Bringing together almost 20 years of product litigation experience and decades of scientific expertise in the field of chemicals such as PFAS, the panelists will discuss the legal issues that companies are facing from current or legacy uses of PFAS (whether intentional or not) and practical solutions that can be taken pre-lawsuit to understand and minimize risk.
Frank Pagone, PhD, CIH
Frank Pagone has over 10 years of education, research, and EHS consulting. Dr. Pagone received his B.S. from Purdue University, his M.S. in Public Health – Industrial Hygiene and Ph.D. in Public Health from the University of Illinois at Chicago (UIC), and is certified by the American Board of Industrial Hygiene (ABIH) in the comprehensive practice of industrial hygiene (CIH). His graduate research topics included human health risk assessment including probabilistic risk assessment, exposure assessment and cancer risk analysis, spatial statistics, and Geographic Information Systems (GIS). He is also certified in Geospatial Analysis and Visualization with a focus on GIS.
Dr. Pagone provides support and execution of environmental health and safety services defining, analyzing, characterizing, assessing, and managing occupational and non-occupational risks to human health and the environment and conducts research of a variety of environmental health and safety topics. He has also consulted on data management and analysis including collection of population, health, employment, environmental risk/hazard, and housing data, taught a variety of topics including air and water quality and management, industrial hygiene, and statistics, and assisted with the evaluation of industrial point-source emissions to residential receptor sites in surrounding communities for purposes of assessing risk for both cancer and non-cancer endpoints.
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We work with our clients to develop solutions to their most pressing concerns. Understanding exposures and risks through a grounding in a sound, defensible, state- of- the- art scientific approach gives our clients peace of mind. Empowered by a comprehensive understanding of exposures we can provide, clients are better equipped to recognize previously unseen business risks, manage known risks, target areas for control systems, comply with regulations, and to be braced for regulatory or litigation actions. Senior staff have served as experts in front of stakeholders, public, workers, regulatory, and State and Federal courts.
Transcript: HB Litigation Conferences – PFAS Consumer Fraud Webinar (Nov. 2022)
PFAS Chemical / Chemical Bonds (3:15-4:51): PFAS Chemicals & Chemical Bonds
“They are a group of more than 9,000 manufactured chemicals that have been used in industry and consumer products since the 1940s. The carbon-fluorine bond is one of the strongest chemical bonds in existence. It is what gives PFAS chemicals the properties that make them useful and desirable for industry: making them boil water and stain resistant. PFOA or Perfluorooctanoic acid, and Perfluorooctane sulfonic acid (PFOS) for example are the two most widely used and studied chemicals in the PFAS group. These are considered long-chain PFAS, which is defined by having 6 or more carbons. And their counterpart, the short-chain PFAS, usually consist of 7 carbons or less, depending on their chemical make-up. Other classes of PFAS compounds that should be of interest and should be considered fluorotelomer alcohols (FTOHs), fluorotelomer methacrylates, and fluorotelomer acrylates, and arachidonic (arachibotic-cilic) acids; all of which have this bond relationship.
There is no single definition for a PFAS but the EPA’s working definition for PFAS is described in the agency’s National PFAS testing strategy is PFAS identifies chemicals with at least 2 adjacent carbon atoms where one carbon is fully fluorinated and the other is at least partially fluorinated.”
PFAS Uses and Exposure Pathways (4:52-5:50)
“PFAS chemicals are highly stable, soluble, and resistant to degradation in the natural environment. Which is why they are referred to as ‘forever chemicals’. They’ve been used in numerous materials find in our homes and workplace such as fire extinguishing archways-foams or atrics-lefts, food packaging, household products such as carpets, upholstery, clothing and other fabrics. Cleaning products, non-stick cookware, paints, varnishes, sealants, its been found in household dust and in personal care products. Current research has shown that people can be exposed to PFAS in numerous different ways such as working in occupations, firefighting, chemical manufacturing and processing, and drinking water contaminated with PFAS, eating certain foods that may contain PFAS such as fish, swallowing contaminated soil or dust or breathing air contaminated with PFAS”
PFAS Life Cycle/Fate & Transport (5:51-6:53)
“The diagram here provides a graphical representation of the cycle of PFAS throughout the environment. The primary sources of PFAs contamination includes manufacturing sites that produce PFA or use PFAS in the industrial process and release chemicals into the environment. This could be through wastewater discharge into surface water, through the municipal sewer system, or emissions into the air that can deposit into the waterways. PFAS chemicals or mixtures of PFAS chemicals have been detected in air emissions from facilities, wastewater from the industrial facilities and municipal sources, in the soil and water around firefighter training sites, groundwater surrounding landfills, and are sometimes found with no obvious source at all. So looking at this diagram you can see the progression from the industrial facilities in the way it can be incorporated into the water system and all different areas and ways in which it can fate and transport through the environment. Obviously there are numerous ways in which this can occur.”
