here has never been a time in history with as much going on in food safety and food law. Scott Haskell lists over 20 issues that industry and regulators need to look out for in 2022. How many of these directly relate to your organization?
Scott Haskell teaches the online course “Global Animal Health, Food Safety, and International Trade” each fall semester, and “The Law of the Preventive Controls for Human Food Rule” each spring semester.
Each year it is estimated that in the United States more than 33 million people become ill as a direct result of foodborne disease. Of this number, more than 9,000 people die. The cost in medical bills, insurance claims and lost wages ranges from between US$7.7 and US$23 billion a year. In 2018 the World Bank reported on the economic burden of the foodborne diseases. They reported that the total loss of productivity associated with foodborne infections in low- and middle-income nations was estimated to cost US$95.2 billion per year! They also note that the annual cost of treating global foodborne illnesses is estimated at US$15 billion. This is a substantial global issue for society to deal with.
The year 2022 is just dawning on us and food safety issues are everywhere within our industry. New challenges to food safety will continue to emerge due to:
- “Changes in our food production and supply, including more imported foods.
- Changes in the environment leading to food contamination.
- Better detection of multistate foodborne outbreaks.
- New and emerging bacteria, toxins, and antibiotic resistance.
- Changes in consumer preferences and habits.
- Changes in the tests that diagnose foodborne illness.” (CDC Food Safety)
So how do our current challenges within food safety fit in? Covid-19 for sure, but others are equally pressing. Cannabis laws and regulations, new food trends, supply chain issues, potential sweeping changes in regulations, antimicrobial resistance, labeling changes, traceback, continued issues with open trade with Canada and Mexico, cultured meat products and food security and defense.
So what issues are of importance in 2022? Here goes…
Covid-19: COVID-19 precautions are of continued importance in food safety globally. With the emergence of new virulent virus variants (e.g., Delta, Omicron) we can expect cases to continue at least through 2022 and beyond. Food safety measures/precautions and industry transparency is critically important during these times. COVID-19 has impacted the supply chain which has increased food and supply process times and negatively impacted the food industry. At the same time, changes in supply chain distribution have affected food safety. Finally, our food harvest and production workforce has changed how we finalize food management, with new laws and regulations needed during this restructuring. Beyond this, the domestic food chain continues to embrace the ‘culture of food safety’ and personnel will require new and improved safety measures.
Cannabis: Cannabis is going to require diverse changes in how we perceive this industry in our food supply. States differ in their understanding and acceptance of cannabis products. Quality control is a looming issue for 2022 and cannabis. As FSMA stipulates, GMPs, HARPC/HACCP requirements with hazard identification, and controls need reworking and rethinking. CBD and THC content specifications need adjustment, and new regulations are needed with continued improvements in testing procedures and transparency. Each step requires regulations and industry acceptance of these standards and development to ensure quality control. Of what I have seen, the government needs to take an important look at labeling requirements for these new cannabis containing food products. Right now, many consumers often find cannabis labeling of many products quite confusing. It is currently uncertain if the FDA will utilize primarily the rules associated with FSMA or for dietary supplements. Either way, regulatory guidance for the development of a framework is necessary.
New food trends: The continued growth of e-comments is essential for government plans to be useful. As technology and innovation continue to grow, data management within the industry will have to grow accordingly. Will restaurants make a comeback in 2022 or will they remain rapidly increasing their outside sales and takeout? It does appear that restaurants were growing rapidly in 2021 prior to the Omicron development.
The EU is set to list house crickets on their list of novel foods. This move will add this insect to those approved as a food. This move will be the third insect which has been approved. Others currently are migratory locust and yellow mealworms. A “novel food” listing is “anything that was not consumed in the EU to a significant degree before May 1997.” Additionally, there are currently nine applications for insects for consumption. The European Food Safety Authority (EFSA) is the evaluating body.
California (CA) voters passed Proposition 12 by a 2/3 majority affecting the sale of pork in California. Proposition 12 bans the sale of meat from pigs born to sows who spent their pregnancy in ‘farrowing’ or ‘gestational’ crates. Additional states have passed similar though less inclusive statutes. “Ten states have voter-approved statutes that ban gestation crates on commercial farms”. Massachusetts passed a similar animal welfare law in 2015. Both the California and Massachusetts laws go into effect January 1, 2022. These laws stipulate minimum housing space requirements for pigs, veal calves, and hens. Additionally, they ban the sale of any pork, eggs, and veal, from animals that do not meet these CA specified criteria no matter what state they originate in. Whole Foods, Walmart, McDonald’s, and more than 50 other industry leaders that sell pork also agree with these laws. It’s conclusive that the pork industry as well as poultry and veal will be mandated to change production techniques to remain in the game. (Haskell, 2021)
In 2022 the FDA will be holding public meetings to discuss the recently released proposed rule “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water.” The purpose of the public meetings is to discuss the proposed rule, which was issued under the FDA Food Safety Modernization Act.
