Document QkZZnjj32773bX8y2vk5VjqKL

1:00 p.m. 1:01-1:02 1:02-1:12 1:12-1:15 1:15-1:30 1:30-1:35 1:35-1:55 1:55-2:05 2:05-2:35 2:35-3:05 3:05-3:50 3:50-4:20 4:20-4:30 4:30-4:35 4:35-4:45 4:45 AGENDA CMA EXECUTIVE COMMITTEE MEETING 1:00 p. m. , Monday, September 8, 1980 The Lodge at Pebble Beach (Library) Pebble Beach, California TAB 1. Call to Order -- Chairman Oreffice 2. Approval of Meeting Minutes -- B. M. Barackman June 4, 1980 (Regular Meeting) June 5, 1980 (Special Meeting) 3. Financial Report -- G. C. Herrman 4* Director Resignation (Class of 1981) -- H. Barclay Morley 5. Review of Committee Reports to the Board -Chairman Oreffice 6. Association Activities: a. Technical & Functional Committees -- B. M. Barackman b. Hazardous Waste Response Center -Charles L. Sercu, Chairman, EMC c. Discontinuance of Technical Publications -- G. V. Cox d. Risk Benefit Analysis -- Carl W. Umland, Exxon Chemical Americas & G. V. Cox e. Special Committee on Hazardous Communications -W. C. Krumrei f. Superfund Report - Louis Fernandez g- ChemCAP Status Report and Budget Review -J. N* Sites/R. A. Roland h. Regulation of Export of Hazardous Substances i. Proposed New Task Group on United Nations Study (International Trade Group) 3 4 5 6 7 8 9 10 11 7. New Business 8. Adjournment CMA 062808 MINUTES OF MEETING CMA EXECUTIVE COMMITTEE The Lodge at Pebble Beach Pebble Beach, California September 8, 1980 1. The meeting was called to order at 1:00 p.m. by the Chairman, There were present: Paul F. Oreffice, Chairman Harry W. Buchanan J. Earl Burrell Louis Fernandez Alexander F. Giacco James B. Henderson Richard J. Hughes H. Barclay Morley L. John Polite, Jr. Robert A. Roland William G. Simeral Raymond C. Tower Bruce M. Barackman, Secretary Edmund B. Frost, General Counsel Gary C. Herrman, Treasurer By Invitation: Lee R. Bobker, Vision Associates Inc. Stephanie Chan, Vision Associates Inc. Geraldine V. Cox, CMA Richard F. Gold, Stauffer Chemical Company Stephen L. Goldstein, Olin Corporation Myron T. Foveaux, CMA William C. Krumreii The Procter & Gamble Company Victor H. Peterson, CMA Edward B. Poliak (SOCMA), Olin Corporation Robert J. Reichert, E. I. du Pont de Nemours St Company Charles L. Sercu, Dow Chemical U. S. A. James N. Sites, CMA William M. Stover, CMA Carl W. Umland, Exxon Chemical Americas part time 2. Minutes of the June 4, and June 5, 1980 Meetings The minutes of the June 4 and June 5, 1980, meetings of the Executive Committee, as distributed, were approved. 3. Treasurer's Report A. In addition he advised: Mr. Herrman's report is attached as Exhibit CMA 062809 2- - It is too early to discuss projected year-end results with any accuracy, but appropriate comments will be included in the August report. As of the end of August, nine companies had not paid their dues. These are being followed up at the appropriate level. Through the end of August CMA has received $2, 460, 000 from the January 1980 ChemCAP assessment. Three companies have not yet remitted their assessment. They are being followed up at the executive level. The second assessment under ChemCAP will be billed in December 1980 with a due date of January 1981. It will be for 43% of the dues amount and is designed to raise approximately $3.6 million. Recent cash flow projections indicate that we will have advanced the program approximately $1. 2 million before the cash from the second assess ment begins to come in. Final pricing on the majority of the items for the new headquarters has been received and it appears that we will exceed the original capital equipment estimate by about $75, 000. The actual date of building completion has been moved back by several months. A relocation date of mid to late November is now being estimated. CMA is doing better in acquiring subtenants than was originally estimated and this, combined with the later moving date, should result in net rental savings to the Association during the first year of occupancy. 4. Director Vacancy Mr. Morley advised that John .D. Ong, Chairman of the Board, The BFGoodrich Company, would be nominated for election as a director of the Association at the Board meeting tomorrow, filling the vacancy created by the resignation of Charles W. Parry, Aluminum Company of America. 5. Review of Committee Reports to the Board Mr. Oreffice not d the recommendations of Mr. Lowrey, Chairman of the Government Relations Committee. Following discussion it was agreed to table the recommenda tion that an Association PAC be established. This action was taken pending the resolution of certain legal considerations at which time it will be re considered. The Executive Committee also acknowledged the importance, as stressed by the Government Relations Committee and others, of economic impact data of regulations and legislation. The CMA staff was requested to study techniques to improve the capability to develop this data and report their recommendations. CMA 062810 -3- 6. Association Activities (a) Technical and Functional Committees The following appoint ments were approved: Donald L. Heywood, Union Carbide Corpo ration, to the Chemical Regulations Advisory Committee for a term ending May 31, 1981; George E. Knowles, Diamond Sham rock Corporation, to the Energy Committee for a term ending May 31, 1982; and John E. Aiken, M.D,. Cities Service Company, to the Occupational Safety and Health Committee for a term ending May 31, 1981. (b) Hazardous Waste Response Center (HWRC) Mr. Reichert highlighted, with a slide presentation, the attached report. Exhibit B. Following discussion, the Executive Committee approved con tinuance of the HWRC at its present level, with emphasis on: the training of member company personnel in site management; the development of protocols for site management, such as personnel safety and drum waste consolidation -- for use by member com panies and agencies; work with EPA as outlined in their letter to develop protocols, advise and guide them in approaching and pri oritizing the overall program. Some further site studies, work ing directly with EPA, primarily for personnel training (both member company and EPA personnel) are envisioned. The EMC and Hazardous Waste Response Center were requested to return to the Executive Committee in October with a detailed program of activities tailored to conform to the foregoing constraints. A recommendation to change the scope of the HWRC to include data generation by member company individuals in this activity was referred to the General Counsels' Group. It will be recon sidered in October. (c) Discontinuance of Technical Publications The discontinuance of technical publications as recommended in Exhibit C was ap proved. (d) Public Risk Analysis Mr. Umland illustrated with a slide presentation the attached report, together with recommendations. Exhibit D. This was approved following discussion. Dr, Weis was appointed chairman of the Public Risk Analysis Special Com mittee thus established. (e) Hazards Communications Special Committee Mr. Krumrei's remarks are attached as Exhibit E. Following his presentation the Executive Committee approved part A of Exhibit F relating to the committee organization and formation of task groups. Part B of Exhibit F, beginning with page B-3, was deleted and Exhibit G substituted therefor. This in turn was amended by CMA 062811 -4- adding a footnote to the bottom of page 4 (B-6) which explains that the matrix is not based on scientific data; it is for illus trative purposes only. With the foregoing substitution as amended. Part B was approved. Distributed to those present was a list of member companies together with a list of trade associations active in the Hazards Communications Special Committee. (f) Superfund Report Dr. Fernandez referred to Exhibit H as containing a good status report of Superfund legislation and also invited attention to the attached waste end fee concept being advanced by CMA. He advised that the House bills H.R. 85 and H.R. 7020 are scheduled to come to the floor this week. He re viewed the strategy previously agreed to, i. e. H.R. 7020 or better, and noted that meanwhile H. R. 7020 has changed in terms of size of the fund. The hope was expressed that Congressman Florio would initiate action to lower the amount closer to the original proposal. In regard to S. 1480, which is unacceptable, CMA will testify in opposition to the bill before the Senate Finance Committee on September 11 and the Senate Commerce Committee on September 12. Included in the testimony will be the waste end fee proposal. Dr. Fernandez summarized by saying that there have been no real substantive changes in policy. He urged the members of the Executive Committee to continue their personal involvement. Mr. Simeral reviewed results of contact with the White House, con cluding that the chances are remote that anything positive will develop. (g) ChemCAP Status Report and Budget Review Mr. Bobker presented a rough interlock of the new CMA film "DOING SOME THING". This is described in Exhibit I under the old title, "PROTECTING OUR ENVIRONMENT; What Five People Are Doing About It". The film was endorsed following its review and the pro ducers were directed to edit it for preview at the October meeting in Houston. Mr. Sites briefly reviewed the ChemCAP program and the materials produced to date. He said the key question is, "What do we do after June 1981?" The Communications Committee is preparing recom mendations to present for consideration by the Communications Policy Review Group. A full Board report will follow in January. CMA 062812 -5- (h) Regulation of Export of Hazardous Substances was approved. Exhibit J (i) Proposed New Task Group on United Nations' Study ing discussion of Exhibit K the Executive Committee: Follow Approved participation by CMA in a meeting scheduled for September 30 regarding the preparation of a United Nations' report on the structure and characteristics of transnational corporations. Rejected CMA involvement in a second report intended to pro file specifically five U. S. chemical companies. Agreed further participation by CMA after the September 30 meeting will be reviewed after additional information concerning the scope of the study has been received. Ongoing monitoring will be effected by involved corporate counsel, CMA counsel, and staff. 7. New Business Mr. Roland recommended that Dr. Otto Sturzenegger, Chairman of the Board and CEO, CIBA-GEIGY Corporation, be asked to chair the CMA Special Projects Advisory Group. This was approved. The Executive Committee was advised that the guidelines for the Special Projects Advisory Group will be on the agenda for the October meeting. This generated a discussion of the'growing proliferation of ad hoc or "splinter" groups. The view was ex pressed that there are good justifications such as marketing or advocacy for single product groups being formed. However, a basic concern was expressed with the tendency to divide the research, technical, and advocacy activities, which doesn't appear to make sense-----nor does the establishment of splinter groups. Concern was also expressed for the potential destructive effect on long-range strategy of organizations, such as CMA, resulting from the activities of splinter groups unaware of the complexities involved. It was suggested that when a group is proposed, each member company should consider carefully where the group would be best located. CMA is the place to discuss the matter when it arises. Mr. Roland invited attention to the fact that twelve percent of the new headquarters working space will be devoted to conference rooms. They will require $300,000 to furnish. Any member CMA 062813 6- - company wishing to help with the financing will be given the opportunity to do so. A dedicated conference room would be identified by a bronze plaque suitable to the donor. In the conduct of future Executive Committee meetings, Mr. Oreffice requested that presentations not be made. It will be assumed that reports and recommendations in the workbook have been read by those in attendance. Only a summarization of action requested should be necessary. This will maximize time available for discussion. Certified correct: PauLF. Oreffice, Chairman CMA Executive Committee Bruce Ivl. Barackman Secretary CMA 062814 Exhibit A TREASURERS REPORT Three Month's Ending August 31, 1980 This report will be prepared and distributed following the end of the month. For your reference, the following is provided: The 1980-81 annual budget as originally approved. The reclassification of expenses to provide for the hiring of a technical writer and secretary to offset outside technical consulting. The 1980-81 annual budget as amended. CMA EC-9/8/80 BD-9/9/80 CMA 062815 CHEMICAL MANUFACTURERS ASSOCIATION Budget for Fiscal Year 1980-81 (As amended through August 31, 1980) REVENUE: 1980-81 Annual Budget Membership Dues & Entrance Fees CHEMCAP Special Assessment Jan. 1980 CHEMCAP Special Assessment Jan. 1981 Investment Income General Meeting Income (Net Of Exp.) publications Sales Overhead Reimbursement - Special Projects $ 8,677,300 891,800 3,600,000 700,000 129,200 22,000 400,000 TOTAL $14,420,300 GENERAL OPERATING EXPENSES: General Counsel Government Relations & Econ. Affairs Communications & Public Relations CHEMCAP Technical Administration Health, Safety & Chemical Regs. Distribution, Energy, Engineering Environment & Haz. Waste Center CHEMTREC Special Research Projects Executive Department Finance, Accounting & Business Printing & Distribution $ 638,700 860,700 965,300 4,491,800 187,700 521,600 367,400 743,900 503,300 453,800 891,000 665,300 289,700 TOTAL OPERATING EXPENSES $11,580,200 LEGAL & RESEARCH Legal Fees & Expenses Research & Consulting TOTAL TOTAL EXPENSES $ 1.420.000 1.373.000 $ 2,793,000 $14,373,200 Contribution to Reserves $ 47,100 Approved Amendment $ -- -- -- -- $ 1980-81 Budget as Amended $ 8,677,300 891,800 3,600,000 700,000 129,200 22,000 400,000 S14,420,300 $ -- __ -- 79,700 -- -- -- __ -- $ 79,700 $ 638,700 860,700 965,300 4,491,800 187,700 601,300 367,400 743,900 503,300 453,800 891,000 665,300 239,700 $11,659,900 $ (79,700) $ (79,700) $-- $-- $ 1,420,000 1,293,300 $ 2,713,300 $14,373,200 $ 47,100 CMA 062816 Exhibit B HAZARDOUS WASTE RESPONSE CENTER Problem Objective: Background Recommendations: Impact Money: Company Personnel: Staff Personnel: Action Required i Some abandoned hazardous waste sites have created hazards to the environment and to human health. These sites have offered both financial and techni cal challenges to clean-up efforts. Attendant publicity has given the chemical industry a bad name. 1. To assist government agencies by bringing chemical industry expertise to bear on the problems of failing, hazardous waste sites. CMA through its Environmental Management Committee (EMC) and HWRC task group acting in conjunction with the U.S.E.P.A. has completed a pilot program limited to the investigation of three abandoned, failing hazardous waste sites. The program has been well received and acknowledged as an important part of solving a critical problem. The EMC recommends that these activities be continued over the next 12-15 months and that the primary objectiv should be to provide expert company assistance to state and federal agencies to assess potential (and failing) hazardous waste disposal sites. The proposed program will require an estimated 125,000 out of pocket costs to CMA member companies. No additional funds are anticipated as necessary for CMA budget. A total of 6.2 years of total personnel time divided among 30 persons. A total of 2.5 years of staff effort. Approval of recommendation contingent upon securing adequate liability insurance. CMA 062817 HAZARDOUS WASTE RESPONSE CENTER Pilot Program On June 6, 1979, in White Sulfur Springs, W.V., the Executive Committee of the Chemical Manufacturers Association (CMA) unani mously approved the formation of Hazardous Waste Response Center (HWRC) as a means for assisting governmental agencies by bringing chemical industry expertise to bear on the problems of failing, hazardous waste sites. CMA undertook a pilot program which was limited to three sites and subject to the following constraints The U.S. Environmental Protection Agency (EPA) would select candidate sites for study subject to CMA approval. CMA would consider only those sites which were both failing and orphaned (no respon sible party identified). Candidate sites would not be in litigation or under imminent threat of litigation. CMA would assess sites using only existing data and not by generating new data through sampling and testing. To implement the pilot program, CMA formed a HWRC task group which reports through a sponsor to the Environmental Management Committee. The HWRC task group has organized Advisory Response Teams (ARTs) to conduct site investigations, directed ART activities, selected sites for study, and reviewed work products - The EPA referred some 12 candidate sites to the HWRC task group. Three sites representative of the types likely to be encountered were chosen for study under the pilot program. These sites were: Lipari Landfill - an inactive, leaking landfill at Pittman, New Jersey. Motco - a series of abandoned lagoons containing hazardous materials near Texas City, Texas. Tate Cove - an abandoned pile of corroded and leaking chemical waste drums near Ville Platte, Louisiana. ARTs have visited these sites, made investigations, and submitted reports of their findings to the EPA. Fifteen CMA member companies have participated directly in CMA 062818 (2) the pilot program by contributing the efforts of some 30 knowl edgeable representatives. Five task group members and three ART captains expended a total of 1,100 man-hours (a commitment of 7% of their time) while twenty ART members contributed approximately 1,000 man-hours (2.5% committed time). Member company "in-house" staff supported ART member activites with an additional 480 man hours, Costs of the pilot program are summarized below. Manpower Costs of Pilot Program Task Group Members ART Captains ART Members ART Support (5ea) (3ea) (20ea) Man-Hours 860 240 1,000 480 Total 2,580 Direct Costs of Pilot Program To Member Companies Travel Expenses To CMA Salary & Overhead Insurance Protective Gear Reaction to the Pilot Program Amount $ 22,000 Total 82,500 7,500 2,000 $114,000 Both state and federal regulatory agencies have cooperated in the pilot program. To date, personnel from six state agencies, three regional EPA offices, and EPA-Washington have participated. EPA-Region II has had the most opportunity to evaluate ART performance. Region II cooperated with CMA on the Lipari site investigation and provided most of the information for the basis of the Lipari report. The informal (verbal) report by EPA Region II to the final Lipari report expressed a certain measure of dis satisfaction in that the report lacked site specific engineering specifications. EPA Region VI cooperated in the CMA investigations of the Tate Cove and Motco and we await its comments once the final reports are submitted to that office. EPA-Washington's evaluation of the pilot program, although informal, has been quite favorable. On June 2, 1980, CMA sent a letter to Mr. H. Snyder, Chief Hazardous Waste Site Control Branch, requesting feed back on CMA investigations of Lipari, Motco, and Tate Cove sites, and comments on the overall program in order to complete the evaluation of the CMA pilot program. No formal written comments have been received to date. CMA 062819 (3) Mr. Snyder did, however, meet with HWRC task group representa tives on August 7, 1980 to express his views on the work of the HWRC. He described the work of HWRC as a source of useful reports which will be helpful as tools in making management decisions about the investigated sites, as references on specific sites, anc as text books for training personnel in managing waste disposal sites. Representatives from the states of New Jersey, New York, Maryland, Pennsylvania, Texas, and Louisiana have met with the HWRC task group during the course of the three site investigations. State and local agency personnel have indicated a willingness to cooperate whole heartedly with CMA in efforts to solve the techni cal problems associated with hazardous waste sites while relegating political considerations to the background. Although publicity was not sought in the pilot program, CMA, in speeches given by its officers, staff, and member company person nel, in seminars, and in its general press releases and publications has generated considerable public interest in the HWRC. Contacts from the academic community to supply technical expertise also resulted. CMA received requests from councils of state legislators and governors, and various commissions for such hazardous waste technical expertise. Recommended Future Program Both the HWRC task group and the Environmental Management Committee recommend that the HWRC activities be continued. We feel the primary effort of the future program should center on generating and maintaining a high level of recognition for CMA and the chemical industry as experts in hazardous waste site assessment and hazardous waste management. We forsee the follow ing benefits from this program. Fulfilling a social responsibility of the chemical industry to express and demonstrate a significant concern for the harm caused by failing chemical waste disposal sites. Deterring unwarranted action against the chemical industry stemming from exaggerated hazard assessment. Exercising an oversigt function on the expen diture of superfund monies and thus reducing its cost to the chemical industry. Participating in the development of regula tions implementing superfund legislation. Positioning CMA as expert to protect the chemical industry from potential regulatory CMA 062820 (4) threat now developing as groundwater policy. Producing reference materials for agency and member company technicians of proper procedures for site hazard assessment and corrective action. Regulatory agency activities have become a fact of life and there is agreement that they are very costly to the chemical industry. Thus it is prudent for the chemical industry to seize every possible opportunity to insure that these activities are cost effective. The EPA is presently developing ground water policy which will cover any and all waste sites which are con taminating ground water. The potential cost of poorly developed regulations to the chemical industry is staggering. As a recog nized waste site expert, CMA will be in a strong position to monitor the development of regulations and to challenge unwork able solutions. The HWRC task group recommends an expanded 12-15 month HWRC program to include: Investigations of up to 9 sites with the option of taking data as determined desireable. Prepare certain protocols, i.e. drum consol idations and site study personnel safety practice. Be available to make a few selected limited site investigations, when and if such invest igations would be beneficial to HWRC's overall objectives. Continue to work with the EPA, but be author ized to handle site surveys that originate with states. The proposed program is one which requires an increase in both committed man-hours and direct costs over those required for the pilot program. We anticipate a need for some 10,000 man hours of effort divided amongst 30 representatives from member companies plus some 2,400 man-hours of back-up support for these representatives. CMA staff committed time will also increase but the change can be accomodated with existing personnel. Both direct costs and manpower requirements of the proposed program are detailed below. CMA 062821 (5) RESOURCES REQUIRED Personnel Needs No. People Member Company Personnel Task Group Members ART Members ART Support Subtotal 11 19 30 60 % Time Personnel in Committed Yr. Equivalents 20 2.2 15 2.8 4 1.2 -- -- 6.2 Staff Personnel Professional Legal Support Subtotal 1 100 1 50 1 100 3-- 1.0 0.5 1.0 2.5 Budget Requirements Additional Operating Cost - None, projected expenses are within the approved FY 80/81 budget. Research & Consulting - The EMC budgeted $68,000 for the proposed HWRC program versus a projected total of $70,000. CMA BD- 9/8/80 EC-9/9/90 CMA 062822 Exhibit C Technical Publications -- Proposal to Discontinue Problem The Technical Publications program is not financially viable. It cannot be reviewed in accordance with outside counsel's instruc tions for periodic review and update without substantial increase in costs. Information which was once available only from CMA but is now available from other sources negates our need to provide this service. Objective CMA should continue to disseminate information, but we should use other mechanisms such as trade publications, scientific jour nals or other appropriate vehicles which would not require a man datory update. The preliminary shifting of workload burden for TSCA activities to the positions previously authorized to support the Technical Publications should continue in order to relieve the external workload pressure in the high priority hazards communi cations and TSCA areas. Background Technical Publications have formed a part of CMA activities for almost forty years. Last year the Executive Committee voted to discontinue the publication of material safety data sheets, and CMA's projected revenue dropped $122,000. Our operating cost was about $260,000 (including $93,000 insurance) for FY 79-80 while our revenue from sales was reduced to $32,500. The remaining Technical Publications include Cargo Informa tion Cards, Chem-Cards, Safety Guides and miscellaneous publica tions. The cards are no longer needed based on a membership poll. The Safety Guides could and should be published in the scientific press. Over 50% of CMA's existing Safety Guides currently re quire major revisions. Other publications require major revisions -- the Laboratory Waste Disposal Manual will cost $63,000 to revise and approximately $5,000 to publish. Recommendations Discontinue CMA Technical Publications as described in the background material and continue the shift of resources to support, the higher priority hazards communications and TSCA activities. Impact Money: CMA will need to continue the estimated $93,000 annual cost for insurance for several years and CMA 062823 2- - will spend about $5,000 for advertisements'noti fying the public of the discontinuation of these publications. The financial impact of law suits from CMA's prior publishing activities is impos sible to predict but could be substantial. Company Personnel: More than 1.5 years of company staff time will be saved. Staff Personnel: The full-time staff executive and sup port staff will be assigned to the hazards communications and other health, safety and chemical regulations activities. Publications clerks and fulfillment effort can and should be shifted to support the increasing ChemCAP activities. Action Required Approval to discontinue CMA's Technical Publications activi ties as of this date. * CMA EC - 9/8/80 BD- 9/9/80 CMA 062824 Technical Publications Background for Discontinuation Technical Publications should be discontinued for the follow ing reasons: without material safety data sheets, the program is not financially viable; the information needs that CMA previously supported are now met through other sources; the liability associated with the program outweighs its benefits; (Insuring against liability in this area will become increasingly expensive and possibly unobtainable with the potential of severe financial loss for CMA.) staff could be used more effectively in other CMA programs; and company participation is insufficient to meet the publications program needs. 