Potential Health Implications (6:54-8:41)
“Research involving human subjects suggests that high levels of certain PFAS may lead to the following: increased cholesterol levels, decreased vaccine response in children, changes in liver enzymes, increased risk of high blood pressure or pre-eclampsia in pregnant women, small decreases in infant birth weights, increased risk of kidney or testicular cancer (PFOA). However the cause and effect relationship between these and PFAS has not been established and many of these are correlations and a lot of additional research is needed regarding these health effects. The EPA continues to conduct quite a bit of research pulling through a wealth of information on the website, tox information on their data base. Other federal agencies and academia industry are also continuing to review the growing body of research on PFAS.
Health effects associated with the exposure to PFAS are difficult to ascertain specifically for many reasons such as there’s thousands of PFAS with variant levels effect of toxicities, yet most of these are focused on a limited number of the better-known PFAS compounds, as I mentioned PFOS, PFOA. People can be exposed to PFAS in different ways and different stages of life, and the type and use of PFAS changes over time which can make it challenging to track and assess how exposure to these chemicals occur, how it will effect human health. Furthermore, the widespread availability of PFAS in the environment can also make it challenging to find a group in which exposure was minimal.”
PFAS Laboratory Analytical Methods (8:42-12:15)
“Scientists at the EPA and other agencies such as ASTM, ISO and FDA are developing analytical methods for a number of media for sampling, such as drinking water, groundwater, surface water, wastewater, and solids. Solids include sediment, bio-ota, bio-solids, which all of these research and standards can eventually become standard methods and research methods that can be used at the laboratory level. EPA’s developed, validated and published 3 methods to support the analysis of 29 PFAS in drinking water. That’s method 533, 537, and 537.1. EPA’s method 8327, published as final in August 2021, is designed for non-potable water, such as surface water, groundwater and wastewater. Published in August 2021, draft method 1633, closely resembles the analysis of PFAS by isotope dilution and can quantify 40-count ?? a wide range of solid ?? matrices. Keep in mind or just to consider this method of note, as it will likely replace laboratory specific SOPs, state and DOD guidance and methods once it does become a confirmed method.
Other test methods that have not yet gone through the agency rule making process, but are urgently needed to support agency initiatives so other test methods, being OTM, OTM 45 was issued in a draft in January 2021 by the EPA emission measurement center to promote consistency and best practices with sampling and analyzing PFAS stack emissions. PFAS pre-cursors are classic PFAS compounds that can degrade to terminal PFAS compounds or PFEAS under the right environmental circumstances. Total oxo dycical precursors or TOP ASA, which you may hear if you are observing or reading laboratory analytical methods across many different laboratories, oxidizes PFAS precursors most of which are compounds not currently measured by targeted techniques described above and turned them into terminal PFAS that can be measured.
Many laboratories have their in-house methods for determining the presence and level within landfill leachate, biosolids, non-aqueous liquids, AFFF, or consumer products. Which is also referred to as modified EPA method 537. This title is somewhat misleading because the drinking water method EPA 537 cannot itself be modified. The laboratories have created this modified method 537 designation as it takes on similar LCMS or similar scientific techniques to evaluate presence or absence of concentration within the matrices. In addition, there are also blood test available for PFAS which can be useful when they are part of a scientific investigation or health study. Its important to note that a blood test will not provide information to pinpoint a health problem nor will it provide information for treatment, it will not also predict to rule out development of future health problems related to PFAS exposure. It is a screening tool, it can be useful when used as part of a scientific investigation or health study.”
Detection and Quantitation (12:15-14:25)
“Detection limits and quantification and quantitation are two terms that will come up often when evaluation laboratory analytical techniques. Detection limits for instance are referred to as the minimum concentration of an analyte that can be detected. Quantification limits refer to minimum concentration of an analyte that can be measured within a specific limit or precision and accuracy. Two different terms taking on different, ultimately different reports.
In 2016, the EPA published a health advisory but not a regulatory standard on PFOA and PFOS where they established safe levels of chemicals in drinking water at no more than 70 parts per trillion. On June 15th of this year, EPA issued a term-updated drinking water health advisory for PFOA and PFOS that replaced those that the EPA-issued in 2016. Based on the current methods, the health advisory levels of PFOA and PFOS, are below the level of both detection, as I mentioned determining whether or not a substance is present, and quantitation the ability to reliably determine how much of a substance is present.
