Sorry to confuse you, Charles,
I agree non-safety related EMA doesn't need full consideration in a food safety plan. But how do we know if a certain type of EMA could create a food safety hazard unless we do a hazard analysis?
In the olive oil example you provided, the hazard analysis process would identify that sunflower oil adulteration could occur, then decide it isn't a food safety risk. So it doesn't need a control. In the peanut/cashew example you would identify the hazard, then determine that such adulteration could cause a food safety risk, so it does need a control.
Here is the FDA guidance which requires such:
188.8.131.52 Chemical hazards that may be intentionally introduced for purposes of economic gain
The PCHF requirements specify that you must consider, as part of your hazard identification, known or reasonably foreseeable hazards that may be intentionally introduced for purposes of economic gain (21 CFR 117.130(b)(2)(iii)).
Thks for the links. Jogged my memory as to the appearance of EMA in the FSPCA manual. Sadly, this important aspect is omitted (since presumably redundant) in the otherwise impressive example of a FSMA compliant Plan in the FSPCA's Appendix.
I suppose the OP's FSMA difficulty is hardly surprising since haccp/EMA(FSMA) are derived from disparate origins, ie accidental contamination/safety vs intentional adulteration/non-safety>safety.
I noticed these 2 vaguely related GFSI/FSMA comments -
While both programs [VACCP/TACCP] have been adopted by the Global Food Safety Initiative (GFSI) in Europe, neither have been formally accepted by the US Food and Drug Administration (FDA). The Food Safety Modernization Act (FSMA) includes the Mitigation Strategies to Protect Food Against Intentional Adulteration Rule but this focuses only on public health concerns. Adulteration that does not present a risk to food safety is outside of the scope of the FSMA Rules.
And yet it is necessary to implement EMA within FSMA !
Similarly, in a GFSI context, approximating EMA to VACCP, and food defense to TACCP -
QA. How can TACCP and VACCP integrate with FSMA to add value?
Sklare. It’s not really a question of integrating with FSMA any more than HACCP integrating with FSMA. They are tools to help to support a FSMA compliance program. TACCP and VACCP complement HACCP. TACCP and VACCP are designed to mitigate the vulnerabilities involved in acts of intentional contamination which HACCP is not.
As far as FSMA is concerned, they are tools that can be used to satisfy requirements of FSMA such as food defense and intentional adulteration. The additional value they could provide is that they will help satisfy the requirements of FSMA and go beyond them.
No surprise IMO that the OP got stuck with a "square peg".
PS - here is one suggested response to the OP's query -
haccp plus EMA.pdf 115.74KB
Edited by Charles.C, 13 March 2020 - 10:54 AM.