1. Financial In FY 79-80, the following income was recorded: Chem-Cards Cargo Information Cards All others Total revenue $ 9,700 7,000 15,800 $32,500 The expenses for the same period were: Direct Expenses: Insurance Other directexpenses Total directexpenses $ 93,000 113,000 $206,000 Estimated Indirect Expenses : 54,000 Total $260,000 If Technical Publications are discontinued, the insurance policy must be continued for several years to protect liabili ties. Close-out expenses must include advertisements in trade publications to limit liability from use of outdated materials. This should run approximately $5,000. CMA 062825 2- - 2. Information needs are met through other organizations. CMA received only 42 responses from a survey of 240 distri bution contacts, CHEMTREC Advisors and project team members. Of those responding, only one-third recommended that we continue the Chem-Card program and one-half recommended that we continue the Cargo Information Card program. Of all of the company personnel surveyed, only 6% recommended continuing the Chem-Card program and 9% recommended continuing the Cargo Information Cards. The Department of Transportation said that cancellation would not pose regulatory problems. The trucking association supplies this information in book form. Safety Guide materials are generally available from the professional literature. (See Appendix for list of Technical Publications to be discontinued.) 3. Liability We publish about 170 Cargo and Chem-Cards which cost about $1,000 each for printing. This does not include the labor to review the cards prior to publication. A $50,000 three-year revenue cannot support this. PRIVILEGED MATERIAL REDACTED At present, revisions on SG-2, -4, and -17 are in draft form. SG-3, -5, -6, -7, -9, -10, -11, -18, -19, -20, -23, and -24 need revision. Each revision will cost $3,000 for publication alone. The largest revenue item outside of the material safety data sheets ($75,000/year) was the discontinued Laboratory Waste Dis posal Manual. It was discontinued because the recommendations violated the Federal Water Pollution Control Act. A contractor has bid $63,000 to revise the Manual and it would cost $5,000 to publish. If republished, it would require revision every three years plus staffing to process inventory, mailing and billing. 4. Staff could be assigned to other projects. The personnel assigned to Technical Publications could be used for hazards communications activities and toxic substances issues. In staff's opinion, this will have a greater value for the industry than the Technical Publications. 5. Company participation is insufficient. Our experience has shown enthusiastic support for drafting the original document, but little support for revisions. The bur den falls upon CMA staff to prepare these revisions. CMA 062826 APPENDIX TECHNICAL PUBLICATIONS These are-publications of particular interest to managers and op erators of chemical-producing plants. Environment Guidelines for Chemical Plants in the Prevention, Con trol, and Reporting of Spills (1973) WR-i A Guide for Subsurface Injection of Waste Fluids from Chemical Manufacturing Plants (1976) SI .00 SI.SO Safety and Health Occupational Epidemiology, A Brief Overview Case Histories of Accidents in the Chemical Industry. Vol. One--1962 Vol. Two--1966 Vol. Three--1970 Vol. Four--1975 Index* of Cas* Histories of Accidents in the Chemical Industry Set'of All Four Volumes and Index Guidelines, for Risk Evaluation and Loss Prevention in Chemical Plants (Revised 1976) Si .00 S3.75 S3.75 S3.75 $3.75 $1.00 $15.00 52.50 4 CMA 062827 SAFETY SERIES These are technical publications specifically designed to assist in the safe commercial production and transportation of chemicals. Safety Guides $2.50 EACH Preplanning for safety. Practices and procedures useful to those engaged in many aspects of chemical manufacturing, but especially those at the plant level. Health Factors in the Handling of Chemicals (1979) SG-1 Emergency Organization for the Chemical Industry (1979) SG-4 Electrical Switch Lockout Tag and Try Procedures < 1978) SG-8 Maintenance and Inspection of Rre Protection Equipment (1978) SG-13. Safety in the Scale-up and Transfer of Chemical Processes (1978) SG=-14 Training of Process Operators (1978) SG-15- Liquid Chemicals--Sampling of Tank-Car and Tank Truck Shipments (1979) SG-16 Rre Protection inthe Chemical Industry (i960) SG-17' Safety Inspection Committee for a Small Plant (1973) SG-20 Guidelines for a Chemical Plant Safety Program and Audit (1978) SG-21 Siting and Construction of New Control Houses for Chem ical Manufacturing Plants (1973) SG-22 NOTE: Future issues in this series may be obtained on a continuing sub scription basis, billed at the end of each year TRANSPORTATION EMERGENCY GUIDES 500 EACH CMA CHEM-CARDS. Each card gives useful information in case of accidents, involving overland shipments (truck, rail) of dangerous cargoes. Cards are 17.5 cm x 25.4 cm (7" x I0")..3-hole punched. Acetaldehyde Acetone Acetone Cyanhydnn Acetonitrile Acrolein (Inhibited) Acrylonitrile Ally) Alcohol Allyl Chloride Ammonia. Anhydrous Ammonia, AquaAnhydrous Hydrazine Aniline Oil Benzene Benzyl Chloride Boron Tnfluoride CC-49 CC-23 CC-34 CC-64CC-76 CC-15 CC-35 CC-63 CC-44 CC-66 CC-7 CC-51 CC-17 CC-54 CC-87 5 TRANSPORTATION EMERGENCY GUIDES 50c EACH--Continued Bromine Butadiene Butyl Acetate Butyl Alcohol (Secondary or Tertiary) Butyllithium Butraldehyde Carbolic Acid (Phenol) Caustic Potash (Liquid) Caustic Soda (Liquid) Chlonne Chlonde Trifluoride Chlorosulfonic Acid Cresol Cyclohexane Oiethyiamine- (Anhydrous) DiethyfenetriamineDimethyl Ether Dimethyl Sulfate Epichlorohydnn Ethanol Ether (Ethyl) Ethyl Acetate Ethyl Acrylate Ethyl Chloride Ethylene Dichlonde Ethylene Oxide Ruorine (Liquid) Formic Acid Hydrazine/UDMH Hydrochloric Add Hydrofluoric Add (Anhydrous or Aqueous) Hydrogen, Liquid Hydrogen Peroxide (High Strength) Isopropanol Isopropylamine Isopropyl Ether Methanol Methyl Acrylate Methylamines (Anhydrous) Methylamines (Aqueous) Methyl Bromide (Liquid) Methyl Chlonde Methyl Ethyl Ketone Methyl Isobutyl Ketone Methyl Methacrylate Mixed Acid Monomethyl Hydrazine Motor Fuel Antiknock Compound Nitnc Acid Nitric Acid (Red, Fuming) Nitrobenzol (Liquid) 6 CC-59 CC-81 CC-60 CC-80 CC-28 CC-50 CC-48 CC-32 CC-33 CC-53 CC-2 CC-73 CC-77 CC-20 CC-27 CC-72 CC-61 CC-55 CC-29 CC-70 CC-16 ' CC-18 CC-35 CC-24 CC-62 CC-36 CC-10 CC-83 CC-9 CC-82 CC-42 CC-12 CC-14 CC-71 CC-56 CC-58 CC-69 CC-74 CC-26CC-84, CG-38 CC-67 CC-22 CC-57 CC-43 CC-65 CC-11 CC-30 CC-47 CC-3 CC-79 CMA 062828 TRANSPORTATION EMERGENCY GUIDES 50C EACH--Continued Jitrogen. Liquid Jitrogen Tetroxide Dleum 3xygen, Liquid 'entaborane Peracetic Acid Jerchloryl Fluoride Phosphorous Oxychloride Phosphorous Pentasulfide Phosphorus Trichloride Phosphorus (White or Yellow in Water) sodium (Metallic) Sulfur Dioxide sulfur Tnoxide sulfuric Acid Toluene dnsymmetncal Dimethyl Hydrazine Vinyl Acetate Vinyl Chloride Vinyiidene Chloride Xylene CC-6 CC-i CC-68 CC-13 CC-5 CC-86 CC-4 CC-39 CC-41 CC-40 CC-37 CC-31 CC-78 CC-52 CC-25 CC-19 CC-8 CC-21 CC-46 CC-75 CC-45 NOTE: Future issues in this series may be obtained on a continuing sub* scnption basis biiled at the enG o< each year CARGO INFORMATION CARDS 50$ EACH Each card gives useful information in case of accidents involving barge shipments of dangerous cargoes. Cards are 17.5 cm .< 25 x .4 cm (7" x 10") Varnish Coated. Acetaldehyde Acetic Acid Acetic Anhydride Acetone Cyanohydnn Acetonitrile Acrylonitrile Adiponitrile Allyl Alcohol Ally! Chlonde Aminoethylethanolamine Ammonia, Anhydrous Ammonium Hydroxide Aniline Benzene Butadiene (Inhibited) n-Butyi Acrylate n-Butyraldehyde Camphor Oil Carbolic Oil Carbon Bisulfide or Carbon Disulfide Carbon Tetrachlonde C1C-1 CIC-2 CIC-3 CIC-4 CIC-5 CIC-6 CIC-7 CIC-8 CIC-9 CIC-10 CIC-11 CIC-12 CIC-13 CIC-14 CIC-15 CIC-16 C1C-17 CIC-18 CIC-19 CIC-20 CIC-21 7 CARGO INFORMATION CARDS 500 EACH--Continued Caustic Potash Solution Caustic Soda Solution Chlorine Chlorobenzene Chloroform Chlorohydrins (Crude) Chlorosulfonic Acid Cresols Crotonaldehyde Dichlorodifluoromethane Dichloropropane Dichloropropene Diethanolamine Diethyienetriamine Diisopropanoiamme DimethylamineEpichlorohydrin Ethyl Acrylate Ethyl Chloride. Ethyl Cyanohydrin Ethylenediamine Ethylene Oichlonde Ethyleneimine Ethylene Oxide Ethyl Ether 2-thyl-3-Propylacrolem Formaldehyde Solution Formic Acid Furfural Hydrochloric Acid Hydrofluonc Acid Hydrogen Chloride Hydrogen Fluonde Isobutyl Acrylate or Butyl Acrylate (iso) Isobutyraldehyde or Butylraldehyde (iso) Isoprene Methyl Acrylate Methyl 8romide Methyl Chloride Methyl Methacrylate Monochlorodifluoromethane Monoethanolamtne Monoisopropanolamine Morpholine Motor Fuel Antiknock Compounds Oleum Phenol Phosphoric Acid Phosphorous Propionic Acid Propylene Oxide 8 CIC-22 CIC-23 CIC-24 CIC-25 CIC-26 CIC-27 CIC-28 CIC-29 CIC-30 CIC-31 CIC-32 CIC-33 CIC-34 CIC-35 CIC-36 CIC-37" CIC-38 CIC-39 CIC-4Q CIC-4-1 CIC-42 CIC-43 CIC-44 CIC-45 c:c-46 CIC-47 CIC-4S CIC-49 CIC-50 CIC-51 CIC-52 CIC-53 CIC-54 CIC-55 CIC-56 CIC-57 CIC-58 CIC-59 CIC-60 CIC-61 CIC-62 CIC-63 CIC-64 CIC-65 CIC-66 CIC-67 CIC-68 CIC-69 CIC-70 CIC-71 CIC-72 CMA 062829 CARGO INFORMATION CARDS 50c BACH--Continued Styrene Sulfur, Liquid Sulfunc Acid Sulfuric Acid, Spent Triethanolamine Triethylenetetramme Vinyl Acetate Vinylidene Chloride (Inhibited) Compressed Gases Cargoes with flashpoints of 20 F andlower Cargoes with flashpoints above 20 F to and including 80 F Cargoes with flashpoints above 80 F Cargoes with flashpoints above 80 F and requiring, heat for transfer CIC-73 CIC-74 CIC-75 CIC-76 CIC-77 CIC-78 CIC-79 CIC-81 CIC-82 CIC-83 CIC-84 C!C*85 CIC-86 NOTE. CIG-S2- through CIC-86 are"generic''type cards approved lor use with"cargoes listed in U.S. Coast Guard regulations 46 CFR. A list of appiioaole cargoes is given on the-reverse ol each card. Future issues in this series may be obtained on a continuing subscnpbon basis, billed at the end of the year. 9 CMA 062830 Exhibit D Formation of a Public Risk Analysis Special Committee Objective Purpose Background To follow and impact the development of risk analysis as a regulatory decision tool. This special committee will evolve chemical in dustry positions on the value, limitations and practice of risk analysis. The chemical industry has advocated risk analy sis for several years as the most logical deci sion-making tool for highly complex issues such as chemical safety. The recent Supreme Court Benzene decision forces OSHA to consider risk and benefits of benzene before it modifies regulatory action. Congressmen are discussing possible legislation to define acceptable risk at this time. The National Association of Manufacturers will coordinate trade association activities in risk analysis, and AIHC is working on the topic as it relates to chronic health issues. The American Petroleum Institute and the Business Round Table also have activities in progress. The public decision issue of risk analysis will have a unique impact on the chemical industry which is more intense and broader that will be covered by the other associations -- distribution of hazardous chemicals, for example. Methods of risk analysis are being developed in universities and government. Industry must under stand and participate sufficiently to impact the evolving application of risk analysis. This group must be sensitive to the concerns of other indus tries as this issue evolves. This is well beyond the conventional view of mere "risk/benefit". This CMA special group will coordinate with the other Association activities, but will focus on the special problems confronting the chemical industry. CMA 062831 2- - Recommendations Form a special committee with an Executive Committee member as chairman. This Committee will operate for one year and during that period it will develop strategies for chemi cal industry responses. (This may be a rec ommendation for formation of a standing committee or some other action.) A special committee is recommended because of the in tense concentration of varied disciplines that must be coordinated to manage this emerging issue. Impacts Money: Until the committee develops an action plan, it is difficult to estimate. A budget request will be prepared along with the charter and will be submitted later. Company Personnel: A total company time commitment is approxi mately 1.5 years. Staff Personnel: A one-year contract company person will be used as a staff executive. It will be nec essary to hire a secretary to support this activity. Action Required Approve formation of a special committee on public risk analysis for one year. * CMA EC - 9/8/80 BD - 9/9/80 CMA 062832 SOCIAL DECISION MAKING: A CHALLENGE FOR THE '80s THE NEED FOR SOUND DECISION MAKING IN THE HEALTH/SAFETY AREA CONSTITUTES A MAJOR NATIONAL POLICY ISSUE DEMANDING URGENT AND CONCENTRATED ATTENTION AND EFFORT CC - 9/8/80 BD - 9/9/80 CMA 062833 INTRODUCTION ns report outlines some major, critical issues which must be addressed in the health/safety area as society develops a sound policy for managing chronic health risks. The report also summarizes some general conclusions about indicated action for the business community in providing a positive contribution to the development of this needed social policy. BACKGROUND This report summarizes the work of an ad hoc group, whose members address the same health and safety issues in a variety of other trade associations (CMA, AIHC, API, and the Business Round Table). This group arose from a common concern that the increasing interest in the interrelated concepts of "risks", "benefits", and "costs" among a variety of groups in industry, the regulatory agencies, the Congress, academia, and the public were not supported by adequate identification of issues, definitions of terms, or development of a sound conceptual structure. There was concern that the seductively simple and logical concept of "risk/benefit" analysis was gaining broad acceptance without a valid understanding of its complexities, its inappropriateness for many situations, and pragmatic problems of execution. Common sense dictates that a sound, integrated national policy for dealing with health and safety issues should incorporate two basic concepts: 1) Policy decisions should be based upon sound science, which reflects all available scientific data. 2) Policy decisions should reflect a reasonable, socially and politically acceptable, and rational balancing of risks, benefits, costs, social and economic issues, and the abstract but important issue of assuring personal freedom of choice. This report is presented as a step toward clarifying some of these issues and as a basis for future evaluation by others. WORKING HYPOTHESES A number of working hypotheses seem to be gaining a broad-based acceptance as a part of a general conceptual framework in the health/safety policy area: 1) A risk-free society is neither feasible nor affordable. 2) Degree of "risk" can vary widely from the "trivial" to the "unacceptable" and the degree of regulatory control should vary according to the risk involved. 3) Sound regulatory policy requires that different standards for regulation be applied to risk where the exposure is "voluntary", vs. those for which the exposure is "involuntary." 4) For risks which are not "unacceptable" and for which exposure is voluntary, the appropriate degree and type of regulatory action should provide society with an opportunity for informed freedom of choice on quality of life issues. CMA 062834 2- - 5) There is a developing consensus that it is a proper function of government to educate the public on relative levels of risk, but there is also recognition that some degree of risk is so generally associated with most aspects of daily life, that there is a potential for creating confusion among the public by over-communication. 6) There is a developing recognition that naturally-occurring risks (e.g., carcinogens) present special and difficult problems. KEY ISSUES To resolve current confusion and problems, and to establish a socially and politically acceptable and scientifically sound framework, we believe the following key issues must be addressed jointly by government legislative and regulatory groups, industry, academia, and the public: 1) What should the relative roles be for industry and government in protecting the public against risks in the health and safety area? What are the responsibilites of each to the individual member of the public? 2) To the extent that a "zero risk" approach to risk management is abandoned, what are the responsibilities of government and industry to advise the exposed public of the degree of risk to which they are exposed? How can adequate communication be provided without so overloading the public's circuits as to "turn them off?" 3) Recognizing that risks differ in kind, degree, reversibility, timeframe, population at risk, and voluntariness (or involun tariness) of exposure; can these risks be "scaled" by order of magnitude? If so, should similar levels of risk be communicated equally to the public and be regulated equally? 4) Recognizing that the interests of many different constituencies (e.g., labor unions, industries, the consumer, and the environ mentalists) vary widely and are often contradictory, how can a socially and politically acceptable policy framework be developed? 5) What role should industry play in developing a framework for such policy and to what extent should industry undertake the responsi bility for informing and gaining support of government and other interested groups for such a policy framework? If industry undertakes this responsibility, what should be the locus of developmental effort? 6) A-6 Given the near-term realities of legislation in Congress under active consideration on these issues, of developing regulatory concepts within IRLG and individual agencies, and of judiciallyinitiated concepts which require clarification (e.g., "significant CMA 062835 -3- risk", "significant reduction in risk," and "substantial evidence" on the benzene case); how can industry play a responsible role in the absence of a conceptual framework which is acceptable to all parts of industry? How do we avoid having such issues resolved in a manner which might obviate or complicate appropriate options in an industry-developed conceptual framework, before that framework is developed? Concepts of objectively established, science-based quantitative risk assessment and "relative risk" may be cornerstones of an appropriate conceptual framework, but how does industry keep its options open? These and a wide variety of other issues are detailed in the attached: "Risk-Benefit-Cost Background Report: Issues, Terms, Methodologies, and Activities." INDICATED ACTION AND CONCLUSIONS There are no easy answers to the above issues, but we believe that responsible industry must act now to address these issues. We propose the following: 1) Industry should undertake the formulation of a sound conceptual framework for regulation of health/safety hazards in our society . . . with particular emphasis on chronic health hazards. 2) This project should be approached on a pan-industrial basis to permit resolution of parochial and often contradictory interests and problems before the framework is presented to the government, the public, and special interest groups for their consideration and critique. 3) This is an enormous undertaking. An unusual organization, with a central forum or locus of responsiblity within industry should be set up to coordinate the effort. The alternative is to allow the regulatory agencies, the legislative branch, or special interest groups to take the initiative on this issue . . . and for industry to be in a responsive mode, with ill-prepared and conflicting points of view. 4) Key trade associations must be encouraged to undertake extraordinary commitments to both internal and coordinated effort. This will involve allocation of resources and parceling of issues to avoid unwarranted duplication of effort to deal with the near-term issues in this area simultaneously with the development of the longer-term concept ual framework. 5) Industry must commit itself not only to the development of the concept, but also to the broad political task of educating other constituencies about our proposal and motivating their support. 6) A-7 The benzene decision provides a brief opportunity to inject common sense into a national policy for sound decision making on societal issues. We urge active commitment by industry to participate in the development of a soundly conceived policy. CMA 062836 RISK-BENEFIT-COST BACKGROUND REPORT: ISSUES, TERMS, METHODOLOGIES, AND ACTIVITIES Document developed for Risk-Benefit-Cost Scoping Study Steering Group June 1980 H. G. Haight - E. I. duPont de Nemours & Co. L. P. Haxby - Shell Oil Company P. W. If!and - Procter & Gamble Company A. M. Norberg - Monsanto Company 0A EC - 9/8/80 BD - 9/9/80 CMA 062837 INDEX INTRODUCTION I. BACKGROUND: LEGISLATIVE AND REGULATORY IMPETUS AND CONFLICTS II- ISSUES IN RISK-BENEFIT-COST ANALYSIS III. TERMS AND DEFINITIONS IV. METHODOLOGIES IN THE HEALTH AND SAFETY AREAS V. ACTIVITIES APPENDICES 1-2 3-4 5-9 10-12 13-21 22-33 CMA 062838 INTRODUCTION The intent of this brief report is to bring together pertinent background information in the Risk-Benefit-Cost arena to facilitate informed decision-making by industry representatives responsible in this field. Its purpose is to serve as a beginning primer to acquaint the reader with the issues, the meanings of some of the currently used terms, the methodologies, and some of the key players or leading spe cialists in this area. It will attempt to identify where in government, academia, and the private sector some of the Risk-Benefit-Cost work and studies are being conducted. Risk-Benefit-Cost analyses are used formally and informally in nearly every activity of life. In certain areas, quantification of the risks, benefits, and costs is quite rigorous. However, in health, safety, and environmental areas many of the elements of an analysis are intangible and not immediately perceivable. Believing that the interest of the Risk-Benefit-Cost Scoping Study Steering Group lies mainly in the health and safety areas, our cursory survey has confined itself, where necessary, to the following materials controlled by well defined statutes and where risk assessment is used in their regulatory practice. Material (Media) Air Air Quality Standards Carcinogens Chemical Substances Drugs Food Material and Ingredient Additive Contaminant Statutes Clean Air Act (CAA) Toxic Substance Control Act (TSCA) Federal Food Drug and Cosmetic Act (FFDCA) FFDCA CMA 062839 Water Water Quality Standards Priority Pollutants Clean Water Act & Safe Drinking Water Act Workplace Health Safety Occupational Safety & Health Act (OSHA) Within this framework, this report attempts to fulfill the following listed charges given by the Steering Group to the working party: 1. Develop listing of issues. 2. Identify centers and range of activities by others on these issues. 3. Develop definitions of risks, benefits, and ancillary terminology with range of use. 4. Establish what methodologies are currently used for standard setting. The report is organized by Chapters which address the above topics. Finally, we have included reprints of selected articles which the Task Force recommends as particularly germane to the use of risk-benefit-cost analysis in regulatory practice. These four reprints include: Bazelon, D. L. 1979. Risk and Responsibility. Science 205:277-280. Leape, J. P. 1980. Quantitative Risk Assessment in Regulation of Environmental Carcinoqens. Harvard Environmental Law Review 4:86-116. Okent, D. 1980. Comment on Societal Risk. Science 208 (4442):372375. U. S. Congress. Senate. Benefits of Environmental Health and Safety Regulation. Committee on Governmental Affairs. 