Tag Archives: regulations

By Jennifer Allen

On March 19, 2024, the USDA implemented revised regulations on organic foods. The overall purpose of the revisions is to strengthen enforcement of the regulations, with a focus on greater accountability for organic food fraud. This article does not go into every detail of the changes. That would be a long and rather dull read, and you could just as well go read the new regulations for yourself. But it does highlight some of what this writer believes are the most significant changes, and to the extent your compliance with the organic regulations has been on autopilot, this is a reminder to take the wheel and make sure you know how the new regulations affect you.

Perhaps the most significant change is to the scope of what it means to “handle” organic products. Before the revisions, handling meant selling, processing, or packaging agricultural products. Now, handling includes trading, facilitating the sale or trade on behalf of a seller or yourself, importing and exporting, as well as a number of other activities including conditioning, containerizing, and labeling. Thus, the universe of individuals and entities that could be on the hook for organic fraud, and who may need to be certified by the USDA, just got significantly larger. What this means is that even if all you do is hit buttons on a computer keyboard, and you never lay your hands on a piece of produce, you can still be responsible if the product you are trading turns out to be falsely labeled or otherwise noncompliant. There are exemptions from certification, but you still need to be compliant with the rules.

There are some changes in exemptions under the revised rule. Restaurants and stores that cook or prepare food and then sell it to consumers at the same location are exempt. But online sellers are not. Companies that store packaged and sealed products are exempt, but those who store bulk and unpackaged products must be certified. Customs brokers and logistics brokers – those who merely connect operations with carriers and storage facilities – are exempt. Likewise, businesses whose only job is to transport products are exempt, but handlers must still use audit trails and traceability to ensure that their carrier does not compromise the organic integrity of the product.

With respect to fraud, the term “organic fraud” is now defined, as “deceptive representation, sale or labeling of nonorganic agricultural products or ingredients as . . . organic.” New regulations relating to traceability make it easier to follow a product from birth to sale. New language requires certified operations to keep records that “span the time of purchase or acquisition, through production, to sale or transport and be traceable back to the last certified operation.” And certifying agents must conduct risk-based supply chain traceability audits to trace products across multiple links in a supply chain.

These are just some of the changes that USDA has made to ensure that consumers paying a premium for organic products are getting what they pay for. If you are part of the chain of organic products, then make sure you know how the changes affect your organization.

December 19, 2022

Conference for Food Protection Accepting Issues for Consideration

By Food Safety Tech Staff

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The 2023 Biennial Conference for Food Protection (CFP) will take place on April 24-28 in Houston, Texas, and the organizers are accepting issues for consideration. Food industry professionals and stakeholders who would like to submit issues for consideration can review the guidelines on the CFP Issue Submission Process Page. The period for online submissions opened on Monday, December 19, 2022, and will close on Monday, January 23, 2023.

The CFP brings together representatives from the food industry, government, academia, and consumer organizations to identify and address emerging problems of food safety and to formulate recommendations for possible inclusion in the FDA Food Code. Though the Conference has no formal regulatory authority, it does influence model laws and regulations among all government agencies and seeks to minimize disparate interpretations and implementation.

The conference’s objectives include:

Identifying and addressing problems in the production, processing, packaging, distribution, sale, and service of foods
Focusing on and facilitating the food protection programs governing the foodservice, retail food store, and food vending segments of the food industry
Adopting sound, uniform procedures which will be accepted by food regulatory agencies and industry
Promoting mutual respect and trust by establishing a working liaison among governmental agencies, industry, academic institutions, professional associations, and consumer groups concerned with food safety
Promoting uniformity among States, territories, and the District of Columbia

June 30, 2021

FST Soapbox

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

By Nathan Libbey

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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

Stirling, DA. (2002). Harvey W. Wiley. Toxicological Sciences, 67(2), 157-158.
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.
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.

August 4, 2020

Food Fraud Quick Bites

Prosecution Puts an End to Cash Cow

By Susanne Kuehne

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

Sulfites and sulfur dioxide can make meats look fresher than they truly are, and therefore are banned by the FDA The Australia New Zealand Food Standards Code also prohibits the addition of sulfites to raw meat. Not only is there a risk of meat past its prime getting into the food supply, sulfites may also pose a danger to allergy and asthma sufferers. More than 23 tons of ground beef were freshened up illegally with sulfites and sold in New Zealand to consumers. The manufacturer was recently sentenced to a fine in this two-year old case.

