April 2023

How to Save Time & Money in Regulatory Response? Enter Study Management.

Regulations. For those working with chemicals, compliance with regulations and appeasing their respective regulatory agencies is an ongoing and expensive part of today’s business world. Concerns over a chemical’s impacts on humans or ecological effects can compound a regulatory response and lead to the need for scientific studies. These studies may originate with the responding business or be requested from regulatory agencies, such as EPA, FDA, REACH, and PMRA, to fill in data gaps for chemical registration. As anyone who works within the regulatory world knows all too well, studies can quickly escalate in terms of time, effort, and, most notably for business, cost. Fortunately, there is a way to mitigate regulatory costs through an innocuously named and underused step: study management.

Savvy scientists and regulatory managers reduce their business risk (and headache) by employing study management practices while developing an overall regulatory strategy. This single decision can save a business significant money while preventing unnecessary delays, particularly when working in multiple locations and dealing with agencies globally. It may sound overly simple, but study management is more than monitoring work within a laboratory or out in the field; proper study management elevates the process to a strategic level by evaluating the need for data, identifying gaps within both the work and regulatory submittal, and determining if there is any supplementary information that can take the place of a laboratory study. It’s by identifying those gaps that study management creates the ability to negotiate agency waivers and prepare position statements, while saving:

Cost: Whether it is through successfully securing waivers or by avoiding duplicate or unnecessary studies, proper study management is a boon to the bottom line. An experienced study manager can look at the data and, much like a CPA poring over an individual’s taxes, find opportunities that will save money and streamline the submittal process. Should a study be warranted, having a study manager who has a finger on the pulse of laboratory availability, pricing, and expertise will save a business time and money during the data development stage all the way through to recommendations for study placement.

For example, the EU’s recent move to ban animal testing has impacted the pharmaceutical, veterinary sciences, health and beauty and many other industries. Without the use of laboratory animals, the question has been, “how are businesses going to introduce new chemicals/uses and show their new drug/products’ effects”? Our own study management team has been able to satisfy regulatory requirements by employing a combination of tools that have included literature reviews and evaluation of structural analogs through modeling. By combining available tools with strategically written positioning papers, no animals are harmed and viable compliance results are gained at a significant savings.

Time: As the saying goes in business, time is money, and the costs associated with long-term studies can quickly add up. An expert study manager can look at data and identify an opportunity to streamline or waive-off the regulatory request.

For example, let’s consider a manufacturer with an agency request for a 2-year, multi-generational fish study. The estimate for conducting this study is upwards of $500,000, not to mention the costs associated with the delay in getting their product to market. Rather than waste that time and money, our study managers suggested... Read the Full Article >>

Digital Surveys on the Farm and in the Environment

Data. Where would our modern world be without its constant stream of information available any time of day? The knowledge data provides is vital to answering science questions of today, particularly when we consider the farm and surrounding environment where data can be used to:

Aid researchers with environmental questions related to water quality, air quality, biodiversity, and climate change.
Support growers with management decisions that can improve production on their farms and increase profitability.
Help farmers and stakeholders select best management practices (BMPs) that support soil and water stewardship goals.
Assist scientists with improving environmental risk assessments.

The classic data collection process has to be a survey which have traditionally been conducted on paper, making for a less reliable outcome. Modern technology has come to the rescue in the form of mobile and desktop applications that can collect digital surveys from any device (i.e., phones, tablets, and computers), record locations using GPS, collect photos, support offline data collection in areas with poor cellular service, and require little training to use. The data captured via these channels is immediately available online, where results... Learn more >>

Every day is Earth Day at Waterborne

This past Saturday, April 22nd, saw the world celebrating Earth Day, a time set aside to reflect on and work toward a more environmentally friendly life. At Waterborne, we treat every day like Earth Day. One could say that our very existence supports the Earth Day mission! In addition to recycling, limiting single-use products, and making overall greener choices, our team daily supports the Earth by:

