Follow-Up Q&A: FSMA Preventive Controls for Human Food: Exemptions, Requirements & Deadlines for Very Small Businesses
The following questions were posed by participants in this ACS Member Webinar, led by Michael Kalish, co-founder of Food Safety Guides and FSPCA Lead Instructor. As timing did not allow for all questions to be addressed within the scope of the live webinar, Michael kindly responded to the questions afterwards in this Q&A. If you have any questions or would like clarification on the responses below, please contact the ACS office at 720-328-2788 or [email protected].
(1) Our state inspectors are not always well informed about FSMA deadlines and requirements. What steps are being taken by FDA to coordinate with state agencies to ensure those subject to FSMA are in compliance?
Great question. Several State inspectors have informed me that they are aware of the changes being made, but have not yet received training or input from FDA. Please refer to Response #5 in the Preamble to learn more about FDA’s intention to form “partnerships” with other agencies.
(2) In the case of a very small facility under inspection during the period before the compliance date (Sept 18), are there clear grounds to deny FDA agents documentation, specifically regarding environmental monitoring?
I am not sure which date you are referring to, as the compliance date for very small businesses to comply with Part 117 is Sept. 17, 2018. That does not mean that FDA is powerless. The Food, Drug and Cosmetic Act’s 414 (Maintenance and Inspection of Records) has different compliance dates, which depend on how many Full Time Employees (FTE) you have. If you have 10 or less, you must comply with section 414 by Sept. 18, 2017 (NOT 2018!). If you have less than 500 but more than 10, your compliance date is March 17, 2017. Refer to Table 55 or my timelines in the presentation for accurate dates. FDA was given this power by FSMA (sec. 101 – Inspection of Records). To learn more, please see its corresponding provision in the US Code: 21 U.S. C. (350c).
(3) We are affiliated with a winery. Wine and alcohol are not regulated by FDA, so in the calculation of the $1 million guideline for gross revenue, revenue for wine sales would not be included, correct?
Correct, you have an exemption from subpart C and G (not subpart A or B). Please refer to 117.5(i).
(4) Are “very small business” and “qualified facility” ALWAYS used interchangeably?
Great question, a very small business will be considered a qualified facility if it follows the appropriate procedures to establish and maintain its status, as described in subpart D. If a very small business does not follow procedures to establish and maintain its status, it will, by default, be treated as a business that must comply with subparts C and G. The reason they are not synonymous is because there is another set of criteria for a business to be considered a qualified facility, that is distinct from the definition of a very small business. See 117.3’s definition of a qualified facility.
(5) Supply Chain Program question – for example, a cheesemaker sells cheese to a distributor and provides all necessary paperwork, is it then that the responsibility shifts to the distributor? If Listeria is found in the cut-and-wrap room, is the cheesemaker off the hook?
In the context of your question, the “distributor” is more than a logistics provider and 3rd party warehouse for unexposed food (which would have benefit from subpart D’s modified requirements). This “distributor” would be considered a receiving facility, as defined in 117.3. As such, it is responsible for approving suppliers and collecting and verifying assurances (as described in subpart G), among other things. If it finds Listeria monocytogenes in its facility, the presumptive positive will need to be addressed, which may or may not involve the cheesemaker. Because a cut-and-wrap facility has product exposed to the environment and there exists environmental pathogens of concern, it is likely that they will have a preventive control that will need to describe an appropriate corrective action for responding to a presumptive positive. If Lm can be identified by a “Distributor” (or a 3rd party warehouse, for that matter) as being from a cheesemaker’s product, the contaminated product is in commerce and so would need to be recalled and reported within 24 hours on the online Reportable Food Registry by the responsible owner, operator, or manager in charge of the cheese making facility (Read Q&E “E.5” on the Draft Guidance for the Reportable Food Registry, which is non-binding, but the best reference I can give you from FDA).
(6) With the question of distributor liability when cutting, what about retail counters? Are the inspections going to be stepped up to hold them accountable?
I have never heard of cheese retailers conducting sampling and testing of product, but if they were to receive a customer complaint that a cheese consumed was presumed to be contaminated with L. monocytogenes, that report should be forwarded to the cheesemaker, who should follow up on the complaint with a Health Hazard Evaluation, as prescribed in FDA recall guidance. I use the word, “should” because the retailer may not be obligated to do this and the cheesemaker might not necessarily consider the complaint legitimate. However, I would be careful as a retailer, because (1) you don’t want to destroy customer loyalty or life, (2) be sued for negligence (what if it were a result of your own hygienic practices?), and (3) a responsible cheesemaker would want to know! If someone is getting sick and received no answers from a retailer, I would imagine they would make a complaint elsewhere, which would find its way to FDA (see FDA’s Recall 101 webpage – section “First Alerts”). Might as well handle it.