Resource

News Desk. (July 27, 2020). “NZ company fined for adding sulfites to ground beef”. Food Safety News.

The 2020 Food Safety Consortium Virtual Series features an episode on Food Integrity & Food Fraud. The episode takes place on Thursday, October 22. Learn more about 2020 FSC now!

July 13, 2020

FST Soapbox

COVID-19: We’re In This Together

By Chris Keith

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It’s no secret that the COVID-19 pandemic had a major impact on industries and individuals around the world. According to the World Health Organization, as of June 21, 2020, there have been 8,708,008 reported cases of COVID-19 globally, including 461,715 deaths. In a recent article by Forbes, healthcare contributor William Haseltine stated that we are gathering personal stories and statistics right now around COVID-19 survivors who have suffered permanent injuries from the virus. Many experts believe that COVID-19 is also an economic downturn trigger. Author and financial planner Liz Frazier says that even as recessions are a normal part of the U.S. economic cycle, lasting about five and a half years on average, the possibility of a recession starting due to the outbreak would be unprecedented.¹ The COVID-19 pandemic is a natural disaster that rocked the world and is a reminder of how connected people are in a global economy.

As quarantine regulations and temporary closures happened across the United States, businesses had to mobilize quickly, pivoting their strategies, distribution efforts, products and beyond to accommodate the new safety measures and external pressures. The food and beverage industry was no different. Although food manufacturers were deemed essential in the United States by Cybersecurity & Infrastructure Security Agency (CISA), manufacturers had to adapt to a new normal during the shutdown.² Some of the biggest changes that occurred in the food manufacturing industry include fluctuating customers, prices, product and ingredient availability, packaging, distribution, and food quality and safety.

Shifting Demand, Customers and Food Pricing

Sharp changes in food prices and product availability shocked supply and demand and impacted the entire food supply chain across the United States. According to the USDA, there were record levels of demand for food at grocery stores, and, on the supply side, there has been a reduced supply of meat products over the period of quarantine as meatpacking plants faced temporary closures, decreased slaughter pace, and slower production due to COVID-19 regulations.³ Poultry prices took a sharp dip and have been rebounding, hot dog prices are at an all-time high due to increased demand, and beef prices have been climbing due to scarce supply and limited fresh production. Food pricing fluctuation is one of the largest food industry impacts felt directly by the general public and the on-premise sector. Restaurants and bars were crushed by the skyrocketing ingredient prices and mandatory temporary closures due to COVID-19.

As restaurants, school cafeterias and hotels were temporarily shut down due to quarantine restrictions, the food manufacturing industry’s most prominent customers practically disappeared. Before COVID-19, the USDA reported that in 2018, restaurants provided approximately 50% of meals consumed on a daily basis, up from 41% in 1984.⁴ When COVID-19 hit, consumer trends showed a monumental shift to eating at home. During the height of the pandemic, more people ordered take out from fast-casual dining places and ate from home. A recently published study reveals survey findings that suggest American’s food habits are shifting, as 54% of respondents confirmed they are cooking more, and 46% of respondents, baking more.⁵ As customers and demand changed, products and packaging had to follow suit.

Scores of manufacturing facilities had to rapidly respond with different products to meet changing consumer demand, despite already being in mid-production for products for restaurant kitchens, cafeterias, and the like. Most of these large-scale and wholesale products would never make it to their original, intended destinations. Manufacturers swiftly adapted their production, creating retail-ready goods from product made or intended for restaurant or fast food supply. These food production facilities had to creatively find ways to change product packaging sizes, salvaging good product with take-home cartons and containers. Some processors pre-sliced deli meat for grocery stores around the country, as markets were unable to slice the meat in-store, dealing with restrictions on the number of people who could work at any given time. The food manufacturing industry showed great ingenuity, repurposing food and getting creative in order to keep the country fed and bridge the gap in convenience shopping that consumers have grown used to.

