This is addenda to previous post regarding USDA hand sanitizers. Seems that I missed a portion of USDA’s history so my initial comments, eg hsan1, not the whole picture. Sorry about that.
Apparently FSIS’s program for the approval of nonfood compounds and proprietary substances for use in meat and poultry establishment ceased in 1999.
After FSIS announced its discontinuation of the approval program, NSF International - a not-for-profit, non-governmental organization - launched a voluntary Nonfood Compounds Registration Program to re-introduce the previous authorization program. All products used in and around food processing establishments (nonfood compounds), such as hand cleaners and sanitizers as well as hard surface sanitizers are now eligible for NSF listing. NSF listing assures inspection officials and processors that the product formulation and labels have been reviewed and meet appropriate food safety regulations.
food safety and hand hygiene,2006.pdf 753.41KB
The official USDA version of the 1999 change appears to be described here –
1999 changeover.pdf 6.7MB
(large file, may be a bit slow)
The introduction section is, IMO, rather obscure in its precise interpretation inasmuch as it “seems” (onwards) to be simultaneously approving both the established previous (pre-1999) recommendations and/or (?) further added regulatory material ex FDA, eg see “2-301.16 Hand Sanitizers” in same document.
(Just as an aside this "USDA" document also has a comment on the use of dual function, hand cleaning stations ,–
2-301.15 Where to Wash
Food employees shall clean their hands in a handwashing lavatory or approved automatic handwashing facility and may not clean their hands in a sink used for food preparation, or in a service sink or a curbed cleaning facility used for the disposal of mop water and similar liquid waste. )
The two Appendices containing pre-1999 requirements are no longer directly attached but can be seen here (and on the USDA net) –
appendices, pre1999.pdf 4.88MB
(especially see intro appendix1 and material beginning appendix2)
The relevant additional FDA-related material appears very similar to that in my previously attached hsanX documents.
The crux of the above as far as quaternary compounds are concerned is that they should (for hand use) be
listed somewhere in the variously stated reference documents. According to ISSA (2003), they (benzalkonium chloride) certainly appear in the fabled OTC, long time running, monograph where their “tentative” status as category3 is, as yet, neither approved/disapproved although (strangely?) sale is nonetheless permitted. Based on various adverts, they are apparently approved by NSF (whose standards appear to require money). I am still rather unclear as to the precise linkage between NSF and USDA although obviously close -
There are a few (food-related) comments here and there that suggest alcohol–based hand sanitizers may be preferable but nothing definitive AFAIK. Such (alcohol) items are possibly also more easily matched to the regulatory aspects. For examples, here are 2 items, first more operational (see closing comments), second more “promotional” (see the nice-looking “validation” chart near the end –
ground beef recall.pdf 792.16KB
Alpet hand sanitiser.pdf 565.45KB
If some detail/opinions still missing, USA meat people here only too welcome to further enlarge my knowledge.
Rgds / Charles.C
Summary for Quaternary Compounds Regarding Approval for Use as Hand Sanitizer
(1) For Processes under FDA Jurisdiction
(a) Processes within Jurisdiction of Food Code Control (latest ed.2013)
Requirement – Compliance with Paragraphs such as in attachments hsan2,3 (updated to 2013 if necessary)
An example of compliance data is in attachment (“Alpet ….”) in this post
(b) Processes not within Jurisdiction of Food Code
Eg seafood in general. Currently No Idea. Suggestions welcome.
(2) For Processes under USDA/FSIS Jurisdiction ( eg Meat / Poultry)
The following comments are speculative for reasons such as the rather bizarre last paragraph of the introduction in the attachment referred in (iii) below.
The possibilities seem to be –
(i) A chemical approved by USDA prior 1999 (eg see appendix2 in attachment “appendices,pre 1999”)
(Presumably implies one of the type “E” products. AFAI can see, there is no explicit mention of quaternary compounds.)
(ii) A chemical “approved” by NSF, (presumably) since 1999
(iii) A chemical approved as described in section 2.301.16 in the attachment “1999 changeover ….”
(this section is probably a direct extract from the Food Code, ie similar to (1)(a) above)