Document bBk9BLazKddyy22KDX8yq0Dm6

TUESDAY, OCTOBER 24,1978 PART IV PLAINTIFF'S EXHIBIT KM-375 ENVIRONMENTAL PROTECTION AGENCY TOXIC SUBSTANCES CONTROL ACT Policy for Revised Inventory Reporting; Draft Report Form VGA* 49688 [6560-01-M] ENVIRONMENTAL PROTECTION AGENCY Offie* of Toxic Subttonces [FRL-993-5; OTS-081002C) POLICY FOR REPORTING FOR THE REVISED INVENTORY DRAFT REPORT FORM AGENCY: Environmental Protection Agency. ACTION: Policy for Revised Inventory Reporting; draft report form. SUMMARY: The inventory reporting regulations, promulgated under the authority of the Toxic Substances Control Act (TSCA), govern the re porting of chemical substances to create an Inventory of chemical sub stances manufactured, imported, or processed in the United States for a commercial purpose. Under these reg ulations the Inventory will be com piled in two phases. In early 1979, the Agency will publish an Initial Inven tory of Chemical Substances manufac tured or imported for a commercial purpose since January 1, 1975. Follow ing publication of the Initial Inven tory, there will be a special, 210-day period during which processors and certain importers of chemical sub stances will have an opportunity to add substances to the Inventory in order to insure compliance with TSCA. This second phase will result in publication of a Revised Inventory sometime in 1980. This notice addresses Agency policy concerning reporting for the Revised Inventory and proposes a draft report form for public comment. In addition, persons may use the coupon provided in this notice to reserve a copy of the Initial Inventory in printed form or microfiche. EPA will publish another notice in the Federal Register to an nounce the beginning of the 210-day reporting period. DATES AND ADDRESS: Comments on the proposed report form must be received on or before December 8, 1978, and should be addressed to: Ms. Joyce Barbour. U.S. Environmental Protection Agency, Office of Toxic Substances (TS-793), 401 M Street SW,, Washington, D.C., 20460. Com ments should bear the identifying no tation OTS-081002C. All written com ments filed pursuant to this notice will be available for public Inspection at the above address in room 711A, East Tower, from 8 a.m. to 4 p.m. Monday through Friday. FOR FURTHER INFORMATION CONTACT: Director, Industry Assistance Office, Office of Toxic Substances (TS-788), Environmental Protection Agency. 401 M Street SW,, Washington, D.C., NOTICES 20460. Or call the toll-free number, 800-424-9065. In Washington, D.C., please call 554-1404. Applications for reserving copies of the Initial Inven tory should be sent to the above ad dress. Persons who wish to receive copies ' of the Inventory reporting regulations and supplements to the regulations should call the toll-free number listed above. SUPPLEMENTARY INFORMATION: The Inventory reporting regulations (40 CFR Part 710) were promulgated under the authority of section 8(a) of the Toxic Substances Control Act (90 Stat. 2003; 15 U.S.C. 2601 et seq.) here inafter referred to as TSCA. These regulations were published in the Fed eral Register on December 23, 1977 (42 FR 64572), and were supplemented on March 6. 1978 (48 FR 9254) and April 17. 1978 (43 FR 16178). The reg ulations implemented section 8(b) of TSCA. which requires the Administra tor of the Environmental Protection Agency (EPA) to compile, keep cur rent, and publish a list of chemical substances manufactured, imported, or processed in the United States for a commercial purpose. Section 710.6 of the Inventory re porting regulations establishes a twophase reporting schedule designed to prevent duplicative reporting. During the initial reporting period, which ended on May 1. 1978, certain manu facturers and importers reported to EPA concerning chemical substances they manufactured or imported for a commercial purpose since January 1. 1975. Based on these reports, EPA will publish an Initial Inventory early in 1979. Persons who begin manufacture or importation of a chemical substance after May 1. 1978, are permitted to report that substance for the Inven tory up to 30 days after publication of the Initial Inventory. At that time the premanufacture notification require ments of section 5(a)(1)(A) of TSCA will take effect for all persons who in tended to manufacture or import (in bulk form), for a commercial purpose, a chemical substance not included on the Initial Inventory. Rules governing premanufacture notification are cur rently being developed by EPA and will be proposed in the Federal Regis ter for public comment. A second reporting period lasting 210 days will begin when the Initial Inventory is published. During this period, a person may report a chemical substance that was not included on the Initial Inventory