Regulations Under the Genetic Information Nondiscrimination Act of 2008, 9056-9071 [E9-4221]
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Federal Register / Vol. 74, No. 39 / Monday, March 2, 2009 / Proposed Rules
concerning consumer perception of fuel
rating labels. Does this new information
indicate that the Rule should be
modified? If so, why, and how? If not,
why not?
(8) Please provide any evidence that
has become available since 1993
concerning consumer interest in
particular fuel rating issues. Does this
new information indicate that the Rule
should be modified? If so, why, and
how? If not, why not?
(9) What benefits, if any, has the Rule
provided to businesses, and in
particular to small businesses? What
evidence supports the asserted benefits?
(10) What modifications, if any,
should be made to the Rule to increase
its benefits to businesses, and
particularly to small businesses?
(a) What evidence supports your
proposed modifications?
(b) How would these modifications
affect the costs and benefits of the Rule
for consumers?
(c) How would these modifications
affect the costs and benefits of the Rule
for businesses?
(11) What significant costs, including
costs of compliance, has the Rule
imposed on businesses, particularly
small businesses? What evidence
supports the asserted costs?
(12) What modifications, if any,
should be made to the Rule to reduce
the costs imposed on businesses, and
particularly on small businesses?
(a) What evidence supports your
proposed modifications?
(b) How would these modifications
affect the costs and benefits of the Rule
for consumers?
(c) How would these modifications
affect the costs and benefits of the Rule
for businesses?
(13) What evidence is available
concerning the degree of industry
compliance with the Rule? Does this
evidence indicate that the Rule should
be modified? If so, why, and how? If
not, why not?
(14) Are any of the Rule’s
requirements no longer needed? If so,
explain. Please provide supporting
evidence.
(15) What potentially unfair or
deceptive practices concerning the
rating, certifying, and posting of the
rating of automotive fuels, if any, are not
covered by the Rule?
(a) What evidence demonstrates the
existence of such practices?
(b) With reference to such practices,
should the Rule be modified? If so, why,
and how? If not, why not?
(16) What modifications, if any,
should be made to the Rule to account
for changes in relevant technology,
including development of new liquid
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alternative fuels, or economic
conditions?
(a) What evidence supports the
proposed modifications?
(b) How would these modifications
affect the costs and benefits of the Rule
for consumers and businesses,
particularly small businesses?
(17) Does the Rule overlap or conflict
with other federal, state, or local laws or
regulations? If so, how?
(a) What evidence supports the
asserted conflicts?
(b) With reference to the asserted
conflicts, should the Rule be modified?
If so, why, and how? If not, why not?
(c) Is there evidence concerning
whether the Rule has assisted in
promoting national consistency with
respect to the rating, certifying, and
posting the rating of automotive fuels?
If so, please provide that evidence.
(18) Are there foreign or international
laws, regulations, or standards with
respect to the rating, certifying, and
posting the rating of automotive fuels
that the Commission should consider as
it reviews the Rule? If so, what are they?
(a) Should the Rule be modified in
order to harmonize with these foreign or
international laws, regulations, or
standards? If so, why, and how? If not,
why not?
(b) How would such harmonization
affect the costs and benefits of the Rule
for consumers and businesses,
particularly small businesses?
List of Subjects in 16 CFR Part 306
Fuel ratings, Trade practices.
Authority: 15 U.S.C. 2801 et seq; 42 U.S.C.
17021
By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. E9–4282 Filed 2–27–09: 8:45 am]
BILLING CODE 6750–01–S
EQUAL EMPLOYMENT OPPORTUNITY
COMMISSION
29 CFR Part 1635
RIN 3046–AA84
Regulations Under the Genetic
Information Nondiscrimination Act of
2008
AGENCY: Equal Employment
Opportunity Commission.
ACTION: Proposed rule.
SUMMARY: The Equal Employment
Opportunity Commission (‘‘EEOC’’ or
‘‘Commission’’) is issuing a proposed
rule that would implement Title II of the
Genetic Information Nondiscrimination
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Act of 2008 (‘‘GINA’’). Congress enacted
Title II of GINA to protect job
applicants, current and former
employees, labor union members, and
apprentices and trainees from
discrimination based on their genetic
information. Title II of GINA requires
the EEOC to issue implementing
regulations. The Commission is
proposing these rules under that
authority to provide all persons subject
to Title II of GINA additional guidance
with regard to the law’s requirements.
The Commission invites written
comments from members of the public
on these proposed rules and on any
specific issues related to this proposal.
DATES: Comments regarding this
proposal must be received by the
Commission on or before May 1, 2009.
Please see the section below entitled
ADDRESSES and SUPPLEMENTARY
INFORMATION for additional information
on submitting comments.
ADDRESSES: You may submit comments
by any of the following methods:
By mail to Stephen Llewellyn,
Executive Officer, Executive Secretariat,
Equal Employment Opportunity
Commission, 131 M Street, NE., Suite
6NE03F, 20507.
By facsimile (‘‘FAX’’) machine to
(202) 663–4114. (There is no toll free
FAX number.) Only comments of six or
fewer pages will be accepted via FAX
transmittal, in order to assure access to
the equipment. Receipt of FAX
transmittals will not be acknowledged,
except that the sender may request
confirmation of receipt by calling the
Executive Secretariat staff at (202) 663–
4070 (voice) or (202) 663–4074 (TTY).
(These are not toll free numbers.)
By the Federal eRulemaking Portal:
https://www.regulations.gov. After
accessing this Web site, follow its
instructions for submitting comments.
Instructions: All comment
submissions must include the agency
name and docket number or the
Regulatory Information Number (RIN)
for this rulemaking. Comments need be
submitted in only one of the abovelisted formats, not all three. All
comments received will be posted
without change to https://
www.regulations.gov, including any
personal information you provide.
Copies of the received comments also
will be available for inspection in the
EEOC Library, FOIA Reading Room, by
advanced appointment only, from 9 a.m.
to 5 p.m., Monday through Friday
except legal holidays, from March 2,
2009 until the Commission publishes
the rule in final form. Persons who
schedule an appointment in the EEOC
Library, FOIA Reading Room, and need
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assistance to view the comments will be
provided with appropriate aids upon
request, such as readers or print
magnifiers. To schedule an appointment
to inspect the comments at the EEOC
Library, FOIA Reading Room, contact
the EEOC Library by calling (202) 663–
4630 (voice) or (202) 663–4641 (TTY).
(These are not toll free numbers.)
FOR FURTHER INFORMATION CONTACT:
Christopher J. Kuczynski, Assistant
Legal Counsel, or Kerry E. Leibig, Senior
Attorney Advisor, at (202) 663–4638
(voice) or (202) 663–7026 (TTY). (These
are not toll free numbers.) This notice
also is available in the following
formats: large print, Braille, audio tape,
and electronic file on computer disk.
Requests for this notice in an alternative
format should be made to the
Publications Information Center at 1–
800–669–3362 (voice) or 1–800–800–
3302 (TTY).
SUPPLEMENTARY INFORMATION:
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Introduction
On May 21, 2008, President Bush
signed the Genetic Information
Nondiscrimination Act of 2008
(‘‘GINA’’), Pub. L. 110–233, 122 Stat.
881, codified at 42 U.S.C. 2000ff et seq.
into law. Congress enacted GINA in
recognition of, among many
achievements in the field of genetics,
the decoding of the human genome and
the creation and increased use of
genomic medicine. As Congress noted,
‘‘New knowledge about genetics may
allow for the development of better
therapies that are more effective against
disease or have fewer side effects than
current treatments. These advances give
rise to the potential misuse of genetic
information to discriminate in health
insurance and employment.’’ GINA
Section 2(1), 42 U.S.C. 2000ff, note.
Experts predict that the twenty-first
century will see tremendous strides in
the new field of genomic medicine,
bringing it into mainstream medical
practice. The National Human Genome
Research Institute, the institute within
the National Institutes of Health
responsible for the mapping of the
human genome, notes that ‘‘by
identifying the genetic factors associated
with disease, researchers may be able to
design more effective drugs; to prescribe
the best treatment for each patient; to
identify and monitor individuals at high
risk from disease; and to avoid adverse
drug reactions.’’ NHGRI, The Future of
Genomic Medicine: Policy Implications
for Research and Medicine (Bethesda,
Md., Nov. 16, 2005), available at
https://www.genome.gov/17516574 (last
visited July 16, 2008).
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Many genetic tests now exist that can
inform individuals whether they may be
at risk for developing a specific disease
or disorder. But just as the number of
genetic tests increase, so do the
concerns of the general public about
whether they may be at risk of losing
access to health coverage or
employment if insurers or employers
have their genetic information. Congress
enacted GINA to address these
concerns, by prohibiting discrimination
based on genetic information and
restricting acquisition and disclosure of
such information, so that the general
public would not fear adverse
employment- or health coverage-related
consequences for having a genetic test
or participating in research studies that
examine genetic information. Scientific
advances require significant cooperation
and participation from among members
of the general public. In the absence of
such participation, geneticists and other
scientists would be hampered in their
research, and efforts to develop new
medicines and treatments for genetic
diseases and disorders would be slowed
or stymied.
GINA Title I applies to group health
plans sponsored by private employers,
unions, and state and local government
employers; issuers in the group and
individual health insurance markets;
and issuers of Medicare supplemental
(Medigap) insurance.1 Title I generally
prohibits discrimination in group
premiums based on genetic information
and the use of genetic information as a
basis for determining eligibility or
setting premiums in the individual and
Medigap insurance markets, and places
limitations on genetic testing and the
collection of genetic information in
group health plan coverage, the
individual insurance market, and the
Medigap insurance market. Title I also
provides a clarification with respect to
the treatment of genetic information
under privacy regulations promulgated
pursuant to the Health Insurance
Portability and Accountability Act of
1996 (HIPAA).
Title II of GINA prohibits use of
genetic information in the employment
context, restricts the deliberate
acquisition of genetic information by
employers and other entities covered by
Title II, and strictly limits such entities
from disclosing genetic information.
The law incorporates by reference many
of the familiar definitions, remedies,
and procedures from Title VII of the
1 These regulations do not interpret the
requirements of GINA Title I relating to genetic
nondiscrimination in health coverage. Those
requirements are administered by the Departments
of Health and Human Services, Labor, and the
Treasury.
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Civil Rights Act of 1964, as amended,
and other statutes protecting federal,
state, and Congressional employees
from discrimination.2
Summary of the Proposed Regulation
GINA section 211, 42 U.S.C. 2000ff–
10, requires the EEOC to issue
regulations implementing Title II of the
Act within one year of its enactment.
The Commission is issuing this
proposed rule in compliance with this
requirement and pursuant to the
Administrative Procedures Act, 5 U.S.C.
553. The Commission seeks public
comment on the proposed rule, the
discussion in this preamble, and other
Title II issues not addressed in either
document.
The report for the bill introduced into
the Senate in 2007 noted that ‘‘[a]s a
guiding principle, [GINA] is designed to
extend to individuals in the area of
genetic discrimination the same
procedures and remedies as are
provided under Title VII of the Civil
Rights Act of 1964, as amended [(‘‘Title
VII’’)].’’ S. Rep. No. 110–48 at 27.
Although the Senate and House
modified the bill between its initial
introduction and final passage, the idea
of extending Title VII protections to
applicants and employees in the area of
genetic information did not change.
In developing this proposed
regulation, the Commission closely
followed the terms of the statute. The
Commission’s goal is to implement the
various provisions of Title II consistent
with Congress’s intent, to provide some
additional clarification of those
provisions, and to explain more fully
those sections where Congress
incorporated by reference provisions
from other statutes. For example, where
GINA section 201(2)(A)(i) defines
employee by reference to Title VII of the
Civil Rights Act of 1964 and other
statutes, this proposed regulation
expands on that reference by importing
language from these statutes so that
those using the proposed regulation
need not refer to other sources when
determining the scope of GINA’s
coverage.3
The Commission also recognizes that
Title II of GINA includes terms that are
outside the areas of its expertise. In
particular, the definition of ‘‘genetic
2 Currently, Executive Order 13145 prohibits
federal executive branch agencies from
discriminating against applicants and employees on
the basis of genetic information and limits access
to and use of genetic information. Upon its effective
date in November 2009, GINA will protect federal
employees from genetic discrimination.
3 Unless otherwise noted, use of the term ‘‘GINA’’
means ‘‘Title II of GINA.’’ When needed for clarity,
the preamble will refer to Title I of GINA or Title
II of GINA.
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test’’ refers to ‘‘analysis of human DNA,
RNA, chromosomes, proteins, or
metabolites that detects genotypes,
mutations, or chromosomal changes.’’
None of these terms are common to
employment discrimination law. For
this reason, Commission staff sought
and obtained technical assistance from
the National Human Genome Research
Institute, the institute within the
National Institutes of Health responsible
for decoding the human genome and for
developing technologies applicable to
the study of the genetic components of
complex disorders.
The Commission also coordinated
with the Departments of Labor (DOL),
Health and Human Services (HHS), and
the Treasury, which have responsibility
for issuing regulations applicable to
GINA Title I. In particular, DOL, HHS
(the Centers for Medicare & Medicaid
Services) and the Treasury (the Internal
Revenue Service) are responsible for
issuing regulations applicable to GINA
sections 101–103. The HHS Office for
Civil Rights is responsible for issuing
the regulations applicable to GINA
section 105. The National Association of
Insurance Commissioners has issued
conforming model regulations relating
to section 104. Among the various Title
II provisions are several that address the
relationship between Title I and Title II,
and the relationship between Title II
and several statutes that the
Departments enforce, including the
Employee Retirement Income Security
Act of 1974 (ERISA), the Public Health
Service Act, the Internal Revenue Code,
and HIPAA.
Section-by-Section Analysis of the
Regulation
Section 1635.1
Purpose
In this section, the Commission sets
forth the general purposes of GINA.
Title II of GINA restricts the deliberate
acquisition of genetic information by
covered entities, prohibits use of genetic
information in employment decisionmaking, requires that genetic
information be kept confidential (which
includes maintaining written genetic
information that exists in paper or
electronic form as a confidential
medical record), and places strict limits
on disclosure of genetic information.
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Section 1635.2
Definitions—General
The Commission reiterates the
definitions set forth in GINA section
201, many of which come from Title VII
of the Civil Rights Act of 1964.
However, where the statute merely
incorporates by reference different
categories of covered employees, the
proposed regulation describes more
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fully the employees GINA protects.
Moreover, GINA specifically provides
that the term ‘‘employee’’ includes
applicants, see 42 U.S.C. 2000ff–1(a)(1),
and the Supreme Court has held that the
term ‘‘employee’’ under Title VII
includes former employees. See
Robinson v. Shell Oil Co., 519 U.S. 337,
346 (1997). Accordingly, the proposed
regulation makes clear that the term
‘‘employee’’ includes an applicant and a
former employee. Similarly, the
proposed regulation provides a concise
explanation of the employers covered by
GINA, rather than following the statute’s
example of providing citations to
definitions of ‘‘employer’’ provided by
other laws. For example, the proposed
regulation explains that Indian tribes, as
well as bona fide private clubs (other
than labor organizations) that are
exempt from taxation under section
501(c) of the Internal Revenue Code of
1986, are not employers, rather than
merely referring to Title VII’s exclusion
of these groups from the definition of
‘‘employer.’’ See 42 U.S.C. 2000e(b)(1)
and (2).
The proposed regulation includes a
definition of ‘‘covered entity.’’ This
proposed regulation uses the term to
refer to all entities subject to Title II of
GINA: The different categories of GINAcovered employers (private sector, state
and local government, Congressional
employers, executive branch, federal/
civil service), as well as employment
agencies, labor organizations, and joint
labor-management training and
apprenticeship programs. The proposed
regulation uses the term ‘‘covered
entity’’ when describing the
requirements or prohibited practices
applicable to all entities subject to Title
II of GINA, thus avoiding some of the
repetition found in sections 202–205 of
the statute. This use of the term
‘‘covered entity’’ as a simplifying
shorthand to aid in the readability of the
proposed regulation is similar to EEOC’s
use of ‘‘covered entity’’ in the regulation
implementing Title I of the Americans
with Disabilities Act, 42 U.S.C. 12111
(ADA). The term ‘‘covered entity’’ in
this proposed regulation is not intended
to be synonymous with use of the same
term in Title I of GINA, in regulations
implementing Title I of GINA or HIPAA,
or in section 206(c) of GINA (which
specifically refers to HIPAA covered
entities).
The proposed regulation says that the
term ‘‘covered entity’’ includes an
‘‘employing office.’’ The term
‘‘employing office,’’ referenced in
sections 201 and 207 of GINA, is used
in the Congressional Accountability Act,
which protects employees in the
legislative branch. See 2 U.S.C. 1301(9).
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Although the EEOC has no enforcement
authority under the Congressional
Accountability Act, as the only agency
with authority to issue regulations
under Title II of GINA, we believe that
referencing that law in this proposed
regulation is appropriate to put
employees in the legislative branch and
covered employing offices on notice of
their rights and responsibilities under
GINA.
Section 1635.3 Definitions Specific to
GINA
GINA includes six terms not found in
any of the other employment
discrimination statutes that the
Commission enforces. This proposed
regulation provides some additional
guidance regarding these terms, and
EEOC seeks comment both as to what is,
and is not, included in this preamble or
in the text of the proposed regulation.
The Commission notes that DOL, HHS,
and the Treasury have published a
Request for Information (RFI) under
GINA Title I. See 73 FR 60208 (October
10, 2008). All comments submitted
under this proposed rule and the RFI are
being shared among the Federal
Agencies.
Section 1635.3(a) Family Member
The statute defines an individual’s
‘‘family member’’ both by reference to
ERISA section 701(f)(2) and as
extending to the individual’s fourth
degree relatives. First, section 201(3)(a)
of GINA states that family member is
defined as ‘‘a dependent (as that term is
used for purposes of section [701(f)(2) of
ERISA]’’ of the individual. For purposes
of Title II, the Commission has
determined that the dependents covered
by Title II are limited to persons who
are or become related to an individual
through marriage, birth, adoption, or
placement for adoption.4
Second, GINA includes as family
members persons related from the first
to the fourth degree of an individual.