New Distribution Pressures

There were also disruptions in the food industry’s distribution channel, and the logistics of distribution were adversely affected. Facilities faced increased pressure to have tighter production turnarounds from new consumer behavior and out-of-stock situations as many markets dealt with temporary panic shopping at the beginning of the crisis. Food manufacturing facilities have always faced tight deadlines when dealing with fresh and refrigerated product. However, COVID-19 introduced new critical, immediate needs to the food supply, and, more than ever before, facilities were pressed for time to deliver. Some facilities didn’t have enough dock loading time, and certain cold storage facilities could not meet the raised demands for dock times, making it harder to get product through the distribution channel to consumers. Shipping and logistics came at a premium. Drivers and logistics companies were at capacity with their service offerings, and unable to mobilize to meet the needs of every manufacturing company.

On top of the pressures from consumer demand, manufacturing facilities had to procure PPE (personal protective equipment) in mass for all employees and adjust employee schedules to meet new national and state-wide quarantine restrictions that strained the system. The PPE requirements are part of the distribution logistics, as plants are unable to distribute safe product without adhering to the system’s regulations. Senior Vice President of Regulatory and Environmental Affairs for the National Milk Producers Federation, Clay Detlefsen, said in an article for Food Shot Global that the whole food industry’s system has been turned on its head, as manufacturers are concerned that if they start running out of PPE and sanitation supplies, they would ultimately be forced into shutting down their food processing plants.⁶

Regulating Food Quality and Safety

Perhaps one of the biggest concerns surrounding the food supply chain during the height of COVID-19 for both producers and consumers was food safety. While safety and quality are always a high priority in the food industry, rising concern around the transmission of COVID-19 became a new and unprecedented challenge for food quality experts. In February the FDA declared that COVID-19 is unlikely to pass through food or food packaging, but that didn’t stop public concern.⁷ It was critical for food manufacturers and producers to ease public fear, keep the food supply stable and eliminate foreign material contamination that would adversely affect consumers and brand reputation. A mass recall due to foreign material contamination would have dire consequences for the strained food supply chain during this historic crisis. At the same time, the pandemic limited quality and food safety teams, as key teams had to work remotely, shift schedules had to drastically change to meet new safety regulations, production lines cut in half, and quality and safety teams had to make rushed decisions when it came to reworking product.

Some plants that faced potential foreign material contamination risked sending their product into distribution without a thorough rework, up against tight deadlines. And some plants adopted a multifaceted strategy and did something they’ve never done before: Reworked product on hold for potential foreign material contamination themselves. Many of these companies reworked product with their extra available lines, to keep as many of their workers as possible, despite the fact that food production employees are untrained in finding and extracting foreign contaminants. Inline detection machines are also typically limited to metal detection, often incapable of consistently catching many other types of contaminants such as glass, stones, plastic, bone, rubber, gasket material, container defects, product clumps, wood and other possible missing components. Food safety is of the utmost importance when a crisis hits as the food supply chain is crucial to our success as a nation and as an interconnected world. Facing new pressures on all sides, the food industry did not neglect food safety and quality, even while adopting new strategies. There was never a doubt that the industry would overcome the new challenges.

Looking Forward

The food industry has rapidly switched business strategies, swiftly turned around new products, found new ways to align product traceability and work remotely while still meeting industry standards and production expectations. Manufacturing facilities repackaged and repurposed food to keep the country fed, maintained job security for many employees and procured PPE in mass. The food industry is also full of manufacturers and plants that accomplished things they’ve never done before. There are shining examples of heroism in the food and beverage space as a growing list of food businesses, restaurants and delivery services have donated to healthcare workers on the front lines. Many large companies donated millions of dollars and pounds of food to feed their teams, their communities and the less fortunate.⁸ In the midst of a large obstacle, we have reached new heights and discovered new capabilities.

The challenges aren’t over. The food industry is still facing the effects of COVID-19 shutdowns on businesses even during this period of re-opening in different parts of the country. A lot of places and companies have been hit hard, some even closing their doors for good. Forbes reported at the onset of the pandemic that Smithfield Foods shut down one of its pork processing plants after hundreds of the plant’s 3,700 employees tested positive for coronavirus.⁸ Tyson Foods also shut down several meat processing plants under threat of the virus.⁸ Smithfield and Tyson were not the only ones. Food Dive has a compiled tracking system for coronavirus closures in food and beverage manufacturing facilities, recording reduced production, temporary closures, and permanent shutdowns across the industry. We expect some of the COVID-19 challenges to alleviate over time and hope that business will slowly return to normal and previously closed facilities will be able to re-open. However, we strongly hope some changes to the industry will remain: Creativity, ingenuity, resilience, adaptability, and a strong commitment to customers and partners. The bottom line is we’re in this together––together, we’re resilient.