25 March 1980. Prepared for Committee by the Center for Policy Alternatives at the Massachusetts Institute of Technology. ^Nicholas A. Ashford, Co-principal Investigator. -2cMA 062840 CHAPTER I Background: Legislative and Regulatory Impetus and Conflicts. The United States, together with many developed nations, experienced rapid economic growth and improvement in our standard of living in the decades immediately following World War II. Development of the petro chemical industry contributed a major component of the growth rate. Technological innovation has resulted in rapid expansion of basic materials, an introduction of many new substances each year, and broadscale dispersion of these and older substances in wide application in industrial processes and consumer products. Some products of technological growth have involved risks of toxicity to man and his environment. In response to society's perception of these risks, the United States Congress in the 1970's enacted several laws that govern the conditions under which chemicals or products may be introduced into the environment. (See Appendix I, Table 1.) Paralleling this legislation is the rapid growth of the bureaucracy required to develop, administer, and enforce the regulations. The various regulatory agencies have greatly enlarged their manpower, scientific capability, and the scope of screening and monitoring programs. (See Appendix I, Table 2.) This growth has been mainly piecemeal, incremental, responsive to crisis, and lacking in a basic policy for the coherent management of the nation's health and safety resources. As a result, a variety of problems have arisen. The nation has laws and regulations with inconsistent dictates: some too strong to be met (e.g. by marginal industries), others too weak to provide protection (e.g. to high-risk groups). There are agencies with overlapping mandates (e.g. FDA, EPA, and CPSC). There are inconsistencies between different approaches to risk assessment and risk management, and conflicts between the public, industry, and government. The statutes are not consistent in requiring regulatory agencies to consider the economic, environmental, social, and technological costs and benefits of regulating risks. Table 3 (in Appendix I), developed for the National Academy of Sciences Study on Food Safety Policy, sum marizes for eleven statutes 1) the statutory standard for regulatory action and 2) the agency concerns in regulatory action. Health, safety and social requirements are closely linked. However, early legislation in these areas separated issues according to media of exposure, often resulting in overlapping or conflicting requirements. As recognition of these commonalities has occurred, there is a greater tendency for generic regulations encompassing broad areas of control with hundreds of materials being affected by a single sweeping regulation. To cope with the increasing complexity, modeling is used more and more to assist in the decision-making process. As the complexity of the regulatory process increases, modeling techniques as a part of -3CMA 062841 risk-benefit-cost analysis will be extended into more areas of regulatory decision making. As these concepts are utilized by government groups (legislative and regulatory) to fit their particular needs, inductry needs to develop unified positions on methodology and policy in order to interact effectively. Since much of the critical information in the decision making process will derive from the industry sources, insuring its proper interpreta tion and application can best be done with industry involved. Thus, regulatory decision making process must permit and encourage industry participation. -4- CMA 062842 CHAPTER II Issues in Risk/Benefit/Cost Analysis "A thing is safe if its risks are judged to be acceptable. "(1) This simple statement embodies all of the complex and controversial elements of risk/benefit analysis. The statement clearly emphasizes that two very different kinds of activities are involved: measuring the risk and judging the acceptability of that risk. The estimation of risk is basically a scientific activity, although it can be extended to include economic factors as well. The judgment of the acceptability of the risks involves value judgments in which benefits figure prominently. The fundamental issue is how to allocate our national resources in order to obtain the greatest improvement in health and safety for the resources expended. It should be recognized, particularly at this time, that the national resources which can be expended in improving health and safety are not unlimited. We need to allocate these resources as wisely as possible with due consideration, not only for the humanistic and ethical implications, but with consideration of economics as well. Now what is needed is a process which will set national priorities, based on objective evaluation of costs, risks, and benefits. The current approach on a piecemeal, case-by-case basis has frequently led to use of resources to obtain less than optimal results. The more detailed listing of issues which follows further subdivides the problem into three broad areas: scientific, societal, and structural/ policy. A) Scientific - Estimation of the risk involved in a particular activity is primarily a scientific exercise. The process is based on the development of the technical facts around the consequences of exposure and estimation of the means and extent to which the negative consequences will be experienced by various populations. This process, at its best, is objective and free of value judgments. Specific issues are as follows: ' How to get the highest quality and most objective scientific assessment. Both industry and regulatory scientists have been criticized for lack of objectivity. In cases of unusual importance the National Academy of Sciences, as an objective, unbiased, prestigious, scientific group, has been drawn in to make risk assessments. Even this group has not always been able to keep from letting value judgments creep into their assessments. (1) Of Acceptable risk - Science and the Determination of Safety; Lowrance, William W., William Kaufmann, Inc.; Los Altos, California; 1976. -5- CMA 062843 Should the scientific assessment of risk be separated organizationally from the regulatory and enforcement functions? The regulatory process needs to find a way to develop the scientific assessment of risk as free from value judgments and political pressure as possible. Furthermore, we need to improve the effectiveness of the interface between scientific assessment of risk and the political/social assessment of benefits and the balancing of these benefits against the entailed risks. How to handle scientific uncertainty. Even with the most conscientious effort, scientific information, particularly on chronic, long-term issues, is seldom definitive. Scientists are left with some uncertainty which is most often handled by conservatism. If the scientific uncertainti are expressed, they frequently are conveyed to the public and to regulators, and only tend to increase anxiety. How to update risk assessment without losing face as new scientific information becomes available. How to communicate conclusions based on highly technical information to the societal sector understandably and effectively. How to handle "trans-scientific problems." These are problems in which definitive scientific information is unobtainable, but, nevertheless, decisions must be made. It has been suggested that these kinds of problems cannot be handled by scientific means a!one--there are political implications which must be integrated into the decision. The special case of risks from cancer. The scientific debate between the threshold theory and the one-hit theory of carcinogenesis has not been resolved. Uncertainty about the mechanism of initiation of cancer continues to complicate risk assessment in this area. How do we deal with remote but finite probabilities of a risk occurring? How do we determine the point at which a risk becomes so remote that it is not worth considering? How to quantitate the increase in probability of a risk occurring due to human error, equipment malfunction and improper maintenance and combinations of these items, e.g. Three Mile Island. How do we evaluate the acceptability of risks to future generations; of risks whose manifestations come only later and of combinations of hazards, e.g. cigarette smoking and asbestos exposure? -6- CMA 062844 B) Societal Issues - Once the magnitude of the risk has been established by the scientists it falls to the politicians arc courts, more or less responsive to public opinion, to make t--e value judgments as to whether or not the risk is acceptable. These judgments are clearly influenced by advocacy groups anc by lobbyists. The process generally evolves to a subjective judgment based on scientific findings, but importantly in fluenced by political and policy considerations. Much of the controversy over the usefulness of risk/benefit analysis and its practice in setting regulatory standards stems from the subjective value judgments which are made. The "zero risk" approach to regulation finds its roots in this part of the process. Following are some of the societal issues involved. How to preserve freedom of individual choice. Benefits may be valuable to some but perceived of no value, and therefore, not worthy of risk to others. How do we regulate risk while still preserving the basic democratic tenet of freedom of choice? How to articulate benefits which are psychological or aesthetic. In a risk/benefit analysis any risk involved must be balanced against benefits. If the benefits are intangible, they still may be of value and therefore worth some risk. Rather than evaluating risks and benefits on an absolute scale, would it be better to position risks relative to others with which society is familiar and which have been accepted? How to equitably distribute risks and benefits. Society frequently asks people to take risks while others enjoy the benefits. Should risk-takers who do not receive the benefits be compensated, and if so, how? 0 How to quantitate all of the risks and alj of the benefits. Any rigorous benefit/risk/cost analysis has to balance all of the consequences. The task of making a global assessment of all of the consequences most often is not possible. How to handle the fact that risks and benefits are in different units. Here the purely economic approach runs into the morally distasteful task of putting a dollar 1 value on human life. Similarly, how can such intangible items as peace of mind and quality of life be evaluated in dollar terms--should we even try? Should we be using the concept of efficacy rather than benefit? The concept of benefit in the regulatory context implies a value judgment which someone must make on behalf of others. Would we be better off to think in terms of efficacy, as is now done in drug regulation where the question is much simple!--"Does it do the job for which it is intended?" -7- CMA 062845  The philosophical basis for risk assessment needs to be re-examined. Should we be trying to define, what is an unacceptable risk rather than trying to define which risks are acceptable? How should society account for risks which may be statistically remote, but the consequences if the risk is realized are huge?--e.g. a major nuclear power plant disaster. There is a wide range of personal acceptance between known (familiar) and unknown (not familiar) risks, and between risks voluntarily accepted and risks involuntarily imposed on us by someone else. How are these factors handled in a benefit/risk analysis? An analysis of the risk/benefit/costs of a given action also needs to include a similar analysis of not acting. The consequence of inaction is most frequently ignored. C) Structural/Policy Issues - In an ideal society the consequences of a given action can be rigorously analyzed and used in legislative and regulatory decision making for the optimized good of the society. Ideally we could make a global assessment of the risks-benefits-costs, and allocate our national re sources to get the best overall result. However, there are a number of other issues which need to be resolved before this can be achieved. 0 Who is responsible? In times past a commercial enterprise took full responsibility for the consequences of its actions. More recently, the responsibility for protect ing the society from unacceptable risk has been assumed by government stimulated by public interest groups. Much of the conflict around regulatory constraints has arisen because of the shifting responsibility. 0 As government has assumed increasing responsibility in the health and safety area, the incentives for action or re straint have shifted. A business enterprise, motivated to make a profit for shareholders, draws a careful balance between risks and benefits recognizing that undue risk jeopardizes the company's reputation, the product's viability, and risks reducing profit. The government's approach has been to provide incentive for responsible action through imposition of penalties. What is the most appropriate way to encourage commercial enterprise to responsible action? -8- CMA 062846 0 How can regulatory agencies avoid the personal and organizational risk-avoidance approach to regulation? 0 Are the techniques of risk/benefit analysis sufficiently well developed that they can be used as a rigorous part of the decision-making process? With all the deficiencies and uncertainties described above, is our society ready to rely on risk/benefit analysis as a central part of the process? Would we be better off to recognize that risk/benefit analysis is still an imprecise science and accept that it is only a tool to help organize the analyses process as some have suggested? What is the media's role and responsibility in shaping a balanced opinion on risk taking? Labor unions appear to be violently opposed to the use of risk/benefit analysis in decision making. Would their interests be better served long term by a process which brings to the public attention such issues as jobs lost or gained as a result of proposed action? In the spirit of preserving the right to individual choice, what action is needed to make this choice an informed one? 0 How should our society develop an enlightened policy arourud risk assessment and the judgment of what is an acceptable risk? If we had such an enlightened policy, how does this become a part of the legislative and regulatory processes? -9- CMA 062847 CHAPTER III Terms and Definitions This chapter attempts to define some of the terms commonly used in risk-benefit-cost analysis. Broadly speaking, the terms are used with con sistent meaning by workers in the field. Where confusion arises, it is usually in the limitations of the scope applied in using the term--e.g. what kind of elements are considered as benefits or as risks. Value judgments may be used by the analyst or by the public, sometimes unin tentionally, in defining the scope of the terms as it is used in a specific instance. The following definitions are stated in the broadest terms: Risk: Rates of occurrence of undesirable events. Risk Assessment: The total process of quantifying a risk. Risk Management: A process utilizing the three elements of 1) risk assessment, 2) cost/benefit analysis, and 3) value judgment to arrive at an optimal decision. Safety: A judgment of the acceptability of risk. Benefit: Whatever promotes social welfare. Reductions in social costs. Costs: Whatever outlay of time, money, labor, self-denial, etc., is required to secure benefit. Cost-Benefit Analysis: Evaluation and comparison of costs versus benefits. Cost/Benefit Analysis: Evaluating the ratio of costs to benefits. Cost-Effectiveness Analysis: Comparison of alternatives to achieve lowest cost/benefit ratio. The following are some examples of how these terms have been defined by experts to suit their specific needs: Risk Hazards exist (trees will fall) as possible events. "Risk is the potential for realization of unwanted negative consequences of an event." (W.D.Rowe) "A measure of the probability and severity of harm to human health" (ob jective but probabilistic). (W.W.Lowrance) Carcinogenic Risk - "A quantitative estimate in probabilistic terms of cancer occurring due to exposure to specific agents." (RARG) -10- CMA 062848 Risk Assessment "The total process of quantifying a risk and finding an acceptable level of that risk for an individual, group, or society. It involves both risk determination and risk evaluation." (W. D. Rowe) "Human risk assessment is a very inexact exercise, based largely upon theoretical assumptions concerning interspecies extrapolation." (Food Safety Council) (See references Chapter IV.) Process steps are: 1. Define conditions of exposure. 2. Identify adverse effects. 3. Relate exposure with effect (Dose-Response). 4. Estimate overall risk. "When policy decisions are based on calculated probabilities, the base numbers should be supplemented with 'confidence limits'." (J. R. Ravertz) Safety "A matter of personal and social value judgement." (W. W. Lowrance) "The acceptability of risks cannot be simply derived from a scientific study of quantified probabilities, costs, and benefits. The human factor influences the analysis at every point. But fairness in discussions and effectiveness in controls of risk can be approached by the use of scientific methods among others, provided that the diversity of human interests, values and perceptions of risks is always respected." (M, Swann, et al.) Benefit ". . . anything received that causes a net improvement to accrue to the recipient" and "a result of a specific action that constitutes an increase in the production possibilities or welfare level of society." (W. D. Rose) Cost "A result of a specific action that constitutes a decrease in the produc tion possibilities or welfare level of society." (W. D. Rowe) Cost/Benefit Analysis "An attempt to delineate and compare in terms of society as a whole the significant effects, both positive and negative, of a specific action." (W. D. Rowe) -11- CMA 062849 Cost-Effectiveness Analysis "A term less specific than cost/benefit analysis, usually meaning the selection of the lowest cost alternative that achieves a pre-determinec level pf benefits. Alternatively, the analysis and selection of the path that yields the largest social benefit for a pre-determined speci fied level of social costs." (W. D. Rowe) Appendix III, Table 1 provides a more extensive glossary of terms taken from W. D. Rowe, Anatomy of Risk, (1977). REFERENCES Lowrance, W. W. 1977. Of Acceptable Risk: Science and the Determination of Safety. William Kaufman, Inc., Palo Alto, CA. RARG (Regulatory Analysis Review Group). Council on Wage and Price Stability. OSHA Proposal for Industry. Submitted 24 October 1978. Ravertz, J. R. 1977. The Risk Equation--The Political Economy of Risk. New Scientist 75. Rowe, W. D. 1977. An Anatomy of Risk. John Wiley and Sons, New York. Swann, M. 1977. The Acceptability of Risks. Council for Science and Society. Barry Rose Ltd., London. -12- CMA 062850 CHAPTER IV Methodologies in the Health and Safety Areas A complete, full fledged risk-benefit-cost analysis is a complex, sophisticated multi-disciplined exercise, still in an evolutionary develop ment stage. The basic elements of the analysis are: an estimate of the exposure required to produce a biological effect; an estimate (frequently in probabilistic terms) of the frequency at which the population will experience the biological effect based on projected exposure; an estimate of all costs required to limit or control the exposure; and an estimate of all the benefits expected from the expenditure required to reduce exposure. Each step in the procedure normally involves assumptions and un certainties which should be identified and expressed as fully as possible. The first steps, i. e., the estimation of exposure required to pro duce a biological effect and an estimate of the exposure the population will experience, are basically scientific. Many techniques (listed below and more fully described in Appendix IV) have been devised to improve the quality of risk estimation. Nonetheless, many critical issues re main for investigation--the theory of cancer initiation, problems with the extrapolation from animals to man, and so forth. The remaining steps in the process, estimation of costs and benefits, are economic and societal. Much of the controversy in interpreting results from risk-benefit-cost analysis lies in the biases and value judgments which are inevitable in the subjective part of the process. The diagram on the following page illustrates the many elements and their sequences in a typical analysis scheme. Two examples of risk assessment methodologies are briefly outlined in the next sections of this chapter. -13- CMA 062851 AMERICAN PETROLUEM INSTITUTE PROJECT PROPOSAL: RESOURCE STUDY OF RISK ANALYSIS AND DECISIONMAKING ICOSH RISK ASSESSMENT TASK FORCE CMA 062852 14- Food and Cosmetics Toxicology published two decision trees in 1976, which are abstracted here. FEMA (Flavor and Extract Manufacturers Association) FSC (Food Safety Council) See references 1) and 2) below for a complete discussion of the methods. FEMA DECISION TREE - See diagram on following page. 1. The decision tree consists of 33 questions, each answered "yes" or "no". Each answer leads to another question or to final classi fication into one of three classes (I, II, II) reflecting a pre sumption of low, moderate, or serious toxicity. 2. The tree is for use with all ingested, structurally defined organic and metallo-organic substances. Major chemical classifications are the organized branches of the tree. 3. Answering the questions requires chemical or biochemical training, and relies primarily on features of chemical structure. 4. The tree takes into consideration: 0 occurrence in body tissues and fluids, and 0 natural occurrence in food. 5. The logic of the tree rests heavily on known metabolic and toxicity data. 6. To establish priorities and to define tentatively the extent of appropriate testing, one can combine: 0 the classification according to presumptive toxicity, with knowledge of human intake to provide for each substance a "protection index". 1) FEMA Cramer, G. M., and R. A. Ford. 1978. Estimation of Toxic Hazard--A Decision Tree Approach. Food and Cosmetics Toxicology. 16(3):255-276. 2) FSC Food Safety Council. (Scientific Committee) 1978. Proposed System for Food Safety Assessment. Chapter 11: Quantitative Risk Assessment. Food and Cosmetics Toxicology, 16($uppl. 2): 109-136. " -15- CMA 062853 FEMA DECISION TREE (Figure 1) Decision tree prediction of toxic riak A. r? i 3 ID 4 25 26 -A S\ 22 D X 33 D D mi is nr 28 33 n is m 22 *% 33 D mi i 22 13 /\ /\ mI A n ID I Fig. 1. A achemetic diagram ofa dedaion tree for the eatimation ofprobable toxidty. Aaaeasor ahould (a) atart with queation 1. (b) proceed by 'no'S or \ 'ye*\(cl move from any underacored number encountered to aame circled number and (d) proceed to final daaaea I, II or III. Working downward* through the tree, theaymbola deaignatethe following grouping*: biological normality ( aaae ), high and low toxidty ( a a a ); heterocyclic* (-----); terpenoid* (---); aliphatic* (-o-o-o- ); aromatic* (c-a-O-a); alicyde* -16- CMA 062854 3') FSC Revised Quantitative Risk Assessment * 1. Introduction 2. Mathematical Models: Probit Model Logit Model One-Hit Model 0 Gamma Multi-Hit Model 0 Armitage-Doll Model Weibull Model Simplified Statistico-Pharmacokinetic Model Joint Effects of Two or More Agents 3. Biological Factors: 0 Evaluation of Chronic Cancer Bioassay Data 0 Evaluation of Characteristics of the Compound 0 Population at Risk 4. Methods Available for Low-Dose Risk Assessment: 0 Mantel-Bryan Procedure (most common) 0 Method Based on the One-Hit Model (low-dose linearity) (most common) Methods based on the Armitage-Doll Model AMethod Based on the K-Hit Model AMethod Based on the Weibull Model AMethod Based on the Pharmacokinetic Model 5. Performances of the Gamma, Armitage-Doll, Weibull and One-Hit Models--Tables 2, 3, and 4. Dose-response data from 14 different experiments with the following 14 substances: 0 NTA Aflatoxin 81 Ethylenethiourea 2, 3, 7, 8-tetrachlorodibenzo-p-dioxin Dimethyl Nitrosamine Vinyl Chloride Hexachlorobenzene Botulinum toxin Type A Bischloromethyl urea Sodium Saccharin 0 Ethylenethiourea 3)J. B. Cordaro--Executive Director of the Good Safety Counci1-provided a pre-publication draft of the substantially revised Chapter 11, "Quantitative Risk Assessment", of the Scientific Committee's report- This revised chapter is the basis of our summary. Food and Cosmetics Toxicology will publish the revised chapter in the next few months. -16- CMA 062855 o Dieldrin O DDT o Rapeseed (span) oil 6. Recommendations for Risk Assessment Methods: a. Choice of the models currently seen usable for low-dose extrapolation: (See Appendix IV for brief description.) Probit One-Hit K-Hit 0 Armitage-Doll Weibull b. Choice of extrapolation procedure: inexactness ofbehavior of models in low-dose range, cannot be firmly justified on either statistical (goodnessof-fit) or biological grounds; choice of extrapolation procedure is matter of judgment. 0 pick one ofmodels whichincorporate low-does linearity as well as non-linearity, (K-Hit; Weibull; Armitage-Doll) together with extrapolation procedure with desired conser vativeness. c. Choice of Societal Risk Level (Risk Level PO to which one ex trapolates.) 7. Other Considerations of Low-Dose Risk Assessment: 0 Combination of results for two or more species. Combination of separate studies on the same species. 0 Interspecies extrapolation. 0 Accounting for variations in human ingestion. 0 Multiple responses. Concurrent and historic controls. 0 Confidence limits versus best estimates. 8. Summary: Risk Assessment Involves Risk and Benefit. a. Recommended use of calculations of VSD's {virtual safe dose) from four models: One-Hit Armitage-Doll Weibull 0 Gamma Multi-Hit as inputs into the decision procedures. b. These calculations should be done for a variety of risk levels in the range of societal concern. -17- CMA 062856 c. Choice of estimates made should reflect the use of the mere flexible models: Armitage-Doll Weibull 0 Multi-Hit when they fit better and seem appropriate biologically. Conservative procedure: one-hit model or some other low-dose linear extrapolation procedure seems justified. Blind use of low-dose linear extrapolations or conservative onehit model appear scientifically indefensible. Returning to the diagram on page 14, the areas relating to cost/ benefit analysis require three areas of activity: 1. Identify the negative aspects (costs) and the positive aspects (benefits): 0 Individual - Group - Society 0 Direct - Indirect 0 Tangible - Intangible 0 Economic - Welfare 2. Measure the above factors in terms of: Quality of Life Health Safety Environmental Amenities Dollars 0 Risks 3. Compare costs with benefits: Explicit - Implicit 0 Ethics Value Judgments 0 Discounting for Timing Differences In the first activity, a lot of uncertainty and confusion exists. The identification of all non-trivial effects of a particular decision demands the widest possible exploration on the total system impacts by knowledgeable representatives of areas affected by the decision. Short-term and long-term effects are both possibilities. Who and what is affected, and how needs determination. Societal, group and individual impacts can by psychological and emotional as well as material. -18- CMA 062857 The application of measure, especially dollars for comparative pur poses, in the second activity is heavily value-laden. Quoting B. R. Putnam, American Cyanamid, (CEP, February, 1980): "The most emotionally gripping argument against ' cost-benefit, and especially risk-benefit, is that it is impossible to put a dollar value on improvements to human safety or health. The plain fact, however, is that both industry and government make such valua tions every day, whether they recognize it or not. As Robert W. Crandall, senior fellow of the Brookings Institution has asked: "Why do regulators set limits ...which are greater than zero? Why did OSHA not argue for 0 parts per million for benzene? Or why are not all of the primary ambient air standards set at 0 ppm? Surely it is not because we know with certainty that reducting current standards to 0 ppm would im prove one's health. It is, quite simply, because the administrators of EPA and OSHA do not believe the additional health benefits are "worth it." Or, alterna tively, they do not think that the courts will sustain such a high value placed on human health. Either way, we have social institutions reaching judgments about the value of improvements in human health. They must. They cannot avoid it. "Therefore, all a proponent of sensible judgments would ask is that they write down these values and defend them, and that they use them consistently in evaluating all regulations and options to each regula tion. It is that simple." It is time for the regulatory agencies to acknowl edge this responsibility publicly. That their decisions do have significant economic consequences is undeni able. That these consequences should be weighed against identified anticipated benefits is equally clear. Costs versus benefits is a process that already exists in regulatory decision making; what remains is formal acceptance of the philosophy underlying the process'?1 In the comparison activity of risk assessment, the ethical con siderations arise. Are we to promote just the greatest good for the greatest number, or do we wish to see that the benefits are distributed such that all persons are as well or better off with no additional harm to anyone? CMA 062858 -19- CHAPTER IV REFERENCES API, American Petroleum Institute. 1980. Project Proposal: Resource Study of Risk Analysis and Decisionmaking. Interdepartmental Committee on Occupational Safety and Health (ICOSH) Risk Assessment Task Force. (Flow Chart). Food Safety Council (FSC), (Scientific Committee). 