Gradient scientists Drs. Isaac Mohar and Tom Lewandowski will present at the American College of Toxicology (ACT) 42nd Annual Meeting 2021 (Virtual).  Their poster presentation is titled, “Toxicology-Based Exposure Limits for Residual HEK-293T Cell DNA and Protein.”  Learn about the conference here.

The objectives of this research were:  (1) determine if the World Health Organization (WHO) limit of 10 ng of residual host cell DNA per dose can be applied to the HEK-293T cell lineage and (2) identify a toxicology-based limit for residual HEK-293T cell protein.

Gradient scientists will present at the Society of Environmental Toxicology and Chemistry North America 42nd Annual Meeting 2021 (Virtual).  Learn about the conference here.

Ifeoluwa A. Bamgbose will present a poster, “Microplastics in the Terrestrial Environment: Is there a real threat and risk?”  The objective of this poster is to assess the weight of evidence for microplastic biological effects in soil, biota, and other terrestrial matrices.

Thomas Lewandowski (Jiaru Zhang, Joel Cohen) will give a talk, “West Coast States and Taking Different Approaches to Alternatives Assessment.”  This talk will review California’s Safer Consumer Products (SCP), Oregon’s Toxic Free Kids, and Washington State’s Alternatives Assessment programs, including the key features of these three programs to understand their similarities and differences.

Charlotte Marsh (Kim Reid, Carrie Claytor) will present, “Looking Beyond the CAS Number: Considering Form Specificity in Hazard Assessment of Metals.”  This talk will present technical issues related to assigning form-specific hazards and opportunities to address challenges within current assessment tools.

Jiaru Zhang, Joel CohenThomas Lewandowski will present a poster, “Lessons Learned from Conducting Alternatives Analyses Under California’s Safer Consumer Products Program.”  This poster will share lessons learned and key recommendations after conducting the first two Alternative Assessments submitted under California’s Safer Consumer Products (SCP) program.

The California Department of Toxic Substances Control Approves the First Product to go through the
Regulatory Alternatives Analysis Process

The California Department of Toxic Substances Control (DTSC) has approved the preliminary alternatives analysis (PAA) for paint removers containing methylene chloride, which was authored by Gradient scientists.


Methylene chloride-based paint removers are the first product to go through DTSC’s groundbreaking regulatory alternatives analysis process.  The work involved gathering, scoring and comparing data on chemical hazard, exposure potential and product performance across several product formulation categories.  As this was the first product to go through the process, Gradient scientists had detailed conversations with Agency staff to help ensure that the submitted PAA could be approved by DTSC within the 30-day final review period.


In the PAA, Gradient identified at least one alternative paint remover formulation which will receive a more in-depth evaluation in stage two.  The deadline for that final alternative analysis report is December 2020.

Gradient conducted the work on behalf of several responsible entities who manufactured the product as of the effective date of the regulation. A copy of the PAA can be obtained from the CalSAFER website.

Gradient Experts:

Tom Lewandowski, Ph.D., DABT, ERT, ATS

Principal

Joel Cohen, Sc.D., DABT

Senior Toxicologist

Science and Strategies for Health and the Environment | www.gradientcorp.com

Scientific Integrity at a Glance

A tripartisan group from academia, business, and government joined together to author advice on scientific integrity, including paying more attention to transparency, supporting findings by publishing underlying data, and posting detailed methods, among other things, to overcome the rising distrust in science.

Scientific Integrity Issues in Environmental Toxicology and Chemistry: Improving Research Reproducibility, Credibility, and Transparency

In a “post-truth” world, where objective facts are becoming less influential in shaping public opinion (and policy) than appeals to emotion and personal belief, a group of industry, academic, and government scientists took it upon themselves to explore the topic of scientific integrity. Gradient scientists Mr. Mayfield and Dr. Verslycke contributed to this effort and co-authored an upcoming publication in the journal Integrated Environmental Assessment and Management, titled “Scientific Integrity Issues in Environmental Toxicology and Chemistry: Improving Research Reproducibility, Credibility, and Transparency.”

The authors describe scientific integrity as a set of norms similar to those taught from a young age:

Specifically, the authors describe how scientific integrity can be harnessed by high quality environmental research that is characterized by rigor, relevance, reproducibility, and objectivity and discuss each of these in more detail in the paper. The authors conclude with a number of actions that could be taken to maintain and improve a culture of scientific integrity, such as: scientific institutions should increase attention to quality management training; scientific journals should require that all supporting data of a published study be included and strongly discourage accepting studies that lack such data; science users should be discouraged from judging science solely on the basis of its funder and should instead maintain an open-minded skepticism; and professional societies should help foster respectful evidence-based dialog during meetings and support scientific integrity training seminars.

Kurt Herman has been appointed to the Editorial Advisory Board of Remediation Journal.

Kurt Herman is a licensed Professional Geologist in Washington state.

Technologically enhanced naturally occurring radiological material, or TENORM, has moved onto the regulatory and legislative agendas in multiple states. TENORM is material that contains naturally occurring radioactive elements, such as uranium, thorium, or radium, that have been concentrated or brought into waste streams as a result of human activities.

