Chapter: Ethical and legal aspects of biological monitoring
Jean Grassman, Health and Nutrition Sciences, Brooklyn College-CUNY, Brooklyn, New York
Book: Biological Monitoring Guideline
Editor, Shane Que Hee, Department of Environmental Sciences, School of Public Health, UCLA, Los Angeles, CA
American Industrial Hygiene Association Press
February 16, 2004
8.1 Ethical and Legal Aspects of Biological Monitoring
8.2.1 Introduction
Biological monitoring creates both ethical and legal challenges for the industrial hygienist 28,29. You may oversee the collection of human blood or waste samples, activities that are usually associated with medical diagnostics28. Yet, if all potentially exposed employees participate in the biological monitoring program, you will acquire information about inadvertent dermal exposures and unanticipated failures in controls30. This knowledge will make it possible to improve controls and reduce the risk of adverse health effects.
From the employee’s point of view, biological monitoring outside of a strictly medical setting often provokes anxiety. Workers may not be comfortable providing blood samples. They may worry that their tissues may be sampled for illicit drugs rather than to confirm specified workplace exposures. They may have concerns that their ability to obtain health insurance may be affected after being found highly exposed. Regulations like the Lead Standard3 provide basic protections such as requiring that employees will not be financially penalized for medical removal. However, even the best regulatory standard does not fully protect employees from negative outcomes when they participate in biological monitoring. Therefore, protections guided by the principles of ethical conduct are needed. Adherence to ethical conduct will ultimately make the industrial hygienist’s task easier.
The scope of this discussion is limited to human biomarkers of exposure and biomarkers of effect that are being used as part of routine industrial hygiene programs. This discussion does not address the ethical or legal issues associated with the use of biomarkers in molecular epidemiological studies31. Research contexts may use either validated or experimental biomarkers to study disease processes. These research programs generally differ from routine biological monitoring because the biomarkers may not be validated, medical removal is not an issue, and the presence of external funding makes it less likely that the biological monitoring activity will compete with other industrial hygiene activities. This discussion also does not address biomarkers of susceptibility (genetic testing) that measure either genetic or functional variations that affect the metabolism of toxicants or predispose an individual to disease31. The importance of the legal, ethical, and social implications of genetic testing is acknowledged. However, genetic testing is predominantly aimed at testing the suitability of the employee for work. In contrast, the biomarkers of exposure and biomarkers of effect discussed below reflect the impact of the workplace upon the employee.
8.2.2 Ethical and Legal Basics
Ethics is defined here as “the discipline of the conduct of a person or the members of a profession dealing with what is good and bad and with moral duty and obligation” (Merriam Webster Dictionary).
The ethical principles presented here are based on the conventional medical ethics developed to administer medical tests28.
They include:
● Autonomy (the right to refuse a test in a voluntary program);
● Right to have notification of results;
● Right to confidentiality;
● Right to equity/lack of harm.
These principles provide general guidance that can be expanded and adapted for biological monitoring. In particular, biological monitoring may challenge the principles of equity and lack of harm in ways that are distinctly different from those encountered with medical testing. For instance, critics have warned that biological monitoring uses employees as sampling devices (“guinea pigs”). They are concerned that biological monitoring may compete or replace other activities, such as air area monitoring and prevention-control activities. An ethically designed biological monitoring program would recognize situations where there is a potential for employee harm and appropriately use biological monitoring to provide additional information rather than supplant other important industrial hygiene activities. However in some cases, biological monitoring may be the only avenue to assess whether an exposure situation is in control or not, for example, blood lead or blood/urine cadmium concentrations when PPE are worn, or when skin absorption is the dominant exposure route.
The legal guidelines for biological monitoring will be mentioned, but for compliance purposes the hygienist is referred to the regulatory standard. Direct OSHA oversight of biological monitoring is limited to three chemical specific standards (cadmium 29 CFR 1910.10274; lead 29 CFR 1910.10253, and benzene 19 CFR 1910.10282) and the rules regarding access to exposure and medical records (29 CFR 1910.1020) 6. OSHA also provides non-mandatory biological monitoring guidelines for a number of chemicals including mercury and vinyl chloride (see Section 8.1.3.2 and Tables 8-3 and 8-4). Depending on the standard, there may be provisions for confidentiality, notification of individual results, controlled access, and medical removal without penalty.
