Spider Silk Jeans or Spider Silk Genes?

The Future of Genetic Testing in the Workplace

Presentation for Yale Medical School
Occupational and Environmental Health
October 24 2000
by Prof. Ilise L. Feitshans JD and ScM
Adjunct Faculty Cornell University ILR and
THE George Washington University
107 Centre Street Haddonfield NJ USA 08033
856 428 0605 FAX 856 428 4198
ilf2@cornell.edu Or ilise@prodigy.net

Introduction:
When I was driving home one afternoon in August 2000, I heard for the first time about spider silk
genes. It=s one of those things heard on the radio that I so often hesitate to citeC even from as reliable a
source as NPRB because the journalist=s account seems so unreal I think I either misheard or perhaps
that the data was incorrect or that the entire newsstory was a hoax. The fashion reporter, of all sources,
was explaining on the radio that Spider silk genes were studied and cloned to make fabric for lightweight
athletic gear. To be woven into the loom, just like any other threads. Visually, I could see the
spider web in my brain and the picture of genes used to make stronger, lighter genes made very good
sense to me. It was an image that holds logic. But the second part of the same newsstory account made
little sense: it was stated that the same researchers were studying not the characteristics of spider silk,
but the ability to replicate spider silk genes, so that athlete could undergo gene therapies that would
enable their tendons or muscles to heal more rapidly and withstand more stress. Fewer surgeries for
fewer reasons and the ability to heal less often. It all sounds too good to be true. And perhaps it is. But
what does the prospect of spider silk genes in humans mean for the future of occupational health?
This small potential example brings forth important questions to examine about where the law
draws the line for society regarding any incentives or limits upon genetic research: Does society=s rights
expressed under law trump the rights of individuals regarding genetic information and the application of
genetic technologies to various situations? Whether discussing the information revealed through genetic
testing and diagnosis or gene therapy and engineering, important questions arise under law. Present
public health powers can be Used to laws mandate testing or treatment to fix some of the bad genes or
enhance existing genetic traits. How much of such genetic modification and retooling will law allow ?
Will spider silk genes become part of the basketball or soccer player=s job descriptions? And what of
the athletic parent who refuses such treatment for an unborn offspringB will that parent have not done
enough for their child? Will the law allow employers to include genetic traits in job criteria for
employment? Or will employers be required to accommodate every conceivable genetic disability under
ADA, prohibiting genetic discrimination even if a genetic condition or the absence of a genetic
enhancement exists by choice?
The laws that govern this area of human behavior, or human interaction with other species are yet to be
written. Likely, too, the opportunity to write or implement any of these unwritten laws of the future will
be given to every person in this room, in three areas of law and science: privacy; human rights and the
legal definition of Ahuman being@ and the application of those laws to labor relations, specifically in
workplace health and safety.
A. The Role of the Rule of Law
Critics of genetic research long ago cautioned, that AThe mapping of the genome… does not tell us
anything about function, which is what the gene sequences do in the organism,@
1
and therefore have
raised several policy questions about genetic testing. Consequently, critics of the Human Genome
Project and related ABig science@ spending in commercial fields have expressed their concerns
regarding the impact of new genetic tests on autonomy and informed consent, mindful that there can
never be true informed consent in a workplace situation without also eroding protections under law that
prevent workers from accepting the Aassumption of the risk@.
Despite the temptation to immediately implement the medical advances that are represented by
this new technology, the development of genetic testing based on >merely= taking a >simple= blood
sample holds important implications for the autonomy of workers and their right to informed consent
before testing. Looking at precedents in the case of HIV testing, the modern paradigm has shifted away
from the >invasiveness= of testing, towards a hard look at the emotion burden that testing places upon
patients. At present, there are no clear bioethical or legal standards to determine, how much
information is necessary to be informed? Can a rational patient nonetheless make decisions that appear
to be informed but are not, and are contrary to their own best interest?
This brings into question the conflict between principles of beneficence and principles of
autonomy in bioethics and their implications for the theoretical construct that surrounds genetic testing in
the workplace and any safeguards that ensuring that workers have undergone requisite gene therapies,
as a part of occupational health care. To the extent that occupational health services also deal with
pregnant workers, the role of gene therapies, fetal surgeries or genetic screening and testing as a part of
prenatal care, possibly in response to workplace toxins or other aspects of the working environment,
may also become included in the panoply of services that will be included in modern occupational health
care. Further, preserving the workers= rights to demand informed consent procedures such as
counseling and the dissemination of information is crucial to preserving the right to refuse testing and
treatment.

1
Sydney Brenner >The Human Genome: the nature of the enterprise.= in Human Genetic Information:
Science, Law and Ethics, (ed.) Ciba Foundation Symposium 149 p.6 at p.7
B. Implications for a >New Eugenics=
Just when US President Clinton joined other world leaders to announce the completion of genetic
cartography, four philosophers from academia have stepped forward together to perform an Aethical
autopsy= of eugenics: exploring the implications of eugenic theory for new genetic interventions. From
Chance to Choice: Genetics and Justice2
could not be more timely. Appearing in print contemporary to
press releases heralding the completion of full-scale mapping of the human genome, the authors could
not have written for themselves a better timing for their book. As the title suggests, their treatise raises
fundamental issues of justice, fairness and equality that lurk in the shadows of eugenics, just beneath the
glitzy research of ABig Science@ used to map the human genome. What does it mean when society views
a trait as desirable? Does that make the trait good? Which traits trump others? Does genetic-based
medicine only look for disease (whatever that is) or also for desirable traits? If so, which desirable traits
are more important?
At the root of the eugenics movement was the fear that “racial poisons were threatening the health
of the race; that the criminal, mentally ill, and morally dissolute were out breeding the more upstanding
elements of society.” One basic tenet of the eugenics movement was “biological determinism–the idea
that biology lies at the root of most human talents and disabilities.” States enacted sterilization laws
aimed at “purifying and keeping pure blood in America.” In 1907, Indiana passed the United States’
first sterilization law, forcing the sterilization of people based on genetic defects. The Us Supreme Court
upheld the sterilizations, the Court has never specifically overruled this decision. See Buck v. Bell, 274
Us 200 (1927) (per curium). The Court upheld Virginia’s forced sterilization law for “mental defectives”
and found that the law did not violate the Fourteenth Amendment’s Due Process or Equal Protection
Clauses. Similar laws, never overturned, form an important part of our society=s legal matrix.
II. Privacy
A. Personal Privacy versus Commercialism
“Genetic information is not only of value to the individual patient; employers, insurers, educational
institutions, law enforcement officials and others may wish to gain access to an individual’s personal
genetic profile….[with a] great potential for third parties to misuse information3
” Yet, there is no national
consensus whether privacy of any type should be protected and what that law looks like in the USA. It
seems that most people want to protect their personal privacy, but also want information about the
people around them. Privacy rights are a fragile cluster of protections for personhood “Although
compulsory vaccinations, compelled blood tests, extractions of contraband narcotics from the rectal
cavity and even surgical removal of a bullet have sometimes been upheld on a showing of clear
necessity, procedural regularity, and minimal pain, in each case the matter has been taken with enough

2.From Chance to Choice: Genetics and Justice By Allen Buchanan Dan W. Brock. Norman Daniels
and Daniel Wikler Cambridge University Press 2000 provides a succinct and concise statement of the
questions that society will confront as genetic technology and interventions become commonplace in the
years ahead. REVIEW BY: Ilise L. Feitshans New England Journal of Medicine Sept 2000
3Lori Andrews 39 Emory Law Journ.,1990 atp.624.
seriousness to warrant a conclusions that an aspect of personhood was at stake, and that government’s
burden was to provide more than minimal justification for its action”4

Consequently, the current status of privacy law in the USA is a patchwork of rules with many
exceptions. There is no US Constitutional right of privacy, other than relating to sexual relations between
married people, to clarify or defend the right to privacy that people, especially occupational physicians
prize. There is an important question whether there exists any especially protected information within the
constitutionally protected “zone of privacy” concerning genetic information in personal or reproductive
decision making, as defined by the US Supreme Court. Privacy preserves the right to the most intimate
forms of freedom that impact on personhood and sense of self.5
AFew values so fundamental to society
as privacy have been left so undefined in social theory”6
according to Westin. He traced the role of
privacy in the animal world and in primitive societies, fundamental and inherent character within social
organizations. The flip side of privacy is the public interest in the otherwise protected information itself: If
there are genes with high risk for Alzheimer’s disease or some other disorder, should the newspaper be
allowed or compelled to publish the President’s genome? Genetic information can trafficked, to target
markets for procuring or selling commodities based on individual genetics.
The race to find genetic information and apply genetic technology unleashed a fierce battle in
public health law regarding individual rights to privacy and informed consent, competing with society=s
interest in applying genetic information for commercial purposes and public health planning. Examples
include: mandatory testing and registration of genetic information; commercial access to the names and
identifying information of people with desirable genes that could be purchased for medical purposes,
such as creating new tissue for gene therapies.
Is there a right to refuse treatment, or testing, as a part of genetic privacy regarding
medical decisions? Is there a right to keep the Amagic gene@ that will cure someone else=s
ailment for oneself, one=s family or the highest bidder? Or an obligation to accept such a
cure, regardless of an individual=s will or the will of a parent regarding the future health of a
minor child because of the greater public good? Will people who are tested and refuse
treatment for themselves or their children be held liable in tort for the subsequent
consequences of their refusal? Even if the refusal is part of their religious beliefs? Is there

