Document kmwy483O5L5KZBxOoeda2yrDO

[^crft7^/u>duc& J INTEROFFICE MEMORANDUM RECEIVED JUN o 6 1978 k_SLj^iect ff\ VV ^ *r.a Date June 1, 1978 Jutis TSCA Committee Meeting To From TSCA Compliance Committee C. E. Blades Distribution: W. M. Smith L. B. Tepper R. H. Schenck A. J. Diglio J. C. Novak J. H. Body J. Egan R. Mayo (Location, Orginlzation, or Department) [Location, Organization, or Department) W. Ent G. Handley W. Custead G. Frieling M. G. Zellner C. D. Kalb J. Urenovitch E. I. Handwerk The next meeting of the TSCA Compliance Committee is set for MDNDA.Y, JUNE 12, 1978, at 1:30 PM in the Main Office Building, Allentown, ROOM 113G The objective of the meeting will be met when assigned tasks have been com pleted and the current issues have been identified with appropriate assignments made to assure continuing ability of the company to comply with developing regu lations under TSCA. The Agenda is: (1) Approval of minutes of May 1, 1978 meeting. (2) Follow-up business (i) R. H. Schenck assignment for draft to go on purchase orders. (ii) Inventory report - document file status. (iii) Trademark inventory update (status, issues, new input). (iv) New product introductions prior to end of year. (v) MID progress report. .(vi) PCB bulletin. Are there any questions? C3) Substantial Risk Notification - Procedure questions - Distribution of procedure, (4) New developments within EPA (PMN, Tiers, etc.) (5) Forecast of EPA actions for upcoming year.Tssues. C6) Ancillary activities -- RCRA - Waste Disposal OSHA - Carcinogen Policy EPA - Spills into Waterways / CEB:sk (3201 AP00049023 INTEROFFICE MEMORANDUM RECEIVED law DE^t. {.- "V?.? t May 1, 1978 TSCA Nfeeting Minutes - May I, 197S ToDistribution____________________________________ __________ __________ _______________________ (Location, Organisation, or 0*P*Kmnl) From______ C. E. Blades ____________________________________ Piscataway (Location, Organisation, or Oepartmont) Distribution: ^* R. Fleming D. Baker W. M. Smith L. B. Tepper J, C. Novak A. .J. Diglio R. H. Schenck d J. H. Body E. I. Handwerk G. G. Handley W. L. Ent J. Urenovi tch J. M. Egan T. B. Collins M. G. Zeliner A. I. Dalton W. Custead G. Frieling R. Mayo 1.. Approval of Minutes - TSCA Meeting/March. 13, 1978 Minutes approved with the following coirerents: . a)' R. H. Schenck to prepare a statement of warranty on purchase agreements for vendor certification that supplied products have been reported for the inventory. b} The Ames mutagenicity test result on 2-ethylhexaldehyde was negative. O NFj has been submitted for Ames testing. Results still pending. \y 2. Inventory Reporting a) At the time of this meeting, inventory reporting forms for CSD, IGD, and Houdry Chemicals had been submitted to the EPA. Reports for Industrial Chemicals and MSD will be certified and mailed today. Today, May 1, 1978 is the deadline for submittals. However, any chemical substances manufactured for a commercial purpose between May 1 and 30 days following publication of the initial inventory may be reported when manufactured. In cooperation with the business and manufacturing areas, E. Handwerk is preparing a document file to support reporting actions taken with emphasis on unique and complex reporting circumstances. Such areas become "gray areas" within a short period of time. b) The deadline for the Trademark Inventory has been extended to July 15, 1978. An amendment to the certification statement permits manufacturers of trademarked products to report processed components of the trademark during the 210 day revised inventory reporting period, thereby allowing continued.......... (320) AP00049024 TSCA Meeting Minutes May 1, 1978 -2- May 1, 1978 the manufacturer to report trademarks for which he may not be able to certify that all components ha\re been reported for the initial inventory. APCI will report trademarked chemical substances and utilize the revised inventory reporting period to report components not present on the initial inventory. 