Document wqBgaMV4xZ1Mr2Y2Bk1rj6R2D

TO: TSCA COMPLIANCE CmtlTTEE FROM: C. E. BLADES cc: W. x< Smith L. Teppor J R, H. Sdienck^ J. C. Novak A. J. Diglio R. Collins W. Ent G. Handley E, Hcuiuiwt,i">c . J. Starr R. Fleming DATE; Sept. 8, 1977 TSCA BULLETIN NO. 17 Four forms_ (Form A, Form B, Form C, Form D) are proposed by EPA for reporting chemical substances according to reproposed rules (Aug. z, 1977). Form A - For substances on the Candidate List (Strawman). Form B - For substances not found on Candidate List but which have an assigned CAS Registry No. Form C - For Confidential or for substances with no assigned CAS Registry No. Form D - Voluntary reporting of product trademarks to certify all - . ingredients have been reported elsewhere in the inventory. Details available from TSCA Chairman (C. . Blades). CEB:sk Enel. 12 J977 ^AVV DEPT. AP00049159 rr* A Current Report Reporting EPA PROPOSES TRADEMARK LIST TO CERTIFY INVENTORY INCLUSION Reporting of commercial products by trademark names with a certification that all constituents have been included in the inventory list of chemical substances required under the Toxic Substances Control Act was proposed by the En vironmental Protection Agency August 24. The proposal was presented at a public meeting in Washington held to hear comments on CPA's reproposed in ventory reporting regulations (Current Report, July 29, pp. 695, 710). Cynthia Kelly, chairman of the inventory work group in the Office of Toxic Substances, presented drafts of four reporting forms (see Full Text section of this issue) for public comment. Forms A and B are revisions of forms in cluded in the originally proposed regulations (March 18, p. 3). Forms C and D are new. Proposed Form A would be used to report chemicals in cluded on the EPA candidate list {April 22. p. 161). Repor ting would be done by Chemical Abstracts Service Registry Number and the EPA code designation printed in the can didate list, which is used to verify the accuracy of the CAS number. Proposed Form B would be used for substances not included on the candidate list but which do have a CAS number. Proposed Form C would be used for substances for which there is a request that the identity be kept confidential and/or for which no CAS number is known. Proposed Form D would be for voluntary reporting of product trademarks to certify that all ingredients have been reported for inventory in compliance with TSCA. Kelly noted that not ail substances included in the can didate list will be on the inventory list. Items that will be automatically included are spelled out in the reproposed regulations. Apart from these, it is the responsibility of manufacturers to make sure that their products are includ ed. Principe! Issues The main issues discussed at the meeting concerned the depth and detail to which reporting should be done, definitions of and responsibilities of small manufacturers, and various confidentiality issues -- what can be claimed as confidential and how confidentiality can be maintained and assured. The divergence of views among regulators, those who would be regulated, and public-interest groups was marked. Representatives of chemical companies argued that re quirements for reporting of production site and volume con tained in the reproposed regulations went beyond the congressional intent for inventory reporting authorized by Section 8 (b) of TSCA. They said reporting of use. volume, exposures, and health effects is separately authorized under Section 8 (a) of TSCA and that by mixing the two, EPA is go ing beyond its authority and collecting useless data on chemicals that do not pose a threat to health or the environ ment. Jackie Warren, Environmental Defense Fund, said there was nothing illegal about EPA's combining authority under Sections 8 (a) and 8 (b) and that the clear intent of Congress was for EPA to have information on which to base regulatory decisions and that this should certainly include site and volume data. Warren said that EDF would haix- preferred the inclusion of use data as well. On the matter of confidentiality, I^ouis Slesin, .Witursl Resources Defense Council, was hissed and jeered he said that the Act won't work if data are kept secret. said .NRDC would obj'ect to secrecy, in the strongest possible terms. Chemical company representatives testified that site-specific data is highly variable, ephemeral, fluctuates with supplies and markets, and must be kept confidential ior the viability of business operations. OSHA Testimony Tiie lead witness was Grover Wrenn, deputy director of the health standards program. Occupational Safety and Health Administration. Wrenn said OSHA had been working closely with EPA in the development of the regulations, and ne com mended EPA for the reproposed regulations. He said mat volume and plant-site data were urgently needed to allow rapid response in emergencies. He said such data could r'.so be used to schedule health inspections of high-risk chemicals. Wrenn urged that emergency reporting be required regardless of the size of the manufacturer and S3id that CSHA urges reconsideration of small-manufacturer exemp tions contained in the proposed regulations because data from small