References

Frazier, L. (April 21, 2020). “How COVID-19 Is Leading The US Into A New Type Of Recession, And What It Means For Our Future.” Forbes.
Krebs, C. (May 19, 2020). “Advisory Memorandum on Identification of Essential Critical Infrastructure Workers During COVID-19 Response.” Homeland Security Digital Library.
Johansson, R. (May 28, 2020) “Another Look at Availability and Prices of Food Amid the COVID-19 Pandemic.” USDA.
Stewart, H. (September 2011). “Food Away From Home.” The Oxford Handbook of the Economics of Food Consumption and Policy. 646–666. Oxford University Press. doi: 10.1093/oxfordhb/9780199569441.013.0027
The Shelby Report. (April 17, 2020). “New Study Reveals Covid-19 Impact On Americans’ Food Habits.”
Caldwell, J. (April 16, 2020). “How Covid-19 is impacting various points in the US food & ag supply chain”. AgFunderNews.
Hahn, M.D., S. (March 27, 2020). Coronavirus (COVID-19) Supply Chain Update. FDA.
Biscotti, L. (April 17, 2020). “F ood And Beverage Companies Evolve, Innovate And Contribute Amid COVID-19 Crisis.” Forbes.

July 8, 2020

FDA Expects to Release Blueprint for New Era of Smarter Food Safety Soon

By Food Safety Tech Staff

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On October 1, Frank Yiannas will be the keynote speaker for the 2020 Food Safety Consortium Virtual Series || The series takes place during the weeks of September 3 through December 17Expect the much-anticipated blueprint for FDA’s New Era of Food Safetyto be released soon. The agency has not provided an exact date but in an update prior to the July 4th holiday, FDA stated it would be rolled it out “in the coming weeks”.

“The challenges we’ve faced during the pandemic have made it clear that the goals we set forth in the New Era blueprint are more important now than ever. Some of them, like enhanced traceability, are particularly meaningful in light of recent events,” Frank Yiannas, FDA’s Deputy Commissioner for Food Policy and Response, stated in an agency consumer update. “What we have learned from the pandemic is that we’re on the right track with the New Era of Smarter Food Safety. The steps that we’ll take will prepare us to protect the safety of our food supply, no matter what challenges we face.”

In addition to the focus on emerging digital technologies, traceability in the supply chain, ensuring safety in the home delivery of food (e-commerce), and food safety culture, FDA will be including the lessons learned from the COVID-19 pandemic as part of the blueprint structure.

June 12, 2020

Retail Food Safety Forum

The New Normal for Grocery Store Health and Safety

By Todd Frantz

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Grocery stores have become some of the most important retail establishments over the past few months. They’ve kept people fed and provided access to essential supplies such as toilet paper, cleaning agents and over-the-counter medications. Grocery retailers have taken extraordinary steps to help protect the health and safety of their workers and customers during the worldwide pandemic, understanding that viruses can spread quickly with high customer traffic.

While many grocery stores made operational changes to stay open during this time, more adjustments are needed to help stem future infections. Guest occupancy limits, face-covering recommendations and single-directional aisles are here to stay, at least for the near term. Customers are likely to continue online shopping, which has its own set of challenges for food and delivery safety. It will be critical for retailers to obtain reliable information, specific to the store’s location and to follow local, state and federal mitigation guidelines. Trusted sources of such information include the National Institutes of Health (NIH), the CDC and the World Health Organization (WHO), plus state and local health departments.

Grocery retailers should also consider how and when employees interact with customers. Acrylic barriers at checkout lines are one method of physical control. Providing personal protective equipment and appropriate training on its use is another good method for maintaining infection control. As regulations relax, retailers need to evaluate what, if any, other changes should occur to keep safety at the forefront.