The degree of relationship, which
reflects the average proportion of genes
in common between two individuals, is
determined by counting generational
levels separating them. The GINA
4 The Commission’s definition of ‘‘dependent’’ is
solely for purposes of interpreting Title II of GINA,
and is not relevant to interpreting the term
‘‘dependent’’ under Title I of GINA or under section
701(f)(2) of ERISA and the parallel provisions of the
Public Health Service Act and the Internal Revenue
Code. The Commission believes its interpretation of
the term ‘‘family member,’’ particularly the way in
which GINA’s reference to section 701(f)(2) of
ERISA relates to that term, is consistent with the
plain language of both section 701(f)(2) and Title II
of GINA, furthers Congress’s intent to prohibit
genetic discrimination in the employment context,
and provides covered entities with clear standards
governing compliance with the law.
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provisions thus include the individual’s
children, siblings, and parents (first
degree) and extend to great-great
grandparents and first cousins once
removed (the children of a first cousin),
as well as family members who are in
between the individual and these
persons (including parents, siblings,
half-siblings, nieces, nephews,
grandparents, great grandparents, aunts,
uncles, great aunts and uncles, and first
cousins).
Section 1635.3(b)
History
Family Medical
The proposed regulation includes a
definition of ‘‘family medical history’’
because it is a term used in the statute’s
discussion of prohibited employment
practices, but it is not specifically
defined by the statute. In the legislative
history of GINA, Congress stated that
the term ‘‘family medical history
[should] be understood as it is used by
medical professionals when treating or
examining patients.’’ S. Rep. No. 110–
48, at 16. In particular, the Senate
Report notes as follows:
[T]he American Medical Association (AMA)
has developed an adult family history form
as a tool to aid the physician and patient to
rule out a condition that may have developed
later in life, which may or may not have been
inherited. This form requests information
about the patient’s brothers, sisters, and their
children, biological mother, the mother’s
brothers, sisters, and their children, maternal
grandfather, maternal grandmother,
biological father, the father’s brothers, sisters,
and their children, paternal grandfather and
paternal grandmother. The committee
expects that the use of ‘‘family history’’ in
this bill will evolve with the medical
profession and the tools it develops in this
area.
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Id. The Report further notes that ‘‘a
family medical history could be used as
a surrogate for a genetic trait,’’ id., and
that the definition of ‘‘genetic
information’’ had to include ‘‘family
medical history’’ to prevent a covered
entity from making decisions about an
individual’s health based on the
existence of an inheritable disease of a
family member. See also id. at 28
(reiterating the Title I discussion of
family medical history in the Report
section addressing Title II).5
5 Since 2004 the U.S. Surgeon General’s Family
History Initiative has actively promoted the
collection and use of family history information in
clinical settings, including featuring a bilingual
Web-based tool through which the user creates and
organizes his/her family health history (https://
www.hhs.gov/familyhistory/). GINA is not intended
to limit the collection of family medical history by
health care professionals for diagnostic or treatment
purposes.
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Section 1635.3(c) Genetic Information
GINA section 201(4) and the proposed
regulation define genetic information to
include information from genetic tests,
the genetic tests of family members,
family medical history, and genetic
information of a fetus carried by an
individual or an individual’s family
member or an embryo lawfully held by
an individual or family member
receiving assistive reproductive
services. Genetic information also
includes information about an
individual’s or family member’s request
for or receipt of genetic services. The
statute and proposed regulation exclude
from coverage information about an
individual’s or family member’s age or
gender.
Section 1635.3(d) Genetic Monitoring
Genetic monitoring is defined in
GINA section 201(5) as the ‘‘periodic
examination of employees to evaluate
acquired modifications to their genetic
material * * * caused by the toxic
substances they use or are exposed to in
performing their jobs.’’ The proposed
regulation uses language similar to that
found in the statute in defining the
term. As more fully described in
1635.8(b)(5) and its accompanying
Preamble discussion, a covered entity
may acquire genetic information as part
of genetic monitoring that is either
required by law or voluntarily
undertaken, provided the entity
complies strictly with certain
conditions.
Section 1635.3(e) Genetic Services
The term ‘‘genetic services’’ is defined
in GINA section 201(6). It includes
genetic tests, genetic counseling, and
genetic education. Making an
employment decision based on
knowledge that an individual has
received genetic services violates GINA,
even if the covered entity is unaware of
the specific nature of the genetic
services received or the specific
information exchanged in the course of
providing them.
Section 1635.3(f) Genetic Test
GINA section 201(7) defines ‘‘genetic
test’’ to mean the ‘‘analysis of human
DNA, RNA, chromosomes, proteins, or
metabolites, that detects genotypes,
mutations, or chromosomal changes.’’
Genetic tests are used to detect gene
variants associated with a specific
disease or condition. For example, tests
to determine whether an individual
carries the genetic variant evidencing a
predisposition to breast cancer—
whether the individual has the BRCA1
or BRCA2 variant—or to determine
whether an individual has a genetic
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variant associated with hereditary
nonpolyposis colorectal cancer are
genetic tests. It is important to note,
however, that the presence of a genetic
variant relating to a predisposition to
disease is not evidence of, and does not
equate to, disease. Similarly, a positive
test for a genetic variant as strongly
penetrant as Huntington’s Disease does
not equate to the presence of the
disease, even though development of
the disease is almost inevitable.
The Commission invites comments on
the scope of the term ‘‘genetic test.’’ The
proposed regulation includes two
examples of tests that are not genetic: a
test for the presence of a virus that is not
composed of human DNA, RNA,
chromosomes, proteins, or metabolites
and a test for drug or alcohol use.
Another example of what is not a
genetic test and might be mentioned,
either in the text of the regulation or in
the final preamble, is a test for
infectious and communicable diseases
that may be transmitted through food
handling, which, the Commission
believes, is not covered by the definition
of ‘‘genetic test.’’ Similarly, routine tests
such as complete blood counts,
cholesterol tests, and liver-function tests
would not be protected under GINA. We
seek comment as to how the term
should be applied, whether the
proposed regulation should be more or
less expansive, and whether it or the
preamble should provide examples of
what should be included or excluded.
The Commission further notes that
the Title II definition of ‘‘genetic test’’
differs from the definition of this term
in Title I. Specifically, the Title II
definition of ‘‘genetic test’’ does not
have the express exclusion that Title I
does for ‘‘an analysis of proteins or
metabolites that is directly related to a
manifested disease, disorder, or
pathological condition that could
reasonably be detected by a health care
professional with appropriate training
and expertise in the field of medicine
involved.’’ GINA 101(d), 29 U.S.C.
1191b–(d)(7)(B). Title II does not require
this language of exclusion because
Congress determined that these uses
‘‘are not applicable in the employment
context.’’ S. Rep. No. 110–48 at 28.
However, as explained below, the
Commission borrowed from Title I’s use
of the term ‘‘manifest’’ in the definition
of ‘‘genetic test’’ in formulating a
definition of ‘‘manifested or
manifestation.’’
Section 1635.3(g) Manifestation or
Manifested
We have added a definition of
‘‘manifestation or manifested’’ to the
proposed regulation, because sections
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201(4)(A)(iii) and 210 use the terms.
Specifically, GINA section
201(4)(A)(iii), defining ‘‘genetic
information,’’ refers to the
‘‘manifestation of a disease or disorder
in family members’’ of an individual,
and section 210, entitled ‘‘Medical
information that is not genetic
information,’’ refers to a ‘‘manifested
disease, disorder, or pathological
condition.’’ The definition of
‘‘manifestation or manifested’’ was
developed with the assistance of the
National Human Genome Research
Institute, an Institute within the
National Institutes of Health. The
proposed regulation defines
‘‘manifestation or manifested’’ to mean,
with respect to a disease, disorder, or
pathological condition:
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That an individual has been or could
reasonably be diagnosed with the disease,
disorder, or pathological condition by a
health care professional with appropriate
training and expertise in the field of
medicine involved. For purposes of this part,
a disease, disorder, or pathological condition
is not manifested if the diagnosis is based
principally on genetic information or on the
results of one or more genetic tests.
This understanding of the term
‘‘manifested’’ is consistent both with the
definition of genetic test found in Title
I, which permits use of certain
diagnostic tests in order to determine
whether an individual has a current—or
manifest—disease, disorder, or
condition, see id. at 16, and with the
notion, discussed above in conjunction
with the definition of genetic test
(section 1635.3(f)), that the mere
presence of a genetic variant does not
mean that an individual has an
associated condition, disease, or
disorder. The presence of a genetic
variant alone does not constitute a
diagnosis; other signs or symptoms must
be present. This interpretation is
consistent with current ERISA
regulations which prohibit a group
health plan, and a health insurance
issuer offering group health insurance
coverage, from imposing a preexisting
condition exclusion relating to a
condition based solely on genetic
information. However, if an individual
is diagnosed with a condition, even if
the condition relates to genetic
information, the plan may impose a
preexisting condition exclusion with
respect to the condition, subject to other
HIPAA portability requirements. See 29
CFR 2590.701–3(b)(6)(i). Thus, for
example, a woman who has group
health plan coverage and has the BRCA1
gene variant may not be subject to a
preexisting condition exclusion merely
because she has the variant. Id. Example
at 2590.703(b)(6)(ii).
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Similarly, Huntington’s disease (HD)
is an example of a genetic disease that
is not diagnosed solely through use of
a genetic test; other signs and symptoms
must be present. The presence of the
genetic variant virtually guarantees the
later development of disease, but the
disease does not usually manifest until
adulthood. Therefore, even when a
genetic variant is 100 percent predictive
for development of disease, the presence
of the variant does not by itself equal
diagnosis of the disease.
Section 1635.4
In General
Prohibited Practices—
In describing the prohibited practices
under GINA Title II, Congress adopted
language similar to that used in Title VII
and other equal employment statutes,
evincing its intent to prohibit
discrimination with respect to a wide
range of covered entity practices,
including hiring, promotion and
demotion, seniority, discipline,
termination, compensation, and the
terms, conditions, and privileges of
employment. In separate GINA sections
203–205, the statute notes additional
covered actions of employment agencies
(failing or refusing to refer for
employment), labor unions (excluding
or expelling from membership), and
training, retraining, and apprenticeship
programs (denying admission to or
employment in such programs).
Section 1635.5 Limiting, Segregating,
and Classifying
The proposed regulation reiterates the
statutory language barring actions by
covered entities that may limit,
segregate, or classify employees because
of genetic information. For example, an
employer could not reassign someone
whom it learned had a family medical
history of heart disease from a job it
believed would be too stressful and
might eventually lead to heart-related
problems for the employee. This section
also makes clear that although the
language of the statute specifically
prohibits actions that have the ‘‘purpose
or effect’’ of limiting, segregating, or
classifying individuals on the basis of
genetic information, neither the statute
nor the proposed regulation creates a
cause of action for disparate impact.
Section 208 of GINA specifically
prohibits such actions, and establishes
the Genetic Non-Discrimination Study
Commission, to examine ‘‘the
developing science of genetics’’ and
recommend to Congress ‘‘whether to
provide a disparate impact cause of
action under this Act.’’ The proposed
regulation does not address the
establishment of this Commission,
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which is scheduled to begin its work on
May 21, 2014.
Section 1635.6 Causing an Employer
To Discriminate
GINA sections 203(c), 204(c), and
205(d) expressly bar employment
agencies, labor organizations, and
apprenticeship or other training
programs from causing an employer to
discriminate on the basis of genetic
information. These sections recognize
that employers engage in most of the
employment-related activities that the
Act reaches. Other covered entities,
however, might engage in conduct that
could cause an employer to
discriminate. For example, an
employment agency or union might
share or attempt to share genetic
information it obtained (whether legally
or not) about a client or member with
an employer in an effort to affect the
individual’s employment prospects.
Such conduct would violate sections
203(c) and 204(c).
Although section 202 does not
include a similar provision explicitly
prohibiting an employer from causing
another covered entity to discriminate,
it is well settled under Title VII that the
definition of employer includes
employers’ agents under common law
agency principles. See Vinson v. Meritor
Savings Bank, 477 U.S. 57, 72 (1986).
Because GINA incorporates Title VII’s
definition of employer, including the
application of common law agency
principles, GINA would bar an
employer from engaging in actions that
would cause another covered entity
acting as its agent to discriminate. For
example, an employer that directed an
employment agency to ask applicants
for genetic information or told the
employment agency not to send it
candidates with a family medical
history for certain conditions would
violate GINA. An employment agency
that acted pursuant to the employer’s
direction would be liable for violating
GINA either directly, because the law
applies to employment agencies, or as
an agent of the employer. Similarly, an
employer would violate GINA if it used
a labor organization’s hiring hall to
obtain genetic information in making
job referrals, and the labor union would
be liable under GINA either directly or
as the employer’s agent.
Section 1635.7 Retaliation
The proposed regulation reiterates the
statutory prohibition against retaliation
where an individual opposes any act
made unlawful by GINA, files a charge
of discrimination or assists another in
doing so, or gives testimony in
connection with a charge. Because
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Congress adopted in GINA the language
of the anti-retaliation provision in Title
VII of the Civil Rights Act of 1964, the
Commission believes that Congress
intended the standard for determining
what constitutes retaliatory conduct
under GINA to be the same as the
standard under Title VII, as announced
by the Supreme Court in Burlington
Northern & Santa Fe Ry. v. White, 548
U.S. 53 (2006). In that case, the Court
held that Title VII’s anti-retaliation
provision protects an individual from
conduct, whether related to
employment or not, that a reasonable
person would have found ‘‘materially
adverse,’’ meaning that the action ‘‘well
might have ‘dissuaded a reasonable
worker from making or supporting a
charge of discrimination.’ ’’ Id. at 57–58
(citations omitted).
Section 1635.8 Acquisition of Genetic
Information
Each of the discrete GINA sections
addressing the conduct of employers,
employment agencies, labor
organizations, and apprenticeship or
other training programs includes a
section prohibiting covered entities
from requesting genetic information
from applicants, employees or other
individuals; from requiring that
applicants or employees provide genetic
information; or from purchasing genetic
information about an applicant or
employee. Each section also includes
the same five exceptions. Sections 202,
covering employers, and 205 covering
joint labor-management training and
apprenticeship programs, include a
sixth exception. The proposed
regulation addresses each of the
exceptions. Covered entities are
cautioned, however, that the use of
genetic information to discriminate, no
matter how that information may have
been acquired, is prohibited.
Inadvertently Requesting or Requiring
Genetic Information: First, a covered
entity that ‘‘inadvertently requests or
requires family medical history’’ from
an individual does not violate GINA.
Congress intended this exception to
address what it called the ‘‘ ‘water
cooler problem’ in which an employer
unwittingly receives otherwise
prohibited genetic information in the
form of family medical history through
casual conversations with an employee
or by overhearing conversations among
co-workers.’’ S. Rep. No. 110–48, at 29;
see also H.R. Comm. on Education and
Labor, Genetic Information
Nondiscrimination Act of 2007, H.R.
Rep. No. 110–28 part I, 37–38 (2008)
(H.R. Rep. No. 110–28, part I). Congress
did not want casual conversation among
co-workers regarding health to trigger
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federal litigation whenever someone
mentioned something that might
constitute protected family medical
history. The Commission’s proposed
regulation thus notes that a covered
entity inadvertently acquires family
medical history where a manager or
supervisor overhears a conversation
among co-workers that includes
information about family medical
history (e.g., a conversation in which
one employee tells another that her
father has Alzheimer’s Disease), or
receives an unsolicited e-mail message
from a co-worker that includes genetic
information.
Although the language of this
exception in GINA specifically refers to
family medical history, the Commission
believes that it is consistent with
Congress’s intent to extend the
exception to any genetic information
that an employer inadvertently acquires.
The Commission does not believe, for
example, that Congress intended that an
employer would be liable for the
acquisition of genetic information
because it overhears a conversation in
which one employee tells another that
her mother had a genetic test to
determine whether she was at increased
risk of getting breast cancer. If the
exception were read to cover only
family medical history, this type of
acquisition of genetic information
would violate GINA, even though it
occurred inadvertently, because
information that a family member has
had a genetic test, while genetic
information, is not information about
the occurrence of a disease or disorder
in a family member.
The Commission also understands
this exception to apply in any situation
in which an employer might
inadvertently acquire genetic
information, not just situations
involving conversations between coworkers that are overheard. The
proposed regulation provides an
illustrative list of situations where we
believe the acquisition comes within
Congress’s intent. Thus, for example,
the exception applies when the covered
entity, acting through a supervisor or
other official, receives family medical
history directly from an individual
following a general health inquiry (e.g.,
‘‘How are you?’’) or a question as to
whether the individual has a manifested
condition. Similarly, a casual question
between colleagues, or between a
supervisor and supervisee, concerning
the health of a parent or child would not
violate GINA (e.g., ‘‘How’s your son
feeling today?’’).
A covered entity that asks for family
medical history or other genetic
information as part of an inquiry or
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medical examination related to an
applicant’s or employee’s manifested
disease, disorder, or pathological
condition will not be considered to have
acquired such information
inadvertently. Thus, even though the
ADA allows an employer to require a
medical examination of all employees to
whom it has offered a particular job, for
example, to determine whether they
have heart disease that would affect
their ability to perform a physically
demanding job, GINA would prohibit
inquiries about family medical history
of heart disease as part of such an
examination. Such a limitation will not
affect an employer’s ability to use a
post-offer medical examination for the
limited purpose of determining an
applicant’s current ability to perform a
job.
Covered entities should ensure that
any medical inquiries they make or any
medical examinations they require are
modified so as to comply with the
requirements of GINA. In particular, we
note that at present, the ADA permits
employers to obtain medical
information, including genetic
information, from post-offer job
applicants. As we interpret GINA, this
will change on the November 21, 2009
effective date of Title II of GINA:
Employers no longer will be permitted
to obtain any genetic information,
including family medical history, from
post-offer applicants. Employers will
likewise be prohibited from obtaining
this type of information through any
type of medical examination required of
employees for the purpose of
determining continuing fitness for duty.
