Document wDL6kGyY7pBavM37BVEe4xVrE

DEC 07 1977 INTEROFFICE MEMORANDUM Q?Jm Date December 6, 1977 Subject Meeting Agenda - TSCA Compliance Comm. December 12, 1977 To TSCA Conpliance Committee From C. E. Blades* (Location, Organization, or opanment) Piscataway (Location. Organization, or Qpartnsnt> Distribution: W. M. Smith L. B. Tepper R. H. Schenck A. J. Diglio J. C. Novak W. Ent R. Collins G. Handley J. Egan T. Collins J. Body H. Parke E. Handwerk B. Dalton The next meeting of the TSCA Compliance Committee is scheduled for 1: SO P.M., December 12, 1977 in Room 113G, Main Office Building, Trexlertown. The agenda will be as follows: 1. Approval of Minutes -- November 14, 1977 meeting. 2. Old Business: a) Significant Adverse Reactions (i) Acceptance of the Definitions and Procedure circulated earlier C. E. Blades (ii) G. Handley report on methodology to assure complete collection from GEG. (iii) A. J. Diglio report on resolution of questions raised. bj Raw Materials Inventory Preparations to clarify that all raw materials purchased will be on the Inventory List. C. Blades/T. Collir c) Report on Product File Requirements per MID, Oct. 1U 1977 proposal. C.Blades/T.Collins d) Substantial Risk Notice to Enployees Consideration of draft notices prepared for executive approval and action. Blades/Smith/Schenck continued <3?m AP00049105 INTEROrncn MEMORANDUM Subject Onto 21 November 1077 Significant Adverse Reactions ToTSCA Compliance Committee From {Location, Oigan i/dlion, or Dct>.n tment) C. E. Blades___________ ______ ________'. (Location, O'jonifallo n, or Dcf>ai tmetil) Committee: A. 0. Diglio W. L. Ent G. G. Handley 0. C. Novak R. H. Schenck V/. 1-1. Smith 1. B. Tepper, cc: 0. H. Body This letter dealing with significant adverse reactions is now issued with the benefit of comments from the TSCA Compliance Committee. The Problem TSCA requires that manufacturers mainta/n records of Significant Adverse Reactions to health or the environment./caused by the company's chemical products. There are three sources'for'such records and responsibility for each one is given in the chart below: Source Generated By Time Retained Maintenance By (yrs) Customer/Consumer Comp!aints Profit Center TSCA Chairman 5 Environmental Harm Environmental TSCA Chairman 5 Employee Health Safety/Medical Medical Dir. 30 Insofar ass there is a developing uncertainty concerning the types of incidents to be reported, a directive is required. It shall be the purpose of this memo randum to define the types of information required from reporting units in the corporation. Proposal . ^ -- The Act requires manufacturers to maintain records of significant adverse reactions in the health of humans or in the environment/caused by the company's chemical products. These records arc background documentation for such adverse reactions and the Act has identified the sources for such records as follows: {320} AP00049106 \ f t < f jC'ti'fiw atm. To: TSCA Compliance Cony tee 2- - V ''ovember 1977 {1) Employee Health Records These are routine medical examination records designed to identify employee health problems and have them organized in such a fashion that repetition of grouped effects may be correlated with a common cause--cspccially if it should he work related. Adverse health problems which repeat in the medical records of several employees can be readily recalled from the computerized record on demand. Such problems will come tu the attention of the medical director in a variety of ways. Once suspect, it is possible to ask the system if these are repeated actions. (2) Customar/Consumer Complaints Customers/consumers of company chemical products which observe or think they observe adverse health or environmental reactions attributable to the company's products v/Tfl7 issue a complaint. Such complaints do not need to be sought. But the profit center or discreet business entity is required to set up a collection device for customer/consumer complaints and to segregate those involving, or alleging to involve, harm to health or the environ ment and then report those cases to the TSCA Chairman (APCI) for retention in files for a five-year period. A periodic view of the records by the TSCA Chairman will constitute a report. The Committee recommends an EPMS type computerized monitor be set up. (3) environmental Harm ^ J rrj Environmental harm a^-i-si-ruj from the operations and involving company products or by-products within the company or during transportation to a customer or other location'are to be recorded with details of the event and the remedia1 and/or clean-up action taken. The defini tion of "environmental harm" has not been given. Thus it would be prudent to be conservative in adoption of criteria for environmental harm until such definition is provided by the EPA. Thus we should report all transportation accidents resulting in releases or spills, all releases in effluents to the waterways and to the atmosphere from our plants which exceed established guidelines. It is proposed that reporting be mandatory on releases which result in a fish kill, destruction of vegetation, contamination of ground waters, any materials of low biodegradability liable to persist in the environ ment and eventually enter the food chain. It is further proposed that the reporting unit place on file documentation of the adverse reaction reported. At the 12 December TSCA Compliance Committee Meeting we will review again these guidelilies. If approved, it is proposed that reporting units be informed by an appropriate directive. Attached hereto are reporting forms currently in use. An EPMS type system will also be considered. CEB:sjd Attachment - Deport Forms AP00049107 GROUP ENVIRONMENTAL HARM REPORT POR PERIOD.