Although there is no national regulatory framework for handling TENORM, piecemeal regulatory updates by individual states have recently been promulgated as states have become aware of the potential presence of TENORM in waste streams from the energy, paper and pulp, phosphate fertilizer, and sewage treatment sectors. For example, legislative bodies in Pennsylvania and North Dakota have enacted new regulations pertaining to levels of radioactivity for the handling and disposal of certain TENORM wastes. Other states, such as Colorado, Kentucky, Montana, and West Virginia, are either in the process of gathering information or developing new regulations. The evolving regulatory landscape surrounding TENORM could potentially affect multiple stakeholders in various industrial sectors.

Evaluating the impacts of new or proposed regulations requires an understanding of the factors that generate TENORM in different types of waste as well as background levels of radioactivity. TENORM content can vary considerably depending on the waste source (e.g., pipe/tank scale, waste phosphogypsum, or combustion residuals). Moreover, consideration of local background radioactivity levels can be important for interpreting TENORM concentrations in those wastes at specific sites. Gradient has experience providing scientific comments on proposed regulations, evaluating the TENORM content of wastes, assessing radiological risks, and evaluating appropriate remediation alternatives. If you would like to discuss these issues further, please contact one of our scientific experts listed below.

Andrew B. Bittner, M.Eng., P.E.
Principal Scientist
abittner@gradientcorp.com
Thomas Lewandowski, Ph.D., DABT, ERT, ATS
Principal
tlewandowski@gradientcorp.com
Samuel A. Flewelling, Ph.D.
Principal Scientist
sflewelling@gradientcorp.com
Christopher M. Long, Sc.D., DABT
Principal Scientist
clong@gradientcorp.com
Kurt Herman, M.Eng., P.G.
Principal
kherman@gradientcorp.com
Matt Tymchak, M.S.
Senior Hydrologist
mtymchak@gradientcorp.com
 

Gradient is an environmental and risk sciences consulting firm renowned for our specialties in Toxicology, Epidemiology, Risk Assessment, Product Safety, Contaminant Fate and Transport, Industrial Hygiene, Geographic Information Systems, and Environmental/Forensic Chemistry. We employ sound science to assist national and global clients in resolving their complex problems relating to chemicals in the environment, in the workplace, and in consumer products.

Gradient is happy to announce that we are a Third-Party Profiler of EPA’s Safer Choice program, which helps consumers identify products with lower inherent hazard and more sustainable chemical ingredients.  Previously known as EPA’s Design for the Environment (DfE) label, the Safer Choice label may be found on many commercially available products used in households, schools, hotels, offices, and sports venues.  Some examples of Safer Choice-certified products include all-purposes cleaners, car-care products, carpet cleaning products, dish soaps, laundry products, odor removers, pet care products, window cleaners, floor care products, and many others.

If you are interested in displaying the Safer Choice label on your product, contact Gradient for information and a possible evaluation.  Gradient’s Safer Choice Third Party Profiler services contacts:

Kim Reynolds Reid
Principal Scientist
kreid@gradientcorp.com

Joel M. Cohen, Sc.D.
Senior Toxicologist
jcohen@gradientcorp.com

Learn more about the Safer Choice label at EPA’s website.

Gradient is an environmental and risk sciences consulting firm renowned for our specialties in Toxicology, Epidemiology, Risk Assessment, Product Safety, Contaminant Fate and Transport, Industrial Hygiene, Geographic Information Systems, and Environmental/Forensic Chemistry. We employ sound science to assist national and global clients in resolving their complex problems relating to chemicals in the environment, in the workplace, and in consumer products.

www.gradientcorp.com

Introduction

The Globally Harmonized System for Classification and Labeling of Chemicals (GHS) is a hazard identification (classification) and communication (labeling) framework that is currently being implemented around the world.  In the US, the implementation deadline is June 1, 2015 as promulgated in the OSHA Hazcom rule.[1]  Although a key objective of GHS is to “harmonize” hazard communication, it is not a regulation in itself and different countries or jurisdictions have modified and implemented  GHS principles based on their specific needs.  Furthermore, several elements of the GHS framework are subject to scientific interpretation.   It is therefore not uncommon for a chemical to be classified and labeled differently across countries and jurisdiction.  This poses several business challenges, including inconsistent communication of hazards to the consumer, as well as issues related to protecting confidential business information.

Despite these challenges, the GHS implementation offers unique opportunities for companies to build a comprehensive understanding of their chemical and product portfolio.  This can be leveraged into a robust product stewardship program that integrates GHS activities with emerging market demands for “sustainable” products.  Several non-profit organizations have taken this to heart and have developed “green” classification and labeling systems that are based largely on GHS principles.

The objectives of this two-part webinar series are to: (1) provide an overview of the GHS and key technical and business challenges associated with its implementation; and (2) provide an overview of business opportunities associated with the GHS implementation.  Overall, this webinar series is intended to explore the scientific, legal, and business implications brought on by the widespread implementation of GHS principles.

Module 1 – Introduction to the GHS and Challenges Associated With Its Implementation

Module 1 will provide a brief introduction to the GHS and how it is being implemented across various countries and jurisdictions.  Through various “mock” examples, we will illustrate how scientists may use the same data to arrive at different hazard conclusions. When ambiguous data lead to uncertain hazard conclusions, we will explore how a company’s risk philosophy may influence final hazard determinations. Module 1 will also explore the differences in GHS implementation across jurisdictions, as well as the legal and business implications with producing jurisdiction-specific hazards vs. maintaining a consistent hazard profile across all jurisdictions.  In particular, we will focus on how GHS assignments can affect the disclosure of confidential business information.