Rules and Documents Relevant to FSMA Very Small Business Exemption
I semi -retired from the Food Manufacturing/Food Safety industry two years ago and of course am not longer at the top of my game. I was given to believe that at one juncture during the FSMA implementation that very small businesses were to be exempt from major portions of FSMA if 1), their gross sales were under 1 million dollars and or 2), 50% or less of their sales is to other food establishments as opposed to final consumers if proper records are kept.
Furthermore, that such a very small business was exempt from having to register under the “Public Health Security and Bioterrorism Preparedness and Response Act”.
The context under which I am asking is a spice and herb grinding, blending and packaging operation currently under the jurisdiction of the county health department. If any of my colleagues out there with subject matter expertise in this area would speak to the question of whether I am in error or point me the relevant document of the current CFR requirements and interpretations, I would be most grateful.
Kind Regards,
Xylough
Hey Xylough. All rules under FSMA don't necessarily define "Very Small Business" qualifications in the same way. Take a look at this to get a better idea: http://ifpti.org/wp-...egalees-PDF.pdf
Thank you Kmalvetti2,
I realize now I failed to state a crucial piece of information. The actual exemption to which I'm speaking Is not foremost a small business exemption under FSMA, but rather an exemption under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (now updated in 2016).
My understanding is that under The Act, a retail food business supplying directly to consumers (as opposed to other food businesses) where more than 50% of their gross sales are directly to final consumers is exempt from registration under The Act. The secondary consequential exemption is under FSMA which allows that a retail food business which is exempt from registration under the Bioterrorism Act is also exempt from compliance with the the Preventative Controls Final Rule and is only required to comply with the updated CGMP (CFR 21 section117) aspect of FSMA.
So I would restate my question in the light of this new piece of information, whether I am in error in my understanding about the Bioterrorism Act registration exemption and the subsequent FSMA exemption? Any perspective or relevant documents would be most welcome.
Kind Regards,
Xylough
Hi Xylough,
No idea as to the answer to yr query but just to Welcome yr reappearance on this Forum !
Hopefully kmalvetti or others can help.
The question/answer section of the preventive control rule touches on this slightly when discussing R&D plants:
In general, a foreign or domestic facility that manufactures, processes, packs, or holds human food for consumption in the United States and that has to register with FDA under section 415 of the Federal Food, Drug, and Cosmetic Act is subject to the requirements related to preventive controls (primarily located in subpart C and subpart G) of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR part 117; 80 Fed. Reg. 55908) (CGMP & PC rule), unless subject to an exemption (see 21 CFR § 117.5 for exemptions). Note that an establishment may also be subject to the Current Good Manufacturing Practice (CGMP) requirements in subpart B; those requirements are not dependent on whether a facility is required to register.
If a research and development (R&D)/pilot plant or test kitchen is a facility required to register (see 21 CFR § 1.225 , it will be subject to the requirements of the CGMP & PC rule, unless an exemption applies (see 21 CFR § 117.5 for exemptions).
In the rule itself, it looks like non-registered facilities are defined as "mixed type" but then they go on to only use the term in reference to farms, so unhelpful there.
I can't find anything in the actual law stating that registration status has any impact on which portions of the law you must be in compliance with, just references that registered facilities are only exempt if they fall under one of the exemptions.
I would treat the two categories separately. If your facility handles food, and works in interstate commerce, then I would operate under the assumption that you need to look at the exemptions listed under each FSMA final rule for it's applicability, independent of registration status. Basically everyone assumes that if you had to register, then you fall under the rules unless an exemption applies. But if you didn't have to register you likely fall under an exemption, but registration is not a prerequisite as to whether you fall under the rule (at least according to the law as written, FDA guidance may state differently).
Note that FDA and amazon are currently having a fight over the retail exemption, so this is going to be grey area as long as FDA doesn't bring the hammer down on that particular dispute. I interpret the stand-off there being that amazon is "technically" correct in their interpretation of the law, but FDA expects such facilities to register regardless.
They have a confusing note on this final rule page:
Registrations are now required to contain the type of activity conducted at the facility for each food product category. This will be required when the final rule becomes effective on July 14, 2016. The final rule also amends the definition of a retail food establishment in a way that expands the number of establishments that are considered retail food establishments, and that are therefore not required to register with the FDA as food facilities. However, all food establishments, including retail food establishments, continue to have a responsibility to ensure their food is safe.
Thank you for your considerate reply to my query. You have provided me with a great deal of leads and homework. I had not considered looking into each separate FSMA rule, believing the combination of the Bioterrorism Act exemption from registration for retail establishments directly supplying final consumers and the FSMA exemption for very small retail businesses not required to register with the Food Registry, completely exempted them from all the FSMA Rules excepting the updated CGMP CFR 21 part 117. It would seems I need to reexamine my assumptions and take a fresh look.
Kind regards