3. Substantial Risk - Updated Policy Corporate Policies has prepared a Standard Procedure (revised) for Substantial Risk Notification. The standard will be distributed to corporate policy manual holders and to individuals on the revised Substantial Risk Notification distribution list. Highlights of the updated policy are: a) Employees fulfill their legal obligation through notification by company procedure. b) Persons capable of appreciating the significance of pertinent information are subject to the act. c) Notification to the EPA should occur within 15 working days of receipt of information. d) Single In Vitro Tests for mutagenicity are not substantial risk items unless, or until, corroborated by additional affirmations. e) Emergency incidents of environmental contamination are to be reported by telephone. f) Pre January 1, 1977 information is to be reported if it is drawn to our attention since Jan. 1, 1977. g) The decision group must notify submittees of the disposition of their notices. 4. TSCA Timetable a) MZDrs Role (1) Establish a cross-reference to available TSC1 related files based on the Chemical Abstracts Service registry number. (2) Establish a Chemical substances data base to permit rapid location of data elements concerning reported chemical substances, e.g., con fidentiality claims, toxicity data, hazardous properties, etc. (3) Prepare TSCA files such that they can also meet the needs of other departments, e.g.. Corporate Safety. continued AP00049025 TSCA Meeting Minutes May 1, 1978 -3- May 1, 1978 b) Premarket Notification Rules are expected to be promulgated in the July to September 1978 period, PMN will become effective 30 days after publication of the initial inventory. c) C. E. Blades presented an orientation of the areas in which records must be maintained to meet TSCA regulations. Such areas include production data, information reported for the Inventory, adverse reactions, health and safety studies and substantial risk notification. (See Addendum for full text) d) C. E. Blades will issue a bulletin on handling of PCB's, 5. Priority List The Interagency Testing Committee, in April, published a first addendum to the Priority List. This addendum called a "list of 8" contained 4 chemical substances and 4 categories (see Figure 1). The initial list (Figure 2) of 10 contained 4 substances and 6 categories (in fact between 40-50 chemical substances). The TSCA limits the priority list to 50 at any given time. EPA has made an end run on this number through the use of "categories". Figure 3 illustrates the basis for inclusion of the chemicals and categories on a list for priority testing. The EPA must define testing required within 1 year of list issue or explain why testing is unnecessary. A submission by industry of sufficient data to determine risk could remove need for additional tests. The next TSCA meeting is scheduled for NDNDAY, JUXE 12 at 1:30 P.M. CEB/EIH/sk Ends. AP00049026 Fie,. / LIST OF EIGHT (April 1978) ACRYLAMIDE 64MM lbs,, 20,000 workers ARYL PHOSPHATES 65MM LBS,, - PLASTICIZERS, HYDRAULIC FLUIDS, LUBRICANTS CHLORINATED NAPHTHALENES Lubricating and cutting oil additives, dielectrics DICHLOROMETHANE 500mm lbs., 9% growth rate HALOGENATED ALKYL EPOXIDES Epichlorohydrin 500mm lbs., 50,000-140,000 workers POLYCHLORINATED TERPHENYLS 400,000 lbs. imported 1975 - observed in human BLOOD >PCB'$ PYRIDINE 60mm lbs,, 249,000 workers 1,1,1-TRICHL0R0ETHANE Cleaning solvent, metals 630mm lbs., 3mm workers * Categories AP00049027 TITC LIST OF 10 FOR PRIORITY TESTING ALKYL PEROXIDES ALKYL PHTHALATES CHLORINATED PARAFFINS Q{LORO> ETHANE CRESOLS HEXACHLQRO-1,3-BUTADIENE (HCBD) M3NQ- and DI-CHLOROBENZENES NITROBENZENE TOLUENE XYLENES * Categories Ft&. 2 AP00049028 / PRIORITY LIST OF CHEMICALS (OCT, 4, 1977) j^RG3^A>CTffTS^RHLEASED_TO JTHE ATMOSPHERE XYLENES (0.9 k*m lbs./yr.) TOLUENE (1.0 bm LBS./TR) QILORC* ETHANE (1.75 m LBS./YR.) LARGE MOUNTS.