Tag Archives: legislation

Nathan Libbey, PathogenDx
FST Soapbox

On the Eve of 115 Years of Food Regulation in the United States

By Nathan Libbey
No Comments
Nathan Libbey, PathogenDx

As we look back on the history of food safety in the United States, it is easy to take pride in how far we have come—from disparate, state-specific food laws with no interstate oversight, to highly codified regulations such as FSMA, food and consumer safety has evolved a great deal since the passage of the Pure Food and Drug Act in June of 1906. However, despite our advancements, we see evidence of significant gaps that currently exist and must be addressed to improve safety and save lives moving forward, no different than what occurred in the time leading up to the initial Act.

The 1906 Act

Revisionist history will tell us that the consumers’ outcry due to the publication of Sinclair’s The Jungle, coupled with Roosevelt’s disgust after reading the novel, is what ultimately led to the passage of the Act. What has not changed in 115 years is that one book does not yield the power to force the hand of what is largely a deadlocked U.S. Legislature. What moves us from an emotional standpoint often does not translate into real change, and the Pure Food and Drug Act was no exception.

By many accounts the largest proponent of the Act, sometimes referred to as the Wiley Act, was Harvey Wiley, son of an Indiana preacher and former professor at Purdue University. Wiley spent much of his time at Purdue studying the chemistry of sugar and was particularly interested in sugar and other foods’ adulteration. He took on the burden of challenging the food system and improving the safety of consumer products. Wiley is known for his work on “The Poison Squad,” but also was a budding food safety poet:

“We cannot help asking “What’s in it? Oh, maybe this bread contains alum and chalk, Or sawdust chopped up very fine, Or gypsum in powder about which they talk”.1

Despite Wiley’s significant studies and subsequent passion for food safety that he brought to the U.S. Bureau of Chemistry, little was done to advance the status of food safety in the United States. Many bills were attempted, but like today, a bill introduced and backed with fervor in the House did not reach a meaningful Senate vote and vice versa—politics was politics. When McKinley was shot and subsequently died, leaving Theodore Roosevelt to take the helm, Wiley caught the break he needed. Roosevelt had been convinced he had been a victim of the “Embalmed Beef Scandal” while serving in the Spanish American War and had a rather progressive agenda that fit well with Wiley’s evangelization of food safety.2

Flash forward to 1906, Sinclair’s book is published, everyone loses it on the atrocities that exist in food production, including the President. We romanticize that this led to the passing of the Act and future development of what was to become the Food and Drug Administration. In addition to the Act, companion legislation, The Meat Inspection Act of 1906 that would later give rise to the FSIS, was also on the docket for 1906, signaling imminent changes for meat producers. Sure, a role was played by the tale of Jurgis and Elzbieta (the main characters in The Jungle), but more than 25 years of reports and proposed reforms are what lead to significant legislation, and this is the case with the Pure Food and Drug Act—1906 was just the year it all came together.

At the same time, industry had come around. While they had vehemently opposed to earlier iterations of what was deemed over-regulation, they had come to grips with the reality—change was necessary. What their stalling of the bills did, as it does for industries of all makes and models today, is buy them time to adjust. Changes, such as replacing flour laced with sawdust with the real thing, takes changes in processes, personnel, and ultimately money. The industry needed to plan financially prior to enacting and, more importantly, embracing changes. Unlike FSMA, which was rolled out in phases over a decade, early legislation was far less comprehensive and did not account for the impact on firms of various sizes.

Implications for Today

Back to the original points, look how far we have come. Sure, the political landscape is seemingly murky, but it has been for centuries. What binds us all together, and ultimately moves us forward is our collective effort toward continuous improvement. In the spirit of Harvey Wiley, we strive to move forward as lawmakers, food producers and consumers. An unhealthy consumer is indeed bad for business for us all. As was stated during the arguments in the Senate in 1906 by Senator Porter McCumber:

“We are coming more and more to understand that our health depends more upon the character of food we consume than upon the medicines that are given to allay and destroy disease. We are coming more and more to understand that a proper diet varied to meet the conditions of each individual is not only the greatest panacea for but also the greatest preventitive [sic] against the evils with which humanity seems to be afflicted.”3

Quotes like this should give us direction—it has been and will be the backdrop of our cause for food safety and overt disease prevention. The same mantras from 1906 that guided our first piece of food safety legislation are still relevant; we need profound, driven, bold thinkers today just as we did then.

What also remains is the fact that we are still largely siloed, we have macro-level deficiencies as a result of our micro-level programs. An example of our delay, that is the public need is outpacing our industry standards, is our unwillingness to share food safety data. Traceability initiatives and FDA guidance are moving this forward, but the implications will not be felt overnight, just as Sinclair’s book did not change policy overnight. Another area where our lack of system and big-picture thinking impacts our consumers negatively is with the myriad versions, some dating back to 2000 (MS-DOS, anyone?), of Food Code that are adopted by our individual States for retail and foodservice settings. Lastly, the existence of food desserts and larger issue of food insecurity is a macro issue that we deal with (or ignore) on a micro level.