^________________rn|19________ TO____________________ __________ 19 REPORTED BY^________________________: 1,, List here reference memoranda describing event which caused the environmental harm. 2. Summarize here the action taken in each case and assess the ex.tcnt of damage or environmental impact* The foregoing is an accurate and complete report of all environmental harm events for the indicated period and group within the company. (Signed) Date 19_ TSCA 8-1 CARD) (;>/l s/77) AP00049108 PROP IT CENTER POR PERIOD, REPORTED BY CUSTOMER COMP!,AIN'T REPORT ] 9 TO 19 1, List here the names of complainants (company name). (Attach copy) 2. Summary of action taken (or attach memorandum and give reference here). The foregoing is an accurate and complete report of all cus tomer complaints and their disposition for the above indicated period and Profit Center. (Signature) Date 19 SCA 8-2(APD)(3/15/77) AP00049109 DIRECTIVE ON SUBSTANTIAL PJSK NOTIFICATION Noveir.ber 29, 197? The Toxic Substances Control Act, signed by President Ford in October 1976, became effective January 1, 1977. One of the features of the act which became effective on January 1, 1977 is contained in Section 8(e) know as "Substantial Risk Notification". As passed by the Congress, any person engaged in the manu facture, processing, or distribution of chemical substances, who obtains information which lesdar-to the conclusion that substantial risk to human health or the environ ment exists is required to notify the Envii*onmental Protection Agency of such risk. Referring to APCI's standard practice (p. 5) and to directions given at the training sessions on TSCA compliance, the company procedure for dealing with matters of potential "substantial risk" is given. It is reproduced here. "The Company is required to inform the EPA immediately if it obtains any information which reasonably supports the conclusion that one of its chemical products presents a substantial risk of injury to health or the environment. Any one in the Company obtaining such information shall immediately forward it through the appropriate line management to the Group/Division Manager with environmental responsibility and to the TSCA Chairman who, along with the committee and appropriate management shall evaluate the degree of risk presented." On September 9, 1977, the EPA published in the Federal Register a "proposed guidance" for Substantial Risk Notification. It is important to recognize that such is a "proposed" guidance. It, therefore, represents the thinking of a particular group of people within the EPA. Comments were invited and the TSCA Committee of APCI has submitted such to the agency. There is reason to expect that specifics of the proposed guidance will be altered as a result of APCI's and others' comments. continued.... (320) AP00049110 Directive on Substantial nvsk Notification -2- Nov. 29, 1977 The key concerns to enployees are: Cl) All employees capable of appreciating pertinent information relative to substantial risk are required to submit pertinent information tp corporate processing. (2) The tine period required to notify the EPA foilwing receipt of pertinent information is short. (EPA has suggested 15-60 days in different options.) (3) An employee's responsibility under the Act is conpleted when he has advised his supervisor in writing of his concerns. Failure to advise v his supervisor could open the way for agency enforcement action. The purpose of this notice is to advise APCI employees of the company pro cedures for compliance with TSCA Section 8(e); Substantial Risk Notification. The following procedures are to be followed in all sectors of the company: (1) All employees capable of appreciating pertinent information relative to substantial risk are required to notify their line supervisor in writing with a copy to the TSCA. Compliance Committee Chairman ( C. E. Blades) . Such bitten notification requires documentation with attached reports describing the information which leads to a potential conclusion of substantial risk to health or the environment. (2) Beginning January 1, 1978, all orders for toxicological testing are to be placed through the TSCA Chairman's office. Reports of results, the management of toxicological testing contracts, and the responsibility for evaluation and pertinence of testing will reside with C. E. Blades and the TSCA Compliance Committee. For your guidance, we summarize below the types of information which could lead to a Substantial Risk Notification. (a) Demonstrated instances (or a series of events in a pattern which lead to a conclusion of a relationship) in which a product produces cancer, gene mutations, birth defects, death, ot serious or prolonged incapacitation in humans. continued... AP00049111 Directive on Substantial Risk Notification 3- Nov. 29, 1977 (b) Epidemiological studies, bioassays (in vitro or in vivo) which would reasonably support the conclusion of substantial risk of injury to human health or the environment when levels of exposure and degree of toxic hazard are taken into consideration. (c) Information which illustrates: f(i) : extreme persistance or non-biodegradability. } (ii) pronounced bioaccumulalion (e.g., 50,000 x in 30 days for fish) or ( 10,000 partition coeff.) (iii) interference with biogeochemical cycles (e.g., kills or inhibits nitrifying bacteria). (iv) stimulates primary producers in aquatic ecosystems (e.g., phos phates and algae). (d) Emergency incidents, especially spills which endanger human health or the environment as in (a) , (b) , (c) . CEB:sk C. E. Blades AP00049112 *T7 5 u* CO CD 6 u >U_ tr T5 Cj o i> M c-w n( it Ct Co ii o *r <> c V> H ? " /S '! 77 AP00049113 EXHIBIT II ($000) To Profit Centers Processes & Catalysts Chemical Additives Acetylenics Polymers Industrial Chemicals Ammonia Plastics Fabricated Plastics Specialty Gas TOTAL TSCA Costs By Profit Center Budget FY 1978 From Coordinator s Office From Outside Testinq $n 23 17 2 29 6 2 1 23 $114 $67 33 - - - - - $100 From Profit Center Marketi nq $- - - - 9 - 1 7 $17 From Profit Center R&D $26 25 - - - - r- $51 Total $ 11 116 17 60 38 6 3 1 30 $282 A P 0 0 0 4 9 114 HWP/dls 11/10/77