Tag Archives: guidelines

FST Soapbox

FDA Announces Inspections Will Resume…Sort Of

By Trish Wester
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FDA Commissioner Stephen Hahn, M.D. recently announced that food safety inspections will resume in July, but inspectors will be given leeway to accommodate the coronavirus pandemic. Inspections will be prearranged by appointments. The agency suspended routine inspections in late March as a result of the pandemic response, which closed down much of the country.

USDA/FSIS has continued to provide inspection services for eggs, meat and poultry throughout the COVID-19 outbreak, with a significant number of establishments involved in outbreak clusters and periodic shutdowns.

The “White House Guidelines for Opening Up America Again” calls for the FDA to send out investigators for on-site inspections by the week of July 20, using the COVID-19 Advisory Rating system, which utilizes state and national data about infection rates to determine the regions where enforcement can resume.

In a July 10 FDA statement Hahn noted, “resuming prioritized domestic inspections will depend on the data about the virus’ trajectory in a given state and locality, and the rules and guidelines that are put in place by state and local governments.”

One of the most significant modifications for domestic inspections in the announcement is that they will be pre-announced to FDA-regulated businesses. “This will help assure the safety of the investigator and the firm’s employees, providing the safest possible environment to accomplish our regulatory activities, while also ensuring the appropriate staff is on-site to assist FDA staff with inspection activities,” Hahn said. Previously, most inspections were unannounced.

It’s not entirely clear how FDA will use the White House guidelines to determine where they can schedule inspections. There is mention of a prioritization mechanism that will identify high-risk operations, but that has traditionally been part of FDA’s approach to inspections.

The CDC published phased guidelines for states to follow in reopening, which are referred to in the announcement. The guidelines document outlines the gating criteria for states, but published versions do not mention inspection requirements. Many states began reopening without meeting all of the gateway criteria for Phase 1, and continued to accelerate reopening activities in a way that makes it unclear which phase criteria they may have actually met when compared to the phase under which they claim to be operating.

Further complicating the safety issue is the recent rising number of COVID-19 cases that is causing some states to pause or rollback reopening activities. Since publishing the announcement, several states have emerged as new COVID-19 hot spots, including Texas, Arizona and Florida; In addition, Florida has surpassed New York in total cases. California, another food producing state heavily affected by the pandemic, is seeing a significant increase in cases and is considering issuing new shelter-in-place orders. It was recently reported that CDC has identified 21 states as “Red Zones”, with at least 11 states on the verge of surging cases.

In other words, with the virus on the rise, there may not be a significant number of inspections actually performed, regardless of whether or not inspections have technically resumed, simply because there just isn’t a safe way to send inspectors out.

The FDA has also published the “New Era of Smarter Food Safety Blueprint”, which includes ways the agency could use technology to support compliance activities. There may be an opportunity for the FDA to implement new tools such as remote verification in lieu of onsite inspections, but that remains to be seen. Among such tools, remote audit pilots were recently completed and those results will be available for public presentation at the end of August.

In the short term, should FDA determine you are an inspection candidate, you will contacted in advance to schedule a day and time.

Susanne Kuehne, Decernis
Food Fraud Quick Bites

Spreading False Claims

By Susanne Kuehne
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Susanne Kuehne, Decernis
Food fraud, spread
Find records of fraud such as those discussed in this column and more in the Food Fraud Database. Image credit: Susanne Kuehne.

In India, low-cholesterol or zero-cholesterol claims on product labels for spreads as well as their advertising must follow strict guidelines set by the Food Safety and Standards Authority India (FSSAI). At two Indian companies, nearly $100,000 worth of products was confiscated due to mislabeling. The spreads’ labels and nutrition panels falsely claimed that they were cholesterol free, while containing significant amounts of saturated fats.