4
.TRIBE, LAURENCE, AMERICAN CONSTITUTIONAL LAW, p.1331-2
5
See Kendall Thomas “Beyond the Privacy Principle,” 92 COLUMB. LAW REVIEW 1431 (19__) (writing
about Bowers v. Hardwick, “the most private of all privacy cases,”at 1437 and 1448, “By recognizing a
physical zone of privacy into which the state may not intrude to interdict consensual intimate conduct,
the Supreme Court has shown itself to be sensitive to the mutually constitutive relationship between the
intimate life of the individual and the places in which that intimate life unfolds.”) See Also: Ruth Macklin
Genetics and the Law III
6
See also: Alan F. Westin, Privacy and Freedom Atheneum, New York 1967 at 7
informed refusal?
Heralding the benefits of genetic advances, the U.S. Supreme Court stated AScientists, among them
Nobel laureates, are quoted suggesting that genetic research may pose a serious threat to the human
race… We are told that genetic research and related technological developments may spread pollution
and disease, that it may result in a loss of genetic diversity, and that its practice may tend to depreciate
the value of human life… We disagree.@
7
1. Benefits to Society That Outweigh Individual Genetic Privacy: Two theories of ownership
of this information have emerged under the law.
a.Individual Ownership: Genetic information inately belongs to any one individual because it is
personal and medical in nature.
b.Common Inheritance of Mankind: Yet, because genetic inheritance is shared within families,
whole races or ethic groups, there is a competing view that it is actually Aowned@ by not one person, but
society as a whole. This theory views gene pool information as public property because it was
developed with public funds, and the use of this data benefits society as a whole, rather than any given
individual. This has implications for both: the testing and use of seemingly personal genetic information,
and for the determination of ownership of Adiscoveries@ and patentable inventions based on manipulation
of genetic material. It would be diffiuclt, from the standpoint of practice, to set forth a consistent rule that
would uphold personal privacy in genetic information while also promoting commercial ownership and
development of gentic technologies using genetic information. The inherent conflict in these two positions
may explain the schizophrenic attitude regarding privacy and confidentiality manifest in the USA laws.
c. Sale of Databases of Human Genetic Information: Personal health information is presently
transferred to third parties, including the Medical Information Bureau (MIB) under existing insurance
laws, with no limitation based on the patient=s general release at the time of treatment. This database can
include genetic information, including genetic predictors for disease and candidates for transfer of
desirable genetic material. There is fear also that such databases could be used for genetic discrimination
in employment, or regarding eligibility for health insurance. Writing in reaction to a case where harm
caused by gossip did not give rise to a cause of action at common law, Pollard v. Photographic Co.
Pollard v. Photographic Co8
. Warren and Brandeis stated:”The intensity and complexity of life,
attendant upon advancing civilization, have rendered necessary some retreat from the world, and man,
under the refining influence of culture, has become more sensitive to publicity so that solitude and
privacy have become more essential to the individual… The possibility of future profits is not a right of

7 Diamond v. Chakrabarty 447 US 303 at 316-17. E. Richard Gold, Body Parts: Property Rights and
the Ownership of Human Biological Materials (1996); Pauline Newman, Intellectual Property Law and
the New Biology, Judges’ J., Summer 1997, at 46. See: rachel@rachel.org;
rachel-weekly@europe.std.com rachel-weekly@europe Rachel #666: The Bad Seed Friday,
September 03, 1999 12:02 AM
8
Pollard v. Photographic Co. Pollard v. Photographic Co. 40 ch, Div, 345 (1888).
property which the law ordinarily recognizes; it must, therefore, be an infraction of other rights which
constitutes the wrongful act, and that infraction is equally wrongful, whether its results are to forestall the
profits that the individual himself might secure by giving the matter a publicity obnoxious to him, or gain
an advantage at the expense of his mental pain and suffering.9
2. A Broader View of Ownership: If genetic information is indeed the property of more people
than any given individual, this has implications for individual genetic privacy, public health strategies and
intellectual property as well as privacy regarding the disclosure of information. Property rights therefore
may have implications for a variety of social and private contracts regarding genetic information and the
subsequent use of genetic technology, based on personal genomic status. Legal resolution of these
property rights will determine: who to tell genetic information, (mother? father? extended family?
employers? Insurers? Prospective spouse and family? other third parties?) Using property analysis,
individual genetic information could be safeguarded in a shroud of procedural confidentiality. On the
other hand, the individual right to genetic privacy may be outweighed, on balance by countervailing
social and commercial interest: information should be readily available to third parties for the greater
social good of promoting public health or generating financial profits. Balancing these existing rights
against individuals in favor of the public health or commercial rights may mean that an individual who
has a Agenetic defect= required to change it, or to make available desirable genes for medical or
corporate purposes. Extending these concepts from individuals to commercial uses of genetic
information has implications for the mixture of human genetic material with other genetic information
from other species, for genetically manufactured foods, cloning and sale of human body parts made
from transgenic (or multi-parent genetic) material and genetic materials used in medical treatments. In
light of new genetic technologies, society must decide whether or not to apply existing under disability
laws, insurance laws and other regulatory mechanisms, to protect people against suffering from
discrimination based on genetic conditions.
3. Who cares about Privacy? Precedents Regarding Wrongful Use of Genetic Information
and Eugenic Laws: Changes in technology alter our understanding of health. 10 The disease that was
viewed as incurable decades ago can now be cured and the irritating conditions that people lived with
slowly become the red flag signals for other diseases and illness; thus changing whether the same person
is regarded as manifesting an illness or in Agood health@. This is especially true for genetic diseases. For
example, in the 1970s, sickle cell anemia screening programs were aimed at identifying carriers of sickle

9
Warren and Brandeis AThe Right to Privacy@ at P. 205
10Preamble, World Health Organization (WHO) Constriction: AHealth is a state of complete
physical, mental and social well-being and not merely the absence of disease and infirmity@. This
remarkably broad definition of bespeaks the basic human need for health. For this reason, it has
been the undisputed benchmark of many practical standards as well as a host of national health
laws. This definition is so encompassing, however, that it has been criticized as making virtually
any human endeavor a matter of health jurisdiction. It encompasses vaccines and preventive
strategies as well as medical programs.
cell anemia, a disease common among African Americans and also among ethnic groups from Asia
minor. Government programs were identified both healthy Acarriers@ individuals who had sickle cell
anemia. The mistaken notion that carriers might be hyper-susceptible to certain workplace toxins such
as benzene, lead, cadmium, carbon monoxide, and cyanide was used as an accepted reason to exclude
black workers out of high- paying jobs in the heavy industries. In this time period, many state
legislatures mandated sickle cell testing, leading to further fear and discrimination. Inadequate measures
to keep the test results confidential led to stigmatization and discrimination against sickle cell carriers in
employment. Ignorance about sickle cell trait compared to the genetic illness, sickle cell anemia, was
mixed up with other prejudices, and became the touchstone of discrimination against many carriers of
the trait even though Acarriers@ could not develop the disease.11Thirty states enacted legislation requiring
African Americans to be tested for the sickle cell trait. 21 states have not repealed their sickle cell
screening laws. Some states required children be tested upon entering school while others would only
issue marriage licenses if the individuals had been tested12. Thus, the United States Air Force Academy
refused African Americans who were carriers of sickle cell to participate in pilot training, fearing that the
low-oxygen environment in flight would cause them to undergo a sickling episode13. Under these
theories, there is a national if not international communitarian interest in any person=s health that
transcends notions of individual privacy.
B. Public Health Implications of Genetic Testing At Work
Existing law may be interpreted to address genetic technologies to require mandatory testing or
treatment to Acorrect@ so-called genetic disorders ranging from arthritis to obesity and change personal
attributes like intelligence and skin color. This information can potentially benefit society: cures and
treatments for currently incurable genetic disorders. Critics fear that a concept of Agenetic fitness@ could
be used to choose between parents in custody battles, or to determine whether future employment or
incurability without regard to other human traits.14 Concepts of genetic fitness exist under eugenic-based
sterilization laws from the early 20th century that were upheld by the US Supreme Court and have not