However, Title II of GINA will not
apply to information obtained by a
health care professional in the course of
a medical examination, diagnosis, or
treatment unrelated to a determination
of fitness for duty, except to the extent
the information is obtained as part of an
employer-provided voluntary wellness
program subject to 1635.8(b)(2) of this
proposed rule. For example, a doctor
working at a hospital may ask for family
medical history from a hospital
employee who requests a medical
examination. See 29 CFR 1635.8(b)(2)
(allowing collection of genetic
information, under certain specified
conditions, when an employer offers
health or genetic services as part of a
voluntary wellness program).
The proposed regulation notes that
when a covered entity seeks information
from an individual who requests a
reasonable accommodation under the
ADA or other state or local law, the
acquisition of genetic information as
part of the documentation that the
individual provides in support of the
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request is considered inadvertent, as
long as the request for documentation
was lawful (e.g., was not overly broad).
For information on the type of medical
information an employer may lawfully
request in connection with a request for
reasonable accommodation see EEOC’s
Enforcement Guidance on Reasonable
Accommodation and Undue Hardship
Under the Americans with Disabilities
Act, EEOC Notice No. 915.002 (Oct. 17,
2002), available at https://www.eeoc.gov/
policy/docs/accommodation.html. We
note that GINA’s prohibition on
requesting, requiring, or purchasing
genetic information would control
during the interactive process used to
determine an appropriate reasonable
accommodation. The Commission
knows of no reason why a covered
entity would need to request genetic
information to determine an
individual’s current physical or mental
limitations and whether those
limitations can be accommodated.
The Commission further recognizes
that other federal, state, or local laws
may allow covered entities to obtain
medical information about employees
(other than genetic information). The
proposed regulation makes it clear that
a covered entity that inadvertently
receives genetic information in response
to a lawful request for medical
information under such a law would not
violate GINA, including, for example,
where a covered entity received genetic
information in connection with the
FMLA’s employee return to work
certification requirements.
The Commission believes that the first
exception to the general prohibition of
requesting, requiring, or purchasing
genetic information should also apply
when an individual requests leave
pursuant to a leave policy independent
of a federal, state, or local leave or
disability law, unless the covered
entity’s request was overbroad. For
example, a request for an employee’s
entire medical record or the entire
medical record related to a particular
impairment is likely to include family
medical history. An employer who
receives family medical history or other
genetic information in response to such
a broad request would violate GINA. For
information on the appropriate scope of
inquiries in response to requests for
leave (other than as a reasonable
accommodation), see EEOC’s
Enforcement Guidance on DisabilityRelated Inquiries and Medical
Examinations of Employees Under the
Americans with Disabilities Act, 8 Fair
Empl. Prac. Man. (BNA) 405:7701,
Questions 15–17 (July 27, 2000)
(‘‘Enforcement Guidance’’), available at
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https://www.eeoc.gov/policy/docs/
guidance-inquiries.html.
In addition to complying with
relevant EEOC guidance, covered
entities may wish to take proactive
measures to avoid even the inadvertent
acquisition of genetic information. For
example, as a best practice, an employer
that asks an employee to have a health
care professional provide
documentation about a disability in
support of a request for accommodation
could specifically indicate on a
questionnaire provided for this purpose
that family medical history or other
genetic information about the employee
should not be provided.
Health or Genetic Services: Second,
GINA permits covered entities to offer
health or genetic services, and notes that
a covered entity that meets specific
requirements may offer such services as
a part of a wellness program. The
proposed regulation reiterates the
statutory provision, but further notes
that a wellness program seeking medical
information must be voluntary, which is
a requirement set forth in the ADA. The
Commission notes that according to the
Enforcement Guidance, a wellness
program is voluntary ‘‘as long as an
employer neither requires participation
nor penalizes employees who do not
participate. Id., Question 22. The
Commission has not further addressed
how the term ‘‘voluntary’’ should be
defined for purposes of the ADA’s
application to wellness programs. We
invite comments regarding the scope of
this term.
The proposed regulation lists the
specific requirements in the statute as
prerequisites to the acquisition of
genetic information when providing
genetic services: A request in writing
and in language reasonably likely to be
understood by the individual from
whom the information is sought; a
description of the information being
requested; and a description of the
safeguards in place to protect against
unlawful disclosure. The proposed
regulation states that individually
identifiable information may be
provided only to the individual from
whom it was obtained and that covered
entities are entitled only to receive
information in aggregate terms that do
not disclose the identity of specific
individuals. Although not stated in the
proposed regulation, a covered entity
that receives ‘‘aggregate’’ information
may still violate GINA where the small
number of participants, alone or in
conjunction with other factors, makes
an individual’s genetic information
readily identifiable.
The Commission notes that although
this provision permits covered entities
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to implement wellness programs that
seek family medical history voluntarily,
other provisions in GINA Title I place
strict limits on the genetic information
that group health plans may request or
require from covered individuals. In this
regard, the Commission further notes
that DOL, HHS and the Treasury are
responsible for addressing the
limitations on group health plans and
insurance issuers under Title I. Covered
entities that sponsor, establish, or
maintain group health plans that
implement wellness programs or other
health-related services are cautioned to
consider carefully whatever limitations
these Departments place on group
health plans with respect to the
acquisition of genetic information.
The Commission also notes that
Congress made clear at section 206(c)
that GINA’s Title II provisions are not to
be construed to interfere with or
otherwise apply to uses and disclosures
of health information that are governed
by the privacy regulations promulgated
pursuant to HIPAA (‘‘the HIPAA
Privacy Rule’’). As discussed below, the
proposed rule implements this general
statutory provision at proposed
1635.11(d) by excluding from coverage
genetic information that is health
information otherwise protected by the
HIPAA Privacy Rule. Consistent with
proposed 1635.11(d), the Commission
further notes that nothing in section
1635.8 should be read as applying to or
otherwise restricting the use or
disclosure of genetic information that is
protected health information subject to
the HIPAA Privacy Rule. Thus, where a
health care provider covered by the
HIPAA Privacy Rule is providing health
or genetic services, that provider is
subject to the requirements of the
HIPAA Privacy Rule with regard to uses
and disclosures of protected health
information, including HIPAA’s
conditions on disclosures to employers,
and not this proposed regulation’s
provisions.
Family and Medical Leave Act: Third,
GINA recognizes that individuals
requesting leave under the Family and
Medical Leave Act (FMLA) or similar
state or local law might provide family
medical history. For example, an
individual requesting FMLA leave to
care for a seriously ill relative may
disclose family medical history when
completing the certification required by
section 103 of the FMLA. A covered
entity that receives family medical
history under these circumstances
would not violate GINA. Because this
information is still subject to GINA’s
confidentiality requirements, however,
the information must be placed in a
separate medical file and must be
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treated as a confidential medical record,
as more fully described below.
Commercially and Publicly Available
Information: Fourth, GINA provides an
exception for the purchase of
commercially and publicly available
materials that may include family
medical history. As with the exception
applicable to the inadvertent acquisition
of family medical history, the
Commission reads this exception as
applying to all genetic information, not
just to family medical history. For
example, an employer would not violate
GINA if it learned that an employee had
the breast cancer gene by reading a
newspaper article profiling several
women living with the knowledge that
they have the gene.
The statute identifies newspapers,
magazines, periodicals, and books as
potential sources of genetic information.
The proposed regulation adds to that list
information obtained through electronic
media, such as the Internet, television,
and movies. The exception does not
include family medical history
contained in medical databases or court
records. Research databases available to
scientists on a restricted basis, such as
databases that NIH maintains for the
scientific community, would not be
considered ‘‘commercially and publicly
available.’’ The Commission invites
public comment on whether there are
sources similar in kind to those
identified in the statute that may
contain family medical history and
should be included either in the group
of excepted sources or the group of
prohibited sources, such as personal
Web sites, or social networking sites.
Further, we would appreciate comment
regarding whether the additional
sources that are noted in the proposed
regulation should be deemed similar in
nature to those contained in the statute
so as to remain a part of the regulation.
Genetic Monitoring: Fifth, the statute
permits a covered entity to engage in the
genetic monitoring of the biological
effects of toxic substances in the
workplace. The statute and proposed
regulation note that monitoring must
meet certain requirements. First, a
covered entity must provide written
notice of the monitoring and, where the
monitoring is not specifically required
by federal or state law, must obtain an
individual’s prior knowing, written, and
voluntary authorization. Second, the
proposed regulation describes the type
of authorization the employer must
provide in order to ensure that it is
knowing and voluntary. The
authorization must be written in a way
that is reasonably likely to be
understood by the person from whom
the information is being sought, must
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describe the type of genetic information
that will be obtained and the general
purposes for which it will be used, and
must describe the limitations on
disclosure of the genetic information.
Third, all monitoring must comply with
all applicable provisions of the law and
implementing regulations, including
regulations promulgated pursuant to the
Occupational Safety and Health Act of
1970 (29 U.S.C. 651 et seq.), the Federal
Mine Safety and Health Act of 1977 (30
U.S.C. 801 et seq.) , and the Atomic
Energy Act of 1954 (42 U.S.C. 2011 et
seq.).
Whether or not the monitoring is
undertaken pursuant to federal or state
law, GINA requires that the individual
receive results of the monitoring and
that the covered entity receive
information only in aggregate terms that
do not disclose the identity of specific
individuals. As noted above in the
paragraph addressing genetic services,
covered entities that engage in genetic
monitoring, particularly when done on
a voluntary basis, are cautioned where
the monitoring encompasses only a few
individuals: Information obtained in the
aggregate may make a particular
individual’s genetic information
identifiable.
DNA Testing for Law Enforcement or
Human Remains Identification
Purposes: Finally, sections 202(b),
covering employers, and 205(b),
covering apprenticeship or other
training programs, include a sixth
exception for employers that engage in
DNA testing for law enforcement
purposes as a forensic lab or for
purposes of human remains
identification. GINA provides that these
entities may request or require ‘‘genetic
information of such employer’s
employees, apprentices, or trainees, but
only to the extent that such genetic
information is used for analysis of DNA
identification markers for quality
control to detect sample contamination
and maintained in a manner consistent
with such use.’’ This is a very limited
exception and, if properly conducted,
an employer or training program would
not obtain health-related genetic
information. The EEOC invites
comments on the impact of this
exception on law enforcement.
Section 1635.9
Confidentiality
GINA section 206 addresses
confidentiality of genetic information
generally, establishes permitted
disclosures, and describes the
relationship between GINA and HIPAA.
Each of these items is discussed below.
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Section 1635.9(a) Treatment of Genetic
Information
Under GINA, covered entities are
required to treat genetic information the
same way they treat medical
information generally. That is, covered
entities in possession of genetic
information must keep the information
confidential and, if the information is in
writing, must keep it apart from other
personnel information in separate
medical files.6 Congress made express
the requirement that covered entities
keep genetic information confidential by
using the confidentiality regime
required by the ADA generally for
medical records. H.R. Rep. 110–28, part
I, at 39. GINA does not require that
covered entities maintain a separate
medical file for genetic information.
Genetic information may be kept in the
same file as medical information subject
to the ADA.
As noted above, a covered entity does
not violate GINA when it acquires
genetic information available through
publicly available sources. For example,
an employer that purchased a
newspaper with an obituary about a
family member of an employee
indicating that the employee’s relative
died of a disease or disorder that has a
genetic component would not violate
GINA. Similarly, a labor organization
may lawfully acquire a magazine or
periodical with an article about a
member that includes family medical
history information about the member’s
parent, sibling, or child. In neither
instance, nor in any similar instance
where a covered entity acquires family
medical history through publicly
available sources, must the covered
entity place the information into a
confidential medical file. Moreover,
inasmuch as one of GINA’s purposes is
the protection from disclosure of
otherwise private genetic information,
disclosure of publicly available
information does not violate the Act.
However, a covered entity may not use
family medical history to make
employment decisions, even if the
information was acquired through
commercially and publicly available
sources.
Section 1635.9(b) Limitations on
disclosure
GINA permits disclosure of genetic
information in limited circumstances.
First, a covered entity may disclose
genetic information to the individual to
whom it relates, if the individual
6 Genetic information that a covered entity
receives verbally and does not reduce to writing
must still be kept confidential, except to the extent
that GINA permits disclosure.
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requests disclosure in writing. Second,
the section states that genetic
information may be provided to an
occupational health researcher ‘‘if the
research is being conducted in
compliance with the regulations under’’
45 CFR part 46.
The third exception permits
disclosure in compliance with a court
order. It provides that the disclosure of
genetic information must be carefully
tailored to the terms of the order and the
covered entity must inform the
individual about the order and what
information it disclosed. This exception
does not allow disclosures in other
circumstances during litigation, such as
in response to discovery requests that
are not governed by an order specifying
the genetic information that must be
disclosed.
The fourth exception permits
disclosure of relevant genetic
information to government officials
investigating compliance with the
statute. The fifth exception permits
disclosure consistent with the
requirements of the FMLA or similar
state or local leave law. For example, an
employee’s supervisor who receives a
request for FMLA leave from an
employee who wants to care for a child
with a serious health condition may
forward this request to persons with a
need to know the information because
of responsibilities relating to the
handling of FMLA requests. Finally, the
sixth exception permits disclosure of
family medical history to federal, state,
or local public health officials in
connection with a contagious disease
that presents an imminent hazard of
death or life-threatening illness. The
statute requires the covered entity to
notify the employee of any release of a
family member’s medical history
information when undertaken for this
purpose.
Section 1635.9(c) Relationship to
HIPAA Privacy Regulations
GINA section 206(c) provides that the
provisions of Title II of GINA are not
intended to apply to uses and
disclosures of health information
governed by the HIPAA Privacy Rule.
Accordingly, and consistent with the
general rule of construction
implementing this statutory provision at
1635.11(d), this proposed rule provides
at 1635.9(c) that nothing in 1635.9
should be construed as applying to the
use or disclosure of genetic information
that is protected health information
subject to the HIPAA Privacy Rule. See
discussion of Section 1635.11(d), infra,
for an example of the interaction under
GINA between the HIPAA Privacy Rule
and this proposed regulation.
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Section 1635.10
Remedies
Enforcement and
In crafting GINA’s enforcement and
remedies section, Congress recognized
the advisability of using the existing
mechanisms in place for redress of other
forms of employment discrimination. In
particular, the Senate noted that this
section intends to take ‘‘advantage of the
expertise and process of the EEOC.’’ S.
Rep. No. 110–48, at 31 & n.17. In this
regard, GINA and the proposed
regulation provide the following:
• The enforcement mechanism
applicable and remedies available to
employees and others covered by Title
VII apply to GINA as well. The statute
references sections 705–707, 709–711,
and 717 of Title VII, 42 U.S.C. 2000e–
4, et seq. The Commission notes that its
implementing regulations found at 29
CFR parts 1601 (procedural regulations),
1602 (recordkeeping and reporting
requirements under Title VII and the
ADA), and 1614 (federal sector
employees) apply here as well.
• The procedures applicable and
remedies available to employees
covered by sections 302 and 304 of the
Government Employee Rights Act of
1991, 42 U.S.C. 2000e–16(b) & (c)
(GERA) apply under GINA. EEOC
regulations applicable to GERA are
found at 29 CFR part 1603.
• The procedures applicable and
remedies available to employees
covered by 3 U.S.C. 401 et seq. are set
forth in 3 U.S.C. 451–454. These
sections provide for counseling and
mediation of employment
discrimination allegations and the
formal process of complaints before the
Commission using the same
administrative process generally
applicable to employees in the
Executive Branch of the Federal
government; that is, the process set forth
in 29 CFR part 1614.
Employees covered through the
Congressional Accountability Act of
1995 must use the procedures set forth
in that statute. The Commission has no
authority with respect to the
enforcement of GINA as to employees
covered through this provision.
The proposed regulation includes a
separate reference to the remedies
provisions applicable to GINA. Similar
to other federal anti-discrimination
laws, GINA provides for recovery of
pecuniary and non-pecuniary damages,
including compensatory and punitive
damages. The statute’s incorporation by
reference of section 1977A of the
Revised Statutes of the United States (42
U.S.C. 1981a) also imports the
limitations on the recovery of
compensatory damages for future
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pecuniary losses, emotional pain,
suffering, etc., and punitive damages
applicable generally in employment
discrimination cases, depending on the
size of the employer. Punitive damages
are not available in actions against the
federal government, or against state or
local government employers.
Finally, the proposed regulation notes
that covered entities are required to post
notices in conspicuous places
describing GINA’s applicable
provisions. The Commission, prior to
GINA’s effective date, will publish in
the Federal Register appropriate
language for use in such notices.
Section 1635.11 Construction
GINA section 209 and this section of
the proposed regulation set forth rules
of construction applicable to GINA’s
coverage and prohibitions. They address
principally GINA’s relationship to other
federal laws covering discrimination,
health insurance, and other areas of
potential conflict.
Section 1635.11(a) Relationship to
Other Laws Generally
The subsection first addresses the
relationship of Title II of GINA to other
federal, state, local, and tribal laws
governing genetic discrimination, the
privacy of genetic information, and
discrimination based on disability. Over
40 states have laws addressing genetic
discrimination in employment. Some
may be more stringent than GINA;
others less so. GINA makes clear that it
does not preempt any other state or
local law that provides equal or greater
protections than GINA from
discrimination on the basis of genetic
information or improper access or
disclosure of genetic information.
Additionally, Title II of GINA does not
limit the rights or protections under
federal, state, local or Tribal laws that
provide greater privacy protection to
genetic information.
Similarly, GINA does not affect an
individual’s rights under the ADA, the
Rehabilitation Act, or state or local laws
that prohibit discrimination against
individuals based on disability. So, for
example, an individual could challenge
the disclosure of genetic information
under the ADA where the information is
also considered medical information
subject to that law. Additionally, even
though information that an employee
currently has a disease, such as cancer,
is not subject to GINA’s confidentiality
provisions, such information would be
protected under the ADA, and an
employer would be liable under that
law for disclosing the information,
unless a specific ADA exception
applied.
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GINA does limit, however, an
employer’s ability to obtain genetic
information as a part of a disabilityrelated inquiry or medical examination.
For example, upon the effective date of
GINA, an employer will no longer be
able to obtain family medical history or
conduct genetic tests of post-offer job
applicants, as it currently may do under
the ADA.