The American Disabilities (ADA), administered by the Equal Employment Opportunities Commission (EEOC), gives civil rights protections to individuals with disabilities similar to those provided on the basis of race, color, sex, national origin, age, and religion. A recent court case is pertinent to the use of medical screening and possibly, biological monitoring. In Chevron U.S.A. Inc. v. Echazabal (2002 DJDAR 6379 (06/10/02)), a California was employed by a maintenance contractor in a coker unit since 1972. The worker, Mario Echazabal, applied for a full-time position in Chevron in 1992 but failed Chevron’s medical examination on the basis of high liver enzymes that indicated the liver ailment would be aggravated by continued exposure to coker toxins. Echazabal continued to work at the maintenance position, but was found to have had liver damage from past hepatitis C infection. He again applied for a full-time position in 1995, and was rejected again since he still had high liver enzymes. Furthermore Chevron asked the maintenance company to remove Echazabal to a safer job that did not involve exposure to coking unit solvents, or to remove him from the refinery altogether. To make matters more complicated, the EEOC had issued a regulation (29 CFR U 1630.15(b)(2)(2001)) stating that a threat to oneself would be a reason for disqualifying someone from a job. By this guideline, Chevron could refuse to hire Echazabal. In addition, California Labor Code, Sections 6402, 6403, and 6423, also forbids any workplace that “is not safe and healthful”, and states that the employer must not “permit” an employee to work in such a place. Furthermore, a “serious” violation (defined as a risk to life) is a crime under this California Labor Code. After being laid off in 1996, Echazabal sued on the basis of the violation of the provisions of the ADA, with the result that the district court ruled in favor of Chevron. On appeal, the Ninth Circuit Court of Appeals in a split decision ruled that an employee with a medical condition can not be excluded from the workplace even if continued employment placed his or her health at risk. The Supreme Court appeal was decided in June 2002 by reversing the Ninth Circuit Court of Appeals decision on the basis that the ADA does not only cover a potential employee’s “threat to others in the workplace” but also “for risks to the potential employee’s own health and safety as well.” The precursor to ADA, the Rehabilitation Act of 1973, recognized an employer’s right to consider threats to self and others as grounds for denying employment. Although the ADA does not specifically mention “threat to self”, the policies of the EEOC do include such directives. Chevron had also argued that the refusal was reasonable because the company had an interest in avoiding time lost to sickness, excessive turnover from medical retirement or death, litigation under state tort law, and risk of violating OSHA. The Supreme Court rejected the charge that Chevron had reacted in a “paternalistic manner.” However the Supreme Court did ask the Ninth Circuit Court to consider whether or not Chevron engaged in the type of individualized medical assessment required by ADA in order for a “direct threat” argument to be used as justification for not hiring a potential employee.
On remand, in July 2003, the Ninth Circuit Court ruled against Chevron saying that there was not adequate evidence to conclude that Echazabel’s medical condition posed a significant hazard to his health and safety and therefore there was no basis for the “direct-threat” decision. They rejected the “direct threat” argument primarily be Chevron failed to perform “individual assessment”. It was concluded that the assessment of Echazabel’s liver enzymes by Chevron’s physicians was not adequate evidence of future risk to himself. Rather, the evidence of “direct threat” would need to be based on an assessment of liver function or toxicity by specialists. This revives the case which can once again be taken up by the Supreme Court if Mr. Echazabel chooses to do so.
This outcome of this case may serve as a precedent for potential employees with high body burdens of toxicants who wish to work at a job where there was the likelihood of further exposure. The lead and cadmium standards prevent the continued working of the over-exposed employee who claim the protection of ADA since the criteria for Mandatory Medical Removal are the objective levels of lead or cadmium in blood. However, in general the case for use of data for biological monitoring markers of dose or effect in a similar manner has not been legally tested. There is concern that should the “direct threat” argument be established as a precedent, employers could use biological hiring results in hiring and job assignment situations.