if the person has processed or used the chemical sub stance (including use in the manufac ture of a mixture or article containing the chemical substance) for a commer cial purpose since January I, 1975, or the person has imported the substance as part of a mixture or article for a commercial purpose since January 1, 1975. A manufacturer or importer (in bulk) of a chemical substance for a commercial purpose may not report for the Revised Inventory; he is sub ject to premanufacture notification re quirements 30 days after the Initial Inventory is published. Reporting by processors and users for the Revised Inventory is solely intended to supple ment the Initial Inventory. EPA will publish one or more supplements to the Initial Inventory during the re vised Inventory reporting period. These supplements will include sub stances that were omitted from the Initial Inventory due to late reporting or errors, substances reported for the Revised Inventory, and substances that have completed premanufacture review. The Agency expects to publish the Revised Inventory sometime in 1980. After publication of the Revised In ventory, it will become unlawful for any person to process or use for a com mercial purpose a chemical substance that was.manufactured or processed in violation of section 5 of TSCA. Thirty days after publication of the Revised Inventory, the premanufacture notifi cation requirements of section 5 of TSCA will be applied to importers of new chemical substances as part of mixtures. Imported Articles In the near future EPA will issue proposed rules to govern the premanu facture notification review program under TSCA. These proposed rules would maintain the policy established under the Inventory reporting regula tions with respect to the premanufac ture notification requirements for im porters of chemical substances. Under this policy, set forth in the Federal Register on October 3. 1977 (14 FR 53804), December 23, 1977 (42 FR 64572), and March' 6, 1978 (43 FR 9254), premanufacture notification ini tially will apply only to importation of new chemical substances in bulk form (30 days after publication of the Ini tial Inventory) and to importation of new chemical substances as part of mixtures (30 days after publication of the Revised Inventory). Importers of chemical substances as part of articles will not be subject to premanufacture notification requirements at this time. However, at a later date the Agency may propose to apply premanufacture notification requirements to certain categories of chemical substances im ported as part of articles after provid ing importers an opportunity to report existing substances falling within such categories for inclusion on the Inven tory. The proposal would be followed by a public comment period prior to any change in the Agency's current policy. EPA continues to welcome comments on this issue. FEDERAL REGISTER, VOL. 43, NO. 206--TUESDAY, OCTOBER 24, 1978 NOTICES 49689 Processors and Users For purposes of the Inventory re porting regulations, "processors" and "users" of chemical substances "for commercial purposes" are persons who (1) prepare for distribution in com merce or (2) use as an intermediate a chemical substance that has already been manufactured. (See 710.2 (t), (u). and (v)). Examples are persons who use chemical substances to manu facture mixtures or articles and per sons who grind, pulverize, blend, or re package chemical substances for a commercial purpose. A person who uses a chemical substance as an inter mediate in the intentional manufac ture of another chemical substance is considered a processor of the interme diate. EPA wishes to emphasize that pro- ccMotw mid users of chemical sub stances are not required to report sub stances for the Inventory. The Revised Inventory reporting period is an op portunity for them to add to the In ventory substances that may not have been reported by a manufacturer of importer, in order to insure a continu ing supply of a particular substance and avoid penalties under TSCA. Once a chemical substance has been report ed by a processor or user and included on the Inventory, it may be manufac tured or imported for a commercial purpose without going through pre manufacture notification. Reporting Trademarks Chemical substances reported for the Revised Inventory must qualify as "reportable chemical substances" (see Chapter II, "Reporting for the Chemi cal Substance Inventory," (December 1977)), and must not be included on the Initial Inventory. All reported substances must be identified as specifically as possible. EPA will not process report forms on which a substance is identified only by a trademark or brand name. However, EPA recognizes that processors may know certain products only by a trade