Author Archives: ricknelson

ToxStrategies scientists Dr. Rayetta Henderson, Kara Franke, Lauren Payne, and Dr. Allison Franzen have published an article titled, “Cannabidiol Safety Data: A Systematic Mapping Study” in Cannabis and Cannabinoid Research. This study is the first systematic map of the safety-related information available for CBD in the peer-reviewed literature and is part of an ongoing effort to establish a foundation for future research initiatives to support the determination of a safe CBD intake level for consumer use. The objective was to systematically map the publicly available safety-related literature for CBD, to provide a comprehensive overview of the current state of knowledge, assist in identifying data gaps and trends, and inform future hazard-based decision making. Available evidence was gathered and collated to demonstrate the current landscape of studies that report health outcomes to inform safety evaluation, as well as to identify outcomes or other subtopics that may warrant further research.

Several EpidStrategies scientists are among the collaborating authors of seven new studies on respiratory syncytial virus (RSV) published in a special supplement to the Journal of Infectious Diseases. The authors include Ms. Mina Suh, Ms. Naimisha Movva, Ms. Xiaohui Jiang, Ms. Heidi Reichert, and Ms. Lauren Bylsma, and the studies describe the morbidity and mortality burden of RSV among US-born infants and children under 5 years old.

RSV affects nearly all infants and children <5 years old. Our studies confirm that RSV is the leading cause of infant hospitalizations in the US. Even those born full term and otherwise healthy may be at risk of developing serious illnesses from RSV, including pneumonia. In addition, infants insured with Medicaid experience twice as many hospitalizations and emergency-room visits as privately insured infants, indicating potential health-care equity issues.

This journal supplement is the culmination of an ongoing research program that involved EpidStrategies scientists and academic and industry collaborators. Please contact Mina Suh (msuh@epidstrategies.com) for more information about this work.

The seven publications, listed below, are available from the journal via open access.

• Suh M, Movva N, Jiang X, Bylsma LC, Reichert H, Fryzek JP, Nelson CB. 2022. Respiratory syncytial virus (RSV) is the leading cause of United States infant hospitalizations 2009–2019: A study of the National (Nationwide) Inpatient Sample. J Infect Dis 226(Suppl 2):S154–S163, open access.
• Movva N, Suh M, Reichert H, Hitze B, Sendak MP, Wolf Z, Carr S, Kaminski T, White M, Fisher K, Wood CT, Fryzek JP, Nelson CB, Malcolm WF. 2022. Respiratory syncytial virus during the COVID-19 pandemic compared to historic levels: A retrospective cohort study of a health system. J Infect Dis 226(Suppl 2):S175–S183 open access.
• Suh M, Movva N, Jiang X, Reichert H, Bylsma LC, Fryzek JP, Nelson CB. 2022. Respiratory syncytial virus burden and healthcare utilization in United States infants, <1 year of age: Study of nationally representative databases, 2011–2019. J Infect Dis 226(Suppl 2):S184–S194, open access.
• Suh M, Movva N, Bylsma LC, Fryzek JP, Nelson CB. 2022. A systematic literature review of the burden of respiratory syncytial virus disease and health care utilization among United States infants younger than 1 year. J Infect Dis 226(Suppl 2):S195–S212, open access.
• Movva N, Suh M, Bylsma LC, Fryzek JP, Nelson CB. 2022. Systematic literature review of respiratory syncytial virus laboratory testing practices and incidence in United States infants and children <5 years of age. J Infect Dis 226(Suppl 2):S213–S224, open access.
• Reichert H, Suh M, Jiang X, Movva N, Bylsma LC, Fryzek JP, Nelson CB. 2022. Mortality associated with respiratory syncytial virus, bronchiolitis, and influenza among infants in the United States: A birth cohort study from 1998 to 2018. J Infect Dis 226(Suppl 2):S246–S254, open access.
• Bylsma LC, Suh M, Movva N, Fryzek JP, Nelson CB. 2022. Mortality among United States infants and children under 5 years of age with respiratory syncytial virus and bronchiolitis: A systematic literature review. J Infect Dis 226(Suppl 2):S267–S281, open access.

The ToxStrategies team is pleased to announce the addition of Ms. Amy Sheppard to our Food and Consumer Products practice. Ms. Sheppard has held increasingly responsible positions with multiple global consumer product manufacturers during her 30-year career, the latter third of which she spent with SC Johnson. Her roles have ranged from a summer intern to practicing scientist in product safety to middle and senior management positions, and her experience includes the use of data-driven risk assessments for products that need to achieve regulatory compliance. She has helped bring to market a variety of consumer- and professional-level products, including cosmetics, over-the-counter drugs, cleaning products, biocides, and pest control products.