There are many other common sense practices retailers can adopt to help minimize the spread of any virus. Viral illnesses spread primarily between individuals, so the most important act of prevention is to keep employees healthy and safe. Hand washing is one of the most important steps we can take to help prevent the spread of illnesses. Most states require grocery stores to post restroom signs mandating that employees wash their hands, but these signs typically lack specific instructions. The CDC recommends cleaning hands in a specific way to avoid getting sick and spreading germs to others. The steps are the following:

Dispense a paper towel, so it is ready before wetting hands
Wet hands with warm (100°F/38°C) water
Apply an appropriate amount of soap
Rub hands vigorously together for 20 seconds
Clean between the fingers, the backs of the hands and the fingertips
Rinse hands under warm water to remove soap
Dry hands with the paper towel
Turn off faucet with a paper towel
Use the paper towel to contact door surfaces to exit
Throw away paper towel in a trash receptacle

Because grocery store workers touch food, increasing their handwashing frequency can help prevent the transmission of other types of illnesses beyond respiratory viruses. Employees should take care to wash their hands before donning gloves for any food preparation, after touching exposed skin, after handling soiled utensils and after engaging in any other activities that could soil hands.

Facility sanitization is another essential aspect in preventing the spread of illnesses. Grocery stores already have rigorous cleaning protocols that explain how to mix and use chemicals correctly. Additional instruction on how to apply cleaning agents to surface areas as well as visual reminders reminding workers how long a cleaning solution needs to remain before wiping with a cloth. To prevent the spread of infection, many stores have added more frequent cleaning for high-touch surfaces like door handles, touch screens and carts.

When approved sanitizers run low, however, some people turn to chlorine sanitizing agents like unscented bleach. Bleach can be a highly effective sanitizer, but it can also be potentially hazardous when misused. Specifically, when mixed with other cleaning products that contain ammonia, it creates a highly toxic chlorine gas. The cleaning staff needs proper training on how to mix and use cleaning solutions, use the appropriate personal protective equipment (PPE), such as wearing gloves or a protective outer garment, and to provide appropriate ventilation in rooms where sanitizers are mixed and stored.

Grocery stores have been at the forefront of the pandemic response for some time and they will be the first to adopt “new normal” procedures. Specific guidelines around health and safety evolve, but the fundamentals of health and safety stay the same. Stores that strive to maintain high standards around cleanliness and sanitation are likely to be better positioned for the inevitable next time.

June 8, 2020

FST Soapbox

The COVID-19 Record Retention Conundrum

By Melanie Neumann, JD, MS

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During this global pandemic, the U.S. Equal Employment Opportunity Commission (EEOC) green-lighted employers to take temperatures checks of employees and to administer COVID-19 testing for workers prior to returning to work without running afoul of the Americans with Disabilities Act (ADA). This appears straight-forward upon first reading, however, several practical uncertainties about implementation, including confidentiality, discrimination, and how long to retain records remain.

As such, deciding whether to take temperatures and/or require COVID- 19 testing as a return to work strategy is more complicated than it may seem.

Temperature Screening & Testing Considerations

Temperature screening and COVID-19 mandatory testing are both permitted medical examinations during this pandemic but are otherwise prohibited during non-pandemic times. Before adopting, employers should understand the requirements impacting the records these tests generate, including the need to protect confidentiality and to retain records for longer than one may expect.

Temperature Screens
Under normal circumstances, temperature checks are considered a prohibited medical examination under the ADA. During a pandemic, however, the Equal Employment Opportunity Commission (“EEOC”) makes an exception, allowing employers to take temperatures/use temperature checks and exclude employees from the workplace should temperatures exceed public health recommendations. If employers keep records of temperatures, they must retain these records per applicable regulations. This is important because an “employee medical record” would likely result if employers take employees’ temperatures or collect temperature related records. As we will see below, there are regulatory requirements that require how we conduct these screens, and where and for how long we must retain them.

COVID-19 Testing

COVID-19 testing also constitutes a permissible medical exam under ADA during this pandemic, per the EEOC-issued guidance regarding mandatory employee testing.

For medical examinations to be allowed under the ADA, the test must be “job related and consistent with business necessity,” and employers must treat information as a confidential medical exam.

The initial guidance acknowledged that the spread of COVID-19 is a “direct threat,” hence meeting the requirement that a medical exam be “job related and consistent with business necessity” and that temperature screenings were therefore appropriate. For the same reasons, in updated guidance released at the end of April 2020, the EEOC expanded that guidance to clarify that employers may choose to administer COVID-19 testing to employees before they enter the workplace to determine if they have the virus for the same reasons.

When reading the EEOC’s language closely, the permission granted by EEOC appears to be for diagnostic tests, as the guidance states testing is to determine if employees have the virus before allowing employees to return to work. It is unclear whether antibody testing is included in the above analysis because antibody tests do not determine if someone is currently infected.