This means that is it possible for PFOA and PFOS to be present at levels that exceed health advisories even though the testing indicates no level of these chemicals is present.
EPA is continuing to conduct research and monitor advances in these testing technologies, methods and techniques to improve the ability to measure PFAS at lower levels. However, this is certainly an area of question and concern moving forward.
When evaluating non-detects – referred to in statistics as censored data – there’s really a number of approaches to consider, such as substituting the value from the non-detect, for example half the detection limit or using a statistical method called ‘maximum likelihood estimation’ or MLE. Each of these techniques and each of these evaluation procedures have their own advantages and limitations and should be considered before conducting any analysis.”
Testing Consumer Products (14:30-17:37)
“Many laboratories can conduct analysis using in-house methods to determine the level of PFAS within consumer products. The key to this process is to discuss the analytical method and materials with the laboratory based on the product you are testing as the testing options will influence the reported results. As I mentioned previously, labs have their own user-defined methods such as 537M to analyze PFAS and PFAS in products. They will also have their own detection limits, their own limits (inaudible) quantification, particularly if these methods are in-house developed methods. It is important to consult with the laboratory on what level of detection and level of concentrations they can arrive at following analysis. In addition to what procedures should be performed when preparing these materials. There’s quite a number of considerations to take into account when piecing these materials together when putting them into the appropriate sampling media or container as being PFAS is available in many different products, cross-contamination is a concern. Another way to avoid that process is to submit a blank or a control sample. AS I mentioned, many of these laboratories will have their own available procedures and well defined steps for the individual or company submitting the product to follow in order to avoid any of these issues. Some of the tests you may see generally with regard to these modified versions, including total fluorine test which measure all fluorine present in a sample, which this can be simple, it also measures inorganic fluorine which is also present in many products – calcium fluoride, sodium fluoride. So total fluorine testing is helpful for products that contain no ingredients within organic fluorine. Another consideration to make sure you speak with the lab about is cross-identification or things in which can be flagged as a fluorine chemical which is something that is not aligned with PFAS. Targeted analysts tests which are more focused determine the concentration of specific PFAS compounds results from targeted analysis can extremely be helpful to understand how PFAS are entering the supply chain. So that can allow the laboratory to identify in library of available PFAS compounds, to identify generally which compound is present in the material.
As an update to the standard, ASTM is in the process of organizing a subcommittee to develop standards that provide guidance on how to prepare analyze a wide variety consumer product samples for PFAS.”
PFAS Database Resources (17:38-19:29)
“For lists of currently identified PFAS chemicals, as I mentioned there are quite a few – up to 9,000 PFAS chemicals identified. The EPA has a few databases of chemical lists to reference if you’re looking to align the chemical with available data. CompTox Master List of PFAS chemicals is one chemical list and tiered testing methods, and ChemView is another, both of which are offered by USEPA. Additionally, the National Library of Medicine has an interactive database called ChemID Plus which can be used as a search engine and gather information on these chemicals. The information and databases are available to gather information. Unfortunately there are more chemicals that have more information generally, as I mentioned, the more highly studied PFAS – such as PFOS and PFOA – will likely have more information on them. Much less known PFAS chemicals may have limited information, so it is important to follow and search these databases for what’s available to help inform the background chemicals you have in your products.
In the changing scientific and regulatory landscape, its really important to stay abreast of the emerging science and developing federal actions related to PFAS. The regulatory and scientific landscape is rapidly changing and really has a wide range of implications.”
What is the scientific process a human health risk assessor may take to go from hazard identification to risk characterization? (46:13-47:32)
“In terms of simplicity, generally understanding, with my human health risk background and certainly my focused area of covering each areas of understanding the human health risk from all factors of a risk paradigm – high hazard identification, which is Step 1 – identifying whether the material or chemical is a hazard – how is this defined is also important. And then going into Dose Response, followed by Exposure Assessment which takes into account all different things that occur when it may become at the hands of the consumer such as frequency and duration of use, how often they may be exposed, and finally developing a Risk Characterization. Generally, in terms of the scientific process, going from hazard identification to ultimately risk characterization that’s the process that risk assessors or human health risk assessors will take from beginning to end, to of course, aligning with a threshold or health endpoint.