Before discussing the guidelines for performing ethical and legal biological monitoring, OSHA’s classification scheme for biological monitoring activities should be clarified. OSHA considers biological monitoring results as either exposure records or medical records depending on whether the chemical or its effects are being measured. Biological monitoring results that are considered medical records have a greater degree of confidentiality and more stringent requirements for access by individuals other than the employee than is the case for exposure records. According to OSHA, “biological monitoring results which directly assess the absorption of a toxic substance or harmful physical agent by body systems (e.g., the level of a chemical in the blood, urine, breath, hair, fingernails, etc) but not including results which assess the biological effect of a substance or agent or which assess an employee’s use of alcohol or drugs” are considered to be exposure records. In contrast, biological monitoring for biomarkers of effect is considered to be medical records, which are “the results of medical examinations (pre-employment, preassignment, periodic, or episodic) and laboratory tests (including chest and other X-ray examinations) taken for the purpose of establishing a baseline or detecting occupational illnesses, and all biological monitoring that is not defined as an “employee exposure record”.” Mandatory medical removal at designated blood concentrations of lead and cadmium cause these records to become medical records, so that the classification is not as clear cut as it seems. However, it is clear that the exposure records of workers who do not suffer medical removal are not medical records.
8.2.3 Ethical and Legal Considerations for Implementing Biological Monitoring
The process of biological monitoring can be divided into the ethical and legal considerations encountered before, during and after performing the biological monitoring. Throughout the process, steps should be taken to ensure equity and lack of harm among those participating in the program.
8.2.3.1 Before Biological Monitoring
● Develop an industrial hygiene program that ensures the ethical treatment of employees.
Ethical conflicts arise when industrial hygiene programs rely solely upon biological monitoring rather than integrating biological monitoring into a comprehensive program of evaluation and controls. When biological monitoring is used in place of environmental monitoring, hazardous conditions will be detected only by overexposing employees. The problem of over reliance upon biological monitoring is compounded when financial resources for a comprehensive industrial hygiene program are scarce or unavailable.
Industrial hygiene programs should be designed to accomplish the following29:
■ Whereever possible, environmental monitoring should be the principal mode of assessment with biological monitoring as the secondary indicator of failures in control.
■ The biological monitoring program should not divert resources from other industrial hygiene activities which reduce toxicants through engineering or other controls, that is, it should be cost-effective.
● Choose biological monitoring tests that are accurate, reliable and have high predictive values30
Biological monitoring tests that meet these requirements constitute a good use of resources by the employer and help employees by informing them about the magnitude and circumstances of their exposures. See Sections 6 and Appendix I for more details.
● Employees should have the right to choose whether or not to participate.
Although it is beneficial to have the participation of all workers, they may be reluctant to participate because of personal, cultural, or religious reasons. Employees who choose not to participate should not be identified or penalized. Continuation of employment or job access should not be contingent upon participation in the biological monitoring program. Employers have made participation in biological monitoring programs a condition of employment, a practice that may be legal but is not ethical.
● Informed consent
Employers should inform employees in writing about the risks and benefits of any planned biological monitoring. Some employers have Institutional Review Boards to manage informed consent. The informed consent should convey:
■ That participation is voluntary (this assumes that the requirement for autonomy is fulfilled);
■ The chemical(s) that will be measured;
■ The media in which the agents will be collected (exhaled air, blood, urine, etc);
■ Risks associated with the biological sampling;
■ A summary of how results will be reported (individual vs aggregate and the times the reports will be issued);
■ The benefits and disadvantages of the planned sampling to the worker
Some examples of Informed Consent Forms are provided in Appendix V.
8.2.3.2 Performing Biological Monitoring
Biological monitoring should be performed using the least invasive method possiblen 29,30. The biological material collected from the worker should be analyzed only for the chemicals for which the employee was informed. Biological monitoring analysis for additional substances, such as drugs or other chemicals about which the employee was not informed, should not be performed. Doing so will damage employee trust and undermine the biological monitoring program. See Sections 7.1 through 7.6 for more details on how to do sampling for specific biological materials.