Legal Issues in Ecogenetics

1
Legal Issues in Ecogenetics

• PHC 6921
• Carmel Joseph

2
Discussion Points

• Introduction
• Genetic susceptibility testing
• Role of science and law
• Legal issues
• Genetic susceptibility testing in the workplace
• Incentives and limits to testing at the workplace
• Conclusion

3
Introduction

• Using genomic technology to identify individuals
  with increased susceptibility to environmentally
  induced diseases potentially minimizes risk of
  adverse health outcomes however, it raises
  concern of the legal issues involved which have
  yet to be addressed by the courts or legislative
  and regulatory bodies to protect the rights of
  those tested while promoting health and safety.

4
Role of Science and Law in Genetic Susceptibility
Testing

• Predictive genetic testing offers the potential
  for improvements in environmental health and
  safety. Tension exists between the potential for
  health benefit and the risk of premature
  applications of genetic tests with uncertain or
  limited predictive value or disease onset.

5
Role of Science and Law in Genetic Susceptibility
Testing, cont.

• It is anticipated that the law will increasingly
  be used as a tool to define socially acceptable
  practices in the development and application of
  environmental genomics, especially in genetics
  susceptability testing. The current state of
  scientific evidence surrounding predictive
  genetic tests militates in favor of a cautious
  approach to clinical, and occupational
  applications.

6
Genetic Susceptability Testing Relevant Legal
Issues
The law can set standards and prevent misuse of
technology by use of

• Federal or state laws and regulations
• Guidelines administered through various federal
  and state bodies (NIOSH, OSHA)
• The courts

7
Genetic Susceptability Testing Relevant Legal
Issues, cont.
The law can also act retrospectively to redress
injuries, through administrative or statutory
enforcement or review through application to the
judicial system.
8
Genetic Susceptability Testing Publicly Funded
Research
Title 45, Part 46 of the U.S. Code of Federal
Regulations specify that publicly funded research
undergo prior, independent ethics review by a
human subjects review committee (IRB) before
enrolling human subjects. The regulations
mandate review and approval to minimize risk and
to strike a balance between risk and benefit,
including risk to privacy and confidentiality.
9
Genetic Susceptability Testing Privately Funded
Research
Privately funded research, such as industry
supported research conducted by a private
consulting company, does not fall within the
jurisdiction of federal oversight and regulation.
Some states have similar legal requirements that
apply to all research conducted within a state.
Private companies are legally responsible for
notifying the EPA of adverse effects of chemical
exposures revealed in studies.
10
Genetic Susceptability Testing Privately Funded
Research, cont.
The APHA (1948-present) is in support of
institutional review of privately funded research
in occupational health and safety because of
concerns the adequacy of worker protections.
11
Genetic Susceptability Testing Legal Protections
There are no explicit legal protections for human
subjects in the federal regulations specifically
applicable to genetics research or research
conducted in the occupational setting. In the
meantime, the IRB assesses compliance with
regulatory protection on a case-by-case basis.
12
Genetic Susceptability TestingLegal
Protections, cont.
The IRB evaluates measures to preserve
confidentiality to prevent genetic discrimination
(by employer or insurer). The NIH issues a
certificate of confidentiality to protect
identifiable research data from disclosure in a
legal proceeding. Additional protections for
research participants address special populations
deemed to be vulnerable, including children,
prisoners, and pregnant women. Additional
protection has been advocated for current and
former workers from employers and unions.
13
Genetic Susceptability TestingCommercialization
Government regulation and oversight of genetic
tests is limited. As they move from the research
arena to the marketplace, test kits must undergo
premarket and, in some cases, postmarket
evaluation for safety and effectiveness. Although
the FDA is authorized to require premarket and
postmarket testing, it has chosen not to enforce
this requirement for genetic tests that are
manufactured by a laboratory for in-house use.
14
Genetic Susceptability TestingCommercialization,
cont.
The Clinical Laboratory Improvement Act (CLIA) of
1988 provides another potential source of
regulation by overseeing the proficiency of the
laboratories authorized to perform genetic tests.
It has yet to recognize genetics as a specific
laboratory specialty. State regulation of
laboratories performing genetic tests varies,
but, with the exception of New York, does not
provide more stringent oversight of genetic tests
than the federal government.
15
Genetic Susceptability Testing General Issues
Legal issues involving genetic testing usually
pertains to the application of susceptible
testing for occupational screening programs,
public health programs, or individual efforts for
health promotion and protection. Results of
genetic testing brings concern of discrimination
as related to employment, health insurance, life,
disability and long-term care insurance. State
and federal government have passed genetic
antidiscrimination legislation limiting access to
and use of genetic information by insurers and
employers.
16
National Human Genome Research Institute (NHGRI)
Policy and Legislation Database

