Document kmG7gywrMVmKwY8EaKzEdDw90

a J INTRODUCTION O ne of che critical issues of the Corporation is the reduction in concern about the health effects of beryllium. Based on this charter, our Mission is to develop and lead the strategy to economically overcome major health effects and environmental issues surrounding the safe manufacture and use of beryllium. As a part of this mission, we participate in the legislative and regulatory process to assure an ongoing, affordable supply of beryllium to our governmental and commercial customer base. The health effects issue, particularly strong misunderstanding of the potential hazards of handling beryllium, permeates our business. Health and safety concerns are a major obstacle to the sale of beryllium (Critical Issue l.'o (l)). Critical Issue 3 calls for che reduction in beryllium health and safety concerns by: a. Overcoming negative market perception through education, communication, enhanced product price/performance balance; b. Managing regulatory threats and challenges; c. Reducing exposure in the workplace and resulting potential for liability; d. Enhancing diagnostic tools; and, e. Increasing our knowledge of C3D and related beryllium hazards. There are three disease entities which drive this critical issue: chronic beryllium disease (CBD), cancer caused by inhalation, and cancer caused by ingestion. Of these entities, CBD is the only real legitimate concern from an occupational disease standpoint. Nevertheless, the perceived threat of cancer affects our business probably more negatively than CBD. Our medical knowledge of the mechanisms controlling CBD has expanded widely in the past few years. Improved techniques have resulted in an earlier detection of the disease and a change in the diagnostic criteria. This has contributed to a significant increase in the num ber of cases diagnosed, placing significant financial pressure on the industry. On the other hand, we are confident that the increase in medical knowledge will reverse this trend in the long run. Tne perceived threat of cancer by either inhalation or ingestion of beryllium may have a greater negative impact than CBD. Within the past several months, three significant occurrences have contributed to a worsening of the situation: a. Researchers at the Inhalation Toxicology Research Institute (ITR I) discovered an increase in cancer in rats, rendering our position on the absence of good quality animal data no longer tenable; 3 F 0 0 10 9 0 5 b. The NIOSH paper which showed an increase in human cancer in 1 o f 7 beryllium plants will be published as a peer-reviewed article; and c. The International Association for Research in Cancer (IARC) will rew ork its beryllium document. None of these findings indicate any significant risk to the public either from the manufacture or the use of beryllium. Nevertheless, the perception affects us negatively in the market. Probably the greatest impact on our business is the non-existent threat of cancer by oral ingestion; the limited medical data show no evidence of cancer by this route. Nevertheless, we are regulated to a no observable adverse effects level (NOAEL) which is used to determine the limits for all water quality regulations. This very conservative m ethod of risk assessment drives drinking water and water quality standards, landfills, closures, permitting, etc. In dealing with these highly complex issues, our philosophy has been to gather and communicate the facts surrounding the health effects of beryllium. W here data do not presently exist, we are increasing the knowledge base. If advocacy doesn't succeed, especially with the regulatory agencies, we will pursue legal action, but as a last resort. In the case of CBD, our primary focus is on workforce protection throughout the industry. Our medical screening program is designed to detect the disease at the earliest possible stage. Epidemiological studies, coupled with medical screening, will help isolate those processes that are potentially high sources of disease, adding focus to our m dustriafhygiene programs. Medical research, sponsored by the Beryllium Industry Scientific Advisory Committee (BISAC), is already yielding significant knowledge of the origins and the mechanisms of the disease. It seems likely that we are w'el1 along the road of understanding, and, therefore, better controlling the incidence of the disease. We must continue to advocate our position with the authorities. Domestically, beryllium is regulated as a suspect carcinogen by all routes, while in Europe it is regulated by inhalation