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by Prof. Feitshans:      BRAC Statement   |  Lessons Learned  |  Reproductive Health at Work
Reproduced for this website by permission. Copyright  Ilise L. Feitshans ALL RIGHTS RESERVED

Prof. Ilise L. Feitshans, JD and ScM
Health International
107 Centre Street, Haddonfield New Jersey USA 08033
Fax/phones 856 428-0605 FAX- 856 428 4198
Email [email protected]

TESTIMONY IN SUPPORT OF THE CHRONIC
BERYLLIUM DISEASE PREVENTION PROGRAM


Office of Environment, Safety and Health, Department of Energy
Proposed Rulemaking and Public Hearings.

To: Jacqueline Rogers, US Department of Energy US Dept of Energy
Office of Environment, Safety and Health EH-51
Docket Number EHRM-98-BRYLM
1000 Independence Ave NW Wash DC 20585

Comments concerning: The Value of Early Detection from the Ethical and Legal Standpoint of Workers at High-risk for Chronic Beryllium Disease (CBD)

Based on the Presentation: "Ethical and Legal Issues raised By Lymphocyte Proliferation Testing (LPT) Among Previously-Exposed Beryllium Workers" at the Request of the Secretary of Energy for the Beryllium Rulemaking Advisory Committee (BRAC)Washington, D.C. Sept. 30, 1997.

Prepared by: Ilise L. Feitshans, JD and ScM (BRAC Member) at the request US DOE


     My name is Prof. Ilise Feitshans and I currently serve as Legal Advisor to the WHO/RAMS Committee of Experts on Reproductive Health at Work and Adjunct Faculty at Cornell University School of Industrial and LaborRelations (NYS-SILR) and author, BRINGING HEALTH TO WORK, the Emalyn Press, 1997. Since 1997  I have served on the International Commission on Occupational Health (ICOH); I also am Former Acting Director, Legislative Drafting Research Fund, Columbia University School of Law; Expert on International Health Law and Womens' Health Law to the Global Alliance for Womens' Health, having represented GAWH at the UN Fourth World Conference on Women NGO Forum Author, DESIGNING AN EFFECTIVE OSHA COMPLIANCE PROGRAM (1993 and Supplements) and Editor-in-Chief, Occupational Safety and Health Law, (Cumulative Supplement 1995); Chapter Author, in the United Nation's International Labor Organization Encyclopaedia of Occupational Health and Safety, 4th Edition & OSHA Editor of the CORPORATE CONDUCT QUARTERLY and Editorial Advisory Board Member, COMPLIANCE MAGAZINE.

     I am here today in my capacity as a Member of the Beryllium Rulemaking Advisory Committee (BRAC) which was convened in 1997 to grapple with some of the difficult legal, ethical and scientific issues caused by long-term exposure to beryllium in the workplace. As noted in 63 FR 66942 No 232 Thursday Dec 3, 1998, "The BRAC which consisted of a diverse set of stakeholders and recognized experts from DOE, other federal agencies industry, labor, medicine, and academia, generated a set of recommendations for consideration in the development of a rule".

     BRAC studied uncertain scientific questions and the hard policy choices to be made in guiding an even-handed policy that promotes worker health in light of the undisputed need to (1) minimize the number of workers exposed to beryllium; (2) minimize exposures; (3) establish medical surveillance and (4) assist affected workers who are dealing with beryllium health effects.

     In its deliberations, BRAC heard testimony from a vast variety of experts and also from injured workers who suffer from CBD and their families, who live with the fallout of their breadwinner's occupational illness. I was asked to provide a short presentation that considered, "Ethical and Legal Issues raised By Lymphocyte Proliferation Testing (LPT) Among Previously-Exposed Beryllium Workers". I examined several aspects of liability, the inadequacies of the workers' compensation system in addressing illness such as Chronic Beryllium Disease that had a latency period which outlasted the statute of limitations in several states, such as Ohio and Tennessee; the fact that beryllium sensitization as determined by LPT could render a person "disabled" for the purposes of the Americans With Disabilities Act (ADA) (which protects individuals with sub-clinical illness and prohibits discrimination against people who have a disease that is not "manifest") but that such sensitized individuals had difficulty obtaining the expensive necessary medical care, medical monitoring and related treatments, if any .

     Lastly, I reported to BRAC that these problems raised major issues of equity and fairness regarding past and present employees; questions of future liability and disclosure of risk to future employees. Given the patriotic nature of the work performed by this special class of employees, who in their testimony before BRAC continually emphasized that they were the unseen casualties of our nation's winning the Cold War through nuclear superiority, the complex issues of disclosure (both in the past, when information was classified and therefore secrecy was matter of national security and for future employees, who do not yet have the benefit of scientific understanding CBD's natural history) I recommended that there be some mechanism for retrospective compensation for former employees, with positive incentives for compliance extended to employers within the DOE Complex for medical monitoring and related medical surveillance programs for present and future employees. This was consistent also, with the main thrust of our Committee's charge under law and the consensus among our 33 members (of which I was the sole voting woman, once our Chair resigned).

