Premanufacture Notification PMN

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)... 

The U.S. premanufacture notification (PMN) requirements have been in effect for approximately three years, and more than 1250 PMN s have been submitted to EPA. The EEC s premarket notification requirements took effect in September 1981,... 

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. 

Aside from the Premanufacture Notification (PMN) requirements. Section 5 rules have not been used to a great extent. Nearly all of the compliance activity since July of 1979 has been geared toward meeting PMN requirements. Whether the agency s failure to use the subsections of 5 that are designed to restrict potentially harmful substances from reaching the marketplace has resulted from lack of real necessity, a failure in the Agency s risk assessment process, or an inherent non-workability in the Law itself, remains to be seen. 

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 ... 

At the heart of the TSCA is a premanufacture notification (PMN) requirement under which a manufacturer must notify the EPA at least 90 days prior to the production of a new chemical. In this context, a new chemical is a chemical that is not listed in the TSCA-based Inventory of Chemical Substances or is an unlisted reaction product of two or more chemicals. Eor chemicals already on this list, a notification is required if there is a new use that could significantly increase human or enviromnental exposure. No notification is required for... 

Under the TSCA, a new chemical is a chemical substance that is not already included on the TSCA Inventory, and is intended to be used for a commercial purpose (other than as a drug or pesticide) in the USA. Section 5 of the TSCA requires manufacturers or importers of a new chemical to notify the EPA (i.e., submit a premanufacture notification, PMN) before manufacturing or importing the chemical. The EPA has only 90 days (extendable to 180 days under certain circumstances) from the time of receipt of the notification to determine if an unreasonable risk may or will be presented by any aspect of the new industrial chemical, and make risk management decisions and take action to control any unreasonable risks posed by the chemical [17]. If after 90 days the submitter of a new chemical is not notified by the EPA of any regulatory restrictions or test requirements, they can legally market or import the chemical. 

SARs have been used for decades by medicinal chemists in the design of highly efficacious drug substances [47] and by the US Environmental Protection Agency (EPA) for assessing the toxicity of new, untested commercial chemicals prior to commercialization [i.e., chemicals submitted to the EPA in the form of Premanufacture Notifications (PMNs)] [48]. However, despite the structure-activity data available for many classes of commercial chemical substances, the use of SARs has been given much less attention by chemists as a rational approach for designing new, less toxic, commercial chemical substances. 

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 primary objective of the TSCA Inventory is to define what chemical exist in U.S. commerce for purposes of implementing the Toxic Chemicals Control Act. Specifically, chemicals not included on the Inventory are considered to be new chemicals under TSCA and are subject to the premanufacture notification (PMN) requirements stipulated under section 5 (a) of TSCA. The purpose of the TSCA Inventory is to identify those chemicals that exist in U.S. commerce, which have commercial applications that are not specifically addressed under other existing environmental legislation. 

Section 5(a) requires premanufacture notification (PMN) to be submitted by an operator at least 90 days before a new substance is produced or imported or before an existing substance is used in what has been determined by an EPA rule to be a... 

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... 

It is generally not necessary to make an exposure estimate for every chemical/exposure source combination since many will be of such low significance that they can be neglected. For those chemical/exposure source combinations that could be near the top of the priority list, the exposure estimate is probably not needed beyond an order of magnitude. Methods for making this type of estimate have been developed by the EPA for the purpose of evaluating Premanufacturing Notifications (PMNs). 

For chemicals that do not appear on the U.S. EPA list of Chemical Substances in Commerce, it is necessary to submit a Premanufacture Notification (PMN) to the EPA before making the new material for commercial purposes. The EPA approval is based on adequate documentation of planned manufacturing procedures, anticipated by-products, health and environmental effects test data, and procedures for safe use, handling, and disposal. 

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... 