In addition, there are other considerations employers should assess before adopting a testing protocol. EEOC reminds employers that they must review the accuracy and efficacy of the selected test per FDA and CDC recommendations. Moreover, pragmatic considerations, such as how to maintain social distancing and employee privacy, determining who will perform the testing and at what the frequency, not to mention evaluating whether there is enough test capacity to perform employee-wide testing at a meaningful cadence should be evaluated.

Records Management & Retention

There is another often over-looked question: What do employers do with documented test records? This question applies whether the employer conducts the test, requires tests from employee’s healthcare providers to be off work to self-isolate, or as a return to work requirement.

It was clearly outlined above that temperature records and COVID-19 test records constitute employee medical records. Why is this important? Because there are specific requirements relating to employee medical records, including what appears to be a surprisingly long retention requirement.

Where to retain: An employer should store all medical information related to COVID-19 in existing medical files, separate from the employee’s personnel file, per the ADA, limiting access to this employee confidential information. This includes an employee’s statement that he has COVID-19 or suspects he/she has the disease, or the employer’s notes or other documentation from questioning an employee about symptoms.

How long to retain: That is the 30-year question. The Department of Labor’s Occupational Safety and Health Agency (OSHA) provides retention requirements for employee medical records in certain situations for a period of an employee’s employment plus 30 years.

While COVID-19 test results and temperature screening documentation are deemed medical examinations under the applicable regulations, are the documented results deemed medical records? We turn to applicable EEOC OSHA regulations in section 1910.1020 for answers.

OSHA Requirements

The OSHA general duty clause, section 5(a)(1) requires employers to furnish to each of its employees a workplace free from recognized hazards that are causing or likely to cause death or serious physical harm. COVID-19 appears to rise to this threat level. But is that fact alone dispositive to falling under the applicable OSHA retention requirements?

OSHA regulation section 1910.1020 requires employers to retain employee exposure or employee medical records relating to employee exposure to certain hazards. This section applies to each general industry, maritime and construction employer who makes, maintains, contracts for, or has access to employee exposure or medical records, or analyses thereof, pertaining to employees exposed to toxic substances or harmful physical agents (Emphasis added).

Is SARS-CoV-2, the virus that causes COVID-19, considered a “toxic substance or harmful physical agent?”

Most would quickly assume the answer is ‘yes’. But it may not be as clear as the black and white letter of the law would hope. Let’s review some key definitions in the applicable regulation to help shed more light on this question.

What are Toxic Substances or Harmful Physical Agents?

The record retention requirement pivots on the last phrase of 1910.1020, that is “…pertaining to employees exposed to toxic substances or harmful physical agents.”

Toxic substances or harmful physical agents are defined as follows;

1910.1020(c)(13) “Toxic substance or harmful physical agent” means any chemical substance, biological agent (bacteria, virus, fungus, etc.), or physical stress (noise, heat, cold, vibration, repetitive motion, ionizing and non-ionizing radiation, hypo – or hyperbaric pressure, etc.) which:
- 1910.1020(c)(13)(i) is listed in the latest printed edition of the National Institute for Occupational Safety and Health (NIOSH) Registry of Toxic Effects of Chemical Substances (RTECS) which is incorporated by reference as specified in Sec. 1910.6; or
- 1910.1020(c)(13)(ii) has yielded positive evidence of an acute or chronic health hazard in testing conducted by, or known to, the employer; or
- 1910.1020(c)(13)(iii) is the subject of a material safety data sheet kept by or known to the employer indicating that the material may pose a hazard to human health. (Emphasis added by author).

The use of “or” clarifies that only one of the criteria need to be met. Based on the above, while subsections (c)(13)(i) and (c)(13)(iii) do not appear relevant, subsection (c)(13)(ii) appears to apply as SARS-CoV-2 has shown to result in acute health hazard, resulting in the disease COVID-19. Whether there is a chronic health impact remains to be seen given the novelty of this virus. That said, acute health impact appears sufficient to determine SARS-CoV-2 as a “toxic substance or harmful physical agent” for purposes of this analysis.

This alone doesn’t automatically place an employer in a 30-plus year requirement to retain employee medical records. What constitutes an “employee medical record” and “employee exposure record” for purposes of this regulation must be further understood before determining appropriate retention.

