Premanufacture notification regulations

Impurities are exempt from the premanufacture notification regulations. 

All of the definitions in the premanufacture notification regulations apply to SNURs. ... 

Fed. Reg. 15096 (April 22, 1986) Toxic Substances Revisions of Premanufacture Notification Regulations Final Rule 51 FR 15096 PMN Revisions 4-22-86... 

Fed. Reg. 16298 (Mar. 29, 1995) Premanufacture Notification Revisions of Premanufacture Notification Regulations Final Rule 60 FR 16298 PMN Revisions 3-29-95... 

The Toxic Substances Control Act (TSCA) was enacted in 1976 to identify and control toxic chemical ha2ards to human health and the environment. One of the main provisions of TSCA was to estabUsh and maintain an inventory of all chemicals in commerce in the United States for the purpose of regulating any of the chemicals that might pose an unreasonable risk to human health or the environment. An initial inventory of chemicals was estabhshed by requiring companies to report to the United States Environmental Protection Agency (USEPA) all substances that were imported, manufactured, processed, distributed, or disposed of in the United States. Over 50,000 chemical substances were reported. PoUowing this initial inventory, introduction of all new chemical substances requires a Premanufacturing Notification (PMN) process. To be included in the PMN are the identity of the new chemical, the estimated first year and maximum production volume, manufacture and process information, a description of proposed use, potential release to the environment, possible human exposure to the new substance, and any health or environmental test data available at the time of submission. In the 10 years that TSCA has been in effect, the USEPA has received over 10,000 PMNs and up to 10% of the submissions each year are for dyes (382)... 

Unfortunately, EPA initially proposed ambitious regulations that could have expanded premanufacture notification ("PMN") requirements well beyond the limits embodied in the statute. For example, EPA had testified in Congress that manufacturers would merely be required to complete and submit a two-page PMN form. But the PMN that EPA proposed in January of 1979 was an extremely detailed form which called for nearly 40 pages of mandatory information, and 20 more pages of optional information. CMA, and other industry commenters, urged drastic modifications in EPA s proposal in order to conform to the terms of the statute and lessen the burden on innovation. In particular, CMA developed and provided to EPA, a draft PMN form which called for much less information, but would still be adequate to facilitate EPA s review function under Section 5. 

Where in a product s life a regulation such as TSCA is imposed becomes important in terms of resource diversion. Ideally, imposition of Premanufacture Notification after scale-up and successful line trials would necessitate filing notifications only for those products that actually become commercial. In the usually compressed Coatings and Resins lifeline, this is not always, and in fact very seldom, possible. 

Regulation of New As Well As Existing Chemicals. An evaluation of TSCA s impact would differ from that of most environmental statutes in that the former purports to regulate new as well as existing chemicals. The objective of the premanufacturing notification (PMN) system under section 5 is to permit EPA to make a reasoned evaluation of new chemicals ... 

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. 

Of all governmental regulatory agencies worldwide, the EPA probably has the most widespread application of, and expertise in, QSAR. The use is underpinned by TSCA, which provides the framework for the regulation of new industrial chemicals by the EPA. Within TSCA, Section 5 of the Act specifies the premanufacture reporting requirements for new chemicals. Within TSCA the burden of proof is placed on the EPA to demonstrate risk and exposure for a new chemical. Since there is no requirement at the premanufacture notification (PMN) stage for the producer to provide... 

The TSCA regulations are found in Title 40 of the Code of Federal Regulations (40 CFR), Parts 700-789. Probably the most important sections of TSCA to the plastics industry in general and the coloring of plastics in particular are Section 5 Premanufacture notification (PMN) and SNUR (Significant New Use Rules) Section... 

The Toxic Substance Control Act (TSCA) was passed in 1976 and is contained in 15 USC 2601 et seq. It regulates toxic substances, other than wastes, that are not adequately covered by other statutes. Promulgation of TSCA gave the EPA the authority to manage chemicals from production to final disposal. In fact, if a compound (e.g., carbon tetrachloride) is found to pose unreasonable risk to human health or the environment, the EPA can immediately remove it from commerce. The TSCA s requiring a premanufacture notification (PMN) 90 days prior to manufacture has minimized the occurrence of immediate emergency removal of toxic chemicals. The PMN contains information on the physical/chemical properties, health... 