1978. Proposed System for Food Safety Assessment. Chapter 11: Quantitative Risk Assessment. Food and Cosmetics Toxicology 16(Suppl. 2):109:136. Food Safety Council, (Social and Economic Committee). 1980. Principles and Processes for Making Food Safety Decisions. Food Technology. 34(3):79-125. Food Safety Council. Pre-publication of revised Chapter 11 provided by J. 8. Cordaro--Executive Director of the Food Safety Council. Food and Cosmetics Toxicology will publish the revised Chapter 11 in the next few months. National Academy of Sciences (NAS). 1979. Food Safety Policy: Scientific and Societal Considerations. Trauberman, J. Appendix C: A Comparison of FDA Food Safety Regulation with Federal Regulation of Other Environmental Hazards. Putnam, B. R. 1980 (February), CEP American Cyanamid. (Incomplete citation.) Scientific Bases for Identification of Potential Carcinogens and Estimation of Risks' Report of IRLG, Work Group on Risk Assessment. Federal Register 44(131):39858-39879. 6 July 1979. Journal of National Cancer Institute. 63(1):242-268. July, 1979. CMA 062859 -20- CHAPTER V Activities: Centers and/or Principal Individuals Involved in RiskBenefit-Cost Activities. Risk-benefit-cost activities are on an exponential growth curve. The proliferation of centers and individuals involved in these activities in the last year is tremendous now that risk assessment, risk analysis, risk-benefit analysis, and cost-benefit analysis have become "buzz" words in Washington. None of these activities are new as this report attempts to document. For example, risk assessment has replaced tech nology assessment -- which has not lived up to promises its advocates hoped for. The literature is massive. The authors of this report have culled the literature, conferred with numerous individuals, and gladly accepted the Steering Group's suggestions in developing a list of centers and principal individuals involved in risk-benefit-cost activities. We have selected the following eight categories which comprise the body of this chapter as an organizational framework. I. II. III. IV. V. VI. VII. VIII. Washington GovernmentalActivities Washington Quasi-Governmental Activities Academia Centers, Contractors, and Organizations Contractors Law Public Interest Groups Trade Associations We accept responsibility for those individuals and centers that we intentionally or unintentionally did not include. We welcome the Steering Group's comments and further additions and deletions to our selected listing -- as this is a working document. In addition to the several bibliographies assembled independently by Haight, Haxby, Ifland, and Norberg, we requested two formal computer generated literature searches: 1) Toxline using different combinations of the following sets of terms: (Risk or Risks)(A$se$sment or Analysis or Evaluation)(cancer or carcinogen or carcinogenic)(cost and Benefit and Analysis)(impact) and (chronic) augmented by Chemical Industry Institute, and 2) Smithsonian Science Information Exchange. These bibliographies are on file and available as well as some of the selected references, at the American Industrial Health Council, 1612 K Street NW. Washington D.C. CMA 062860 -21- I. Washington Governmental Activities*, U. S. Congress Office of Technology Assessment Assessment of Technologies for Determining Cancer Risks from The Environment. Project Personnel: Michael Gough and Robert Fensterheim Topics: Environmental cancer estimates, testing technologies, extrapolation techniques, "unreasonable risk". Associated Conference: N.Y. Academy of Sciences Workshop on Management of Assessed Risk for Carcinogens. 17-18 March 1980. Impacts of Applied Genetics. Project Director: Zsolt Harsanyi Topics: Identify, characterize, and analyze environmental social, and ethical issues accompanying the use of genetic technologies. Environmental Contaminants in Food. December, 1979. (GPO 052-003-00724-0) 0TA-F-103. House of Representatives: H.R. 4939 0 Ritter 24 July 1979 "To provide for a Federal mechanism within the Office of Science and Technology policy for assessing the comparative risks involved in actions in scientific, technical, and related fields." (Referred to Committee on Science and Technology.) H.R. 5091 0 Martin et al. 2 August 1979 "To amend the Federal-Food, Drug, and Cosmetic Act to authorize the issuance of a regulation for a food additive on the basis of an evaluation of the risks and benefits of the additive. . (Referred to Committee on Interstate and Foreign Commerce.) * Individuals and/or activities worthy of special attention for their current and potential future significant contributions. 0 Individuals whose names appear within one or more categories indicating potential crossover influence. CMA 062861 -22- H.R. 6521 Wampler and Grassley 13 February 1980 "To establish the National Science Counci 1 to decide questions of scientific fact which arise in agency adjudications involving restricting the use of certain substances which are primarily used in food production, processing, or marketing, and which may be harmful to human health. . ." (Referred jointly to Committees on Agriculture, Interstate and Foreign Commerce, and Science and Technology.) Committee on Interstate and Foreign Commerce Subcomittees on Oversight and Investigations and/or Consumer Protection and Finance. Hearings: Cost-Benefit Analysis by Regulatory Agencies. Witnesses: 30 July 1979 0 Lester Lave Robert Crandall Baruch Fischoff 0 Nicholas Ashford 24 October 1979 Mark Green 0 James C. Miller, III 0 Murray L. Weidenbaum 0 Allen R. Ferguson 17 April 1980 H. L. Krieger (GAO) 0 Congressman Herbert E. Harris, III Committee on Science and Technology 1. Risk/Benefit Analysis in the Legislative Process. 24 and 25 July 1979. (Committee Print 71 and Serial KK) Joint Hearings before: Subcommittee on Science, Research and Technology of Committee on Science and Technology. Subcommittee on Science, Technology, and Space of the Senate Committee on Commerce, Science, and Transportation AAAS Congress/Science Forum Witnesses: Aaron Wildavsky Harold P. Green (George Washington University) Edwin Diamond (MIT) Eula Bingham (OSHA) 0 Congressman James G. Martin 0 Nicholas Ashford Samuel W. Greenhouse (George Washington University) Lewis H. Sarett (Merck and Co.) Marvin Schneiderman (NCI) CMA 062862 -23- Senator Paul Tsongas 0 Hon. Howard T. Markey John H. Gibbons (OTA) 0 Congressman Don Ritter 0 David Okent Daniel Callahan Paul Slovic Congressman Richard L. Ottinger Congressman John W. Wydler 0 William Lowrance Robert P. Morgan (Washington University) John Stewart (Senate Subcommittee) 2. Committee Report 96-61 to accompany H.R. 2729Appropriations to the National Science Foundation (NSF). Recommendation by Committee that NSF: a) "Sponsor systematic research to improve the methods for evaluation of long-term comparative risks of alternative technological solutions, including inaction, to such national concerns as energy, materials, environmental quality, food or drugs." b) "Promote education in risk assessment methods and stimulate public and professional application of comparative risk research." (See also NSF and NRC entries.) 3. Hearing scheduled for 14 and 15 May 1980 before Subcommittee on Science, Research, and Technology. Potential Witnesses: FDA, EPA, CPSC, and OSHA. Topic: H.R. 4939 (. Ritter) Federal mechanism for use of risk assessments in choosing between alternative scientific or technological options. (See Appendix V) Committee on Judiciary. Hearings on Regulatory Reform, H.R. 3263. SENATE: S. 2234 Stevenson Recombinant DNA (Referred to Committee on Labor and Human Resources.) Committee on Governmental Affairs. 1) Hearings on Regulatory Reform Legislation. (S. 262, S. 755, S. 445, S- 93) Parts 1 and 2. Held in March, April, May, and June of 1979. Over 81 witnesses testified. 2) S. 2147. -24CMA 062863 3. o Benefits of Environmental, Health, and Safety Regulation. Prepared for the Committee by the Center for Policy Alternatives (MIT). 25 March 1980. Nicholas A. Ashford, Co-principal Investigator. 4.- Study on Federal Regulation. 6 vol. 1977. Committee on Commerce, Science, and Transportation; Subcommittee on Science, Technology, and Space. See House Committee on Science and Technology joint hearings on Risk/Benefit Analysis in the legislative Process. Hearing scheduled for 20 May 1980 on "Industrial Applications of Recombinant ONA Techniques." (See Appendix V) National Science Foundation (NSF) (See previous entry under House Committee on Science and Technology) Technology and Risk Assessment Group Joshua Menkes and Vincent Covello Activities; 1) Funding grants on risk assessment. 2) Requested National Research Council (NRC) to assess the current state of knowledge concerning major issues in risk assessment, and the use of information about risk in the decision-making process, and to develop an agenda for future research on the science and technology policy aspects of risk assessment. Ethics and Values in Science and Technology Program Arthur L. Norberg Activities; Joint funding of grants with the Technology and Risk Assessment Group (NSF) and with the National Endowment for the Humanities (NEH) on ethical issues in regulation, risk assessment, and risk management. -25- CMA 062864 Intergovernmental Regulatory Liaison Group (IRLG) (CPSC, EPA, FDA, and FSQS of USDA) 1. Scientific Bases for Identification of Potential Carcinogens and Estimation of Risks. Report of IRLG, Work Group on Risk Assessment. Federal Register. 44(131):39858-39879. 6 July 1979. Journal of NationalTancer Institute. 63(1):242-268. July, 1979. 2. Chemical Testing Guidelines -- Acute Eye Irritation, Acute Oral Toxicity, Acute Dermal Toxicity, Acute Inhalation, Teratogenicity. Consensus Testing Requirements. 9 April 1979. Food and Drug Administration (FDA) 1. Symposium on Risk/Benefit Decisions and the Public Health. Proceedings of the Third FDA Science Symposium. Colorado Springs, CO. 15-17 February 1978. (Conducted in conjunction with EPA, CPSC, and OSHA.) 2. Sensitivity of Method (SOM) -- ongoing. 3. Delaney Clause and other food safety aspects of the FFDCA. Modification recommendations; document for submission to Congress in response to PL 95-203. 4. Formaldehyde/IRLG. Environmental Protection Agency (EPA) 1. See also Regulatory Council and IRLG. 2. Risk assessment: Mutagenicity Assessment Group (MAG) Carcinogenicity Assessment Group (CAG) Teratogenicity Assessment Group (TAG) 3. Office of Toxic Substances. Lets many grants and contracts. 4. Specific examples include: FIFRA Hazard Evaluation Guidelines. Federal Register 44(187):55213-55218. 25 September 1979. Proposed Guidelines for Registering Pesticides in the United States; Hazard Evaluation: Humans and Domestic Animals. -26- CMA 062865 Airborne Carcinogens Federal Register 44(197):58642-58670. 10 October 1979. National Emission Standards for Identifying, Assessing, and Regulating Airborne Substances Posing a Risk of Cancer. Cancer Risk Assessment. Federal Register 45. 29 February 1980. Proposal to report production and exposure-related data on approximately 2300 chemicals -- for ranking chemicals for investigation and for preliminary risk assessment. Consumer Product Safety Commission (CPSC) 1. See IRLG. 2. Selection of Chemical for Toxicological Testing: Peter Preuss -- Health Sciences. Occupational Safety Health Administration (0SHA) Identification. Classification, and Regulation of Potential Occupational Carcinogens.. Final Rule? Federal Register 45(15):5001-5269. 22 January 1980. National Toxicology Program (NTP) 1. NHS Agencies; FDA/NCTR NIH/NCI/NIEHS/NIOSH CDC 2. David P. Rail, Director (NIEHS) 3. Activities: Toxicology Research and Testing Coordinative Management of Activities Annual Report of Carcinogens, mandated by PL 95-622, scheduled for release in mid-summer. Risk Assessment Methodologies grants to academia. Office of Recombinant DNA Activities (0RDA), NIAID, NIH. William J. Gartland Federal Register publishes changes in the NIH Guidelines for Research Involving Recombinant DNA Molecules. -27- CMA 062866 Council on Environmental Quality (CEQ) 1. August, 1979. Toxic Substances Strategy Committee March/April, 1980 -- draft revision of above. 2. December, 1979. (released 21 April 1980.) The Benefits of Air and Water Pollution Control: A Review and Syntheses of Recent Estimates. A. Myrick Freeman, III, (Bowdoin College). Regulatory Council Statement on Regulation of Chemical Carcinogens; Policy Request for Public Comment. Federal Register 44(202):60038-60049. 17 October 1979. Office of Science and Technology Policy (0STP) Calkins, D. R., R. L. Dixon, C. R. Gerber, G. S. Omenn, and D. Zarin. 1980 Framework for Federal Carcinogen Policy. JNCI 65(1). (Adapted from "Identification, Characterization, and Control of Potential Human Carcinogens: A Framework for Federal Decision-Making". 1 February 1979. Office of Management and Budget (0MB) Office of Regulatory and Information Policy (organized 1 February 1980). Jim J. Tozzi, Director. Activities: End unnecessary regulation and develop regulatory cost-accounting system. II. Washington Quasi-Governmental Activities National Research Council (NRC) 1. Review of Risk Assessment in NRC Reports: 25% of all NRC studies concerned with risk assessment; 25% devoted to management of known hazards. 2. Perspectives on Benefit-Risk Decision Making. Report on a colloquium conducted by the Committee on Public Engineering Policy. 26-27 April 1971. Washington,D.C. National Academy of Engineering. 1972. 3. Food Safety Policy: Scientific and Societal Considerations. March, 1979. Institute of Medicine. Mandated by PL 95-203. -28- CMA 062867 4. Committee for a Planning Study for an Ongoing Study of Costs of Environment-Related Health Effects. Institute of Medicine. (Study mandated by PL 95-623.) 7 May 1980. Public meeting to receive views on current and future needs for information in assessing environment related hazards to human health and in assessing costs associated with those hazards. 5. Committee on Risk and Decision Making (CORADM). See previous entry in NSF (p. 26.) Technology and Risk Assessment Group. Project Title: Risk and Decision Making: Development of Systematic Research to Improve Risk Analysis and Decision Making Public Meeting (workshops) to be held summer of 1980. Members: Raiffa, Howard (Chair) Mosteller, Frederick C. 0 Wilson, Richard Ruina, Jack 0 Schuck, Peter Serene, Eileen Lindblom, Charles E. 0 Kates, Robert W. Tuersky, Amos Yalow, Rosalyn Loury, Glenn C. Coleman, James Radner, Roy Ruckelshaus, William D. A. Karim Ahmed David Cohen Harvard University Harvard University Harvard University MIT Yale University Yale University Yale University Clark University Stanford University Bronx Veterans Hospital University of Michigan University of Chicago Bell Telephone Weyerhauser National Research Defense Council Common Cause Staff: 0 James W. Vaupel and John D. Graham. III. Academia Clark University UCLA Harvard University "*R. W. Kates and R. Kasperson *David Okent "Richard E. Wilson MIT (Center for Policy Alternatives) University of Maryland Georgetown University UC, Davis Bryn Mawr College Carnegie Mellon Stanford University American University UCLA Yale University Duke University UC, Berkeley Washington University Harvard University "Nicholas Ashford "Martin J. Bailey Edward J. Burger M. Goldman Jane C. Kronick "Lester Lave "William D. Lowrance William D. Rowe Rakesh Sarin Peter Schuck "James W. Vaupel "Aaron Wildavsky "Murray L. Weidenbaum Richard Zeckhauser New York University Bernard Altschuler "See listing of CORADM members within NRC, Section II. University of Chicago University of Indiana University of North Carolina IV. Centers, Contractors, and Organizations Hastings Center Food Safety Council Brookings Institution The Conservation Foundation Decision Research (Perceptronics) Franklin Institute Resources for the Future American Enterprise Institute(AEI) Electric Power Research Institute American Health Foundation Daniel Callahan J. B. Cordaro "Robert Crandall "Lester Lave Terry Davies "Baruch Fischoff Sarah Lichtenstein "Paul Slovic Gio B. Gori Allen Kneese "James C. Miller "Martin J. Bailey "Murray L. Weidenbaum Chauncey Starr Chris Whipple E. L. Wynder General Motors Research LaboratoryDept, of Societal Analysis Walter A. Albers, Jr. New York Academy of Sciences CMA 062869 -30- V. Contractors Clement Associates, Inc. Decision Research Engineering Science, Inc. Arthur D. Little, Inc. Mitre Corporation Rand Corporation Science Research Systems SRI International Tracor Jitco, Inc. Warner North C. R. Barden R. E. Wechsler John Van Ryzin K. Rai Kenny S. Crump M. Merkhoffer VI. Law Franklin Pierce Law Center U.S. Court of Appeals Harvard Law School U. S. Court of Customs and Patent Appeals (Washington law firm; formerly FDA) Covington and Burling M. S. 8aram Hon. David L. Bazelon J. P. Leape Hon. Howard T. Markey Richard M. Cooper Peter Barton Hutt VII. Public Interest Groups Congress Watch Corporate Accountability Research Group Environmental Defense Fund Environmental Law Institute Public Interest Economics CenterVIII. Mark Green Norman Waitzman Robert Rousch R. C. Anderson Allen F. Ferguson VIII. Trade Associations American Industrial Health Council (AIHC) American Petroleum Institute (API) business Roundtable Chemical Manufacturers Association (CMA) -31- CMA 062870 Two proposed business sponsored projects in the regulatory riskbenefit-cost area deserve special attention. The proposals -- developed independently by the American Petroleum Institute (API) and by the Business Roundtable--directly address many of the central interests and concerns of the Steering Group. Both projects may serve to complement and supplement the ongoing CORADM study undertaken for NSF at Congressional urging. (See pages 25, 26, 30.) First, the American Petroleum Institute's Interdepartmental Committee on Safety and Health (ICOSH) Risk Assessment Task Force has approved funding for a one-year contract to conduct a retrospective study on the use of risk management by selected Federal regulatory agencies. (See Appendix V for a detailed summary of the API proposal. The schedule shown has been delayed by about six months, but is now underway. The objectives of the study are to: isolate/identify basic principles of risk analysis and its use in decision making. describe what is happening in selected Federal regulatory agencies, and provide a mechanism for business, government, and academic experts to work together on these issues. Second, the Business Roundtable Task Force on Risk, Cost, Benefit Analysis is considering publication of a book dealing with improving regulatory analysis and decision making for health and safety. Business, academia, and government will contribute articles to the document, which will serve as the basis for a Business Roundtable's position paper in this area. The Task Force visualizes that the contributed articles will develop a set of standards for : assessing scientifically the magnitude of possible health and safety hazards; presenting these assessments in an informative and balanced way that places the risks in perspective; "appraising the economic and social benefits and costs of alternative regulations and of other approaches to reducing risks, and "synthesizing the available scientific, economic, and social evidence in a systematic "policy analysis" report. CMA 062871 Report to the CMA Executive Committee on September 8, 1980 by William C. Krumrei The Procter & Gamble Company Exhibit E I do not plan to give a detailed report since most of my report is already covered under Tab 7. There are some areas, however, that I would like to cover briefly to ensure that I have your approval and also to discuss some of the things that are coming up. First of all, you have an outline of the committee organization, which you will note from the chart on page A-4 involves five separate Task Groups. (An EPA Task Group, an OSHA Task Group, an Economic Impact Task Group, a Confidentiality Task Group, and an International Labeling Issue Task Group.) Their charters are also in the book beginning on page A-5. On the committee, we also have representatives of the Distribution Committee, CRAC, and the OSH Committee of CMA and the Internal Affairs Group which is formed jointly between SOCMA and CMA. The nominees for membership are listed on page A-3. Mr. Chairman, I would appreciate Executive Committee confirmation of those nominees. My advisers on the staff tell me that we expect that we will be able to live within the presently projected expenditures in the current budget. However, you should know that the Economic Impact Task Group will require hiring an outside consultant to prepare their reports and therefore there is a possibility that we may have to request additional money depending on what our current negotiations with those organizations will yield. One other general item which is not included in your book but which is at your place is a listing of the companies and associations represented on our Task Groups. In total, the number of people involved in these groups is about 80, representing 41 companies. I will separate the EPA and OSHA rules since they are quite different and within EPA separate the Acute Hazard Labeling Rule and the Chronic Hazard Labeling Rule. Both EPA documents will be published late this month. We have been successful with EPA in getting them to separate the Acute Hazard Labeling Rule from the chronic and a summary of the Acute Hazard Rule and its potential impacts is listed on page C-l. We believe that this is a fairly straightforward area in which CMA representatives have CMA 062872 2- - been working for years, and, therefore, there seems to be no essential disagreement. The area that I would like to spend some time on is the Chronic Hazard Labeling Rule of EPA, the summary begins on page B-l. We believe a decision is required by you to allow us to participate in nego tiations and subsequent preparation of comments for both agencies. Although this may seem to some of you to be a somewhat trivial subject to bring to your attention and on which to request approval, we nonetheless feel it is important because for the first time a large number of companies will have to face up to the fact that we will label materials within our plants and in commerce as potential cancer-causing materials. Cur committee has prepared a proposed CMA position, the full text of which begins on page B-3. The essentials of this are: 1. No signal word other than cancer. 2. Separation of human and animal carcinogens. 3. Fully compatible with AIHC proposals. 4. Inclusion of potency differences. 5. Continued separation of chronic and acute labeling rules. With have discussed the above in generalities with EPA. The have requested that we provide a position in writing so that they can possibly modify theirs. Mr, Chairman, before I discuss the OSHA proposal, we would appreciate the approval of this proposal or an appropriate modification. The next item I would like to bring to your attention is the OSHA Hazards Labeling Rule. There is a short summary on Page D-l in your docket. Subsequent to the writing of that, we had a meeting with the repre sentatives of OSHA who are actually drafting the document. Several things came out of that meeting which should be of interest to you. Dr. Arthur Olnick, Professor of Public Health, University of Michigan, who is an M. D. and a Lawyer, has taken primary responsibility for writing the proposal. He is on leave from the university until this month but then plans to spend one-half time with OSHA every week until as he puts it "we have gone all the way through the Supreme Court." He is assisted by Mr. Richard Banks, a Union lawyer, and they both admit that the deadline of the end of September for the publication of their proposal in the Federal Register is dictated by the needs of the present administration to get something out there before election. CMA 062873 -3- In the meeting two weeks ago, we obtained some concessions but it is still a very detrimental and costly proposal. The improvements that have been made from the original draft are: 1. They will not require safety testing beyond that which is already in existence either in the literature or in company files. 2. Companies will make the decision based on a review of all of the available literature as to whether the material is hazardous and, therefore, requires a label. 3. The provisions do not apply to consumer products, foods, drugs, or cosmetics, but do apply to chemicals used in those products until such time as they have established a product identity. They also apply to pesticides. 4. They claim that good science rather than allegations will prevail and that both animal and human experience will be considered. They will not rely on test tube tests such as the Ames test to determine whether a material is a carcinogen. 5. They have eliminated the need to separately label mutagens, teratogens, and reproductive toxins, but are lumping those together into the general term, "reproductive effect materials. " 6. They will not require the analysis of byproducts or chemicals for impurities, which will save us a considerable amount of money and manpower. 7. If the toxic material in a mixture is unknown, they will not require its analysis, but will simply require that the mixture be labeled by its generic name and hazard warning. 8. In spite of much argument, they would not give up the use of the C. A.S. number but indicated that they will consider dropping the chemical name and the substitution of the common name on the label. 9. They would not require Manufacture of MSD sheets but if they are already available, they must be made available to the employees. 10. The employees must not only have the label available but also a substance employee exposure list which would include the name and the C. A.S. number of the chemicals, and the employees which have potentially been exposed to this material. They would require updating of such lists when any change occurs and retention of those CMA 062874 -4- lists on a quarterly basis for thirty years. In addition, the list of all literature reviewed and internal data on safety must be made available to the employees and kept for three years. 11. They do agree that all of this information would not be necessary at the work site but could be kept at a central location, as long as the information could be made available to the employee, his physician, the Union representative, the NIOSH Director, and the OSHA Assistant Secretary within a period of up to seven days, 12. We were unable to change their opinion on the necessity of making such information available to Union leaders even though we stressed the trade secret concerns in this area. They rejected out of hand the possibility of having national Union leaders sign confidential , disclosure agreements which could then be used as the basis for a lawsuit against the national Union in the event of a breach of such a document. 