mark or brand name (e.g., "Brand X"). Such products may be comprised of one or more reportable chemical sub stances. Processors should either de termine that the component sub stances are included on the Initial In ventory and therefore should not be reported, or obtain the specific identi ties of the substances from the suppli er and report them for inclusion on the Revised Inventory. The procedure outlined below should assist processors in obtaining this information. To determine whether the sub stances comprising a trademarked product are included on the Initial In ventory, a processor should first con sult the Product Trademark List. This list, which is currently being compiled from Form D reports submitted during the initial reporting period, will be available in advance of the Initial In ventory. Manufacturers who reported their product trademarks for inclusion on this list were required to certify that all reportable chemical sub stances comprising the trademarked product had been reported for the Ini tial Inventory. Processors who report ed product trademarks were required to certify that any component chemi cal substance not reported for the Ini tial Inventory would be reported by them for the Revised Inventory. (Refer to 43 FR 9254, March 6. 1978.) Therefore, if a trademark appears on the Product Trademark List the com ponent chemical substances should not be reported for the Revised Inven tory by anyone other than the person who reported the trademark. Reporting of trademarks for inclu sion on the Product Trademark List was strictly voluntary. Therefore, not all eligible trademarks will be included on the list. If a trademarked product does not appear on the Product Trade mark List, a processor should ask his supplier to (1) provide him with a letter certifying that all reportable chemical substances comprising the trademarked product have been re ported for the Inventory, or (2) reveal to the processor the identity of the component substances so that the pro cessor may determine whether or not the substances are reportable, and, it they are. report them for the Revised Inventory. If the supplier refuses to do either of the above, the processor should submit a report form to EPA, providing the name and address of the supplier and the name of the trade marked product, and . indicating that his supplier has refused to provide him the information necessary to de termine whether he should report for the Revised Inventory. EPA will then attempt to obtain the necessary infor mation directly from the supplier. An importer of a chemical substance as part of a mixture or article may not know the true identity of the chemical substance because the foreign supplier may choose to keep it confidential. In this situation, the Importer may be as sisted in reporting by the foreign sup plier, who would report the substance identity directly to EPA. EPA has es tablished a procedure for reporting in this manner in the instruction booklet "Reporting for the Chemical Sub stance Inventory" (December 1977). A revised edition of this booklet will be available in advance of publication of the Initial Inventory. Draft Report Form EPA is proposing a single report form to be used in reporting for the Revised Inventory. This form, on which one chemical substance may be reported, would replace Forms A, B, and C, which were used during the Ini tial Inventory reporting period. This single form approach represents a slight deviation from {710.5(b) of the Inventory reporting regulations, which specifies use of three separate forms depending on whether (1) the substance appeared on the TSCA Can didate List of Chemical Substances (Form A), (2) the substance did not appear on the Candidate List but had a Chemical Abstracts Service (CAS) Registry Number (Form B), or (3) the substance had no CAS Registry Number or the substance identity was claimed as confidential (Form C). The draft form is essentially a revised From C, and would be used to report a chemical substance that falls within any of the above three categories. EPA expects to receive reports on relatively few chemical substances during the Revised Inventory report ing period. Most of the substances eli gible for inclusion on the Inventory should have been reported by their manufacturers and importers during the initial reporting period. The large number of substances reported during this period justified the printing and distribution of three separate forms, two of which were designed to allow reporting of several substances on a single form. There should be few cases in which a processor reports a chemi cal substance not reported by a manu facturer or importer during the initial reporting period. In addition, persons who import chemical substances