The food system and supply chains continue to change and evolve at an accelerated pace. That introduces new risks and challenges—and heightens some familiar ones. As we move into 2022, the Food and Drug Administration (FDA) continues to strengthen its focus on the four core elements of its New Era of Smarter Food Safety to address several ongoing challenges in food safety. In addition to those identified in FDA’s New Era, KTL’s food safety experts have identified some of the key trends they are tracking in 2022—along with some guidance on how to prepare for the future.

Food Traceability

Food traceability is the ability to track any food through all stages of the supply chain—production, processing, distribution—to ensure food safety and operational efficiency.  There is a real need for standardization, stronger linkages throughout the supply chain, improved communication and recordkeeping, and faster response. Notably, one of the core elements of FDA’s New Era is Tech-Enabled Traceability, which involves the use technology to create food traceability advancements. Under this, FDA has taken several actions to reduce foodborne illness:

• The proposed Food Traceability Rule was published on September 23, 2020, as required under the Food Safety Modernization Act (FSMA) Section 204(d), to enhance traceability recordkeeping for certain identified foods beyond a limited “one-up, one-back” traceback approach. The final rule must be submitted by November 7, 2022.
• FDA’s 2021 Foodborne Outbreak Response Improvement Plan sets the stage to “enhance the speed, effectiveness, coordination, and communication of foodborne outbreak investigations” through tech-enabled product traceback, root cause investigations, stronger analysis and dissemination of outbreak data, and operational improvements.

To prepare: Familiarize yourself with FDA’s proposed rule. Review the Food Traceability List (FTL) and start building systems and processes now that address requirements for traceability lot codes, critical tracking events (CTEs), key data elements (KDEs), and recordkeeping.

Food Safety Culture

An organization’s food safety culture is ultimately reflected in the way food safety is managed in the workplace. A strong food safety culture creates an atmosphere where everyone in the organization is aware of and helps to prevent any process and/or operational issues and deviations that may impact the safety and/or quality of their products. Food safety culture is another core element of the FDA’s New Era. It is also a key component of the GFSI Benchmarking Requirements Version 2020 and, subsequently, is being integrated as a requirement into many of the benchmarked food safety certification standards. Best-in-class food safety cultures have robust systems in place to ensure consistent commitment, communication, procedures, training, performance measurement, and trust.

To prepare: The incorporation of food safety should translate to all aspects of the business. Assess current food safety program elements, identify improvements that are internally desirable and required, and implement those updates that will create a strong food safety culture. 

Sustainable Food Management

Wasted food makes up the largest percentage—over 20%—of any one material sent to landfills and incinerators each year in the U.S. With more customers and businesses focusing on making sustainable changes, food businesses need to work hard to ensure less food is being wasted. According to the Environmental Protection Agency (EPA), sustainable management of food is “a systematic approach that seeks to reduce wasted food and its associated impacts over the entire lifecycle, starting with the use of natural resources, manufacturing, sales, and consumption, and ending with decisions on recovery of final disposal.” The EPA, U.S. Department of Agriculture (USDA), and FDA joined forces to address the magnitude of wasted food impacts across the U.S. through the U.S. Food Loss and Waste 2030 Champion program. Efforts to promote sustainable food management have also extended to the state level.

To prepare: A thorough food and packaging assessment can help identify appropriate strategies to avoid waste, cut down on disposal costs, reduce over-purchasing and labor costs, reduce water and energy use associated with food production, and reduce GHG emissions. Based on the outcomes of the food waste assessment, there are some common strategies for reducing wasted food and packaging.

Health & Safety and Environmental Focus

During the pandemic, businesses had to find new ways of working to ensure health and safety. Employee protection will remain a top priority, particularly with potential increases in Occupational Safety and Health Administration (OSHA) funding to make improvements in workplace safety protection for American workers, as well as significant increases in OSHA’s maximum penalties. In addition, 2021 brought a significant uptick in EPA multi-media inspections, enforcement actions, and large penalties for violations, particularly related to anhydrous ammonia storage, risk management, and chemical accident prevention planning. Anhydrous ammonia is widely used as refrigerant in food facilities, including meat, poultry, and fish processing facilities; dairy and ice cream plants; wineries and breweries; fruit juice, vegetable juice, and soft drink processing facilities; cold storage warehouses; other food processing facilities; and seafood processing facilities aboard ships.

To prepare: Make sure you have the processes, programs, and systems in place—and documented—to ensure you are always protecting employees’ safety and health and meeting OSH Act requirements. If your facility uses anhydrous ammonia, you must understand the hazards posed by chemicals at the facility and design and maintain a safe facility to prevent accidental releases.