only. Again, our approach is to assure that the regulatory bodies on both continents have the best data available. Where data are lacking or inconclusive, we plan, on a focused basis, to fill these gaps. Particular pressure comes from the EEC, where advocacy is complicated by the highly bureaucratic regulatory process. We will concentrate in Germany, as well as in France and UK, where most of the regulatory pressure originates. . O f particular importance in the EEC is the Preparations Directive, which regulates any mixture containing >0.1 percent of a carcinogen as a carcinogen. This will be one of our main focal points for our advocacy in EC, attacking this concept for its lack of scientific basis. 2 BF 00 10 98 6 The BISAC will provide the scientific basis for our cancer strategy by: a. Breaking the iink, if possible, between animal and human experience; b. Determining the applicability of invicro testing to differentiate between product lines; c. Examining cancer risk assessment methodology; and, & Reviewing and recommending protocols for animal testing. Ultimately, given the nature of the data on the topic and current conditions in the workplace, we see'cancer as posing not a true medical threat, but rather a perceived threat, making the reai issue one of providing proper education. Therefore, we have formed a cancer strategy group which will deal wich the combined medical, legal, operational, and promotional aspects of beryllium as a suspect carcinogen. Beryllium as an ingestive, or oral, carcinogen drives all water quality issues domestically. Fundamentally, ail water quality regulations, nationally and locally, are derived from the oral risk assessment in the Integrated Risk Information System (IRIS). Recently, the Federal Drinking W ater Standard was promulgated on a reference dose basis derived from a NOAEL based on a single study (Schroeder and Michener). O ur approach is to gain acceptance of the more realistic Morgareidge studies which demonstrate a much higher NOAEL. Failing this, we will initiate further animal feeding studies. O ur primary approach is advocacy with the Agency; however, we have been forced by the timing to file an appeal in Federal District Court. Hopefully, we can avoid litigation by negodadon and advocacy. In a worst-case scenario beryllium could ultimately be classed as a human carcinogen, which might result in limited end use opportunities in consumer markets. Nevertheless, we only have to look at the nickel industry to know this isn't a "going out of business" scenario. We believe that the strategies which we have in place will allow us to manage our way through this critical issue. ASPECTS OP ENVIRONMENTAL, HEALTH i SAPETY ACTIVITIES . A. Environmental and healthregulation management B. Environmental compliance C. CBD D. Cancer E. Communication F. Employee health and safety protection G. Liability avoidance BF Q 0 I D 9 9 4 A. Environmental and Health Regulation Management 1. Strategy for avoiding unnecessa^ and restrictive regulations 2. Communication with various agencies who cither have o r would establish regulations which could affect our business, e.g., a. EPA b. OSHA c. NIOSH d. JARC 3. Participation on studies relating to beryllium health effects 4. Retaining and management of outside resources as needed to assist in conveying our positions to appropriate authorities ' ' B. Environmental Compliance 1. Strategy and plans for complying with all applicable EHS regulations 1 Audits 3. Education of plant management and other appropriate managers 4. Prioriuzauon of compliance activities 5. Capitai/cxpense budgets CBD Leadership 1. Leadership and oversight of medical research Z BISAC role and direction 3. Employee testing, e.g., BLIT 4. CBD policy Responsible STSQnfa) Hanes Hanes Hanes/Reg. Leg. Working Group BISAC Hanes/ Markham Hanes Kolanz Plant Management Kolanz Kolanz Operadons/r/H Plant Management BISAC Har.es/Powcrs Markham/HJR.. Ops Team/CBD Working Group Rrfgrcrx III. A. 3 III. B HI. B III. B HI. A UI. C 8 F 00 109 95 MEETING .SCHEDULE Beryllium 5H S Communications Steering Team January 6, 1993 March 30,1993 July 1,1993 " St. Clair - Sc. Clair - Sc, Clair Em plnYfffT Communications Team January 22, 1993 February 12, 1993 March 12, 1993 - St. Clair * St. Clair - St. Clair C u sto m er EHS Communications T&aill January 18,1993 March 9, 1993 - St. Clan S t Clair Refuiacorv/Legislative H H S Communications .T&am January 21, 1993 M arch 18, 1993 - S t Clan- S t Clair BI.SAQ January 11-12,1993 April 7-8, 1993 July 7-8, 1993 O ctober 4-5, 1993 - Key West - Washington, DC - Elmore - Denver