Document DDDdJYOZRR93q73XxxRRjJkD4

INTEROFFICE MEMORANDUM A 7"/ a.CES late 12 December 19 77 Subject Record Keeping for TSCA _________ To. C. E. Blades i. From 3' M` Egan ec: L. C. Claitor T. B. Collins Administration - Piscaeavay (Location, Organisation, or Department) Management Information Department-- (Location, Organisation, or Department) ^ fM*r. 7 C&- At our planning meeting on 7 December 1977, we discussed several require** ments for record-keeping information for TSCA during Fiscal Year 1978. Following please find a description of the several areas discussed and a proposed plan of activity for each. Raw Materials. All raw materials used should be identified, and their presence on the Inventory List ascertained. While discussing this requirement, a plan evolved to achieve this objective efficiently. To test the methodology, it is proposed that a sample 10% of the Chemicals Group raw materials list, which is in hand, be identified, and a report written which evaluates the procedure and calculates the time and cost for completing the activity. This evaluation can be accomplished in approximately one man-week over an elapsed period of one month. Product Files. The various product files resident on Che computer were reviewed and the long-term objective of cross-referencing all products to C. A. Registry number was discussed. HID proposes to establish an internal procedure to assign C. A. Registry numbers for all new products. For inventory purposes, the present products must be identified and entered into product master files. It is recommended that the identi fication information be gathered when other inventory information is requested of the various product managers. Chemical Substances Data Base. The objectives of having such a data base were reviewed. They include: - To have a reference collection for all APCI products that contain* data regarding: 1. Physical properties 2. Toxicological data 3. Studies and other source material 4. Reference to use and production information. - To provide a cross-reforence tool between APCI products and chemical substances registered In the market place. (320) "t. Hi? T- AP00049075 2- - C. E. Blades J. M. Egan 12 December 1977 It Is suggested that an initial step in establishing such a data base is to define the data elements and to collect the information. Accordingly, MID will prepare a Project Authorization for your approval to conduct such a study and prepare a report which will recommend the data elements and a procedure for collecting them. . JMErms AP00049076 INTEROFFICE MEMORANDUM To_______TSCA Compliance Committee From E. Blades__________________ Subject Date December 3, 1977 Notes on Conference Re Computerized Record Keeping ___________________ ______ (Location, Organisation, or Department) (Location, Organisation, or Department) Item 1 - Preparation For The Certification of Raw Materials Relative To fePA Inventory List There is a Commodity Classification Listing of all chemical raw materials purchased by Chemicals Group plants. These are listed in many cases by their Trade Mark name (e.g., Betz Slimtrol, Alipal C0433, etc.). The list is claimed to be comprehensive. A validation is possible and is in order. It is proposed that each item on this Classification Listing be keyed to the Chemical Abstract Service Registry Number (CAS No.), Although presently complete only for Chemicals Group, MID has a plan to compile a similar list for GEG. In order to accomplish the keying operation, existing data bases will be used to determine the potential for rapid accomplishment of the objective. Bases available are CAS, NLM, Nferck Index (manual). In addition, it is also proposed that APD products be included in the list with the ultimate objective to key all ingredients or raw materials to products. Item 2 - The Product List Attached is the abstracted information which J. Starr listed as required record keeping under TSCA. There are existing systems now which collect in the main business related information (e,g., COPIS, Spec. Gas List, GEG List) which are keyed to products only. It is thought that products need to be related to components which through the CAS Reg. No. will lead into available information on file both inside APD and in national systems and bases. The concept proposed is to develop a tystem or a series of systems which will collect and catalog data on a continuing basis. Then, when EPA (OTS) requests reports, the information will be readily accessable though not in a single organized package. continued {3201 AP00049077 ' Computerized Record Y-ping -2- Dec. 8, 1977 An internal code supplementing the CAS Registry No. will be required for mixtures not expected to receive CAS registration. ACTION: Joanne Egan/Tom Collins will prepare a proposal with objectives and expected costs. The proposal will contemplate the need to study the TSCA and from it predict the type of information which EPA (OTS) will require in the record-keeping system. To do this, MID will assign an individual to scope the situation through review of the act, the published opinions and ideas of the EPA, and discussion with appropriate individuals within and without the company. A plan will then be developed for presentation to the TSCA Committee for decision. Elements of such a plan would include: (i) A definition of the data elements required. (ii) A proposal for a technique to gather the data. (iii) An example of the steps envisioned in information retrieval to prepare a report. E, I. Handwerk will coordinate the study for the TSCA Chairman. CEBrsk End. cc: W. M.Smith J. C. Novak L. B. Tepper A. J. Diglio W. Ent R. Collins G. Handley R. Schenck J. Egan T. Collins E. I. Handwerk C. E. Blades AP00049078 REPROPOSED TIMETABLE THE FOLLOWING IS A REPROPOSED TIMETABLE TOR COMPLIANCE AS IT NOW STANDS: DECEMBER 23, 1977 JANUARY 1978 JANUARY 1, 1978 MAY 1, 1978 NOVEMBER 1978 DECEMBER 1978 my 1979 LATE 1979 FINAL INVENTORY REGULATIONS PUBLISHED. REPORTING FORMS FOR INITIAL INVENTORY MAILED TO SIC GROUPS 28 AND 2911 AND AVAILABLE FROM EPA. Q0M4FHCEMENT OF INVENTORY REPORTING. END OF INITIAL REPORTING PERIOD FOR THOSE WHO MUST REPORT. PUBLICATION OF INITIAL INVENTORY. THIRTY DAYS AFTER PUBLICATION OF INITIAL INVENTORY, PRE-MANUFAC1URE NOTIFICATION BEGINS TOR MANUFACTURERS AND IMPORTERS OF NEW CHEMICAL SUBSTANCES. DEADLINE FOR SUBMISSIONS TO REVISED INVENTORY. (210 days after initial invcntoiy is published) EPA PUBLISHING OF REVISED INVENTORY LIST*. 