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.

Get to know our KTL team! This month, we are catching up with KTL Senior Consultant and Partner Andy Smith.  Andy has over 10 years of experience providing project oversight, technical support, and IT solutions on a variety of EHS and engineering projects for a wide range of clients and industries. Andy is based out of our Madison, WI office.

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

I started working at KTL in 2011, mainly to support a large data gathering and management project. From there, I managed to prove myself useful in other areas and stuck around. Since joining KTL, I’ve worked on a wide variety of projects and developed plenty of IT skills, including SharePoint development, GIS, statistics/data analysis, etc. My primary areas of expertise these days would be leveraging those IT skills on projects involving asset retirement obligations (AROs), EHS and regulatory compliance, and general project management.

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

Most of my client work has been focused on the private sector, with the bulk of my current time spent with chemical manufacturing companies. However, I have also worked extensively with transportation and manufacturing companies.

Overall, the most common issue the clients I work with face is managing regulatory, environmental, and workplace safety risks while balancing the need to maintain and manage a productive company.

What would you say is a highlight of your job?

I enjoy working on a wide variety of projects and continuously improving the work KTL performs. Sometimes this will show up in doing a task more efficiently than we had in the past. Other times it might mean leveraging an IT platform like SharePoint or management system approach to make the work considerably more repeatable and manageable.

What do you like to do in your free time?

I bike a fair amount and play semi-convincing soccer regularly. Beyond that, my free time is consumed by books, random stuff, and hanging out with the cat.

Read Andy’s full bio.

The Food Safety Consortium Fall Edition is kicking off this October with five weekly sessions featuring critical thinking topics that have been developed for both industry veterans and knowledgeable newcomers. KTL will be a featured presenter during the Recalls: Trends and Analysis episode on Thursday, October 14:

How to Respond to Recalls
Thursday, October 14
1:10 pm – 1:55 pm ET (includes Q&A)
Presented by KTL Senior Consultant Roberto Bellavia