Notice of Commencement

After the PMN period has expired, manufacturers and importers who have filed a PMN must notify the EPA within thirty calendar days of commencing manufacture or import of the PMN substance. The notification must be made on the NOC form, which is EPA form 7710-56. The thirty day period begins to run on completion of manufacture of the first amoimt of the PMN substance made for a nonexempt purpose, i.e., when it is made for commercial purposes and not for research and development, test marketing, or another purpose exempt from the PMN filing requirements. For an import, the thirty day period begins to run after the PMN substance has cleared U.S. Customs.  

An NOC may not be filed when a manufacturer uses surplus stocks of a chemical handled under the R D exemption from the PMN requirements. The NOC may only be based on manufacture of substances for a purpose that is not exempt from the PMN requirements, and so a manufacturer must wait until it makes the substance for non-R D purposes before it files the NOC. 197 

The NOC results in the substance s Ksting on the Inventory. If the chemical identity is claimed as coiffidential on the NOC and the EPA does not challenge this claim, the substance will be put on the confidential Inventory and only the generic name will be made pubhc. If there is no confidentiality then the substance will be put on the pubhc Inventory and the chemical identity will be published. 

NOCs for PMNs filed after the April 6,2010 effective date of the new electronic filing regulations must be made using the electronic submission software, and may be filed on paper, via CD, DVD, or CDX for one year after the effective date of the new rules, and thereafter must be submitted via CD, DVD, or CDX for the next year, and then only via CDX. NOCs for PMNs filed before the effective date must be on paper.  

There is no personal certification on the NOC form. However, willful false statements of material facts to the U.S. government are felonies, even in the absence of the additional statements required by the certification on the PMN form. °° 

---

The PMN must be presented at least 90 days before the production of the new substance. New substances presented with a PNM are added to the list only after a 90-day review period and after the producer has submitted the so-called Notice of Commencement (NOC) within 30 days of the start of production. The notifier is asked for the following information Chemical Abstracts Service (CAS) number, chemical name, structural and molecular formulas, trade name, spectral analysis, type and percentage of impurities, and use. Initially, no experimental data are requested but if valid data are available, they must be included. Existing chemicals (those already listed) can be classified and consequently handled based on criteria given by the Occupational Safety and Health Agency (OSHA) and the National Institute for Occupational Safety and Health (NIOSH). 

If the PMN is approved and the substance is imported, a Notice of Commencement (NOC) is required to be submitted to EPA within 30 days of first importation. After the EPA receives the NOC, the subject chemical substance will be added to EPA s TSCA Inventory of existing chemical substances for future importation and/or domestic production. 

On the other hand, the EPA may take no action if the data show that there is no substantial exposure or risk. In that case, the substances deemed new are then added to the TSCA Inventory when EPA receives a Notice of Commencement (NOC) from the manufacturer or importer following the completion of the 90 day review period. The NOC must be filed within 30 days of manufacture or import. At this time, the substance in question becomes an existing chemical for regulatory purposes under TSCA and anyone can then begin to manufacture or import the chemical. 

A PMN must be made to the H A, under Section 5 of TSCA, 90 d before a new chemical substance is manufactured or imported into the USA. A new substance is one not on the Chemical Substances Inventory, which is the list of existing and previously-notified substances. A notification is also required for a new use of a listed substance which is subject to a Significant New Use Rule (SNUR). Notified substances are listed in the TSCA inventory only afto- being supplied and the mandatory Notice of Commencement of Manufacture or Import is filed with the EPA. Notified substances can be placed in the confidential section of the TSCA inventory, on justified request. Howev, potential suppliers can establish from the EPA whether the substance of concern is listed and hence is not notifiable by filing a bona fide intent to manufacture or import... 

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. 

The Inventory was established in two versions, a public Inventory available and searchable by the public, and a confidential Inventory. The initial public Inventory was published in 1979 and has been continually supplemented. TSCA 14 allows the submission of information imder a claim of confidentiality. Manufacturers and processors were allowed in making initial submissions to the Inventory, and are allowed in submitting PMNs, to claim as confidential certain business information, including specific chemical identity, composition, and process details. If the chemical identity is claimed as confidential, a generic name is used for fifing the Notice of Commencement (NOC). A NOC must be filed after the first manufacture or import of the substance after the PMN process is complete, in order to put the substance on the Inventory. Only the name on the NOC goes on the public Inventory. 