^IN UASTE_A AQUATIC. ENTTRO^ENT (SO NW LBS./YR) HEXACHLORQ-1,3-BUTADIENE (BY-PRODUCT WASTE) INgUSTOAJLJVDRXERJEXPOSURS SIGNIFICANT f alkyl epoxides" | S PI-CHLORINATED CRESCL (2 K4 WORKERS) I CHLOPOETHAT | (31,000 WORKERS) VILELY USED HOUSEHOLD PRODUCTS NITROBENZENE (RAPIDLY ABSORBED THRU SKIN LUNGS) \ CHLORINATED PARAFFINS jbject D. 3m CATALOG NO. 15 3M CENTER. ST. PAL MADE IN U 5. A. AP00049029 ADDENDUM TO TSCA MEETING MINUI'ES toy 1978 Talk Presented at TSCA. Meeting May 1, 1978 - C. E. Blades ISSUES INVOLVED IN COMPLIANCE WITH TSCA -OTHER REPORTING REQUIREMENTS The stated purpose of the Toxic Substances Control Act is: Reduce the risk of potential ham to health and environment arising from toxic hazards of chemical substances. There are many sections in the act. The one we are going to talk about today is Section 8, The title of Section 8 is "Reporting and Retention of Information" (SLIDE 1) There are 5 subsections to Section 8, as shown on the slide. To get an appreciation for the work load that would be imposed upon industry by virtue of Section 8, it is well to look at the next slide. (SLIDE 2) Here we see a block diagram of-what we might refer to as the "industrial unit" or the "company". Within the company, it will be necessary for records to be kept which deal with information which the EPA will, on. occasion, and on demand, request be sent to the EPA in the form of reports. Now the kinds of reports which can be demanded by the EPA from industry fall into the five categories which are represented by the five subsections of Section 8. They are: (1) Production and related information [8(a)], Part of the information that has been submitted on tire inventory has been requisitioned under the provisions of 8(a) -- namely, volume and site facilities for pro duction of various materials. (2) Information on inventory [8(b)], This is the section of the Act which has been invoked in order to make an inventory of existing chemical substances. (3) Information on adverse reactions [8(c)], We have been concerned for over a year now in collecting information on adverse reactions, I think AP00049030 -3- May 1, 1978 adverse reaction records. It is not now presently mandated by the law, therefore, but will be shortly. Some of the problems in collecting that kind of information have now surfaced and we will need to address ourselves to that as soon as the rules are promulgated, or before. Section 8Cd), dealing with Health and Safety Studies, have raised some interesting questions. Proposed rules have already issued. These have been instigated by the need to obtain health and safety studies from industry pertaining to the list of 10 substances and categories on the Priority List. It is well to understand that the Interagency Test Committee has recommended to EPA a list of 10 chemical substances and categories of substances which they believe require additional test data in order to evaluate the risk of harm to health and the environment arising from the use of these chemicals in commerce. Within one year of the publication of the list, EPA must take action. ' The action they take will depend upon the type of information that they receive relative to the hazard descriptions of these products. It would seem to ire, therefore, that it is in the interest of industry to submit all test data that is in their hands and not in the hands of the EPA. In order to write the rule, EPA has probably gone overboard in the sense that they have asked for all health and safety studies known to exist, or in the hands of industry. Not only final reports, but preliminary reports. There is no indication that they want reports on studies that are in progress or contemplated. There is a concern with the request for preliminary information because this could be misleading if placed in the wrong context. I have in my possession some correnents that were prepared by the Olin Co. on these rules. They draw attention to two or three facts. (1) There is a feeling that the agency should first request lists of studies, adequately identified so that when requests for the actual study copies are received, EPA will not be deluged with duplicate copies through multiple client studies. There is also a provision for companies to identify studies they