Reviewing New Chemicals
One of the targets in "Goal Four" in EPA's Strategic Plan is to ensure that new chemicals introduced into commerce do not pose unreasonable risks to workers, consumers, or the environment. The plan foresees this target being met by 2011.
Under the Toxic Substances Control Act (TSCA), EPA uses its traditional regulatory authorities to control or keep potentially hazardous new chemicals out of the market. EPA's New Chemicals Program (NCP) is one of the Agency's premier risk management programs, and serves a key gatekeeper function.
Specifically, under TSCA Section 5, EPA must be given notice before a new chemical substance can be manufactured or imported into the United States. This pre-manufacture notice (PMN) must be submitted at least 90 days prior to the manufacture or import of the chemical.
The New Chemicals Program reviews submissions to determine if any of the chemicals warrant prohibiting or limiting their manufacture, processing, or use. Because many PMNs include little or no toxicity or fate data, the program uses several risk screening approaches to facilitate assessment in the absence of specific data. This enables rapid evaluation of potential risks and making risk-management decisions for the new chemicals within the 90-day timeframe prescribed by TSCA.
More information on the New Chemicals Program.
- A total of 1,724 valid Section 5 notices were received from January 2007 through June 2008. The majority of the submissions were pre-manufacture notifications (PMNs) with 1,071 received during this time period. The next largest group was low-volume exemptions with 630 received during this time period. The remaining notices were Low Release and Exposure (LoREX) Exemption notices and Test Marketing Exemption (TME) notices.
- The NCP's P2 Recognition Project recognizes, through an annual award, innovative new chemical submissions that are inherently safer than those currently in use and that reduce sources of pollution. The program is especially interested in promoting chemistries that substitute for existing chemicals that pose greater risks. The P2 Recognition Project honored three companies in 2007 that provided new, less polluting, innovative chemistries and processes:
- An innovative approach is encouraging companies to "pre-screen" their chemical submissions: Those who submit low-hazard, low-risk new chemical notices may receive an expedited review, if they have pre-screened the chemical for hazard and risk concerns using the Sustainable Futures (SF) models.
From January 2007 through June 2008, in EPA's New Chemicals Program 114 PMNs were "self-assessed" using Sustainable Futures models, which accounted for approximately 11 percent of the 1,071 PMN submissions received during this period. More than 56,000 chemicals were screened using the PBT Profiler during this same period of time. The PBT Profiler, one of the Sustainable Futures models, estimates potential for persistence, bioconcentration potential in the environment and aquatic toxicity, and warns users when the PBT characteristics exceed Agency PBT criteria. The PBT Profiler can be used to evaluate both new and existing chemicals.
- From January 2007 through June 2008, 22 new chemical submissions for nanoscale materials were submitted to and reviewed by OPPT or are in the review process. Nanoscale materials are chemical substances at dimensions of roughly 1 to 100 nanometers that may have novel properties that enable applications that differ from the same materials at a larger scale. To assist potential PMN submitters, EPA has developed a document, TSCA Inventory Status of Nanoscale Substances-- General Approach (2008) (PDF) (7 pp, 37K, About PDF), describing EPA's current thinking regarding whether a nanoscale material is a "new" or "existing" chemical substance under TSCA. Read the nanoscale materials section of this report for more information on OPPT’s chemicals work on nanoscale materials.