manufacturers would provide "useful infor mation.'' Wrenn also said that OSHA strongiy supported a proposal that claims of confidentiality accompany data, rather than being submitted separately later. Small Manufacturers Robert Polack, general counsel of Reilly Tar 3rd Chemical Corporation appeared on behalf of the Synthetic Organic Chemical Manufacturers Association. He sat/, that SOCMA's membership objected strongiy to the 'Cvs'-iy ar.d largely unnecessary burden" that would be caused by the proposed regulations. The regulations define, for purposes of inventory report ing, a small manufacturer as one "who <aJ has only a smz'.e manufacturing site, and either (b) has total annual sales of less than 3100,000, based on the manufacturer's latest com plete fiscal year or (c) has no more than 2,OQO pounds annuai production (i.e., amount manufactured and imported) of each manufactured chemical substance." Polack said, "The proposed 5100,000 total sales limitation is not only ridiculously low in light of the burdensome nature of the reporting requirements, but also so low that it will ex clude virtually all small manufacturing companies. It she .11 be noted that the statement in the preamble [to the proposed regulations) that as many as 20 percent of the manufac turers in SiC 28 have sales of less than 5100,000 is simply in correct." The proposed regulations would require inventory repor ting only by industries in Standard industrial Classifications 28 (chemical and allied products) and 2911 (petroleum refining). Polack said thatSIC 28,includes processors as well as manufacturers. He said that SOCMA was unaware of any of its members who are manufacturers who could meet the proposed sales limit. Polack said that the 2,000-pound limit on production volume is "even more absurd," and said that SOCMA was Capyrighi 1977 by The Bureau of Na'ionol Affair*, Inc. CtfBM. 0E6. &ePo/tT%- f/iiA, AP00049160 CHEMICAL REGULATION RtPORTun unaware of any company al. whose products are produced in quantities of 2.000 pounds or less. Presenting SOCMA's recommendations. Polack said. "V.'e urge that a firm be considered a small manufacturer if it meets any of the following three criteria. 1. Sates of less than 530 million in its last fiscal year, or 2, Less than 300 employees, or 3. Less than 515 million in assets.'' David Gleason, manager of sales and marketing for Hardwicfce Chemical Company. Elgin, S.C.. also said he knew of no company that could qualify as a small manufac turer either through the $100,000 total sales limitation or the 2,000-pound production limit. He said that his company qualified as a small business within the Federal Government as defined by the Small Business Administration. The current sire of the company is 65-75 employees with annual sales between 59 and 511 million. Gleeson said, and he added that even in its first year of operation when it had eight employees, It could not have qualified under the criteria proposed In the regulations. Gleeson said that in his company all personnel have line duties and that no one is assigned full-time to administrative affairs or regulatory compliance. He said that his company is currently spending $4,635 per employee annually to meet regulatory requirements, which is more than the company spends on the employee benefit package that includes group medical and life insurance, retirement plans, social securi ty, and other employee benefits. Gleeson estimated that to comply with the reproposed in ventory regulations his company will have to spend an ad ditional $75,000-$100,000. Confidentiality ' Gleeson also said, "I would also point out that disclosure of our captive intermediates is a threat to our existence. Several of our processes are proprietary and confidential due to the nature of our technology. Disclosure of these In termediates could reveal to a potential competitor both raw materials used and the nature of the technology. Loss of our confidential technology could well mean the end of our com pany. "We feel it is imperative our confidential data be protected and seriously question EPA's ability to provide that protection. Further, can SPA guarantee that other federal agencies, i.e., the Food and Drug Administration, OSHA, and the Consumer Product Safety Commission will be bound by the same claims of confidentiality as EPA is un der TSCA? We recommend: that any chemical identity be entitled to confidential treatment; that the inventory be published with nonconfidential chemicals or code numbers for confidential entities; that any company, organization, or person inquiring of a product on the inventory list certify their intent to manufacture said product and; that requests for confidential data be denied." When you c .der that even a small manufacturer mav produce 50 products, each one of which may include several 'isolatable* intermediates in its production, the potential cost of this reporting program will be considerable, far in ex cess of its value to those receiving the reports. "One of the principal reasons for the high cost of com pliance is tliat the proposed regulations require chemical manufacturers to report not only what products they moke, but also each 'isolatable