FSMA Update: Farmers Now Required to Retain Records to Prove “Qualified Exemption” Status

Written by M. Sean High – Staff Attorney

On January 26, 2016, the federal Food Safety Modernization Act (FSMA) Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption became effective [21 CFR 112].  As a result, beginning on January 26, 2016, all farmers that seek to claim qualified exemption status under FSMA must maintain records that support the claim.

Under FSMA, the federal government has established rules to regulate produce safety.  Nevertheless, FSMA has provided an exemption for small produce growers that can meet (and verify) certain requirements. 

According to FSMA, a produce grower is entitled to receive a qualified exemption if: (1) during the previous three years, the average annual sales of all foods (not just produce) was less than $500,000, and (2) the majority of the food sold was sold directly to qualified end-users [21 CFR 112.5(a)].

To define the term food, FSMA uses the definition found in Section 201(f) of the federal Food, Drug, and Cosmetic Act which states: “(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article [21 U.S.C. 321(f)].” Additionally, FSMA defines the term food to also include “seeds and beans used to grow sprouts” [21 CFR 112.3(c)].

FSMA defines qualified end-users as consumers, restaurants, or retail food establishments (such as grocery stores) that are: (1) located in the same state (or Indian reservation), and (2) not more than 275 miles from the farm claiming the end-user for purposes of qualified exemption statues [21 CFR 112.3(c)].

Importantly, farmers are now required to establish and keep records (such as sales receipts) that demonstrate that a farm has met all of the qualified exemption requirements [21 CFR 112.7].  The compliance date for maintaining records to support eligibility for the qualified exemption began January 26, 2016 (the effective date of the rule).

Finally, FSMA requires that a farm seeking a qualified exemption must “including a written record reflecting that you have performed an annual review and verification of your farm's continued eligibility for the qualified exemption" [21 CFR 112.7].  According to the final rule for Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, however, farmers do not need to complete this written requirement until the farm’s general compliance date [80 FR 74353].