I have included in today s presentation three of these issues first, the distinction between a "new" and a "naturally occurring" chemical substances for the purpose of the applicability of the premanufacture notification (PMN) requirement of TSCA second, the scope of the research and development exemption from the PMN requirements, and its implication for open field testing of microorganisms and third the type and amount of information that EPA might need for risk/benefit analyses of new microorganisms. I will also briefly mention some technical areas in which further research would greatly facilitate the processes of risk/benefit assessment. 

New substances may be added to the TSCA Inventory through the Premanufacture Notification (PMN) process, which typically adds... 

The Environmental Protection Agency (EPA) explained the conventions applied to listings of polymeric chemical substances for purposes of Premanufacture Notification (PMN) reporting and the TSCA Inventory. The principal guidance document in which the conventions are explained is titled Toxic Substances Control Act Inventory Representation for Polymeric Substances, which was published on 29 March 1995. This discussion of polymer nomenclature conventions under TSCA begins with general guidelines, followed by a discussion of how polymers are identified... 

The TSCA Inventory, established under Section 8(b) ofthe Act, comprises substances considered to exist in US commerce. A substance not already included on the Inventory is considered to be a new chemical substance pursuant to TSCA Section 3(9). Under TSCA Section 5(a), a person must submit a Premanufacture Notification (PMN) to the EPA at least 90 days before commencing manufacture or import, for a commercial purpose, of a chemical substance not on the Inventory, unless the substance is exempt from reporting. After PMN review and upon receipt of a Notice of Commencement of Manufacture or Import (NOC), the EPA adds the chemical substance to the Inventory, which then becomes an existing chemical substance. Certain nanoscale substances that will be manufactured or imported for commercial purposes are expected to be new chemical substances and therefore subject to the TSCA new chemical reporting requirements, as are any other new chemical substances. 

Specifically with respect to nanotechnology, the EPA is reviewing nanoparticle Premanufacture Notifications (PMN) and subjecting certain restrictions for them under SNUR, but there is concern... 

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. 

There are numerous exclusions and exemptions from the premanufacture notification (PMN) process. Chemicals that are excluded from the Toxic Substances Control Act (TSCA) definition of chemical substances are excluded from the PMN requirements, as well as all TSCA programs. Chemicals that are excluded from the definition of chemical substances include mixtures (but not the constituents of a mixture, each of which is a chemical substance ), pesticides, tobacco, firearms, nuclear materials, food, food additives, drugs, cosmetics, and devices under the Federal Food, Drug, and Cosmetic Act. ... 

The EPA notes in the action plan for chlorinated paraffins that some of the chemicals in this class that are currently manufactured in or imported into the United States are not on the Inventory, and their manufacturers and importers must submit premanufacture notifications (PMNs). °° Section 5(e) orders may result from the PMN process for those chemicals. EPA is considering issuing a finding under TSCA 6(a) that short-chain chlorinated paraffins present or will present an unreasonable risk, and is also considering bans or restrictions under 6 ° ... 

Section 15 of TSCA, entitled Prohibited Acts, enumerates the acts that violate TSCA. It says, somewhat obviously, that a violation of any reporting obligation, any test rule, or any other requirement of 4 or 5 is a violation. Similarly, it is a TSCA violation to fail to maintain required records or allow the EPA to inspect a facility. It adds a very critical dimension to the list of violations by stating that using a substance that was manufactured in violation of TSCA is itself a violation of TSCA. The most significant language is that it shall be unlawful for any person to. .. (2) use for commercial purposes a chemical substance or mixture which such person knew or had reason to know was manufactured, processed, or distributed in commerce in violation of the 5 and premanufacture notification (PMN) rules, a ban or restriction under TSCA 6 or 7, or a rule or order under those sections. 

A major responsibility of the Office of Pollution Prevention and Toxics is the implementation of the Toxic Substances Control Act (TSCA) (7). Central to TSCA is section 5, which requires manufacturers to submit premanufacture notifications (PMNs) to EPA before they begin manufacture of new chemical substances. Under section 5, EPA may limit or ban the production of a new chemical substance that may present an unreasonable risk to human health or the environment. 

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-... 

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