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In the United States, new chemicals are regulated by the US EPA Toxic Chemicals Control Act (TSCA), amended by the LCSA in June 2016. When a new chemical substance, as defined by the TSCA regulations is to be put into commerce there are specific data and information requirements for submittal and approval to the EPA. The EPA must in essence approve the commercial production of the chemical based on the data provided and the known uses, exposures, and releases for the product.

For the research phase of new chemicals, there are actually a number of regulatory exceptions in terms of hazard assessment, hazard communication, and provision of information in the more limited supply chain of research and development.

When a manufacturer moves to the point of gaining approval for commercial activity by submitting a Premanufacture Notification (PMN) for a new chemical, PS is evidenced in the PMN form. In Part II of the form, Human Exposure and Environmental Release, submitters have the opportunity to describe use and exposure conditions in their workplace as well as in the sites not controlled by them, specifically the customer or chemical user workplace. The more accurate and precise the information, the better the results of the EPA review can be. Doing a good job in understanding exposure and use can lower the potential for testing requirements or risk management controls such as a significant new use rule (SNUR). The applicable portions of the form are shown below. The PMN form requirements are found in EPA regulations, 40 CFR Part 723 (5).

In 2007, there were 10 countries around the world that had a similar form of chemical control regulation. In 2018, there were over 15 countries and regions. In addition to the United States, they are Australia, Canada, China, European Union, Japan, Korea, New Zealand, Philippines, and Switzerland.