Compliance Efficiency Tools

Managing the complexities of a management system is challenging. That is because every regulatory agency (e.g., FDA, USDA, OSHA, EPA) and voluntary certification (e.g., GFSI-benchmarked standards, gluten-free, organic, ISO) calls for companies to fulfill compliance requirements—many of which overlap. Supply chain and internal requirements can create further complications and confusion. And more frequently than not, companies may not understand or have the resources to manage everything that needs to be in place to satisfy requirements. This is an area where compliance efficiency and tracking tools are becoming essential to allow companies to do more with fewer resources.

To prepare: An integrated compliance management system (CMS) is intended to bring various tools together to create one system that effectively manages compliance requirements, enables staff to carry out daily tasks and manage operations, and supports operational decision making by tracking and trending data that is collected daily by the team charged with implementation.

Food Fraud

In May 2016, FDA issued its final rule on Mitigation Strategies to Protect Food Against Intentional Adulteration (IA). While this is not a new rule, supplier approval/verification programs, vulnerability assessments, and written food defense plans will remain a key focus as a surge in food demand and lack of supply has created an environment ripe for food fraud. It is likely that FDA IA inspections could also ramp up, especially when more onsite inspections resume.

To prepare: Develop a food defense plan. This should include conducting a vulnerability assessment and developing the required programs to remove the risks of IA and food fraud.

Others to Watch…

• Food Irradiation. Food irradiation is a food safety technique used to kill pathogens, including bacteria, viruses, and parasites, and extend shelf life. Irradiation provides excellent safe food processing. FDA continues to research and approve irradiation for a variety of foods. Despite consumer resistance, expect this trend to continue.
• Food Investments. We are seeing more and more private equity firms investing in food companies and, subsequently, in their food safety infrastructure. Food safety is a critical factor in these acquisitions. Expect a thorough assessment of the condition of operations (i.e., personnel, equipment, processes, plant); level of food safety compliance/certification status; and any other potential risks that would impact the transaction.
• Cannabis. The regulatory framework for managing cannabis production is still murky. However, this is a rapidly growing market, and we anticipate progress—whether at the state level or federal level—in the development and implementation of regulations and controls (e.g., Good Manufacturing Practices (GMPs), labeling requirements, etc.).
• Labeling. COVID significantly increased the number of new food preparation and delivery/takeout services and ready-to-eat (RTE) food products. These new business models heighten the importance of appropriate labeling, particularly regarding allergens and instructions for safe food production.

Set Your Goals for 2022

As FDA continues to push its New Era of Food Safety forward and new challenges surface, it is important to understand the current landscape, set priorities, and commit the appropriate resources to ensure long-term sustainability. Consider undertaking the following activities:

• Implement a CMS to help coordinate, organize, control, analyze, and visualize the information necessary to remain in compliance and operate efficiently.
• Conduct third-party assessments to provide an outside perspective of food safety systems and compliance/certification to identify gaps in programs that need development/updates.
• Explore technological advancements that allow for further digitization and promote more timely and accurate collection and management of important data.
• Conduct root cause analysis, as needed, to identify underlying issues and ensure similar problems do not occur in the future.
• Build a strong food safety culture that focuses on changing from a reactionary to a preventive mindset that promotes safety and quality.

If you would like help evaluating your current food safety risk level and assessing your priorities for 2022, please contact KTL. 

As we’ve seen businesses manage their way through the pandemic over the past two years and a new Administration take hold in office, a number of environmental, health, and safety (EHS) trends are rising to the surface. Some of these may sound familiar, as certain challenges and opportunities in EHS remain ongoing. Some are just gaining traction as we move into the new year.

Here are the top EHS trends KTL’s EHS professionals are keeping watch on in 2022—and some advice on what you can do to prepare…

OSHA Enforcement: Happy 50^th Birthday OSHA!

The Build Back Better Act (BBBA) introduced the first amendment to the Occupational Safety and Health (OSH) Act in nearly 20 years. This would include increased funding to make significant improvements in workplace safety protection for American workers, as well as significant increases in the Occupational Safety and Health Administration’s (OSHA) maximum penalties. While the future of the BBBA is uncertain, it provides a good picture of where OSHA is headed by enacting high enough penalties to significantly impact businesses that violate the law and injure or kill workers. While OSHA doesn’t have the resources to audit or fine everyone, the agency will likely make an example of a few major violators to deter others from non-compliance.

To prepare: Make sure you have the processes, programs, and systems in place—and documented—to ensure you are always protecting employees’ safety and health and meeting OSH Act requirements.

