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  3. Guidance & Regulation (Food and Dietary Supplements)
  4. Food Safety Modernization Act (FSMA)
  5. FSMA Inflation Adjusted Cut Offs
  1. Food Safety Modernization Act (FSMA)

FSMA Inflation Adjusted Cut Offs

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.

NOTE: As of 2024, the U.S. Bureau of Economic Analysis (BEA) uses 2017=100 for estimating the GDP deflator instead of 2012=100. We have updated all the values in the tables on this page to reflect the changes to the GDP deflator. BEA current standard practice is to update the base for GDP deflator every 5 years; FDA will update in unison and provide that update here.

  2019 2020 2021 2022 2023
GDP Deflator 104.008 105.381 110.213 117.973 122.273

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. Determine your annual sales and/or revenue information (depending on the FSMA rule) for each of these years: 2021, 2022, and 2023;
  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 2021 – 2023.”

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.

Baseline Value for Cut-offs (2011) Value in 2019 Value in 2020 Value in 2021 Value in 2022 Value in 2023 Average 3 Year Value for 2021 - 2023
$1,000,000 $1,136,936 $1,151,944 $1,204,764 $1,289,590 $1,336,594 $1,276,983

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.

Baseline Value for Cut-offs (2011) Value in 2019 Value in 2020 Value in 2021 Value in 2022 Value in 2023 Average 3 Year Value for 2021 - 2023
$500,000 $568,468 $575,972 $602,382 $644,795 $668,297 $638,491

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.

Baseline Value for Cut-offs (2011) Value in 2019 Value in 2020 Value in 2021 Value in 2022 Value in 2023 Average 3 Year Value for 2021 - 2023
$2,500,000 $2,842,339 $2,879,860 $3,011,910 $3,223,975 $3,341,486 $3,192,457

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.

Baseline Value for Cut-offs (2011) Value in 2019 Value in 2020 Value in 2021 Value in 2022 Value in 2023 Average 3 Year Value for 2021 - 2023
$500,000 $568,468 $575,972 $602,382 $644,795 $668,297 $638,491

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 remained in effect until Nov. 7, 2023. In April 2023, FDA issued guidance to help explain how farms may transition from the temporary policy back to the usual qualified exempt criteria in the Produce Safety Rule.

Baseline Value for Cut-offs (2011) Value in 2019 Value in 2020 Value in 2021 Value in 2022 Value in 2023 Average 3 Year Value for 2021 - 2023
$500,000 $568,468 $575,972 $602,382 $644,795 $668,297 $638,491

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).

Baseline Value for Cut-offs (2011) Value in 2019 Value in 2020 Value in 2021 Value in 2022 Value in 2023 Average 3 Year Value for 2021 - 2023
$25,000 $28,423 $28,799 $30,119 $32,240 $33,415 $31,925

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.

Baseline Value for Cut-offs (2011) Value in 2019 Value in 2020 Value in 2021 Value in 2022 Value in 2023 Average 3 Year Value for 2021 - 2023
$1,000,000 $1,136,936 $1,151,944 $1,204,764 $1,289,590 $1,336,594 $1,276,983

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.

Baseline Value for Cut-offs (2011) Value in 2019 Value in 2020 Value in 2021 Value in 2022 Value in 2023 Average 3 Year Value for 2021 - 2023
$2,500,000 $2,842,339 $2,879,860 $3,011,910 $3,223,975 $3,341,486 $3,192,457

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.

Baseline Value for Cut-offs (2011) Value in 2019 Value in 2020 Value in 2021 Value in 2022 Value in 2023 Average 3 Year Value for 2021 - 2023
$500,000 $568,468 $575,972 $602,382 $644,795 $668,297 $638,491

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.

Baseline Value for Cut-offs (2011) Value in 2019 Value in 2020 Value in 2021 Value in 2022 Value in 2023 Average 3 Year Value for 2021 - 2023
$10,000,000 $11,369,355 $11,519,441 $12,047,638 $12,895,902 $13,365,945 $12,769,828

On November 21, 2022, FDA published the Food Traceability Final Rule, which includes various provisions in which a value is adjusted for inflation and averaged on a rolling basis over 3 years. The compliance date for the final rule is January 20, 2026. We intend to post relevant values adjusted for inflation in future updates to this webpage.

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