11 King, Past As Prologue in Annas Gene Mapping (noting that these programs began with the best
intentions, and were supported by African American leaders until they realized that such measures
“would be used to stereotype and disadvantage the very people they sought to help.).
12Federal Law: National Sickle Cell Anemia Control Act withholds federal funding from states unless
sickle cell testing is voluntary. National Sickle Cell Control Act, Pub. L. No. 92-294, 86 Stat. 136
(1972) (as amended at 42 U.S.C. ‘ 300b (1976).
13See King, Past As Prelude 99 (discussing how the mandatory testing of African Americans for sickle
cell anemia negatively affected them).
14See Office of Tech. Assessment, U.S. Congress, Genetic Monitoring and Screening in the Workplace
15, tbls.1-2 (1990); Brian R. Gin, Genetic Discrimination: Huntington’s Disease and the Americans with
Disabilities Act, 97 Colum. L. Rev. 1406, 1411 (1997) (suggesting that in the future adoption agencies
may choose suitable parents based on their genetic potential and that the same information may be used
by courts in determining custody of children in divorce settlements)
been repealed.15 Absent uniform privacy and confidentiality protections throughout the USA, health
care institutions, insurance companies and self-insured employers who transmit health information
through interstate commerce, patients may lack the basis for meaningful consent to disclosure of
information. The costs and benefits of genetic technologies may force to closure previous policy debates
about privacy regarding medical data.
1 The State=s Obligation to Protect Genetic Information:
The clearest and most succinct statement of the traditional approach to regulation of public health
policy under law is Frank Grad’s classic work, The Public Health Law Manual.16 This invaluable
reference covers the legal sources of public health powers, restriction of the person, permits, licenses
and registrations, abatement of nuisances, civil sanctions, etc. in the USA. Traditional approaches of
public health regulation, include: quarantine and other restrictions of the person, mandatory testing for
vaccination, and registration and reporting of communicable disease. These measures are firmly based in
the well-established doctrine of Parens Patriae the societal need for control over disease and public
health uses of personal information in order to protect the public good. Under this construct, the socalled
“police power” of the State provides the traditional justification that supports invasions of privacy
or breaches of confidentiality, that are both implicit and expressly articulated in public health laws
following the traditional public health paradigm. The Use of the police power is rooted in the
government=s obligation to the people, as protector of the people in the social contract between a
populace and its government.
C. Privacy Rights Under the US Constitution:
Genetic information from research may create preventive treatments, provide information about
protective effects of genetic conditions considered to be defects; or about new diseases that were never
viewed as genetically linked. Some conditions may be an admixture of environmental factors and genetic
propensities. Other genes will not impact on the individual who is a Acarrier@, but may, through the
happenstance of fate and attraction, appear in the next generation, depending on who the parent
chooses as partners in reproduction. What will a judicial system in the twenty-first century do with
information that particular genes give individuals a propensity for certain types of behavior? Will
employers have the right to set forth particular genetic characteristics as part of their job criteria for
employment? Or will such criteria violate the precepts of the Americans With Disabilities Act (ADA)
which prohibits discrimination? Will any of the embryos and fetal tissue cloned or raised using genetic
technologies be endowed with individual rights and Ahuman@ status? Will there be a new underclass,
created from materials using genetic technologies, or from the Aold-fashioned@ form of human
reproduction without enhanced genetic techniques?

15 See: Buck v. Bell US Supreme Court
16The Public Health Law Manual, American Public Health Association, Washington, D.C. 1990
Constitutional basis for protection of privacy rights are found in several Amendments. Henkin17
views privacy rights as a public good. These rights include protection from unreasonable searches and
seizures. Under his construct, “The essential private right”, freedom, was established by the 13th
amendment. The US Supreme Court created “substantive due process” as a limitation of the authority of
government. “The Constitution does not confer private rights; they are antecedent to and independent of
the constitution…Justices Stone and Cardozo suggested that the freedoms of speech, press and religion
required extraordinary judicial protection against invasions even for the public good, because of their
place at the foundations of democracy and because of the unreliability of the political process in regard
to them.” “since the Constitution… protects rights which partake of privacy it protects other aspects of
privacy as well, indeed it recognizes a general complete right of privacy”.
First Amendment concepts of freedom of association include “The associational model of the right
of privacy presumptively insulates its holders from state interference even when that right is exercised in
the public sphere”. U.S. Constitution, First Amendment, discussed by Thomas, supra. This theory of
privacy severely limits the government’s ability to require genetic testing or to compel disclosure of
genetic information within marriage or in reproductive decision making. Under the Fourth Amendment:
Prohibition against warrant less intrusions among the rights of privacy; this protection extends to the
home as well as the person. This protection is limited to non-criminal purposes and might not reach
DNA “fingerprinting” used in criminal prosecutions. Under the Ninth Amendment, this right against
genetic discrimination is grounded fundamental attributes of the person, also as discussed in the
jurisprudence of international human rights, (below). The touchstone for US Constitutional privacy, to
the extent it exists, is embedded within “those personal rights that are fundamental… not confined to the
specific terms of the Bill of Rights.@ In Justice Goldberg=s concurrence in Griswold v. Conn, the Court
stated that a married couple’s right to privacy regarding contraception outweighed a state law that
prohibited the use of contraceptives. Relevant to genetic privacy for purposes of family planning, the
Court viewed the case as one that “operates directly on an intimate relation of husband and wife and
their physician’s role in one aspect of that relation”. 18

As stated in Eisenstat v Baird, , “If the right of privacy means anything, it is the right of the
individual, married or single, to be free from unwarranted government intrusion into matters so
fundamentally affecting a person as the decision whether to bear or beget a child”19. This view could be
construed as having implications for the disclosure of human genomic information during family planning,
absent an overarching public health interest. The US Supreme Court was not contemplating
sophisticated advances in genetic testing when it made this statement, but the right to privacy may
prevent governmental intrusion via mandatory genetic testing, absent a strong governmental interest. The

17Louis Henkin, APrivacy and Autonomy@ 77 COLUM. L. REV. 1977 .
18Griswold v. Conn, 381 U.S. 479 at 486
19Eisenstate v. Baird 405 U.S. 453 (1972) struck down a State law that prohibited unlicenced
distribution of contraceptives to unmarried people.
Court did not, however indicate which governmental interests would be sufficiently important to
outweigh personal privacy concerns and thereby justify intrusion into personal privacy, if information
was needed by third parties to save their life.
Under the Ninth Amendment also, abortion cases have determined that Constitutional protections
for privacy extend to the decision whether or not to terminate a pregnancy20
. The U.S. Supreme Court
took a broad brush approach to safeguard information surrounding abortion decisions finding “freedom
from unwarranted governmental intrusion into individual decisions in matters of childbearing.”
Thornbourgh v. ACOG Stevens, J. Concurring21, autonomous decision making was not to be
“burdened” by a statutory requirement for parental notification regarding the decision to have an
abortion.
The government’s ability to limit the exercise of independent decision making in matters that would
otherwise be considered private was discussed in Whalen v. Roe. The constitutional right to privacy in
personal information was outweighed by the legitimate state interest in preventing drug abuse, when a
state was allowed to require mandatory reporting of names and other identifying information for persons
who were the recipients of prescriptions for controlled substances. It seems as if one interpretation of
the case could allow it to serve as precedent for allowing genetic testing of individuals by the
government, insofar as it asserts the government’s ability to gather data when there is a state interest in
otherwise confidential, personal information. Under Whalen, government interests in the name of public
health can provide a compelling state interest.
Protection against disclosures, even if self-incriminating, is found under the Fourth and Fifth
Amendment.In Justice Brandeis’ dissent to Olmstead v. United States, concerning the admissibility of
evidence obtained by wiretapping of homes and offices, he argued that the Government should not have
the ability “to obtain disclosure in court of what is whispered in the closet.” Thus, Justice Brandeis
recognized privacy interests against government intrusion under the Us Constitution’s Fourth and Fifth
Amendments. Taken together, these Amendments “conferred, as against the Government, the right to be
let alone— the most comprehensive of rights and the right most valued by civilized men.”22
Brandeis= opinion applied principles he had written about in a famous law review article entitled
AThe Right to Privacy@. Although privacy is not viewed as an inherent right under the common law.23
.
The precinct call for an expanded scope to legal protections for the concept of individual privacy