intermediate' winch occurs in the reaction sequence leading up to the final product. Ln many cases, information on Lhe identity of these intermediates is not readily available. What information is available will have to be compiled and checked by somebody with a background In chemistry equivalent to a doctor's degree." Polack and other industry witnesses recommended '-hat the definition should apply to substances that actually are isolated and produced for use or distribution in commerce, rather than to substances that could be isolated. MCA Testimony Curtis W. Smith, representing the Manufacturing Chemists Association, said MCA would have further written comments for EPA and summarized MCA's recommen dations as follows: Regulation of new uses would be premature: Clarification of the relationship between inventory reporting and pre-manufacturing notice is required; Production reporting should be in ranges by powers of 10, i.e., 1,000 pounds to 10,000 pounds, 10,000 pounds to 100,000 pounds, etc. Post-inventory reporting procedures should allow for Inclusion in the inventory where good cause for failure to report can be demonstrated; Persons outside SIC groups 2? and 2911 should also have responsibility for assuring that their products appear on Lhe inventory; Ail changes since the original proposal of the regulations in March should be subject to comment; MCA assumes that intermediates of pesticides and FDA-regulated materials are exempt from TSCA and re quests clarification of this point if it is needed: Clarification of the distinction between manufacturers of mixtures and chemical processors is required: If computer-tape reporting is permitted, EPA should publish the format; MCA support the definition of small manufacturer presented in SOCMA testimony; Expansion of the inventory to include site and volume data will create substantial problems with respect to the protection of confidential information. MCA recommends that EPA develop strict computer-security procedure to pre vent the dlvulgence of unauthorized information. Intermediates The reproposed regulations define an intermediate as "any chemical substance (a) which is deliberately present in a chemical reaction sequence used to manufacture or process another chemical substance, (b) whose presence is known or reasonably ascertainable, and (c) which could be isolated and identified under conditions which are practical ly encountered in the environment." Polack, in his testimony for SOCMA said, "Several members of SOCMA. including Reilly Tar and Chemical Cor poration, estimated that complying with the original inven tory reporting requirements would cost between $175-5200 per chemical. We estimate that obtaining and providing production data for each of those chemicals will raise the cost twofold, to approximately 5300-5409 per chemical. What Next? Written comments may be submitted on the reproposed regulations until September 16, 1977. They should be sent to Vicki Briggs. EPA Office of Toxic Substances fWH-557;. 401 M St.. S.W., Washington, D.C, 20450, in triplicate with the identifying number OTS-0810D02, In November the final regulations should be published, and reporting forms will be mailed to SIC Groups 23 and 2311. The reporting period will end 90 days after the final regulations are published, so that reports should be in in February 1978, In the summer of I97B the inventory will be published and a 120-day. period will start during which processors may report chemical substances not on the inventory. Premanufacturing notification begins 30 days after publication of the inventory, presumably in the fall of 1378. Chemical Regulation Reporter I AP00049161 'T^lOc/ucM- and C/lCmica& TO: TSCA COMPLIANCE CONMITTEE FROM: C. E. BLADES_____________ cc: W. 'L L. . j r. h. J. C. A. J- Smj.th Tapper .^riT^nri- Novak Diglio R, Collins W. Ent g. riandley E. t tandwe rk J, Starr R. Fleming DATE: Sept. 3, 1977 C- 3 r TSCA BULLETIN NO. 18 Substantial risk definitions and guidelines appeaT to be in process of development." The attached extract from Chemical Regulation Reporter (Aug. 19, 1977) gives some idea of EPA thinking. The overlap between "Substantial Risk" and "Significant Adverse Reactions" records is also surfacing. CEB:sk Ends. C. E. Blades AP00049162 cstici orke' UK IREU 4i|U* CURRENT REPORT 79 The study, which followed 3,070 workers exposed lo issued soon by the Environmental Protection Agency, acco- beryllium some time between January l, 1942, ami ding to Edward Brooks of the EPA Office of Toxi December 31, 1967, will be cited by NIOSII in testimony at a Sub.sLmces. public hearfng on a proposed Occupational Safety and Health Brooks, who is branch chief for coordination an i Administration beryllium standard. N'lOSH U scheduled to procedures in OTS, told Chemical Regulation Reportc testify August 19. August 16 that the guidelines, as required by Section 8 (e) c A total of S84 deaths occurred among exposed workers at the Toxic Subslances Control Act. have been submitted t the beryllium extraction, processing, and fabrication plant, the Administrator for his approval. ; compared with the 829.41 expected. The excess of Although the EPA formal guidelines have yet to appear