FSMA-Food Adulteration Exemption
Hello everyone!
I am needing assistance finding what the process is to get exemption from this part of the FSMA rules. We are a small business & meets the revenue requirements but, I am having trouble finding where to begin to start the process. Any suggestions are helpful!
Kindly,
Terina
If you are talking about a "Qualified Facility", which is exempt from the Preventive Controls and Supply Chain Control portion of FSMA, then you need to fill out an attestation form, FDA3942a and submit it to the FDA by September 17, 2018. The information for how this is done is pasted below. Remember, you must maintain documents that show you continue to be exempt, and re-submit the form every two years after 2020.
You still are required to submit the attestations that are underlined and in red below, and you may be required to notify your customers that you are a qualified facility.
Martha
PC.11 What is a qualified facility?
A "qualified facility" is (when including the sales by any subsidiary; affiliate; or subsidiaries or affiliates, collectively, of any entity of which the facility is a subsidiary or affiliate) either:
- A "very small business," a business (including any subsidiaries and affiliates) averaging less than $1,000,000, 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 (e.g., held for a fee), or
- A facility to which both of the following conditions apply: During the 3-year period preceding the applicable calendar year,
(1) the average annual monetary value of the food manufactured, processed, packed or held at such facility that is sold directly to qualified end-users exceeded the average annual monetary value of the food sold by such facility to all other purchasers; and
(2) 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.
(See 21 CFR section 117.3 for definitions of "qualified facility," "very small business," and "qualified end-user")
PC.12 What are the requirements applicable to a qualified facility?
A qualified facility is exempt from subparts C (Requirements for Hazard Analysis and Risk-Based Preventive Controls) and G (Requirements for a Supply-Chain Program) of the preventive controls for human food rule. However, a qualified facility is subject to modified requirements. It must submit two attestations to FDA: (1) an attestation that it is a qualified facility and (2) either an attestation that it has identified potential hazards, is implementing preventive controls to address the hazards, and is monitoring performance of the preventive controls or an attestation that the facility is in compliance with non-federal food safety laws and regulations. Further, a consumer notification requirement may be applicable, depending on which attestation a qualified facility provides.
The compliance date for a business meeting the definition of a “qualified facility” (including a “very small business”) is September 17, 2018. However, there is an earlier compliance date of January 1, 2016 for a facility to maintain (but not submit) financial records to support its status as a qualified facility.
The rule also establishes two additional compliance dates applicable to qualified facilities. First, it establishes December 17, 2018 as the compliance date for (1) the initial submission of the attestation by a facility that it is a qualified facility and (2) the attestation by a qualified facility about its food safety practices or that it is in compliance with non-federal food safety law. Second, it establishes January 1, 2020, as the compliance date for the consumer notification requirement. The consumer notification requirement applies to a qualified facility that submits an attestation that it is in compliance with applicable non-federal food safety law and requires such a facility to notify consumers as to the name and complete business address of the facility where the food was manufactured or processed.
PC.13 What records must be kept by a qualified facility regarding its attestations?
A qualified facility must maintain those records relied on to support the attestations (see 21 CFR section 117.201(f)).
PC.14 What form is used for qualified facility attestations?
Form FDA 3942a (for Human Food) is an attestation form for a food facility meeting the definition of a “Qualified facility.” A facility must determine and document its status as a qualified facility on an annual basis no later than July 1 of each calendar year. The attestations required must be:
- Submitted to FDA initially:
- By December 17, 2018, for a facility that begins manufacturing, processing, packing, or holding food before September 17, 2018;
- Before beginning operations, for a facility that begins manufacturing, processing, packing, or holding food after September 17, 2018; or
- By July 31 of the applicable calendar year, when the status of a facility changes from “not a qualified facility” to “qualified facility” based on the annual determination; and
- Beginning in 2020, submitted to FDA every 2 years during the period beginning on October 1 and ending on December 31.
- When the status of a facility changes from “qualified facility” to “not a qualified facility” based on the annual determination, the facility must notify FDA of that change in status using Form 3942a by July 31 of the applicable calendar year.
More information about the qualified facility attestation form can be found at: http://www.fda.gov/f...ion/default.htm