EPA Inspections and Enforcement: Focus on Ammonia Refrigeration

With the new Administration, 2021 brought a significant uptick in Environmental Protection Agency (EPA) multi-media inspections, enforcement actions, and large penalties for violations, particularly related to anhydrous ammonia storage, risk management, and chemical accident prevention planning. Many of these violations have been uncovered as part of a National Compliance Initiative (NCI), which is working to enforce the regulatory aspects of the Clean Air Act’s (CAA) Chemical Accident Prevention Program, including Risk Management Plan (RMP) regulations (40 CFR Part 68), General Duty Clause (GDC) (CAA Section 112(r)), Emergency Planning and Community Right-to-Know Act (EPCRA) (CAA Section 312), Process Safety Management (PSM) regulations (29 CFR 1910.119).

To prepare: If your facility uses anhydrous ammonia and you have not conducted a hazard analysis, you are at significant risk of incurring enforcement actions of fines. It is important you invest the time and resources required to:

• Understand the hazards posed by chemicals at the facility.
• Assess the impacts of a potential release.
• Design and maintain a safe facility to prevent accidental releases.
• Coordinate with local emergency responders.
• Minimize the consequences of accidental releases that do occur.

PFAS/PFOA Contamination

Because of per- and polyfluoroalkyl substances’ (PFAS) persistence in the environment and widespread use in firefighting foams and products that resist grease, water, and oil, PFAS contamination is an extremely complicated issue—and concern is mounting over its impacts and how to regulate these chemicals going forward. On October 18, 2021, EPA Administrator Michael Regan announced EPA’s comprehensive Strategic Roadmap to tackle PFAS contamination through increasing investments in research, leveraging authorities to act now to restrict PFAS chemicals from being released, and accelerating cleanup of PFAS contamination. More and more facilities are going to be directly impacted by mitigation efforts and future regulatory action.

To prepare: Proper usage strategies, a comprehensive environmental management system (EMS), and a forward-thinking Emergency Response Plan will remain vital tools for companies potentially dealing with PFAS to effectively manage the associated risks.

Resource Constraints and Compliance Efficiency Tools

There are a few trends we see time and again, which generally can be tied back to many EHS “departments” (which often consist of just one person) lacking the resources—financial and personnel—to manage the sheer number of EHS requirements they are required to comply with. Frequently, companies may not understand or have the resources to manage everything that needs to be in place to satisfy compliance requirements. This is an area where EHS compliance efficiency and tracking tools are becoming essential to allow companies to do more with fewer resources.

To prepare: A compliance management system (CMS) brings information technology (IT) and management systems together to coordinate, organize, control, analyze, and visualize information in such a way that helps organizations remain in compliance and operate efficiently. A CMS can help provide operational flexibility, generate business improvement, and prepare organizations to address these and other EHS compliance challenges that will continue to surface. 

Hazardous Waste Incineration Backlog

The changing hazardous waste market continues to create a fair amount of uncertainty regarding whether hazardous waste management capacity can actually meet demand. Many Large Quantity Generators (LQGs) and Small Quantity Generators (SQGs) are still experiencing a hazardous waste incineration slowdown, and most of the permitted transport, storage, and disposal facilities (TSDFs) are backlogged. EPA predicts that this backlog may not fully resolve until the end of the first quarter of 2022. EPA has offered multiple existing regulatory options for various regulated entities that generate and manage hazardous waste as temporary solutions to address the backlog.

To prepare: If you are in the situation where you are coming up against your time limits, contact your EPA Regional Administrator and ask for guidance on how to manage the situation. Keep very careful and accurate records of all hazardous waste information to demonstrate appropriate management.

Environmental Justice and Citizen Science

On January 27, 2021, President Biden issued Executive Order (EO) 14008 – Tackling the Climate Crisis at Home and Abroad, amending EO 12898, which directed federal agencies to develop environmental justice (EJ) strategies to help federal agencies address disproportionately high and adverse human health or environmental effects of their programs on minority and low-income populations. EO 14008 further directs Federal agency actions to support making EJ part of its mission by identifying and addressing the effects of all programs, policies, and activities on minority and low-income populations. As part of EPA’s EJ efforts, the Agency is charting a new pathway for the use of citizen science. Citizen science engages the public in identifying research questions, collecting and analyzing data, interpreting results, and developing technologies and applications to resolve environmental problems. Citizen science provides a resource in times of restricted budgets and to address dispersed or hyperlocal environmental issues.

To prepare: Equipment loan programs are available for anyone who would like to participate. KTL is aware of clients receiving money from the state to make equipment updates. In addition there are a number of EJ grants, funding, and other technical assistance available.    

