Confidential Inventory

The TSCA Inventory is divided into two parts (1) the publicly accessible non-confidential Inventory that is readily accessed using the CASRN for chemical substances and (2) a confidential Inventory accessible only by the EPA through their TSCA Inventory Master File. For substances listed on the confidential portion of the Inventory, a generic name that masks the specific chemical identity of the substance and an accession number are placed on the non-confidential portion of the Inventory, and the specific chemical name is placed only on the confidential portion of the Inventory. 

The molecular formula for this substance is Cj5Hjg02 (C3H5CIO) The chemical name and the molecular formula indicate that this is not a copolymer of BPA and ECH, but rather a homopolymer of ECH with a single molecule of BPA in the middle, and repeat units of ECH on both sides, hence the 2 1 ratio. This polymeric substance is not on the publicly accessible TSCA Inventory, although it may be present on the confidential Inventory. The latter is accessible only through a bona fide request to the EPA by a company that indicates that it intends to manufacture/import the substance if it is present on the confidential Inventory. 

The civil and criminal penalties for making, importing, or processing a chemical that is not on the Inventory can be severe, not to mention the potential for business disruption that could result if a company finds that one of its products should be on the Inventory but is not there. Therefore searching the Inventory to determine whether chemicals that will be manufactured, imported, or processed are fisted is a central function in TSCA compliance. This task is greatly complicated by the fact that there is also a confidential Inventory, composed of chemicals whose identities are not released to the public. 

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. 

To request a search of the confidential Inventory, the requestor must demonstrate that it has a bona fide intent to manufacture or import the chemical for commercial purposes. Because this information is only available to potential manufacturers and importers, downstream processors and users cannot request a search, and must rely on suppliers for compliance information. 

The regulations require the EPA to determine if the submittal adequately documents a bona fide intent to manufacture or import, and if so the EPA must conduct the search of the confidential Inventory and respond within thirty days of receipt of a complete submission. EPA will also notily the original submitter of the Inventory submission that another party has... 

Is the substance on the confidential Inventory This can be answered by filing a bona fide request with the EPA if there is any possibiHty that the substance falls within the pubficly available generic description of a substance on the confidential Inventory. If it is on the confidential Inventory no PMN is necessary. 

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. 

If a manufacturer or importer needs to know if any of the monomers to be used in excess of two percent are on the confidential Inventory, it can submit a bona fide notice of intent to manufacture to the EPA. The EPA will respond and tell the submitter if the monomer is on the confidential Inventory. The EPA will not respond to a submitter that does not intend to manufacture or... 

A disadvantage of filing a PMN is that any other manufacturer or importer may make or import the polymer without going through the time consuming PMN process, and in essence may take a free ride on the work done to shepherd the chemical through the PMN process. Even if the substance is listed on the confidential Inventory, anyone who has actual plans to manufacture or import the chemical may submit a request to the EPA to search the confidential Inventory to see if the substance is listed there. ... 

To determine whether the product is on the TSCA Inventory, check the nonconfidential portion of the Inventory, or, if it is on the confidential Inventory, submit a bona fide intent to import to the EPA or request a warranty and indemnification from the foreign suppHer. Determine whether a product subject to TSCA is subject to (i) a SNUR under TSCA 5(a)(2), (ii) rules prohibiting or limiting importation, processing or distribution under TSCA 5(e), 5(f), or 6 or (iii) a judicial order under TSCA 7. ... 

Step 3. The MRC shaU search the publicly available TSCA Inventory and determine if the chemical substance is listed. If the substance is not on the publicly available TSCA Inventory, the MRC shall determine based on the chemistry of the substance and the generic chemical names on the confidential Inventory whether it is possible that the substance is on the confidential Inventory. If it may be on the confidential Inventory, the MRC shall confer with the requester and decide if it is appropriate to submit a bona fide letter to request confirmation from the EPA about the Inventory status of the substance. 

In the United States, CAS number 88-73-3, Benzene, l-chloro-2-nitro-, is listed on the Toxic Substances Control Act (TSCA) Non-Confidential Inventory with no Significant New Use Rule (SNUR) [38]. It has been designated as a High Production Volume (HPV) chemical [39]. In the European Union (EU), ONCB has been notified under REACH as an intermediate and as a chemical produced or imported at 100-1,000 tormes per armum. The REACH notifications refer to use as an intermediate in closed processes, and to use as a laboratory reagent [40]. In China, ONCB is listed on the Inventory of Existing Chemical Substances Produced or Imported in China (lESC) it is also listed in the Catalog of Hazardous Chemicals [41]. 

Under the EU requirements, second or subsequent importers or manufacturers of a new substance must also notify a new substance, whereas under the United States regulations this obligation does not apply once the substance has been added to the TSCA inventory. If the identity of an Inventory substance is confidential, it will be listed in the public Inventory by a generic name. There is a procedure (CER 720.25) under which the ERA will inform whether a substance is on the confidential Inventory provided a bona fide intent to manufacture or import is established. 

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