What are Employee Medical Records and Employee Exposure Records?

“Employee medical records” are defined in section 1910.1020(c)(6), and means a record concerning the health status of an employee that is made or maintained by a physician, nurse or other healthcare personnel, or technician, including: Medical and employment questionnaires or histories, the results of medical exams, lab test results, medical opinions/doctor’s recommendations, first aid records, employee medical complaints, and descriptions of treatment or prescriptions.

Section 1910.1020(d)(1)(i) goes on to specifically prescribes a minimum of a 30-plus year retention period as follows: “The medical record for each employee shall be preserved and maintained for at least the duration of employment plus thirty (30) years.”

“Employee exposure records,” are defined in subsection 1910.1020(d)(1)(ii), as: “Each employee exposure record shall be preserved and maintained for at least thirty (30) years,…”. Some exceptions are listed in this subsection for records relating to health insurance claims, first aid records and records relating to employees working less than one year.

What Constitutes Employee Exposure?

One must also look at what “employee exposure” means in light of this regulatory requirement to determine applicability of the 30-plus year retention.

1910.1020(c)(8) defines “exposure” or “exposed” to mean that an employee is subjected to a toxic substance or harmful physical agent in the course of employment through any route of entry (inhalation, ingestion, skin contact or absorption, etc.), and includes past exposure and potential (e.g., accidental or possible) exposure, but does not include situations where the employer can demonstrate that the toxic substance or harmful physical agent is not used, handled, stored, generated, or present in the workplace in any manner different from typical non-occupational situations.

Conclusion

Short of additional guidance issued by Department of Labor’s OSHA, ultimately this will likely be decided by the courts when the first lawsuit on this topic arises, known as decision via case law. What do employers do in the interim while these shades of gray are not yet adjudicated? It is recommended to err on the side of caution. Find ways to adjust your company’s record retention procedures and systems to be able to accurately retain these records for the duration of your employee’s employment plus 30 years.

Resources

OSHA Laws & Regulations. OSH Act of 1970. SEC 5. Duties. Retrieved from https://www.osha.gov/laws-regs/oshact/section5-duties
OSHA Standards. Part 1910, Standard 1910.1020. Retrieved from https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1020
OSHA. Access to Medical and Exposure Records. (2001). U.S. Department of Labor, OSHA. Retrieved from https://www.osha.gov/Publications/pub3110text.html
U.S. Equal Employment Opportunity Commission. “What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws”. (Updated May 7, 2020). Retrieved from https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws. See A. 6 and B.1.

April 30, 2020

FST Soapbox

How Are Companies Impacted by Labor Shortages?

By Brian Sharp

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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.

Michele Pfannenstiel, Dirigo Food Safety

January 23, 2020

FST Soapbox

Quality Assurance and Food Safety in Cannabis-Infused Products

By Michele Pfannenstiel, DVM

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The legal cannabis-infused products industry is growing with impressive and predictable rapidity. But because the rollout of new regulations occurs in an awkward and piecemeal fashion, with stark differences from one state to another, and sometimes even one county to another, uncertainty reigns.¹ Many entrepreneurs are diving headlong into the nascent industry, hoping to take advantage of an uncertain regulatory environment where government audits and inspections are rare. These business owners will see quality assurance and product safety as burdens—costs to be avoided to the greatest extent possible.

I have seen this time and time again, even in the comparatively well-regulated food industry, and it is always a mistake.

If you find yourself thinking about quality assurance or food safety as a prohibitive cost, annoyance or distraction, I encourage you to change your thinking on this issue. The most successful businesses realize that product safety and quality assurance are inextricably linked with profitability. They are best thought of not as distractions, but as critical elements of an efficient and optimized process. Proper QA and safety are not costs, they are value.

Food safety and quality assurance should be seen as important elements of the process that you undertake to enforce the high standards and consistency that will win you repeat customers. The fact that they guard against costly recalls or satisfy meddlesome auditors is only a bonus. Realizing this will make your business smarter, faster and more profitable.

Learn more about the science, technology, regulatory compliance and quality management issues surrounding cannabis at the Food Labs / Cannabis Labs Conference | June 2–4, 2020If today you cannot clearly communicate your product standards to your employees and to your customers, then you have some work to do. That’s because quality assurance always begins with precise product specifications. (A good definition of “quality” is “conformance to specifications.”) How can you assess quality if you don’t have a definitive standard with which to evaluate it? My consulting firm works with food businesses both small and large, and this is where we begin every relationship. You might be surprised how often even a well-established business has a difficult time naming and describing every one of its products, let alone articulating objective standards for them.

