Toxic premanufacture notice

Anon. Reproposal of Toxic Substances Control Act (TSCA) Premanufacture Notice (PMN) Forms and Previsions of Rules FR. 1979, 44. 59763-882. 

The US Environmental Protection Agency (EPA) Office of Pollution Prevention and Toxics (OPPT) has only a 90-day review period to issue a decision on Premanufacture Notices filed under the TSCA for any new compound to be manufactured or imported. The availability of inexpensive approaches for reliable assessment of hazard to environment and human health could be of immense value to OPPT. Likewise agencies such as the European Center for the Validation of Alternative Methods (ECVAM) aim to promote the scientific and regulatory acceptance of alternative methods... which reduce, refine, or replace the use of laboratory animals [5]. 

Notification of new chemical substances in the USA under the Toxic Substances Control Act (TSCA) [13] differs from other notification schemes based on the OECD MPD, in that a Premanufacture Notice (PMN) can be submitted inoMparating only the existing data on the substance. However, the EPA can require studies to be conducted if necessary for adequate evaluation of the safety of the substance. 

The polymer exemption is an exemption from the premanufacture notice requirements and not an exemption from all of the many programs under the Toxic Substances Control Act. An exempt polymer is subject to all of the other TSCA programs, including (but not limited to) the substantial risk reporting in 8(e) of the statute, Significant New Use Rules, import certifications, and export notifications. 

Several of the exemptions from the PMN requirements do not apply on their face to SNURs because they state they are exemptions from certain of the premanufacture notice requirements of section 5(a)(1)(A) of the Toxic Substances Control Act, and that is a reference to the premanufacture notification program only. The SNUR program is authorized in TSCA 5(a)(1)... 

If a chemical s manufacture, processing, distribution, use, or disposal would create unreasonable risks, the U.S. ERA, under the TSCA, can regulate it, ban it, or require additional testing. TSCA mandates the U.S. ERA to monitor and control the use of toxic substances by requiring the Agency to review the health and environmental effects of new chemicals [referred to as Premanufacturing Notice or PMN Section 5(a)(1) of TSCA] and chemicals already in commerce. The U.S. ERA also has Significant New Use Rules (SNUR) under Section 5(a)(2) ofTSCA which provides away for the U.S. ERA to restrict uses of a chemical substance already in commerce that are proposed for new uses. All of the solvents discussed are already commercially available, so a PMN would not apply some could be... 

Office of Pollution Prevention And Toxics, 2008. Regulation of a New Chemical Substance Pending Development of Information. Re Premanufacture Notice Number P-08-0177, Consent Order and Determinations Supporting Consent Order. Environmental Protection Agency, Washington, DC. Available at . 

Toxic substances are regulated under CFR Title 40. Before a substance can be manufactured, it must be properly registered with the EPA in accordance with the Toxic Substance Control Act (TSCA). In the case of a new substance not on the TSCA inventory, a premanufacturing notice (PMN) must be submitted to the EPA. This notice must contain information on ... 

New chemicals introduced in the United States are regulated under the Toxic Substances Control Act (TSCA) [1]. Review of new substances before distribution in commerce is incorporated into Section 5 of TSCA. A premanufacture notice... 

The Toxic Substances Control Act (TSCA) refers to "new chemicals" as those not on the TSCA Inventory of Chemical Substances which lists about 55,000 existing commercial chemicals. All new chemicals must enter EPA s premanufacture notification program (PMN) for review before manufacture. This program is the most complete record of development of new chemicals by U.S. industry over the past 2 1/2 years. To date over 1,000 notices have been submitted, many including confidential business information (CBI). Despite the CBI, it is possible to summarize EPA s experience with new chemical substances and to evaluate the PMN program and its impact on product innovation. That is essentially the aim of this paper. 

Premanufacture Notification - The Toxics Act requires chemical manufacturers to give EPA 90 days notice before commencing commercial production on any new chemical substance. Through premanufacture notification, the Agency is charged with the responsibility of regulating unreasonable risks from these new chemicals before they occur. 

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