Other provisions in this section
clarify that GINA does not (1) Limit or
expand rights or obligations under
workers’ compensation laws; (2) limit or
expand the rights of federal agencies to
conduct or support occupational or
other health research conducted in
accordance with the rules found in 45
CFR part 46; or (3) limit the statutory or
regulatory authority of the Occupational
Safety and Health Administration or the
Mine Safety and Health Administration
or other workplace health and safety
laws and regulations. Another provision
addresses the exemption from GINA of
the Armed Forces Repository of
Specimen Samples for the Identification
of Remains.
The final provision in this subsection
makes clear that GINA does not require
that a covered entity provide
individuals with any specific benefits or
specialized health coverage. A covered
entity does not have to offer health
benefits that relate to any specific
genetic disease or disorder. GINA
merely requires that the covered entity
not discriminate against those covered
by the Act on the basis of genetic
information.
Section 1635.11(b) Relationship to
Other Federal Laws Governing Health
Coverage
GINA section 209(a)(2)(B) includes
four subsections that address the
relationship between Title II and
requirements or prohibitions that are
subject to enforcement under other
federal statutes addressing health
coverage. Section 209(a)(2)(B)(i) states
that nothing in Title II provides for
enforcement of or penalties for
violations of requirements or
prohibitions subject to enforcement for
a violation of GINA Title I. The three
following subsections, sections
209(a)(2)(B)(ii)–(iv), state that nothing in
Title II provides for enforcement of or
penalties for any requirement or
prohibition subject to enforcement for a
violation or violations of various
sections of ERISA, the Public Health
Service Act, and the Internal Revenue
Code, which generally prohibit a group
health plan or health insurance issuer in
the group market from:
• Imposing a preexisting condition
exclusion based solely on genetic
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information, in the absence of a
diagnosis of a condition;
• Discriminating against individuals
in eligibility and continued eligibility
for benefits based on genetic
information; and
• Discriminating against individuals
in premium or contribution rates under
the plan or coverage based on genetic
information, although such a plan or
issuer may adjust premium rates for an
employer based on the manifestation of
a disease or disorder of an individual
enrolled in the plan.
The intent of this section is to create
a clear ‘‘firewall’’ between GINA Titles
I and II. Section 209(a)(1)(B) eliminates
‘‘double liability’’ by preventing Title II
causes of action from being asserted
regarding matters subject to enforcement
under Title I or the other genetics
provisions for group coverage in ERISA,
the Public Health Service Act, and the
Internal Revenue Code. The firewall
seeks to ensure that health plan or
issuer requirements or prohibitions are
addressed and remedied through ERISA,
the Public Health Service Act, or the
Internal Revenue Code and not through
Title II and other employment
discrimination procedures. The
proposed regulation reiterates the
language of the section, noting the
specific sections from ERISA, the Public
Health Service Act, and the Internal
Revenue Code that the section covers.
The Commission notes that the
firewall does not immunize covered
entities from liability for decisions and
actions taken that violate Title II,
including employment decisions based
on health benefits, because such
benefits are within the definition of
compensation, terms, conditions, or
privileges of employment. For example,
an employer that fires an employee
because of anticipated high health
claims based on genetic information
remains subject to liability under Title
II. On the other hand, acts or omissions
relating to health plan eligibility,
benefits, or premiums, or a health plan’s
request for or collection of genetic
information remain subject to
enforcement under Title I exclusively.
Section 1635.11(c) Relationship to
Authorities Under GINA Title I
The final subsection in GINA section
209 provides that nothing in GINA Title
II prohibits a group health plan or group
health insurance issuer from engaging in
any activity that is authorized under
GINA Title I or the provisions identified
in GINA section 209(a)(2)(B)(i)–(iv),
including any implementing regulations
thereunder. The section and the
proposed implementing regulation
reiterate the limitations imposed on
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Title II in the area of group health
coverage.
Section 1635.11(d) Relationship to
HIPAA Privacy Regulations
Proposed section 1635.11(d)
implements section 206(c) of GINA Title
II by providing, as a general rule of
construction, that this proposed
regulation does not apply to health
information subject to the HIPAA
Privacy Rule. Thus, entities subject to
the HIPAA Privacy Rule must continue
to apply the requirements of the HIPAA
Privacy Rule, and not the requirements
of GINA Title II and these implementing
regulations, to genetic information that
is protected health information. For
example, if a hospital subject to the
HIPAA Privacy Rule treats a patient
who is also an employee of the hospital,
any genetic information that is obtained
or created by the hospital in its role as
a health care provider is protected
health information and is subject to the
requirements of the HIPAA Privacy Rule
and not those of GINA. In contrast,
however, any genetic information
obtained by the hospital in its role as
employer, for example, as part of a
request for leave by the employee,
would be subject to GINA Title II and
this rule.
Section 1635.12 Medical Information
That Is Not Genetic Information
The proposed regulation states that a
covered entity does not violate GINA by
acquiring, using, or disclosing medical
information about a manifested disease
or disorder that is not genetic
information, even if the disease or
disorder may have a genetic basis or
component. It further notes, however,
that the Americans with Disabilities
Act, and the applicable regulations
issued in support of the Act, would
limit the disclosure of genetic
information that also is medical
information and covered by the ADA.
Regulatory Procedures
Executive Order 12866
Pursuant to Executive Order 12866,
EEOC has coordinated this proposed
rule with the Office of Management and
Budget. Under section 3(f)(1) of
Executive Order 12866, EEOC has
determined that the proposed regulation
will not have an annual effect on the
economy of $100 million or more or
adversely affect in a material way the
economy, a sector of the economy,
productivity, competition, jobs, the
environment, public health or safety, or
state, local or tribal governments or
communities. Therefore, a detailed cost-
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benefit assessment of the proposed
regulation is not required.
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Paperwork Reduction Act
This proposal contains no new
information collection requirements
subject to review by the Office of
Management and Budget under the
Paperwork Reduction Act (44 U.S.C.
chapter 35).
Regulatory Flexibility Act
Title II of GINA applies to all
employers with fifteen or more
employees, approximately 822,000 of
which are small firms (entities with 15–
500 employees) according to data
provided by the Small Business
Administration Office of Advocacy. See
Firm Size Data at https://sba.gov/advo/
research/data.html#us.
The Commission certifies under 5
U.S.C. 605(b) that this proposed rule
will not have a significant economic
impact on a substantial number of small
entities because it imposes no reporting
burdens and only minimal costs on such
firms. GINA is intended to prevent
discrimination based on concerns that
genetic information about an individual
suggests an increased risk of, or
predisposition to, acquiring a condition
in the future. Because individuals
protected under GINA do not have
currently manifested conditions that
would result in any workplace barriers,
the law imposes no costs related to
making workplace modifications. To the
extent GINA requires businesses that
obtain genetic information about
applicants or employees to maintain it
in confidential files, GINA permits them
to do so using the same confidential
files they are already required to
maintain under Title I of the Americans
with Disabilities Act.
The Act may require some
modification to the post offer/preemployment medical examination
process of some employers, to remove
from the process questions pertaining to
family medical history. We do not have
data on the number and size of
businesses that obtain family medical
history as part of a post-offer medical
examination. However, our experience
with enforcing the ADA, which required
all employers with fifteen or more
employees to remove medical inquiries
from their application forms, suggests
that the cost of revising post-offer
medical questionnaires to eliminate
questions about family medical history
would not impose significant costs.
GINA will require that covered
entities obtain and post revised notices
informing covered individuals of their
rights under the law. Employers will not
incur any costs related to obtaining or
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posting these notices, because the
Commission provides employers, at no
cost, a poster explaining the EEO laws
that will be updated to include
information about GINA.
To the extent that employers will
need to expend resources to train
human resources staff and others on the
requirements of GINA, we note that the
EEOC conducts extensive outreach and
technical assistance programs, many of
them at no cost to employers, to assist
in the training of relevant personnel on
EEO-related issues. In FY 2008, for
example, EEOC’s outreach efforts
included 5,360 education, training, and
outreach events reaching over 270,000
people. EEOC conducted over 700
outreach events directed specifically
toward small businesses, reaching
35,515 small business representatives.
In FY 2009, we expect to include
information about GINA in our outreach
programs in general and to offer
numerous GINA-specific outreach
programs, once the regulations
implementing Title II of GINA become
final. We will also post technical
assistance documents on our Web site
explaining the basics of the new
regulation, as we do with all of our new
regulations and policy documents. We
estimate that the typical human
resources professional will need to
dedicate, at most, three hours to gain a
satisfactory understanding of the new
requirements, either by attending an
EEOC-sponsored event or reviewing the
relevant materials on their own. We
further estimate that the median hourly
pay rate of an HR professional is
approximately $45.00. See Bureau of
Labor Statistics, Occupational
Employment and Wages, May 2007 at
https://www.bls.gov/oes/current/
oes113049.htm#5#5. Assuming that
small entities have between one and five
HR professionals/managers, we estimate
that the cost per entity of providing
appropriate training will be between
approximately $135.00 and $675.00, at
the high end. EEOC does not believe
that this cost will be significant for the
impacted small entities.
We urge small entities to submit
comments concerning EEOC’s estimates
of the number of small entities
impacted, as well as the cost to those
entities.
Unfunded Mandates Reform Act of 1995
This proposed rule will not result in
the expenditure by state, local, or tribal
governments, in the aggregate, or by the
private sector, of $100 million or more
in any one year, and it will not
significantly or uniquely affect small
governments. Therefore, no actions were
deemed necessary under the provisions
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of the Unfunded Mandates Reform Act
of 1995.
Dated: February 23, 2009.
For the Commission.
Stuart J. Ishimaru,
Acting Chairman.
List of Subjects in 29 CFR Part 1635
Administrative practice and
procedure, Equal employment
opportunity.
For the reasons set forth in the
preamble, the EEOC proposes to amend
29 CFR chapter XIV by adding part 1635
to read as follows:
PART 1635—GENETIC INFORMATION
NONDISCRIMINATION ACT OF 2008
Sec.
1635.1 Purpose.
1635.2 Definitions—general.
1635.3 Definitions specific to GINA.
1635.4 Prohibited Practices—in general.
1635.5 Limiting, segregating, and
classifying.
1635.6 Causing an employer to
discriminate.
1635.7 Retaliation.
1635.8 Acquisition of genetic information.
1635.9 Confidentiality.
1635.10 Enforcement and remedies.
1635.11 Construction.
1635.12 Medical information that is not
genetic information.
Authority: 110 Stat. 233; 42 U.S.C. 2000ff.
§ 1635.1
Purpose.
The purpose of this part is to
implement Title II of the Genetic
Information Non-Discrimination Act of
2008, 42 U.S.C. 2000ff, et seq. Title II of
GINA prohibits use of genetic
information in employment decisionmaking, restricts deliberate acquisition
of genetic information, requires that
genetic information be maintained as a
confidential medical record, and places
strict limits on disclosure of genetic
information. The law provides remedies
for individuals whose genetic
information is acquired, used, or
disclosed in violation of its protections.
§ 1635.2
Definitions—general.
(a) Commission means the Equal
Employment Opportunity Commission,
as established by section 705 of the Civil
Rights Act of 1964, 42 U.S.C. 2000e–4.
(b) Covered Entity means an
employer, employing office,
employment agency, labor organization,
or joint labor-management committee.
(c) Employee means an individual
employed by a covered entity, as well as
an applicant for employment and a
former employee. An employee,
including an applicant for employment
and a former employee, is
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(1) As defined by section 701 of the
Civil Rights Act of 1964, 42 U.S.C.
2000e, an individual employed by a
person engaged in an industry affecting
commerce who has fifteen or more
employees for each working day in each
of twenty or more calendar weeks in the
current or preceding calendar year and
any agent of such a person;
(2) As defined by section 304(a) of the
Government Employee Rights Act, 42
U.S.C. 2000e-16c(a), a person chosen or
appointed by an individual elected to
public office by a State or political
subdivision of a State to serve as part of
the personal staff of the elected official,
to serve the elected official on a policymaking level, or to serve the elected
official as the immediate advisor on the
exercise of the elected official’s
constitutional or legal powers.
(3) As defined by section 101 of the
Congressional Accountability Act, 2
U.S.C. 1301, any employee of the House
of Representatives, the Senate, the
Capitol Guide Service, the Capitol
Police, the Congressional Budget Office,
the Office of the Architect of the
Capitol, the Office of the Attending
Physician, the Office of Compliance, or
the Office of Technology Assessment;
(4) As defined by, and subject to the
limitations in, section 2(a) of the
Presidential and Executive Office
Accountability Act, 3 U.S.C. 411(c), any
employee of the executive branch not
otherwise covered by section 717 of the
Civil Rights Act of 1964, 42 U.S.C.
2000e–16, section 15 of the Age
Discrimination in Employment Act of
1967, 29 U.S.C. 633a, or section 501 of
the Rehabilitation Act of 1973, 29 U.S.C.
791, whether appointed by the President
or any other appointing authority in the
executive branch, including an
employee of the Executive Office of the
President;
(5) As defined by, and subject to the
limitations in, section 717 of the Civil
Rights Act of 1964, 42 U.S.C. 2000e–16,
and regulations of the Equal
Employment Opportunity Commission
at 29 CFR 1614.103, an employee of a
federal executive agency, the United
States Postal Service and the Postal Rate
Commission, the Tennessee Valley
Authority, the National Oceanic and
Atmospheric Administration
Commissioned Corps, the Government
Printing Office, and the Smithsonian
Institution; an employee of the federal
judicial branch having a position in the
competitive service; and an employee of
the Library of Congress.
(d) Employer means any person that
employs an employee defined in
§ 1635.2(c) of this part, and any agent of
such person, except that, as limited by
section 701(b)(1) and (2) of the Civil
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Rights Act of 1964, 42 U.S.C.
2000e(b)(1) and (2), an employer does
not include an Indian tribe or a bona
fide private club (other than a labor
organization) that is exempt from
taxation under section 501(c) of the
Internal Revenue Code of 1986.
(e) Employing office is defined in the
Congressional Accountability Act, 2
U.S.C. 1301(9), to mean the personal
office of a Member of the House of
Representatives or of a Senator; a
committee of the House of
Representatives or the Senate or a joint
committee; any other office headed by a
person with the final authority to
appoint, hire, discharge, and set the
terms, conditions, or privileges of the
employment of an employee of the
House of Representatives or the Senate;
or the Capitol Guide Board, the Capitol
Police Board, the Congressional Budget
Office, the Office of the Architect of the
Capitol, the Office of the Attending
Physician, the Office of Compliance,
and the Office of Technology
Assessment.
(f) Employment agency is defined in
42 U.S.C. 2000e(c) to mean any person
regularly undertaking with or without
compensation to procure employees for
an employer or to procure for employees
opportunities to work for an employer
and includes an agent of such a person.
(g) Joint labor-management committee
is defined as an entity that controls
apprenticeship or other training or
retraining programs, including on-thejob training programs.
(h) Labor organization is defined at 42
U.S.C. 2000e(d) to mean an organization
with fifteen or more members engaged
in an industry affecting commerce, and
any agent of such an organization in
which employees participate and which
exists for the purpose, in whole or in
part, of dealing with employers
concerning grievances, labor disputes,
wages, rates of pay, hours, or other
terms or conditions of employment.
(i) Member includes, with respect to
a labor organization, an applicant for
membership.
(j) Person is defined at 42 U.S.C.
2000e(a) to mean one or more
individuals, governments, governmental
agencies, political subdivisions, labor
unions, partnerships, associations,
corporations, legal representatives,
mutual companies, joint-stock
companies, trusts, unincorporated
organizations, trustees, trustees in cases
under title 11, or receivers.
(k) State is defined at 42 U.S.C.
2000e(i) and includes a State of the
United States, the District of Columbia,
Puerto Rico, the Virgin Islands,
American Samoa, Guam, Wake Island,
the Canal Zone, and Outer Continental
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Shelf lands defined in the Outer
Continental Shelf Lands Act (43 U.S.C.
1331 et seq.).
§ 1635.3
Definitions specific to GINA.
(a) Family member means with
respect to any individual
(1) A person who is a dependent of
that individual as the result of marriage,
birth, adoption, or placement for
adoption; or
(2) A first-degree, second-degree,
third-degree, or fourth-degree relative of
the individual, or of a dependent of the
individual as defined in § 1635.3(a)(1).
(i) First-degree relatives include an
individual’s parents, siblings, children,
and half-siblings.
(ii) Second-degree relatives include an
individual’s grandparents,
grandchildren, uncles, aunts, nephews,
and nieces.
(iii) Third-degree relatives include an
individual’s great-grandparents, great
grandchildren, great uncles/aunts, and
first cousins.
(iv) Fourth-degree relatives include an
individual’s great-great grandparents,
great-great grandchildren, and first
cousins once-removed (i.e., the children
of the individual’s first cousins).
(b) Family medical history. Family
medical history means information
about the manifestation of disease or
disorder in family members of the
individual.
(c) Genetic information. (1) Genetic
information means information about:
(i) An individual’s genetic tests;
(ii) The genetic tests of that
individual’s family members;
(iii) The manifestation of disease or
disorder in family members of the
individual (family medical history);
(iv) An individual’s request for, or
receipt of, genetic services, or the
participation in clinical research that
includes genetic services by the
individual or a family member of the
individual; or
(v) The genetic information of a fetus
carried by an individual or by a
pregnant woman who is a family
member of the individual and the
genetic information of any embryo
legally held by the individual or family
member using an assisted reproductive
technology.
(2) Genetic information does not
include information about the sex or age
of the individual or the sex or age of
family members.
(d) Genetic monitoring means the
periodic examination of employees to
evaluate acquired modifications to their
genetic material, such as chromosomal
damage or evidence of increased
occurrence of mutations, caused by the
toxic substances they use or are exposed
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to in performing their jobs, in order to
identify, evaluate, and respond to the
effects of or control adverse
environmental exposures in the
workplace.
(e) Genetic services means a genetic
test; genetic counseling (including
obtaining, interpreting, or assessing
genetic information); or genetic
education.
(f) Genetic test—(1) In general.