Food supply chain issues: Within the food supply chain, some of the major issues continue to be with the transportation sector. Rising freight prices are increasing consumer prices. Moving raw materials, fresh produce, meat, and milk have become significantly more expensive and will continue to rise in 2022. Additionally, there has become an inflexibility of plants that process much of the food consumers buy. Most food processing plants are designed to handle specific types of food and have limited flexibility to change production according to demand. Demands have changed!! To help remedy this for our future, there needs to be improved and enhanced Crisis Management Programs (CMP) within our industry. Supplier Approval Programs are also necessary to help diminish the domestic and global supply chain issues. Natural disasters have also affected the food supply chain in 2021. Last August, Hurricane Ida, hit the Gulf region which greatly diminished our crop exports. Sixty percent of our grain and soybean exports move through Gulf ports.
Needed regulation changes: FDA continues to strengthen its focus on its New Era of Smarter Food Safety strategy. “In 2019, the FDA launched the New Era of Smarter Food Safety, an initiative that builds on the foundations laid by FSMA, with an increased focus on leveraging technology and other tools to create a more digital, traceable food system, and thereby a safer food supply. In 2020, the FDA released the New Era of Smarter Food Safety Blueprint, which outlines specific approaches the FDA and others will take over the next decade to address food safety in the rapidly changing food system. The blueprint contains four “Core Elements,” which address new food safety challenges the food system will face as well as new technologies (e.g., tracing technologies, genomics, advancements in detection methodologies, and advanced analytics) that can be harnessed to improve food safety.” The FDA’s Foodborne Outbreak Response Improvement Plan (FORIP) is an extremely important step that “the FDA is taking to enhance the speed, effectiveness, coordination, and communication of outbreak investigations.”
“This Foodborne Outbreak Response Improvement Plan is focused on multi-state outbreaks that require significant engagement coordinated by FDA’s CORE Network. This plan is intended to complement two of the blueprint’s Core Elements: “Tech-Enabled Traceability” and “Smarter Tools and Approaches for Prevention and Outbreak Response.” It is also important to recognize that many foodborne outbreaks occur at the local level and are tied to contamination that occurs in retail settings, which is the focus of separate activities under the Core Element “New Business Models and Retail Modernization.” Important aspects include:
- Tech-enabled product traceback
- Root cause investigations (RCIs)
- Analysis and dissemination of outbreak data
- Operational improvements”
The federal government through the expanded use of whole genome sequencing will allow the improvement of outbreak diagnosis and containment in 2022. With a continued focus on risk analysis especially around produce, genome sequencing should enable produce operations to better understand that risk and help prevent foodborne outbreaks.
Labeling: Two areas need regulatory addressing in 2022 – The Nutrition Facts label and the National Mandatory Bioengineered Food Disclosure Standard. Nutrition labeling on packaged foods was updated in 2016 to help reflect much needed updated scientific information. This labeling includes new information concerning the link between our diet choices and chronic diseases (e.g., obesity, heart disease, hypertension). These updated label requirements will improve consumers knowledge and help them to make better informed food selection choices. This updated nutritional labeling will appear on the majority of food packages. “Manufacturers with $10 million or more in annual sales were required to update their labels by January 1, 2020; manufacturers with less than $10 million in annual food sales were required to update their labels by January 1, 2021. Manufacturers of most single-ingredient sugars, such as honey and maple syrup, and certain cranberry products have until July 1, 2021, to make the changes. The compliance dates are still in place, but the FDA is working cooperatively with manufacturers to meet the new Nutrition Facts label requirements.” (Nutrition Fact Label) It is our hope that this is not ‘swept under the table”.
Another rule that will be important to 2022 establishes the new national mandatory bioengineered (BE) food disclosure standard (NBFDS or “Standard”). This new “Standard” requires food manufacturers, importers, and other associated food industries which label foods for retail sale to disclose information about bioengineered food and food ingredients that also are BE. This rule is important that it is intended to help provide a uniform mandatory national standard for BE foods. It will help provide the disclosure of information to consumers about the BE status of foods they are consuming. This will allow consumers to make informed decisions on the food they eat. The establishment and implementation of the new “Standard” is now required by an amendment to the Agricultural Marketing Act of 1946.