Sustainability

As developing nations continue to industrialize and increase their material consumption, resource demands and pressures on our supply chains will only increase. The Biden Administration has committed to a net zero economy by 2050, and the number of net zero commitments from local governments and businesses continues to grow and push further down the supply chain. There are more incentives for businesses to find clean/renewable energy solutions and to manage waste more sustainably. As one example, Sustainable Material Management (SMM) considers the entire of a product and/or process to help create a circular economy.

To prepare: Consider the following sustainability activities as part of your company’s business strategy:

• Conduct a lifecycle analysis (LCA) to identify and quantify the inputs and outputs in a process and use data to assess the potential environmental impacts across the lifecycle.
• Check with your local utility to have an energy audit completed of your facilities.
• Get input from employees on what initiatives are important to them by enacting a sustainability committee or adding sustainability to your EHS agenda.

Set Your Goals for 2022

With these trends toward more regulations, more enforcement, and more focus on sustainability, EHS management needs to play a more integral role in company strategy. Companies must take the time to be informed, be prepared, and be proactive. Establish company-wide EHS priorities and goals and commit the appropriate resources to ensure the required programs and systems are in place for 2022 and beyond.

If you would like help evaluating your current EHS risk level and assessing your priorities for 2022, please contact KTL. 

BioForward Wisconsin closely follows news stories about its members and invites them to contribute blogs and profiles to inform and advance the Wisconsin biohealth community. Read the recent BioForward Wisconsin member blog on KTL’s scalable systems for helping companies manage compliance business processes more efficiently and effectively.

Get to know our KTL team! This month, we are catching up with KTL Consultant Meghan Stenslien. Meghan has a diverse background working in food safety; quality; and environmental, health, and safety (EHS) compliance and excels at managing compliance and certification programs. She is based out of LaCrosse, Wisconsin. 

Tell us a little bit about your background—what are your areas of expertise?

I have my bachelor’s degree in biochemistry and began my career performing quality and environmental lab analysis for food manufacturers. I quickly realized that I have a passion for designing and implementing management systems, helping companies meet their certification requirements, and working with them to further improve their current systems.

What types of clients do you work with? What are the biggest issues you see them facing right now?

I currently work with clients whose needs span both KTL’s food safety and EHS disciplines. Across the board, I am seeing issues with staffing. A combination of COVID-19 highlighting a shortage of skilled labor throughout the workforce and the need to stretch budgets further has created a “perfect storm” that needs to be addressed—and soon for many organizations. I am proud that KTL has the opportunity to work with these companies—many of which are struggling to get everything done—to implement efficient and quality programs that will sustain them through these times.

What would you say is a highlight of your job?

Variety is the spice of life for me! I enjoy the broad range of clients and services that I get to work with in my role at KTL. Each day presents new challenges and new opportunities to not only create lasting solutions for our clients, but also expand my own knowledge base. I feel fortunate to have so many experienced subject matter experts as colleagues whom I collaborate with daily.

What do you like to do in your free time?

I enjoy spending time with my wonderful 16- and 14-year-old daughters, my husband, and our pets. I love hiking and exploring uncharted places; traveling and experiencing new cultures; baking for family and friends; working on our home renovation; expanding my indoor garden; and doing crafts.

Read Megan’s full bio.

The Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act was passed on May 15, 2020 to respond to the COVID-19 outbreak and its impact on the economy, public health, state and local governments, individuals, and businesses. Part of this bill involves protecting workers by requiring the Occupational Safety and Health Administration (OSHA) to issue an enforceable emergency temporary standard (ETS) that covers all workers from COVID-19 infections.

OSHA announced the COVID-19 Vaccination and Testing ETS on November 4, 2021. Just one day later, the Fifth U.S. Circuit Court of Appeals put a temporary halt to the ETS by granting an emergency motion/stay pending an expedited review because of “cause to believe there are grave statutory and constitutional issues with the [ETS]”. November 12, 2021 marked another court ruling against the ETS vaccine directive. The court ordered that OSHA “take no steps to implement or enforce” the ETS “until further court order.”

According to the OSHA website, “While OSHA remains confident in its authority to protect workers in emergencies, OSHA has suspended activities related to the implementation and enforcement of the ETS pending future developments in the litigation”–leaving many employers questioning how to proceed.

ETS at a Glance

The COVID-19 ETS requires employers with more than 100 employees to develop, implement, and enforce a mandatory COVID-19 vaccination policy or a policy requiring employees to choose to either be vaccinated or undergo regular COVID-19 testing and wear a face covering.