13. We also were unable, to date, to stop the labeling of all vessels, pipes, pumps, valves, tanks, etc. We have now gotten them to re'cognize CMA as the association represent ing the chemical industry. We were also able to get them to agree to provide us with a copy of their latest draft which is due today, and to also get their agreement to try to include our views in this latest draft prior to their sending it to the Government Printing Office later this month. We will immediately begin our preparation of cost impact and our comments for submission at the hearings. We were informed that there would be a total of five or six hearings throughout the country and we were encouraged to submit testimony as an association and individually at as many of these as we felt desirable. We think our strategy has to be to submit the strongest arguments and testimony that we can possibly muster, including economic impact, and that we prepare as strong a record as possible for litigation in the future. I am convinced that we will be able to make some modification by the time the final draft is published but I am also convinced that we as an industry will not be satisfied with the final regulations. The last item I would like to discuss is the activity that is now going on in some of the states and local areas, such as California, New York, and Philadelphia. In both California and New New the laws have been passed. CMA 062875 -5- We stand a reasonable chance of potentially winning the battle at the Federal level and losing the war by default at the state and local level. Our committee has addressed itself to this and I have talked with George Polzer, who unfortunately could not be here today, to try to see if CMA could reach a resolution of some method of handling these problems. George has informed me that his committee is still in the throes of decision making and does not have anything to help us solve our current and ongoing problems. I talked with Mr. Theodore Brenner, President of the Soap and Detergent Association, who has a network of roughly forty state lobbyists or representatives and he has agreed to act as our eyes and ears to alert us to upcoming legislation in the next year. We have provided him and his people with some background information on areas of interest. We are planning to also work with him in the future to try to reach some agree ment as to how we can utilize his people to help us fight these particular laws. Unless we can devise some method, we are literally going to have a very diverse set of regulations with which we must comply. I would like to ask you gentlemen for help on three things. First, we need the help of your companies and those of the rest of the companies within CMA and our affiliated associations to try to get the best possible feel for the total cost and impact of the proposed regulations and our alternatives. Secondly, we would like the participation of your people if you are not already represented on Task Groups so that we can get as broad a viewpoint as possible on the many items we are going to be dealing with. Lastly, we would appreciate your help and thoughts as to how we can handle the state activities. CMA EC-9/8/80 CMA 062876 Exhibit F SPECIAL COMMITTEE ON HAZARDS COMMUNICATIONS William C. Krumrei A. Committee Organization, Formation of Task Croups Action Required: Confirm Committee Nominees B. EPA Chronic Hazards Labeling Rule Action Required: Approve Carcinogen Policy C, EPA Acute Hazards Labeling Rule Action Required; None - Information Only D, OSHA Hazards Labeling Rule Action Required: None - Information Only CMA 062877 Hazards Communications Special Committee Organization and Formation of Task Groups Problem: Background: Impact: Money Action Required: Both the Environmental Protection Agency (EPA) ar.c the Occupational Safety and Health Administration (CSHA' have drafted proposed rules to regulate labeling of hazardous and toxic substances. Those rules, as ini tially drafted, could adversely impact the chemical industry if not mitigated. Such impacts include un necessarily burdensome and inefficient regulations, direct costs of compliance and the potential for disclosure of trade secrets and proprietary infor mation. Litigation of these rules may be necessary. On May 13, 1980, the Executive Committee approved the formation of and a charter for the Hazards Communica tions Special Committee. (See Attachment 1). On June 23, 1980, letters were mailed to each CMA Executive Contact requesting nominees for that committee. Fif teen nominees were selected, for Board confirmation, at a CMA meeting on July 23. (See Attachment 2) . Mr. william C. Krumrei, Dr. Curtis Smith, Mr. Robert Roland and other CMA staff attended that meeting. Following the tentative selection of committee nomi nees, the committee was structured to provide five task groups -- composed of industry experts who hac been active on other CMA labeling groups -- to develop prospective CMA positions on the labeling issues. (See Attachment 3). For each task group, charters were developed, chairmen were appointed and tentative task group memberships were compiled. Those charters, approved by the Hazards Communications Special Com mittee at its first meeting, August 11, are included as Attachment 4. Successful completion of the project will require expenditures for legal and technical consultants. Expenditures already projected in the fiscal year-81 proposed budget should be sufficient. While there is, at this time, no basis for predicting an overrun, the committee will be notified if additional expenses are to be incurred. Confirm members nominated to the Committee. Attachments CMA EC - 9/8/80 9/9/80 A1 CMA 062878 Attachment 1 HAZARDS COMMUNICATIONS SPECIAL COMMITTEE CHARTER Within limits of authority specified by the Executive Committee, the Special Committee will oversee Association hazards communications activities. The scope of these activities includes EPA and OSHA proposals for product labeling, in-plant labeling, material safety data sheets and substance identifica tion lists. Within this scope, the Special Committee will identify key issues and focus on matters of greatest significance to the chemical industry; establish specific objectives and mobilize resources to produce timely results; advocate responsible regulation within existing statutes; and seek relief from unreasonable regulation by providing alternative language to the agencies, submitting comments to proposed rulemaking, and initiating legal action where appropriate. The Special Committee will communicate major trends and developments to the Executive Committee, the Board of Directors, the Association President, member companies and other trade associations. The Special Committee will serve for a period of two years on an ad hoc basis. At the end of two years, the Committee's status will be reviewed by the Executive Committee. CMA EC EC BD - 5/13/80 9/8/80 9/9/80 A-2 CMA 062879 Attachment 2 HAZARDS COMMUNICATIONS SPECIAL COMMITTEE Nominees for Membership Krumrei, Willi am C. (Chairman) Smith, Curtis W. (Vice Chairman and Chairman - OSHA TG) Arnold, Grant Bittenbender William A. Brubaker, Bruce H. Carmody, Thomas W. (Chairman - Economics TG) Evans, Thomas F. Hanes, James H. Marino, Maryann S. McMillan, Graham W. Plaut, Jonathan (Chairman - International ing issues TG) Label Spainhour, J. D. Sullivan, William F. Trexel, James J. Umland, Carl W. (Chairman - EPA TG) The Procter & Gamble Co. Shell Chemical Company Ethyl Corporation Borden Chemical Diamond Shamrock Corporation Union Carbide Corporation Monsanto Company The Dow Chemical Company Koppers Company Inc. International Minerals & Chemical Corporation Allied Chemical Corporation Borg-Warner Chemicals American Hoechst Corporation E. I. du Pont de Nemours & Co. Exxon Chemical Company CMA EC BC - 9/8/80 9/9/80 A-3 CMA 062880 A tta c h m e n t mm EXECUTIVE COMMITTEE i 'H ROBERT A. ROLAND CMA PRESIDENT CRAC OSHC ,f 4. " TM TM TM ' '-i lii-.r" ^ ""Mr HAZARDS COMMUNICATIONS SPECIAL COMMITTEE ' (15 Members) Chairman* William C. Krumrei Vice Chairman* Curtis- W* Smith -------------------------------- ------T------ DISTRIBUTION COMMITTEE INTERNATIONAL AFFAIRS GROUP 00 CO CN < o EPA TASK GROUP Chairmant Carl Umland CONFIDENTIALITY TASK GROUP Chairman* J. T. O'Reilly ECONOMICS TASK GROUP Chairman* Thomas Carmody INTERNATIONAL LABELING ISSUES, TASK GROUP* Chairman* Jonathan Plaut "--Sr OSHA TASK GROUP Chairman t Curtis W. raith' Straight line means direct reporting and management* Dotted lin meins* (1) Communication; (2) Overlapping representation; (3) Opportunity t<^^nvolve Greenbrier procedures. 00 ? 1 o><* 1I slug UK* CONFIDENTIALITY TASK GROUP Attachment 4 Charter: Consider confidentiality issues raised by proposals of U.S. agencies and foreign govern ments and groups that may impact the U.S. chem ical industry and recommend to the Hazards Communications Special Committee CMA positions on confidentiality issues. Chairman: James T. O'Reilly Membership: 5-10 members appointed for 12 months Established: July 23, 1980 Sunset Date: July 23, 1982 CMA EC - 9/8/80 BD - 9/9/80 A-5 CMA 062882 ECONOMICS TASK GROUP Charter: Chairman: To review national proposals for labeling and determine the industry's probable costs of compli ance; consider and evaluate alternative proposals/ compare CMA and agency estimates of costs; and report to the Hazards Communications Special Committee its findings and recommendations. Thomas W. Carmody Membership: 5-15 members appointed for 12 months Established: July 23, 1980 Sunset Date: July 23, 1982 CMA EC - 9/8/80 BD - 9/9/80 A-6 CMA 062883 INTERNATIONAL LABELING ISSUES TASK GROUP Charter: Monitor through liaison with the CMA/SOCMA Interna tional Affairs Group international initiatives on labeling of hazardous and toxic substances, compare those proposals to existing and proposed U.S. agency labeling rules and standards and recommend to the Hazards Communications Special Committee actions and positions necessary to protect United States chemical industry interests. Chairman: Jonathan Plaut Membership: 5-15 members appointed for 12 months stablished: July 23, 1980 Sunset Date: July 23, 1982 CMA EC - 9/8/80 BD - 9/9/80 A-7 CMA 062884 EPA TASK GROUP Charter: Review EPA and other proposals for labeling of haz ardous substances, acute and chronic hazards, iden tify key issues and develop CMA recommended positions and actions for commenting on EPA proposed rules. Meet with government representatives in concert with Hazards Communications Special Committee to negotiate final EPA hazardous substance labeling and records and reports rules acceptable to the chemical industry. Chairman: Carl W. Umland Membership: 5-25 appointed for 12 months Established: July 23, 1980 Sunset Date: July 23, 1982 CMA EC - 9/8/80 BD - 9/9/80 A-8 CMA 062885 OSHA TASK GROUP Charter: Review OSHA and other proposals for labeling of haz ardous substances, acute and chronic hazards, iden tify key issues and develop CMA recommended positions and actions for commenting on OSHA proposed stand ards. Meet with government representatives in concert with Hazards Communications Special Committee to negotiate final OSHA hazardous substances labeling standards, material safety data sheets and records and reports requirements acceptable to the chemical industry. Chairman: Curtis W. Smith Membership: 5-25 appointed for 12 months Established: July 23, 1980 Sunset Date: July 23, 1982 CMA EC - 9/8/80 BD - 9/9/80 A-9 CMA 062886 ENVIRONMENTAL PROTECTION AGENCY CHRONIC HAZARDS LABELING RULE, JULY 29, 1980 SUMMARY BACKGROUND EPA has announced its intent to issue a regulation desig nating specific chemical substances as carcinogens and requiring that they be labeled as such. This concept was initially inclu ded in the February 1980 draft of a proposed regulation govern ing hazard warning labeling. As a first step, CMA urged EPA to separate the proposed regulations for acute hazard labeling from that for chronic hazards, because such different issues are involved. EPA has accepted this'position and has separated the two proposals (although EPA states that it intends to publish both at the same time.) The February draft would require any chemical designated as a carcinogen, or any mixcure containing that chemical at a level of 1 percent or more, to be labeled "Cancer Hazard." CMA representatives met with EFA to discuss this draft proposal and suggested that (1) the determination of carcinogenicity should be made by a group of independent scientists on the basis of sound scientific data; (2' a distinction should be made between substances known to be hu*'ian carcinogens and those shown to be carcinogenic in laboratcry animals; and (3) some way must be found to distinguish among carcinogens on the basis of their potency. In July, a revised draft was issued by EPA, which it states will be the version published as a proposal in the Federal Register. None of the CMA comments were accommodated. In the July draft, any designated carcinogen, or any mixture containing 0.1 percent or more of a designated carcinogen, must be labeled as "DANGER! Cancer Hazard" and "Any exposure may be harmful." No distinction is made between human and animal carcinogens and potency is not reflected in any way in labeling. The CMA task group has worked hard in developing a consensus position on this matter. Unlike acute hazard warning labeling, for which there is a long history of chemical industry involvement, cancer warnings are a relatively new idea and the chemical industry has little experience on which to rely. Because of the importance of this matter, CMA representatives cannot take a firm position on carcinogen labeling with EPA until the Executive Committee approves such a position. It is therefore essential that the position recommended by the CMA be acted upon at the Executive Committee meeting on September 8. B-l CMA 062887 This will allow CMA representatives to advocate CMA's position with EPA in order to obtain some modification of the present draft. Unless a definitive CMA position is reached on September 8, CMA representatives will be in a very poor position to attempt to modify the July EPA draft proposal before it appears in the Federal Register. The essence of the proposed CMA position is as follows: (1) No signal word other than "cancer"; (2) Separation of human and animal carcinogens; (3) Fully compatible with AIHC; (4) Inclusion of potency differences; and (5) Separation of chronic and acute labeling rules. There should be little disagreement on #2,3,4 and 5; there is work group consensus on all of the items. While this proposed position is specific to carcinogens, it is expected to be of value as a model for other chronic hazards as well (e.g., mutagenicity, teratogenicity, etc.). ACTION REQUIRED Approve CMA carcinogen policy (attached). Attachment CMA EC BD - 9/8/80 9/9/80 B-2 MA 062888 Draft S/18/80 CMA POSITION ON LABELING CHEMICAL CARCINOGENS 1. TSCA provides that the determination' by EPA that, a chemical is a carcinogen which must be labeled as such pur suant to Section 6(a) (2) is subject to a hearing pursuant to Section 6(c) and to judicial review pursuant to Section 19. 2. A cancer warning in labeling for a chemical or a mixture containing that chemical should be required only under the following two conditions. a. First, there is sound scientific evidence that a chemical is a human carcinogen or an animal carcinogen. i. It is insufficient that a chemical is listed on some governmental or other list of carcinogens. In each instance, existing scientific evidence must be reviewed in detail to determine whether a substance is a human carcinogen or an animal carcinogen. ii. CMA supports the AIKC position that the determination of carcinogenicity requires the use of informed expert scientific judgment. Accordingly, this determination should be made by eminent experts on a Science Panel that is independent from industry, EPA/ or any other regulatory agency whose action is affected by this determination. -- B-3 CMA 062889 iii. Because a determination of carcino genicity requires the exercise of informed expert scientific judgment, it would be inappropriate for E?A or other agencies ,r to establish' a list of rigid rules or criteria for making this determination. A determination of-carcinogenicity should be based upon all available data and information, including animal tests, metabolism studies, pharmacokinetics, epidemiology and other human experience, and other pertinent information. In general, such a determination should be based upon positive results in scientifically valid tests with appropriate doses and relevant routes of administration. Examples of suitable criteria for such determinations have been formulated by AXHC. b. Second, under customary or reasonably foresee able conditions of handling or use, taking into account its physical and chemical properties, the chemical may result in a form of exposure that could present a potential hazard. 3. Chemicals determined to be carcinogenic should be divided into three separate and distinct categories: human carcinogens, probable human carcinogens, and animal carcinogens. This distinction should be reflected in labeling as follows: a. Those substances determined to be human car cinogens should be labeled: "Cancer Hazard." Tb. Those substances determined to be probable human carcinogens based upon animal tests (see paragraph 4) 3-4 CMA 062890 should be labeled: "Cancer Hazard Based cn Tests with Laboratory Animals . " c. Those substances determined to be animal carcinogens.should be labeled: "Possible Cancer Hazard Based on Tests with Laboratory Animals." d. Any cancer hazard statement should not be required to include any of the traditional signal words used for acute hazard warnings, and should be placed cn the label in a prominent place separate from acute hazard warnings. The term "cancer", is itself an adequate signal word. 4. In a few instances, there may be such overwhelming evidence that a chemical is an animal carcinogen that it is highly probable it also presents a serious risk of human cancer. This occurs, for example, where cancer is found in virtually all test animals of all species and sex tested even at relatively low dose levels. Where animal test data are so conclusive and overwhelming that a chemical should be regarded as a probable human carcinogen, its labeling should reflect that increased level of risk. 5. The actual risk posed to humans by any human car cinogen or animal carcinogen varies widely, depending upon the potency o-f the carcinogen. The range of potency among carcino gens is greater than one million fold. This dramatic difference in risk should be reflected in the minimum levels below which B-5 CMA 062891 a chemical product containing a human carcinogen (inducing a probable human carcinogen) or animal carcinogen would not be required to bear a cancer hazard warning. a. Carcinogens should be divided into human and animal carcinogens. This reflects the degree of certainty about the existence of a human, risk. b. Both human and animal carcinogens should be further divided into high, moderate, and low potency. This reflects the relative degree of hazard represented by a given amount of a carcinogen. c. The following matrix should be used to deter mine the cut-off points below which the presence cf a human or animal carcinogen in a chemical product would not require a cancer hazard warning: - Low Potency Medium Potency High Potency Human Carcinogen (Including Probable Human Carcinogen) 2.0% 1.0% 0.1% Animal Carcinogen 5.0% 2.0% 1.0% d. For any of these categories, EPA or manufac turers or distributors should be permitted to present evidence at a public hearing on the proposed regulation, or by subsequent petition, to show that a higher or lower cut-off level is appro priate for a particular chemical substance. B-6 CMA 062892 6. Labeling should be required ao the above levels only if the manufacturer knows or has cocc reason to believe that the substance is present in the product, either because it is intentionally added or on the basis of other valid scientific information. If the manufacturer knows or has good reason to believe that the substance is present in the product at the above levels, it should be required either to analyze the product to determine whether the substance is present above or below the cut-off level or to label as though it were present without the necessity cf analyzing for the substance. If the manufacturer does not have good reason to believe that the substance is present at those levels, it should not be required to conduct such analyses. 7. Under all circumstances, the manufacturer'or distributor of a chemical substance that is a human carcinogen or an animal carcinogen may voluntarily provide additional in formation about the substance and its potential risk not re quired by the EPA regulation. Such information must be accurate and not misleading. 8. In addition to the cancer warnings set out above, the label should also bear appropriate information respecting preventive and precautionary measures. Such information should be affirmative rather than negative in nature, and should inform the worker what to do about the hazard rather than just scaring B-7 CMA 062893 him about the hazard. For example, --he label should state "Avoid Exposure" rather than "Ary Exposure .May Be Harmful." B-8 CMA 062894 ENVIRONMENTAL PROTECTION AGENCY ACUTE HAZARDS LABELING RULEr JULY 29, 1980 SUMMARY BACKGROUND EPA has announced its intent to issue a regulation under Section 6 of TSCA to require acute hazard warning labeling for chemical substances and mixtures. The regulation will be closely patterned after similar regulations issued by the Department of Transportation pursuant to the Hazardous Materials Transportation Act and the Consumer Product Safety Commission pursuant to the Federal Hazardous Substances Act, as well as the voluntary standard for labeling chemical hazards adopted by the American National Standards Institute with the cooperation of the chemical industry. An initial draft of the proposed regulation was made public by EPA in February. The February draft contained four types of problems: (1) extremely burdensome recordkeeping requirements; (2) a number of technically deficient definitions and other provisions; (3) a failure to include either broac categories of exclusions or a mechanism for specific exclusions of the type used by DOT, CPSC, and ANSI; and (4) insufficient flexibility in implementation. CMA committees worked extensively on the February draft and met with EPA representatives in an attempt to improve the proposed regulation. EPA recognized the validity of a large number of CMA objections. On Jijly 31, EPA made public a revised draft of the pro posed regulation. This craft accommodates many, but certainly not all, of the CMA objections. All of the recordkeeping pro visions were eliminated. Some of the technical deficiencies were corrected; some remain. There is greater flexibility in implementation, but it is still insufficient. Of major importance, there is still no broad or specific exclusions for those chemicals that fall within the various definitions for hazardous products but that nonetheless do not present a significant risk under actual conditions of exposure and use. (e.g., lubricating oils are flammable but there is no need to label them as such). CMA has prepared and submitted comments on the July draft to EPA in two written documents. One document details the specific wording changes that CMA recommends to correct the deficiencies that remain. The second document explains each of those recommended changes. CMA representatives have met with Mr. Jellinek and h:.s staff to discuss these matters. C-l CMA 062895 It is anticipated that a proposed regulation will be published in the Federal Register early this fall, The precis b timing remains quite uncertain. Publication of the proposal will result in an administrative hearing on the matter. The extent to which CMA will be required to appear and present evidence at that hearing will depend entirely upon the degree to which the CMA objections are accommodated in the final proposal. ACTION REQUIRED None. For Information only. CMA EC BD - 9/8/80 9/9/80 C-2 OMA 062896 OCCUPATIONAL SAFETY AMD HEALTH ADMINISTRATION HAZARDS LABELING RULE, JULY 28, 1980 SUMMARY BACKGROUND OSHA's current proposal for chemical identification of defined hazardous chemical substances and mixtures goes far beyond EPA and current industry practice. CMA has discussed with OSHA the extreme nature of their proposals and has presented more costeffective alternatives with little apparent impact to date. While these efforts to communicate with OSHA will continue, the Hazards Communications Special Committee (HCSC) is proceeding to develop: 1) formal objections to OSHA's proposed regulation projected for early fall, and 2) an alternative proposal. These will be supported by legal arguments and economic impact assess ments. We are preparing for the probability that it may be necessary to challenge OSHA regulations in the courts. Because of the apparent multibillion dollar cost of the expected pro posal, efforts will be made to develop political support wher ever that appears feasible. Written comments to OSHA have been submitted by CMA: o On March 28, 1977, in response to a January 28, 1977, advance notice of proposed rulemaking. o On May 19, 1978, in response to an April 4, 1978, discussion with Grover Wrenn. o On May 11, 1980, in response to discussion with Drs. Flo Ryer and Bailus Walker concerning an unpublished December 1979 draft. OSHA has recently hired two outside consultants -- Dr. Arthur Oleinick, an M.D. and attorney, and Mr. Richard Banks, an attorney with an outside firm that represents labor unions -- to draft their proposed regulation. These two have not released an official draft rule. An unofficial draft dated July 28, but not released by OSHA, provides the basis for most of the following comments. It should be remembered that this is a draft and is subject to change. In a meeting scheduled for August 27, Dr. Oleinick has promised to review OSHA's latest thinking and has invited technical reaction. Legal or written reactions were rejected until after publication of the proposed regulation in earlv fall. D-l CMA 062897 This proposal involves chemical identification of defined haz ardous chemical substances in the workplace and commerce by a system: labeling of containers, providing listings that crossreference regulated substances and mixtures with employees ex posed to them, making available Material Safety Data Sheets (MSDSs) pertaining to such substances and mixtures, and provid ing access to relevant records. The proposal goes beyond ANSI and EPA by including as hazardous substances mutagens, teratogens, reproductive toxins, materials that cause mental disturbances or behavioral alterations, or other adverse health effects. Again the proposal goes beyond EPA by including as regulated substances: pesticides, food additives or drugs, hazardous byproducts, impurities, or inter mediates and untested mixtures which contain as little as 1% of a hazardous substance or carcinogen. Beyond the usual definition, "containers" include stationary storage tanks, pipes, pumps, reaction vessels and stacks. Each container of a hazardous substance or mixture must be labeled with the chemical and common names and CAS numbers of hazardous substances present in as little as 1%. All substances are to be listed in order of relative concentration. For labeling of pipe contents, permanent codes must be applied on the pipe body close to valves, flanges, branches, pipe reactors, where pipes pass through walls or floors or enter or leave the ground. Placards must be placed at reasonable convenient locations giving the most current legend for the codes. Legends must cross-reference each code to show the chemical name, common name, CAS number and hazard warning. Where available, a piping system schematic with appropriate codes must be appended to the placards and lists. One copy of a Material Safety Data Sheet (MSDS) must each first shipment and a full set of MSDSs must be every work area. accompany placed in All backup information on hazard assessment must be available for examination and copying. The only concession to trade secrets is that process information and exact percentage composition are protected. COMMITTEE ACTION: None. Information only. CMA EC BD - 9/8/80 9/9/80 D-2 CMA 062898 Exhibit C- CMA POSITION ON LABELING CHEMICAL CARCINOGENS 1. TSCA provides that the determination by EPA that a chemical is a carcinogen which must be labeled as such pursuant to Section 6(a)(2) is subject to a hearing pursuant to Section 19. 