Food Safety Modernization Act

The U.S. Food and Drug Administration's Food Safety Modernization Act (FSMA), H.R. 2751, is the largest reform of food safety laws since the Food, Drug and Cosmetic Act in 1938. FSMA is made up of seven major rules that address fresh produce, human food, animal food, transportation and imported food.

FSMA aims to ensure the U.S. food supply is safe by shifting the focus from responding to food contamination and outbreaks to prevention. The law has a farm-to-plate approach and impacts all parts of the supply chain, including:

Growers and farmers
Processors
Distributors and shippers

Producers of human foods and beverages, and animal food/feed must comply with these new regulations and update or set up controls such as Good Manufacturing Practices (GMP’s) and Risk-Based Preventive Controls for human food and animal food.

Growers of ready-to-eat fruit and vegetables in the United States and abroad will be required to use Good Agricultural Practices on the farm.

Affected businesses

The law applies to:

All FDA-registered food and dairy processors of products not regulated by USDA FSIS (meat and poultry)
Foreign food processors registered with FDA and exporting food and animal feed to U.S.
Manufacturers of pet food and animal feed
Farms that grow certain fruits and vegetables
Trucking companies and railroads

As of Jan. 26, 2016, the Produce Safety Rule is in effect. The compliance dates vary with farm size:

Large business — Earns more than $500,000 in average produce sales during the previous three-year period. Compliance by Jan. 26, 2018.
Small business — Earns more than $250,000 but no more than $500,000 in average annual produce sales during the previous three-year period. Compliance by Jan. 28, 2019.
Very small business — Earns more than $25,000 but no more than $250,000 in average annual produce sales during the previous three-year period. Compliance by Jan. 27, 2020.
Labeling requirement for qualified exemptions — Jan. 1, 2020.
Retention of records supporting eligibility for a qualified exemption — Jan. 26, 2016.

Produce Safety Rule

The Food Safety Modernization Act (FSMA) Produce Safety Rule was made final on Jan. 26, 2016, and establishes science-based minimum standards for the safe growing, harvesting, packing and holding of fruits and vegetables grown for human consumption.

Many, if not all farms will be impacted by at least part of the FSMA Produce Safety Rule, even those that are very small. Compliance dates for some parts of the rule are already underway, with full compliance for many farms starting in January 2018.

What does the FSMA Produce Safety Rule cover?

The Produce Safety Rule, outlined in Section 105 of FSMA, establishes science-based minimum standards for safe production and harvesting of fresh fruits and vegetables. These standards are based on a foundation of Good Agricultural Practices. The rule is divided into several parts, including standards for:

Worker health, hygiene and training
Agricultural water, both for production and post-harvest uses
Biological soil amendments (e.g., compost, manure)
Domesticated and wild animals
Equipment, tools, buildings and sanitation
Production of sprouts

To find out if your farm is covered by the Produce Safety Rule complete this self-guided decision tool.

Exemptions

Information for qualified-exempt or exempt growers

Not all growers are fully subject to the FSMA Produce Safety Rule (PSR) — various exemptions exist for some growers depending on what they grow, whether it is processed, how much they sell, and whom they sell to.

UI Extension has developed a decision tool resource — an anonymous self-guided online questionnaire — to aid growers in deciphering their coverage under the rule.

Applying for exemptions

Even if your operation is exempt or qualified-exempt from the PSR, this status is not automatic and there are still requirements for documenting and maintaining an exemption. Individuals must apply with the Idaho State Department of Agriculture (ISDA) to obtain and annually maintain exemption.

Below are helpful forms for your operation to complete and submit to ISDA if you want to apply for one of the applicable exemptions.

Idaho State Department of Agriculture FSMA produce safety verification form (pdf)

It is recommended for all produce farms to file this form with ISDA.
This form is used by ISDA to identify your coverage under the PSR and it serves as the application for exemption for farms that fall under the Exempt and Qualified-Exempt categories (use the Decision Tool above to determine what you can apply for).
If you are unsure how the PSR applies to you after using the Decision Tool, this application will also prompt ISDA to contact you to guide you through your coverage under the PSR.

Average annual produce sales worksheet (pdf) — Farms that sell under $25,000 per year in total gross produce sales, averaged over a three-year period (adjusted for inflation), are not covered by the PSR. This form is for your personal use to help you determine your average produce sales over a three-year period and if you are covered by the PSR based on your sales bracket. Do not send this form to ISDA.

Qualified-exempt worksheet (pdf) —

This form is for growers who sell over $25,000 in just produce sales (so they are covered by the PSR) but under $500,000 in total food sales (so they may qualify for an exemption still).
Under the PSR, if a farm sells less than $500,000 per year, averaged over a period of three years (adjusted for inflation), but over 50% of those sales were made to a qualified end-user* you will qualify for a qualified exemption.
This worksheet is for your personal use to help determine how the PSR applies to you based on your food sales (all food, not just produce) over a three-year period and how to calculate what percentage of those sales to qualified end-users was.

*Qualified end-users are consumers of food or restaurants or retail food establishments that are in the same state or Indian reservation as the farm that produced the food, or not more than 275 miles from such farm. Both of the following requirements must be met for qualified exemption: (1) more than 50% of your average annual food sales are to qualified end-users and (2) annual food sales are less than $500,000. 21 CFR §112.5 (a)(1)(2)

These forms can also be accessed online on ISDA's website.

Submit applications to:

ISDA FSMA Produce Program
PO Box 7249
Boise, ID 83707

Or email to: FSMA@isda.idaho.gov.