Premanufacture Notification Program

The Toxic Substances Control Act (TSCA)i called for the creation of a massive list of all the chemicals in commerce in the United States. The list is the TSCA Inventory, or more simply, the Inventory. To compile the Inventory, the United States Environmental Protection Agency (EPA) issued an Inventory Reporting Rule in 1977 requiring companies to report all the chemicals they had manufactured or imported in the previous three years, and the result was inclusion of approximately sixty-two thousand chemicals on the Inventory. Since that time, over twenty-one thousand more chemicals have been added to the Inventory.  

All of the chemicals that are on the Inventory are called existing chemicals. The chemicals that have yet not been put on the Inventory are called new chemicals. In general, companies may import and manufacture existing chemicals, but unless there is an exception to the general rule no one may manufacture or import a new chemical that is not on the Inventory. 

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. 

Anyone who submits a PMN must disclose known information concerning the manufacturing, physical, and toxicological properties of the chemical. 

The EPA typically has a ninety day opportunity to review the PMN and determine if restrictions should be placed on the substance s use or manufacture or handling. 

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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. 

Section 5 of TSCA,(4) "Manufacturing and processing notices," establishes the U.S. premanufacture notification program. Sections 3, 8(a) (b), 15-17, and 19 also are important. 

Persons and Activities Covered. TSCA 5 creates a premanufacture notification program, whereas the Sixth Amendment requires the submittal of premarket notifications. Thus, U.S. PMN s must be submitted no later than 90 days prior to the completion of R D activities, unless EPA grants permission to produce limited amounts for test marketing purposes. In contrast, companies in... 

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)... 

This part compares basic provisions of the U.S. premanufacture and the EEC premarket notification programs.(3)... 

EPA s D.G. Bannerman reviewed these impacts on the market introduction of new chemicals. He summarized EPA s experience and analyzed the classes and types of new chemicals, company size, market areas, and, among other data, the number of notified chemicals actually reported to be commercialized. He stressed a new joint industry-EPA program to assist the smaller chemical companies to comply with TSCA, especially with premanufacturing notification. This will minimize negative impacts on product innovation without reducing the effectiveness of EPA s assessment of risks of new chemicals. 

The section of TSCA that will most directly effect innovation, research, and development in new chemicals is premanufacturing notification. Consequently, a more detailed description of this program would be appropriate. 

There are two aspects of this program that will effect the research and development investment decision. First, the costs of premanufacture notification (including testing costs) will increase the investment in R D necessary to develop and market new chemicals. The health and safety properties of a chemical must now be considered an intrinsic part of the new chemical development process, right alongside consideration of the substances commercial properties. Both are equal parts of the "total product". Tb the extent that this results in increased testing for health and environmental effects, the amount of investment required to achieve a given level of output from R D will also rise. 

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 notice of inspection may limit the inspection to one TSCA program. For example, the inspection could be limited to compliance with 8(e) requirements to submit notices of significant risk information, it could be directed to the premanufacture notification requirements of 5, or it could cover all TSCA requirements. The letter will typically specify the kinds of documentation that the inspectors will want to inspect. It is advisable to review these materials in advance to see exactly what the inspector will see, and avoid the element of surprise if there is a violation on the face of a document. It will often be possible to refute any inference of a violation, and all the arguments should be marshaled at this point. For example, if the inspection notice states that all notices of export under 12(b) should be assembled, and a quick review shows that some letters were not submitted until after the export may have taken place, it may be possible to gather documentation showing that the exports occurred later than expected and the notices were indeed timely. 

Fed. Reg. 16336 (Mar. 29, 1995) Premanufacture Notification Exemption Revision of Exemption for Chemical Substances Manufactured in Small Quantities Low Release and Exposure Exemption Final Rule 60 FR 16336 LVE LoREX 3-29-95 64 Fed. Reg. 31987 (June 15, 1999) Recordkeeping Requirements for Low Volume Exemption and Low Release and Exposure Exemption Technical Correction 64 FR 31987 LoREX 6-15-99 67 Fed. Reg. 76282 (Dec. 11, 2002) Sustainable Futures—Voluntary Pilot Project Under the TSCA New Chemicals Program Notice 67 FR 76282 Sustainable 12-11-02... 

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. 

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