‘‘Genetic test’’ means an analysis of
human DNA, RNA, chromosomes,
proteins, or metabolites that detects
genotypes, mutations, or chromosomal
changes.
(i) An analysis of proteins or
metabolites that does not detect
genotypes, mutations, or chromosomal
changes is not a genetic test.
(ii) A medical examination that tests
for the presence of a virus that is not
composed of human DNA, RNA,
chromosomes, proteins, or metabolites
is not a genetic test.
(2) Alcohol and drug testing. (i) A test
for the presence of alcohol or drugs is
not a genetic test.
(ii) A test to determine whether an
individual has a genetic predisposition
for alcoholism or drug use is a genetic
test.
(g) Manifestation or manifested
means, with respect to a disease,
disorder, or pathological condition, that
an individual has been or could
reasonably be diagnosed with the
disease, disorder, or pathological
condition by a health care professional
with appropriate training and expertise
in the field of medicine involved. For
purposes of this part, a disease,
disorder, or pathological condition is
not manifested if the diagnosis is based
principally on genetic information or on
the results of one or more genetic tests.
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§ 1635.4
Prohibited practices—in general.
(a) It is unlawful for an employer to
discriminate against an individual on
the basis of the genetic information of
the individual in regard to hiring,
discharge, compensation, terms,
conditions, or privileges of employment.
(b) It is unlawful for an employment
agency to fail or refuse to refer any
individual for employment or otherwise
discriminate against any individual
because of genetic information of the
individual.
(c) It is unlawful for a labor
organization to exclude or to expel from
the membership of the organization, or
otherwise to discriminate against, any
member because of genetic information
with respect to the member.
(d) It is an unlawful employment
practice for any employer, labor
organization, or joint labor-management
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committee controlling apprenticeship or
other training or retraining programs,
including on-the-job training programs
to discriminate against any individual
because of the individual’s genetic
information in admission to, or
employment in, any program
established to provide apprenticeship or
other training or retraining.
§ 1635.5 Limiting, segregating, and
classifying.
(a) A covered entity may not limit,
segregate, or classify an individual, or
fail or refuse to refer for employment
any individual, in any way that would
deprive or tend to deprive the
individual of employment opportunities
or otherwise affect the status of the
individual as an employee, because of
genetic information with respect to the
individual.
(b) Notwithstanding any language in
this part, a cause of action for disparate
impact within the meaning of section
703(k) of the Civil Rights Act of 1964,
42 U.S.C. 2000e–2(k), is not available
under this part.
§ 1635.6 Causing an employer to
discriminate.
An employment agency, labor
organization, or joint labor-management
training or apprenticeship program may
not cause or attempt to cause an
employer, or its agent, to discriminate
against an individual in violation of this
part, including with respect to the
individual’s participation in an
apprenticeship or other training or
retraining program, or with respect to a
member’s participation in a labor
organization.
§ 1635.7
Retaliation.
A covered entity may not discriminate
against any individual because such
individual has opposed any act or
practice made unlawful by this title or
because such individual made a charge,
testified, assisted, or participated in any
manner in an investigation, proceeding,
or hearing under this title.
§ 1635.8 Acquisition of genetic
information.
(a) General prohibition. A covered
entity may not request, require, or
purchase genetic information of an
individual, except as specifically
provided in paragraph (b) of this
section.
(b) Exceptions. The general
prohibition against requesting,
requiring, or purchasing genetic
information does not apply:
(1) Where a covered entity
inadvertently requests or requires
genetic information of the individual or
family member of the individual. This
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exception to the acquisition of genetic
information applies in, but is not
necessarily limited to, situations
where—
(i) A manager, supervisor, union
representative, or employment agency
personnel learns genetic information
about an individual by overhearing a
conversation between the individual
and others;
(ii) A manager, supervisor, union
representative, or employment agency
personnel learns genetic information
about an individual by receiving it from
the individual or third-parties without
having solicited or sought the
information;
(iii) An individual provides genetic
information as part of documentation to
support a request for reasonable
accommodation under Federal, State, or
local law, as long as the covered entity’s
request for such documentation is
lawful;
(iv) An employer requests medical
information (other than genetic
information) as permitted by Federal,
State, or local law from an individual,
who responds by providing, among
other information, genetic information;
(v) An individual provides genetic
information to support a request for
leave that is not governed by Federal,
State, or local laws requiring leave, as
long as the documentation required to
support the request otherwise complies
with the requirements of the Americans
with Disabilities Act and other laws
limiting a covered entity’s access to
medical information; or
(vi) A covered entity learns genetic
information about an individual in
response to an inquiry about the
individual’s general health, an inquiry
about whether the individual has any
current disease, disorder, or
pathological condition, or an inquiry
about the general health of an
individual’s family member;
(2) Where a covered entity offers
health or genetic services, including
such services offered as part of a
voluntary wellness program. This
exception applies only where—
(i) The individual provides prior
knowing, voluntary, and written
authorization that
(A) Is written so that the individual
from whom the genetic information is
being obtained is reasonably likely to
understand the form;
(B) Describes the type of genetic
information that will be obtained and
the general purposes for which it will be
used; and
(C) Describes the restrictions on
disclosure of genetic information.
(ii) Individually identifiable genetic
information is provided only to the
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individual (or family member if the
family member is receiving genetic
services) and the licensed health care
professional or board certified genetic
counselor involved in providing such
services; and
(iii) Any individually identifiable
genetic information provided under
paragraph (b)(2) of this section is only
available for purposes of such services
and is not disclosed to the covered
entity except in aggregate terms that do
not disclose the identity of specific
individuals.
(3) Where the employer requests
family medical history to comply with
the certification provisions of the
Family and Medical Leave Act of 1993
(29 U.S.C. 2601 et seq.) or State or local
family and medical leave laws.
(4) Where the covered entity acquires
genetic information from documents
that are commercially and publicly
available for review or purchase,
including newspapers, magazines,
periodicals, or books, or through
electronic media, such as information
communicated through television,
movies, or the Internet, except that a
covered entity may not research medical
databases or court records, even where
such databases may be publicly and
commercially available, for the purpose
of obtaining genetic information about
an individual.
(5) Where the covered entity acquires
genetic information for use in the
genetic monitoring of the biological
effects of toxic substances in the
workplace. In order for this exception to
apply, the covered entity must provide
written notice of the monitoring to the
individual. This exception further
provides that such monitoring:
(i) Either is required by federal or
state law, or conducted only where an
individual gives prior knowing,
voluntary and written authorization to
the monitoring that—
(A) Is written so that the individual
from whom the genetic information is
being obtained is reasonably likely to
understand the form.;
(B) Describes the genetic information
that will be obtained;
(C) Describes the restrictions on
disclosure of genetic information;
(ii) Ensures that the individual is
informed of individual monitoring
results;
(iii) Is conducted in compliance with
any Federal genetic monitoring
regulations, including any regulations
that may be promulgated by the
Secretary of Labor pursuant to the
Occupational Safety and Health Act of
1970 (29 U.S.C. 651 et seq.), the Federal
Mine Safety and Health Act of 1977 (30
U.S.C. 801 et seq.), or the Atomic Energy
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Act of 1954 (42 U.S.C. 2011 et seq.); or
State genetic monitoring regulations, in
the case of a State that is implementing
genetic monitoring regulations under
the authority of the Occupational Safety
and Health Act of 1970 (29 U.S.C. 651
et seq.); and
(iv) Provides for reporting of the
results of the monitoring to the covered
entity, excluding any licensed health
care professional or board certified
genetic counselor involved in the
genetic monitoring program, only in
aggregate terms that do not disclose the
identity of specific individuals.
(6) Where an employer that conducts
DNA analysis for law enforcement
purposes as a forensic laboratory or for
purposes of human remains
identification requests or requires
genetic information of its employees,
apprentices, or trainees, but only to the
extent that the genetic information is
used for analysis of DNA identification
markers for quality control to detect
sample contamination and maintained
in a manner consistent with such use.
(c) A covered entity may not use
genetic information obtained pursuant
to the exceptions in § 1635.8(b) of this
part to discriminate, as defined by
§§ 1635.4, 1635.5, or 1635.6, and must
keep such information confidential as
required by § 1635.9.
§ 1635.9
Confidentiality.
(a) Treatment of genetic information.
(1) A covered entity that possesses
genetic information in writing about an
employee or member must maintain
such information on forms and in
medical files (including where the
information exists in electronic forms
and files) that are separate from
personnel files and treat such
information as a confidential medical
record.
(2) A covered entity may maintain
genetic information about an employee
or member in the same file in which it
maintains confidential medical
information subject to section
102(d)(3)(B) of the Americans with
Disabilities Act, 42 U.S.C.
12112(d)(3)(B).
(3) Genetic information that a covered
entity receives orally need not be
reduced to writing, but may not be
disclosed, except as permitted by this
part.
(4) Genetic information that a covered
entity acquires through publicly
available sources, as provided by
§ 1635.8(b)(4) of this part, is not
considered confidential genetic
information, but may not be used to
discriminate against an individual as
described in §§ 1635.4, 1635.5, or
1635.6 of this part.
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9069
(b) Limitations on disclosure. A
covered entity that possesses any
genetic information, regardless of how
the entity obtained the information
(except for genetic information acquired
through publicly available sources), may
not disclose it except:
(1) To the employee or member (or
family member if the family member is
receiving the genetic services) about
whom the information pertains upon
receipt of the employee’s or member’s
written request;
(2) To an occupational or other health
researcher if the research is conducted
in compliance with the regulations and
protections provided for under 45 CFR
part 46;
(3) In response to an order of a court,
except that the covered entity may
disclose only the genetic information
expressly authorized by such order; and
if the court order was secured without
the knowledge of the individual to
whom the information refers, the
covered entity shall inform the
individual of the court order and any
genetic information that was disclosed
pursuant to such order;
(4) To government officials
investigating compliance with this title
if the information is relevant to the
investigation;
(5) To the extent that such disclosure
is made in support of an employee’s
compliance with the certification
provisions of section 103 of the Family
and Medical Leave Act of 1993 (29
U.S.C. 2613) or such requirements
under State family and medical leave
laws; or
(6) To a Federal, State, or local public
health agency only with regard to
information about the manifestation of a
disease or disorder that concerns a
contagious disease that presents an
imminent hazard of death or lifethreatening illness, provided that the
individual whose family member is the
subject of the disclosure is notified of
such disclosure.
(c) Relationship to HIPAA Privacy
Regulations. Pursuant to § 1635.11(d) of
this part, nothing in this section shall be
construed as applying to the use or
disclosure of genetic information that is
protected health information subject to
the regulations issued pursuant to
section 264(c) of the Health Insurance
Portability and Accountability Act of
1996.
§ 1635.10
Enforcement and Remedies.
(a) Powers and procedures: The
following powers and procedures shall
apply to allegations that Title II of GINA
has been violated:
(1) The powers and procedures
provided to the Commission, the
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Attorney General, or any person by
sections 705 through 707 and 709
through 711 of the Civil Rights Act of
1964, 42 U.S.C. 2000e–4 through 2000e–
6 and 2000e–8 through 2000e–10, where
the alleged discrimination is against an
employee defined in 1635.2(c)(1) of this
part or against a member of a labor
organization;
(2) The powers and procedures
provided to the Commission and any
person by sections 302 and 304 of the
Government Employees Rights Act, 42
U.S.C. 2000e–16b and 2000e–16c, and
in regulations at 29 CFR part 1603,
where the alleged discrimination is
against an employee as defined in
§ 1635.2(c)(2) of this part;
(3) The powers and procedures
provided to the Board of Directors of the
Office of Compliance and to any person
under the Congressional Accountability
Act, 2 U.S.C. 1301 et seq. (including the
provisions of Title 3 of that act, 2 U.S.C.
1381 et seq.), where the alleged
discrimination is against an employee
defined in § 1635.2(c)(3) of this part;
(4) The powers and procedures
provided in 3 U.S.C. 451 et seq., to the
President, the Commission, or any
person in connection with an alleged
violation of section 3 U.S.C. 411(a)(1),
where the alleged discrimination is
against an employee defined in
§ 1635.2(c)(4) of this part;
(5) The powers and procedures
provided to the Commission, the
Librarian of Congress, and any person
by section 717 of the Civil Rights Act,
42 U.S.C. 2000e–16, where the alleged
discrimination is against an employee
defined in § 1635.2(c)(5) of this part.
(b) Remedies. The following remedies
are available for violations of GINA
sections 202, 203, 204, 205, 206, and
207(f):
(1) Compensatory and punitive
damages as provided for, and limited
by, 42 U.S.C. 1981a(a)(1) and (b);
(2) Reasonable attorney’s fees,
including expert fees, as provided for,
and limited by, 42 U.S.C. 1988(b) and
(c); and
(3) Injunctive relief, including
reinstatement and hiring, back pay, and
other equitable remedies as provided
for, and limited by, 42 U.S.C. 2000e–
5(g).
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§ 1635.11
Construction.
(a) Relationship to other laws,
generally. This part does not—
(1) Limit the rights or protections of
an individual under any other Federal,
State, or local law that provides equal or
greater protection to an individual than
the rights or protections provided for
under this part, including the
Americans with Disabilities Act of 1990
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Jkt 217001
(42 U.S.C. 12101 et seq.), the
Rehabilitation Act of 1973 (29 U.S.C.
701 et seq.), and State and local laws
prohibiting genetic discrimination or
discrimination on the basis of disability;
(2) Apply to the Armed Forces
Repository of Specimen Samples for the
Identification of Remains;
(3) Limit or expand the protections,
rights, or obligations of employees or
employers under applicable workers’
compensation laws;
(4) Limit the authority of a Federal
department or agency to conduct or
sponsor occupational or other health
research in compliance with the
regulations and protections provided for
under 45 CFR part 46;
(5) Limit the statutory or regulatory
authority of the Occupational Safety and
Health Administration or the Mine
Safety and Health Administration to
promulgate or enforce workplace safety
and health laws and regulations; or
(6) Require any specific benefit for an
employee or member or a family
member of an employee or member
(such as additional coverage for a
particular health condition that may
have a genetic basis) under any group
health plan or health insurance issuer
offering group health insurance
coverage in connection with a group
health plan.
(b) Relation to certain Federal laws
governing health coverage. Nothing in
GINA Title II provides for enforcement
of, or penalties for, violation of any
requirement or prohibition of a covered
entity subject to enforcement for a
violation of:
(1) Amendments made by Title I of
GINA.
(2) Section 701(a) of the Employee
Retirement Income Security Act (29
U.S.C. 1181) (ERISA), section 2701(a) of
the Public Health Service Act (42 U.S.C.
300gg(a)), and section 9801(a) of the
Internal Revenue Code (26 U.S.C.
9801(a)), as such sections apply with
respect to genetic information pursuant
to 29 U.S.C. 1181(b)(1)(B), 42 U.S.C.
300gg(b)(1)(B), and 26 U.S.C.
9801(b)(1)(B), respectively, of such
sections, which prohibit a group health
plan or a health insurance issuer in the
group market from imposing a
preexisting condition exclusion based
solely on genetic information, in the
absence of a diagnosis of a condition;
(3) Section 702(a)(1)(F) of ERISA (29
U.S.C. 1182(a)(1)(F)), section
2702(a)(1)(F) of the Public Health
Service Act (42 U.S.C. 300gg–1(a)(1)(F)),
and section 9802(a)(1)(F) of the Internal
Revenue Code (26 U.S.C. 9802(a)(1)(F)),
which prohibit a group health plan or a
health insurance issuer in the group
market from discriminating against
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Fmt 4702
Sfmt 4702
individuals in eligibility and continued
eligibility for benefits based on genetic
information; or
(4) Section 702(b)(1) of ERISA (29
U.S.C. 1182(b)(1)), section 2702(b)(1) of
the Public Health Service Act (42 U.S.C.
300gg–1(b)(1), and section 9802(b)(1) of
the Internal Revenue Code (26 U.S.C.
9802(b)(1)), as such sections apply with
respect to genetic information as a
health status-related factor, which
prohibit a group health plan or a health
insurance issuer in the group market
from discriminating against individuals
in premium or contribution rates under
the plan or coverage based on genetic
information.
(c) Relationship to authorities under
GINA Title I. GINA Title II does not
prohibit any group health plan or health
insurance issuer offering group health
insurance coverage in connection with a
group health plan from engaging in any
action that is authorized under any
provision of law noted in § 1635.11(b) of
this part, including any implementing
regulations noted in § 1635.11(b).
(d) Relationship to HIPAA Privacy
Regulations. This part does not apply to
genetic information that is protected
health information subject to the
regulations issued by the Secretary of
Health and Human Services pursuant to
section 264(c) of the Health Insurance
Portability and Accountability Act of
1996.
§ 1635.12 Medical information that is not
genetic information.
(a) Medical information about a
manifested disease, disorder, or
pathological condition. (1) A covered
entity shall not be considered to be in
violation of this part based on the use,
acquisition, or disclosure of medical
information that is not genetic
information about a manifested disease,
disorder, or pathological condition of an
employee or member, even if the
disease, disorder, or pathological
condition has or may have a genetic
basis or component.
(2) Notwithstanding paragraph (a)(1)
of this section, the acquisition, use, and
disclosure of medical information that is
not genetic information about a
manifested disease, disorder, or
pathological condition is subject to
applicable limitations under sections
103(d)(1)–(4) of the Americans with
Disabilities Act (42 U.S.C. 12112(d)(1)–
(4)), and regulations at 29 CFR 1630.13,
1630.14, and 1630.16.
(b) Genetic information related to a
manifested disease, disorder, or
pathological condition.
Notwithstanding paragraph (a) of this
section, genetic information about a
manifested disease, disorder, or
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pathological condition is subject to the
requirements and prohibitions in
sections 202 through 206 of GINA and
§§ 1635.4 through 1635.7 and 1635.9 of
this part.
[FR Doc. E9–4221 Filed 2–27–09; 8:45 am]
BILLING CODE 6570–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Parts 160, 161, 164, and 165
[USCG–2005–21869]
RIN 1625–AA99
Vessel Requirements for Notices of
Arrival and Departure, and Automatic
Identification System
Coast Guard, DHS.
Notice of second public
meeting; request for comments.