• The State of Florida currently has state laws and
  statutes in the following areas of genetic
  testing and research
• Genetic Testing and Counseling
• Employment/Insurance Discrimination
• Employment/Insurance Discrimination, Genetic
  Testing and Counseling
• Nonmedical Applications (Adoption)
• Informed Consent, Privacy of Genetic Information
  
• http//www.genome.gov/PolicyEthics/LegDatabase/pub
  search.cfmm

17
Genetic Susceptability Testing in the Workplace
Employer interest in genetic testing is seen as a
mechanism for protecting workers, improving
productivity, reducing liability exposure, and
minimizing expenses for employee healthcare.
Workers, however, express concern about genetic
testing and implications of job dislocation,
health insurance, workers compensation programs,
and efforts to reduce hazards.
18
Genetic Susceptability Testing in the Workplace,
cont.
State laws governing workers compensation plans
provide an incentive for employers to use genetic
screening tests for employee safety. Since
workers compensation is state mandated,
employers are required to provide compensation
and medical coverage to workers who suffer
injuries or illness resulting form their job.
At least one state, California, has addressed
this issue in the context of pesticide workers
who are exposed to the pesticide chlorpryifos.
Californias mandatory biomonitoring program for
agricultural workers provides worker compensation
benefits for those workers who decide to stay on
the job during work release, when biomonitoring
results show toxic levels of exposure.
19
Limits to Genetic Susceptability Testing in the
Workplace
Title VII of the Civil Rights Act prohibits
discrimination on the basis of race, ethnicity,
gender, or religion. In Norman Bloodsaw v.
Lawrence Berkeley Laboratory, 135 F.2d 1260 (9th
Cir. 1998), the 9th Circuit Court of Appeals
concluded that this federal law prohibits
workplace genetic testing that has a disparate
impact on a protected group, when it is performed
without the employees knowledge or consent. To
successfully defend a Title VII claim, an
employer must show that the genetic testing
program is job-related and a business necessity.
20
Limits to Genetic Susceptability Testing in the
Workplace, cont.
The Americans with Disabilities Act (ADA)
regulates the circumstances in which employers
can pursue medical screening and monitoring,
including genetic testing.
21
Limits to Genetic Susceptability Testing in the
Workplace, cont.
The ADA divides the employment process into three
stages Application Employers cannot make any
inquiries regarding a prospective employees
health or medical history and cannot require any
medical screening. Conditional offer Employers
can require medical screening and can be as
comprehensive as employers deems necessary (not
limited to job-related conditions, and can
include genetic testing). Information obtained
cannot be used to discriminate in job placement
or benefits unless the action is job-related or
dictated by business necessity. Employed ADA
does not permit genetic testing of existing
employees unless the testing is directly related
to the employees qualifications to complete the
job, is necessary for employee safety, is
dictated by business necessity, or is voluntary.
22
Limits to Genetic Susceptability Testing in the
Workplace, cont.
In February 2000, President Clinton issued an
Executive Order that generally prohibits federal
employers from requiring or requesting genetic
tests as a condition of a workers being hired or
receiving benefits (DOL Feb. 8, 2000). It also
exempts federal employers from requesting or
requiring employees to undergo genetic tests to
evaluate their ability to perform a job. The
scope of the Executive Order has yet to be tested
in the courts, however, 30 states (including
Florida) have laws prohibiting genetic
discrimination in employment.
23
Limits to Genetic Susceptability Testing in the
Workplace, cont.
The ADA, the Rehabilitation Act of 1972, the
Executive Order, HIPAA (Health Insurance
Portability and Accountability Act), privacy
regulations, and various state genetic privacy
and nondiscrimination laws contain provisions
intended to protect the confidentiality of
employees genetic information.
24
Conclusion
Testing capabilities for biomarkers and genetic
susceptibility tests are still in the development
stages, however, the regulation of laws and
statutes are necessary to protect the rights and
reduce the risk of those tested. Creating a legal
framework at the federal and state levels will
help minimize the social harms resulting from
genetic susceptibility testing.