As it was during the stalemate legislative sessions around the turn of the 20th century, it takes all stakeholders to move the status quo forward, not just those with the end vote. Consumers, regulators, and industry must remember our collective drivers and be willing to share best practices, propel continuous improvement, and, yes, accept increased regulation in order to move the bar forward if necessary. 115 years post-Pure Food and Drug Act, we have evolved, 10 years post-FSMA, we have evolved, but we must increase our rate of evolution. We have tremendous, untapped capacity to create significant change and save lives during the technologically advanced, partisan, hyper-politicized, woke, lit, insert adjective here decade that is and will be the roaring 20s v2.0—let’s be sure to take advantage of it.

References

  1. Stirling, DA. (2002). Harvey W. Wiley. Toxicological Sciences, 67(2), 157-158.
  2. Keuchel, E F. (1974). Chemicals and meat: the embalmed beef scandal of the Spanish-American war. Bulletin of the History of Medicine, 48(2), 249-264.
  3. Barkan, I. D. (1985). Industry invites regulation: The Passage of the pure food and drug act of 1906. American Journal of Public Health (1971), 75(1), 18-26.
Craig Powell, Natura Life ≠ Science
FST Soapbox

Standardization of the Cannabis Supply Chain Drives Product Safety and Consumer Trust

By Craig Powell
No Comments
Craig Powell, Natura Life ≠ Science

When it comes to mainstream consumer food brands, customers expect to receive the same product each time they buy it. That consistency brings consumers back to the same brands over and over again. Unfortunately, the same can’t be said about products sold in the cannabis industry. Consumers aren’t building long-term relationships with brands because consumers don’t have consistent product experiences and often take their business to other brands.

This inconsistency plaguing the cannabis industry can be attributed to an unreliable supply chain, which plays out in multiple ways.

First, cannabis companies are having difficulty meeting state regulations. This happens because the legal cannabis industry is still relatively young and there isn’t a substantial institutional knowledge about regulatory compliance, nor are there any standardized best practices in place. Regulation is expensive and requires human and financial capital that most cannabis companies don’t have in place. Complicating things further, regulations keep changing, making it more difficult for compliant businesses to keep up, even when they have the best intentions.

Second, testing of cannabis products has been complicated. Because cannabis isn’t federally legal, standardized testing guidelines have not been developed, leaving individual states in charge of dictating their own requirements and enforcement framework. There have been numerous reports in the past few years of labs in California either improperly reporting testing results, or worse, submitting fraudulent results.

Third, problems also arise on production end of the supply chain—not only with consistency, but also with consumer safety. According to an estimate from New Frontier Data, approximately 80% of sales are still conducted through the black market. Many growers are using banned pesticides in amounts way beyond recommended levels. In addition, as the recent vape issue has demonstrated, black market manufactured products are being adulterated with toxic substances that pose significant health hazards to consumers.

Given these consistency challenges, the standardization of the supply chain—especially compliance, testing and safety measures—should be a top priority for new cannabis brands. Luckily, many best practices and standardized procedures can be adopted from the food, agriculture and pharmaceutical industries, where companies have successfully developed protocols to ensure safe and reliable products.

In addition to standardization and best practices, cannabis companies should also utilize the following recent innovations in transaction technology to provide peace-of-mind to both new brands and consumers that cannabis products are tested and safe.

Modernized Retail POS systems. Common in other consumer packaged goods industries, such as food, wine, beverages and soft drinks, RFID tags can be used throughout the supply chain to track products from seed to sale. These tags, like the “chips” on credit cards, hold electronically stored information about a product that can be accessed to verify compliance and safety.

QR Codes. While QR codes are mostly used today as marketing gimmicks, they actually have potential to provide true value for curious customers. Batch-specific QR codes could be applied to cannabis products to show detailed information about when and where it was made, what strains of cannabis were used, and testing results. This technology could be used to increase transparency between companies and to consumers.

Data Informatics. A strong information technology infrastructure can be put in place to collect and store inventory and customer data. That data can then be run through algorithms, AI and machine learning systems to help cannabis brands make better decisions about how to optimize the production of their products and how to achieve better results on future batches.

Video Surveillance. Granted, this is a more ‘low-tech’ approach, but effective, nonetheless. Video cameras can go way beyond security purposes. Footage can be viewed and compared to collected data sets to gain a deeper understanding of product flows, personnel movement and logistics that might impact a company’s final product. Video can also be analyzed automatically using AI to provide important insight to help a company fine tune their business strategies.

