all other purchasers.

Preventive Controls for Animal Food

Qualified Facility: Definition 1: Very Small Business - a facility averaging less than $2.5 million (adjusted for inflation) in annual sales per year during the 3-year period preceding the applicable calendar year in sales of animal food plus the market value of animal food manufactured, processed, packed, or held without sale.

Qualified Facility: Definition 2: Average annual monetary value of all food sold during the 3-year period preceding the applicable calendar year was less than $500,000, adjusted for inflation, and sales to qualified end-users during such period exceeded the average annual monetary value of the food sold by such facility to all other purchasers.

Produce Safety

Qualified Exemption: A farm is eligible for a qualified exemption if the average annual monetary value of all food sold during the 3-year period preceding the applicable calendar year was less than $500,000, adjusted for inflation, and sales to qualified end-users during such period exceeded the average annual monetary value of the food sold by such farm to all other buyers.

NOTE: In May 2020, FDA issued guidance announcing flexibility in the eligibility criteria for the qualified exemption from the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Regulation due to disruptions to the supply chain during the COVID-19 public health emergency. This temporary policy is intended to remain in effect only for the duration of the public health emergency, after which FDA intends to issue additional guidance. Read guidance.

Not covered farm: A farm or farm mixed-type facility with an average annual monetary value of produce sold during the previous 3-year period of less than $25,000 (on a rolling basis).

Foreign Supplier Verification Programs

Very Small Importer: Definition 1 for Human Food – an importer (including any subsidiaries and affiliates) averaging less than $1 million per year, adjusted for inflation, during the 3-year period preceding the applicable calendar year in sales of human food combined with the U.S. market value of human food imported, manufactured, processed, packed, or held without sale.

Very Small Importer: Definition 2 for Animal Food - an importer (including any subsidiaries and affiliates) averaging less than $2.5 million per year, adjusted for inflation, during the 3-year period preceding the applicable calendar year in sales of animal food combined with the U.S. market value of animal food imported, manufactured, processed, packed, or held without sale.

Sanitary Transportation of Human and Animal Food

Non-covered business: Shipper, loader, receiver, or carrier engaged in transportation operations that has less than $500,000, as adjusted for inflation, in average annual revenues, calculated on a rolling basis, during the 3-year period preceding the applicable calendar year.

Mitigation Strategies to Protect Food Against Intentional Adulteration

Very Small business: A business (including any subsidiaries and affiliates) averaging less than $10,000,000, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed, or held without sale.