Resources

  1. Neo, P. (February 11, 2020). Food Navigator-Asia. “Cholesterol crush: Major Indian dairy firms lose US$100,000 of products over false labelling claims”.
Brian Sharp, SafetyChain Software
FST Soapbox

How Are Companies Impacted by Labor Shortages?

By Brian Sharp
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Brian Sharp, SafetyChain Software

Food and beverage manufacturers are seeing the effects of the coronavirus when it spreads through their workforce. Recently, there have been multiple closures of facilities operated by meat processors, including Smithfield Foods and Tyson Foods as COVID-19 has infected hundreds of workers.

The backdrop of stressful operations and work: Employees now face increased questions before entering plants and feelings of isolation as lunches and breaks are now solo activities due to social distancing. All of these stressors are compounded when you think about what we’re asking them to do: Go into work and keep food on the grocery store shelves. This is a completely new way to operate, and it has a very real emotional effect on our workers.

We’ve received reports from customers where management is getting out of the back office and putting on hairnets to work the production line. The shortage of workers is a very real problem, and our customers are rising to the challenge. Plus, managing this overall labor shortage while doing more safety and sanitation checks than ever before to make sure transmission risks are eliminated is putting stress on everyone working in plants. It’s never been harder to work in the food industry.

In response to California Governor Gavin Newsom’s actions related to the pandemic, we stand behind any effort that is taken to accommodate the needs of these vital, valuable workers, including the executive order to provide supplemental paid sick leave. Such actions, both locally here in California and at the federal level, are critical to elevating the safety of our food manufacturing and distribution workers. Some heroes wear hairnets.

Temp Workers and Lack of Training Protocols

COVID-19 has had a significant impact on the availability of skilled workers in food facilities. Through all the layoffs stemming from the economic standstill, food manufacturers and grocery workers are reporting increases in hiring to help keep up with demand—and to mitigate the effects of sick employees going on quarantine for two weeks. For instance, Albertson’s, a large food grocery chain store, reported that it was hiring for 2,000 positions.

But hiring temporary workers is only half the battle. The task of training people who may have never worked in grocery or food manufacturing has become more critical in the face of new demands on sanitation and social distancing. With these measures in place, it’s no longer a case of a new employee showing up for work and shadowing another employee or supervisor. Technology can close the gap, especially in food production where the regulations and safety standards require strict adherence to processes. For example, software can facilitate shorter employee training in the areas of quality policies and good documentation practices.

Same Volume with Fewer Workers

We are working closely with customers and partners to cope with new guidelines for social distancing inside food facilities, providing the capability to do remote audits as visitor restrictions have increased. Our software is also being used to screen food manufacturing workers for symptoms of COVID-19 before shift work starts to help prevent the spread of the coronavirus to other essential workers.

In response to increased needs from customers, we have developed three solutions to address the impact of COVID-19. These solutions, which include a personnel screener, changeover manager and remote supplier auditor, can help food and beverage manufacturers efficiently manage physical distancing measures, symptom screening, and travel restrictions.

It can’t be stressed enough: The people who carry out food safety protocols are doing more checks and using more labor time to conform to regulations and guidelines for COVID-19. And, adhering to the systems, regulations and processes used to promote safe, high-quality products (in the same or even higher volumes) remains as crucial as ever. Simplifying these processes by leveraging software has been shown to cut 8 to12 hours of labor per day for a single facility. This is critical at a time when even one person being sick can cause lower throughput.

Plus, this isn’t like manufacturing a car where a line will be built to produce hundreds of thousands of cars over a two- to three-year period. Food manufacturers must often change a line over to produce a different flavor, package type or food type altogether, in as little time as possible to keep production going. Robots and automation can help, but in a crisis like this where immediate productivity gains are needed, software can make the much-needed difference.

Jill Ellsworth, Willow Industries
FST Soapbox

Modeling Cannabis Safety from Food and Beverage Quality Regulations

By Jill Ellsworth
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Jill Ellsworth, Willow Industries

There’s a reason you can eat or drink pretty much anything you want from American grocery stores and not get sick. Food manufacturing is highly regulated and subject to rigorous quality control.