     The history and law of informed consent regarding new or uncertain medical testing bears witness to the notion that sometimes legal and ethical issues are distinct, but in this situation they are not insofar as "sensitization" has occurred among those workers whose body is adversely affected after beryllium specific lymphocyte proliferation testing has demonstrated an individual's immune response to beryllium exposure. From the standpoint of occupational safety and health policies regarding past, present and future beryllium exposure, the ethical and legal issues are inextricably linked. For this reason, the proposed rule has adopted a wise path by embracing medical surveillance programs for Former Employees as well as current employees and by requiring baseline data and periodic medical evaluations.

     BRAC was persuaded that confounding variables such as inadequate data and the effect of genetic predisposition made it difficult, if not impossible to resolve issues regarding thresholds and margins of safety for exposed beryllium workers. For this reason, each of the components of the medical surveillance program outlined in the Propped Rule is necessary and appropriate and consistent with BRAC's findings.

     The proposed rule as published in the Federal Reigister correctly reflects BRAC's concern that workers have access to sound, on-going medical information, and the opportunity to have counseling regarding complex decisions about their future treatment, when making available Lymphocyte Proliferation Testing, in light of individual risks (past, present or future exposure), predictive value of the test and benefits to the employee of having such information.

     Ethical concerns about balancing cost- benefits of testing, the availability and accessibility of reliable testing that has a good predictive value; employee (or former employee) right to know information; the rights and consequences of not knowing such information; informed consent and future obligations to provide medical care and follow-up can be examined from the standpoint of the past, present and future exposures were also discussed in our meetings.

     The informational requirements and the detailed components of the medical surveillance program in the Proposed rule therefore constitute a good faith effort to incorporate the Best Practices into a flexible regulatory framework, to provide workers with needed information, and to embrace new preventive medical technologies as they emerge. Specifically, the approach requiring a written medical surveillance plan, medical removal protections, and counseling regarding the appropriateness, potential consequences, benefits and related information regarding LPT is a crucial linchpin to providing the beryllium exposed population with choices and relevant information to make intelligent life-saving decisions regarding the risks associated with their work and future medical testing and treatment.

     Although BRAC no longer is in existence, I am here to testify to the fact that there was a consensus among BRAC Members that the we have some moral, ethical or legal obligation to provide people with testing (free of charge or at low cost) to compensate for the failure to provide adequate information at the time that they were placed at risk of beryllium exposure. BRAC examined questions such as: If an LPT result is positive, should there be a second opinion? Follow-up treatment? Medical surveillance and special exposure monitoring? What is the scope of such coverage for present employees? Who pays for such medical protections? And, If there is an implicit effect on the employee's insurability (i.e. that medical coverage may be denied) is there a duty to inform employees of this possible consequence? Is that enough for an employee who also has past exposure? Is there some duty on the part of US DOE or a facility operator to attempt to ensure coverage for this class of employees, thorough negotiation with the insurer or through legislation? Can this class of workers have adequate protection, regardless whether they have a negative LPT? BRAC recommended that there be some requirement for pre-test or post test counseling, with some attention to established notions of informed consent.

     The USDOE's proposed rule correctly recognizes also, consistent with BRAC's recommendations, that there is some duty to disclose information (without giving names) about people who took the test and how it impacted upon their work and their lives? For this reason, the Department realizes that some workers may elect not to participate in the medical surveillance program, "because they may believe that a diagnosis of CBD ... could have a negative impact on future employment opportunities or on their health insurance, thereby impeding participation in even the best of well-intended programs. Outreach programs are also an important part of this approach and will save many lives from needless suffering by providing greater access to appropriate medical care.

     In conclusion, The US Department of Energy is to be commended for attempting to reduce harm and minimize risks to workers who have potential exposures to Chronic Beryllium Disease, even if, in the case of some workers and their families this action is belated. This rule represents an important recognition of a latent, salient problem in occupational health; a Rule that can serve as a model to inspire other agencies to protect their employees. A Rule that will also honor the hard work of people whose health may have been compromised in the patriotic endeavor of protecting Our Nation through the peaceful manufacture, transport and storage of nuclear weapons; it will save lives and it will serve as a model for excellent health protections in other areas of occupational health in the future.

     This proposed rule therefore should be brought to fruition as a final regulation

     Thank you for your attention.

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