2. A cancer warning in labeling for a chemical or a mixture containing that chemical should be required only under the following two conditions. a. First, there is sound scientific evidence that a chemical is a human carcinogen or an animal carcinogen. i. It is insufficient that a chemical is listed on some governmental or other list of carcinogens. In each instance, existing scientific evidence must be reviewed in detail to determine whether a substance is a human car cinogen or an animal carcinogen. ii. CMA supports the AIHC position that the determination of carcinogenicity requires the use of in formed expert scientific judgment. Accordingly, this de termination should be made by eminent experts on a Science Panel that is independent from industry, EPA, or any other regulatory agency whose action is affected by this deter mination. -1-- -B3- CMA 062899 iii. Because a determination of carcinogenicity requires the exercise of informed expert scientific judgment, it would be inappropriate for EPA or other agencies to establish a list of rigid rules or criteria for making this determination. A determination of carcinogenicity should be based upon all available data and information, including animal tests, metab olism studies, pharmacokinetics, epidemiology and other human experience, and other pertinent information. In general, such a determination should be based upon positive results in scientifically valid tests with appropriate doses and relevant routes of administration. Examples of suitable criteria for such determinations have been formulated by AIHC. b. Second, under customary or reasonably foreseeable conditions of handling or use, taking into account its physical and chemical properties, the chemical may result in a form of exposure that could present a potential hazard. 3. Chemicals determined to be carcinogenic should be divided into three separate and distinct categories: human carcinogens, probable human carcinogens, and animal carcin ogens. This distinction should be reflected in labeling as follows: a. Those substances determined to be human carcinogens should be labeled: "Cancer Hazard." b. Those substances determined to be pro bable human carcinogens based upon animal tests (see paragraph 4) should be labeled: "Cancer Hazard Based on Tests with -- -B4- CMA 062900 Laboratory Animals." c. Those substances determined to be animal carcinogens should be labeled: "Possible Cancer Hazard Based on Tests with Laboratory Animals." d. Any cancer hazard statement should not be required to include any of the traditional signal words used for acute hazard warnings, and should be placed on the label in a prominent place separate from acute hazard warnings. The term "cancer" is itself an adequate signal word. 4. In a few instances, there may be such overwhelming evidence that a chemical is an animal carcinogen that it is highly probable it also presents a serious risk of human cancer. This occurs, for example, where cancer is found in virtually all test animals of all species and sexes tested even at relatively low dose levels. Where animal test data are so conclusive and overwhelming that a chemical should be regarded as a probable human carcinogen, its labeling should reflect that increased level of risk. 5. The actual risk posed to humans by any human carcinogen or animal carcinogen varies widely, depending upon the potency of the carcinogen. The range of potency among carcinogens is greater than one million fold. This dramatic difference in risk should be reflected in the minimum levels below which a chemical product containing a human carcinogen (including a probable human carcinogen) or animal carcinogen would not be required to bear a cancer hazard warning. --3-- -B5- CMA 062901 a. Carcinogens should be divided into human and animal carcinogens. This reflects the degree of certainty about the existence of a human risk. b. Both human and animal carcinogens should be further divided into high, moderate, and low potency. This reflects the relative degree of hazard represented by a given amount of a carcinogen. c. The following matrix*should be used to determine the cut-off points below which the presence of a human or animal carcinogen in a chemical product would not require a cancer hazard warning: Human Carcinogen (Including Probable Human Carcinogen) Animal Carcinogen Low Potency 2.0% 5 .0% Medium Potency 1.0% 2 .0% High Potency 0.1% 1 .0% d. For any of these categories. EPA manufacturers or distributors should be permitted to present evidence at a public hearing on the proposed regulation, or by subsequent petition, to show that a higher or lower cut-off level is appropriate for a particular chemical substance. 6. Labeling should be required at the above levels only if the manufacturer knows or has good reason to believe that the substance is present in the product, either because it is -4- ,b6- CMA 062902 ^NOTE: This matrix is not based on scientific data. It is for illustrative purposes only. ntentionally added or on the basis of other valid scientific information. If the manufacturer knows or has good reason to believe that the substance is present in the product at the above levels, it should be required either to analyze the product to determine whether the substance is present above or below the cut off level or to label as though it were present without the necessity of analyzing for the substance. If the manufacturer does not have good reason to believe that the substance is present at those levels, it should not be required to conduct such analyses. 7. Under all circumstances, the manufacturer or dis tributor of a chemical substance that is a human carcinogen or an animal carcinogen may voluntarily provide additional information out the substance and its potential risk not required by the EPA regulation. Such information must be accurate and not mis leading. 8. In addition to the cancer warnings set out above, the label should also bear appropriate information respecting pre ventive and precautionary measures. Such information should be affirmative rather than negative in nature, and should inform the worker what to do about the hazard rather than just scaring him about the hazard. For example, the label should state "Cancer Hazard. Avoid Exposure. Overexposure May Create Cancer Risk." CMA EC-9/8/80 CMA 062903 Exhibit H SUPERFUND: STATUS, OUTLOOK AND CMA PROGRAM SEPTEMBER 8, 1980 The summer months have been marked by continued intense controversy and strategic maneuvering in the Congressional debate over proposed Superfund legislation. It has become abundantly clear that the Administration places a high priority on enactment of a broad bill, and is sparing no effort to speed enactment. Chiefly because of delays in Congressional action on budget and appropriations matters, it is now a virtual certainty that the Congress will return following the November elections. The "lame-duck" legisla tive session is expected to run well into December. This extends the time available for possible approval of Super fund and significantly widens the parlimentary and strategic options of proponents. Despite intensive industry efforts it appears possible hat the House will be in position to approve its two pending ^uperfund bills during the month of September. The Senate timetable is complicated by the likelihood of further com mittee referral and hearings, and floor action on some form of Superfund, though possible, is not expected before the October pre-election recess. Intense media attention to problems associated with the mishandling of chemicals has continued unabated. There are clear indications that EPA is attempting to orchestrate the timing and content of news coverage so as to put pressure on Members of Congress at times when crucial decisions are about to be made. The Ralph Nader organization and other environ mental activist groups have also attempted to employ scare tactics. It is clear that the best efforts of the chemical industry and the widest possible coalition of business groups must focus on Superfund for the remainder of 1980 if we are to avoid imposition of truly onerous, damaging and precedent-setting new law, and if we are to secure enactment of a more limited approach which is responsive to genuine need. A more detailed discussion of legislative status, prospects, and the CMA program follows. CMA 062904 2 HOUSE OF REPRESENTATIVES On August 27, the two Superfund bills pending in' the House are scheduled to come before the Rules Committee, the body which determines procedures for House floor debate and amendment. Rules action had been delayed by the need to resolve jurisdictional squabbles among the various committees which have acted on the bills. The bill H.R.85 has been considered in turn by the Committees on Merchant Marine and Fisheries, Public Works and Transportation, and Ways and Means. It encompasses both ocean oil spills and spills of hazardous substances, and has been opposed by CMA since the addition of chemical spills coverage by the Public Works Committee. We believe it creates a new, unnecessary, and overlapping regime, and we oppose its inclusion of a broad range of third party damages H.R.7020 was considered in turn by the Committees on Interstate and Foreign Commerce, and Ways and Means. The Com merce Committee version, drafted by Subcommittee Chairman James Florio (D-NJ) and a bipartisan group of supporters, represents a substantial improvement over earlier versions. While not wholly perfect, the Florio bill is a product of com promise and represents a step toward constructive new law. Its enactment could be supported by a broad segment of the business community. Further maneuvering by Superfund advocates and the Admin istration threatens in two additional ways: first, it is likely that efforts will be mounted on the House floor to amend on or both bills to make them even more stringent? and second. House passage of H.R.85 increases the chances for an eventual "ultra fund" conference between House and Senate. House approval of H.R.7020 alone could influence a narrowing in the scope of an eventual conference since that bill is limited to abandoned and inactive disposal sites. With these factors in mind, industry efforts have been directed toward delaying or avoiding action on H.R.85 and avoiding damaging floor amendments on either bill. However desirable, these objectives may not be achievable in view of the influence and strategic advantages of Superfund propo nents, and the forceful lobbying efforts of the Administration. CMA's program of communications in the House has encom passed specifically assigned contacts with relevant House Members, constacts with the Leadership, direct discussion with important elements of the Administration, interaction with other segments of business community, and a full range of appropriate technical and legal support services. CMA 062905 3 U.S. SENATE A later version of the unacceptable Culver-Muskie bill, S.1480, has cleared the Committee on Environment and Public Works, and is now the center of jurisdictional maneuvering by other committees and strategic pressures applied by pro ponent Senators. CMA remains deeply troubled by and opposed to onerous and precedent-setting concepts which appear in the Committee bill, namely: - The scope of the legislation far exceeds the problem of abandoned disposal sites and includes a "release into the environment" concept - An onerous liability scheme could force companies to to pay more than their fair share - The Federal liability provisions are a radical depar ture from current State tort law and make previously acceptable disposal practices unlawful retroactively - Economic implications and insurance implications of the proposed liability changes are unmeasured and certain to be massive - The primary petrochemicals and feedstocks to be taxed bear little, if any, relationship to the problem; feed stocks funding will have drastic commercial and economic results falling unevenly and unfairly on a broad range of businesses - The size of the fund is likely to have a negative effect on the domestic chemical industry and the nation's economy, and need not be nearly so large in order to ad dress the true problem of orphan disposal sites. The Senate Finance Committee appears likely to secure sequential referral of S.1480 in order to explore revenue-raising implications falling within its jurisdiction. Hearings to be conducted by Senator Patrick Moynihan (D-NY) are due to begin September 11. Committee markup is tentatively set for September 16, 17 & 18. CMA has asked to testify. Our testimony will address the above-listed issues in the context of Finance Committee jurisdiction. In addition, we will advocate a specific regime for industry funding by means of a waste end tax system. (See attachment one for specifics) Our funding approach envisions a tax, per ton, levied on those listed wastes in Section 3001 of RCRA. All currently exempted wastes under the RCRA regulations would be statutorily exempted. The development of a waste end degree of hazard tax CMA 062906 4 system would be mandated within two years. We believe the unfolding RCRA regulations will provide an excellent basis for a very workable degree of hazard tax system. A waste-end fee concept was included in the "CMA bill" endorsed by the Board and Executive Committee at their June meeting, and intended for use in the Senate. The present proposal is a refined implementation of that concept. In the Committee on Commerce, Science and Transporation there is a high level of concern among key members and staff over the jurisdictional implications of S.1480. Though initially rebuffed in its request for sequential referral, influential Commerce Committee Members remain concerned over the potential reach of S.1480 into areas affecting interstate commerce, common-carrier transportation, insurance, hazardous materials shipment, and ocean oil spills. The resolution of these concerns can have an effect on both the timetables and substance of the final Senate bill. After omitting Superfund from a July listing of priority measures, the Senate Leadership has come under increasing pressure to expedite action. Senators Bradley, Heinz, and Levin initiated an effort which resulted in a joint request to the Leadership for prompt action co-signed by twenty-five Members. (See attachment two) Our Senate objective is to stop S.1480 and to produce a climate where enactment of a "H.R.7020-type" bill is possible. An extremely active program of visits with Senate Leaders, Administration decision-makers, and other industry groups has been conducted in the context of our Senate objectives. We have prepared and are distributing specific amendments to S.1480 and are exploring opportunities for substitute language, delay or parlimentary advantage. In all likelihood our efforts must be continued into the closing days of the 96th Congress. The Association, through its involved committees and staff, are conducting a full-scale program of technical advocacy, legal preparation and response, and public relations. These are designed to support and augment the direct legislative communications/strategy effort being mounted by the CMA Government Relations Committee, our Washington Representatives, and other like-minded organizations and indi viduals. A major factor in the success of this effort will be the direct and personal involvment of the top level executives of our industry. CMA EC-9/8/80 BD-9/9/80 CMA 062907 CMA WASTE END FEE CONCEPT Attachment 1 August 11, 1980 I. General Discussion of a Waste End ResDcnse Fund- There are several basic considerations which must be addressed in the process of developing a workable tax on hazardous wastes. The first consideration should be the definition of a "hazardous waste." The problem of old aumpsites is caused by "hazardous wastes" which were buried years ago. Although not everyone agrees on the definition of "hazardous waste," the RCRA Regulations promulgated in hay 1980 have listed numerous substances, waste streams and characteristics which are now defined as "hazardous." These Regulations provide the basis for a waste end fee system. In addition, there are several large volume, low toxicity waste streams which should be treated separately from the RCRA regulated wastes and not subject to a Superfund tax. Examples of such wastes are: the aqueous portions of large volume, low toxicity waste streams, mining and milling wastes, fly ash, bottom ash, drilling fluids, and certain agricultural wastes among others. The risks that these wastes pose to human health and the environment are usually minimal. A tax imposed on hazardous waste would encourage reuse and recycling, sound waste management, including reduced waste generation and waste destruction. Moreover, the Superfund tax should focus on wastes that are truly hazardous. It should accomodate generators in an equitable manner, such as by CMA 062908 2 statutory exclusion where appropriate or by a lower tax based on relative degree of hazard. For those industies which generate large volume waste streams with some hazardous waste constituents, listed by the RCRA Regulations, an apportioned tax could be calculated. The second important consideration involves the selection of factors needed to develop a waste end tax. Depending on the alternative selected, the tax should rely only on those factors tfhich can be readily accounted for and consistently measured. Suggested tax mechanisms have been based on: the volume of all Listed wastes generated; the volume of all listed wastes received at disposal facilities; and, the dry weight volume of :>oth these alternatives. The factors chosen must also address i related problem -- administration. A mechanism for ^tracking my of these suggested alternatives must be already in place >r capable of quick implementation. Eased on evaluations of these alternatives and considering idministrative complexity, the recommended system would be to >lace a tax on RCRA regulated hazardous waste generation, with :ertain statutory exemptions. The tax would be assessed on the renerated hazardous wastes which are disposed of at a hazardous raste disposal facility as defined in EFA's RCRA Regulations, hch disposal facilities would include landfills, land treatment, 'cean disposal, surface impoundments used as disposal sites, jnd deep injection wells, but would not include waste treatment acilities, recycling facilities or incinerators. CMA 062909 -3 The data base for such a tax system has already been established in the final RCRA Regulations, Section 3002 and 3004 Record anc Reporting requirements. The Department of the Treasury would develop a tax reporting form, utilizing this existing data base, from which a Superfund hazardous waste tax payment would be made. The exemptions to the waste tax would be specific, and would have the dual effect of initially exempting high volume/ low hazard wastes, and taxing only hazardous wastes which are "disposed" in the context of the final RCRA Regulations. Specific statutory language would direct the development and incorporation of the degree of hazard concept into the fee on hazardous waste disposal within a two year period. Another consideration is the immediate generation of funds for emergency actions on failing dumpsites. One method would be to provide for a loan program through the Treasury Department if fund monies are inadequate at any point in the four year program. Such loans could not exceed one year's revenue in any given year and the Secretary of the Treasury would prescribe the rules and regulations for such borrowing. II. Operation of a Waste End Response Fund The Department of the Treasury would be authorized to establish a Response Fund. The Fund would be administered by the President and the Secretary of the Treasury. Components of the Fund would be taxes collected on waste disposal, moneys recovered on behalf of the Fund, Congressionally appropriated CMA 062910 money and interest received from the investment of Fund money. The total amount which may be collected in taxes shall not exceed $50 M for fiscal year 1981, $75 M for fiscal year 1982, $75 M for fiscal year 1983 and $100 M for 1984. The authorized appropriations for the following fiscal years would be: 1981 - $50 M, 1982 - $75 M, 1983 - $75 M, 1984 - $100 M. In order to distribute the costs as broadly as possible among those who generate hazardous wastes while minimizing the burden of collection and encouraging treatment, reuse and recycling of hazardous wastes, a tax would be collected on all hazardous wastes received at, and which will remain at, hazardous waste disposal facilities. Each generator of hazardous wastes listed in Appendix I will pay a tax for each dry weight ton of hazar dous wastes generated, delivered to, and remaining at,' a hazar dous waste disposal facility. Such hazardous waste disposal facilities shall include landfills, land treatment, ocean dis posal, surface impoundments used as disposal facilities, under ground injection, and any other facility where hazardous wastes will remain after facility closure. Taxes will not be assessed on any hazardous waste which after generation is either treated (rendered non-hazardous) at any permitted (including interim permitted) hazardous waste treatment facility (as defined in 40 CFR Part 260.10) or is reused or recycled. The list of hazar dous wastes in Appendix I should be reviewed annually by Congres based on changes made to the list of hazardous wastes regulated by EPA under Section 3001 of RCRA. The following materials will CMA 062911 5 not be considered hazardous wastes for the purpose of the tax: (A) Domestic sewage; (B) Any mixture of domestic sewage and other wastes that pass through a sewer system to a publicly owned treat ment works; (C) Industrial discharges regulated under Section 402; (D) Source, special nuclear or by-product material as defined by the Atomic Energy Act of 1954, as amended, 42 U.S.C. 2011 et. seq.; (E)'Materials subjected to in situ mining techniques which are not removed from the ground as part of the extrac tion process; (F) Household waste, "household waste" means any waste material (including garbage, trash and sanitary wastes in septic tanks) derived from households (including single and multiple residences, hotels and motels); (G) Wastes generated by any of the following and which are returned to the soil as fertilizers (1) The growing and harvesting of agricultural crops, (2) The raising of animals, including animal manure; (H) Mining overburden returned to the mine site and waste generated by beneficiation of ore; (I) Fly ash waste, bottom ash waste, slag waste, and flue gas emission control waste generated primarily from the combustion of coal or other fossil fuels; CMA062912 6 (J) Drilling fluids, produced waters, and other wastes associated with the exploration, development, or production of crude oil, natural gas or geothermal energy; and (K) Any other waste excluded by regulation or act of Congress. For the first year, the tax imposed on all hazardous wastes listed in Appendix I received at, and which will remain at, hazardous waste disposal facilities after such hazardous waste facility is closed in accordance with Subtitle C of the Solid Waste Disposal Act, will be $3 per dry weight ton. In succeeding years, the Secretary of the Treasury in consultation with the EPA Administrator may modify the tax based on the projected total dry weight tons of such hazardous waste to be disposed in that calendar year. The tax will not, however, exceed $4 per dry weight ton of hazardous waste disposed. The tax will be paid semiannually or at a frequency to be determined by the Secretary of the Treasury, based on a form provided by the Department of the Treasury, utilizing the information collected and submitted to EPA pursuant to Sections 3002 and 3004 of the Solid Waste Disposal Act. The information contained in the form should include: o The amount, in dry weight tons, of each hazardous waste listed in Appendix I disposed of at a hazardous waste disposal facility (as identified by the Environmental Protection Agency Handling Code at 40 CFR Part 265, Appendix I, Table 2 - Part 3, "Disposal") (45 F.R. 33253). CMA 062913 -7- The Secretary of the Treasury or his delegate will collect the taxes under provisions of Subtitle F of the Internal Revenue Code of 1954. The Secretary of the Treasury may invest excess Fund monies in interest-bearing ventures of the United States. If at any time Fund monies are inadequate to meet the obligations of this statute, the Secretary of the Treasury may loan the Fund ah amount equal to one year's revenue, subject to terms and con ditions prescribed by the Secretary of the Treasury. Within two years after the fee is first initiated, the Administrator of the Environmental Protection Agency, after consultation with the Secretary of the Treasury, will- submit a report on the tax system to Congress. Opportunity will be pro vided for public review and comment. The report should include: o A summary of past expenditures from the Fund; and o A brief description of all projects and their current status, specifically listing completed operations and cases. After two years, the Department of the Treasury, with the assistance of EPA, will publish a tiered tax system reflecting the relative degree of hazard, including, for example, such factors as migration potential, persistence, bioaccumulation potential, toxicity and the potential for adverse environmental effects. EPA's background documents used to list wastes under Section 3001 contain the rudiments of a simple degree of hazard system and reference these relative hazards. This information ^ould be used with the additional information provided by the generator's annual report to devise a workable, tiered tax system. CMA 062914 8 Appendix I Hazardous Wastes Subject to Superfund Tax (1) Ignitable wastes as defined in 40 CFR 261.21. (2) Corrosive wastes as defined in 40 CFR 261.22. (3) Reactive wastes as defined in 40 CFR 261.23. (4) EP Toxic wastes as defined in 40 CFR 261.24. (5) Specific hazardous wastes as listed in the attached. CMA 062915 Federal Register / Vol 45, No. 98 / Monday, May 19,1980 / Rules and Regulations 33123 Hnrtoua waste from nonapecffle MUWyanlEMPAHa. HmwWm wain Hazard cod* pm~ The spent ftatogeneted solvents tMd ft a>y<--ng, tetraeWoroethyiene, tnchlaoethytene. methylene ehionde, 1,1, t 'tnchloroeihane, carbon tofraehlonde, and the chtonuted Aucroovoor* and uuiqh horn 0* recmmry of mat* sofvemi * dagr*eimg ooeribons, Tha spam ftstoganaTW aofvena, tetmchtoroethylene, methytana crtonde, tncmoroethylene, i.I.I-tncNoroamane. cMomPanzana. 