Author Archives: ToxStrategies

ToxStrategies congratulates our President and co-founder Dr. Laurie Haws on being elected Vice President-Elect of the Society of Toxicology (SOT)! Dr. Haws and the full slate of newly elected officers and committee members will begin their terms on May 1^st. SOT, founded in 1961, is a professional and scholarly organization of scientists from academic institutions, government, and industry, representing the great variety of scientists who practice toxicology in the US and abroad. Dr. Haws is passionate about the Society’s mission to create a safer and healthier world by advancing the science and increasing the impact of toxicology. She is a graduate of the Curriculum in Toxicology at the University of North Carolina at Chapel Hill, a Diplomate of the American Board of Toxicology (DABT), and a Fellow of the Academy of Toxicological Sciences (ATS). Dr. Haws has more than 30 years of experience in the areas of toxicology, human health risk assessment, risk communication, and scientific and regulatory policy.

ToxStrategies is pleased to announce that the following scientists are running for leadership positions in the Society of Toxicology (SOT):

• Laurie Haws – Vice President, SOT Council
• Lauren Brown – Vice President for the Sustainable Chemicals Through Contemporary Toxicology Specialty Section
• William Klaren – Secretary/Treasurer for In Vitro and Alternative Methods (IVAM) Specialty Section and Junior Counselor for Regulatory and Safety Evaluation Specialty Section (RSESS)
• Rayetta Henderson – Councilor for Food Safety Specialty Section
• Allison Franzen – Junior Councilor for Food Specialty Section and Junior Councilor Mixtures Specialty Section
• Jon Urban – Treasurer for the Carcinogenesis Specialty Section

Ballots are due by Feb 1, 2022.  We wish them all good luck in the upcoming elections!

An emerging class of chemicals of great interest is PFAS, short for per- and polyfluoroalkyl substances.  PFAS have been used for decades in packaging and textiles to help repel water, oil/grease, and stains. Recently, reports have emerged indicating that PFAS may migrate from containers at low levels into the product being contained. This, along with the apparent widespread use of PFAS, has resulted in growing concern about the possible public health risks associated with using products from packages or containers that may contain measurable PFAS. These concerns are magnified by reports that some PFAS has been detected in humans and the increasingly low regulatory limits, (i.e., parts per trillion) that have been proposed to date.

ToxStrategies has supported a variety of clients in assessing exposure and risk from PFAS, including those associated with containers and packaging. Through this work, our scientists have developed expertise in PFAS toxicology, test plan preparation, and critical evaluation of data related to migration of PFAS from packages and containers into products.  We have assessed the potential for health risk from exposure to PFAS based on a wide variety of conditions of use in industrial, commercial and residential products and used available biomonitoring and biological fate data to inform perspective and understand trends. We are also knowledgeable about federal, state, and European Union PFAS regulations and standards; laboratory methods for analyzing PFAS migration in various matrices; and PFAS environmental fate and transport processes.

A new publication presents an overview of a Toxicology Forum virtual workshop held in December 2021, titled, “Assessing [chemical] carcinogenicity: Hazard identification, classification, and risk assessment.” This state-of-the-science workshop looked at the issue of re-examining long-standing test methods and risk assessment approaches based on new understandings. With the US EPA currently updating its guidelines (including the 2005 Guidelines for Carcinogen Risk Assessment), the workshop allowed national and international experts and stakeholders to exchange information and ideas regarding revisions to these guidance documents, looking toward the next steps in modernizing the techniques of carcinogenicity identification and risk assessment.

In the open-access article in Critical Reviews in Toxicology the authors acknowledge that no single new approach method (NAM) is likely to replace the widely used rodent chronic bioassay, and therefore, “activities to combine NAMs into integrated approaches for testing and assessment, or preferably into defined approaches… that include data interpretation procedures, were identified as urgent research needs.”

Dr. Chad Thompson presented a case study involving hexavalent chromium during the panel discussion on mode of action. In addition, ToxStrategies Managing Principal Scientist Dr. Laurie Haws currently serves as Vice President of the Toxicology Forum and will move into the role of president during 2022.

