Many Thks for the info.
A few comments -
Regarding yr OP, afaik (= based on post/thread below) the terminology HARPC has now been abandoned. Officially or not is unclear to me. It certainly does not seem to appear in the primary link of OP or any of its active attachments.
i scanned the issued Chapters. Impressive, wide-scoped, material but, for me, seems to have one immediate critical defect - zero worked examples (cf the FDA's previous practical "magnum opus" - HACCP Fishery Guide,2011).
Presumably substantial overlap with the FSPCA manual. I noted various xreferences.
I am still trying to find an unambiguous answer (ie Yes/No) to one simple, FSMA, question - Is one permitted under FSMA to submit a "Food Safety Plan" which makes use of (named) CCPs ? (I note that the linked document carefully mentions (Pg 11) "You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations." Hmmmm.)
Charles, FDA really never used the term HARPC officially, it has been promulgated by the people who have written about it. That's why you don't see it in the guidance document.
The FSPCA material was derived from the Human Preventive Controls regulations, so the xreferences are to be expected.
You never submit a food safety plan to the FDA. People don't realize that. It's not like a certification where they initially approve your plan, it's just the law. So you don't ever send it to the FDA, but you need it set up for when they appear out of nowhere. The day they show up at your site, you show an inspector what you do, and they determine if it meets the requirements of their regulations. You can make a Human Preventive Controls plan, to make it easy so it's all in one place, but you don't have to. If you have a food safety plan which is almost but not quite compliant, and can produce evidence that you follow the regulations with supplemental plans, it is OK. This was clearly stated at the public meeting at the time of the publication of the Preventive Controls regulations. The recording of that meeting is on the FDA site.
In general, most US regulations are performance based compliance, you are fine as long as you get to where you are supposed to be. How you get there is up to you. There are some regulations which are standard based, which means that you need to follow a specific manner to achieve the compliance. They will spell out the exact things you need to do. An example is the nutritional label, that is standard based compliance. Most of the Human Preventive Controls are performance based, so it does not cause an undue burden on a company. I know this is different from many other countries in the world, but we value our individuality. As long as it comes out right in the end, we can do it how we want.
"...everything can be taken from a man but one thing: the last of the human freedoms--to choose one's attitude in any given set of circumstances, to choose one's own way." Viktor E. Frankl
"Life's like a movie, write your own ending." The Muppets