New Chemicals and Existing Chemicals

Why does EPA regulate a new chemical and not a similar chemical already on the market? This issue is sometimes referred to as a "new chemical bias." Generally, it is a question of the standard EPA must meet before it can take a regulatory action. Before 1976, there was no comprehensive chemical law like TSCA to require the review of new chemicals. Under TSCA, industrial chemicals in commerce in 1975-1977 were "grandfathered" into the Inventory without considering whether the chemicals were hazardous. Once on the Inventory, a substance is considered an "existing" chemical and for EPA to control its use, a legal finding has to be made that the chemical will present an unreasonable risk to human health or the environment. This is a standard which requires EPA to have conclusive data on that particular chemical. By comparison, newly introduced chemicals can be regulated under TSCA based on whether they may present an unreasonable risk and this finding of risk can be based on data for structurally similar chemicals.

This difference can result in situations in which existing chemicals (often of similar or greater toxicity) might not be controlled whereas the Agency would act to control a similar new chemicals under the PMN program. EPA continues to work to lessen this apparent inequity between its regulation of new and existing chemicals. This lack of controls on the older chemicals may cause a misunderstanding that, because there are fewer (or no) requirements, they are considered safer than the new, regulated chemicals.

EPA deals with the concerns raised by existing chemicals through seeking testing which can enable management of the concerns (this work is discussed more fully at the home pages of the Chemical Information and Testing Branch, (CITB) and the Existing Chemical Program). CITB estimates that, of the 70,000 chemical substances on the Inventory, approximately 15,000 are in commerce at this time. In its Existing Chemical Program, EPA screens and selects from among the 15,000 chemicals in commerce those which appear to be of greatest concern to human health and the environment. The Agency then uses a variety of approaches to reduce risks from chemicals that appear to pose problems. Besides the possibility of rules promulgated under Section 6 of the TSCA, these approaches include voluntary agreements, alone or in combination with regulatory approaches; regional, federal, state and local partnerships; dissemination of risk management information to assist the selection of safer substitutes; emphasis on pollution prevention and innovative control technology to reduce exposure and environmental release; use of chemical emission data from the Toxics Release Inventory (TRI) to help address site-specific chemical concerns; refined risk assessment and cost/benefit analysis; and the challenge to industry to meet its own Product Stewardship and Responsible Care goals.

A current voluntary mechanism EPA, with industry partners, is using to respond to concerns on proper balance in its regulation of new and existing chemicals is the Environmental Technology Initiative for Chemicals (ETI), more fully described in its own page. ETI seeks to reduce barriers to innovation in the development of new chemicals by extending new chemical protections to analogous existing chemicals. This effort depends on agreements, entered into as partnerships/MOU with concerned industry. It can take note of innovative control technology, benefits conferred by the chemicals, and/or industry agreement to extend some protection to all members of a class in acceptance of PMN for a new member of that class.

New Chemicals and Existing Chemicals

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