Food and beverage manufacturers doing business in the US must now comply with more stringent important food safety regulations.
Deadlines for small food and beverage company compliance with provisions of the Food Safety Modernization Act (FSMA) are now. The new regulations apply to companies that manufacture, pack, process, or store food, including coffee roasters, bottlers, and tea blenders.
Begining in March 2017 the US Food and Drug Administration (FDA) made a priority of enforcing the new rules with large food manufacturers and importers during the initial stages of implementation but now even small firms, those earning $1 million and less, must meet FSMA mandates.
These include:
- A Hazard Analysis and Risk-based Preventive Controls (HARPC) Plan
- Preventive Controls Qualified Individuals (PCQIs) training
- Food Defense Plans
- Foreign Supplier Verification Program (FSVP)
“During the past year the FDA has taken a very reasonable stance on FSVP, explicitly saying it would blend education with soft enforcement to help importers ramp up,” explains Joseph DeRupo, former NCA external relations director and FSMA regulatory consultant. “But time is up as the FDA steps up enforcement, leaving many importers unaware and vulnerable to stopped shipments, legal action, and fines,” says DeRupo.
“They’re also risking an FDA Import Alert, which could blacklist their imports for automatic detention without physical examination (DWPE). To get the regulatory veil lifted, they’d need to develop a full FSVP program, deploy it successfully, and then rack up five consecutive compliant entries before they can petition the FDA for release,” he explains.
“Bottom line – it’s time to act, and quickly,” he advises.
The deadline for Preventive Controls compliance was Sept. 17, 2018. Very small businesses may choose to comply by either implementing a HARPC Food Safety Plan and Supply Chain Program or by submitting a qualified facility attestation with FDA.
Filing can be done electronically using the FDA Unified Registration and List System (FURLs) beginning Oct. 1, 2018 (or by mailing FDA a completed Form 3942).
The form will take half an hour to complete after first calculating annual sales and market value of all foods manufactured, packed, or held in the preceding three years to determine eligibility. This total includes any subsidiaries and affiliates. The FDA asks for calculations and financial supporting documents.
The primary concern is safety, says Spencer Turer, v.p. at Coffee Enterprises, a laboratory equipped to evaluate coffee quality and “determine when coffee is within specification and expectation and when it is not.”
He said FSMA’s requirements for preventative controls “have increased the demand for analysis of pathogens (E. coli, salmonella, staphylococcus, listeria (LPT), clostridium perfringens, bacillus cereus); microbiological analysis (coliform, yeast & mold, aerobic plate count, 5-day anaerobic plate count); pesticide analysis, and mycotoxin multi-screening (aflatoxins B1 B2 G1 G2, ochratoxin A, total fumonisin, T-2 toxin, HT-2 toxin, vomitoxin, and zearalenone).
“Very often, a food safety or chemical analysis project is commissioned to answer a specific question or for an individual concern by the customer of our client,” he said.
Typical roaster controls include physical, sensory, and chemical analysis of green coffee products prior to receiving them in their facility, using sorting and/or cleaning equipment for green coffee within process controls, and process controls with full lot traceability from purchase, through manufacturing to product sales.
Turer says that “strong relationships and direct communications with the importer, farmer, and milling operation can increase chances of preventing unwanted contamination or quality deterioration issues.”
“Roasters should coordinate with their importers regarding inspections and hazard analysis protection. Requesting quality control and analysis reports is suggested,” he said.
Tea blenders face similar challenges, complicated by the large number of spices, herbs, fruit, and floral inclusions.Last year FDA noted failure to comply with FSVP in 108 citations, it is probable that FSMA violations will increase significantly following the latest deadlines.