20 See Roe v. Wade. 410 U.S. 113 (1973) (the right to terminate or continue pregnancy
21 Thornbourgh v. ACOG Stevens, J. Concurring 476 U.S. 747 (1986)
22Olmstead v. United States, 277 Us 438, 478 (1928) (JUSTICE Brandeis Dissenting).
23The benchmark for discussion of privacy jurisprudence under the common law is, Samuel D. Warren
and Louis D. Brandeis “The Right to Privacy” HARV. L. REV. Vol IV No 5 (1890)
decried several developments of the modern age, is often cited by the dissent throughout the 20th
century cases about privacy. “That the individual shall have full protection in person and in property is a
principle as old as the common law; but it has been found necessary from time to time to define anew
the exact nature and extent of such protection. … Later there came a recognition of man’s spiritual
nature, of his feelings and intellect. Gradually the scope of these rights broadened; and now the right to
life has come to mean the right to enjoy life– the right to be let alone…”.
Warren and Brandeis recognized the need for legal remedy for unauthorized Use of portraits and of
modern inventions that replicated images and speech without authorization by the individual who was the
subject of the portrait. This has direct relevance for genetic testing and cloning of human genetic material
for medicine, Aspare parts@ or creating new human beings. Genetic technology can isolate and examine
in detail the chromosomal image of an individual without the individual’s knowledge or consent, and in a
manner that has intrusive effects of embarrassment, social stigma and even detrimental judgements by
unseen third parties, just as photography once had. Warren and Brandeis understood these problems,
raised by new technologies for replication of a human image, as they stated the case for judicial
recognition of these rights.Warren and Brandeis= ideas, although appealing from a conceptual
standpoint, were not widely embraced by the courts in the twentieth century; although their influential
documentation was often cited, theirs did not become the majority view. Their views represented the
high water mark of rights to privacy that “ought” exist, rather than a realistic appraisal of rights under
common law and therefore remains important when examining new assaults against personal rights to
information Used in decision making. Legal scholars in the 20th century have used their article asthe
conrnerstone for the principle that there is a right to privacy that is intrinsic in Apersonhood@. For Warren
and Brandeis construct, rights as derived not from contract or special trust, “but are rights against the
world … The principle which protects personal writings and any other productions of the intellect or of
the emotions is the right of privacy, and the law has no new principle to formulate when it extends this
protection to the personal appearance, sayings, acts, and to personal relation, domestic or otherwise”. 24
This theory, not codified in USA laws is found under international law. UDHR Article 12, regarding
privacy states:@No one shall be subject to arbitrary interference with his privacy, family, home or
correspondence, nor to attacks upon his honor and reputation. Everyone has the right to the protection
of the law against such interference or attacks@.
25 International Covenant on Civil and Political Rights
Article 17.1 “No one shall be subjected to arbitrary or unlawful interference with his (sic) privacy,
family, home….” and further assures the right to protection against such “attacks” against privacy.
Similarly, ICCPR Article 19.2 guarantees the right to receive and impart information “of all kinds”. This
provision suggests the ICCPR provides protection for genetic privacy within the family and for personal
health information.26

Warren and Brandeis The Right to Privacy at p 213
25UDHR) art 25, Sec. 1, U.N.G.A. Res. 217 A U.N. Doc. A/810 (1948).
26But See Alaska Stat. 18.065.087 (1998), which authorizes the Department of Public Safety to
maintain a central registry of sex offenders and to make the following information about those
offenders available to the public: name, address, photograph, place of employment, date of birth,
1. Applying Privacy Principles to Genetic Information
Privacy of medical records has implications under consumer protection laws as well as insurance
laws. If a patient discloses personal information to a health care professional believing it is private, the
professional may be liable in tort for disclosure without the patient’s consent. Laws do not protect
confidential medical information that is disclosed with the patient=s consent. Most medical record and
claims data enter the public domain through the Use of blanket consent forms As a condition to apply
for insurance or process claims. The forms often permit release of information to others not directly
involved as a provider, i.e. the Medical Information Bureau (MIB). MIB tracks patient information for
insurance companies to evaluate applications for coverage and to develop targeted marketing. This
data is made available to MIB through the general release. Several laws have been proposed in
Congress provide uniform and confidentiality for individual genetic information
2. Federal Regulation of Health Insurance: Use of medical records and claims data by third
parties, such as medical and health policy researchers, employers, marketers, public health officials and
the law enforcement community has led to Congressional hearings addressing the privacy rights of
individuals balanced against access to the data, including medical and health policy researchers, whose
work may benefit the public at large.27 Title V of The Patient Protection Act, passed by the House of
Representatives on July 24, 1998, contained provisions that would authorize the Use of identifiable
health care information for “health care operations.”28.Future laws following these bills may: prohibit
denial or cancellation; prohibit changing premiums, terms, or conditions of policies; prohibit the request
or requirement of a genetic test; or protect individual confidentiality “on the basis of any molecular
genetic information about a healthy individual.” 29

crime for which convicted, date of conviction, place and court of conviction and lengthy of
sentence. This information on the Internet at Sex Offender Registration Report
http://www.dps.state.ak.Us/sorcr
27See Congressional hearings: The Fair Health Information Practices Act of 1994, H.R. 4077, 103d
Cong. (1994). Medical Information Protection Act, S. 2609; the Consumer Health and Research
Technology Protection Act, H.R. 3900; the Health Care Personal Information Nondisclosure Act, S.
1921; the Medical Information Privacy and Security Act, S. 1368; the Medical Privacy in the Age of
New Technologies Act, H.R. 1815; and the Fair Health Information Practices Act of 1997, H.R. 52.
28See H.R. 4250 1185, 105th Cong. (1998
29See S. Res. 89, 105th Cong. 9811 (1997); H.R. Res. 306, 105th Cong. 713 (1997); S. Res. 1045,
105th Cong. (1997); S. Res. 1694, 104th Cong. 2 (1996); H.R. 2748, 104th Cong. (1995); n86.
See S. 1898, 104th Cong. 302 (1996); S. 422, 105th Cong. 402 (1997). . See H.R. 341, 105th
Cong. 6 (1997). The bill prohibited an insurer from rejecting, denying, limiting, canceling, refusing to
renew, increasing the rates, or otherwise affecting coverage.
Although state laws historically stipulated that medical records were the sole property of the health
care provider, most state laws also required health care professionals to maintain the confidentiality of a
patient’s personal information.30 Medical records and claims data has spurred advances in quality and
access to medical treatment. Access is needed by medical and health policy researchers to medical
records and claims data has spurred advances in quality and access to medical treatment. The American
regulatory regime on medical record access has politely been characterized as “fragmented” and less
politely as a “black hole31.” For this reason, the Health Insurance Portability & Accountability Act
(HIPAA): HIPAA specifically requires insurers to provide on-going health insurance to previously
insured individuals without regard to Apre-existing conditions.@ Pregnancy and genetic conditions are
expressly included in the list of situations that cannot be the legitimate reason for exclusion from a policy,
despite the expense and high-risk among these populations. 32
D. Ignorance is Bliss: The Ultimate Bastion of Privacy
Discovery of the gene for Huntington’s Disease has altered the meaning of genetic testing and
brought closer the promise of a cure for affected families. At the same time, genetic discoveries have
raised issues of personal genetic privacy at the cutting edge of genetic jurisprudence. In light of these
developments, the International Huntington Association (IHA) and the World Federation of Neurology
(WFN) have proposed Recommendations to provide guidelines for the Use of the Huntington’s Disease

30 See Helena Gail Rubinstein American Journal of Law & Medicine 1999 25 Am. J. L. and Med. 203
If I Am Only for Myself, What Am I? A Communitarian Look at the Privacy Stalemate
31See Us Senator Edward M. Kennedy cited in Helena Gail Rubinstein American Journal of Law &
Medicine 1999 25 Am. J. L. and Med. 203 If I Am Only for Myself, What Am I? A Communitarian
Look at the Privacy Stalemate. See also William W. Lowrance, Department of Health and Human
Services, Privacy and Health Research: A Report to the Secretary of Health and Human Services 6
(May 1997), See Richard C. Turkington, Medical Record Confidentiality, Law, Scientific Research
and Data Collection in the Information Age, 25 J.L. Med. & Ethics 113, 115 (1997). Senator Edward
M. Kennedy, Statement on the Introduction of the Medical Information Privacy and Security Act (Mar.
10, 1999).
32See Health Insurance Portability and Accountability Act, Pub. L 104-191, 264, 110 Stat. 1936
(1996) (codified as amended at 42 U.S.C. ‘ 1320d-2).See Protecting Our Medical Information,
Rights, Responsibilities and Risks, Hearings Before the Senate Comm. on Labor and Human
Resources, 105th Cong. (Oct. 28, 1997); Confidentiality of Patient’s Medical Records, Hearings
Before the Subcomm. on Gov’t Management, Info. and Technology of the House Comm. on Gov’t
Reform and Oversight, 105th Cong. (May 19, 1998) (statement of Richard Harding, M.D., on behalf of
health insurers, medical and health policy researchers and pharmaceutical companies. See
Confidentiality of Medical Information, Hearings Before the Senate Comm. on Labor and Human
Resources, 105th Cong. (Feb. 26, 1998)
Molecular Genetics Predictive Test 33. The first recommendation and comments indicates that
individuals should have updated information “in order to make an informed voluntary decision”. 34 The
second recommendation ensures that taking the test is the “sole choice” of each individual, free of
coercion from families, physicians insurance companies, employers or other third parties,35 although
recommendations 3 and 3.1 indicate that “the patient should be encouraged to select a partner to
accompany him/her throughout the different stages” of testing. The test would, under this approach, be
offered without regard to financial status but only to people who have reached majority, with a strict
prohibition against testing for the purpose of adoption. Recommendation 2.5 urges that laboratories
meet “rigorous standards”. Recommendation 4 prohibits the disclosure of test results to third parties,
absent the written consent of the patient. Recommendation 5.3 indicates the types of formation that
should be given to the patient regarding potential consequences of taking the test. These consequences
include the effect of test results on the individual patient, patient’s spouse, parents, other family
members, and socio-economic consequences pertaining to “employment, insurance, social security, data
security and other problems”. 36 Recommendation 5.4 ensures that patients will have access to
“alternatives” to taking the test, including but not limited to not taking the test or storing their DNA.37