According to Deputy Assistant Secretary of Labor for OSHA Jim Frederick, “While vaccination remains the most effective and efficient defense against COVID-19, this ETS will protect all workers, including those who remain unvaccinated, by requiring regular testing and the use of face coverings by unvaccinated workers to prevent the spread of the virus.”

Additional provisions of the ETS include the following:

• Determine, obtain acceptable proof of, and maintain accurate records of the vaccination status of every employee.
• Provide paid time off to workers to get vaccinated and to recover from any side effects.
• Require each worker who is not fully vaccinated to test weekly for COVID -19. Note: Employers are not required to pay for testing.
• Ensure every employee who has not been fully vaccinated wears a face covering when indoors or in a vehicle with another person for work purposes. Note: Employers are not required to pay for face coverings.
• Require employees to provide prompt notice when they test positive for COVID-19 so they may be removed from the workplace (whether vaccinated or not) until they meet required criteria to return to work.

These new mandates may also be accompanied by higher risk of OSHA enforcement and significantly increased penalties depending on the status of the Build Back Better Act (BBBA) (see related article).

Compliance Deadlines

OSHA has recently extended the comment period for the COVID-19 ETS by 45 days to January 19, 2022. If the ETS moves forward—which is still an unknown at this time—covered employers would have 30 days to develop, implement, and enforce their COVID-19 vaccination and/or testing policy. Employers then have 60 days for employees to actually be fully vaccinated or begin testing requirements. This ETS also serves as a proposal for normal rulemaking of a final standard.

Preparing to Comply

Many legal experts recommend employers prepare to comply regardless of ongoing court challenges and litigation. Corbin Carter, an attorney with Mintz in New York City, said in a Society for Human Resource Management (SHRM) article, “The Supreme Court may ultimately weigh in. But employers likely cannot await a court ruling on the new rule’s fate before properly engaging in the appropriate tasks—convening stakeholders, reviewing the relevant rules, assessing options—given the rule’s tight timeline.” 

When—or if—this mandate goes forward, tracking and documentation of vaccination and/or testing status will be a key part of complying with standards. This is not unlike other records OSHA requires for training, inspections, incidents, etc. A document/compliance management system (CMS) can allow for easier tracking and access to employee records to demonstrate compliance with the ETS. If your company is preparing for the ETS—or if you are simply interested in developing a strong, organized CMS—KTL can integrate our expertise in OSHA regulatory compliance into our SharePoint data management solutions to develop a system that will meet your organization’s needs.

OSHA intends to offer robust compliance assistance to help businesses implement the ETS and will continue to monitor COVID-19 infections and deaths as the pandemic evolves to change measures, as needed. Get more information and guidance from OSHA on the COVID-19 Vaccination and Testing ETS.

After months of negotiations, the House of Representatives passed the Build Back Better Act (BBBA), H.R. 5376—also known as the reconciliation bill—on November 19, 2021. The BBBA is intended to fulfill aspects of President Joe Biden’s Build Back Better Plan. And while some would consider the most recent version less ambitious than previous iterations, it retains many major provisions related to social programs, taxes, climate change, family aid, and worker safety.

Amendments to the Occupational Safety and Health Act

As currently proposed, the BBBA would include the first amendment to the Occupational Safety and Health (OSH) Act in nearly 20 years, when it was updated to reflect bioterrorist threats to workers in the aftermath of 9/11. This includes increasing funding to make significant improvements in workplace safety protection for American workers:

• $707 million to Occupational Safety and Health Administration (OSHA) for carrying out enforcement, standards development, whistleblower investigations, compliance assistance, funding for state plans, and related activities within OSHA.
• $133 million to Mine Safety and Health Administration (MSHA) for carrying out enforcement, standard setting, technical assistance, and related activities.

Perhaps even more immediately impactful to industry, the BBBA would also include significant increases to OSHA’s maximum penalties:

• Penalties for serious violations would increase from a current maximum of $13,653 (inflation adjusted) to $70,000.
• Penalties for willful, repeated, and failure-to-abate violations would increase from a maximum of $136,530 (inflation adjusted) to $700,000 (and from a minimum of $9,753 to $50,000).

Note that these are maximum penalties on a per-day basis. Small- to medium-size businesses would likely incur lesser fines based on the four factors OSHA considers when deciding the actual penalty level, including:

• Gravity of the violation
• Employer’s size
• Employer’s “good faith”
• Employer’s history of compliance 

According to former OSHA head David Michaels, “Many large employers treat current OSHA fines as cheaper than the cost of a safety consultant. This dramatic increase will save lives by encouraging firms to eliminate hazards before workers are hurt.”