“The implementation date of the Standard is January 1, 2020, except for small food manufacturers, whose implementation date is January 1, 2021. The mandatory compliance date is January 1, 2022. Regulated entities may voluntarily comply with the Standard until December 31, 2021.” (BE disclosure)
Antimicrobial Resistance (AMR): AMR is reflective of ‘super bugs’ that do not respond to current antimicrobial agents. This AMR pandemic is already claiming 700,000 lives globally each year. Domestically, one person dies every 15 minutes due to antibiotic resistant organisms. In the United States alone, it is responsible for more than 35,000 preventable deaths every year. It is currently estimated that by the year 2050, on a global basis as many as ten million people per year could die from these infections. (WHO, 2019) Antimicrobial resistance is a global crisis that risks reversing a century of progress in human and animal health. This should be scary news.
AMR has been declared by the World Health Organization (WHO) as one of the top ten global public health threats facing humanity in 2021. Antimicrobics used in both animals and humans are of importance to global food safety. The agriculture community and their production environments, as well as food supply sectors play a pivotal role when it comes to AMR. Sadly, in many regions of the world, animal agriculture antimicrobial use is far greater than in humans. This allows poor animal husbandry practices to flourish. AMR is threatening global food systems, food safety, food security, the environment, our public health systems, and food economics.
Two recent federal announcements emphasize the continued investment by the US government in combatting “superbugs”. These are a recent Biomedical Advanced Research and Development Authority (BARDA) Broad Agency Announcement (BAA) and the FY 2022 Inpatient Prospective Payment System (IPPS) proposed rule from the Centers for Medicare and Medicaid Services (CMS). Additionally, federal legislative proposals include: the Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act and the Pioneering Antimicrobial Subscriptions to End Up-surging Resistance (PASTEUR) Act. These measures if enacted would reform the industry.
Food security and defense: FDA will begin enforcement of the Intentional Adulteration (IA) rule in 2022. “The FDA Food Safety Modernization Act (FSMA) added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) several new sections that reference intentional adulteration. For example, section 418 of the FD&C Act (21 U.S.C. 350g) addresses intentional adulteration in the context of facilities that manufacture, process, pack, or hold food, and that are required to register under section 415 (21 U.S.C. 350d). Section 420 of the FD&C Act (21 U.S.C. 350i) addresses intentional adulteration in the context of high-risk foods and exempts farms except for farms that produce milk.” (Mitigation strategies)
Open trade with Canada and Mexico: On July 1, 2020, the new Canada-United States-Mexico Agreement (CUSMA) entered into force. CUSMA outcomes help preserve and emphasize key elements of our long-term trading relationship and incorporates new and updated provisions that address newer trade issues. Currently there has been a Canadian delay of an important piece of legislation affecting CUSMA: Phase 3 of the Safe Food for Canadians Regulations (SFCR). Although the Safe Food for Canadians Regulations (SFCR) was enacted on January 15, 2019, certain requirements may still apply in 2020, 2021 and 2022. These delays are based on business size, food commodity groups, and type of activity specified.
Cultured meat products: Plant-based ‘meats’, ‘meat’ analogues, cell-based cultured ‘meat’, and edible insects/worms, can be major meat alternatives in our food supply. These meat replacement alternatives reflect an ever-changing consumer palate. ‘Meat’ replacements are the wave of the future for many human and pet foods. Within this new industry, technical difficulties of mass production, cost of product development, quality control and palatability, legal and regulatory guidance are key impediments for the food industry. Plant-based (‘meat’ analogues derived from plant proteins) and cultured cell-based (‘meat’ derived from cell cultures) products will provide new and advanced industry alternatives requiring regulatory alternatives to enhance our current system of production. (Alternative meat)
Plant-based ‘meat’ (PBM) and cell-based ‘meat’ (CBM) are new and/or revitalized approaches to human and animal ‘meat’ production. Novel food alternatives are being commercialized with improved and enhanced sensory characteristics reflecting consumer attitudes and demands for the final product. “Cellular Agriculture” is at the forefront in developing sustainable animal meat alternatives. Cellular agriculture has opened an entirely new industry producing ‘meat’ and protein commodities based on both animal and plant cellular components. Though industry evidence suggests a ‘healthier’ final product, it is necessary to evaluate the impacts of PBMs and CBMs comprehensively and scientifically on human and pet health, potential cell-culture issues and the environmental effects of these novel production processes.