AGENCY:
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ACTION:
SUMMARY: In response to requests
received, the Coast Guard announces a
second public meeting, to be held
March 25, 2009, in Seattle, WA, to
receive comments on a notice of
proposed rulemaking to amend Coast
Guard regulations governing Notice of
Arrival and Departure (NOAD) and
Automatic Identification System (AIS)
requirements. This is an additional
meeting to the one previously
announced for March 5, 2009, in
Washington, DC.
DATES: A public meeting will be held in
Seattle, WA, on March 25, 2009, from 1
p.m. to 3:30 p.m. The comment period
for the proposed rule closes April 15,
2009. All written comments and related
material must be received by the Coast
Guard on or before April 15, 2009.
ADDRESSES: The March 25, 2009, public
meeting will be held at the following
location:
• Seattle, WA—Henry M. Jackson
Federal Building, 915 Second Ave.,
Fourth Floor North Auditorium, Seattle,
WA 98174–1067.
A government-issued photo
identification will be required for
entrance to the building.
Written comments and related
material may also be submitted to Coast
Guard personnel specified at that
meeting. All comments and related
material submitted after the meeting
must be submitted using any one of the
following methods:
(1) Federal eRulemaking Portal:
https://www.regulations.gov under
docket number USCG–2005–21869.
(2) Fax: 202–493–2251.
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12:24 Feb 27, 2009
Jkt 217001
(3) Mail: Docket Management Facility
(M–30), U.S. Department of
Transportation, West Building Ground
Floor, Room W12–140, 1200 New Jersey
Avenue, SE., Washington, DC 20590–
0001.
(4) Hand delivery: Same as mail
address above, between 9 a.m. and 5
p.m., Monday through Friday, except
Federal holidays. The telephone number
is 202–366–9329.
To avoid duplication, please use only
one of these four methods.
FOR FURTHER INFORMATION CONTACT: If
you have questions concerning the
NOAD portion of this proposed
rulemaking or concerning the public
meeting, please contact Lieutenant
Sharmine Jones, Office of Vessel
Activities (CG–543), Coast Guard,
Sharmine.N.Jones@uscg.mil, telephone
202–372–1234. If you have questions on
the AIS portion of this proposed
rulemaking, contact Mr. Jorge Arroyo,
Office of Navigation Systems (CG–5413),
Coast Guard, Jorge.Arroyo@uscg.mil,
telephone 202–372–1563. If you have
questions on viewing or submitting
material to the docket, call Ms. Renee V.
Wright, Program Manager, Docket
Operations, telephone 202–366–9826.
SUPPLEMENTARY INFORMATION:
Background and Purpose
We published a notice of proposed
rulemaking (NPRM) in the Federal
Register on December 16, 2008 (73 FR
76295), entitled ‘‘Vessel Requirements
for Notices of Arrival and Departure,
and Automatic Identification System.’’
In it we stated our intention to hold a
public meeting, and to publish a notice
to announce the location and date of the
public meeting. 73 FR 76296. In this
notice, we announce an additional
public meeting, to the one previously
announced for March 5, 2009, in
Washington, DC (74 FR 7534), to receive
comments on this proposed rule.
In the NPRM, we proposed to expand
the applicability of Notice of Arrival
and Departure (NOAD) and Automatic
Identification System (AIS)
requirements to more commercial
vessels, modify NOAD reporting
requirements, establish a mandatory
method for electronic data submission
and establish a separate requirement for
certain vessels to submit notices of
departure. The proposed rulemaking
would also clarify existing AIS
requirements and extend the
applicability of AIS requirements to
additional vessels and beyond Vessel
Traffic Service areas to all U.S.
navigable waters.
You may view the NPRM in our
online docket, in addition to supporting
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9071
documents prepared by the Coast Guard
(Regulatory Analysis & Initial
Regulatory Flexibility Analysis, Valuing
Mortality Risk Reductions in Homeland
Security Regulatory Analyses—Final
Report June 2008, and an Environmental
Checklist), and comments submitted
thus far by going to https://
www.regulations.gov. Once there, select
the Advanced Docket Search option on
the right side of the screen, insert
USCG–2005–21869 in the Docket ID
box, press Enter, and then click on the
item in the Docket ID column. If you do
not have access to the Internet, you may
view the docket by visiting the Docket
Management Facility in Room W12–140
on the ground floor of the Department
of Transportation West Building, 1200
New Jersey Avenue, SE., Washington,
DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal
holidays. We have an agreement with
the Department of Transportation to use
the Docket Management Facility.
We encourage you to participate in
this rulemaking by submitting
comments either orally at the meeting or
in writing. If you bring written
comments to the meeting, you may
submit them to Coast Guard personnel
specified at the meeting to receive
written comments. These comments
will be submitted to our online public
docket. All comments received will be
posted without change to https://
www.regulations.gov and will include
any personal information you have
provided.
Anyone can search the electronic
form of comments received into any of
our dockets by the name of the
individual submitting the comment (or
signing the comment, if submitted on
behalf of an association, business, labor
union, etc.). You may review a Privacy
Act notice regarding our public dockets
in the January 17, 2008, issue of the
Federal Register (73 FR 3316).
Information on Service for Individuals
With Disabilities
For information on facilities or
services for individuals with disabilities
or to request special assistance at the
public meeting, contact Lieutenant
Sharmine Jones at the telephone number
indicated under the FOR FURTHER
INFORMATION CONTACT section of this
notice.
Public Meeting
The Coast Guard will hold a public
meeting regarding this proposed
rulemaking on March 25, 2009, from
1 p.m. to 3:30 p.m., in Seattle, WA, at
the Henry M. Jackson Federal Building,
915 Second Ave., Fourth Floor North
Auditorium, Seattle, WA 98174–1067.
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Agencies
[Federal Register Volume 74, Number 39 (Monday, March 2, 2009)]
[Proposed Rules]
[Pages 9056-9071]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-4221]
=======================================================================
-----------------------------------------------------------------------
EQUAL EMPLOYMENT OPPORTUNITY COMMISSION
29 CFR Part 1635
RIN 3046-AA84
Regulations Under the Genetic Information Nondiscrimination Act
of 2008
AGENCY: Equal Employment Opportunity Commission.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Equal Employment Opportunity Commission (``EEOC'' or
``Commission'') is issuing a proposed rule that would implement Title
II of the Genetic Information Nondiscrimination Act of 2008 (``GINA'').
Congress enacted Title II of GINA to protect job applicants, current
and former employees, labor union members, and apprentices and trainees
from discrimination based on their genetic information. Title II of
GINA requires the EEOC to issue implementing regulations. The
Commission is proposing these rules under that authority to provide all
persons subject to Title II of GINA additional guidance with regard to
the law's requirements. The Commission invites written comments from
members of the public on these proposed rules and on any specific
issues related to this proposal.
DATES: Comments regarding this proposal must be received by the
Commission on or before May 1, 2009. Please see the section below
entitled ADDRESSES and SUPPLEMENTARY INFORMATION for additional
information on submitting comments.
ADDRESSES: You may submit comments by any of the following methods:
By mail to Stephen Llewellyn, Executive Officer, Executive
Secretariat, Equal Employment Opportunity Commission, 131 M Street,
NE., Suite 6NE03F, 20507.
By facsimile (``FAX'') machine to (202) 663-4114. (There is no toll
free FAX number.) Only comments of six or fewer pages will be accepted
via FAX transmittal, in order to assure access to the equipment.
Receipt of FAX transmittals will not be acknowledged, except that the
sender may request confirmation of receipt by calling the Executive
Secretariat staff at (202) 663-4070 (voice) or (202) 663-4074 (TTY).
(These are not toll free numbers.)
By the Federal eRulemaking Portal: https://www.regulations.gov.
After accessing this Web site, follow its instructions for submitting
comments.
Instructions: All comment submissions must include the agency name
and docket number or the Regulatory Information Number (RIN) for this
rulemaking. Comments need be submitted in only one of the above-listed
formats, not all three. All comments received will be posted without
change to https://www.regulations.gov, including any personal
information you provide. Copies of the received comments also will be
available for inspection in the EEOC Library, FOIA Reading Room, by
advanced appointment only, from 9 a.m. to 5 p.m., Monday through Friday
except legal holidays, from March 2, 2009 until the Commission
publishes the rule in final form. Persons who schedule an appointment
in the EEOC Library, FOIA Reading Room, and need
[[Page 9057]]
assistance to view the comments will be provided with appropriate aids
upon request, such as readers or print magnifiers. To schedule an
appointment to inspect the comments at the EEOC Library, FOIA Reading
Room, contact the EEOC Library by calling (202) 663-4630 (voice) or
(202) 663-4641 (TTY). (These are not toll free numbers.)
FOR FURTHER INFORMATION CONTACT: Christopher J. Kuczynski, Assistant
Legal Counsel, or Kerry E. Leibig, Senior Attorney Advisor, at (202)
663-4638 (voice) or (202) 663-7026 (TTY). (These are not toll free
numbers.) This notice also is available in the following formats: large
print, Braille, audio tape, and electronic file on computer disk.
Requests for this notice in an alternative format should be made to the
Publications Information Center at 1-800-669-3362 (voice) or 1-800-800-
3302 (TTY).
SUPPLEMENTARY INFORMATION:
Introduction
On May 21, 2008, President Bush signed the Genetic Information
Nondiscrimination Act of 2008 (``GINA''), Pub. L. 110-233, 122 Stat.
881, codified at 42 U.S.C. 2000ff et seq. into law. Congress enacted
GINA in recognition of, among many achievements in the field of
genetics, the decoding of the human genome and the creation and
increased use of genomic medicine. As Congress noted, ``New knowledge
about genetics may allow for the development of better therapies that
are more effective against disease or have fewer side effects than
current treatments. These advances give rise to the potential misuse of
genetic information to discriminate in health insurance and
employment.'' GINA Section 2(1), 42 U.S.C. 2000ff, note. Experts
predict that the twenty-first century will see tremendous strides in
the new field of genomic medicine, bringing it into mainstream medical
practice. The National Human Genome Research Institute, the institute
within the National Institutes of Health responsible for the mapping of
the human genome, notes that ``by identifying the genetic factors
associated with disease, researchers may be able to design more
effective drugs; to prescribe the best treatment for each patient; to
identify and monitor individuals at high risk from disease; and to
avoid adverse drug reactions.'' NHGRI, The Future of Genomic Medicine:
Policy Implications for Research and Medicine (Bethesda, Md., Nov. 16,
2005), available at https://www.genome.gov/17516574 (last visited July
16, 2008).
Many genetic tests now exist that can inform individuals whether
they may be at risk for developing a specific disease or disorder. But
just as the number of genetic tests increase, so do the concerns of the
general public about whether they may be at risk of losing access to
health coverage or employment if insurers or employers have their
genetic information. Congress enacted GINA to address these concerns,
by prohibiting discrimination based on genetic information and
restricting acquisition and disclosure of such information, so that the
general public would not fear adverse employment- or health coverage-
related consequences for having a genetic test or participating in
research studies that examine genetic information. Scientific advances
require significant cooperation and participation from among members of
the general public. In the absence of such participation, geneticists
and other scientists would be hampered in their research, and efforts
to develop new medicines and treatments for genetic diseases and
disorders would be slowed or stymied.
GINA Title I applies to group health plans sponsored by private
employers, unions, and state and local government employers; issuers in
the group and individual health insurance markets; and issuers of
Medicare supplemental (Medigap) insurance.\1\ Title I generally
prohibits discrimination in group premiums based on genetic information
and the use of genetic information as a basis for determining
eligibility or setting premiums in the individual and Medigap insurance
markets, and places limitations on genetic testing and the collection
of genetic information in group health plan coverage, the individual
insurance market, and the Medigap insurance market. Title I also
provides a clarification with respect to the treatment of genetic
information under privacy regulations promulgated pursuant to the
Health Insurance Portability and Accountability Act of 1996 (HIPAA).
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\1\ These regulations do not interpret the requirements of GINA
Title I relating to genetic nondiscrimination in health coverage.
Those requirements are administered by the Departments of Health and
Human Services, Labor, and the Treasury.
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Title II of GINA prohibits use of genetic information in the
employment context, restricts the deliberate acquisition of genetic
information by employers and other entities covered by Title II, and
strictly limits such entities from disclosing genetic information. The
law incorporates by reference many of the familiar definitions,
remedies, and procedures from Title VII of the Civil Rights Act of
1964, as amended, and other statutes protecting federal, state, and
Congressional employees from discrimination.\2\
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\2\ Currently, Executive Order 13145 prohibits federal executive
branch agencies from discriminating against applicants and employees
on the basis of genetic information and limits access to and use of
genetic information. Upon its effective date in November 2009, GINA
will protect federal employees from genetic discrimination.
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Summary of the Proposed Regulation
GINA section 211, 42 U.S.C. 2000ff-10, requires the EEOC to issue
regulations implementing Title II of the Act within one year of its
enactment. The Commission is issuing this proposed rule in compliance
with this requirement and pursuant to the Administrative Procedures
Act, 5 U.S.C. 553. The Commission seeks public comment on the proposed
rule, the discussion in this preamble, and other Title II issues not
addressed in either document.
The report for the bill introduced into the Senate in 2007 noted
that ``[a]s a guiding principle, [GINA] is designed to extend to
individuals in the area of genetic discrimination the same procedures
and remedies as are provided under Title VII of the Civil Rights Act of
1964, as amended [(``Title VII'')].'' S. Rep. No. 110-48 at 27.
Although the Senate and House modified the bill between its initial
introduction and final passage, the idea of extending Title VII
protections to applicants and employees in the area of genetic
information did not change.
In developing this proposed regulation, the Commission closely
followed the terms of the statute. The Commission's goal is to
implement the various provisions of Title II consistent with Congress's
intent, to provide some additional clarification of those provisions,
and to explain more fully those sections where Congress incorporated by
reference provisions from other statutes. For example, where GINA
section 201(2)(A)(i) defines employee by reference to Title VII of the
Civil Rights Act of 1964 and other statutes, this proposed regulation
expands on that reference by importing language from these statutes so
that those using the proposed regulation need not refer to other
sources when determining the scope of GINA's coverage.\3\
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\3\ Unless otherwise noted, use of the term ``GINA'' means
``Title II of GINA.'' When needed for clarity, the preamble will
refer to Title I of GINA or Title II of GINA.
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The Commission also recognizes that Title II of GINA includes terms
that are outside the areas of its expertise. In particular, the
definition of ``genetic
[[Page 9058]]
test'' refers to ``analysis of human DNA, RNA, chromosomes, proteins,
or metabolites that detects genotypes, mutations, or chromosomal
changes.'' None of these terms are common to employment discrimination
law. For this reason, Commission staff sought and obtained technical
assistance from the National Human Genome Research Institute, the
institute within the National Institutes of Health responsible for
decoding the human genome and for developing technologies applicable to
the study of the genetic components of complex disorders.
The Commission also coordinated with the Departments of Labor
(DOL), Health and Human Services (HHS), and the Treasury, which have
responsibility for issuing regulations applicable to GINA Title I. In
particular, DOL, HHS (the Centers for Medicare & Medicaid Services) and
the Treasury (the Internal Revenue Service) are responsible for issuing
regulations applicable to GINA sections 101-103. The HHS Office for
Civil Rights is responsible for issuing the regulations applicable to
GINA section 105. The National Association of Insurance Commissioners
has issued conforming model regulations relating to section 104. Among
the various Title II provisions are several that address the
relationship between Title I and Title II, and the relationship between
Title II and several statutes that the Departments enforce, including
the Employee Retirement Income Security Act of 1974 (ERISA), the Public
Health Service Act, the Internal Revenue Code, and HIPAA.
Section-by-Section Analysis of the Regulation
Section 1635.1 Purpose
In this section, the Commission sets forth the general purposes of
GINA. Title II of GINA restricts the deliberate acquisition of genetic
information by covered entities, prohibits use of genetic information
in employment decision-making, requires that genetic information be
kept confidential (which includes maintaining written genetic
information that exists in paper or electronic form as a confidential
medical record), and places strict limits on disclosure of genetic
information.
Section 1635.2 Definitions--General
The Commission reiterates the definitions set forth in GINA section
201, many of which come from Title VII of the Civil Rights Act of 1964.
However, where the statute merely incorporates by reference different
categories of covered employees, the proposed regulation describes more
fully the employees GINA protects. Moreover, GINA specifically provides
that the term ``employee'' includes applicants, see 42 U.S.C. 2000ff-
1(a)(1), and the Supreme Court has held that the term ``employee''
under Title VII includes former employees. See Robinson v. Shell Oil
Co., 519 U.S. 337, 346 (1997). Accordingly, the proposed regulation
makes clear that the term ``employee'' includes an applicant and a
former employee. Similarly, the proposed regulation provides a concise
explanation of the employers covered by GINA, rather than following the
statute's example of providing citations to definitions of ``employer''
provided by other laws. For example, the proposed regulation explains
that Indian tribes, as well as bona fide private clubs (other than
labor organizations) that are exempt from taxation under section 501(c)
of the Internal Revenue Code of 1986, are not employers, rather than
merely referring to Title VII's exclusion of these groups from the
definition of ``employer.'' See 42 U.S.C. 2000e(b)(1) and (2).
The proposed regulation includes a definition of ``covered
entity.'' This proposed regulation uses the term to refer to all
entities subject to Title II of GINA: The different categories of GINA-
covered employers (private sector, state and local government,
Congressional employers, executive branch, federal/civil service), as
well as employment agencies, labor organizations, and joint labor-
management training and apprenticeship programs. The proposed
regulation uses the term ``covered entity'' when describing the
requirements or prohibited practices applicable to all entities subject
to Title II of GINA, thus avoiding some of the repetition found in
sections 202-205 of the statute. This use of the term ``covered
entity'' as a simplifying shorthand to aid in the readability of the
proposed regulation is similar to EEOC's use of ``covered entity'' in
the regulation implementing Title I of the Americans with Disabilities
Act, 42 U.S.C. 12111 (ADA). The term ``covered entity'' in this
proposed regulation is not intended to be synonymous with use of the
same term in Title I of GINA, in regulations implementing Title I of
GINA or HIPAA, or in section 206(c) of GINA (which specifically refers
to HIPAA covered entities).
