Federal Register, Volume 74 Issue 39 (Monday, March 2, 2009)

[Federal Register Volume 74, Number 39 (Monday, March 2, 2009)]
[Proposed Rules]
[Pages 9056-9071]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-4221]

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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.

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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: http://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 http://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 http://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 (http://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 http://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 http://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.
---------------------------------------------------------------------------

\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.
---------------------------------------------------------------------------

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 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 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 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-

[[Page 9066]]

benefit assessment of the proposed regulation is not required.

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 http://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/pre-
employment 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 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 http://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 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.

Sec. 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
decision-making, 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.

Sec. 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

[[Page 9067]]

(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 policy-making 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
Sec. 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 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-the-job 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 Shelf lands defined in the Outer Continental Shelf Lands
Act (43 U.S.C. 1331 et seq.).

Sec. 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 Sec. 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

[[Page 9068]]

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.

Sec. 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 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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 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

[[Page 9069]]

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 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 Sec. 1635.8(b) of this part to
discriminate, as defined by Sec. Sec. 1635.4, 1635.5, or 1635.6, and
must keep such information confidential as required by Sec. 1635.9.

Sec. 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 Sec. 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
Sec. Sec. 1635.4, 1635.5, or 1635.6 of this part.
(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 life-threatening 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 Sec.
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.

Sec. 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

[[Page 9070]]

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 Sec. 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 Sec. 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 Sec. 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 Sec. 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).

Sec. 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
(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
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 Sec. 1635.11(b) of this part, including any
implementing regulations noted in Sec. 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.

Sec. 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

[[Page 9071]]

pathological condition is subject to the requirements and prohibitions
in sections 202 through 206 of GINA and Sec. Sec. 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