Limited expertise or experience in foods can be found within the cultured meat and plant based ‘meat’ industry. This can increase food safety risk due to limited professional food safety and production expertise, inappropriate sanitary design, limited allergen control in the final product, inadequate hazard analysis, inappropriate sanitary design and reworking the concepts of HACCP/HARPC within the industry. FDA standards of the identity of these products will definitely change labeling concepts. Designating plant-based product requirements as well as labeling of cell cultured products need addressing in 2022. Labeling and transparency are over arching issues.
Pet Food Products: On Dec. 3, 2021, the U.S. Food and Drug Administration issued its final rule establishing the Laboratory Accreditation for Analyses of Foods (LAAF) program as required by the FDA Food Safety Modernization Act (FSMA). This rule was mandated by FSMA and is important to establish uniform and transparent standards for import-related food testing. It will also strengthen the FDA’s oversight over such testing. Much of our domestic pet food is derived from global trading partners without pet food safety regulations. The LAAF rule is necessary for the establishment of a regulatory framework, to be implemented by the FDA. This implementation and changes are important for 2022 and beyond. Accreditation of these new laboratories will allow them to conduct certain types of food testing. FDA will then recognize these accreditation bodies, which will eventually accredit laboratories to the standards established by the rule. Once these accredited laboratories are in place, certain specified types of testing will be required to be conducted using only these laboratories. The rule referrers to these laboratories as “LAAF-accredited laboratories”. The LAAF rule will significantly impact a laboratories ability to test food which is intended for import into the United States but has been detained by FDA as potentially violative. Currently, food and environmental testing, is generally completed by private laboratories with a variety of standards and oversight. This will impact the importation of pet foods from both domestic and foreign suppliers. (FSMA and animal food)
While new major food safety statutes are necessary in 2022, the White House seems to be moving slowly within this arena. However, with increasing foodborne infections occurring on a regular basis, change may necessarily be stimulated. It would also appear that the Department of Justice activity and criminal prosecutions will probably remain consistent with those seen in 2021. Happy New Year!
Understanding the Safe Food for Canadians Regulations: a Handbook for Food Businesses. https://inspection.canada.ca/food-safety-for-industry/toolkit-for-food-businesses/sfcr-handbook-for-food-businesses/eng/1481560206153/1481560532540?chap=0
Safe Food for Canadians Regulations (SOR/2018-108) https://laws-lois.justice.gc.ca/eng/regulations/SOR-2018-108/index.html
FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD) https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd
Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cannabis-and-cannabis-derived-compounds-quality-considerations-clinical-research-guidance-industry
Food Safety and the Coronavirus Disease 2019 (COVID-19) https://www.fda.gov/food/food-safety-during-emergencies/food-safety-and-coronavirus-disease-2019-covid-19#:~:text=July%2017%2C%202020)-,Currently%20there%20is%20no%20evidence%20of%20food%20or%20food%20packaging,facilities%20and%20food%20contact%20surfaces.
FDA. New Era of Smarter Food Safety https://www.fda.gov/food/new-era-smarter-food-safety
New Era of Smarter Food Safety: FDA’s Foodborne Outbreak Response Improvement Plan https://www.fda.gov/food/new-era-smarter-food-safety/new-era-smarter-food-safety-fdas-foodborne-outbreak-response-improvement-plan
Changes to the Nutrition Facts Label https://www.fda.gov/food/food-labeling-nutrition/changes-nutrition-facts-label
USDA BE disclosure https://www.ams.usda.gov/rules-regulations/be
Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-mitigation-strategies-protect-food-against-intentional-adulteration
Food Made with Cultured Animal Cells https://www.fda.gov/food/food-ingredients-packaging/food-made-cultured-animal-cells
Food Safety Modernization Act and Animal Food https://www.fda.gov/animal-veterinary/animal-food-feeds/food-safety-modernization-act-and-animal-food
Federal Register. Laboratory Accreditation for Analyses of Foods https://www.federalregister.gov/documents/2021/12/03/2021-25716/laboratory-accreditation-for-analyses-of-foods
WHO. Food Safety. https://www.who.int/news-room/fact-sheets/detail/food-safety
FDA approves new nutrition fact label for packaged food. https://www.transact-tech.com/upgrade/restaurant-solutions/fda-approves-new-nutrition-fact-label-for-packaged-foods/