Three new US Food Safety Modernization Act (FSMA) rules are effective January 26, 2016 – are you compliant? What about for Food Fraud and EMA? Don’t worry, since compliance requirements are at least a year away… but you shouldn’t wait since there is a LOT to do. By taking a proactive approach that considers the big picture you may find that the overall compliance may not be as daunting as you thought. This is a summary of the three rules, which also includes links to a detailed MSU Food Fraud Insight Report on each rule.
SUMMARY (150 word maximum): This is a review of the FSMA final rules regarding Food Fraud (FF) and Economically Motivated Adulteration (EMA). The ‘Preventative Controls Rule’ was effective November 16, 2015 and these rules as of January 26, 2016. The new rules are ‘Accredited Third-Party Certification,’ ‘Foreign Supplier Verification Program,’ and ‘Produce Safety.’ Compliance is generally required one year from the effective date (November 2016 and January 2016). Regardless of FSMA emphasis on specific hazards, the Food, Drug, & Cosmetics Act still covers all Food Fraud within the “Adulterated Foods” and “Misbranded Foods” sections. Training for industry and FDA inspectors is being developed, so details are still to-be-determined, but FDA has emphasized they will focus on inspecting the “process” and also increasing to an annual basis. Also, GFSI Food Fraud vulnerability and prevention plan guidance appears to meet FSMA FF/EMA requirements. GFSI addresses all fraud, not just hazards. (144/150 words)
While there is still time until the compliance requirement… there is no time to waste. Begin by reviewing the FSMA requirements, such as in our attached reports. Also start reviewing the wide range of Food Fraud Vulnerability Assessment and Prevention Plan resources, such as our “Food Fraud Reference Sheet.” We will expand our reports, training, and education to meet this need.
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BACKGROUND
Here are details on each new Final Rule.
- FSMA-Preventative Controls: Adulteration (FF/EMA) must be addressed. FF/EMA is under Preventative Controls (Food Safety) and not Intentional Adulteration (Food Defense).
- FSMA-Produce Safety: This rule does not address or mention FF/EMA other than indirectly by reinforcing the FSMA-PC rule. There is a frequent reminder that the FD&C is still in effect.
- FSMA-Foreign Supplier Verification Program: FF/EMA is directly addressed with reference back to the FSMA-PC rule and an emphasis on the application only to health hazards. Food Drug & Cosmetics Act (FD&C) sections on “Adulterated Foods” and “Misbranded Foods” are mentioned throughout the Final Rule. But misbranded product is usually clarified to refer only to allergen labeling. The rule specifically mentions the US Pharmacopeia’s (USP) Food Fraud database and the National Center for Food Protection and Defense’s (NCFPD) EMA database as resource for “known or reasonably foreseeable hazard.”
- FSMA-Accredited Third-Party Certification: FSMA-A3P clearly and explicitly requires “an accreditation” process but does not authorize or approve any specific system or scheme. This allows existing systems meets the FDA emphasis to “avoid unnecessary duplication of efforts and costs.” Global Food Safety Initiative (GFSI) private food safety schemes are mentioned and defined. There is a continued and detailed reminder of the application and authority derived from the Food Drug & Cosmetics Act (FD&C). The FD&C has very detailed descriptions of “Adulterated Foods” and “Misbranded Food” that apply to FF/EMA.
Reference: FSMA-PC Compliance
I. From FSMA-PC Final Rule
- Effective and Compliance Dates
- “We proposed that any final rule based on proposed part 117 become effective 60 days after its date of publication in the Federal Register, with staggered compliance dates (78 FR 3646 at 3673).”
- “Businesses other than small and very small businesses would have 1 year from the date of publication of the final rule to comply with the rule, whereas small businesses would have 2 years and very small businesses would have 3 years to comply with the rule.”
- Compliance and Enforcement
- “With regard to inspections, we will conduct regular inspections of domestic facilities to ensure that facilities subject to this rule are adequately implementing the required preventive controls and supply-chain program, pursuant to our inspection authority under section 704 of the FD&C Act. Our inspections will verify that such facilities are implementing systems that effectively prevent food contamination, and in particular, that they comply with the rule by implementing preventive controls, including supply-chain programs, to provide assurances that any hazard requiring a preventive control or supply-chain applied control has been significantly minimized or prevented.”
- “Section 201 of FSMA mandates that FDA inspect domestic high-risk facilities no less than once every 3 years. We are currently meeting this mandate, and even exceeding it with respect to certain domestic high-risk facilities. Once the FSMA rulemakings come into effect, we intend to build on this track record and to have an FDA or State inspection of domestic high-risk human food facilities on an annual basis to ensure hazards have been significantly minimized or prevented in compliance with this rule.”