When it comes to identifying whether a substance is a hazard or not. I think that is a broad range or broad term that can be used. I think that is certainly up for understanding in terms of what is considered to be hazardous and how that goes into hazard – incorporating both acute and chronic, different layers of time – time is a factor in terms of what level of hazard it is. What health outcome indicates the level of whether it is a hazard or not. I think there certainly needs to be and there is an importance to have a strong definition on whether there is a hazard. And again, there really is, with it being such a general term – such as the potential for a substance or a (inaudible) activity to cause harm. That is about as general as it gets to determine whether something is hazardous. This certainly bodes for a more clear definition in terms of what that entails in terms of chemical exposure such as PFAS.”
Top Tier Defense Lines from PFAS-related Lawsuits: Hazard vs Risk (50:11-51:04)
“When it comes to hazard as a general term and as defined, going back to many properties of a chemical, which might be hazardous to the toxicity – flammability, corrosivity, many different factors at play – long term, short term exposure as well as you mentioned, specificity of the chemical itself. Many of these chemicals have a similar makeup in terms of that carbon fluorine strong-bond, but there are tails and chains and other chemical aspects that make them unique to serve certain properties that will also be important to consider when it comes to the overall risk.”
Laboratory analytical techniques and understanding the landscape (52:08-53:55)
“Truly understanding the landscape of chemical composition, chemical itself – if it is in the product as well as where in that process it is occurring – the testing impacts on reporting requirements. With regards to testing and analytical techniques. Working closely with the laboratory, if this is something you are considering, to gather information that ultimately can assist you in understanding where the concentration or detection lies with regards to the current requirements or current thresholds. Because it is a, and there are a wide variety of laboratories that offer their own in-house unique methods, consulting with the laboratories directly to understand what these methods can provide, what compounds they can analyze for because as I mentioned there’s approximately more than 9,000 different PFAS compounds and many of these analytical techniques are limited to a certain number of compounds that they’ve validated and there’s also non-targeted analysis techniques that are much more time intensive and costly. So I think one of the big takeaways there from a lab and analytical perspective is to understand what you’re looking for and speak with the lab directly on ways in which they can provide you with results and what were those levels would stand when they give you results – what chemicals they can look for, and so on and so forth.”
Regulatory Understanding (53:57-55:30)
“Regarding regulatory understanding, I think that’s also very important as we see the EPA roadmap progress form October last year to now, many different regulations have surfaced. And there’s been a strong push towards increasing the amount of regulations that are available. It is certainly important to keep up on those requirements. And within that roadmap not only are there are legal requirements and benchmark requirements that will need to be fulfilled, there’s also research arms of that roadmap that would be also important to keep in mind as they release more chemical-specific information on specific chemicals as the EPA itself dives into all the wealth of toxicological information that’s available. It’s two levels, not only the level of what regulations impact your company product – impact the supply chain, but also what is the health and risk information that is being pushed or at least being shared – keeping up on those, because those will of course have an influence on risk and regulation.”
International PFAS Regulations (59:19- 60:02)
“I do strongly suggest understanding regulations both in the United States and Internationally, and understanding what requirements the EEU has in relation to – specifically if you have International and Worldwide products. There are changing movements both here in the States, and I know I focused primarily on State level laboratory analytical techniques, minimally on the EU – but there is absolutely an importance on what they’re requiring and what they’re not requiring as well as what are required here in the States and how those align, specifically if your product cross borders.”
Pre-Cursers – the Ability to Transform (60:53-62:15)
“The environmental ability for a pre-curser to become a PFAS chemical in the environment. Yes, those are all considerations to evaluate. Understanding what chemicals could lead to that as well. So now you’re looking even deeper into the pipeline of chemicals that could eventually transform into PFAS environmentally and how to address those. I addressed an analytical technique called the TOPSA, which the goal to that is to in fact take the pre-curser and to create and ultimately convert to PFAS to evaluate the concentrations to the pre-cursers. There’s also research going on regarding pre-curser evaluation and pre-curser transformation. Yes, it is important to understand if there’s any transformation abilities and what is available scientifically on chemicals can make that transformation, and what these chemicals and the ability of these chemicals to transform.”
Considering Upcoming PFAS Standards to Minimize Future Risks (64:28-65:05)
“Certainly knowing there is a standard down the pipeline that is going to be developed is almost a preview of what’s to come. Although there is not direct instruction with regards to what that standard entail, knowing that one is coming, in evaluating the previous standards of a similar make-up may be worthwhile. Overall it is absolutely important to use the knowledge on forecasting potential standards, to prepare for the eventual release.”