as part of mixtures or articles had the option of reporting during the initial reporting period, and are expected to add relatively few substances to the Inventory during the Revised Inven tory reporting period. Therefore, EPA has determined that three separate forms would not be necessary and that a single form should be adequate for Revised Inventory reporting. The Agency specifically welcomes comment on the report form. I. Certification Statement The Revised Inventory report form must be signed by a responsible com pany official, attesting to the trust of the following certification statement: "I hereby certify that, to the best of my knowledge and belief: (1) The chemical substance Identified below (a) is not included on the Initial Inven tory, (b) is eligible for Inclusion on the Revised Inventory under 40 CFR 710.3(b) as it has been processed or used for a commercial purpose since January 1, 1975, or has been imported as part of a mixture or article for a commercial purpose since January 1, 1975, and (c) was not manufactured or imported (in bulk form) for a commer cial purpose for the first time after the effective date of premanufacture notification requirements for manu FEDERAL REGISTER,'VOL 43, NO. 206--TUESDAY, OCTOBER 24, 1978 49690 NOTICES facturers of chemical substances and importers of chemical substances in bulk form; (2) all information entered on this form is complete and accurate; and (3) the confidentiality statements on the back of this form are true as to that information for which I have as serted a confidentiality claim. I agree to permit access to, and the copying of. records by a duly authorzed repre sentative of the EPA Administrator, in accordance with the Toxic Substances Control Act, to document any infor mation reported here." A foreign supplier who assists an im porter in reporting a substance for the Inventory must also sign the fom at testing to the completeness and accu racy of all Information he provides on behalf of the importer. A trade associ ation or other agent reporting on behalf of a person must follow the procedures of 710.5(f) of the inven tory reporting regulations. II. Required Information Persons who choose to report for the Revised Inventory must provide the following information on the form: (1) The name and address of the report ing company (or corporation, trade as sociation or other agent); (2) the spe cific identity of the chemical sub stance (including its CAS Registry Number, if known); and (3) the activi ty the reporting company is engaged in with respect to the chemical sub stance (i.e., "process" or "import"). Persons should also provide the name, address, and phone number of a prin cipal technical contact, whom EPA may contact to clarify any information submitted on the form. Detailed instructions for completing the form will be distributed with the forms, and will follow the approach of the in struction booklet for the Initial Inven tory, "Reporting for the Chemical Substance Inventory" (December 1977). III. Confidentiality Section 710.7 of the inventory re porting regulations outlines the confi dentiality provisions. A processor or importer may claim as confidential whether he processes or imports the chemical substance by checking the box labeled "Activity" under the head ing "Confidentiality Claims." In addi tion, he may claim as confidential the link between his company and the chemical substance by checking the box labeled "Company" under the same heading. By signing the certifica tion statement,, he attests to the trust of the following confidentiality state ments appearing on the back of the form. 1. My company has taken measures to protect the confidentiality of the information, and it intends to continue to take such measures. 2. The information is not, and has not been, reasonably obtainable with out our consent by other persons (other than governmental bodies) by use of legitimate means (other than discovery based on a showing of spe cial need in a judicial or quasi-judicial proceeding). 3. The information is not publicly available elsewhere. 