APPENDIX B GENERIC NAMES FOR CONFIDENTIAL CHEMICAL SUBSTANCE IDENTITIES The following list contains generic chemical names for some generic names as submitted in the preinanufacture the substances included in the category “Chemical Sub- notices, accompanied by the word PROVISIONAL in stances with Confidential Identities,” which appears in parentheses after the name. If the claims of confidentiali- the TSCA Inventory. The identities of these substances ty are neither dropped by the submitter nor held invalid have been claimed as confidential business information by EPA, EPA will publish the final generic names for by submitters to the Inventory. The fact that these these substances in future updates or supplements to the substance identities are listed as confidential does not Inventory. mean that EPA has made a determination that all of With the exception of the provisional generic names, these claims of confidentiality are valid. the generic names in this appendix were created accord- Some of the substances that appeared as confidential in ing to the guidelines presented in the following pages. Volume I of the Initial Inventory or Cumulative Supple- These guidelines were publish~d in the introduction to ment II may have been transferred to the non-confiden- Appendix B of the TSCA Initial Inventory and made tial portion of the TSCA Chamical Substance Invento- available by EPA to assist persons who wished to claim ry: 1985 Edition. This is because either EPA determined the precise identity of a chemical substance as confiden- that the chemical identity fails to meet the standard for tial for purposes of the Inventory. Such persons were confidential treatment in section 14 of TSCA, or submit- required to submit a proposed generic name for the ters decided to withdraw their claims of confidentiality. reported substance that was “only as generic as necessary Also, the Agency may have denied the confidentiality to protect the confidential identity of the particular claim based on the factthat another person submitted the chemical substance.” same substance without claiming confidentiality for the chemical identity. Thesesubstances are published on the Persons who intend to manufacture or import for a non-confidential portion of the TSCA Inventory. Their commercial purpose a chemical substance that is not generic names and accession numbers have beenremoved included on the Inventory by a specific chemical name from this list of confidential substances. The Agency but falls within one of the generic names included in this encourages submitters to withdraw their claims of confi- list may ask EPA whether the specific chemical identity dentiality for chemical identity when confidential treat- is included on the Inventory. EPA may disclose such ment is no longer needed. information provided the person establishes a bona [ide This appendix includes generic names for substances intent to manufacture or import the substance for com- that were submitted under the TSCA Inventory Report- mercial purposes, in accordance with the procedures ing Regulations and claimed as confidential by their outlined in section 720.25 of the Premanufacture Notice submitters as well as generic names for substances that Requirements and Review Procedures (48 FR 21722). were not claimed as confidential for purposes of the EPA assigns a unique five-digit accession number to Inventory by their submitters, but which include as each confidential chemical identity on the TSCA Invento- reactants confidential trademark products manufactured ry. Eachsubstance in this appendix is listed inorder of its by other companies. For these substances, the EPA has accession number; any applicable flags follow the acces- developed generic names that mask only the portion of sion number. The flags used are: P, S. XU, Yl, and Y2. the inventory substance that represents the confidential trademark reactant. ILLUSTRATIVE KEY TO ENTRIES AS THEY This appendix also includes generic names for sub- APPEAR IN stances that have been placed on the Inventory following APPENDIX B: GENERIC NAMES FOR premanufacture review and receipt by EPA of a notice of CONFIDENTIAL CHEMICAL SUBSTANCE commencement of manufacture or import. Companies IDENTITIES must reassert and substantiate confidential chemical identity claims at the time of submitting a notice of commencement. EPA reviews the submitter’s substantia- 1 18543XUMonceubetitutedpolymer eatermethanewith pentaerythritolroam, malaic anhydride tion to determine whether a claim of confidentiality is justified. EPA also determines whether the generic name submitted inthe premanufacture notice is appropriate for 45251P,XU Inventory listing purposes. In most cases, the EPA finds Saturated polyester (PROVISIONAL) -~‘-~ that the submitter’s generic name is too generic, and 69499 XU, Y2 develops a mutually agreeable generic name following Polymer .of (alkylene ether) glycol and the procedures in the Preinanufacture Notice Require- methylenebis [iaocyanatobenaenej (D ments and Review Procedures (4) CFR 720.85). This generic name is then listed in the fnventory~ At the time of this printing, a number of commenced 1. The Accession Number appears in boldface PMN substances for which notices of commencement type. have been received were undergoing substantiation re- view or generic name development. To represent these 2. The Generic Name appears in lightface type substances on the printed Inventory, EPA has published under the Accession Number. 