With summer vacation season upon us, most people can relate to the angst of the question, “Are we there yet?”  In fact, I suspect many food industry professionals have recently pondered this question when reflecting on the regulations of the Food Safety Modernization Act (FSMA), and then wondered what is “coming down the pike?”

Upon enactment of the FSMA law in January 2011, the U.S. Food and Drug Administration (FDA) implemented a few requirements immediately, but the most significant rules require years to develop.  The implementation phase of the FSMA regulations officially began two years ago with the beginning of Phase II of the FDA’s operational strategy for FSMA, which included regulator training and targeted risk-based inspection, sampling, testing and data collection activities.

So, where are we now? The implementation of FSMA regulations has endured a few obstacles along the road, but the FDA remains committed to reaching the final destination of a preventive approach to food safety. Facility inspections have been ongoing and the agency has taken an “educate before and while we regulate” approach to facility inspections beginning last September with the implementation of the rule, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.

Recently, the compliance dates took effect for two core FSMA regulations, beginning with the sanitary transport rule in April and followed by the Foreign Supplier Verification Program (FSVP) rule in May.  This month, the agency laid the groundwork for implementation of the third-party accreditation rule by permitting organizations to apply to be accreditation bodies, while the FDA also announced plans to delay the controversial water testing requirements of the Produce Safety rule. The following provides a synopsis of recent and upcoming FSMA activities:

Final rule impacting food transporters
Effective April 6, 2017, the majority of shippers, receivers and carriers that transport human and/or animal food were advised to implement the FSMA requirements for sanitary transportation practices to mitigate food safety risks. The final rule applies to operations that transport food in the United States by motor or rail as well as foreign entities shipping food to the United States in an international freight container by sea or air. To prevent food safety risks during transport, the FDA rule established requirements for vehicles and transportation equipment, transportation operations, training of carrier personnel and the maintenance of records.

FSVP imposes new requirements for importers
The Foreign Supplier Verification Program (FSVP) is the most significant FSMA regulation for ensuring the safety of imported foods. Under the FSVP rule, importers are responsible for numerous activities, including determining known or foreseeable hazards, evaluating their supplier’s performance and conducting supplier verification activities. For most importers, the compliance date for this rule was May 27, 2017. The FDA posted guidance documents to support compliance with this important rule, including:

  • What do manufacturers/processors covered by the PC supply-chain program need to know about FSVP?
  • FSVP:  As compliance date nears, key facts for importers

Accredited Third-Party Certification program advancing
The final rule, Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications, became effective in January 2016, but implementation was postponed until after publication of the final Model Accreditation Standards guidance and the final rule on user fees. In December 2016, the FDA issued the rule for user fees and the long-awaited final guidance for Model Accreditation Standards. Implementation of the accredited third-party certification program will follow the recent launch of an FDA website that permits a government agency or private organization to apply as a third-party accreditation body.  Third-party certification bodies, also known as third-party auditors, must be accredited by FDA-recognized accreditation bodies in order to participate in the Accredited Third-Party Certification program.

Produce Safety – Agricultural water standards delayed
The final rule for Produce Safety established standards for growing, harvesting, packaging and holding produce (unprocessed), including standard practices to prevent biological, chemical and physical hazards. Microbial quality standards for water were emphasized within the FDA’s produce safety rule since fresh produce is often contaminated by pathogens from contaminated agricultural water. The agency revised the proposed rule to provide an updated microbial standard for water, a flexible approach to testing untreated water, and options for farmers to use agricultural water that does not comply with the quality standard.  The final water standards are challenging for growers, and as a result, the FDA recently announced plans to reconsider various issues and to extend the compliance date for the water testing requirements.

Is it time to consider Food Defense?
In May 2016, the FDA issued the final rule  for mitigation strategies for foreign and domestic facilities to prevent the intentional adulteration of food, also known as ‘food defense.’  Under the final rule, each covered facility would be required to prepare and implement a written food defense plan addressing vulnerabilities and actionable process steps, mitigation strategies, monitoring procedures, corrective actions, and verification activities. The rule applies to the majority of domestic and foreign FDA-registered facilities that manufacture, process or pack food. Since the rule introduces several new concepts, the agency extended the original compliance date to permit up to three years for companies – other than small or very small businesses – to comply.  The general compliance date is July 26, 2019.

Coming down the pike
The expression “coming down the pike” refers to something approaching, as a vehicle would on a turnpike.  Despite the current anti-regulation philosophy of the federal government, the FDA is advancing the FSMA regulations as mandated several years ago.  The food industry can expect to see the complete implementation of the remaining FSMA regulations “coming down the pike” within the next few years.

While the FDA will continue its interactive “educate before and while we regulate” approach to facility inspections, the agency also suggested that food processors and importers should expect greater scrutiny this year, including targeted risk-based inspections, and a wider range of sampling, testing and data collection activities.  According to the FDA, a history of food safety violations such as recalls or warning letters will increase a facility’s chance of receiving a risk-based inspection.

Are you prepared to implement FSMA requirements at your facility? Mérieux NutriSciences’ consultants will help you determine the regulations that apply to your company and offer assistance to help you become compliant. Our experts can perform an FDA readiness gap assessment, build your plants’ food safety plans, perform a comprehensive hazard analysis on ingredients and provide PCQI training at your facility. Start your journey to FSMA compliance now.


Meet the Author

Patrick Kennedy
Information Services Manager, Mérieux NutriSciences

Patrick Kennedy is the Information Services Manager for Mérieux NutriSciences. He has over 15 years of food industry experience and has written extensively covering a wide range of food safety and regulatory subjects. He holds a MS degree in information science from the University of Illinois, and is a member of several industry organizations including AOAC, IFT and IAFP.

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