The IHA Recommendations also offer guidance for prenatal and antenatal testing, designed to ensure
the integrity of the patient’s medical decisions. recommendation 8 concerns the delivery of test results to
patients through counseling in person, rather than over the telephone or by mail and the right to refuse
having results. decision making, thereby providing additional protection against undesired disclosure.
HDA’s recommendations therefore give a deeper practical effect to theoretical principles protecting
patient autonomy regarding medical decision making. This approach, giving primacy to autonomous
decision-making, may also be applied to other genetic testing than the decision whether to take the test
for Huntington’s Chorea may also apply to other areas of genetic testing.
IHA Recommendations on the “Right Not to Know” about Huntington’s Chorea: Albert Towle,
Modern Biology 171 (1993). Huntington’s disease is an example of a trait linked to a single allele or
dominant contrasting gene. It causes “loss of muscle control, uncontrollable physical spasms, severe

Concept: Ethical Issues Policy Statement on Huntington’s Disease Molecular Genetics Predictive
Test, IHA and WFN Research Group on Huntington=s Chorea, Committee on Genetic Testing. “The
establishment of a committee with the specific task of preparing such guidelines was decided at the
WFN and IHA conferences in Lille, September, 1985. The recommendations were adopted by both
organizations at their respective meetings in Vancouver, Canada, June 30 to July 3, 1989 and published
in J. Neurol. Sciences 1989; 94; 327-32 and J. Med. Genetics 1990; 27; 34-8″

34 WFN_IHA guidelines, Number 1.

35 WFN-IHA recommendation 2.

36 WFN-IHA Recommendation 5.3.5

37 WFN-IHA Recommendation 5.4
mental illness, and eventual death.” For example, the presence of Huntington’s disease can be detected
with 99% accuracy. See Gin,, at 1415 (pointing out that test to diagnose Huntington’s disease may be
administered at any time in a person’s life and will have no bearing in the accuracy of the diagnosis).
While a positive test result signals that an individual ultimately will get Huntington’s disease, it is
impossible to predict when the disease will manifest itself and how quickly the person will become
debilitated. thus, an individual with the genetic markers for Huntington’s disease may lead a long,
productive life before the onset of the debilitating symptoms. See Gin, supra note 3, at 1414-15
(estimating that the disease begins to surface at age 35). IHA has recommended that genetic testing for
Huntington=s Disease be conducted only after counseling and only on adults.
Despite the clarity of these recommendations, there is an underlying confusion in theories and
jurisprudence of privacy, which ultimately affects the ability to devise analytically clean and forthright
protections for the privacy rights, including the right not to know, as eluded to by the HDA. Consistent
with the salient characteristic of international human rights jurisprudence, these documents represent a
codification of the international consensus to certain individual rights, such as the right to information or
the right to privacy, without offering more than vague support for the notion that there should be
international respect for these principles, and without fully addressing the necessary steps to achieve
implementation of their meaningful protection. Examining these provisions nonetheless provides a Useful
starting point in order to determine the implications of privacy concerns for genetic issues in public health
law and policy. In addition, several international human rights documents express the notion that there
are separate and distinct, or perhaps “special” protections that ensure maternal health, especially during
pregnancy. The intriguing separate regime regarding human rights protections during pregnancy calls into
question whether “special” rights regarding privacy and autonomy also have an impact upon prenatal
medical decisions in general, and genetic testing in the workplace. The sickle cell and sterilization laws
precedent raise concern that mandatory testing is a potential tool for eugenics, enabling the state to filter
out undesirable genetic traits through obligatory testing. Experience with sickle cell anemia testing
suggests the dangers inherent to genetic testing. Like the sickle cell tests of the 1970s, scientists today
understand relatively little about genetic conditions. Although we have the ability to identify an
increasing number of genes, we don=t understand the relationship between genes, diseases and other
human traits. Does this history of discrimination based on inadequate scientific data mean that people
have a right NOT to have such personal information studies, in order to protect them from
discrimination? Or, more importantly, to protect them from the harms they may suffer from Bad
Science, despite the researcher=s best intent?38 The State’s concern for the welfare of an infant justified
blood transfusions notwithstanding the special religious beliefs of the Jehovah’s Witnesses39. But must

38See Troy Duster, Back Door To Eugenics Routledge Press, New York 1990. See also Lippman,
Abby “Prenatal Genetic Testing and Screening: Constructing Needs and Reinforcing Inequities” 17
Amer. Journ, of Law and Med. 15 Nos. 1 &2 (1991) at 34
39 Jefferson decision relied in part on the older case of Raleigh Fitkin-Paul Morgan Memorial Hospital
v Anderson 201 A 2d 537, (N.J.) cert. denied 377 Us 985 (1964.. See also State v. Perricone, 37
N.J. 463 (1962), and (the
be used wisely when fiercely competing interests demand their respective rights. The path we choose
will shape humanity=s destiny for many generations.
III. Legal and Medical Constructs of a Human Being endowed with Human Rights
How much genetic difference through cloning or other genetic techniques will be tolerated under
current definitions of humans? Will the people produced under these technologies accept those
definitions or want a separate regime to govern themselves? Or will they be second class citizens? Kings
or slaves? human rights and the legal definition of Ahuman being@? Tribe asks the precinct question,
(regarding children of sperm donation) “If such a child develops an hereditary disease, does it violate the
donor’s privacy if the state requires the sperm bank to reveal his identity to the parents and physicians of
the child?@
40
A. Who Holds the Human right to Informational Privacy?
There will be two radical changes in the definition of family to cope with social changes produced
by the application and use of genetic technologies: First, genetic technologies will uncover long-standing
historical biological linkages between many people who were treated as outcasts or outsiders to a given
family, either through secrecy, illegitimacy or distant social relations. This will gain importance as we
know more about the effects of that biology and as people who perceive themselves to be victims of
genetically-based or genetically linked discriminations will band together for common protection and
safety in their interactions with the rest of society. Second, even if all people are created equal, the law
will find it necessary to step in and decide who are people and what are their relations to each other.
Can a child who is linked to a celebrity genetically claim inheritance from them, even if that child was
merely linked by donor eggs that were purchased from the celebrity under contract and has different
parents legally? Conversely, will the same celebrity be bound by contract law or other laws to raise and
pay for the children who bear their name, but are not linked to them biologically?
1. Rights of Other Individuals to One=s Genetic Information
Third parties have an interest in genetic information because genetic diseases by their very nature
have an inherent intra familial component that arguably gives rise to a duty to disclose genetic
information. Third parties such as lost extended family or significant others may be affected by
information regarding genetic disease. This approach to the protection of personal genetic information
has in fact been advanced by the Huntington’s Disease Association. International public law concerning
human rights also offers protections for autonomy, integrity of the person and the right to information
about oneself or one’s family members.41

40LAURENCE TRIBE AMERICAN CONSTITUTIONAL LAW , 1360
41 See United Nations Charter, Signed 26 June 1945, Entered into force on 24 October 1945;
Reprinted in: Center for the Study of Human Rights, Columbia University Twenty Five Human Rights
Documents at 1-5, (excerpts). Relevant portions of the UN Charter include: Preamble; Article 13;
Chapter IX, Article 55; Chapter X, Article 62.2.
2. Family members: Who is A Family@?:
Genetic diseases run in families; but the high correlation between many genetic disorders and race
or ethnicity, makes difficult screening applicants for many diseases without violating USA Title VII of
the Civil Rights Act or the ADA. “The identification of relatives found through genome mapping to be at
risk for genetic disease may result in inflicting unwanted information on those individuals”42

Furthermore, genetic information may also therefor reveal other information about family links that
was not previously known but has unpredictable consequences, when an African American claims
lineage to a President two hundred years after his death.43 Sickle cell anemia, Bloom’s Syndrome, and
other genetic diseases inherited from parents are sometimes closely linked to particular ethnic or racial
groups such as African Americans, Ashkenazi Jews and Armenians. 44There is precedent for protecting
the integrity of family-based genetic information, insofar as family genetics are an extension of laws
regarding genetic traits and race. Courts have found that tests for sickle cell anemia disproportionately
impact African Americans. Many states prohibit employer testing for the disease. In EEOC v.
Trailways, Inc.,
45, the court struck down a regulation requiring bus drivers to be clean shaven. The
regulation was struck because it had a discriminatory impact on African Americans who demonstrated a
higher incidence of a skin disorder that made shaving painful.46 Similarly, most of the employers who
pioneered sickle cell testing soon stopped, and some states have now prohibited the testing because of
its disparate impact on African Americans.47