1.1,2- trkiNCMi>-1.22-tnfluofOetnanat o^crtorooaniaoa, tnchforoftooromathane tod tha st* boftome from tha 'ecovery of meat solvent*. Tha ssent norwuiogeniied advents, *yten*. acetone, ethyl acetal*. ethyl benzene, ethyl ttfie, rvOutyi alconoi, cyclohexanone. and tha sti botton* from tha recovery of thaaa soWnts The spent norwiaiogeneted adven* craaots and creeyte add, rvfrabemene. and the sl bottom* from tha recovery of these servants.,.,___ Tha spent nomftaiogenaled advent* methane*, toluene, methyl ethyl ketone, methyl soOutyi ketone, eaibon dauiflde. ooPutand, pyndne and the so* bottoms from the receumy of thee# solvent* Waateeitsr treatment Adgai from aieuiijpiauuy `-y****'-^* ______________ _____ ,, Spent ptstmg bath adubon* from alaulrodaong ooerabone^ ______________________ _...___________________ _...______ ^atng bath sludges from tha bottom of ptaong baths from six in ndsieiy operabona.............. ............ ....... ................. ....................................... Spant strtopng and 3--r*ng bath aotobone from siecfr&piaupg operabona ______________ ____________________ Guenchmg badt dodge from o4 bathe from maul haet oreatmg operabona---------------- ------ - ... ________ _______________ Spam sofubons from salt bath pm cteamg from metal heat treating ooerabone____________________________ ,, _________ ________ Oueneheig waitawaid treefrnent stodgaa bun metal heat treaong ooenpont..................... ..................................................................... FloUbon tattnga from aetocbva flotation from mmeral metals raco i arf operand*........ ........................... .....-___ ____ ---- Cyaradabdi wastpester treatmam taing pond seoimam from rrwienf metals recovery operabone__1______ __ ________________ _______ _ Spent cyanide bath sduSona from no mol metals recovery ooerabone________________________ ______________________ ____ - Omneterod ar poMtfban coned mope adgai from coxa over* and otaat fc***^** ________________ _ m m (i) m (, T) m (R. T) (an (an (a n (a n m m n. m (SUl Hazardous w**t* from specific boutcvs. aWndM6MPANO. WBtt12_. Hazard coda Bottom sedmant dodge from tha iraslf of wt--atars ft that uee craosota and/or pemachtorophend (T) Waneeaip traePnent sludge from tha production of chroma vise and cringe ptgman*......... ............... Wisiaaaiai boatmam sludge from the predjcbon of mofybdata orange pageants....... ...........--_________ Wsaiaeitoi ttoalmant studga from tha pradttoben of one yariow <y*i_______ ____ ____________ Wastowator treatment studga bom tha prediction of chroma gw .....-............ ............. Watxiiai* troatmam stodge from tha production of diromt oade ?een pa/nxits (annydroua and hydrai Wiitonalw treatment studga from tha prodtotion of von btua pgmanta --................... .............. ...... Dw redd* from tha production of chroma gods toot pigm--ii*,,, , ,,.................................... ............ Ctotditton bottoms from Via prokjcaor of acataldohyda from ethyl**.... DtoBiebon pda cuts from (ha prtxfcjction of aeataioahyda from ethyton*,. i tha waatewet* sbtopar m tha production of acryionrtnla__ _______ _ SOI button* from tha Anal purffleabon of acrytontnfe m tha productnn of acrytomrta ^ Bottom stream from tha anoigi strife cobann si the production of acryiorstfba___ _ Bottoms from the acadonrtnfa pvrflcabon eefunn m the production of acryfqmtrSe^-- Sid bottome from tha daaNabon of barayf emuide- Mamry ande or rWMannn reentoba from tha production of carbon tatrUttohda... Hamy ends (aid bottoms) from tha puOteaten column the production of epehtarahydryu Weevy ends from froebonaobn n adryt entorida production . Heavy ends from tha daMetton of etfryfana cScmonde m ettryfane ttchfortoe proctoebon. Hamry ends from bn indefim of vinyl shfonde n vmyt monomer productnn__ Ameca* Mt anbmarw nulit **m tram mawBehiM Oortdabon bottom tare from the protoiedon of phanot/aoslona f OeBdatton H^a ends from tfu *oduebon of phbiafrc annyutoa from mrrfnTnfmn _ Dtoldatton bottoms from the *oducaon of phthsbc amydnda from naraninieiii Ottddiaon bottema from tha producaan of mfrobsrgena by the nmaa*i of Peramd- Sfrwtg sttt teas from tha proaedpn or matryi athyf pyrMM__ ________________ Censduga raaidua fr re tha production of l.l.Unchtaroettiane. i from tha product sttaam sWppm ei ffn produebon of l.l.l-bfrittjruathane- CoMrei bo<toma or haasy anda from d* contolnad production of flWtoiuotfiytsrn and t Ry fioducf sabs jiniimJ in tha proModvi of msma and rnTirtytc **............--.......... ...... Wastewater traiamani ttudga from the poMton of chtordana__________________________________ Wtaw>e and nvi ettor from V* chfcewiaoon of cydopantadana n tha prottodton of dborttane.. i of htiecrtgocytopintidiene in tha pmrhirfinn of c wastowat* ratmant sludgaa gaeiad tr tha production of cremnta.. Sitt bomtin from toluona radametton datttobon * tha production c* itmMton ,, e^iWiiiMSrsniari^lTTwi^ni^rtWwrtlAfcAw ______ frmni hum the and ui^eeig ei fwt+k****-. _____________ fttor ceaa from tha ftbatton of ibadiinhoaphorodWhonc and m Via production of pho-- _ r soatmant ttudga from via produebon of toxaphene- Hatvy ends or dHttatton nart iia from V* ditWalton of tefrachMubembne m the produebon of 2.4.S-T.. me from the poduobon of 24*0.--....................... ... ........ ........... - (T) rn (T) cn (T) m (T) m m, t) (T) (R.T1 rn m rn m m m m (T) m m (T) m m '(R.T) (T) m 0) r(To> mrn m m m fT) CT) m m m tha merutacaafrig and piooe^ng of iipiuwi m - m ttudgoa from tha ffnmdactunni fonutiason m3 toadng of k Oaaosmd m flotation (DAF) boat from *m pasutouw raining ru*mrr,, ~ i aoida from tha petotaien raflnfrig tndffry... r bundto daanmq Qirtga from pie pafroiaum reflnng ssduavy.- tertoh H r tftluMdglMa ffrHomMbiinSpaapawoMuiab roffrang mdusby.. i nmatmg oompounr^L. ----- ------- {*> m m m m m CT) Chroma (Muel tommtnM gamtiitt by 9m fodomng sSmsgsai of 9m (aathar tanning and flmtfwig induaby; hafr p^/ehroma ton/rottfi/ CD < ffrtiafa hat save/chroma ten/fsurvwei tin^fr mtn/nm no baamhoute; baough-tha-biua; and thanttig. CMA 062916 33124 Federal Register / Vp|. 45, No. 98 / Monday. May 19. 1980 / Rules and Regulations 261.33 Hazardous waste from specific sources. --Coronusd 'nbwtoy and EPA H^itfQOUt NQ. HazifOou* wait* KOU......... _... .. ,, ... frirama (ttual wriqi gnr*t0 by cria foiionwnq si^cataqonaa of tfta 'aminq and Wivmaj -nduaoy* ria# puip/crirama lan/rvtan/ ..... ...... wat fa*#t har iM/dTOfm t*n/r*tari/w*i faa* rmMiJvH Hntaft; no b--mrouw: trvouqn-tf^-bkjc and sntaring. ......... Boffag duA janaramj by m# 'oflowng mbcafrgpn-- of tf* atfw tamng and faarioib .rduatry hair pufc/coroma tan/ratan/wat fa** rvav aawt>cnrama '.nvratir/w* fart* ratan/*i fa** no baaiTthouaa; and inraogn-Wo-btua. K06U....... -__ _____ Saw wtawgi jnntid by tfw Wtowng amwgum or 171a wtn* nmtng and fint**ng nduatr rta* pulQ/ctmr* tan/rtan/w*t Iman. nar aava/tfvoma tan/ratao/w* ftrtnrt rann/mw* fan** no baamnouaa; dvoug(vtfia<rtua: and tfrtarfag. KM7_________ _____ _ Wastawatar sraapwa iKAgaa ganarmtad by tna lokywng luOcawgonaa of trta aattw tanning and rtrftanmg mduady; Hw pulp/cnroma tan/ ratm/aai Vart iw uv/diramo tan/rat*n/wwt fa** ratan/wA fa** no baamnooaa: nraugnma-biua and snsarfa^ KOfiB __ ___ ,, ....Waiitaaafar iaaimaK audgaa garwvad by d* foio*ig yAcaTvgonaa of if* t#a&w tamng and finanng industry rr pulp/cnrama tan/ ratw^aat fa** *w saua/cnrama tan/ratan/*3 flna* and thrau^vft+otud. K059____ ________ ____ - Wasttfaatar Ttatman Artgaa janwaiu by tha totoaa^ suocatagvy of Vm mfm taming and fa*Nng mduaay h#r i***/noncnrama tm/raMn/aai faa* iron and SM KOBO___ ___ _ tceka^opviiWA^ K061 ,, .......... . Emiawon cum** duat/dmqa tram tt* atactnc Kmaca praducacn of naat_____ _ KQB2__ _________ , Span* Dtd iquor tram stoat dnafaq aparioona........................................... ....... K043____________ , SKidga tram lima traabnarv of apant pielda tram saaaf faMtg oparAlona.. Primary Coow K0**_ . Aod plant btoadean atary/tfudgo raaLrtng from na thcfcamg of tAmwJuwn slurry from onmary ooooa praductton.... Primary Load: KOBO____ Surfaoa ywpoxrarm* aoidt cantamad m and dm)gau tram aurfaca wyctfwpnarr* at pnmary load amafdng fanaaaa.. Pnmary Zjne KQ6B____________ . Skidga tram baabnant of praoaaa aaAawatar ani/o add pAm bkasUuaw bom pnmary ane praductton_____________ K0B7.................. . EJaevofyae anoda Anvt/sfudgaa from uinaiy zmc ^oaucben__ . --_____ _________________________ K0* Cadmium plant taaen 'ua Cvon endaf from uinaiy one praduawn.___ ________ ________________ t Laa* K<,, Emiaon conffa dm/aadga tram aaeondary load nAfag_ m m m T) <*> m m (C.T) rn m rn m n S 261.33 Discarded Commercial Chemical Praducta, Off-Specification Spedea, Cootainera, and Spill Residues Thereof. The following materials or items are hazardous wastes if and when they are discarded or intended to be discarded: (a) Any commercial chemical product or manufacturing chemical intermediate having the generic name listed in paragraphs (e) or (f) of this section. (b) Any off-specification commercial chemical product or manufacturing chemical intermediate which, if it met specifications, would have the generic name listed in paragraphs (e) or (f) of this section. (c) Any container or inner liner removed from a container that has been used to hold any commercial chemical product or manufacturing chemical intermediate having the generic name listed in paragraph (e) of this section, unless: (1) The container or inner liner has been triple rinsed using a solvent capable of removing the commercial chemical product or manufacturing chemical intermediate; (2) The container or inner liner has been cleaned by another method that has been shown In the scientific literature, or by tests conducted by the generator, to achieve equivalent removal; or (3) In the case of a container, the inner liner that prevented contact of the commercial chemical product or manufacturing chemical intermediate with the container, has been removed. (d) Any residue or contaminated soil, water or other debris resulting from the cleanup of a spill, into or on any land or water, of any commercial chemical product or manufacturing chemical intermediate having the generic name listed in paragraphs (e) or (f) of this Section. [Comment The phrase "commercial chemical product or manufacturing chemical intermediate having the generic name listed in. . refers to a chemical substance which is manufactured or formulated for commercial or manufacturing use. It does not refer to a material such as a manufacturing process waste, that contains any of the substances listed in paragraphs (e) or (f). Where a manufacturing process waste is deemed to be a hazardous waste because it contains a substance listed in paragraphs (e) or (f), such waste will be listed in either $3 261.31 or 261.32 or will be identified as a hazardous waste by the characteristics set forth in Subpart C of this Part.] (e) The commercial chemical products or manufacturing chemical intermediates, referred to in paragraphs (a) through (dj of this sectioa are identified as acute hazardous wastes (H) and are subject to the small quantity exclusion defined in 3 291.5(c). These wastes and their corresponding EPA Hazardous Waste Numbers are: --Commad * No. PQ04P006_ PQO0._ POM. P010P011.. P012- P013- . Am Atgimyan *m POW Aity ateotai Aiumnura phoapftdi (R) alviT %m PO07 Arntnoettryttn* sm P054 MA/TwiarTwtrry>4<dQ220A 4-Aimnotryrttn* A/nmonum irwaymadttf Pi 19 Ammomun ptiratt (R) ANTIMUCIN WOR PQ9S ANTURAT W PQ71 AQUATHOL mm POM ARCHT 9m P020 Ai`tana aod A/taie pamormto Aram inoutp Avrraa. ** poob Aarfdan* a# P0B4 AZOFQS P0B1 AapviNiPMi 9AMTU 9MP072 data* eyvadB 9A$!*TE * TOO BCMC MM PQ1B POtf^ P017P0l8.,, P01_ aavapM BUADAN-M P071 ararrmemm* Sniim 2'Butaoona paobdi 9UFENMBP0B2 Buuphaw sM WJ20 2 aac fluty i.B-tfaoryhi CALOONaM^UO Carbon CEPESAN *M P0B2 CCRE5AN UMVER3A4. tm PQ* CHCMOX QCNOWL 9M P020 CH6MOXPE. awPOn CHEM.TCt ** BB CHaraacaMflaNjda I^CNoio M^CNeraarmV^tltc KNorogmonirti BiiaOBniBliBni Ccppareywtf* CACTOX m Plot P000., CMA 062917 -r Federal Register / Vot. 45, No. 96 / Monday, May 19. I960 / Rules and Regulations 33125 Pdsu P084- ' Hmrtou* lttO NO. $--tanco 1 Cvno9n , Ofvngm Irowtdo . Cyanogen crtort* Cyctodtm wt PMO . g-Cyctanofyl i,6-MMP0ftonrt 0-CON MPOOt oethmor -- pooi QETHNEL jh P0Q1 QFP so# P043 l4^tttoraefNnaay*eetc aod (2,4-0) 0tCrtOT3<jfiOf>ytll'M># Dfcyonogen mi P031 OMdm OELDREX mo J7 OMWit of p praunK mj ftO-OMnya^a-py--anyOpMpRoro^ (LOOtaoiyt i--awwa add, O-pnarognonR 4 3.4-Ojhydoiy opfta (n--hyMioiel --tfifl ba DtMETATE mo POM i .<:Sj-CfrnoO\oriyiaphtfMono, 1,2,3.4.10,10- h--Pfc--i ,4.4o.S.aonMUih>iXo tndo, NM^MyM-2-buMY---O- . Cfrr-->Hoffww)carPorryU asdm* n>iMHyM"RRrff*M AfrOowp a i.iiw( and iota 2.4-Obnmdwnd QtNOSEB mb P03D cnnosebe --fq& 0to*M9fl MO poa &+Cunom-- DNBPM*P020 OOtCO Mouse CEREAL w RIOS 00* GENERAL aoo TOO 00W GENERAL WEED KBJLEA too PBSO OOW SELECTIVE WEED WLLH MO P0 0CMRCK3E 0 too POVO orANAC oo * EASTERN STATES OUOQOC mo HOI ELGETQL MO PD EJiytey--do PASCO PASCRAT POWQCR MO P0D1 FEMMAmoPOPI PwrteeyorMi OuoOo Z-FUeraocoMdo Puurooiok --d. toMjn atO POLCOOL-OO mo W1 POLOOOL M mo P971 FQSFSMO It SO aao P071 fltATOL aao PQSS ftdtOrMod rntuy too POOS AJNGfTOX OR too POOS FUSSCPmoPWT QALLOTOK aoo POtt SEAAFHOB aoo *771 qgmroxtoowaB 1A3.4J0J0H--flroo t,4.4cSJUobo--hy'aq.MAj wtt 1A0A7.7 li--rwawi dtli I wteML HOSTAOUOC MO RHt HOSTAOUK too POM HyOmnmaMPM 9COQNN0 KQP-TVOOOAN-O POOO KVMK40L too P1Q0 KWVCSAN too ff8 KUMAO0 OOO P001 ICYPPARIN too POOI LEYTOSAN mo POOt UQUmM aoa P008 pomP070_ P001- MAUK Mo POSO UAAEVAN MO pooi MAfl-FRlN MO P001 UAATIN'O MAR-FAIN Mo P001 MAVERAN Mo P001 ME6AT0X too POOS , Morcuy futnnoto MERSOUTE too POM METAOO SO too PQ71 METAFOS too PQ71 METAPHOR MO P071 METAPHOS ooo PO?t METASOL SO MO P093 2-MotftyWMno METHYL-E 006 MO P07f MMMhyMW Metftyl oocyanote too P064 Z-MothyUoctgntrto 2M (mottyteortairyf) owmo METHYL NiRON MO PO42 Med^i pormtfw METRON too PQ71 MOLE DEATH Mo PI00 MOUSE-NOTS Mo PlOfl MOUSE-PIO MO P100 MOUSE-rOX MO P100 MUSCIMOL too P007 l-NopMNyLS-VPBUMO Nick* ctAOffyl NiMdcyortdo . fl MNo--nodiyf--yliffMo NYU4ERATE MO POM OCTALOX aoo P007 OmamotfR i^irxft'jMwpidt OCTAN aoo POM 0My4 OcoNi cQAdanood 0tt 2 mem otfiyi qmM OMPAaooPOM OMPAdOE aoo *NS OMPAXaooPOOO OmO** HaroMft y-OtaWfyrwCTZ nhapMPQ a.3 iRteo>0n a PAMVAAPIN 100 P001 PANORAM OOI too P0S7 panthers* om poor PAMftAftFft 00 POOL PENNCAP-MOOOP0FM PENOXYL CARBON H aoo . PoioocPMocftond PontacMO--t-- MO POOC PENTA-KJU. aoo POOO PENTASOL MO *790 P&0NAR aoo POOO PEPMCCE too POSO PERMAOUARO mo POOO PERMATOX too POOO PERMfffMoPOM PERTOX aoo POOO PESTOX10 mo POOS PHENMAD aao POM phenqtan too pom < ^OoPp dMtOfOflflOlO dMffp iTMUftO MO POli PHSJPS 1B01 to* POOO PHIXmoPOM e*ao*tato kM, OJ ddMRp Mtr, 0 mm <Mh NJ< i^nnhp bowrta oPfownada Wwitfpwwwrom aew 0,0 *iwfrp 0 (p nod phanp) wtar m* P0T1 NEPPtPCT MOUSE SOD MO P100 Podoaun cyaoMo PctMoum mm eyanbo mPiirRfVE*^M-o-EpR-aGr_ME.--jto0.1*v POOO Pf^o^OP dwftR tto Piqg Mtfaroouo m No. 2-Protrfn-i-Q\ PRCTHRCMAD<N Sm P001 OUlCKSAM mo P092 QUINTOX mo P037 RAT AND MICE BAIT Mo PQ01 BAT-A-WAY MO P001 BAT-E^jON mo Pool RAT-OClOe #2 MO POT1 RAT-GUAPO too P001 RAT-WLL MO P001 RAT MIX mo P001 fiATS-NO-MORE mo P001 ftATOLA mo P001 RATORS( MO P001 RATTUNAL MO P001 RAT-TROL MO P001 RCW56TH mo P001 RO-OCX moPIOO RCSEX mo P001 ROUGH A READY MOUSE MIX Mo PC SANASEEO mo pio SANTOBRfTE Mo P090 3ANT0PHEN mo P00 SANTOPHEN 20 MO P090 SCHRAOAN MO POSS P100-. __ *JtMOOItOO P104,. _ Srfvor Cyonda SMITE mo P10S SPARCmoPOSO SPOR-XJL mo P093 SPRAY-TROL SAANO ROOEN-TROL t l P001 SPURGE too P030 mi Sodurn am Sedurn eeumodfi too POOt m SodUtepnN Sddwo Pusrooeouto mo P09A SQOtUM WARFARIN MO P001 SOLPARIN MO P001 SOLPOSlACX BE mo PQ*S SOLFOBLACK SS mo P04S P107. __ SPorXMn Wo PiOB.. __ SfrycftrwM and taRi 9UBT6X too P020 SYSTAM *00 P096 TAG FUNGOOE MO PQ02 TEKWAISA MO P071 TIMICmoPOTO TEMIK MO P070 TERM^TROL mo P090 __ TfffiQtflyOAlfMpyopRPNlPMa TaffarMwoPwio Tobopra*phene octd, boaaoip to*tf tao P0S2 TETROSULFUR SLACK PE mo POM TETROSULWUR PSR too F04S P113..-mm. ThaReMMo P114_ P116- T>oRui p--OMda too Pi 19 ThNMitdmR ThaMan (?) atdMo THtFOftMoFtta THIMUL MO P0S2 THIOOAN MO POSO TWOFOR mo P060 THIOMUL aao nSQ THIONEX aao J60 TH10PHEMT mo P071 TNijiiitb WtTTtrtl Ttadtan RM mo POSp -- TToaom THOMPSOPTS W000 FW too P06O HOVEL mo POSO _ Trttrtc--twOianoooA TWIN UGHT RAT AWAY MO POOt UW RN-S aoo PC* USAF EX-MSO mo POOS Vanode tod, tiMdo tdi _ Vanadhao poMMda voFATOx aao Wi WANAOUM0P19 WARCOUMM aoa POOt WARFAAm SCOUM too R101 WARPC106 mo P001 WOPOTOS mi P072 yahocx ooo post YASOKNOCX mo NMS ZlAANttC aoo POOS Pi*1. _ Ztoecyanda PI 22. ----- Snc phoaodP (R.T) 20OC0UMARM too WW1 1 *4*cy YcAidaO Mo Udo dmm 4 wNcft t oa an :n--ion gt a t--do no-- m not Tm 9w 1 motano not baanartio Tho hiqom o Mem*-- --0 odo t Eonom nma CMA 062918 33126 Federal Register / Vol. 45, No. 98 / Monday. May 19, 1980 / Rules and Regulations (0 The commercial chemical products or manufacturing chemical intermediates, referred to in paragraphs (a), (b) and (d) of this section, are identified as toxic wastes (T) unless otherwise designated and are subject to the small quantity exclusion defined in 261.5 [a] and (b). These wastes and their corresponding EPA Hazardous Waste Numbers are: Hazardoui WM NO. SJlotn*' AAFMIUON 0001____ _ Acttaidah^v 0002......- Aettn4(l) nnm.,rr..... > WOWH (l.T) 0004,__ _ fCdlQChMWM IJOOS___ _ 2-4nfy^iTWQ4oMMM 0004,__ AMyl duonlf (C.T) U007,-- Acryiamd* Aty4w KMawH M4 0204 Satytana nMmM w* UZSS 0004____ taytc 10) (1) 0004^-**. AciyWffK ACflOTHENC TT -- UZ20 S-*w-5Kp^uaWimK<fany<>-iH-lA-Ta0<a. hyiSalawauoll 00IQ------- fl-Amoo'i. 142,a.a.4h4Mhy^p a tawmZ,X.%4) pynoiafi^ tidcn 1. 7^n inn U011 ,,,, ,. AfTVMa 0012-...... *n-- (1) 0013____ _ 4l4l 0014____ Auiwimm 0015____ Mwm 0014____ Saatciaatlna 0017____ BaraM i-h^4ni4 UQ14-- B4nx(4jan4WM uoia..,,,,, ,, 04riar 0020____ Sanzanaatsemyt cfSovtfa (Cfl) 0021 OwuxIm IZ niTamUmjai-J-ona. I.I^SoaS* -- U20J SaneUIanavacana taa U01S um .... SanzsUtpyma 0023-- OannwmunUa (CAT) UQ?4. , BWSoamaewyKnaviana 0025. Bl4<2<h4oro4thy4 #4wf 0024--- Nj^eiea^woreaeiyiM miei)iaiaa 0027____ 9(2<NoraMepQoyO ftxr 0024--__ 94<2 #4iytMy4 pmn^^a 0024____ 0030-- 1 Dronimjhnyl phwryl Miar U031,, fvdutyl alcM (1) 1TM C4*oum chwwia CngkudaaulS Cartw, laanJSuiiila taa USM iireci-r.r Carton* fluoflda 0034.____ CMonl 0034____ ChtwwnOuci 0034____ aasdn. 0037____ ChltfiMMumii 0034-- ChlmAMraiaia 0034____ eCort<mrt 004Q-....... Chl0IOl5bl0lHUHM4MM CHLOWOCTHCNt NU 1 U224 0044- CNoroatfiyt wiyl Utm U044__ , CMcntorm (1.T) 0044-- 0047____ 0044 C.L 23040 wm U073 U061___ Cnm* U052-- Grata Q043 CratonaMat^rii 0044,, CfOTytetod 0045 Cumn Cyrtomam U009 0054-___ Cyt*htan (I) 0067...... CVcfetwnanoiM (I) U054._ 000 UO1........ DOT U002.......... LOK)....QtoVTrfiMiffiflrvc** p( i.n IttUfiHrW 0043 UQ6*......... ft.) uootf___ r^nruim 0044........ U047,..,,i ,2-0&qmo4th4n4 tt-n-Outyi pomaitta U070_____ i.MeMootorn** U071 U07J._____ 1,4-Otf^nbttatm U073.,,.___ 3J lymoraftTmarM U074___ *irwnntw6ny< 9 uors 1.1'OKMTMMytM 0041___ 2.Ocr<ofocxnoL UftM.-- Z,5-Ctah*gnjpftno1 1 J-Ocftmp*opn* U066-__ OtaoiMytaitm* (l.T) U054., 0047____ o phuatJiuruJHNeie Otatiyt phtfutata OttydroMfrota JJ-OBix^miymniAini DaiwViylaiiin* (I) 06<wuiytiiTwwafiattwfn 7.12^06M6flFy(b6ia|]*r>tf60W^ WlM uui ....... iioufrM Kioom Ui43,._..... Lmocarmm x Ui44...,, liadtciat*' 0145_____ L 0144_____ L 0147,......... MtMte arnytfwfc 0144._____ Maimc nydrvsM U140____ WVroitnt# MEK Pyomta w# OlOO UiSO____ U1S1___ M4nuv 015 Matnacryiowtnta 015 MatfwwM 0154.,___ 0155.____ Mtahapyrtona Matfiyl alcohol mUiS4 015 U1S7- 3 McarylchotaiHtaMM UKiyi cMorotarmoto 9*0 0154 4.4 Mwnyn &t<2<f*qfwtanl Mtahy* **0h4 (MtK) (1.T) 'Qnfc (R) IU138 Mtthyl oofcutyl katoio Mtfiyt mctfuoyra (RT) n Matnyi it nirn n mantnj^afrM Mtanytawmcl Mitsmym C 9m 0010 Napftttatan* 1,4-NaphthoQUttw 1-NaphthyiiiTWM 2-NaphtfVamno IUT) mo 0104 , t t rumwnytiywfun t .2-Qnihyys>mM 0*T**ff**m*o+r4r* 2.40m*tfyphnol 0(616^ pfttfUMtal 2.40n#o(o6j*n* 14-Qrmmkmm Qfrh-0d)4 oAMM t.iOan* u-cvxnytni^iiiw N-NitrradkH>ropytafflin6 N*NttO0WV4tfiy4#M N-Nrtro60^wnothy4otiono N-Nrtre*op*wtan6 N^Nffroaeoyrroitan# 5-Nlro-o-(oliJdfcio PiraKtaftyda PCN0 9MO154 t.^artadtana (I) Pwc soo 0210 PwUUuvtfpytaiM mo 0210 E9V r EttfyMMtMUOn rT23F*6aU335 UO14 m01m3?,-_---_--- indMMOZJ-UfrlyfM 0134TM 0140------ fl4---,, SMnwn ttitM* RT) S*fNMU233 04........ Stoptoiom 2.4.5-T Mt uza 07__ , 1J 04------- M*U 04___ 1 17 7 TjirirrtnfrwiiiiM IQ.. TaoMMoioMhano Tifraditaranytam -- 0410 11 TMochtoomotfufM U- a.3.4.4>T--rouauiuglinji 0313^--_ TottftyOnAfin (I) 0314_____ThadMik (>) 1 0315_____ ThlM(l)c 0214____ ThtAim (I) cMohdi U317,,, ThaMunKOfi 0211___ 0214___ 0221, I I i i \ 1 i CMA 062919 Federal Register / Vol. 45, No. 98 / Monday, May 19, 1980 / Rules and Regulations 33127 tMM tovNa Strfmanc*1 \J2Z3-------- To*jn* dtooeytratv 0224,,,, Toxapfww 2,4.5-TP m UZX3 U22Q-------- t.I.I-Tncrtcyothif U227,,-- ` uref-H-.... Trvrtovatfiytm M* U229 U22>_____ U230,-----UZM-------- 2,4,6-TtiLf4jW m* UZB-------- Z*3-TilLI*uoutwimyprogiQfic wij 1M. TncftoretotMitt ** U023 TPt-dENE am U22# ' UZ34-------- U23S-------- Trto2J^3nnoprapyO p*T**** U23G__ Trypn ttoa i uzyy--, Unci (TBstftd Ur*tfw Viny* cnonfe mm U043 Wiyfctoff ctoowdi -- U078 ' U239_____ Xytafw 1 Tb* Agancy tidWM ttoM trad* nwr* -* wtncfi it m'l, n vrrniirfm of * fiatm doaa net irnpty mat it m ' not hazuntom, Th* matanit hazarPeua t* * * totrt urvMr to gtrwic nam*. 1 Appendix I--Representative Sampling Methods The methods and equipment used for j sampling waste materials will vary with the form and consistency of the waste materials to be sampled. Samples ; collected using the sampling protocols jT listed below, for sampling waste with properties similar to the indicated materials, will be considered by the r-', Agency to be representative of the P' waste. , Extremely viscous liquid--ASTM Standard Dl40-70 Crushed or powdered material-- ASTM Standard D348-75 Soil or rock-like tmaterial--ASTM Standard D420-89 Soillike material--ASiM Standard Dl452-05 _ Fly Ash-like material--ASTM Standard D2234-78 [ASTM Standards are available -V* from ASTM, 1318 Race St, Philadelphia. y'~ PA 191031 Containerized liquid wastes--"COUWASA"-described in "Test Methods for the Evaluation of Solid Waste, Physical/ Vv. Chemical Methods," 1 US. Environmental ',,V ; Protection Agency. Office of Solid Waste, / - Washington, D.C. 20480. [Copies may be '.if * obtained from Solid Waste Information, UA. Environmental Protection Agency. 28 , J.~- W. St. Clair St, Cincinnati. Ohio 45288} 5/ Uquid waste in pits, ponds, lagoons, and ^V *knilar reservoirs.--"Pond Sampler" described in`Test Methods for the ."."t' Evaluation of Solid Waste, Physical/ i . Chemical Methods." * . This manual also contains additional V information on application of these - protocols. `a. 'These methods are also described in "Samplers nd Sampling Procedure* for Hszatdou* Wnite SOesms," EPA eOD/2-S0-01S, [anuiry loan Appendix D-- EP Toxicity Test Procedure A. Extraction Procedure (EP) 1. A representative sample of the waste to be tested (minimum size 100 grams) should be obtained using the methods specified in Appendix I or any other methods capable of yielding a representative sample within the meaning of Part 260. [For detailed guidance on conducting the various aspects of the EP see "Test Methods for the Evaluation of Solid Waste, Physical/ Chemical Methods," SW-848, U.S. Environmental Protection Agency Office of Solid Waste, Washington, D.C, 20460.'] 2. The sample should be separated into its component liquid and solid phases using the method described in "Separation Procedure" below. If the solid residue 1 obtained using this method totals less than 0.59S of the original weight of the waste, the residue can be discarded and the operator should treat the liquid phase as the extract and proceed immediately to Step 8. 3. The solid material obtained from the Separation Procedure should be evaluated for its particle size. If the solid material has a surface area per gram of material equal to, or greater than, 3,1 cm1 or passes through a 9.5 mm (0.375 inch] standard sieve, the operator should proceed to Step 4. if the surface area is smaller or the particle size larger than specified above, the solid material should be prepared for extraction by crushing, cutting or grinding the material so that it passes through a 9.5 mm (0.375 inch) sieve or, if the material is in a single piece, by subjecting the material to the "Structural Integrity Procedure" described below. 4. The solid material obtained in Step 3 should be weighed and placed in an extractor with 16 times its weight of deionized water. Do not allow the material to dry prior to weighing. For purposes of this test, an acceptable extractor is one which will impart sufficient agitation to the mixture to not only prevent stratification of the sample and extraction fluid but also insure that all sample surfaces are continously 1 Copie* may be obtained from Solid We*te Information. US. Environmental Protection Agency. 28 W. St Clair Street Cincinnati. Ohio 45ZSS. 'The percent jolida la determined by drying the filter pad at BO* C until it reache* constant weight and then calculating the percent solids uaing the following equation: (n*et* ot pad + soad) , (tax watgM o( pad) X 100 - N oM* mail mft ot wrote brought into contact with waJ .mixed extraction fluid. 5. After the solid material ar.d deionized water are placed :s the extractor, the operator should begin agitation and measure the pH of the solution in the extractor. If the pH is greater than 5.0. the pH of the solution should be decreased to 5.0 m 0.2 by adding 0.5 N acetic acid. If the pH is equal to or less than 5.0. no acetic add should be added. The pH of the solution should be monitored, as described below, during the course of the extraction and if the pH rises above 5.2. 0.5N acetic add should be added to bring the pH down to 5.0 O.Z However, in no event shall the aggregate amount of add added to the solution exceed 4 ml of acid per gram of solid. The mixture should be agitated for 24 hours and maintained at 20*--to* C (68*- 104* F) during this time. It is recommended that the operator monitor and adjust the pH during the course of the extraction with a device such as the Type 45-A pH Controller manufactured by Chemtrix. Inc, Hillsboro. Oregon 97123 or its equivalent, in conjunction with a metering pump and reservoir of 0.5N acetic add. If such a system is not available, the following manual procedure shall be employed: (a) A pH meter should be calibrated in accordance with the manufacturer's specifications. (b) The pH of the solution should be checked agd_ if necessary, 0.5N acetic add should be manually added to the extractor until the pH reaches 5.0 0.2. The pH of the solution should be adjusted at is. 30 and 80 minute intervals, moving to the next longer interval if the pH does not have to be adjusted more than 0-5N pH units. (c) The adjustment procedure should be continued for at least 6 hours. (d) If at the end of the 24-hour extraction period, the pH of the solution is not below 52 and the maximum amount of add [4 ml per gram of solids) has not been added, the pH should be adjusted to 5.0 m 02 and the extraction continued for an additional four hours, during which the pH should be adjusted at one hour intervals. 