respiratory disease deaths, the study reported, included both Section 8 (e) requires that effective January 1, 19/7 bronchogenic malignancies (46 observed compared with manufacturers, processors, and distributors notify EPA o 33.33 expected) and nonneoplastic diseases, excluding in any information showing- that a chemical presents . fluenza and pneumonia (32 observed against 19.02 ex "substantial risk" of injury lo health or the environment ur pected). less that persons knows "that the Administrator has beei There also was a significant excess of deaths from heart adequately informed of such information," disease (399 observed rather than 335.15 expected). A few companies have provided information without for An excess of bronchogenic cancer occurred among mal guidance from EPA. according to an EPA official, in beryllium exposed workers only 15 years after first ex eluding a report from E.I. du Pont de Nemours 4: Co., Inc. posure (37 observed, opposed to 24.01 expected). The report on findings that acrylonitrile may be a human carcinogei added that the excess was "most marked" 25 years after (Current Report, May 27, p. 368). first exposure (20 observed compared with 10.88 expected), Brooks said his responsibilities also include developmon and occurred irrespective of the duration of employment. of regulations under Sections 8 (c) and 8 (d) of rhe Act which require manufacturers, processors, and distributor; Litigation of chemical substances to keep records of significan: adverse reactions lo health or the environment ascribed to a OUTSIDE LAWYERS FOR VELSICOL REQUIRED TO TESTIFY IN GRAND JURY INVESTIGATION chemical and to submit health and safety studies as EPA may specify. One Issue that must be resolved in writing those Outside lawyers for Velsicol Chemical Corporation are regulations is whether they should be developed separately required to testify and produce documents in a grand jury in or conjointly, Brooks said, although they probably wiil be vestigation of whether Velsicol, its officers, former issued in final form as two separate rules. employees, or outside counsel withheld from the En EPA has said previously that all guidelines and proposed 4vironmental Protection Agency information which tended to show that pesticides manufactured by Velsicol induced regulations under Section 8 (c) though (e) would be Issued by October 1977 (March 18, p. 6). ___ tumors or cancer in laboratory animals. The U.S. Court of Appeals for the Seventh Circuit ruled July 29 that the attorney-client privilege had been waived and that the work-product rule, which safeguards the con fidentiality of internal memoranda, did not bar production of documents. (Velsicol Chemical Corporation, u, Parsons, Nos. 77-1433, 77-1434). At issue was whether three attorneys for the law firm of Hazardous Materials fVITB ANNOUNCES ACTIONS ON REQUESTS FOR EXEMPTIONS FROM TRANSPORTATION HULLS Notice of action on applications for exemptions from Sellers, Connor and Cuneo could be required to testify hazardous ' materials transportations regulations was before the grand jury and produce documents. The Sellers published by the Department of Transportation's Materials law firm represented Velsicol in administrative proceedings Transportation Bureau August 18 (42 FR -41690). before EPA, and it is the conduct of Velsicol and its officers Modes of transportation involved are (1) motor vehicles, in the EPA proceedings that is the focus of the grand jury In (2) rail freight, (3) cargo vessel, (4) cargo-only aircraft, <5; vestigation. The investigation of Velsicol was commenced in passenger-carrying aircraft. September 1975 by the U.S. Attorney for the Northern Renewals, emergency exemptions granted, and denials District of California. are listed in the table, which is published in the Full Text The Seventh Circuit ruled that previous testimony by section of this issue. Vclsicol's senior house counsel before the grand jury concern ing remarks with attorneys of the Sellers firm had waived the attorney-client privilege. The court also ruled that the work-product rule did not bar compulsory production of Gonaral Policy documents prepared by the Sellers firm, because the focus of the grand jury inquiry is to determine if preparation of the documents was "attended by misconduct." TOXICS MANDATE SET FOR ESWQIAC REVIVAL COSTLE TELLS SENATE PUBLIC WORKS MEMBERS The Environmental Protection Agency intends to revive the now-dormant Effluent Standards and Water Quality In Recordkooping formation Advisory Committee to assist in developing best available technology guidelines for toxic pollutants. EPA GUIDANCE ON REPORTING SUBSTANTIAL RISK TO BE ISSUED SOON But, EPA Administrator Douglas M. Costle told members of the Senate Environment and Public Works Committee the committee should not be re-activated under the Federal Guidance to chemical manufacturers, processors, and dis Water Pollution Control Act. tributors on reporting information on substances posing a In answer to a question from Committee Chairman Jen "substantial risk" to health or the environment is to be nings Randolph (D-WVa), Costle said he is "persuaded that Copyright O 1977 by The Bureoa of Narionol Affair*, Inc, AP00049163