Consumers want to know that the cannabis products they purchase are safe, compliant and tested. Consumers also have a right to know what they are buying and expect product consistency over time from companies they trust. Ensuring supply chain consistency is key to making this happen as the industry matures. An experienced and trusted supply chain partner can help companies across different cannabis sectors, ranging from medical to food, and ensure product safety and consumer trust today through standardization and consistency. Ultimately, cannabis businesses want to cultivate a culture of excitement, not fear or uncertainty, to help the market flourish and bring quality products to our customers.

Megan Nichols
FST Soapbox

Tips to Train Employees and Maintain FSMA Compliance

By Megan Ray Nichols
No Comments
Megan Nichols

Eight years ago, the government passed FSMA. As a manufacturer, training new and existing employees to remain compliant with legislation is paramount. The goal isn’t to make life harder for business owners—it’s to protect American consumers from unsafe food handling and transportation practices.

The following are five tips to help warehouse managers train employees while maintaining FSMA compliance.

Understand FSMA Final Rules

It’s essential for everyone in the facility, from the CEO to the newest hire, to understand the FSMA rules. According to current Good Manufacturing Practices (cGMP), everyone who works in manufacturing, processing or packaging of food is required to train in food hygiene and safety. Managers can offer training in one of two ways—through on the job experience or via an FSMA-accredited classroom curriculum.

For individuals with specialized jobs, such as quality auditors or preventative controls qualified individuals (PCQI), the training option that allows compliance with FSMA rules is an accredited curriculum.

Utilize Warehouse Management Systems

FSMA gives the FDA authority to issue mandatory recalls for any food products if deemed necessary. To meet FSMA standards, record keeping and lot tracking is a necessity. If a product type is linked to a disease outbreak, the FDA wants to know where each product in that lot is within 24 hours. Having the ability to track and trace 100% of the products ensures that the company is FSMA compliant.

A warehouse management system (WMS) can track products, but only if you train employees in its use. While the average employee won’t be responsible for tracing a production lot in the event of a recall, each worker needs to know how to enter data into the system correctly, and how to retrieve the information if necessary. Include training in your WMS to ensure compliance.

Warehouse management systems, when paired with IoT sensors, can prevent recalls and ensure compliance by monitoring temperature fluctuations in climate-controlled areas. According to the Department of Agriculture, frozen food stored at temperatures at or below -0.4° F is always safe. A comprehensive WMS can monitor the temperature inside a facility’s freezers and alert workers or management if there are dramatic fluctuations that may result in a recall.

Seek Out Alliances

Warehouse managers are not alone when it comes to creating a compliant workplace. The FDA has established and funded three alliances—Produce Safety, Food Safety Preventative Controls, and Sprout Safety—each with their own standardized curriculum designed to help those who fall under FSMA rules.These alliances work for the majority of those in the food production industry, though they may not work for everyone.

Seek out the applicable food safety alliance and see if their training curriculums apply to your facility. Even if they don’t fit directly, these alliances can give managers an excellent place to start creating their training curriculum.

Create a Culture of Compliance

FSMA isn’t designed to make life harder for warehouse managers. Its goal is to keep people safe when buying their weekly groceries. Don’t just focus on training to meet FSMA standards. Instead, create a culture of compliance throughout the facility. Make FSMA everyone’s responsibility, and make it easier for employees to communicate with management if they notice a problem that normal channels don’t address.

As part of this culture of compliance, create incentives that reward employees for reporting problems, maintaining compliance levels and completing accredited training. Sometimes incentives can be the best way to motivate employees, whether you’re offering money, paid vacation or other benefits. Walk employees through the process of how to spot a problem and report it to management.

Continue Education Throughout Employment

FSMA compliance training isn’t something you should restrict to an employee’s onboarding. It’s something you should continue throughout their time at your facility. Make FSMA education a priority for every worker in your facility. While you want to start their training with onboarding, it shouldn’t stop there. Offer new training courses once a month or every three months—as often as you’d like without compromising productivity.

As the day-to-day grind continues, most workers forget about rules and regulations. Continuing education ensures FSMA compliance is at the forefront of everyone’s mind throughout their careers. Continuing your employee’s education is also shown to increase loyalty and reduce turnover, keeping things running smoothly and preventing warehouse managers from training new workers every quarter.

Looking Forward

The FDA oversees food safety and can issue a recall when a problem occurs. Yes, as a whole, it’s the responsibility of every single person working in the food production industry—from the highest-paid CEO to the newest employee on the production floor—to maintain compliance. It’s not enough to review guidelines with new employees during onboarding.

Training is essential to ensure everyone in a facility maintains the rules laid down by FSMA. Seek out assistance in the form of the FDA-funded alliances, continue employee education and make it a point to create a culture of compliance from the moment employees walk through the door. Offer continuous training opportunities and you’ll never have to worry about breaking FSMA rules.