House Education and Labor Committee Chair Bobby Scott (D-VA) agreed with these sentiments in a September 9, 2021, press release, stating, “As part of the Build Back Better Plan, workers’ rights are strengthened with provisions to apply civil monetary penalties for labor law violations and by updating the dollar amount of worker safety penalties so they are large enough to serve as an adequate deterrent.”

Get Ready…

There may still be a lot of work to do for the Senate to pass the BBBA—and what the Act’s final provisions will include is still not entirely certain. However, the latest iteration provides a good picture of where OSHA is headed. The federal government recognizes that OSHA’s penalty levels are significantly lower than other agencies and, correspondingly, that OSHA’s rigor in application of penalty has been much lower. 

Over 50 years since the OSH Act was passed, the government is trying to remedy both. The BBBA changes would authorize OSHA to enforce high enough penalties to significantly impact businesses that violate the law and injure or kill workers.

While OSHA doesn’t have the resources to audit or fine everyone, the agency will likely make an example of a few major violators to deter others from non-compliance. The best way to get ready for this potential wave of new enforcement is to be prepared:

• Make sure you have the processes, programs, and systems in place—and documented—to ensure you are always protecting employees’ safety and health and meeting OSH Act requirements.
• Establish a centralized location, like a Compliance Management System (CMS), to track and manage all safety-related information to not only help ensure going compliance but to also provide the documentation required should an inspection occur.
• Understand what to expect from an OSHA inspection and prepare your staff to respond appropriately and locate requested documentation.

And, as always, good faith goes a long way. If there are issues, fix them and document them. Abatement efforts matter.

There are currently more than 4,700 known per- and polyfluoroalkyl substances—more commonly known as PFAS—and these numbers are growing as industry continues to invent new PFAS chemicals.

Because of their persistence in the environment, persistent nature, and widespread use in firefighting foams and products that resist grease, water, and oil, PFAS are found in the blood of people and animals all over the world. In fact, a 2011-2012 report by the Centers for Disease Control (CDC) and Prevention National Health and Nutrition Examination Survey (NHANES) found PFAS in the blood of 97% of Americans tested.

As of August 2021, 2,854 locations in 50 states and two territories are known to be contaminated with PFAS (Environmental Working Group (EWG)). Because of the sheer magnitude of chemicals that fall into this category and its persistence in the environment, PFAS contamination is an extremely complicated issue to regulate and manage—one that no single agency will be able to address alone. And one that industry must pay attention to, because it is not going away.  

Preparing for the Perfect PFAS Storm

All the various impact studies, regulatory actions, and legislative efforts are coming together to form a perfect PFAS storm, and industry must be ready to respond. Consider the following questions and best management practices (BMPs):

• Have you considered the risk(s) of introducing PFAS to your site—or do you know what PFAS you currently have on your site (either in current use or due to historical contamination)?
• Do you have an environmental management system (EMS) to help identify, manage, and prevent the risks associated with PFAS? Is PFAS included as part of your aspects and impacts analysis?
• Do you have the appropriate operational controls and training in place to prevent or minimize a fire at your facility?
• Do you have an Emergency Response Plan?
  • Have you contacted your local emergency responders to discuss the potential for using PFAS-containing aqueous film-forming foam (AFFF) at your facility in the event of a fire?
  • Do you have an emergency response checklist? Does it include inquiring about the foam being used to fight a fire?
  • Have you evaluated when and how to use PFAS-containing foams considering likely fire hazards; properties of the foam; nature of the emergency; risks to life, public safety, and property; and potential environmental, public health, and financial liabilities?
  • Do you conduct any emergency response testing that includes the use of AFFF?
  • Do you have controls in place (e.g., floor drain covers) and adequate supplies to keep foam runoff from leaving your site in the event of a fire?

PFAS Primer

PFAS are a group of manmade chemicals that have been manufactured and used in a variety of industries since the 1940s. PFAS can be found in:

• Food packaged in PFAS-containing materials, processed with equipment that used PFAS, or grown in PFAS-contaminated soil/water
• Commercial household products (e.g., stain- and water-repellent fabrics, nonstick products, polishes, waxes, paints, cleaning products)
• Firefighting foams (i.e., aqueous film-forming foam (AFFF))
• Industries such as chrome plating, electronics manufacturing, oil recovery, automotive
• Drinking water, typically associated with a manufacturer, landfill, wastewater treatment plant (WWTP), firefighter training facility, etc.

PFAS are made of chains of carbon and fluorine linked together. This carbon-fluorine bond is one of the shortest and strongest bonds in nature. It does not easily break down under natural conditions—hence the reason PFAS are often referred to as “forever chemicals”. Correspondingly, PFAS are very persistent in the environment and the human body, where they bioaccumulate in blood and organs over time.