The proposed regulation says that the term ``covered entity''
includes an ``employing office.'' The term ``employing office,''
referenced in sections 201 and 207 of GINA, is used in the
Congressional Accountability Act, which protects employees in the
legislative branch. See 2 U.S.C. 1301(9). Although the EEOC has no
enforcement authority under the Congressional Accountability Act, as
the only agency with authority to issue regulations under Title II of
GINA, we believe that referencing that law in this proposed regulation
is appropriate to put employees in the legislative branch and covered
employing offices on notice of their rights and responsibilities under
GINA.
Section 1635.3 Definitions Specific to GINA
GINA includes six terms not found in any of the other employment
discrimination statutes that the Commission enforces. This proposed
regulation provides some additional guidance regarding these terms, and
EEOC seeks comment both as to what is, and is not, included in this
preamble or in the text of the proposed regulation. The Commission
notes that DOL, HHS, and the Treasury have published a Request for
Information (RFI) under GINA Title I. See 73 FR 60208 (October 10,
2008). All comments submitted under this proposed rule and the RFI are
being shared among the Federal Agencies.
Section 1635.3(a) Family Member
The statute defines an individual's ``family member'' both by
reference to ERISA section 701(f)(2) and as extending to the
individual's fourth degree relatives. First, section 201(3)(a) of GINA
states that family member is defined as ``a dependent (as that term is
used for purposes of section [701(f)(2) of ERISA]'' of the individual.
For purposes of Title II, the Commission has determined that the
dependents covered by Title II are limited to persons who are or become
related to an individual through marriage, birth, adoption, or
placement for adoption.\4\
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\4\ The Commission's definition of ``dependent'' is solely for
purposes of interpreting Title II of GINA, and is not relevant to
interpreting the term ``dependent'' under Title I of GINA or under
section 701(f)(2) of ERISA and the parallel provisions of the Public
Health Service Act and the Internal Revenue Code. The Commission
believes its interpretation of the term ``family member,''
particularly the way in which GINA's reference to section 701(f)(2)
of ERISA relates to that term, is consistent with the plain language
of both section 701(f)(2) and Title II of GINA, furthers Congress's
intent to prohibit genetic discrimination in the employment context,
and provides covered entities with clear standards governing
compliance with the law.
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Second, GINA includes as family members persons related from the
first to the fourth degree of an individual. The degree of
relationship, which reflects the average proportion of genes in common
between two individuals, is determined by counting generational levels
separating them. The GINA
[[Page 9059]]
provisions thus include the individual's children, siblings, and
parents (first degree) and extend to great-great grandparents and first
cousins once removed (the children of a first cousin), as well as
family members who are in between the individual and these persons
(including parents, siblings, half-siblings, nieces, nephews,
grandparents, great grandparents, aunts, uncles, great aunts and
uncles, and first cousins).
Section 1635.3(b) Family Medical History
The proposed regulation includes a definition of ``family medical
history'' because it is a term used in the statute's discussion of
prohibited employment practices, but it is not specifically defined by
the statute. In the legislative history of GINA, Congress stated that
the term ``family medical history [should] be understood as it is used
by medical professionals when treating or examining patients.'' S. Rep.
No. 110-48, at 16. In particular, the Senate Report notes as follows:
[T]he American Medical Association (AMA) has developed an adult
family history form as a tool to aid the physician and patient to
rule out a condition that may have developed later in life, which
may or may not have been inherited. This form requests information
about the patient's brothers, sisters, and their children,
biological mother, the mother's brothers, sisters, and their
children, maternal grandfather, maternal grandmother, biological
father, the father's brothers, sisters, and their children, paternal
grandfather and paternal grandmother. The committee expects that the
use of ``family history'' in this bill will evolve with the medical
profession and the tools it develops in this area.
Id. The Report further notes that ``a family medical history could be
used as a surrogate for a genetic trait,'' id., and that the definition
of ``genetic information'' had to include ``family medical history'' to
prevent a covered entity from making decisions about an individual's
health based on the existence of an inheritable disease of a family
member. See also id. at 28 (reiterating the Title I discussion of
family medical history in the Report section addressing Title II).\5\
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\5\ Since 2004 the U.S. Surgeon General's Family History
Initiative has actively promoted the collection and use of family
history information in clinical settings, including featuring a
bilingual Web-based tool through which the user creates and
organizes his/her family health history (https://www.hhs.gov/
familyhistory/). GINA is not intended to limit the collection of
family medical history by health care professionals for diagnostic
or treatment purposes.
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Section 1635.3(c) Genetic Information
GINA section 201(4) and the proposed regulation define genetic
information to include information from genetic tests, the genetic
tests of family members, family medical history, and genetic
information of a fetus carried by an individual or an individual's
family member or an embryo lawfully held by an individual or family
member receiving assistive reproductive services. Genetic information
also includes information about an individual's or family member's
request for or receipt of genetic services. The statute and proposed
regulation exclude from coverage information about an individual's or
family member's age or gender.
Section 1635.3(d) Genetic Monitoring
Genetic monitoring is defined in GINA section 201(5) as the
``periodic examination of employees to evaluate acquired modifications
to their genetic material * * * caused by the toxic substances they use
or are exposed to in performing their jobs.'' The proposed regulation
uses language similar to that found in the statute in defining the
term. As more fully described in 1635.8(b)(5) and its accompanying
Preamble discussion, a covered entity may acquire genetic information
as part of genetic monitoring that is either required by law or
voluntarily undertaken, provided the entity complies strictly with
certain conditions.
Section 1635.3(e) Genetic Services
The term ``genetic services'' is defined in GINA section 201(6). It
includes genetic tests, genetic counseling, and genetic education.
Making an employment decision based on knowledge that an individual has
received genetic services violates GINA, even if the covered entity is
unaware of the specific nature of the genetic services received or the
specific information exchanged in the course of providing them.
Section 1635.3(f) Genetic Test
GINA section 201(7) defines ``genetic test'' to mean the ``analysis
of human DNA, RNA, chromosomes, proteins, or metabolites, that detects
genotypes, mutations, or chromosomal changes.'' Genetic tests are used
to detect gene variants associated with a specific disease or
condition. For example, tests to determine whether an individual
carries the genetic variant evidencing a predisposition to breast
cancer--whether the individual has the BRCA1 or BRCA2 variant--or to
determine whether an individual has a genetic variant associated with
hereditary nonpolyposis colorectal cancer are genetic tests. It is
important to note, however, that the presence of a genetic variant
relating to a predisposition to disease is not evidence of, and does
not equate to, disease. Similarly, a positive test for a genetic
variant as strongly penetrant as Huntington's Disease does not equate
to the presence of the disease, even though development of the disease
is almost inevitable.
The Commission invites comments on the scope of the term ``genetic
test.'' The proposed regulation includes two examples of tests that are
not genetic: a test for the presence of a virus that is not composed of
human DNA, RNA, chromosomes, proteins, or metabolites and a test for
drug or alcohol use. Another example of what is not a genetic test and
might be mentioned, either in the text of the regulation or in the
final preamble, is a test for infectious and communicable diseases that
may be transmitted through food handling, which, the Commission
believes, is not covered by the definition of ``genetic test.''
Similarly, routine tests such as complete blood counts, cholesterol
tests, and liver-function tests would not be protected under GINA. We
seek comment as to how the term should be applied, whether the proposed
regulation should be more or less expansive, and whether it or the
preamble should provide examples of what should be included or
excluded.
The Commission further notes that the Title II definition of
``genetic test'' differs from the definition of this term in Title I.
Specifically, the Title II definition of ``genetic test'' does not have
the express exclusion that Title I does for ``an analysis of proteins
or metabolites that is directly related to a manifested disease,
disorder, or pathological condition that could reasonably be detected
by a health care professional with appropriate training and expertise
in the field of medicine involved.'' GINA 101(d), 29 U.S.C. 1191b-
(d)(7)(B). Title II does not require this language of exclusion because
Congress determined that these uses ``are not applicable in the
employment context.'' S. Rep. No. 110-48 at 28. However, as explained
below, the Commission borrowed from Title I's use of the term
``manifest'' in the definition of ``genetic test'' in formulating a
definition of ``manifested or manifestation.''
Section 1635.3(g) Manifestation or Manifested
We have added a definition of ``manifestation or manifested'' to
the proposed regulation, because sections
[[Page 9060]]
201(4)(A)(iii) and 210 use the terms. Specifically, GINA section
201(4)(A)(iii), defining ``genetic information,'' refers to the
``manifestation of a disease or disorder in family members'' of an
individual, and section 210, entitled ``Medical information that is not
genetic information,'' refers to a ``manifested disease, disorder, or
pathological condition.'' The definition of ``manifestation or
manifested'' was developed with the assistance of the National Human
Genome Research Institute, an Institute within the National Institutes
of Health. The proposed regulation defines ``manifestation or
manifested'' to mean, with respect to a disease, disorder, or
pathological condition:
That an individual has been or could reasonably be diagnosed with
the disease, disorder, or pathological condition by a health care
professional with appropriate training and expertise in the field of
medicine involved. For purposes of this part, a disease, disorder,
or pathological condition is not manifested if the diagnosis is
based principally on genetic information or on the results of one or
more genetic tests.
This understanding of the term ``manifested'' is consistent both
with the definition of genetic test found in Title I, which permits use
of certain diagnostic tests in order to determine whether an individual
has a current--or manifest--disease, disorder, or condition, see id. at
16, and with the notion, discussed above in conjunction with the
definition of genetic test (section 1635.3(f)), that the mere presence
of a genetic variant does not mean that an individual has an associated
condition, disease, or disorder. The presence of a genetic variant
alone does not constitute a diagnosis; other signs or symptoms must be
present. This interpretation is consistent with current ERISA
regulations which prohibit a group health plan, and a health insurance
issuer offering group health insurance coverage, from imposing a
preexisting condition exclusion relating to a condition based solely on
genetic information. However, if an individual is diagnosed with a
condition, even if the condition relates to genetic information, the
plan may impose a preexisting condition exclusion with respect to the
condition, subject to other HIPAA portability requirements. See 29 CFR
2590.701-3(b)(6)(i). Thus, for example, a woman who has group health
plan coverage and has the BRCA1 gene variant may not be subject to a
preexisting condition exclusion merely because she has the variant. Id.
Example at 2590.703(b)(6)(ii).
Similarly, Huntington's disease (HD) is an example of a genetic
disease that is not diagnosed solely through use of a genetic test;
other signs and symptoms must be present. The presence of the genetic
variant virtually guarantees the later development of disease, but the
disease does not usually manifest until adulthood. Therefore, even when
a genetic variant is 100 percent predictive for development of disease,
the presence of the variant does not by itself equal diagnosis of the
disease.
Section 1635.4 Prohibited Practices--In General
In describing the prohibited practices under GINA Title II,
Congress adopted language similar to that used in Title VII and other
equal employment statutes, evincing its intent to prohibit
discrimination with respect to a wide range of covered entity
practices, including hiring, promotion and demotion, seniority,
discipline, termination, compensation, and the terms, conditions, and
privileges of employment. In separate GINA sections 203-205, the
statute notes additional covered actions of employment agencies
(failing or refusing to refer for employment), labor unions (excluding
or expelling from membership), and training, retraining, and
apprenticeship programs (denying admission to or employment in such
programs).
Section 1635.5 Limiting, Segregating, and Classifying
The proposed regulation reiterates the statutory language barring
actions by covered entities that may limit, segregate, or classify
employees because of genetic information. For example, an employer
could not reassign someone whom it learned had a family medical history
of heart disease from a job it believed would be too stressful and
might eventually lead to heart-related problems for the employee. This
section also makes clear that although the language of the statute
specifically prohibits actions that have the ``purpose or effect'' of
limiting, segregating, or classifying individuals on the basis of
genetic information, neither the statute nor the proposed regulation
creates a cause of action for disparate impact. Section 208 of GINA
specifically prohibits such actions, and establishes the Genetic Non-
Discrimination Study Commission, to examine ``the developing science of
genetics'' and recommend to Congress ``whether to provide a disparate
impact cause of action under this Act.'' The proposed regulation does
not address the establishment of this Commission, which is scheduled to
begin its work on May 21, 2014.
Section 1635.6 Causing an Employer To Discriminate
GINA sections 203(c), 204(c), and 205(d) expressly bar employment
agencies, labor organizations, and apprenticeship or other training
programs from causing an employer to discriminate on the basis of
genetic information. These sections recognize that employers engage in
most of the employment-related activities that the Act reaches. Other
covered entities, however, might engage in conduct that could cause an
employer to discriminate. For example, an employment agency or union
might share or attempt to share genetic information it obtained
(whether legally or not) about a client or member with an employer in
an effort to affect the individual's employment prospects. Such conduct
would violate sections 203(c) and 204(c).
Although section 202 does not include a similar provision
explicitly prohibiting an employer from causing another covered entity
to discriminate, it is well settled under Title VII that the definition
of employer includes employers' agents under common law agency
principles. See Vinson v. Meritor Savings Bank, 477 U.S. 57, 72 (1986).
Because GINA incorporates Title VII's definition of employer, including
the application of common law agency principles, GINA would bar an
employer from engaging in actions that would cause another covered
entity acting as its agent to discriminate. For example, an employer
that directed an employment agency to ask applicants for genetic
information or told the employment agency not to send it candidates
with a family medical history for certain conditions would violate
GINA. An employment agency that acted pursuant to the employer's
direction would be liable for violating GINA either directly, because
the law applies to employment agencies, or as an agent of the employer.
Similarly, an employer would violate GINA if it used a labor
organization's hiring hall to obtain genetic information in making job
referrals, and the labor union would be liable under GINA either
directly or as the employer's agent.
Section 1635.7 Retaliation
The proposed regulation reiterates the statutory prohibition
against retaliation where an individual opposes any act made unlawful
by GINA, files a charge of discrimination or assists another in doing
so, or gives testimony in connection with a charge. Because
[[Page 9061]]
Congress adopted in GINA the language of the anti-retaliation provision
in Title VII of the Civil Rights Act of 1964, the Commission believes
that Congress intended the standard for determining what constitutes
retaliatory conduct under GINA to be the same as the standard under
Title VII, as announced by the Supreme Court in Burlington Northern &
Santa Fe Ry. v. White, 548 U.S. 53 (2006). In that case, the Court held
that Title VII's anti-retaliation provision protects an individual from
conduct, whether related to employment or not, that a reasonable person
would have found ``materially adverse,'' meaning that the action ``well
might have `dissuaded a reasonable worker from making or supporting a
charge of discrimination.' '' Id. at 57-58 (citations omitted).
Section 1635.8 Acquisition of Genetic Information
Each of the discrete GINA sections addressing the conduct of
employers, employment agencies, labor organizations, and apprenticeship
or other training programs includes a section prohibiting covered
entities from requesting genetic information from applicants, employees
or other individuals; from requiring that applicants or employees
provide genetic information; or from purchasing genetic information
about an applicant or employee. Each section also includes the same
five exceptions. Sections 202, covering employers, and 205 covering
joint labor-management training and apprenticeship programs, include a
sixth exception. The proposed regulation addresses each of the
exceptions. Covered entities are cautioned, however, that the use of
genetic information to discriminate, no matter how that information may
have been acquired, is prohibited.
Inadvertently Requesting or Requiring Genetic Information: First, a
covered entity that ``inadvertently requests or requires family medical
history'' from an individual does not violate GINA. Congress intended
this exception to address what it called the `` `water cooler problem'
in which an employer unwittingly receives otherwise prohibited genetic
information in the form of family medical history through casual
conversations with an employee or by overhearing conversations among
co-workers.'' S. Rep. No. 110-48, at 29; see also H.R. Comm. on
Education and Labor, Genetic Information Nondiscrimination Act of 2007,
H.R. Rep. No. 110-28 part I, 37-38 (2008) (H.R. Rep. No. 110-28, part
I). Congress did not want casual conversation among co-workers
regarding health to trigger federal litigation whenever someone
mentioned something that might constitute protected family medical
history. The Commission's proposed regulation thus notes that a covered
entity inadvertently acquires family medical history where a manager or
supervisor overhears a conversation among co-workers that includes
information about family medical history (e.g., a conversation in which
one employee tells another that her father has Alzheimer's Disease), or
receives an unsolicited e-mail message from a co-worker that includes
genetic information.
Although the language of this exception in GINA specifically refers
to family medical history, the Commission believes that it is
consistent with Congress's intent to extend the exception to any
genetic information that an employer inadvertently acquires. The
Commission does not believe, for example, that Congress intended that
an employer would be liable for the acquisition of genetic information
because it overhears a conversation in which one employee tells another
that her mother had a genetic test to determine whether she was at
increased risk of getting breast cancer. If the exception were read to
cover only family medical history, this type of acquisition of genetic
information would violate GINA, even though it occurred inadvertently,
because information that a family member has had a genetic test, while
genetic information, is not information about the occurrence of a
disease or disorder in a family member.
The Commission also understands this exception to apply in any
situation in which an employer might inadvertently acquire genetic
information, not just situations involving conversations between co-
workers that are overheard. The proposed regulation provides an
illustrative list of situations where we believe the acquisition comes
within Congress's intent. Thus, for example, the exception applies when
the covered entity, acting through a supervisor or other official,
receives family medical history directly from an individual following a
general health inquiry (e.g., ``How are you?'') or a question as to
whether the individual has a manifested condition. Similarly, a casual
question between colleagues, or between a supervisor and supervisee,
concerning the health of a parent or child would not violate GINA
(e.g., ``How's your son feeling today?'').
A covered entity that asks for family medical history or other
genetic information as part of an inquiry or medical examination
related to an applicant's or employee's manifested disease, disorder,
or pathological condition will not be considered to have acquired such
information inadvertently. Thus, even though the ADA allows an employer
to require a medical examination of all employees to whom it has
offered a particular job, for example, to determine whether they have
heart disease that would affect their ability to perform a physically
demanding job, GINA would prohibit inquiries about family medical
history of heart disease as part of such an examination. Such a
limitation will not affect an employer's ability to use a post-offer
medical examination for the limited purpose of determining an
applicant's current ability to perform a job.