When EPA rejects a request for a correction, it sends the submitter a denial letter with the reasons for the denial. In some situations, EPA will specify what additional information will be needed for it to reevaluate the request, and a second submittal may lead to an acceptance. If the correction is accepted, the correct substance identity is considered to be legally included in the TSCA Inventory retroactively to the time of the initial Inventory, or to the time when the substance was placed on the Inventory through submission of a Notice of Commencement. When an Inventory correction is accepted, the erroneously listed chemical remains on the Inventory until EPA makes a formal Federal Register announcement of its removal from the Inventory to avoid disrupting commercial activity by the unpublished deletion of a chemical listing upon which some companies may be relying. 

Prior to the EPA s clarification, there had been different interpretations of whether free radical initiators must be listed in the Inventory description for polymers. As a result, the EPA had to adopt a poUcy to prevent unfair burdens on people who had consulted the Inventory prior to the June 28, 1989 clarification. In the clarification, the EPA stated that all polymers that were put on the Inventory or were the subject of a Notice of Commencement filed on before June 28,1989 can be made with any amount of free radical initiator, whether or not the free radical initiator is part of the polymer description on the Inventory. Of course, if the free radical initiator is Usted in the Inventory representation of the polymer, that free radical initiator must be used, but it may be in any amount. 

Once the PMN review period is over, the company that filed the PMN must notify the EPA again when it completes its first commercial manufacturing or importation. This notification is called a Notice of Commencement (NOC). As soon as the NOC is filed, the substance is automatically put on the Inventory, and any other company or person may manufacture or import it, subject to the EPA s authority to restrict its use. 

A notice of commencement is a notice filed with the EPA to inform the EPA that import or manufacture has commenced. It automatically results in listing of the substance on the TSCA... 

If a manufacturer, importer, or processor wants to use surplus R D material for a non-R D purpose, it may file a PMN, a Low Volume Exemption or a LoREX exemption application. Interestingly, the substance will not be put on the Inventory unless it is manufactured or imported subsequently for a non-exempt purpose because no Notice of Commencement (NOC) can be filed for a batch that was manufactured for R D purposes. ... 

Microorganisms are added to the Inventory after the ninety day MCAN review period expires and the filer submits a Notice of Commencement of... 

Staff should cooperate with the inspectors, but they should not volunteer any information that is not specifically requested. Sometimes, in an effort to be cooperative, people will volimteer evidence of previously undetected violations, and this should be avoided. For example, if the inspector uncovers evidence that a particular Notice of Commencement was filed late and explains the issue to the plant employees, it is very tempting to respond that the same thing had happened before without adverse consequences. Everyone should also imderstand that if they volunteer unsolicited information it will not place the fadhty in a better position than if the inspector discovers it for him or herself. The EPA will treat any violations that it learns of during an inspection as if it were discovered by the inspector, even if employees consider them to be voluntarily disclosed, and the EPA will not grant any penalty reductions for self-disclosure. The best course of action is to evaluate self-reporting additional violations that the inspector did not discover after the inspection has concluded. 

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

All Premanufacture Notices (PMNs) and Notices of Commencement (NOCs) that the seller filed. The buyer may find, even many years down the road, that a substance is incorrectly listed on the Inventory. If that is due to one of several specified types of errors in a PMN filed by the seller, the buyer may be able to correct the Inventory listing, and the PMN is important in making the correction. In addition, the buyer may not be able to locate an NOC for a substance that was the subject of a PMN filed by the seller. The EPA has taken the position that a PMN cannot be transferred, so either the NOC must be located or the buyer must file a new PMN. Obtaining a copy of an NOC or PMN from the EPA becomes more involved when information in those forms is confidential business information. 

Has the business filed a Notice of Commencement (NOC) for each substance for which it filed a premanufactiu e notification (PMN) ... 

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... 

Step 19. Within thirty days of completion of the first production or importation of the PMN substance for a purpose that is not excluded or exempted from the PMN requirements, the MRC shall file a Notice of Commencement (NOC) with the EPA, using the EPA NOC form. 

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. 

Notices of Commencement of manufacture or import are an exception, and the substantiation must be submitted with any notice that claims CBI status for information on the form. 40 C.F.R. 720.102(c)(2). For reports of significant risk information submitted under TSCA 8(e), the EPA guidance does not make substantiation mandatory at the time CBI is submitted because it says that the submitter should substantiate any CBI claims. 68 Fed. Reg. 33129, 33140 (June 3, 2002). 

---