3. The flags for SNUR substances, PMN 1. Identity of parent structure (i.e., a chain of substances, et al. appear in lightface type carbon atoms, a ring system, or a coordinated following the Accession Number. The metal). following flags are used: 2. Identity, number, and position of chemical group(s) which are attached to the parent — P indicates a commenced PMN substance. structure(s) or to other chemical groups. 3. Identity and number of counter ions (for — S indicates a substance identified in a proposed or final Significant New Use salts). Rule. See the SNUB Index. 4. Stereochemical relationships. —XU indicates a substance exempt from Generic chemical names are created for Class 1 chemi- reporting under the proposed rule for cal substances by masking structurally descriptive parts Partial Updating of the TSCA of .their specific chemical names. Masking can be accom- Inventory Data Base Production and plished by substituting non-descriptive terms (e.g., “sub- Site Reports. stituted”) for descriptive parts of the name. The structurally descriptive parts of a Class 1 chemical —Y1 indicates an exempt polymer that has name that could be masked when creating a proposed a number-average molecular weight of generic name, are listed below: 1,000 or greater. 1. A locant which specifies the placement of a —Y2 indicates an exempt polymer that is a single chemical group. polyester and is made only from the specified list of low concern reactants. 2. Locant and multiplicative prefixes (e.g., di-, tri-, tetra-) which together specify the number 4. The label PROVISIONAL follows the and placement of a given chemical group. generic name and indicates that the generic name is not considered final by EPA and 3. Identity (but not placement and number) of a that it is subject to change. given chemical group. GUIDEUNES FOR CREATING PROPOSED 4. Identity of a given parent structure, and GENERIC NAMES FOR CONFIDENTIAL locants of substituent chemical groups. CHEMICAL SUBSTANCE IDENTITIES FOR THE TSCA INVENTORY 5. Identity and multiplicative prefixes (specifying the number) of a given simple cation or The procedures presented below were designed by EPA anion of a salt. to provide guidance indeveloping proposedgeneric names for chemical substances whose specific identities were Chemical Group Masking claimed as confidential for purposes of the Inventory. They are included in this Appendix to assist a company in Table 1 efthese guidelines lists by name and molecular deciding if a particular chemical substance is pessib~jt formula the type of chemical groups which can be masked included in the class defined by a generic name an to create a proposed generic name for a Class 1 chemical hence, on the Inventory. The company would then file a substance. bona [ide inquiry to make a more precise determination The groups of atoms found in Table 1 are common of the Inventory status of the substance. chemical structural units; a given group may be listed These guidelines are based on the masking of selected under more than one name. Each group includes at least parts of a specific substance name to disguise the full one atom other than carbon or hydrogen. identity of the substance. Although the guidelines illus- A chemical group which includes a carbon atom having trate the masking of a single structural feature, multiple more than one single free valence (e.g., carbonyl —GO-—) can not be masked ifthe carbon atom is directly attached masking is permitted if the company reporting the to an acyclic carbon atom or is included within a ring substance justifies in writing the need for such additional system; in this circumstance, only the atom or group of masking. atoms attached to the carbon atom can be masked. (See Because of inherent differences in naming Class 1 and Example 2, below, where the oxo group is masked.) Class 2 chemical substances, the guidelines address each Table 1 lists most of the common chemical functional separately. However, in certain instances the procedure for creating proposed generic names for Class 1 sub- groups which contain oxygen,
Details
-
File Typepdf
-
Upload Time-
-
Content LanguagesEnglish
-
Upload UserAnonymous/Not logged-in
-
File Pages4 Page
-
File Size-