4. Disclosure of the Information would cause substantial harm to our competitive position. In accordance with {710.7(e) of the inventory, reporting regulations, a person may claim the specific .identity of a chemical substance as confidential if such person believes that Inclusion of the specific chemical identity on the Inventory would reveal the trade secret fact that the particular sub stance is manufactured, imported, or processed by anyone for a commercial purpose. Such claims must be substan tiated in writing, addressing the points specified in the instruction manual, "Reporting for the Chemical Sub stance Inventory." The person must also propose a generic (less specific) chemical name for the substance and agree to certain other provisions of 710.7(e) of the regulations..Such per sons should adhere to the procedures detailed in the EPA document "Guide lines for Creating Proposed Generic Names for Confidential Chemical Sub stance Identities for the TSCA Inven tory," which may be obtained from the Industry Assistance Office by call ing the toll-free number listed at the beginning of this notice. If EPA deter mines that the specific substance iden tity is entitled to confidential treat ment, the specific identity will not be included on the published Inventory. Rather, EPA will publish a generic chemical name for the substance in the Confidential Chemical Substance Appendix to the Inventory. Reserving a Copy or the Inventory Persons who reported chemical sub stances for the Initial Inventory and persons who have the opportunity to make additions to the Inventory during the second reporting period should carefully examine the Initial Inventory for completeness and accu racy. FTocessors and importers who may report for the Revised Inventory should consult the Product Trademark Ust in addition to the Initial Inven tory. The Product Trademark List will be available in advance of the Initial Inventory, and may be obtained from EPA's Industry Assistance Office by completing the coupon provided in this notice. Persons who are interested in obtaining a copy of the Product Trademark list only are encouraged to check the appropriate box on the coupon. Persons who reserve a copy of the complete Initial Inventory will automatically receive a copy of the Product Trademark List. Because of the anticipated size of the Initial Inventory and the large number of copies EPA expects to make available, printing and distribution costs will be very high. EPA will take the following measures to keep the cost as low as possible: (1) EPA will provide one free copy of the Initial Inventory, in printed form or microfiche, to each company, corpo ration (or subsidiary, division or major department of a large corporation), or interested organization while supplies last. EPA encourages persons to re quest microfiche copies wherever equipment permits, since these copies are less expensive to print and distrib ute. (2) EPA will place reference copies of the Initial Inventory, in printed form or microfiche (as equipment per mits) in the libraries of all large cities, GPO regional depository libraries. State environmental offices, and EPA regional offices. Persons requiring minimal access to the Inventory are encouraged to make use of reference copies, rather than ordering a com plete copy of the Inventory from EPA. (3) Additional copies of the Initial Inventory will be available in printed form and microfiche through the Gov ernment Printing Office (GPO) or other source at a cost to be specified later. ~ (4) A computer readable version of the Initial Inventory will be available at a cost to be specified later. In order to determine the number of copies of the Initial Inventory EPA needs to print in hard copy and on mi crofiche. affected persons are encour aged to complete the coupon below and mail it to the Industry Assistance Office by November 30, 1978. A com pany that reserves a copy of the Ini tial Inventory in this manner can expect to receive its free copy auto matically after the Inventory is pub lished. Dated: October 18, 1978. Steven D. Jelunsk. Assistance Administrator for Toxic Substances. FEDERAL REGISTER, VOL. 43, NO. 206--TUESDAY, OCTOBER 24, 19ft [6560-01-C] NOTICES Initial Inventory (TS-799) Industry Assistance Office E.P.A. 401 Ystreet, S.W. Washington, D.C. 20460 _______ (Date) Please reserve one (1) copy of (check one): complete Initial TSCA Chemical Substance Inventory, or Product Trademark List only in (check one): o Printed Form Microfiche for: (Name) (Company) (Address or P.O. Box) (City) (State) TzTpT My company is a: manufacturer processor importer of chemical substances or other (please check one or more as appropriate). (Signature) 49691 EPA Form 7710-23 (10-78) FEDEKAl REGISTER, VOL 43, NO. 206--TUESDAY, OCTOBER 24, 197S 49692 IVPOPTANT. CBft*wi'v NOTICES e*4 Bvcw-ono* *fOon**i fC* :** One Time (Expires Jan. 1, 1979) EPA Form 7710-A [FR Doc. 78-29874 Filed 10-23-78; 8:45 am] FEDERAL REGISTER, VOL 43, NO. 306--TUESDAY, OCTOBER 24, 1978 JstT 'l i if i /**5I United States Environmental Protection Agency Washington OC 20480 Official Business Penalty for Private Use $300 TS-799 e 3Poli79oOOfl2 OOiMtJoOOOO OOl OOUQ MERRlUi ' i Paco tenTUrs 987 B0MM6RC6 ST SAN 8ARL0S CA 94078 If your address is incorrect or you do not wish to he on our mailing list return the above label to us with your instructions. Send the label not a I reproduction of the label. _____________ h