know of but do not actually have in their possession. In this case, they are to identify those studies and tell where they can be obtained. Thus, a manufacturer or industrial unit provides EPA with the means ta reach into contract laboratories and associations such as CUT to obtain such data, and by law those reports will have to bo provided. Another feature of these rules is that although addressed to tho priority list, it will, in fact, form precedence for the requesting of all AP00049031 -2- May 1, 1978 there is an interplay here between the Substantial Risk Notification^ Events are those which would be collected in our records of significant adverse reactions. If a series of events occurs which would lead to a con clusion that a substantial risk existed, then an 8(e) notice could gc into the agency. The troublesome part of the Significant Adverse Reaction records is that alleged inter-relationships between reaction on the health or the environment and a cause, as it may be related to a product, must be placed in the record. And there are certain retention times that these must have in the record before they can be disposed of. (4) Health 5 Safety Studies [8(d)] -- The interesting thing about Health and Safety Studies is that they can take two forms --a list of such studies or the actual studies themselves. (5) Substantial Risk Notification [8(e)] -- We now have a company procedure covering this. Moving through these various sections, looking at the provisions of then, vre look at the next slide which gives a synopsis, if you like, of the actual provisions of the act. (SLIDE 3), and as Joanne Egan has been talking about, the need to keep records on chemical substances or products within the company, and the categories of those regulations are spelled out in the law. It will be seen that the production records are only a part of the records that need to be kept under this section of the act. Rules need to be proposed and finalized prior to any serious addressing oneself to this section. We need to be aware of the fact that the records need to be kept but the precise form in which the rules will bo written still remains unknown and we tend to sit in a position of suspended animation until those things arise. We will not discuss Section 8(b). We'll move on to Section 8(c) in the next slide (SLIDE 4) . Here you will see the kinds of records that need to be kept and the time retention for each type. We have wrestled with the definitions of what constitutes a "significant adverse reaction". I am proposing that we back off on that activity for the present, insofar as again here we now realize that rules will have to be promulgated for the keeping of significant AP00049032 -4- May 1, 1978 health and safety studies under Section 8(d) of the act. It is to be made clear that health and safety.studies requests for such reports do not necessarily relate to the priority list. The priority list is providing instigation for the initiation of this reporting system. On the next slide (6) I have a list of the original "list of 10" chemical substances and categories proposed for priority testing. Those with asterisks are the categories. Now, because of the category system here, we find that in reality this list deals with in the order of 40 to 50 individual chemicals since one cannot test a "category". Therefore, health and safety studies are being requested on the order of 40-50 chemicals from that list. The types of studies that are being requested deal with the types listed on the next slide (7) > --carcinogenicity, mutagenicity, teratogenicity, other chronic effects [meaning all tests are of repetitive exposure type) epidemiological studies and environ mental effects. In the next slide (8), we list some of the bases for selection of these materials by the Interagency Testing Committee and you will note that there are a series of chemicals which are released to the atmosphere. These are solvents and rather large quantities go to the atmosphere: Xylenes Toluene Chloromethane 0.9 MMM lbs. 1.0 MMM lbs. 1.75 MM