'X ./d H Z d d b RATF Jan. 12, 1978 TO: FROM: Distribution C. E. Blades TSCA BULLETIN NO.: 4S Distribution: w. M. Smith L. B. Tepper R. H. Schenck J. C. Novak A. J. Diglio R. Collins W. Ent G. Handley E. Kandwerk R. Fleming R. Scott J. Body A. I. Dalton H. Deitzer J. Pauloski R. Clark L. Iceman F. Sorg D. Harttor/D. Orr J. M. Bosch T. Coneybeer A. R. Adams J. Egan J. Urenovitch - Hometown J. L. Armstrong M. G. Zellner The attached is a condensation of the newly published rules for compiling the inventory of existing chemical substances under TSCA. Internal procedures and activity to collect the data and develop confidentiality documentation information will issue soon. CEB:sk Attachment C. E. Blades AP00049080 Jan. 12, 1978 MBDRANDUM TO TSCA FILE RE: TSCA INVENTORY REPORTING REQUIREMENTS The first meetings of the EPA Administrator's Toxic Substances Advisory Committee were held on November 50 and December 1. Tnis memorandum discusses the inventory reporting regulations (scheduled to go into effect on January 1, 1978) based upon information available to date. I. Inventory The newly revised timetable for preparation of the inventory of chemical substances is as follows: 12/23/77 Final reporting regulation published--Federal Register 1/1/78-5/1/78 Initial reporting period for chemical substances. 11/78 Publication of initial inventory of chemicals. 12/78-2/79 11/78 Pre-manufacture notification requirements begin for manufacturers and inporters (30 days after publication of initial inventory). Second reporting period; for processors or users of chemical substances which did not appear on the initial inventory, Processors and users are not subject to the pre-manufacture notification require ments during this 210 day period. 11/79 Publication of revised inventory of chemicals. -1- AP00049081 January 12, 19-78 Page 2 II. Scope o the Inventory The purpose of this inventory is to develop a comprehen sive list of chemical substances manufactured, importedor processed for commercial purposes. EPA's regulations define "chemical substances" as any organic or inorganic substance of a particular molecular identity including (a) any combination of such substances occurring in whole or in part as a result of a chemical reaction or occurring in nature and (b) any chemical element or uncom bined radical, and (c) except that chemical sub stance does not include: 1. any mixture 2. any pesticide when manufactured, processed, or distributed in commerce for use as a pesticide 3. tobacco or any tobacco product, but not in cluding any derivative products 4. any nuclear source material, special nuclear material, or nuclear byproduct material 5. any pistol, firearm, revolver, shells, and cartridges 6. any food, food additive, drug, cosmetic, or device, when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic, or device. A chemical substance is manufactured, imported or processed, for a commercial purpose if: 1. It is distributed in commerce 2. It is used as a catalyst or intermediate {chemicals deliberately present in a reac tion sequence used to manufacture or pro cess another chemical substance) 3. It is used either by the manufacturer or for test marketing. AP00049082 -January 12, 1C 73 Page 3 There are several exceptions to the broad reporting require ments defined by these regulations: 1. EPA will automatically include in the inventory naturally occurring chemical substances such as air, water, crude oil, rocks, minerals, ores, etc. 2. Substances solely imported, manufactured, or processed in small quantities for research and development may not be reported. These quantities must be not greater than the minimum necessary for such research. When the pre-manu facture notification requirements become effec tive, these substances may be used only under the direct supervision of a technically quali fied individual. 3. EPA has excluded certain substances from both the inventory reporting requirements and pre manufacture notification requirements. a. Impurities (chemical substances uninten tionally present with another chemical substance) b. Byproducts with no commercial value (by products with value as fuel, landfill or for extraction of marketable components may be included on the inventory) c. Chemical substances which result from chemical reactions which occur during exposure to the environment, storage or end use. This exemption would include dried paint and adhesive, for example. d. Chemical substances which result from chemical reactions occurring during the use of substances such as lubricants, fire retardants, etc., to impart specific characteristics to other materials. e. Chemical substances used to manufacture an article destined for the marketplace without further chemical change (except AP00049083 January 12, 19.78 Page 4 'those changes mentioned above). For the purposes of this section, an article is defined as a manufactured article with a specific shape and design and a func tional end use dependant upon that shape and design. A substance classified as an article may not change its chemical composition during its end use. Fluids and particles are specifically excluded from this classification. Ill. Reporting Requirements A. Manufacturers must report ALL chemical substances at each plant site in 1977 ~i f: 1. 