Scientific studies have begun to show that exposure to some PFAS may be linked to harmful health effects in humans and animals, including developmental delays, reproductive health issues, neuroendocrine issues affecting the kidneys and liver, cancer, thyroid imbalances, and cardiovascular concerns.

Most PFAS exposure comes through ingesting food and water that becomes contaminated with PFAS when it migrates into soil, water, and air during use and/or disposal. Disposal of PFAS-containing items into municipal solid waste landfills can be a significant source of PFAS transport and contamination since PFAS can migrate into the leachate collection system. Since wastewater treatment does not remove PFAS, the subsequent use of wastewater biosolids as fertilizer, etc. may further distribute PFAS into the soil, surface water, and groundwater.

Focus on Firefighting Foam

Aqueous film-forming foam (AFFF) is highly effective foam for fighting high-hazard flammable liquid fires that has garnered a lot of attention for its role in contributing to PFAS contamination. AFFF are Class B commercial firefighting foams historically produced with PFOS or polyfluorinated precursors that break down to PFOA—the two most extensively produced and studied PFAS chemicals. Long-chain PFAS like PFOS and PFOA are of particular concern because they are recognized as persistent, bioaccumulative, and toxic (PBT).

When used, AFFF has the potential to create adverse environmental impacts, particularly if the foam is uncontrolled and reaches drinking water sources, groundwater, or surface waters. Many states and companies have been forced to deal with the aftermath of PFAS used to extinguish fires. State legislatures are considering not only how to remediate the chemicals found on these sites, but also who is responsible for the associated cleanup.

Regulatory Actions

Federal regulatory action related to the management of PFAS contamination thus far has been limited. However, on October 18, 2021, EPA Administrator Michael Regan announced EPA’s comprehensive Strategic Roadmap to tackle PFAS contamination. According to the EPA press release, the Roadmap is centered on three guiding strategies:

1. Increase investments in research.
2. Leverage authorities to act now to restrict PFAS chemicals from being released into the environment.
3. Accelerate cleanup of PFAS contamination.

Strategies are intended to advance more concrete actions that will address the entire lifecycle of PFAS chemicals. Per EPA, this specifically includes:

• Aggressive timelines to set enforceable drinking water limits under the Safe Drinking Water Act (SDWA) to ensure water is safe to drink in every community.
• A hazardous substance designation under CERCLA, to strengthen the ability to hold polluters financially accountable.
• Timelines for action on Effluent Guideline Limitations under the Clean Water Act (CWA) for nine industrial categories.
• A review of past actions on PFAS taken under the Toxic Substances Control Act (TSCA) to address those that are insufficiently protective.
• Increased monitoring, data collection, and research so that the agency can identify what actions are needed and when to take them.
• A final toxicity assessment for GenX, which can be used to develop health advisories that will help communities make informed decisions to better protect human health and ecological wellness.
• Continued efforts to build the technical foundation needed on PFAS air emissions to inform future actions under the Clean Air Act (CAA).  

Along with the Roadmap, EPA has also announced a new testing strategy requiring PFAS manufacturers to provide EPA with toxicity data and information on categories of PFAS chemicals.

Congress has also been working to develop legislation in absence of federal regulations, with more than 80 pieces of legislation introduced within the 116th Congress. The fiscal year 2021 omnibus appropriations bill included nearly $300 million to address the regulation and cleanup of PFAS split among several federal agencies, including Department of Defense (DOD) – remediation efforts; EPA – scientific, regulatory, and cleanup work; and Food and Drug Administration (FDA) – safety of PFAS in food packaging.

In addition, states are taking their own measures. In 2020, state legislatures considered over 180 bills related to PFAS, many of which have focused on efforts such as restricting PFAS in firefighting foam and consumer products, regulating PFAS in drinking water, and appropriating funds for remediation activities. For more information on state actions, visit:

• Safer States
• Environmental Council of the States

Seeking Assistance

KTL does not see the challenges associated with PFAS going away any time soon. If anything, we anticipate more and more facilities will be directly impacted by mitigation efforts and future regulatory action. Proper usage strategies, a comprehensive EMS, and a forward-thinking Emergency Response Plan will remain vital tools for companies potentially dealing with PFAS to effectively manage the associated risks.

If you are facing challenges related to PFAS or would just like a fresh set of eyes to evaluate your current environmental risk level, please contact KTL. Our staff has hands-on experience assessing environmental risks and developing strategies to minimize them to the extent possible. Our team writes Emergency Response Plans and routinely works with LEPCs to coordinate emergency response efforts and exercises to keep communities informed and safe. In addition, we have a strong network of partners that can assist with testing and remediation strategies, when necessary.

