Premanufacture Notifications and Notices

See Chapter 4, Premanufacture Notifications on the premanufacture notification and notice of commencement requirements under TSCA 5. 

Procedure Number Reg. Aff. 2, Premanufacture Notifications and Notices of Commencement Procedure PMNs NOCs... 

The Production Manager shall inform the MRC immediately upon completion of manufacture of the first batch of product made for commercial use other than research and development. The MRC shall file a Notice of Commencement with the United States Environmental Protection Agency in accordance with Procedure Number Reg. Aff. 2 Premanufacture Notifications and Notices of Commencement... 

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. 

As you heard this morning from several speakers, the premanufacture notification provision of TSCA has been in effect since July 1, 1979 and since then EPA has received over 1,000 notices of intent to manufacture and introduce new chemicals into U.S. commerce. This is the only complete and accurate record of the development and commercialization of new chemicals ever compiled and, as such, is a repository of a wealth of information. A major portion of it is classified by EPA as confidential business information - CBI in our lingo - and is closely protected against inadvertent disclosure. 

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. 

Chemical manufacturers submitted 1,031 Premanufacture Notifications in 1980 and 1981. In the same time period, they submitted 290 notifications of commencement of commercial manufacture. In other words, only 28)1 of the substances for which Premanufacturing notices were filed in the past two years of compliance have become commercial. Specifically, for the reactive polymer segment, about 29% of the reported substances have become commercial. These percentages indicate that much of what has constituted the impacts of TSCA has been "protective" filing of notifications. The length and complexity of the process mandated by TSCA has led to unnecessary resource diversion. A more liberal definition of what constitutes a commercial event could have significantly increased the percentages and reduced this type of impact, at least since July, 1979. 

Currently, we are evaluating the public comments that we received on the December 31 FEDERAL REGISTER notice. We are using these and information compiled from panels of scientific and technical experts as a basis for the formulation of a revised statement of policy on biotechnology. I ve hinted today at some of the directions being considered for the key issues of what is "new" and therefore what products are subject to premanufacture notification. 

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. 

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)... 

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. 21722 (May 13, 1983) Premanufacture Notification Premanufacture Notice Requirements and Review Procedures 48 FR 21722 PMNs 5-13-83... 

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... 

Step 7. For a commercial shipment in connection with a cleared Premanufacturing Notification, the ITS shall provide all requested data and documentation to the MRC to support preparation of the Notice of Commencement. 

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. 

---