42Macklin, Ruth “Mapping the Human Genome” in Milunsky, Aubrey and Annas,George Genetics and
the Law III (1984) p 111 See also Andrews, Lori and Jagger, Ami “Confidentiality of Genetic
Information in the Workplace” Amer. Journal of Law and Medicine p.81 Washington
43See A Daughter=s Legacy, Johns Hopkins University Magazine, Sept/Fall 1999 (African American
professor Using DNA is demonstrating that she is the eighth generation after President Thomas
Jefferson=s black son, whose mother was Jefferson=s slave).
Karen H. Rothenberg, Breast cancer, The Genetic “Quick Fix” and the Jewish Community, 7 Health
Matrix 97, 98(1997) (noting that nearly one percent of sampled Eastern European Jews contain a
genetic predisposition to breast and ovarian cancer); See also Katherine Brokaw, Comment, Genetic
Screening in the Workplace and Employers’ Liability, 23Colum. J.L. & Soc. Probs., 317, 324 n.33
(1990).
530 F. Supp. 54 (D. Colo. 1981)
46But see Woods v. Safeway Stores, 420 F. Supp. 35 (E.D. Va. 1976) (upholding the dismissal of
African American employees who grew beards as a result of a skin condition where customers found
bearded workers in a grocery store distasteful
47 See:generally Fla. Stat. Ann. 448.076 (West 1997) (prohibiting sickle cell trait screening as a
condition of employment); La. Rev. Stat. Ann. 23:352 (West 1998) (prohibiting employment
discrimination on the basis of sickle cell trait).
B. Tensions with Disability Rights:
“New genetic knowledge seems destined to bring genetic tests that will collide with a growing
movement for disability rights. The battleground is likely to be prenatal genetic testing. For a disorder
such as Tay-Sachs disease, dying, prenatal testing is generally accepted. Abortion of a prospective child
destined to a short life filled with pain and inability to respond to the world is, to most, a morally
acceptable if tragic choice. Abortion for conditions with greater clinical variability, with a mix of genetic
and environmental causes of lesser severity or with late onset are less obviously beneficial. … Choosing
abortion on the basis of an expected disability raises the specter of choosing what kind of children there
should be. The choices implicitly force judgments that echo debates about what lives are worth living,
arguments that in an earlier era mushroomed into Nazi atrocities.”48
Currently under international law, without stating what blood or other relationship constitutes a
Afamily”, protects “the right to found a family” as a “fundamental group unit” of society, UDHR Article
16.3 provides, “The family is the natural and fundamental group unit of society and is entitled to
protection by society and the State”. This law does not resolve conflicts within this “fundamental group
unit” when there are competing interests, such as the potentialconflict of interest between parent and
fetus.49. For example, neither international norms nor US law specifically grants rights to children or
the unborn. International laws, however, have codified such rights, without defining Ahuman@ or Achild@.
Article 6.1 recognizes that “every child has an inherent right to life”, and Article 6.2, “States Parties shall
ensure to the maximum extent possible the survival and development of the child.”50. This law provides
assurances of education, housing, nationality, a name, prevention of forced separation of children from
their parents. The European Social Charter Part I,(7) clearly states,” Children and young persons have
the right to a special protection against the physical and moral hazards to which they are exposed.”51

48Robert Cook-Deegan, The Gene Wars (1994) p 251.
49See Universal Declaration of Human Rights, (UDHR)Adopted and proclaimed by General Assembly
Resolution 217 A (III) December 1948, Art.23, Sec. 1. Id. International Covenant on Economic,
Social and Cultural Rights, (ICESCR) Articles 6 & 7 (b) and 10, Adopted and opened for signature,
ratification and accession by the United Nations General Assembly resolution 2200 A (XXI) on 16
December 1966.Id
50The Convention on the Rights of the Child Adopted by the United Nations General Assembly on 20
November 1989. Entered into Force on 2 September 1990 in accordance with Article 49(1).
Reprinted in: Center for the Study of Human Rights, J. Paul Martin, [Editor] Twenty Five Human Rights
Documents Columbia University, (1994)
51European Social Charter Signed by the Council of Europe on 18 October 1961. Entered into Force
on 26 February 1965. Id.
IV Application of legal concepts to labor relations and occupational health.
Spider silk jeans or spider silk Genes: can we make people who can work without sleep?
Lescohier described in the History of Labor Laws the evolution of many of the major labor laws
that had come into force in the USA before or during the Great Depression of the 1930’s. That book,52
written contemporary to the Great Depression and therefore before most of the laws impacting health in
workplaces today demonstrates that working conditions in general and employment laws that govern
them have remained remarkably unchanged despite changes in technology; few changes in
circumstances; paradigms remain surprisingly constant53 . This makes good sense, however, if we look
with a very sweeping brush of history at working conditions in different civilizations and cultures across
geographic differences, national boundaries and time. The hallmark of the 20th century was the use of
technology to undo the hard work of the Progressive Era, which brought strong wage and hour laws
and limits on work.
In recent years, Monsanto Corporation spent $8 billion developing genetically modified seeds that
it has patented54. Genetically modified seeds offer a significantly higher yield at harvest, but cannot

52 Don D. Lescohier and Elizabeth Brandeis, History of Labor in the United States, 1896-1932 MacMillan and company
Publishers New York 1935.
53This section is based on Comments to US Dept of Labor=s National Advisory Committee on
Occupational Safety and Health (NACOSH) June 6, 1997and upon a Chapter in the book,
BRINGING HEALTH TO WORK, (Emalyn Press 1997). An earlier version of this paper and the
videotape were presented at the First International conference on Occupational and Environmental
Prevention , International Commission on Occupational Health (ICOH) Rome, Italy, 1998 and Israel
Journal of Occupational Health 2000, Vol. 4, no. 1, pp 63-66 Lessons learned: three centuries of
occupational health laws (excerpts).
Emerging Case Law on Genetically Altered Food: In Brazil, a judge enjoined sale of Monsanto Corp.=s
patented soybean seeds until the government develops biosafety rules. Soybean farmers planned to buy
the seeds illegally from salesmen from Argentina, where they are legal. The farmers say they need the
seeds to boost yields and keep competitive See OCC-ENV-MED-L@LIST.MC.DUKE.EDU
Subject:[OEM] OPPT NEWSBREAK Monday 30 Aug Today’s “Toxic News for the Net”
http://www.epa.gov/opptintr/oppt_nb.txt “Brazil Battles Over Ban on Altered Beans.” Washington
Times, 30 August 99, A14. “Japanese Consumer Groups Convince Government
toLabelModifiedU.SFoods” reports that Japan will require labeling on 28 food items that contain
detectable genetically modified organisms, or GMOs. UN Rulings Regarding Genetically Modified
Food: The Codex Alimentarius Commission, the U.N. Food Safety Agency with 101 member nations
ruled unanimously in favor of the 1993 European moratorium on Monsanto’s genetically engineered
hormonal milk (rBGH). The Codex Commission ruling has stopped the US challenge to the European
moratorium before the World Trade Organization. U.S.A.=s FDA approved the sale of unlabeled
rBGH milk in February 1994, supported by the Food and Agriculture/ World Health Organization’s
reproduce themselves, so farmers must buy seeds from the patent-holder again each year. By contrast,
people cannot genetically engineer or change their own parents; people cannot genetically engineer or
predict their grandchildren.
Within these two constants, the history of agriculture, preventive measures in public health and
medicine is about legally changing the ability to achieve human potential; the possibility to improve or
enhance the human race. In the next years, humanity will have the information to change many of these
aspects of genetic destiny. Genes linked to color blindness, colon cancer, Huntington’s disease, Downs
Syndrome, or other conditions that are considered to be a Adefect@ today may be altered or deleted
through new treatments or cures. For others, genes bring special gifts, such as physical strength, great
intelligence, artistic ability or musical talent. Enhancement will be available to alter the capabilities of
individuals and in turn, human potential, unless there are specific limits or safeguards on such
enhancements under law. Maybe humans are different from foods like vegetable seeds, but maybe also
the organisms that will resemble people but will be produced as a result of genetic engineering are not
humans. Or are treated like human beings for some social purposes, but are not considered to be human
beings under laws. The law has not yet addressed the rights of people or tissue masses that are
cultivated for the manufacture and sale of human parts: Scientists demanded a moratorium on human
cloning research in 1997. In response, President Clinton proposed legislation to impose a five-year ban
on human cloning55
.