lbs. There is a group here that is thought to be getting into wastes and aquatic environment, through leaching etc. There are some that are primarily related to industrial worker exposure and some in the household. In the next slide [9) I have listed the second list of priority chemicals for testing. In this case there are four chemical substances and four categories. I haven't got a breakdown as to how many health and safety studies this will require for submittal. You will notice that there are no Air Products fT Chemical products on here except some of those which are processed by the Specialty Gases Division and you need to take note that these tilings are on this list. AP00049033 -5- May 1, 1978 Of interest is a report of comments made by two citizens groups relative to the proposed health and safety study rules. The first is made by the Environmental Defense Fund. In their consents, they claim that EPA has not gone far enough in requesting health and safety studies. They suggest that some studies may exist which are kno'im to company officials but are not reduced to writing. These should be submitted they say. Secondly, the rule applies to juridical persons. EDF claims that this is not consistent with the 8(e) policy statement. They propose that the requirement to submit health and safety studies be extended to all officers who are responsible and have authority for 8(d) responsibilities. The intent of that would be to make individual employees within companies (especially toxicologists and related professions) personally responsible to submit reports to the EPA under health and safety studies. The Citizens for a Better Environment (CBE) suggests that EPA collect all health and safety studies on a list of 1.0, not just those pertaining to the effects listed. You notice that there were six different categories of effects (types of studies) that were requested. This organization is suggesting that health and safety studies submittals not be restricted to those. This comment is made in the folloi\ring context, "The notorious reluctance of industry to submit data on health hazards". OSHA's Eula Bingham has made a comment which suggests that a generic rule be formulated under which new studies could be inserted at any time. I am not sure just exactly what that means. It would appear that if polynuclear hydrocarbons were a subject of health and safety study submittals, then all health and safety studies that wore run at a future date which dealt with any kind of a polynuclear hydrocarbon would automatically be required to be added to the pot. She also urged that the rule be enlarged immediately to apply to chemicals other than those which arc on the Priority List so that PPA may have at its disposal informa tion on spills, or emergency incidents so that they may know how to deal with those matters. The foregoing is presented to emphasize the fact that extensive requirements are to be imposed upon industry for the keeping of records dealing with the chemicals which are produced and manufactured within the industrial unit. It is easy to see that maintaining of these records at an up-to-date status and in a format whereby requests can be answered in some reasonable period of time, suggests that the data be placed on the computer in a systematic way. It is this forecast which is leading many industrial units in the country to seriously consider the AP00049034 -6- May 1, 1978 placing of all data relating to their chemical products (and especially that which is mandated by the act) in a computer storage system. I think that some form of this type needs to be adopted by Air Products, AP00049035 <D&lu>L REPORTING AND RETENTION OF INFORMATION (a) REPORTS Cb) INVENTORY c) RECORDS OF SIGNIFICANT ADVERSE REACTIONS (d) HEALTH AND SAFETY STUDIES (e) SUBSTANTIAL RISK NOTIFICATION AP00049036 INDUSTRIAL RECORDKEEPING 6 REPORTING FOR EXISTING CHEMIC-VLS *> L.I 0L HEALTH SAFETY STUDIES [8(d)] RECORDS PRODUCTION AND RELATED RECORDS [8(a) 3 OVERLAPS IN RECORDS ADVERSE REACTION RECORDS [8(c)] V REPORTS TO EPA < PRODUCTION $ INFO. ON RELATED INFO, ADVERSE [8(a)] REACTIONS V [8(c)1 INFO. ON INVENTORY [8(b)] HEALTH SAFETY STUDIES V LISTS [8(d)(1)] V COPIES [8(d)(2)] NOTICES OF SUBSTANTIAL RISK [8(e)] AP00049037 LJ SECTION 8(a) (a) REPORTS ` (1) MAINTAIN RECORDS (TO DOCUMENT REPORTS) -- REQUIRED BY EPA TO ENABLE ENFORCEMENT OF THE ACT. RULES REQUIRED. PRIME THRUST AT CHEMICAL SUBSTANCES -NOT MIXTURES. (2) INCLUDES: IDENTIFICATION INFORMATION CATEGORIES OF USE ASDUNTS MANUFACTURED FOR EACH CATEGORY BY-PRODUCTS FROM MANUFACTURE OR USE DATA ON ENVIRONMENTAL 8 HEALTH EFFECTS EXPOSURE DATA METHOD OF DISPOSAL AP00049038 HBBKHBnBBBl SECTION 8Cc){ RECORDS OF SIGNIFICANT ADVERSE REACTIONS MAINTAINED AS RECEIVED BY A MANUFACTURER, PROCESSOR OR DISTRIBUTOR FROM ANY SOURCE EMPLOYEE HEALTH CONSUMER ALLEGATIONS cm--w--ttwwrwaui > -- inww OF PERSONAL INJURY OF HARM TO HEALTH ] REPORTS OF OCCUPATIONAL DISEASE OF OCCUPATIONAL INJURY REPORTS OR COMPLAINTS OF INJURY TO ENVIRONMENT a I3TTYEARSj| AP00049039 HEALTH AND SAFETY'* STUDIES LISTS OF STUDIES EITHER IN POSESSION or KNOWN TO EXIST (and where) COPIES OF STUDIES AP00049040 TITC LIST OF 10 FOR PRIORITY TESTING ALKYL PEROXIDES ALKYL PHTHALATES CHLORINATED PARAFFINS GHLOROMETHANE CKESOLS HEXACHLORO- 1,3-BUTADIENE CHCBD) M3NO- and DI-CHLOROBENZENES NITROBENZENE TOLUENE XYLENES* * Categories AP00049041 STUDY TYPES C45 FR 4-073, Jan. 31, 19781 CARCINOGENICITY MUTAGENICITY TERATOGENICITY OTHER CHRONIC EFFECTS EPIDEMIOLOGICAL STUDIES ENVIRONMENTAL EFFECTS -Zj AP00049042 PRIORITY LIST OF CHEMICALS (OCT, 4, 1977) ' i3LIJ>s-UP IiARGH AMDINTS RELEASED TOJHF^A^DSPHERE CO.9 WU LBS./YR.) TOLUENE (1.0 1.&M LBS./YR) QILOrO'ETHANE (1.75 J-M LBS./YR.) LARGE MOUNTS _IN >rASTE_ AQUATIC ENVIRONENT ALKYL PH1HALATES (PLASTICIZER) CHLORINATED PARAFFINS (50 m LBS./YR) HEXACHLORO-1,5^LtaDIEXk| (BY-PimCT, WASTE) INDUSTRIAL^ VfORKER^EXPOSURE SIGNTFICANT l ALKYL' EPOXIDES | M3NO $ DI-CHLORINATED~ BENZENE [ CEESOL (2 M*I WORKERS) I CKLORCi^ETKAVE (31,000 WORKERS) OTD5LY_USEp HCUSEHpLD. PRODUCT^ NITROBENZENE (RAPIDLY ABSORBED THRU SKIN $ LUNGS) \ QgjoRINATED PARAFFINS JBJECT D. 3JY1 CATALOG NO. 1 5 3M CENTER, ST. PAUL MADE IN U. S- A. AP00049043 Lfpz. LIST OF FIGHT (Aprti 1978) ACRYLAMIDE 64MM lbs., 20,000 workers ARYL PHOSPHATES 65MM LBS,, - PLASTICIZERS, HYDRAULIC FLUIDS, LUBRICANTS CHLORINATED NAPHTHALENES Lubricating and cutting oil additives, dielectrics DICH L0R0METHANE 500mm LBS,, 9% GROWTH RATE HALOGENATED ALKYL EPOXIDES Epichlorohydrin 500mm lbs,, 50,000-140,000 workers POLYCHLORINATED TERPHENYLS 400,000 LBS, IMPORTED 1975 - OBSERVED IN HUMAN BLOOD ^PCB'S PYRIDINE 60mm lbs,, 249,000 workers 1,1,1-TRICHLOROETHANE Cleaning solvent, metals 630MM LBS,, 3MM WORKERS* * Categories AP00049044 \^c7^c^^/icducG-) INTEROFFfCE MEMORANDUM Rcweo apr 2 6 ^76 Subject LAW DP'f* Date April 24, X978 Agenda For TSCA Meeting May 1, 1978___________ To Distribution From__________ C. E. Blades (Location, organization, or Da&artmant] (Location, Organization, or Department) Distribution: . W, M. Smith L. B. Tepper J. C. Novak A, J. Diglio R. H. Schenck W. Ent G. Handley W. Custead G. Frieling Ea I. Handwerk M. G. Zellner J, H. Body A. I.. Dalton J. Egan J. Urenovitch R, Mayo The next TSCA Compliance Committee Meeting will be held on MDNBAY, MAY 1, 1978 at 1:30 P M. in Conference Room 113G, Main Office Building. The agenda will be as follows: 1. Approval of Minutes TSCA Corrmittee Meeting, March 13, 1978. 2. Report on Inventory [a) Existing Chemical Substances (b) Trade Marks Inventory 3. Substantial Risk (a) Distribution List Certification (b) Revision in accord with March 16, 1978 Policy Statement (c) Industry Activity Report. 4. EPA*s TSCA Timetable (a) The record keeping/reporting priority [Section 8] (b) Impact on APCI (c) MED's role and plans (d) Premarket Notification, Inventory Publication.-- the activity and prognosis E. I. Handwerk C. E. Blades continued AP00049045 Agenda/TSCA. Meeting 5/1/78 -2- S. Priority List Development (a) Prognosis (b) Health Safety Study Rules. Apttl 24, 1978 CEB:sk ' C. E. Blades AP00049046