Before food and beverages hit store shelves, the manufacturer must have a Hazard Analysis Critical Control Point (HACCP) system in place. The HACCP system requires that potential hazards—biological, chemical and physical— be identified and controlled at specific points in the manufacturing process. In addition, fresh foods undergo a kill-step. This is the point in the manufacturing or packaging process where food is treated to minimize and remove deadly pathogens like bacteria, mold, fungus and E. coli.

Generally speaking, when cannabis hits dispensary shelves, a less stringent set of rules apply, despite the fact that cannabis is ingested, inhaled and used as medicine. Cultivators are required to test every batch, but each state differs in what is required for mandated testing. Compared to the way food is regulated, the cannabis industry still has a long way to go when it comes to consumer safety—and that poses a considerable public health risk. In the early stages of legalization, the handful of legal states did not have rigid cannabis testing measures in place, which led to inconsistent safety standards across the country. State governments have had a reactionary approach to updating testing guidelines, by and large implementing stricter standards in response to product recalls and customer safety complaints. While local regulators have had the best intentions in prioritizing consumer safety, it is still difficult to align uniform cannabis testing standards with existing food safety standards while cannabis is a Schedule I substance.

The stark differences in safety measures and quality controls were first obvious to me when I moved from the food and beverage industry into the cannabis industry. For five years, I operated an organic, cold-pressed juice company and a natural beverage distribution company and had to adhere to very strict HACCP guidelines. When a friend asked me for advice on how to get rid of mold on cannabis flower, a light bulb went off: Why was there no kill step in cannabis? And what other food safety procedures were not being followed?

What to know more about all things quality, regulatory and compliance in the cannabis industry? Check out Cannabis Industry Journal and sign up for the weekly newsletterThe current patchwork of regulations and lack of food safety standards could have dire effects. It not only puts consumer health in jeopardy, but without healthy crops, growers, dispensaries and the entire cannabis supply chain can suffer. When a batch of cannabis fails microbial testing, it cannot be sold as raw flower unless it goes through an approved process to eliminate the contamination. This has severe impacts on everyone, starting with the cultivator. There are delays in harvesting and delivery, and sometimes producers are forced to extract their flower into concentrates, which really cuts into profits. And in the worst cases, entire crop harvests may have to be destroyed.

So, what do cannabis cultivators and manufacturers have to fear the most? Mold. Out of all the pathogens, mold is the most problematic for cannabis crops, perhaps because it is so resilient. Mold can withstand extreme heat, leaving many decontamination treatments ineffective. And most importantly, mold can proliferate and continue to grow. This is commonplace when the cannabis is stored for any length of time. Inhaling mold spores can have serious adverse health effects, including respiratory illness, and can even be deadly for immunocompromised consumers using it for medical reasons.

What the industry needs is a true kill step. It’s the only way to kill mold spores and other pathogens to ensure that they will not continue to grow while being stored. States that mandate microbial testing will benefit from the kill step because more cultivators will be in compliance earlier in the process. In states that don’t require comprehensive microbial testing, like Washington and Oregon, the kill step is a critical way to provide consumers with a preemptive layer of protection. Microbial testing and preventative decontamination measures encourage customer brand loyalty and prevents negative press coverage.

Adopting a HACCP system would also build additional safeguards into the system. These procedures provide businesses with a step-by-step system that controls food safety, from ingredients right through to production, storage and distribution, to sale of the product and service for the final consumer. The process of creating HACCP-based procedures provides a roadmap for food safety management that ultimately aligns your staff around the goal of keeping consumers safe.

It’s high time for the cannabis industry to adopt FDA-like standards and proactively promote safety measures. Cannabis growers must implement these quality controls to ensure that their products are as safe to consume as any other food or drink on the market. Let’s be proactive and show our consumers that we are serious about their safety.