(FAO/WHO) Joint Expert Committees on Food Additives (JECFA), in its September 1998 report,
which did not find adverse veterinary or public health impacts. The Codex Committee subsequently
endorsed by the parent Codex Health Canada inJanuary1999 issued a formal”notice of
non-Compliance”, disapproving future sales of rBGH.See Monsanto’s Genetically Modified Milk Ruled
Unsafe by The United Nations; http://news.excite.com/news/pr/990818/il-un-milk-safety a. Organic
Food: International guidelines for organic foods were an agenda item of the 23rd Session of the
FAO/WHO Codex Alimentarius Commission, Rome 28 June to 3 July 1999. “International guidelines
on organically produced foods are important for consumer protection and information and because they
facilitate trade. They are also Useful to governments wishing to develop regulations in this area,
including developing countries and countries in Eastern Europe.”
www.fao.org/news/1999/990608-e.htmFuture Directions in USA Laws
55The Cloning Prohibition Act of 1997 would have banned both the public and private sectors from
using cloning technology to create a child but does not impact biomedical and agricultural advances. See
Bioethics Commission Backs Federal Human Cloning Ban Pending More Study, Debate, 15 Mealey’s
Litig. Rep.: Biotechnology, June 13, 1997, at 9 The Human Cloning Research Prohibition Act of 1997
proposed a ban on the cloning of human embryos. The Act does not restrict areas of scientific inquiry
that involves: “(1) the use of somatic cell nuclear transfer or other cloning technologies to clone
molecules, DNA, cells other than human embryo cells, or tissues; or (2) the use of somatic cell nuclear
transfer techniques to create animals other than humans.”
A. Laws Prohibiting Genetic Discrimination
Definitions of disability under law are elastic56; changing to meet new developments in genetics.
Eventually, social constructs determining the interpretation of “disability” under law may not include
certain treatable conditions, that could be “cured” or rendered less debilitating using technology
discovered through the genome project. Conversely, future interpretations of the term “disability” may
have a broader scope, expanding to include conditions and effects of chromosomal abnormalities that
have not yet been discovered57
.
1. Genetic Discrimination In Employment:
Generally, genetic information does not reveal anything about an individual’s present ability to
perform job functions safely and successfully. Rather, the information may reveal risks to the individual,
but not risks to fellow workers. The government can express some interest in the protection of its
workers against unnecessary risk of disease. Risks to co-workers could arguably support intrusive
testing to secure the safety of co-workers.58. The US Congress enacted the Americans with Disabilities
Act of 1990 (“ADA”) to protect individuals with disabilities from discrimination in such critical areas as
employment, housing, public accommodations, education, transportation, and communication59@

56EEOC: The EEOC definition of “disability” includes genetic predispositions under the Americans With
Disabilities Act, (ADA) EEOC Compliance Manual, Volume 2, EEOC Order 915.002, Section 902,
Definition o f the Term,”Disability”. at 45, “This part of the definition of “disability” applies to individuals
who are subjected to discrimination on the basis of genetic information relating to illness, disease, or
other disorders. Covered entities that discriminate against individuals on the basis of such genetic
information are regarding the individuals as having impairments that substantially limit a major life activity.
EEOC Compliance Manual 902.4(c)(2), Definition of the Term “Disability,” at 902-45 (March
1995).See Brian R. Gin, Genetic Discrimination: Huntington’s Disease and the Americans with
Disabilities Act, 97 Colum. L. Rev. 1406, 1406 (1997).
57Major life activity under ADA: US Department of Justice and the Equal Employment Opportunity
Commission define the term “major life activity” in the Code of Federal Regulations as “functions such as
caring for one[“s] self, performing manual tasks, walking, seeing, hearing, speaking, breathing, learning,
and working.” See 29 C.F.R. 1630.2(i) (1998); 28 C.F.R. 36.104(2). In Bragdon v Abbott, an
HIV-infected individual was considered disabled because the possible transfer of disease to the next
generation impaired the ability to reproduce. If a potential parent may pass a Agenetic defect@ to the next
generation, the ADA may be interpreted as prohibiting genetic discrimination as protecting such
individuals based on their impaired ability to reproduce
58 See Leckelt, 909 F.2d at 833
59ADA defines disability as “a physical or mental impairment that substantially limits … [a]
major life activity ….” 42U U.S.C. ‘. 12101(a)(3). AMajor life activity@ includes the ability to
reproduce, Bragdon v Abbott
There are few statutory limitations, but the law does not apply if a disabled person also presents a
direct threat to be “a significant risk to the health or safety of others that cannot be eliminated by a
modification of policies, practices, or procedures or by the provision of auxiliary aids or services60.”
Upon Acceptance of an offer, 42 U.S.C. ‘. 12112(d)(3)(A) allows medical testing upon acceptance
of an offer if all employees are tested as such); 29 C.F.R. 1630.14(c) “A covered entity may require a
medical examination … of an employee that is job-related and consistent with business necessity.” Under
the ADA, an employer cannot conduct pre-offer medical examinations on an applicant unless it can
prove that the information so provided was not used in making job assignments or in any other
discriminatory manner. . In addition, the employer is prohibited from asking an applicant about the
existence or severity of any disability. The employer may, however, inquire into the ability of the
applicant to perform job-related functions so long as employee disclosure is voluntary and
confidential.61According to an often-quoted EEOC policy statement, genetic discrimination falls under
the term disability as defined in the ADA.62 The Ninth Circuit has recognized the possibility of a
privacy claim based on genetic testing in a publicly owned laboratory.63 Congress enacted the
Americans with Disabilities Act of 1990 (“ADA”) to protect individuals with disabilities from
discrimination in such critical areas as employment, housing, public accommodations, education,
transportation, and communication ADA defines disability as “a physical or mental impairment that
substantially limits … [a] major life activity ….” 42 U.S.C. ‘ 12101(a)(3).
The ADA recognizes, however, the right of employers to ask questions about disabilities in limited
situations. In requesting this information the employer must inform the applicant that it is for remedial or
affirmative action purposes, it is entirely voluntary, and that the information will be kept confidential and

6042 U.S.C. ‘. 12182(b)(3) (1994).Lynda M. Fox & Sherman G. Finesilver, Genetics and the
Workplace: ADA Applicability to Genetic Information, 26 Colo. Law. 75, 75 (1997) (citing Using
Gene Tests to Deny Jobs is Ruled Illegal, N.Y. Times, Apr. 8, 1995, at A12) (reporting that the Equal
Employment Opportunity Commission considers the Use of genetic tests discriminatory if Used to deny
employment without informing the applicants of the tests.against discrimination … shall include medical
examinations and inquiries.”). 42 U.S.C..
6142 U.S.C. ‘ 12112(d)(2)(A); See also 42 U.S.C. ‘ 12112(d)(3); see also 29 C.F.R. 1630.14(b)
62See EEOC Compliance Manual 902.4(c)(2), Definition of the Term “Disability,” at 902-45 (March
1995). Lynda M. Fox & Sherman G. Finesilver, Genetics and the Workplace: ADA Applicability to
Genetic Information, Colo. Law., April 1997, at 75, 76.Vice-President Gore has been quoted as
saying, “Genetic progress should not become a new excuse for dis discrimination.” Reuters, Genes and
Discrimination: Gore Urges Laws Banning Bias in Hiring and Insurance, Newsday, Jan. 21, 1998, at
A20.
63See Norman-Bloodsaw v. Lawrence Berkeley Lab., 135 F.3d 1260, 1269 (9th Cir.
1998)(acknowledging a cause of action based on privacy
will not be Used to discriminate against the applicant. EEOC guidelines suggest that an employer may
list the essential job functions and ask an applicant whether he or she is capable of performing those
functions. After the offer of employment has been extended: ADA provides that “[a] covered entity
may require a medical examination after an offer of employment has been made to a job applicant and
prior to the commencement of the employment duties of such applicant, and may condition an offer of
employment on the results of such examination.”64 These examinations must satisfy three requirements.
First, an employer must test all entering employees regardless of disability. n94 Second, the information
collected must be maintained on separate forms and in a separate medical file and treated as
confidential. Medical examination may be used only “in accordance with this sub-chapter.” test for any
medical condition.65
ADA protects applies to individuals who are subjected to discrimination on the basis of genetic
information relating to illness, disease, or other disorders.66. Courts consider several factors in balancing
an employee’s interest against the expense to an employer. The factors to be considered include: (1) the
nature and cost of the modifications; (2) the overall financial resources of the facility; (3) the number of
employees at the facility; (4) the overall financial resources of the entire company; (5) the type of
operations of the company; and (6) the impact the accommodations would have on the operations at the
facility. See 29 C.F.R. 1630.2(p)(2). The EEOC has not given guidelines as to how each of these
factors should be weighed to determine whether accommodating a disabled worker would be an undue
hardship. See 29 C.F.R. 1630.2(p) app. at 353-54 (stating “in other cases, consideration of the
financial resources of the employer … may be inappropriate because it may not give an accurate picture
of the financial resources available to the particular facility that will actually be required to provide the
accommodation”).
B. Occupational Safety and Health Act (OSHA):
1. Purposes of OSH Act
The field of occupational health and safety encompasses many types of work and many aspects
of municipal, state and international laws that could not be embraced by any single Act of Congressional
legislation. Thus the federal Occupational Safety and Health Act of 1970 (OSH Act)67 merely