Reference: Summary and Conclusions for the new Final Rules
II. FSMA-Produce Safety
SUMMARY
The US Food Safety Modernization Act Produce Safety Final Rule (FSMA-PS) does not directly address Food Fraud (FF) or Economically Motivate Adulteration (EMA) other than referring to the FSMA Preventative Controls rule (FSMA-PC) and the US Food Drug & Cosmetics Act (FD&C). FSMA-PS focuses on biological health hazards only and not physical or chemical contaminants. As such, there are no additional FF/EMA regulatory compliance requirements for FSMA-PS. This Final Rule does provide insight to other FSMA compliance questions.
Compared to previously published FSMA rules, the FSMA-PS rule has much more emphasis on the FD&C. The FD&C has very broad definitions of what is unfit for commerce regarding “Adulterated Foods” and goes beyond adulterant-substances to include unintentional root causes such as stolen goods, filthy, spoiled product, etc.). Another applicable FD&C section is “Misbranded Foods.” (Note: the act of stealing goods is intentional but any contamination is unintentional.) (146/150 words)
CONCLUSION
- Regarding FF/EMA, the focus should be on the FSMA-PC rule without neglecting FD&C requirements. The FDA continues rely on the strong and broad requirements of the FD&C regarding intentional and unintentional food safety hazards.
- Similar to our review of FSMA-PC, companies that are compliant with industry standards such as GFSI will be technically compliant with the FF/EMA aspects of the FSMA-Produce Safety rule.
III. FSMA-Foreign Supplier Verification Program
SUMMARY
This is a review of the US Food Safety Modernization Act Foreign Supplier Verification Program for Importers of Food for Humans and Animals Final Rule (FSMA-FSVP) [FDA-2011-N-0143] as it applies to Food Fraud (FF) and the sub-category of Economically Motivated Adulteration (EMA). This rule did directly address EMA in several sections. The FSMA-FSVP was officially published on November 27, 2015 and is effective January 26, 2016.
The FFI Report series reviews the minimum FSMA compliance requirements. An enterprise –a company or country–should consider broader enterprise risk management (ERM) processes to confirm their own comfort level or acceptable risk threshold. E.g. addressing the European horsemeat food fraud scandal would not be required under FSMA since there was no health threat. (122/150 Words)
CONCLUSION
The key FF/EMA related findings include:
- The Final Rule repeatedly emphasizes the preventative controls requirement applies to only health hazards.
- Food Drug & Cosmetics Act (FD&C) sections on “Adulterated Foods” and “Misbranded Foods” are mentioned throughout the Final Rule. But misbranded product is usually clarified to refer only to allergen labeling.
- For FF/EMA this rule frequently refers back to the FSMA Preventative Controls rule.
- FSMA-FSVP specifically mentions the US Pharmacopeia’s (USP) Food Fraud database and the National Center for Food Protection and Defense’s (NCFPD) EMA database as resource for “known or reasonably foreseeable hazard.”
- Similar to our review of FSMA-PC, companies that are compliant with industry standards such as GFSI will be technically compliant with the FF/EMA aspects of this rule.
IV. FSMA-Accredited Third-Party Certification
SUMMARY
This is a review of the US Food Safety Modernization Act Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications Final Rule [FDA-2011-N-0146] as it applies to Food Fraud (FF) and the subset of Economically Motivated Adulteration (EMA). FMSA-A3P does not directly mention or address FF or EMA so this is only a detailed review of the Summary, Executive Summary, and sections specifically concerning Private Food Safety Schemes (e.g., GFSI). FSMA-A3P was published on November 27, 2015 and is effective January 26, 2016.
CONCLUSION
FF/EMA related findings include:
- FSMA-A3P clearly and explicitly requires “an accreditation” process but does not authorize or approve any specific system or scheme. This allows existing systems meets the FDA emphasis to “avoid unnecessary duplication of efforts and costs.”
- Private food safety schemes were explicitly and directly addressed and accepted for regulatory compliance of this Final Rule.
- Global Food Safety Initiative (GFSI) private food safety schemes are mentioned and defined.
- The Final Rule mentions several times – including the emphasis that this is a statutory requirement and the expectation by Congress of –“promoting international consistency and tapping into an existing framework of consensus standards that is familiar to industry.” This then applies to using the “Food Fraud” term (i.e. all deceptions for economic gain using food; a globally recognized term) rather than just the sub-category of “Economically Motivated Adulteration.”
- There is a continued and detailed reminder of the application and authority derived from the Food Drug & Cosmetics Act (FD&C). The FD&C has very detailed descriptions of “Adulterated Foods” and “Misbranded Food” that apply to FF/EMA.
- Similar to our review of FSMA-PC, companies that are compliant with industry standards such as GFSI will be technically compliant with the FF/EMA aspects of this rule.