In addition to her professional scientific roles, Ms. Sheppard serves her community as an Emergency Medical Technician for the local fire department. She is certified in Hazardous Materials Operations and provides instruction in CPR and general first aid.

The Reproductive and Developmental Toxicology Specialty Section of the Society of Toxicology recently awarded its Scientific Achievement Award to ToxStrategies Senior Consultant Dr. John Rogers. The Section presents this award annually to recognize a member’s lifetime contribution to the field of reproductive and developmental toxicology, including such factors as leadership, impact on the field, and mentorship. In presenting the award during the Section’s annual meeting, held virtually on May 3, Dr. Atlee Watson recognized Dr. Rogers’ career longevity, beginning with service in the EPA in the 1980s, as well as his active leadership in SOT and the RDTSS, and his role in numerous scientific panels, seminars, and continuing education initiatives.

ToxStrategies’ Senior Engineer/Industrial Hygienist Dr. LeeAnn Racz spoke on the topic of per- and polyfluoroalkyl substances (PFAS), delivering a keynote address to the National Conference of the Alliance of Hazardous Materials Professionals in March 2022. The widespread use of PFAS in many products and processes (e.g., electronics, textiles, lubricants, cookware, firefighting foams, and carpeting, to name a few) has resulted in global proliferation of these chemicals. The chemical and physical properties of PFAS vary widely, which leads to differences in their environmental persistence and potential for toxicity and bioaccumulation. Toxicology studies have reported harmful effects on animals, particularly at high doses, making PFAS a controversial topic among the public, regulators, and the scientific community. Dr. Racz discussed the evolution of perceptions and uses of PFAS over several decades and resulting trends in developing public policy, and she offered context for risk management.

Dr. Racz also made a technical presentation titled, “Embracing an Agile and Lean Six Sigma culture for worker health.” She discussed how process improvement frameworks have improved productivity, reduced waste, and increased quality in a variety of industries, concluding that occupational and environmental health safety (OEHS) professionals can strengthen their influence dramatically by empowering and enlisting participation from the workers they are charged with protecting.

Dr. Racz is a Board-Certified Environmental Engineer and Certified Industrial Hygienist with a background in environmental health and workplace exposure assessment. She completed a 23-year career with the U.S. Air Force before entering the consulting arena.

ToxStrategies scientist Dr. Kristina Ulrich, who practices in the United Kingdom, has been invited to serve on the selection panel for the UK Register of Toxicologists (UKRT), reviewing applicants for recognition as Registered Toxicologists. Established in 1993, the UKRT is sponsored by the Royal Society of Biology and the British Toxicology Society (BTS). Successful applicants are designated as UK Registered Toxicologists and are entitled to use the post-nominal “ERT” (EUROTOX Registered Toxicologist). Dr. Ulrich will initially serve a 4-year term on the selection panel, which consists of eight members representing a range of toxicological disciplines across academia, government, and the private sector. The panel meets three times each year, with two members reviewing each application.

Dr. Ulrich has held the UKRT+ERT designation since 2012. She currently serves on the BTS Education, Training and Career Development subcommittee, and her passion for toxicology career development in the UK has led her to play an active mentor role in the Society. Regarding her selection to the UKRT selection panel, she looks forward to “supporting the general activities of the UK network of toxicologists, as well as having an impact on the next generation of toxicologists joining the Register.”

A team of ToxStrategies and EpidStrategies scientists are authors on a manuscript being published in Regulatory Toxicology and Pharmacology. The study examines current practices for assessing risk associated with environmental exposure to hexavalent chromium, comparing approaches based on margin of exposure to those using linear extrapolation. The authors assert that regulatory lung cancer potency estimates for Cr(VI) are based on outdated research, whereas more current mechanistic data support an epigenetic role for Cr(VI) and a non-mutagenic mode of action. The article cites a need for new epidemiology data to inform risk assessment of low-intensity exposures, concluding, however, that Cr(VI) in ambient air poses little concern for human health.

ToxStrategies scientists have developed a range of plausible toxicity values for 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) based on application of systematic review methods and quantitative integration of dose response using meta-regression. This research is being published in the journal Toxicological Sciences and will advance risk assessments involving this class of compounds, providing important information to guide risk-based decision-making.