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


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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

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201(4)(A)(iii) and 210 use the terms. Specifically, GINA section 
201(4)(A)(iii), defining ``genetic information,'' refers to the 
``manifestation of a disease or disorder in family members'' of an 
individual, and section 210, entitled ``Medical information that is not 
genetic information,'' refers to a ``manifested disease, disorder, or 
pathological condition.'' The definition of ``manifestation or 
manifested'' was developed with the assistance of the National Human 
Genome Research Institute, an Institute within the National Institutes 
of Health. The proposed regulation defines ``manifestation or 
manifested'' to mean, with respect to a disease, disorder, or 
pathological condition:

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