By Ron Tanner
It has been eight years since Congress passed the sweeping Food Safety Modernization Act. All the regulations are now in effect, even for small and very small businesses.
There are significant activities taking place. These were detailed at the Food Safety Preventive Controls Alliance Annual Conference, which took place in Chicago in October.
Douglas Stern, deputy director of regulatory affairs for the Center for Food Safety and Applied Nutrition, keynoted the conference. He said, “We have made substantial advances through FSMA, but we have not won the battle against foodborne illness.” He added that the new role given to importers through the Foreign Supplier Verification Program and FDA’s increased reliance on its state regulatory partners are important strides forward but there is still much to be accomplished.
FSMA and FSVP Inspections Skyrocket
The most anticipated presentation was from Glenn Bass, program deputy director, Human and Animal Food-West, Office of Regulatory Affairs. Bass serves as agency focal point in coordinating, directing, and assisting the field and headquarters offices with investigative food activities. In other words, he is in charge of FDA facility inspections.
Bass gave an overview of FSMA implementation from 2011 on. The regulations fell under the umbrellas of:
Modernization
- Preventive controls (built on HACCP principles)
- Updated GMPs
- Food defense plans
- Produce safety standards
Accountability
- Greatly increased records access by FDA
- More emphasis on recordkeeping and supporting information
- Supply chain management of domestic and foreign suppliers
- Re-inspection fees
Oversight
- More frequent government inspections, both in the U.S. and internationally
- DA authority to suspend registration (shutting down operations) and require recalls
Since 2017, FSMA-related inspections have increased nearly tenfold. Here is some of the data:
| FSMA-Related Inspections | 2017 | 2018 | 2019* |
| Limited Scope Preventive Controls | 721 | 6,630 | 14,690 |
| Full Scope Preventive Controls | 263 | 612 | 867 |
| Foreign Supplier Verification Program | 285 | 795 | 870 |
*as of October 1, 2019
Throughout the first five years of FSMA, the FDA’s rallying call was “Educate before we regulate.” It has now changed to “Regulate while we educate.”
Bass said, “We have been working to train our inspectors and our state regulatory partners to do Preventive Controls and Foreign Supplier Verification Inspections. All FDA inspectors have been required to complete the FSPCA training as well as augmented FDA training. We now have a trained staff that can oversee industry’s compliance with FSMA.”
The FSMA inspections take time. A Limited Scope Preventive Controls inspection requires three to four days at the facility; a Full Scope Preventive Controls inspection is four to five days. FSVP inspections take a little less time but still require multiple days.
Many of the facilities inspected for Preventive Controls fail. In 2018, Voluntary Action Indicated (VAI) was reported in 2,295 facilities and Official Action Indicated (OAI) in 81 facilities during the Limited Scope Inspections. Facilities undergoing Full Scope inspections recorded 229 VAIs and 42 OAIs. Citations were issued for the following:
- Lack of Hazard Analysis and Identification of Hazard
- Lack of a Food Safety Plan
- Lack of Sanitation Controls Verification Procedures: Establish and Implement
- Lack of Process Controls Monitoring Procedures: Establish and Implement
- Lack of Identifying and Implementing Preventive Controls
FSVP Still a Mystery to Importers
Sharon Mayl, senior advisor for policy in the Office of Food Policy and Response, reported on FSVP. Mayl co-led the team that developed the FSMA import rules and guidance documents.
Even though FSVP inspections are pre-announced, many importers still fail. FDA has never had inspection authority over the import community and many importers are either confused or not paying attention to the law. They failed for the following reasons:
- No FSVP
- No written hazard analysis
- No documented appraisal of the supplier
Mayl stressed that certification by a third party, such as GS1 or SQF, is not sufficient to comply with the FSVP regulation. FDA has not recognized the equivalency of third-party certifiers. This concerns many in the international community.
In 2019, FSVP inspections resulted in 296 No Actions Indicated, 518 VAIs, and 20 OAIs. The OAIs resulted from re-inspections after the importer failed the first inspection. FDA has issued its first Warning Letter for an FSVP violation in relation to a tahini from Palestine that caused a salmonella outbreak in the U.S.
Mayl added that 1,400 FSVP inspections are planned for 2020.
The Final Rule: Intentional Adulteration
The Intentional Adulteration Rule is aimed at preventing intentional adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply. Such acts could cause illness, death, and economic disruption of the food supply. Rather than targeting specific foods or hazards, this rule requires mitigation (risk-reducing) strategies for processes in registered food facilities.
Facilities must prepare and implement food defense plans. The written plan must identify vulnerabilities and actionable process steps, mitigation strategies, and procedures for food defense monitoring, corrective actions, and verification. A reanalysis is required every three years or when certain criteria are met.
All employees who work at a facility and are in contact with food preparation must go through food defense awareness training to acquaint themselves with the possibility of intentional adulteration and how it could happen. The training offered through FSPCA is online and takes about 30 minutes to complete.
The hand-holding period for FSMA is over. FDA is regulating while educating and expects the industry to comply with these rules that protect public health.
Ron Tanner is vice president, education, government, and industry relations for the Specialty Food Association.
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