30 percent of the company 1 s products are chemical substances; or 2. The company produces 1 million or more pounds of chemical substances. B. Manufacturers must report ANY chemical substance produced in quantities of over lOOrOOO oounds in 1977. C. Importers must report ALL chemical substances imported iT~: 1. 30 percent of the company's imports are chemical substances; or 2. The company imports 1 million pounds or more of chemical substances. D. Importers must report ANY chemical substance im ported. in quantities of over 100,000 pounds in 1977. E. Manufacturers and importers may report all chem icals produced or imported since January 1, 1975. EPA representatives noted that manufacturers and im porters should insure that substances they produce or import appear on the inventory since all sub stances not on the inventory will be subject to the stringent pre-manufacture notification APOOC January 12, 197.8 Page 5 requirements. Thus,.even manufacturers or importers not classified as chemical producers may wish to report their products. F. EPA has made several changes in the August 2 in ventory reporting requirements in preparation for the publication of final regulations in the near future. The following are some of the highlights: 1. In the proposed regulations, all inter mediate chemicals (see definition page 2) would have been subject to the re porting requirements. Under the final regulations, the manufacturer will nave to report only those chemicals removed from the equipment in which they are manufactured (i.e., isolated sub stances ) . 2. In the proposed regulations, manufac turers would have been required to report specific production volumes. The new forms apparently will require the manu facturer (or importer) to identify a chemical's production volume by selecting one of a series of ranges provided by EPA (0-1,000 pounds, 1,000-10,000 pounds, etc.). 3. There have been several changes in the reporting requirements for imports. tiuix imports will be subject to the same treatment as chemical substances manu factured in the United States. Importers need not report the components of mix tures, but new mixtures will have to be reported. Reporting the chemical con stituents of imported articles will be voluntary pending a final decision about which components must be reported. 4. For the purposes of this inventory only, small businesses will be defined a? companies with annual sales below SS?-M. AP00049085 January 12, 197S Pago 6 . Companies which qualify as small businesses will not be required to pinpoint the production volume range for their products, so long as the plant produces under 100,000 pounds of the substance. If production is greater than 100,000 pounds, the exact range of production volume must be designated. G. All information required by the inventory reporting regulations must be provided to EPA, but the manu facturer or importer has the option of designating any or all of the data as confidential. Since EPA's goal is to make the public inventory as com plete as possible, all claims of confidentiality with respect to a chemical's identity will be evaluated during the processing of inventory forms. All other inventory information claimed as confi dential will be treated as confidential by EPA until the claim is evaluated as a result of an FOIA request or an internal decision that the information should be made public. The criteria for confiden tiality decisions will be the general criteria elaborated by EPA in October, 1976. Final confi dentiality regulations have not yet been proposed under TOSCA. --* / Substantiation for these claims must be filed with the inventory reporting forms. AP00049086 TSCA CALENDAR 1978 JAN. FEB. MARCH APRIL MAY JUNE JULY AUG. SEPT. OCT. NOV. DEC. DEADLINE FOR INVENTORY SUBMITTALS (SIC 28 or 2911) REQUEST FOR TEST DATA ON PRIORITY- CHEMICALS DEC. 23, 1977 FINAL INVENTORY RULES PUBLISHED TESTING RULES FOR PRIORITY CHEMICALS GUIDELINES FOR PREMARKET NOTIFICATION INVENTORY PUBLISHED PREMARKET NOTIFICATION BEGINS FOR NEW PRODUCTS fit- AP00049087 MEMBER ASSIGNMENTS APPENDIX F 1. C. E. BLADES Overall administration of TSCA Compliance Education of the Company personnel. Awareness Meetings. 2. R. H. SCHENCK Legal Counsel and advisor to Chairman. Interpretation of the Law, the Regulations and Rules re TSCA. Guidance and approval for comments and submissions to EPA. 3. W. M. SMITH Senior Technical Advisor - Chemicals Group Coordination Industry Liaison. Regulatory awareness. 4. xj. B. TEPPER Medical and toxicological advisor. Industrial Health. Medical Health Records. 5. A. J. DIGLIQ Chemicals Group environmental affairs advisor. Significant Adverse Reactions tor Chemicals Group. 6. G. G. HANDLEY GEG Environmental Affairs Advisor. Significant Adverse Reactions Reports for GEG. . Watchdog for CSD relations with TSCA. AP00049088 Member Assignments - Continued 7. W. ENT IGD (including Spec. Gases MPD) representative. Watchdog for IGD relations with TSCA. GEG organizational advisor. 8. R, COLLINS NED Representative Watchdog for MSD relations with TSCA. 9. J. H. BODT, M. G. ZELLNER, A. I. DALTON, J. EGAN Ex-officio observers for correlation and assistance as needed. AP00049089