FDA’s 2018 Guidance Documents for Intentional Adulteration
When using the FDA Food Defense Plan Builder v. the FDA law, could you speak to what those specific gaps are? Will FDA wait to update FSDB once the nine chapters are completed?
Is Intentional Adulteration applicable to manufacturers in EU? How does this relate to FSVP?
Does the Food Defense Plan part of HARPC or is it a separate stand alone program?
When will the Food Defense Plan Builder be upated?
Does the Food Mitigation Plan include Food Fraud? If not what is the Implementation compliance date for Fraud?
Is there any free databases to use (All pay for databases are expensive for SME) where we can get information about detected and/or on-going adulterations ?
When using the FDA Food Defense Plan Builder v. the FDA law, could you speak to what those specific gaps are? Will FDA wait to update FSDB once the nine chapters are completed?
The differences between the regulation and the current FDA food defense plan builder include the following; 1. Capturing the three fundamental elements within the assessment 1. Physical access to product. 2. Ability to contaminate. 3. Public health impact if a contaminate were added. Additionally, the plan builder separates mitigation strategies into broad and focused. This was included in the proposed regulation but removed in the final regulation. The FDA has stated the current food defense plan builder does not meet the new regulatory requirements. They have not stated exactly when just it will be updated soon.
Is Intentional Adulteration applicable to manufacturers in EU? How does this relate to FSVP?
If you are a facility located in the EU and you export product to the United States for consumption in the United States, and you are required to register with the FDA under section 415 of the Food Drug and Cosmetic Act then you are required to follow 21 CFR 121 (the IA regulation) unless you meet an exemption. It is a stand alone regulation.
If you follow a GFSI audit scheme then you are also required to have a food defense plan and vulnerability assessment and mitigation strategies if significant vulnerabilities are identified. Now this requirement is not as detailed in the requirements as the FDA food defense plan requirements.
Does the Food Defense Plan part of HARPC or is it a separate stand alone program?
The requirements of 21 CFR 121 (Food Defense) is a separate program from 21 CFR 117 (HARPC). The requirements for both programs are similar but there are differences.
When will the Food Defense Plan Builder be upated?
Does the Food Mitigation Plan include Food Fraud? If not what is the Implementation compliance date for Fraud?
As of right now the FDA has not specified a date for when the Food Defense Plan Builder will be updated they just say soon.
Both Food Fraud and Intentional adulteration are intentional acts. However, when someone commits food fraud it is not with the intent to harm others. The intent is to make profit. So food fraud is a separate program from intentional adulteration.
The only FDA requirement on food fraud is to consider "Economically Motivated Adulteration" (this means food fraud that leads to a food safety issue). This is to be assessed and included in the hazard analysis as part of the food safety plan. So compliance for this type of food fraud is when your compliance date was reached for 21 CFR 117 (HARPC)
GFSI schemes have different food fraud requirements and compliance is dependent on the scheme.
Is there any free databases to use (All pay for databases are expensive for SME) where we can get information about detected and/or on-going adulterations ?
Trello.com is a potential resource for intentional adulteration issues. In there food fraud section the do include intentional adulteration issues. Another resource is foodsheild.org and the Food Protection and Defense Institute. The last free resource is news and media. As an example the needles in strawberries issue being reported on in Australia.