Issue link: https://iconnect007.uberflip.com/i/1537616
JULY 2025 I PCB007 MAGAZINE 37 Congress's recognition that the public has a right to know more about chemicals in products. The availability of high-quality stud- ies impacts EPA's evaluation of chemical substances under TSCA Section 6 and consequent risk management regulations. Innovators seeking to com- mercialize new chemicals under TSCA Section 5 are at a severe disadvantage if they lack chem- ical and exposure data. The absence of these data results in the imposition of conservative risk assumptions and multiple safety factors during new chem- ical review that make operating conditions less competitive. REACH is premised on simi- lar principles. Under REACH, the greater the production volume, the greater the data burden as a regulatory predicate to mar- keting the chemical. REACH-like laws around the globe are pre- mised on the same principles, creating a regulatory imperative to know more about a chemi- cal's hazard and risk profile as a prerequisite to commercializa- tion. Generating new data is not always necessary, as it's possi- ble to leverage read-across and chemical analogue analysis to fill data gaps. What is no longer acceptable is the adage "What you don't know can't hurt you." Emerging product stewardship principles require manufacturers of industrial chemicals and arti- cles alike to understand the tox- icological, environmental fate, and exposure implications of their products. Incomplete prod- uct profiles translate into product liability, commercially adverse inferences regarding risk poten- tial, and mistrust in commercially significant constituencies like customers, workers, regulators, and neighbors. Savvy companies are conduct- ing data gap analyses for criti- cal products and key chemical components in them and volun- tarily generating defensive data. The availability of these data for- tifies advocacy opportunities in product liability disputes, ful- fills product stewardship com- mitments, and holds entities accountable to answer ques- tions key stakeholders are likely to ask if things go south. This is smart. While facts and science may not always win over juries, defendants have a much stron- ger case when they support their arguments with data. What to Do Now Smart businesspeople are taking stock of their chemical product inventories and critically assess- ing their options. Here are a few to consider: Conduct a data call-in: Com- panies need to know what data they own or have access to through data sharing agree- ments. Trade associations can assist by managing these efforts to ensure they efficiently iden- tify unpublished studies to pres- ent a comprehensive compos- ite overview of a chemical's data, use, and exposure information unique to a commercial sector. Use a lawyer in this exercise to carefully navigate confidentiality claims, competition issues, and related legal sensitivities. Curate data prudently: Com- panies and trade associations must carefully curate existing data to preserve confidential- ity and maximize value. Develop standard operating procedures to routinize these protections and observe them. Prepare data sharing agree- ments to leverage data: To mon- etize data effectively, entities that need to rely on it must be able to access the data and pay fair data compensation. Data sharing agreements should spell out the rights, duties, and obli- gations of the contracting par- ties. Compensation mechanisms need to be standardized. Develop data smartly and carefully: There are many rea- sons to generate chemical data. It is critical that a decision to do so, whether by a company or jointly by a consortium, is based on a review of global regula- tory and testing protocol require- ments. Satisfying Good Labora- tory Practice (GLP), Organization for Economic Co-operation and Development (OECD), and other testing requirements is challeng- ing but essential. It is a brave new world, fueled increasingly by chemical data. Like any asset, it's essential to manage these data smartly and generate new data carefully. These politically agnostic facts are true globally. Start now to embrace them and plan accord- ingly. PCB007 Lynn L. Bergerson is the owner and managing partner of Bergeson & Campbell, P.C., president at The Acta Group, and B&C Consortia Management.