Providing monitoring to assess water quality and potential pollutants in waterbodies
Evaluating potential mitigations for their product to ensure safe use for the environment
Through modeling and GIS, evaluates potential exposure and/or risk to endangered species
Through regulatory compliance as well as stewardship, ensure products used on crops, animals, or down-the-drain, don’t harm the environment
Provide analysis of ecotoxicity studies to generate ecotoxicity endpoints for aquatic and terrestrial species

Join Waterborne Environmental at the upcoming SETAC Europe conference from April 30th through May 4th, 2023 in Dublin, Ireland! We're sending a cotillion of experts who will present short courses and papers (below), and meet with colleagues within the industry. Waterborne's Amelie Schmolke, Brenna Kent and Amy Ritter will all attend EU SETAC in person.If you'd like to set up a meeting, please contact Waterborne's SETAC lead, Amy Ritter, at rittera@waterborne-env.com @waterborne-env.com.

See complete details, including times, locations, and abstracts for the below here.

Waterborne Talks

Model Simulations of UV Filter Exposure to Marine and Freshwater Organisms Authors: Brenna Kent*, W. Martin Williams, Todd Gouin, Raghu Vamshi, Scott Dyer, Nicola Hefner, Eva Klingelmann, Sascha Pawlowski and Amelie Ott

The effect of alternative synthetic hydrographs when quantifying pesticide mitigation efficiencies with VFSMOD in exposure assessments. Talk Authors: Rafael Muñoz-Carpena*, Robin Sur, Stefan Reichenberger, Stephan Sittig, Amy Ritter

Waterborne Posters

Water Stress from Future Climate Changes and Modeling Impacts to the Environment from Consumer Product Chemical Exposure in the United States and Europe. Authors: Brenna Kent*, Raghu Vamshi, Jennifer Crider, Scott Dyer, and Andrea Carrao

Spatial Analysis on the Distribution of Sunscreen Use Patterns from Consumer Surveys Across the United States. Authors: Nick Guth, Andy Jacobson, Brenna Kent*, Scott Dyer, and Andrea Carrao

Solitary Bees and Pesticide Exposures: A Model Approach Authors: Amelie Schmolke*, Nika Galic, Vanessa Roeben, Thomas G Preuss, Mark Miles, and Silvia Hinarejos

Comparison of regulatory waterbody models Authors: Amy Ritter* and Mark Cheplick

Application of a spatially resolved model to refine exposure assessment of down-the-drain chemicals in European rivers Authors: Chiara Maria Vitale*, Susan A Csiszar, Raghu Vamshi, Brenna Kent, Michaela Koopmans, Diederik Schowanek, Ping Sun and Kathleen McDonough

Towards a virtual mesocosm for pesticide risk assessment: a comparison of four models applied to mesocosm data Authors: Chiara Accolla, Amelie Schmolke*, Nika Galic, Steven M. Bartell, Daniel Dawson, Klaus Peter Ebke, Jana Gerhard, Ann-Kathrin Loerracher, Isabel O'Connor, Laura Mudge, Robert Pastorok, Damian V Preziosi, Brandon Sackmann, Juergen Schmidt, Nele Schuwirth, Tido Strauss and Roman Ashauer

Use of hybrid ecosystem/IBM models to mimic outdoor aquatic mesocosms for pesticide risk assessment Authors: Tido Strauss*, Natalie Carmen Dallmann, Josef Koch, Juergen Schmidt, Chiara Accolla, Amelie Schmolke, Nika Galic and Roman Ashauer

Towards a Virtual Mesocosm: Using the CASM-cosm to Assess Pesticide Risks Authors: Steven M. Bartell, Chiara Accolla, Amelie Schmolke*, Cindy Woodard, Peter Ebke, Nika Galic and Roman Ashauer

Waterborne Environmental is a renowned consulting firm that has provided innovative solutions to the world’s most complex environmental problems since 1993. Our experienced, unbiased scientists and engineers work across industries to evaluate environmental, ecological, and human risks. Our work spans across industry and regulatory agencies to support the balance in the needs of a growing population with the environmental impact on our valuable natural resources.

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