EPA’s PFAS Strategic Roadmap

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.

Poster for ACT discusses direct-to-brain pharmaceutical administration

ToxStrategies/21CT scientists are among the authors of a poster for the Annual Meeting of the American College of Toxicology, to be held virtually on November 10 through 19, 2021. The poster (by Amy Kimzey, Brian Welsh, and Marcie Wood) discusses the process of deriving exposure-based limits for impurities that might be encountered in pharmaceuticals for direct-to-brain administration and presents relevant case studies. The poster reviews three case studies—a salt, an alcohol, and an endogenous molecule—that exemplify the challenges of determining a limit for direct-to-brain administration routes.  Dr. Kimzey will be available live on Monday, November 15 from 3:30 to 5:30 EST for a Q&A regarding their findings.

 

New publication allays manufacturers’ concerns over ochratoxin A in coffee

 

A new article by ToxStrategies authors (available from the Journal of Food Science online ahead of print) looks at the potential for the naturally occurring mycotoxin ochratoxin A (OTA) in coffee to produce adverse effects in consumers through the lens of a food safety plan. The Food Safety Modernization Act (FSMA) names OTA among the listed chemical hazards that should be considered as part of a food safety plan, and animal studies have shown kidney toxicity, in particular, to rodents given high doses of it. The study by Melissa Heintz, Candace Doepker, Daniele Wikoff, and Scott Hawks is intended to assist food manufacturers by documenting best current practices to mitigate OTA in the context of its potential presence in coffee products, as well as the possible associated risk. Studying the peer-reviewed literature, food recall databases, and authoritative reviews, the researchers concluded that good agricultural practices and historical precedent indicate that no additional preventive controls are warranted for U.S. coffee manufacturers, based on low severity and likelihood of risk.

Dr. McMillan to present at Science Symposium

Dr. McMillan to present at science symposium

ToxStrategies Senior Consultant Dr. Donna McMillan will be among a distinguished panel of speakers in a Virtual Science Symposium sponsored by the Personal Care Products Council. The symposium will focus on “Current Issues in Safety Assessment,” and Dr. McMillan will draw on her 30 years of industry experience with safety evaluations of consumer products. Her work in safety assessment of botanical and natural substances (BNS) will inform her segment on BNS safety in consumer products.

The symposium takes place on October 26–27, 2021, and information and registration are available on the Council’s website.

 

Federal court upholds legality of GRAS self-determinations

The U.S. FDA and the food industry shared a victory as a federal judge dismissed a suit seeking to find unlawful the process by which companies have been allowed to determine, without notification to FDA, that a food or supplement ingredient is Generally Recognized as Safe (GRAS). Such self-determinations, in use for more than six decades, can exempt substances from pre-market review by FDA and had drawn the ire of (and a lawsuit from) the Center for Science in the Public Interest and the Environmental Working Group. Among other complaints, the lawsuit claimed that self-GRAS evaluations unlawfully subdelegate FDA’s duty to ensure food safety, exceed the FDA’s statutory authority, and violate the Federal Food, Drug, and Cosmetics Act. The decision by Judge Vernon Broderick, of the Southern District Court of New York, effectively ends the litigation (although further appeal is possible), leaving the self-GRAS regulatory framework in place.

ToxStrategies to Chair and Present at SETAC Session on Environmental Justice

The Society of Environmental Toxicology and Chemistry (SETAC) will have its SETAC North America 42nd Annual Meeting (also known as SciCon4) this year on November 14–18. Dr. Bill Rish of ToxStrategies will chair a session titled “Environmental Justice: Methodologies to Incorporate Environmental Justice into Human Health Risk Assessment.” The conference will be virtual, and the session presentations will be available on demand. In addition to chairing the session, two of the nine presentations will be given by ToxStrategies scientists, including:

Dr. LeeAnn Racz  

Exposure Monitoring Toward Environmental Justice

Dr. Bill Rish and Ms. Ann Verwiel

Quantitative Methods for Environmental Justice in Human Risk Assessment: An Overview

Other topics include:

  • EPA’s new guidelines for cumulative risk assessment (CRA), presented by Lawrence Martin, EPA’s leader of CRA guideline development
  • Epidemiology data and methods for vulnerable groups
  • Vulnerable group-specific exposure factors
  • Minnesota’s cumulative air pollution risk model to investigate Environmental Justice
  • Contribution to vulnerability from climate change, extreme events, and water access
  • Incorporating Environmental Justice issues into environmental research needs

Dr. Rish and Ms. Verwiel will also moderate two 50-minute live sessions Tuesday, November 16th starting at 9:30 am PST, wherein session speakers will discuss four key questions:

  1. How can non-chemical stressors, subpopulation susceptibilities and vulnerabilities, and chemical exposures be combined in a quantitative risk assessment? Or can they?
  2. Can quantitative metrics and measures be developed to help decision makers determine whether risks are equitable and acceptable?
  3. Given past environmental justice shortcomings, what is the appropriate role for quantitative risk assessment in making environmental decisions such as siting, discharge limits, air and water quality standards, or regional planning/prioritization?
  4. What are the priority data and research needed to improve the use of risk assessment and epidemiology to support equitable environmental decision making?

 

New publication in BJC on multi-cancer early detection genomic blood test

A recent article by EpidStrategies scientists Dr. Sarah Cohen and Ms. Heidi Reichert, with co-authors from academia and industry, examines a new type of cancer screening that portends a potential paradigm shift in detecting multiple forms of cancer with a single blood test. Multi-cancer early detection (MCED) tests have the potential to greatly improve screening efficacy, to lower the overall cost of follow-up testing by reducing the number of false positives, and to provide early detection of more than 50 types of cancer, many of which have no currently recommended screening tests. This publication demonstrates that MCED test technology added to current cancer screening guidelines may greatly increase the number of cancers detected without a large increase in false positives—all at a relatively low cost per cancer diagnosed. The British Journal of Cancer has made the paper available via open access, along with a corresponding blog piece by the first author, Dr. Allan Hackshaw, of University College London.

Dr. Joe Francisco elected as ACT vice president

ToxStrategies scientist Joe Francisco has been elected to serve as president of the American College of Toxicology (ACT). Beginning December 1, 2021, he will serve one year each as vice-president, president-elect, president, and past president. Dr. Francisco is part of  ToxStrategies’ Biopharmaceutical/Pharmaceutical Practice and has more than 25 years of experience in drug development, from early discovery through preclinical development.

ACT has a diverse membership including scientists in the consulting field, academia, regulatory agencies, and the pharmaceutical and biotech industries. The mission of ACT is to “educate, lead, and serve professionals in toxicology and related disciplines by promoting the exchange of information and perspectives on applied toxicology and safety assessment.”