Read the entire October 18, 2021 EPA press release: EPA Administrator Regan Announces Comprehensive National Strategy to Confront PFAS Contamination.

As discussed in Part 3 of KTL’s series on Creating Sustainable Impacts, wasting food has impacts on the sustainability of our economy, our society, and the environment. Whether it comes from filling landfills, contributing to greenhouse gas (GHG) emissions, consuming valuable resources, or contributing to food insecurity, the magnitude of these impacts is substantial.

Food loss occurs at every stage of the supply chain—from farm to table. How that loss is managed plays a vital role in how it impacts our society. Federal and state regulatory agencies are taking notice of this and incenting—or requiring—organizations to incorporate sustainable food management practices into their operations.

Joining Forces to Address Wasted Food

In 2016, the Environmental Protection Agency (EPA), U.S. Department of Agriculture (USDA), and Food and Drug Administration (FDA) joined forces to address the magnitude of wasted food impacts across the U.S. through the U.S. Food Loss and Waste 2030 Champion program. This joint initiative includes more than 35 member organizations that have made a public commitment to reduce food loss and waste in their own operations by 50% by 2030. This commitment to sustainable food waste management aligns directly with the United Nation’s (UN’s) Sustainable Development Goals.

The Food Recovery Challenge offers participants access to data management software, as well as technical assistance to help them quantify and improve their sustainable food management practices. Participants create data-driven goals, implement targeted strategies to reduce wasted, and report food waste diversion data. They then receive an annual climate profile report that translates their food diversion results into GHG reductions, as well as other measures to help demonstrate the benefits of activities implemented.

The ultimate goal of the Challenge is to encourage organizations to use materials more productively over their entire lifecycle through actions that reflect the food recovery hierarchy, including source reduction, donation, feeding animals, industrial uses, and composting, to divert and prevent food from entering landfills.

Efforts to promote sustainable food management have also extended to the state level. California Senate Bill (SB) 1383 is currently the most far-reaching state-level wasted food legislation. The bill mandates a 50% reduction in organic waste disposal from 2014 levels by 2020 and a 75% reduction by 2025. In addition, SB 1383 requires that not less than 20% of edible food that is currently disposed be recovered for human consumption by 2025. The enforcement provisions of the SB 1383 regulations become effective on January 1, 2022.

Harvesting the Benefits

Transitioning to an organization that champions and promotes sustainable food management requires a culture change across the entire entity, not just a single person or department. That is because the potential to create positive impacts—financial, community, environmental—span the entire food supply chain. Wasted food is a problem on many levels. Sustainable food manage provides the opportunity to not only solve that problem, but deliver many benefits:

• Financial
  • Pay less for trash pickup by keeping wasted food out of the garbage.
  • Receive tax benefits by donating safe and edible food to those who are food insecure.
  • Spend less—and waste less—by buying only food that will be used.
  • Reduce costs (e.g., energy, labor) associated with throwing food away.
• Societal
  • Feed the people who need it by donating food to hunger relief organizations.
  • Create job opportunities; food recycling employs more than 36,000 people.
• Environmental
  • Reduce methane emissions by keeping wasted food that rots and produces methane gas out of the landfills.
  • Save the resources required to make food that ends up wasted (e.g., water, gasoline, energy, labor, land).
  • Return nutrients to the land by composting wasted food to make healthy soils.

Through sustainable food management, it is possible to help businesses and consumers save money, create outlets for those in our communities who do not have enough to eat, and conserve resources for future generations.

KTL will once again be sponsoring the Midwest Environmental Compliance Conference (MECC) held by live streaming video October 26-27. MECC takes a fresh, regional approach to the increasingly difficult task of environmental compliance, permitting, enforcement, and other critical environmental issues that impact Midwest facilities and institutions. KTL will a featured presenter as part of the technical agenda:

Preparing for U.S. EPA Inspections in Region 7
Tuesday, October 26
2:00 pm – 2:40 pm CT

In recent months, regulated facilities have experienced an uptick in U.S. EPA information surveys and multimedia inspections. KTL’s Becky Andersen will present guidance on steps you can take to prepare for inspections and minmize your risk of compliance findings and enforcment actions.

BioForward Wisconsin recently reached out to KTL to tell more of our story and to highlight how our company is helping to support the rapidly growing biotech/biohealth industry. Read our recent interview to learn more about KTL’s work with BioForward, its member companies, and the industry overall.