What is FSMA?

The Food Safety Modernization Act (FSMA) was signed into law in 2011. It is the first comprehensive federal food safety law in over 70 years. FSMA aims to set standards for farms growing fruits and vegetables that may be eaten raw. FSMA is intended to reduce the risk of microbial contamination of fresh produce by shifting focus from responding to contamination to preventing it. It will be administered by the federal Food & Drug Administration (FDA).

FSMA consists of 7 sets of rules that apply to different sectors of the food system. However, this page will focus on one which is of particular is of interest to Rhode Island producers because of their potential impact on current farm operations.

The Produce Safety Rule

The Produce Safety Rule includes a set of standards that are deemed necessary to minimize Microbial risks of fresh produce. It applies to "farms" or those who grow, harvest, pack or hold produce generally eaten raw, i.e. greens, melons, tomatoes, apples, etc. (aka "covered produce" or raw agricultural commodities "RAC's"). It does not apply to produce rarely consumed raw, produce grown for personal consumption, on farm consumption, or on another farm under the same ownership.

What is FSMA's Produce Safety Rule?

Do you have a produce farm? If you operate a farm business that grows, harvests, packs, or holds produce, the Produce Safety Rule likely applies to you.

Do you process a food product? If you operate a business that processes, packs, manufactures, or holds food, the Good Manufacturing Practices (GMP) and Preventive Controls for Human Foods Rule likely applies to you.

If you grow and process food you may be covered by both rules.

Use our Produce Safety Rule Coverage Determination Tool to help you understand if the Produce Rule applies to your Farm.

Exclusion:

You are not covered under the Produce Safety Rule if:

  • You make less than $25,000 in average produce sales.

Qualified Exemption:

You are eligible for Qualified Exemption under the Produce Safety Rule if:

  • Your total food sales averages less than $500,000 for the previous 3 years, AND
  • Greater than 50% of those sales go to qualified end-users.

Other Exclusions:

Additional criteria that may exclude you from the Produce Safety Rule include:

  • You grow produce that is not covered under the Produce Safety Rule;
  • You grow food grains;
  • Your produce is consumed on-farm or for personal use;
  • Your produce undergoes commercial processing, or a "kill step".

If you fall under any of these categories, please see our Qualified Exemptions and Exclusions page to learn more about exemption requirements and access the Produce Safety Rule Exemption Application.

For covered activities, other than those involving sprouts (which have additional requirements and earlier compliance dates):

  • January 26, 2018: Covered farms for which, on a rolling basis, the average annual monetary value of produce the farm sold during the previous 3-year period is more than $500,000.
  • January 28, 2019: Covered farms for which, on a rolling basis, the average annual monetary value of produce the farm sold during the previous 3-year period is more than $250,000 but not more than $500,000 (small businesses).
  • January 27, 2020: Covered farms for which, on a rolling basis, the average annual monetary value of produce the farm sold during the previous 3-year period is more than $25,000 but no more than $250,000 (very small businesses).
chart showing compliance dates for sprouts, produce, water and exemption dates

Additional compliance dates for farms eligible for certain exemptions can be found on the FDA’s FSMA Compliance Dates web page.

Additional Resources