This may be doubly difficult for fledgling businesses in the cannabis world. Because the market is so new, there are fewer agreed-upon standards to fall back on.

When we help businesses create specifications, we always look at the relevant regulations while keeping in mind customer expectations. In cannabis, the regulations just aren’t as comprehensive as they are for conventional food and agriculture. Laws and guidelines are still in flux, and different third-party standards are still competing for market dominance. Different states have entirely different standards, and don’t even agree, for example, whether cannabis edibles should be considered pharmaceuticals or food. To some extent, it’s the wild west of regulation, and as long as the federal government remains reluctant to impose national guidelines, it’s likely to remain so.

The wild west may be a good place for the unscrupulous, but it’s not good for business owners that care about the health of their customers and the long-term health of their brand. Don’t take advantage of confusing quality and safety standards by doing the least possible to get by. At some point there will be a scandal in this country when a novel cannabis product makes dozens of customers sick, or worse. You don’t want it to be yours.

With cannabis-infused products, there is a unique additional factor at play: The strength of THC and other psychoactive compounds. Again, there are few agreed-upon standards for potency testing, and relatively little oversight of the laboratories themselves. This allows labs to get sloppy, and even creates an incentive for them to return inflated THC counts; at the very least, results may hugely differ from one lab to another even for identical products.² Some labs are ISO 17025 accredited, and some are not. Using an unaccredited laboratory may prevent your efforts to create consistent and homogeneous products.

Even in comparatively well-regulated states, such as Colorado, it is ultimately your responsibility to create products that are safe and consistent. And in the states where the politicians haven’t even figured out which department is regulating cannabis products, your standards should be tougher than whatever is officially required.

And so we look to the more established world of conventional food and agriculture as a guide for the best practices in the cannabis industry.

Hazards

The most constructive way to look at food safety, and the way your (eventual) auditors and regulators will view it, is to look at your product and process from the perspective of the potential hazards.

Some day, when regulation finally gets sorted out, you are likely to be asked to implement a Hazard Analysis and Critical Control Points (HACCP) safety system. HACCP framework recognizes three broad categories of hazards:

Physical hazards: Foreign material that is large enough to cause harm, such as glass or metal fragments.
Chemical hazards: Pesticides and herbicides, heavy metals, solvents and cleaning solutions.
Biological hazards: The pathogens that cause foodborne illness in your customers, such as E. coli, and other biological hazards, such as mycotoxins from molds.

All of these hazards are highly relevant to cannabis-infused product businesses.

The HACCP framework asks us to consider what steps in our process offer us the chance to definitively and objectively eliminate the risk of relevant hazards. In a cannabis cookie, for example, this might be a cooking step, a baking process that kills the Salmonella that could be lurking in your flour, eggs, chocolate or (just as likely!) the cannabis extracts themselves.

A good HACCP system is merely the capstone resting atop a larger foundational system of safety programs, including standard operating procedures, good manufacturing practices, and good agricultural practices. It’s important to use these agreed-upon practices and procedures in your own facility and to ensure that your suppliers and shippers are doing the same. Does your cultivator have a culture of safety and professionalism? Do they understand their own risks of hazards?

HACCP offers a rigorous perspective with which to look at a process, and to examine all of the places where it can go wrong. The safety system ultimately holds everything together because of its emphasis on scrupulous documentation. Every important step is written down, every time, and is always double-checked by a supervisor. It sounds like a lot of paperwork, but it is better viewed as an opportunity to enforce consistency and precision.

When you thoroughly document your process you’ll create a safer product, run a more efficient business, and make more money.

References

Rough, L. (2016, March 4). Leafly’s State-by-State Guide to Cannabis Regulations. Retrieved from https://www.leafly.com/news/industry/leaflys-state-by-state-guide-to-cannabis-testing-regulations
Jikomes, N. & Zoorob, M. (2018, March 14). The Cannabinoid Content of Legal Cannabis in Washington State Varies Systematically Across Testing Facilities and Popular Consumer Products. Retrieved from https://www.nature.com/articles/s41598-018-22755-2

Tag Archives: regulations

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