64See 29 C.F.R. 1630.14(a). The Code of Federal Regulations states that: “A covered entity may make
pre-employment inquiries into the ability of an applicant to perform job-related functions and/or may ask
an applicant to describe or to demonstrate how, with or without reasonable accommodation, the
applicant will be able to perform job-related functions.”
6542 U.S.C. ‘ 12112(d)(3); see also 29 C.F.R. 1630.14(b) (“A covered entity may require a medical
examination … after making an offer of employment … and may condition an offer of employment on the
results of such examination.”).
66EEOC Compl. Man. (BNA) 902.8(a) (1995). See also EEOC Interpretive Manual 902.4(c)(1),
Definition of the Term “Disability,” at 902-21 (March 1995)
67 29 USC ‘651.
represents one Act among several laws governing occupational safety and health legislation nationwide.
The OSH Act was passed with the express purpose: “To provide safe and healthful employment and
places of employment for every working man and woman in the Nation … by providing medical
criteria which will assure insofar as practicable that no employee will suffer diminished health,
functional capacity, or life expectancy as a result of his (sic) work experience.”
Employers may have a countervailing duty to use genetic data to protect people with genetic
predispositions to disease by excluding them from certain environments where they are more likely to be
harmed. I.e. people who are slow acetylators, and are sensitive to phenotype aromatic amines used in
dyes. See Ashford, people with this genetic propensity and exposed to certain dyes are believed to
have a higher risk of bladder cancer. This conclusion was based on Ashford’s study concerning workers
with occupational exposure to benzidine. “Qualitatively, therefore, evidence of some increased
susceptibility in this case is relatively strong. It is not possible from these limited data to calculate how
much greater the risk of similar aromatic amine exposure might be for average people with ‘slow’
phenotype. However, the indicated difference seems likely to be at least several-fold. Whether this is
enough to justify screening programs is a social policy judgment that needs to be made in light of the
absolute magnitude of the risk indicated for a specific exposed population, and other opportunities to
reduce risk.”68
2. OSHA=s Role
In the USA, OSHA=s statutory mission makes OSHA responsible for Apreserving our National
Resources@ by protecting safety and health at work. The key term is found in the title and in the
purposes, Sec 2(b) of the Occcupational Safety and Health Act of 1970 (OSH Act) where the US
Congress wrote the word, AHEALTH@. The three decade old statute is consistent with the international
laws discussed above, and clearly shares the values codified by the international human rights laws and
their cultural matrix. Promoting AHEALTH@ is not about the many issues that polarize labor and
management relations; issues that frequently cloud the progress towards achieving OSHA=s statutory
goal of protecting safety and health in every workplace throughout our nation. Promoting health is
about asking hard questions and sometimes making unpopular decisions preventing economic loss to
fragile families; preventing industrial disasters and ultimately saving human life. We do not know today,
whether the redefinition of >work@ Aemployer@ employee@ and Aoccupation@ that we will experience will
undermine occupational health laws, hard-won workers= compensation and wage and hour laws, but it
is easy to predict from this history that a great deal of scientific and medical expert testimony will be
written and evaluated in order to resolve the questions that lay at the heart of these age-old
controversies. Laws have already emerged that prohibit underwriting or rating based on specifically
identified genetic traits. Some states bar genetic testing altogether from underwriting or rating, barring
insurance industry use of genetic information broadened beyond information collected in laboratory
tests, such as the Oregon law that banned the use of genetic tests for employer-based insurance

68NICHOLAS A. ASHFORD, ET. AL. MONITORING THE WORKER FOR EXPOSURE AND DISEASE:
SCIENTIFIC, LEGAL AND ETHICAL CONSIDERATIONS IN THEUSE OF BIOMARKERS, 74 (1990).
purposes.69

C. Legal Models for Informed Consent Regarding Genetic Testing
1. Historical Antecedents of US Informed Consent Law:
Privacy is intertwined with the concept of control over oneself. Cases establishing the requirement
that a patient consent before being administered any medical treatment, every human being of adult
years and sound mind has a right to determine what shall be done with his own body, and a surgeon
who performs an operation without his patient’s consent commits an assault for which he is liable in
damages.70 These notions seem impractical, if not totally utopian in the current workplace context. The
application of these principles presumes a great deal of knowledge and choice that most workers lack in
the overall balance of power in labor relations. Further, the concept of informed consent has two pitfalls:
it presumes the state-of-the-art of genetic testing and application of genetic information will be such that
it will be reliable, without untoward side effects and without unforseen disastrous outcomes. More
importantly, the use of informed consent in the workplace context is problematic because it erodes the
workers= compensation compromise that promised workers would not be accountable under the
assumption of the risk doctrine. That doctrine was used to hold workers unduly liable for any or all
damages in the workplace for hundreds of years. It was overturned by 20th century legislation.
a. Informed Consent: “True consent to what happens to one’s self informed exercise of a choice,
and that entails an opportunity to evaluate knowledgeably the options… The average patient has little or
no understanding of the medical arts, and ordinarily has only his physician to whom he can look for
enlightenment with which to reach an intelligent decision. From these almost axiomatic considerations
springs the need, and in turn the requirement, of a reasonable divulgence by physician to patient to make
such a decision possible.” 71
2. Autonomy-Based Model For Informed Consent Law in the Wake of AIDS:
Bayer and Kirp posit two “polar ideal types”, of a “contain and control strategy” and a
“cooperation and inclusion strategy”, approach to prevention in public health policy, that is the hallmark
of the “post-antibiotic era” where patterns of behavior are “rooted in the normative structures of the
communities at risk”.AIDS-rights advocates lobbied for new laws that protect confidentiality, individual
rights and civil liberties over the traditional “coercive” approach antithetical to civil liberties: quarantine,

69TITLE 51. LABOR AND INDUSTRIAL RELATIONS CHAPTER 659. CIVIL RIGHTS;
UNLAWFUL EMPLOYMENT PRACTICES; GENETIC PRIVACY GENETIC PRIVACY
ORS @ 659.700 (1997) 659.700. Definitions for ORS 659.700 to 659.720
70Schloendorff v. Society of New York Hospital, 1914, Cardozo, J. Majority, quoted in Holtzman N
Proceed With Caution p.186
71Canterbury v. Spence 464 F.2d 772; 790-91 150 Us App. D.C. 263 (1972) at 780. This principal
has been extended to give patients the right to forgo life-sustaining medical care. Patient “consent be
obtained every time information changes hands.”Chouinard v. Marjani, 575 A.2d 238 (Conn. App. Ct.
1990).
partner notification, contact tracing, mandatory testing, registries, mandatory reporting, mandatory
testing for pregnant women as “vectors” of disease and mandatory newborn screening, all without
informed consent. Experience from the AIDS pandemic therefore initiated several legal changes that
provide a valid precedent for preserving genetic privacy to prevent discrimination by employers and
insurers
V. Conclusions: The Path Must Be Chosen Soon
Genetic technology from HGI industry will raise a host of new property, tort, and constitutional
questions. To what extent will we permit intellectual property rights in genetic tests and materials or the
actual ownership of human embryos? Will we be able to patent biological parts just as we can now
patent biologically engineered plants and bacteria? What will the law have to say about cloning human
body parts by test-tube genetic engineering or cloning a human being by manipulating germ cells? Will it
be legal to patent human genetic characteristics? And will any or all of those changes be required under
law, or for specific jobs?
This paper has described the current legal systems that will be used to address emerging genetic
testing issues in the workplace. Law may approach new genetic technologies using traditional laws
family laws, intellectual property, public health and informed consent laws or by embracing existing
definitions of discrimination. As in the case of HIV testing, the modern paradigm has shifted away from
the “invasiveness” of testing, towards a hard look at the emotional burden that testing places upon
patients and how the information will be used: whether as a vehicle for unwanted discrimination, or for
public health benefits, or commercial application of information in profitable new markets. Whether
significant scientific concepts, will play a strong role in shaping the social response, as articulated by
leigslatures and as implemented by occupational physicians in daily practice i up to the people in this
room. Although the legislature is vested with powers that science lacks, there has been a grafting of
science onto the actual laws and texts of the statutes. It can be expected that courts will admit into
evidence a vast variety of genetic information that never would have previously been acceptable in a
court of law. There is no need for a proposal for science courts, as was offered in the early 1960’s
during the Cold War and the ASpace Race@ to bring the latest technology to every school child in the
USA. Our courts of law are de facto science courts already. Instead, what is needed is not a science
court or a new set of science-evidence rules for the application of genetic technologies to daily life; a
system that will meaningfully bring genetics to the science of governance: jurisprudence, by enabling
scientists to bring their full participation and knowledge to existing judicial decisionmaking structures,
that will prohibit certain types of bad uses of information, such as the resurrection of the assumption of
the risk doctrine by providng sham forms for workplace Ainformed consent@.
The US Congress has said that science and medicine have a place and should be appropriately
integrated into the various parts of our legal system. And courts have listened by accepting all types of
scientific and medical testimony that went unheard decades or a century ago. There is ongoing concern,
however that courts will supplant their own judgement regarding the validity, reliability and probative
value of scientific evidence. This can only be remedied by having scientists sit as judges. In fact, such
courts exist under our present laws and with occupational physicians beside the legislatures as they
define genetics for future workplaces.