ToxStrategies is pleased to announce that Managing Principal Scientist Dr. Laurie Haws has been accepted as a Fellow of the Academy of Toxicological Sciences (ATS).  This honor represents a significant milestone in the development of Dr. Haws’ career in toxicology. To be recognized as a Fellow by the Academy, one must have an exemplary record of professional accomplishment, as well as extensive evidence of recognition by peers of competency and sound scientific judgment in toxicology, as reflected by appointment or election to councils, committees, etc. Dr. Haws has more than 30 years of experience in the fields of toxicology, human health risk assessment, and safety assessment and is a co-founder of ToxStrategies, Inc. Please join us in congratulating Dr. Haws on this accomplishment.

ToxStrategies scientists Drs. LeeAnn Racz and Bill Rish have published a Brief Communication titled, “Exposure monitoring toward environmental justice,” in the journal Integrated Environmental Assessment and Management. The paper discusses the need (in light of a Biden Administration Executive Order) to enhance risk assessment methods and exposure monitoring techniques to more explicitly address issues of environmental justice, such as the interaction between chemical exposures and nonchemical stressors, that can affect individual communities, even down to the neighborhood level. The authors suggest using enhanced monitoring with personal and portable sensors and deploying internet-linked sensors, as well as forming community partnerships and thoughtfully managing big data to inform community decision making. In addition to being published in the journal, Dr. Racz will present this work at the North America annual meeting of the Society of Environmental Toxicology and Chemistry (SETAC), to be held virtually November 14–18, 2021.

EPA has proposed a rule requiring companies to report their use of PFAS, which will affect a vast number of entities. As proposed, the rule requires businesses that import, process, or manufacture PFAS to detail these uses for the past 10 years (back to 2011). Information to be reported includes chemical identity, environmental and health effects, volumes processed and manufactured, worker exposure, categories of use, disposal, and by-products. No exceptions are expected to be allowed for small businesses, or for by-products, impurities, or substances formed during product use or aging. The comprehensive reporting requirement could be particularly burdensome to entities that have not previously been required to document or report usage of various substances. The rule was proposed in June 2021, with the public commenting period ending in September. The final rule is anticipated soon.

ToxStrategies has extensive expertise in assessing PFAS environmental and human health exposures, hazards, and effects. We are ready to partner with you in navigating this new and far-reaching rule.

In EPA’s newly released PFAS Strategic Roadmap:  EPA’s Commitments to Action 2021-2024, EPA details its planned efforts over the next 3 years to address per- and poly-fluoroalkyl substances (PFAS), which are ubiquitous in the environment and present in a wide variety of products used around the world. The roadmap describes EPA’s plans to reduce the presence of PFAS in the environment and decrease human exposures. This approach will account for the life cycle of PFAS, to include preventing PFAS from entering the environment, as well as requiring responsible parties to fund cleanups. The roadmap also specifically targets two legacy PFAS compounds—PFOA and PFOS—by adding them to the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) list of hazardous substances and developing drinking-water maximum contaminant levels (MCLs). These actions are expected to have significant impacts on many industries, such as manufacturers, drinking-water providers, and wastewater dischargers. EPA’s PFAS strategy focuses on three central themes:

• Research. The roadmap has a goal of better understanding PFAS toxicities and exposures, effects on human health and the environment, and the best treatment and control technologies. EPA also seeks to understand the contribution of PFAS to cumulative impacts in areas with environmental justice concerns.
• Restrict. The EPA is adopting a comprehensive whole-of-agency approach to prevent unsafe entry of PFAS to land, water, and air. Interactions among statutory authorities will be coordinated to manage and prevent exposures of consumers and workers to PFAS.
• Remediate. The strategy includes expanding and advancing PFAS contamination cleanup to protect human health and the environment.

In addition, EPA will revisit past regulatory decisions related to PFAS and determine whether they are sufficiently protective. The agency is addressing PFAS compounds individually and as groups or classes. Because there are thousands of PFAS compounds in use and in the environment, addressing them as classes, instead of individual chemicals, is expected to ameliorate PFAS impacts more quickly. EPA intends to publish their PFAS testing strategies and priorities soon, with PFAS manufacturers performing and funding the studies. Increased regulation of individual PFAS and PFAS classes will likely have far-reaching impacts on businesses and industry.

ToxStrategies’ knowledge of PFAS and EPA’s path forward can help companies prepare for the ever-changing PFAS regulatory and scientific landscape. Many new and changing requirements will affect a wide variety of businesses and industries, and ToxStrategies is ready to be your partner in helping to understand and mitigate risk.