Covered entities should ensure that any medical inquiries they make
or any medical examinations they require are modified so as to comply
with the requirements of GINA. In particular, we note that at present,
the ADA permits employers to obtain medical information, including
genetic information, from post-offer job applicants. As we interpret
GINA, this will change on the November 21, 2009 effective date of Title
II of GINA: Employers no longer will be permitted to obtain any genetic
information, including family medical history, from post-offer
applicants. Employers will likewise be prohibited from obtaining this
type of information through any type of medical examination required of
employees for the purpose of determining continuing fitness for duty.
However, Title II of GINA will not apply to information obtained by
a health care professional in the course of a medical examination,
diagnosis, or treatment unrelated to a determination of fitness for
duty, except to the extent the information is obtained as part of an
employer-provided voluntary wellness program subject to 1635.8(b)(2) of
this proposed rule. For example, a doctor working at a hospital may ask
for family medical history from a hospital employee who requests a
medical examination. See 29 CFR 1635.8(b)(2) (allowing collection of
genetic information, under certain specified conditions, when an
employer offers health or genetic services as part of a voluntary
wellness program).
The proposed regulation notes that when a covered entity seeks
information from an individual who requests a reasonable accommodation
under the ADA or other state or local law, the acquisition of genetic
information as part of the documentation that the individual provides
in support of the
[[Page 9062]]
request is considered inadvertent, as long as the request for
documentation was lawful (e.g., was not overly broad). For information
on the type of medical information an employer may lawfully request in
connection with a request for reasonable accommodation see EEOC's
Enforcement Guidance on Reasonable Accommodation and Undue Hardship
Under the Americans with Disabilities Act, EEOC Notice No. 915.002
(Oct. 17, 2002), available at https://www.eeoc.gov/policy/docs/
accommodation.html. We note that GINA's prohibition on requesting,
requiring, or purchasing genetic information would control during the
interactive process used to determine an appropriate reasonable
accommodation. The Commission knows of no reason why a covered entity
would need to request genetic information to determine an individual's
current physical or mental limitations and whether those limitations
can be accommodated.
The Commission further recognizes that other federal, state, or
local laws may allow covered entities to obtain medical information
about employees (other than genetic information). The proposed
regulation makes it clear that a covered entity that inadvertently
receives genetic information in response to a lawful request for
medical information under such a law would not violate GINA, including,
for example, where a covered entity received genetic information in
connection with the FMLA's employee return to work certification
requirements.
The Commission believes that the first exception to the general
prohibition of requesting, requiring, or purchasing genetic information
should also apply when an individual requests leave pursuant to a leave
policy independent of a federal, state, or local leave or disability
law, unless the covered entity's request was overbroad. For example, a
request for an employee's entire medical record or the entire medical
record related to a particular impairment is likely to include family
medical history. An employer who receives family medical history or
other genetic information in response to such a broad request would
violate GINA. For information on the appropriate scope of inquiries in
response to requests for leave (other than as a reasonable
accommodation), see EEOC's Enforcement Guidance on Disability-Related
Inquiries and Medical Examinations of Employees Under the Americans
with Disabilities Act, 8 Fair Empl. Prac. Man. (BNA) 405:7701,
Questions 15-17 (July 27, 2000) (``Enforcement Guidance''), available
at https://www.eeoc.gov/policy/docs/guidance-inquiries.html.
In addition to complying with relevant EEOC guidance, covered
entities may wish to take proactive measures to avoid even the
inadvertent acquisition of genetic information. For example, as a best
practice, an employer that asks an employee to have a health care
professional provide documentation about a disability in support of a
request for accommodation could specifically indicate on a
questionnaire provided for this purpose that family medical history or
other genetic information about the employee should not be provided.
Health or Genetic Services: Second, GINA permits covered entities
to offer health or genetic services, and notes that a covered entity
that meets specific requirements may offer such services as a part of a
wellness program. The proposed regulation reiterates the statutory
provision, but further notes that a wellness program seeking medical
information must be voluntary, which is a requirement set forth in the
ADA. The Commission notes that according to the Enforcement Guidance, a
wellness program is voluntary ``as long as an employer neither requires
participation nor penalizes employees who do not participate. Id.,
Question 22. The Commission has not further addressed how the term
``voluntary'' should be defined for purposes of the ADA's application
to wellness programs. We invite comments regarding the scope of this
term.
The proposed regulation lists the specific requirements in the
statute as prerequisites to the acquisition of genetic information when
providing genetic services: A request in writing and in language
reasonably likely to be understood by the individual from whom the
information is sought; a description of the information being
requested; and a description of the safeguards in place to protect
against unlawful disclosure. The proposed regulation states that
individually identifiable information may be provided only to the
individual from whom it was obtained and that covered entities are
entitled only to receive information in aggregate terms that do not
disclose the identity of specific individuals. Although not stated in
the proposed regulation, a covered entity that receives ``aggregate''
information may still violate GINA where the small number of
participants, alone or in conjunction with other factors, makes an
individual's genetic information readily identifiable.
The Commission notes that although this provision permits covered
entities to implement wellness programs that seek family medical
history voluntarily, other provisions in GINA Title I place strict
limits on the genetic information that group health plans may request
or require from covered individuals. In this regard, the Commission
further notes that DOL, HHS and the Treasury are responsible for
addressing the limitations on group health plans and insurance issuers
under Title I. Covered entities that sponsor, establish, or maintain
group health plans that implement wellness programs or other health-
related services are cautioned to consider carefully whatever
limitations these Departments place on group health plans with respect
to the acquisition of genetic information.
The Commission also notes that Congress made clear at section
206(c) that GINA's Title II provisions are not to be construed to
interfere with or otherwise apply to uses and disclosures of health
information that are governed by the privacy regulations promulgated
pursuant to HIPAA (``the HIPAA Privacy Rule''). As discussed below, the
proposed rule implements this general statutory provision at proposed
1635.11(d) by excluding from coverage genetic information that is
health information otherwise protected by the HIPAA Privacy Rule.
Consistent with proposed 1635.11(d), the Commission further notes that
nothing in section 1635.8 should be read as applying to or otherwise
restricting the use or disclosure of genetic information that is
protected health information subject to the HIPAA Privacy Rule. Thus,
where a health care provider covered by the HIPAA Privacy Rule is
providing health or genetic services, that provider is subject to the
requirements of the HIPAA Privacy Rule with regard to uses and
disclosures of protected health information, including HIPAA's
conditions on disclosures to employers, and not this proposed
regulation's provisions.
Family and Medical Leave Act: Third, GINA recognizes that
individuals requesting leave under the Family and Medical Leave Act
(FMLA) or similar state or local law might provide family medical
history. For example, an individual requesting FMLA leave to care for a
seriously ill relative may disclose family medical history when
completing the certification required by section 103 of the FMLA. A
covered entity that receives family medical history under these
circumstances would not violate GINA. Because this information is still
subject to GINA's confidentiality requirements, however, the
information must be placed in a separate medical file and must be
[[Page 9063]]
treated as a confidential medical record, as more fully described
below.
Commercially and Publicly Available Information: Fourth, GINA
provides an exception for the purchase of commercially and publicly
available materials that may include family medical history. As with
the exception applicable to the inadvertent acquisition of family
medical history, the Commission reads this exception as applying to all
genetic information, not just to family medical history. For example,
an employer would not violate GINA if it learned that an employee had
the breast cancer gene by reading a newspaper article profiling several
women living with the knowledge that they have the gene.
The statute identifies newspapers, magazines, periodicals, and
books as potential sources of genetic information. The proposed
regulation adds to that list information obtained through electronic
media, such as the Internet, television, and movies. The exception does
not include family medical history contained in medical databases or
court records. Research databases available to scientists on a
restricted basis, such as databases that NIH maintains for the
scientific community, would not be considered ``commercially and
publicly available.'' The Commission invites public comment on whether
there are sources similar in kind to those identified in the statute
that may contain family medical history and should be included either
in the group of excepted sources or the group of prohibited sources,
such as personal Web sites, or social networking sites. Further, we
would appreciate comment regarding whether the additional sources that
are noted in the proposed regulation should be deemed similar in nature
to those contained in the statute so as to remain a part of the
regulation.
Genetic Monitoring: Fifth, the statute permits a covered entity to
engage in the genetic monitoring of the biological effects of toxic
substances in the workplace. The statute and proposed regulation note
that monitoring must meet certain requirements. First, a covered entity
must provide written notice of the monitoring and, where the monitoring
is not specifically required by federal or state law, must obtain an
individual's prior knowing, written, and voluntary authorization.
Second, the proposed regulation describes the type of authorization the
employer must provide in order to ensure that it is knowing and
voluntary. The authorization must be written in a way that is
reasonably likely to be understood by the person from whom the
information is being sought, must describe the type of genetic
information that will be obtained and the general purposes for which it
will be used, and must describe the limitations on disclosure of the
genetic information. Third, all monitoring must comply with all
applicable provisions of the law and implementing regulations,
including regulations promulgated pursuant to the Occupational Safety
and Health Act of 1970 (29 U.S.C. 651 et seq.), the Federal Mine Safety
and Health Act of 1977 (30 U.S.C. 801 et seq.) , and the Atomic Energy
Act of 1954 (42 U.S.C. 2011 et seq.).
Whether or not the monitoring is undertaken pursuant to federal or
state law, GINA requires that the individual receive results of the
monitoring and that the covered entity receive information only in
aggregate terms that do not disclose the identity of specific
individuals. As noted above in the paragraph addressing genetic
services, covered entities that engage in genetic monitoring,
particularly when done on a voluntary basis, are cautioned where the
monitoring encompasses only a few individuals: Information obtained in
the aggregate may make a particular individual's genetic information
identifiable.
DNA Testing for Law Enforcement or Human Remains Identification
Purposes: Finally, sections 202(b), covering employers, and 205(b),
covering apprenticeship or other training programs, include a sixth
exception for employers that engage in DNA testing for law enforcement
purposes as a forensic lab or for purposes of human remains
identification. GINA provides that these entities may request or
require ``genetic information of such employer's employees,
apprentices, or trainees, but only to the extent that such genetic
information is used for analysis of DNA identification markers for
quality control to detect sample contamination and maintained in a
manner consistent with such use.'' This is a very limited exception
and, if properly conducted, an employer or training program would not
obtain health-related genetic information. The EEOC invites comments on
the impact of this exception on law enforcement.
Section 1635.9 Confidentiality
GINA section 206 addresses confidentiality of genetic information
generally, establishes permitted disclosures, and describes the
relationship between GINA and HIPAA. Each of these items is discussed
below.
Section 1635.9(a) Treatment of Genetic Information
Under GINA, covered entities are required to treat genetic
information the same way they treat medical information generally. That
is, covered entities in possession of genetic information must keep the
information confidential and, if the information is in writing, must
keep it apart from other personnel information in separate medical
files.\6\ Congress made express the requirement that covered entities
keep genetic information confidential by using the confidentiality
regime required by the ADA generally for medical records. H.R. Rep.
110-28, part I, at 39. GINA does not require that covered entities
maintain a separate medical file for genetic information. Genetic
information may be kept in the same file as medical information subject
to the ADA.
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\6\ Genetic information that a covered entity receives verbally
and does not reduce to writing must still be kept confidential,
except to the extent that GINA permits disclosure.
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As noted above, a covered entity does not violate GINA when it
acquires genetic information available through publicly available
sources. For example, an employer that purchased a newspaper with an
obituary about a family member of an employee indicating that the
employee's relative died of a disease or disorder that has a genetic
component would not violate GINA. Similarly, a labor organization may
lawfully acquire a magazine or periodical with an article about a
member that includes family medical history information about the
member's parent, sibling, or child. In neither instance, nor in any
similar instance where a covered entity acquires family medical history
through publicly available sources, must the covered entity place the
information into a confidential medical file. Moreover, inasmuch as one
of GINA's purposes is the protection from disclosure of otherwise
private genetic information, disclosure of publicly available
information does not violate the Act. However, a covered entity may not
use family medical history to make employment decisions, even if the
information was acquired through commercially and publicly available
sources.
Section 1635.9(b) Limitations on disclosure
GINA permits disclosure of genetic information in limited
circumstances. First, a covered entity may disclose genetic information
to the individual to whom it relates, if the individual
[[Page 9064]]
requests disclosure in writing. Second, the section states that genetic
information may be provided to an occupational health researcher ``if
the research is being conducted in compliance with the regulations
under'' 45 CFR part 46.
The third exception permits disclosure in compliance with a court
order. It provides that the disclosure of genetic information must be
carefully tailored to the terms of the order and the covered entity
must inform the individual about the order and what information it
disclosed. This exception does not allow disclosures in other
circumstances during litigation, such as in response to discovery
requests that are not governed by an order specifying the genetic
information that must be disclosed.
The fourth exception permits disclosure of relevant genetic
information to government officials investigating compliance with the
statute. The fifth exception permits disclosure consistent with the
requirements of the FMLA or similar state or local leave law. For
example, an employee's supervisor who receives a request for FMLA leave
from an employee who wants to care for a child with a serious health
condition may forward this request to persons with a need to know the
information because of responsibilities relating to the handling of
FMLA requests. Finally, the sixth exception permits disclosure of
family medical history to federal, state, or local public health
officials in connection with a contagious disease that presents an
imminent hazard of death or life-threatening illness. The statute
requires the covered entity to notify the employee of any release of a
family member's medical history information when undertaken for this
purpose.
Section 1635.9(c) Relationship to HIPAA Privacy Regulations
GINA section 206(c) provides that the provisions of Title II of
GINA are not intended to apply to uses and disclosures of health
information governed by the HIPAA Privacy Rule. Accordingly, and
consistent with the general rule of construction implementing this
statutory provision at 1635.11(d), this proposed rule provides at
1635.9(c) that nothing in 1635.9 should be construed as applying to the
use or disclosure of genetic information that is protected health
information subject to the HIPAA Privacy Rule. See discussion of
Section 1635.11(d), infra, for an example of the interaction under GINA
between the HIPAA Privacy Rule and this proposed regulation.
Section 1635.10 Enforcement and Remedies
In crafting GINA's enforcement and remedies section, Congress
recognized the advisability of using the existing mechanisms in place
for redress of other forms of employment discrimination. In particular,
the Senate noted that this section intends to take ``advantage of the
expertise and process of the EEOC.'' S. Rep. No. 110-48, at 31 & n.17.
In this regard, GINA and the proposed regulation provide the following:
The enforcement mechanism applicable and remedies
available to employees and others covered by Title VII apply to GINA as
well. The statute references sections 705-707, 709-711, and 717 of
Title VII, 42 U.S.C. 2000e-4, et seq. The Commission notes that its
implementing regulations found at 29 CFR parts 1601 (procedural
regulations), 1602 (recordkeeping and reporting requirements under
Title VII and the ADA), and 1614 (federal sector employees) apply here
as well.
The procedures applicable and remedies available to
employees covered by sections 302 and 304 of the Government Employee
Rights Act of 1991, 42 U.S.C. 2000e-16(b) & (c) (GERA) apply under
GINA. EEOC regulations applicable to GERA are found at 29 CFR part
1603.
The procedures applicable and remedies available to
employees covered by 3 U.S.C. 401 et seq. are set forth in 3 U.S.C.
451-454. These sections provide for counseling and mediation of
employment discrimination allegations and the formal process of
complaints before the Commission using the same administrative process
generally applicable to employees in the Executive Branch of the
Federal government; that is, the process set forth in 29 CFR part 1614.
Employees covered through the Congressional Accountability Act of
1995 must use the procedures set forth in that statute. The Commission
has no authority with respect to the enforcement of GINA as to
employees covered through this provision.
The proposed regulation includes a separate reference to the
remedies provisions applicable to GINA. Similar to other federal anti-
discrimination laws, GINA provides for recovery of pecuniary and non-
pecuniary damages, including compensatory and punitive damages. The
statute's incorporation by reference of section 1977A of the Revised
Statutes of the United States (42 U.S.C. 1981a) also imports the
limitations on the recovery of compensatory damages for future
pecuniary losses, emotional pain, suffering, etc., and punitive damages
applicable generally in employment discrimination cases, depending on
the size of the employer. Punitive damages are not available in actions
against the federal government, or against state or local government
employers.
Finally, the proposed regulation notes that covered entities are
required to post notices in conspicuous places describing GINA's
applicable provisions. The Commission, prior to GINA's effective date,
will publish in the Federal Register appropriate language for use in
such notices.
Section 1635.11 Construction
GINA section 209 and this section of the proposed regulation set
forth rules of construction applicable to GINA's coverage and
prohibitions. They address principally GINA's relationship to other
federal laws covering discrimination, health insurance, and other areas
of potential conflict.
Section 1635.11(a) Relationship to Other Laws Generally
The subsection first addresses the relationship of Title II of GINA
to other federal, state, local, and tribal laws governing genetic
discrimination, the privacy of genetic information, and discrimination
based on disability. Over 40 states have laws addressing genetic
discrimination in employment. Some may be more stringent than GINA;
others less so. GINA makes clear that it does not preempt any other
state or local law that provides equal or greater protections than GINA
from discrimination on the basis of genetic information or improper
access or disclosure of genetic information. Additionally, Title II of
GINA does not limit the rights or protections under federal, state,
local or Tribal laws that provide greater privacy protection to genetic
information.
Similarly, GINA does not affect an individual's rights under the
ADA, the Rehabilitation Act, or state or local laws that prohibit
discrimination against individuals based on disability. So, for
example, an individual could challenge the disclosure of genetic
information under the ADA where the information is also considered
medical information subject to that law. Additionally, even though
information that an employee currently has a disease, such as cancer,
is not subject to GINA's confidentiality provisions, such information
would be protected under the ADA, and an employer would be liable under
that law for disclosing the information, unless a specific ADA
exception applied.
[[Page 9065]]
GINA does limit, however, an employer's ability to obtain genetic
information as a part of a disability-related inquiry or medical
examination. For example, upon the effective date of GINA, an employer
will no longer be able to obtain family medical history or conduct
genetic tests of post-offer job applicants, as it currently may do
under the ADA.
Other provisions in this section clarify that GINA does n