6. At the end of the 24 hour extraction period, deionized water should be added to the extractor in an amount determined by the following equation: V- [20J(W}--16(W)--A V w ml ill 'min il water to be added W weight in gram* of solid charged to extractor Aw ml of <L5N acetic acid added during extractitm 7. The material in the extractor should be separated into its component liquid and solid phases as described under "Separation Procedure." 8. The liquids resulting from Steps 2 and 7 should be combined. This Jr-; . AS:v '"-xv,Lt_kj' CMA 062920 QiCrttfeb Jzbiaiics J>enctie WASH INGTCJN, D.C. 10*10 Attachment 2 August 6, 1980 The Honorable Robert C. Byrd, Majority Leader The Honorable Howard H. Baker, Minority Leader United States Senate Washington, D.C. 20510 Dear Senators Byrd and Baker: The Senate Committee on Environment and Public Works has recently acted favorably on S. 1480, major legislation to deal with releases of hazardous substances. The reported bill contains some provisions of interest to other Committees. When those Committees have completed their consider ation or the issues have been otherwise resolved, we urge that S. 1480 be scheduled promptly for floor action. In our view, improper disposal of hazardous substances represents a serious threat to the public health of our nation's citizens. This legislation addresses the hazardous substances problem at a time when existing tools have proven inadequate. We therefore urge you to expedite full Senate consideration of this crucial health and environmental measure and to identify S. 1480 as one of the major legislative proposals which must be completed before the Congress adjourns for the elections. Your cooperation in this matter is appreciated. Sincerely, Carl Levin CMA 062921 2- CMA 062922 -3- ' ? ite&t George J. Mitchell Richard Scnweiker CMA 062923 Exhibit I August 1980 Expanded Company Involvement in ChemCAP Program And Formation of ChemCAP Community Committees Here's what you can do to get this program off the ground within your own company and in your local community: (1) Name a "ChemCAP Coordinator" and give him the responsibility and authority to implement relevant ChemCAP program segments within your company. Please notify CMA of your selection. (2) Set up a special ChemCAP involvement meeting with your company's top executives and communications staff to discuss company-wide action. If you wish to have a ChemCAP expert join this session to explain the program, the materials available and how to use them most effectively, telephone Jim Sites at CMA at (202) 328-4292. (3) Advise your corporate and local executives that they have your approval and support to participate in setting up ChemCAP Community Committees. Much has been written about company-wide communications concerning ChemCAP, as reflected in the ChemCAP "Guide to Program Materials" and CMA's "Checklist" of suggestions for individual company action. Emphasis here is placed on a new phase of local action -- the formation of a nationwide network of ChemCAP Community Committees. A ChemCAP Community Committee would be made up of local company managers and communications professionals and would be designed to tie in directly with and supplement the national communications effort in such tasks as ... (1) Placing speakers on local platforms (2) Distributing our "key issues" booklets to community leaders (3) Raising local funds and placing ChemCAP's national ads with leading local publications C4) Helping localize nationwide news stories and placing these with local news contacts CMA 062924 (5) Identifying prominent radio and TV interview possibilities for appearances by industry executives or members of our Science Advisory Group (6) Monitoring local news developments and informing CMA headquarters of developing problems and opportunities The CMA Communications Committee has chosen a number of chemical plant concentration areas for ChemCAP Community Committee pilot programs. Committee members and CMA staff are ready to visit these areas personally with the aim of building viable operating units. Wherever possible, they will work in cooperation with existing Chemical Industry Councils. Selected areas for possible pilots include... Charleston, w. Va. Chicago Delaware (Wilmington) Houston Michigan New Jersey New Orleans/Baton Rouge Parkersburg/Marietta, W. Va. Philadelphia San Francisco St. Louis Westchester/Fairfield Counties An action point: If you have plants in any of these areas, . it is-essential that you advise your management team and local executives that, when contacted by assigned local people, they have your approval and encouragement to participate in a ChemCAP Community Committee. And if you feel that other localities should be included in this initial pilot program, please let CMA know the city -- as well as the names of any local people you know who are willing to put real effort into organizing and operating a Committee. A list of CMA contacts for special ChemCAP program segments is also attached. -0O0- CMA EC-9/8/80 BD-9/9/30 CMA 062925 CMA Film "PROTECTING OUR ENVIRONMENT: What Five People Are Doing About It" I The 18-minute motion picture will focus on five individual chemical industry employees whose attitudes and actions exemplify people throughout the industry and who suggest to audiences that oheir own attitudes might benefit from some re-thinking. The indi viduals are specialists in the five ChemCA? concern areas: en vironmental protection, hazardous waste, worker safety, product safety and transportation safety The film... (a) Directly addresses public concerns (b) Humanizes the industry (c) Demonstrates the depth of industry action (d) Suggests to the audience that what they believe to be true as a result of media and government attack may not be so. II The 13H~minute version of the above motion picture is designed for public television and the growing cable TV market III The five 60-second public service films (designed for widespread TV spot use) will capsulize the film's five basic sequences, extending recognition of the five people and their activities until the public gets to know them. The 60-second films have a recurrent phrase that will carry forward in all print support materials. It addresses a concern and states... "...that's what I'm doing about it." IV Using the "What We're Doing About It" theme of the ChemCAP booklets, there will be a discussion/user guide. This will be an aid to the individual presenting the film helping assure that any discussion prompted by the film will generate positive answers to audience questions. V The films are designed to reach the broadest possible non-theatrical audience in the marketplace of ideas through clubs, groups, sem inars , the educational community and other arenas where the public convenes. The 18-minute version is also designed for intensive use by CMA member companies, with employees. It is particularly suited to showings that are followed by question-and-answer sessions. IV Distribution targets by film distribution services (first year): --200 prints (18-minute version): 4000 bookings; 400,000 audience --50 prints (133s-minute version) : 225 telecasts, to millions --300-500 prints of 18-minute version will be sold at nominal cost to CMA member companies , for both internal and external uses --Television and public service prints will be made available to member companies for personalized placement with local tele vision stations. CMA EC-9/8/80 BD-9/9/80 CMA 062926 cash oin^p CHART COMMUNICATIONS PROGRAM JUNE 1, 1900 - MAY 31, 1901 Program Segment Outlays 6/1/00- -to 6/1/80 - 9/1/80 ADVERTISING 674,357.00 845,570.00 Ad Exp. Level Test (400,000 budgeted - postponed) 9/1/8012/1/00 045,578.00 12/1/803/1/81 845,578.00 3/1/015/31/81 TOTAL TOTAL -6/80 - 5/01 1979 - 1901 845,579.00 3,382,313.00 4,056,670.00 PR Agency Public Opinion Research (tracking studies) 110,040.00 70,000.00 45,000.00 45,000.00 45,000.00 .75,000.00 45,000.00 180,000.00 75,000.00 290,040.00 145,000.00 Publications (4(Speakers Program) 90,382.00 65,000.00 35,000.00 35,000.ob 35,000.00 170,000.00 260,302.00 Films/AV Materials Industry/News Workshops 966.00 30,000.00 115,000.00 5,000.00 30,000.00 10,000.00 30,000.00 10,000.00 205,000.00 25,000.00 205,996.00 25,000.00 StafC Salaries/ Fringes 100,201.00 53,500.00 53,500.00 66,000.00 66,000.00 239,000.00 339,201.00 Mi sc. (travel, dues, te lephone, postage, supplies, rent, etc. ) 61,741.00 50,000.00 50,000.00 50,000.00 50,000.00 200,000.00 261,741.00 TOTAL ' $ 1)123,607 CMA EC-9/8/80 BD-9/9/80 1 ,089,070 1 ,149,078 1 ,156,570 1 ,001,579 4,476,313 5,600,000 CMA 062927 CMA Slide Presentation "The Chemical Industrv: MEETING THE CHALLENGE OF I KAN I-E" A 20-minute, 72-slide presentation, this new ChemCAP speaker's aid focuses on chemical industry action in managing risk in five concern areas: environment (air and water), hazardous waste, worker safety, product safety and transporting safety. Incorporating both photographs and artwork in 35mm color slides, the show tracks the over-all pattern speech included in the ChemCAP Speakers Resource Manual. It can be presented in two ways: 1) By a speaker articulating the script and operating the projector himself or having an assistant do so. 2) By using an included cassette tape recorded by a professional announcer that incorporates a pulse which automatically advances the projector. The presentation is designed for community groups, seminars, the educational community and other public meeting situations, as well as for employee audiences. The Public Relations contact person at each CMA member company will be provided at no charge with one set of slides, a pulsed tape, a script and an instructional guide. Additional sets of materials will be available at a cost of $15. The presentation can be followed with a question-and-answer session. With company involvement the key to success in the ChemCAP Program, intensive member use of this presentation is critical. It is designed expressly as a catalyst for triggering speaking engagements in every plant community in the country. CMA EC-9/8/80 BD-9/9/80 CMA 062928 Exhibit J RECOMMENDED CMA POLICY ON AN INTERAGENCY WORKING GROUP REPORT ON HAZARDOUS SUBSTANCES EXPORT POLICY A hazardous substances export policy developed by an Administration interagency Working Group proposes that an Executive Order be issued to accomplish the following: 1. Establish an inventory of banned or significantly restricted substances as determined under existing health and environmental laws. 2. Disseminate to foreign governments extensive information on the inventory list. 3. Establish an interagency review of the inventory list, determine those which are severe hazards and place them on a commodity control list. 4. Require validated export licenses for exportation of products on the commodity control list. Administration of the above provisions would be carried out as a component of U. S. foreign policy. The proposal covers drugs, medical devices, cosmetics, foods, pesticides, consumer products, and industrial chemicals approved for use in other countries, but not for use in the United States. This includes: 1. products approved for use in other countries to treat diseases or eradicate pests that do not exist in the United States. 2. new products which have been approved by other countries before completing the approval process in the United States. 3. products for which there is a difference of opinion as to Che safety of their use. CMA 062929 The CMA opposes the export banning provisions* Such exports are already adequately controlled under existing laws. Notification of countries receiving U. S. exports is acceptable, but only with the provisions for protection of information. The universe of substances contemplated by the HSEP cannot be made to conform to a single export policy evidenced in Congressional treatment in the existing laws. The HSEP would be an unnecessary export disincentive. The chemical industry with $17.3 billion of exports in 1979 (11.7% of total chemical sales, and 9.5% of all U. S. exports) is badly needed by the United States. The $9.8 billion dollars trade surplus is an important prop to the U. 3. trade deficit of $24.7 billion. The U. S. chemical industiy has an excellent reputation for quality and safety in its products. There is insufficient evidence presented by the Administration that this sweeping new regulatory process is needed. Creation of a new inventory list of products and a commodity control list will, in effect, become a blacklist to U. S. export customers. The new requirements will, at the very least, get exporters so embroiled in government approvals that sales will be lost to foreign competitors. Regulations still to be issued under some of the laws such as the Toxic Substances Control Act make the HSEP a potentially large inhibitor of chemical exports. There are doubts that the Export Administration Act sufficiently authorizes regulation of hazardous exports. Legal opinions are in hand to support this view. There is some possibility that if the Executive Order is issued, it would apply to exports of foreign subsidiaries and affilates of U. S. companies. Action Required: Approval. CMA EC - 9/8/80 BD - 9/9/80 CMA 062930 ADDITIONAL BACKGROUND INFORMATION ON RECOMMENDED CMA POLICY ON AN INTERAGENCY WORKING GROUP REPORT ON HAZARDOUS SUBSTANCES EXPORT POLICY On August 12, 1980, an Interagency Working Group published a draft report on a hazardous substances export policy (HSEP), presumably to be implemented by Executive Order, a draft of which has been informally circulated by the Administration. The CMA Export of Hazardous Substances Task Group and its parent, the International Trade Group, recommend opposition to the export banning provisions of the HSEP and the corresponding proposed Executive Order. The HSEP is designed to accomplish the following: 1. To establish an inventory of "banned or significantly restricted substances:, which by definition, is to include substances regulated under specified sections of the principle health and safety statutes including the Federal Insecticide, Fungicide and Rodenticide ~ Act; the Consumer Product Safety Act; the Food, Drug and Cosmetic Act; the Public Health Services Act; the Flammable Fabrics Act; the Hazardous Substances Act; and the Toxic Substances Control Act. 2. To disseminate to foreign governments certain information on these substances which will include, as a minimum, the names of the substances; summaries of the potential risks to human health, or safety, or to the environment that are grounds for the agencies actions. The policy also provides for the dissemination of "additional documents" deemed appropriate by the agency with jurisdiction. 3. To establish an inter-agency task force chaired by the State Department to review the inventory and recommend which of these substances, by virtue of severe hazard, should be relegated to the Commodity Control List. (Since the HSEP cites the Export Administration Act as authorizing legislation the CMA 062931 2- - StaCe Department must find that inclusion of a substance on the Commodity Control List "would further significantly the foreign policy of the United States".) Substances on the Commodity Control List will require validated export licenses from the Commerce Department for exportation. The State Department, under this provision can recommend that Commerce grant a license only if the export is consistent with U. S. foreign policy and the foreign country expresses no objections to its import. Scope of Products Affected Categories of substances covered by the HSEP are listed in Section VII of the published draft (45 FR 53764-8). The draft proposal covers drugs, medical devices, cosmetics, foods, pesticides, consumer products and industrial chemicals which have been approved for use in other countries, but not for use in the United States. It covers products approved for use in other countries to treat diseases or eradicate pests that do not exist in the United States, and thus their use may never be considered for approval here. The order also covers new products which have been approved by the regulatory agencies of other countries before having completed the approval process in the United States. It further covers products for which a legitimate difference of opinion exists among scientific experts around the world respecting their risks and benefits, e.g., the artificial sweetener, cyclamate, and the food coloring. Red Dye Number 2 which are both used extensively in other countries, but are not approved for use in the United States -- in effect, imposing its judgments respecting these matters on foreign governments. CMA Position Considering existing controls, economic disincentives, and questionable legal authority, CMA opposes the export banning provisions in the Administration's proposal. CMA, however, would accept a uniform notification scheme, provided it is properly constructed to prevent disclosure of information protected by statute, such as the protection provided under Section 10(g) of the Federal Insecticide, Fungicide and Rodenticide Act. The preferred outcome would be to have the HSEP dropped CMA 062932 -3- by the Administration. However, recent consultations with the U. S. Trade Representative's Office (Ambassador Robert Hormats) and the Commerce Department's Homer Moyer (Deputy General Counsel) have made it clear that these agencies feel obliged to go along with at least a notification plan. Further, legal arguments regarding the HSEP and its implementation under the EAA put a question only on the banning provisions. Lastly, it is the banning authority in HSEP that has provoked recent correspondence from members of Congress to the President pointing out that only the Congress has this authority, not the President. Existing Controls Exports of the substances addressed by the HSEP are already specifically controlled under the Federal Food, Drug, and Cosmetic Act (section 301, 505 and 801), the Consumer Product Safety Act (section 18), the Toxic Substances Control Act (section 12), the Federal Insecticide, Fungicide and Rodenticide Act (section 17), the Public Health Service Act (sections 262 and 263), and the Hazardous Substances Act (section 14). Most of these controls have been imposed by Congress since the mid-1970's and their emphasis on notification to the receiving country of the export of hazardous substances clearly reflects a congressional attitude that it is appropriate for countries to make their own judgments about their needs for hazardous substances, so long as they are adequately informed. Furthermore, because of the extensive U. S. effort within various international regulatory organizations, there is no need for the system proposed in the HSEP. The U. S., for example, already participates in a variety of international organizations which are presently establishing or already have established international controls over the import and export of chemical products. Such include the Organization for Economic Cooperation and Development; World Health Organization; Food and Agricultural Organization; Codex Alimentarius Commission; United Nations Environment Programme, and the Tri-Partitie Pesticide Agreement between the United States, the U. K., and Canada. Finally, the universe of substances contemplated by the HSEP cannot rationally be made to conform to any single export policy. Congress recognized this in shaping quite different regulatory and export policies to accomodate the widely differing circumstances associated with their handling and use. CMA 062933 -4- E c onomic Impac t Congress quite properly developed differing regulatory and export policies to meet the problems posed by these goods. Imposition of a new, blanket policy on top of existing laws and regulations constitutes a potentially sweeping and harmful change in national policy. The chemical industry is a leading exporter. Its $17.3 billion of exports in 1979 was 11.7% of total chemical sales and 9.5% of all U. S. exports. The chemical trade surplus of $9.8 billion was an important contribution to the U. S. trade deficit of $24.7 billion. The industry has an excellent repuuation around the world for the quality and safety of its products. Its customers are found in every country and corner of the world. While it is true that isolated instances of harmful effects from U. S. made products can be found, they do not come close to justifying the HSEP. Unilateral action by the U. S. will lose sales of perfectly safe products, if only from bureaucratic delay, that can be bought elsewhere. At the very least, the Administration should arrive at an international agreement applicable to other exporting countries before taking this drastic action. Unilateral U. S. action may be the easy way, but it is by no means an effective way. More specifically, CMA has the following concerns: 1. An inventory of chemicals is tantamount to a blacklist with customers, and results in all the attendant adverse effects. It offers the opportunity, if not the necessity, to broadly overemphasize whatever problem exists. 2. Embroiling chemical exports in another layer of red tape will further complicate the already serious logistical problems involved in transferring chemicals from point of origin to point of use. Foreign language requirements, letters of credit deadlines, cargo space, special warehousing needs, and government requirements for containers and labels are examples. 3. Pesticide sales to meet agricultural and disease control demands .are highly seasonal, and shipments cannot be delayed. In other non-agricultural cases, such as malaria or typhus outbreak, shipments are on a crisis basis. Timing is critical and bureaucratic CMA 062934 -5- delays in approving exportations could result in extensive crop losses, or human illness. As a result, foreign purchasers will turn to sources outside the U. S. who are more than willing to capture the business. 4. Existing law provides domestic manufacturers with a modicum of protection from government disclosure of their data to foreign manufacturers. The HSEP draft would undercut this protection and set the stage for piracy of American data by foreign producers who are in direct competition with American producers. We do not oppose data disclosure, provided restraint is exercised by the U. S. Government, and some control can be maintained by the owner of the data. 5. Contrary to the view expressed in the HSEP, the economic impact of this policy is unknown and virtually unknowable. This is illustrated by TSCA, whose sections embraced by the HSEP require data to implement. At this time there is little (no) section 4 test data available to trigger a rule. Thus the burden imposed by the HSEP because of TSCA is unknown. Questionable Legal Authority There are substantial doubts that the Export Administration Act (EAA) in fact authorizes regulation of hazardous exports. We are aware of two opinions from the Justice Department on the old EAA and its 1979 revision which state that the foreign policy language is broad enough to encompass the proposed action. However, in on*1 of these opinions the Justice Department enters a significant caveat about existing laws: "Certain statutes presently impose conditions on the export of hazardous substances (e.g., the Toxic Substances Control Act), requiring notice to the recipient nation of product risks. It may be that these statutes foreclose Presi dential discretion to take some actions, for example, banning a product that a statute allows to be exported if notice is given." (Opinion dated April 11, 1980 from Leon Ulman to Esther Peterson.) CMA 062935 6- - Morever, neither act has been used for the purpose of regulating the export of hazardous substances, and, indeed, the latest amendment was designed by Congress to reduce the amount of discretion of the Commerce Department and the President in withholding export licenses. The language of the statute appears rather to support the notion that the EAA is intended to be used as a punitive device, against countries like South Africa. It has been noted by the Chairman and Ranking Minority Member of the House Commerce Committee that the provisions of their laws governing the exports of certain products, supersede the foreign policy controls provisions of section 6 of the Export Administration Act which the draft Executive Order seeks to invoke to ban exports of those products. Section 17 (a) of the Export Administration Act specifically indicates its lack of effect on such laws as follows: "Nothing contained in this Act shall be construed to modify, repeal, supersede, or otherwise affect the provisions of any other laws authorizing control over exports of any commodity". The opinion of a private law firm is that the President does not have the authority to issue the Executive Order as proposed. However, if indeed such power is deemed to be within Presidential jurisdiction, this law firm's opinion is that the Executive Order would extend to foreign subsidiaries and affiliates of U. S. companies. This possibility has not been taken into account fully and must be subjected to full scrutiny before an Executive Order is issued. Action Required: None. Information only. CMA EC - 9/8/80 BD - 9/9/80 CMA 062936 Exhibit K Formation of Task Group on United Nations' Report on Transnational Corporations__ The United Nation's Centre on Transnational Corporation is preparing to write two reports on U* S. companies with investments in developing countries. The first is an overall report stressing the structure and characteristics of the TNC's. The second is to be a profile of five U. S. corporations: Celanese, DuPont, Dow, Union Carbide, and Monsanto. The outcome of these reports can be influential in how U. S. companies are treated in host countries. Experience with United Nation reports would indicate that negative reports are likely. U. S. investment in developing countries by any U. S. firm will be judged on the basis of the 5-company profile so that a number of CMA members will be affected by the reports. The five companies to be profiled have asked that CMA provide staff support for the early, critical phase of contacts with the United Nation staff. Time factors compel consideration of this issue at this meeting; however, necessary staffing regarding possible antitrust and other con cerns cannot be completed until the week of September 1st. Supplementary information will be presented at Pebble Beach. Action Required; Policy determination required. CMA EC-9/8/80 CMA 062937