An intermediate that is nonisolated does not need to be on the TSCA Inventory, and is exempt from the premanufacture notification requirements. It is still a chemical substance, and is subject to other TSCA regulations. 

Another source of the partial TSCA exemption for chemicals for export only is the Premanufacture Notification (PMN) regulations. The preamble to the original PMN regulations confirms that EPA did not adopt the proposed requirement that manufacturers of new chemicals solely for export submit notices under section 5(a) of the Act. ... 

New chemicals are added to the Inventory through the premanufacture notification (PMN) procedure. The Inventory and the PMN procedures are closely related if a substance must be on the Inventory it must get there through the PMN procedure, and if a substance goes through the PMN procedure the ultimate obj ective is Inventory listing, or an EPA approved exemption. For this reason, the Inventory regulations and the PMN regulations have parallel requirements. 

Importers are not specifically mentioned in the statutory or regulatory statements of the PMN requirement, but in both the statute and the regulations manufacture is defined to include both manufacture and import and so all of the premanufacture notification rules that apply to manufacturers also apply to importers. Importers do not need to ensure that substances in articles are on the Inventory because articles are exempt from the PMN process. However, it is important to review the definition of article to check that all of the substances in the article meet the definition. Importers must file PMNs on all new chemicals that they import in bulk or as part of a mixture. ... 

An example of a substance exempted by the (h)(5) exemption is the chemical reaction product that is formed when paint dries. That same chemical would be subject to PMN regulations if it were intentionally made as a commercial product for distribution as a chemical product or an intermediate, but not when it is formed as a result of the use of paint. If the paint is applied to an article, then the chemicals formed on use of the paint are also exempt from the premanufacture notification requirements under the (h)(6) exemption. 

The circumstance of a violation is derived from the harm that either could have occurred or actually did occur as a result of the violation. In the context of a violation of 5 s premanufacture notification requirements, it does not matter whether actual harm occurred—higher penalties will be assessed whenever the EPA would have regulated a chemical substance as if it had a higher potential to harm human health or the environment. Circumstance is based on the potential to cause harm, not whether actual harm occurred and so a violator cannot argue successfully that the circumstance should be reduced based on lack of real harm. All Regions Chemical Labs, Inc. v. EPA. ... 

Fed. Reg. 78261 (Dec. 22,2008) TSCA Section 5 Premanufacture and Significant New Use Notification Electronic Reporting Revisions to Notification Regulations 73 FR 78261 PMN efiling 12-22-08... 

Inventory it is now possible to determine if the chemical in question is produced for commercial purposes and the level of its production. The TSCA Inventory, however, is only a one-time information collection effort by EPA. It does not provide historical production information, and its update depends on the Premanufacture Notification (PMN) and the Significant New Use Regulations (SNUR), which are under development by EPA. The PMN regulation will provide for addition of new compounds to the inventory. The form of the SNUR regulation is not yet clear, but we can expect that manufacturers will be required to report significant new uses for chemicals already listed on the inventory, along with production figures. 

TSCA (Section 5) also provides EPA with the authority to regulate and control the introduction of new chemicals either through manufacture or import, or the processing of an existing chemical for a significant new use. Such manufacturers and importers must file a Premanufacture Notification (PMN) 90 days before producing or importing the chemical. Once a PMN is filed, EPA assesses the information and determines if the chemical poses an unreasonable risk of injury to health or the environment. An additional 90 days may be re-... 

Where necessary the manufacturer must carry out, or arrange for, safety testing. Many countries operate mandatory premanufacturing and premarketing notification schemes of which safety testing is the cornerstone. Within the European Community under Directive 67/548/EEC and its sixth amendment 79/831/EEC, Competent Authorities must be notified before new substances are supplied in the marketplace. In the UK this Directive is enacted by the Notification of New Substances Regulations 1993 (NONS). Exempt are ... 

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