[Federal Register Volume 75, Number 216 (Tuesday, November 9, 2010)]
[Rules and Regulations]
[Pages 68912-68939]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-28011]



[[Page 68911]]

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Part III





Equal Employment Opportunity Commission





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29 CFR Part 1635



 Regulations Under the Genetic Information Nondiscrimination Act of 
2008; Final Rule

Federal Register / Vol. 75 , No. 216 / Tuesday, November 9, 2010 / 
Rules and Regulations

[[Page 68912]]


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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: Final rule.

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SUMMARY: The Equal Employment Opportunity Commission (``EEOC'' or 
``Commission'') is issuing a final rule to 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 
issued a proposed rule in the Federal Register on March 2, 2009, for a 
sixty-day notice and comment period that ended on May 1, 2009. After 
consideration of the public comments, the Commission has revised 
portions of both the final rule and the preamble.

DATES: Effective January 10, 2011.

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 rule also is available in the following formats: large 
print, Braille, audio tape, and electronic file on computer disk. 
Requests for this rule 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 George W. Bush signed the Genetic 
Information Nondiscrimination Act of 2008 (``GINA''), Public Law 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 (NHGRI), 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 7, 2010).
    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 increases, 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 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's health coverage provisions apply 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\ These Title I provisions generally prohibit 
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 
place 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 requires the 
Secretary of Health and Human Services to revise the privacy 
regulations promulgated pursuant to the Health Insurance Portability 
and Accountability Act of 1996 (HIPAA). HHS has published a notice of 
proposed rulemaking that proposes to clarify that genetic information 
is health information, and to prohibit group health plans, health 
insurance issuers (including HMOs), issuers of Medicare supplemental 
policies, and all other health plans covered under the HIPAA privacy 
regulations from using or disclosing genetic information for 
underwriting purposes.
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    \1\ This regulation does 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 employers and other entities covered by 
Title II from requesting, requiring, or purchasing genetic information, 
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\ Prior to November 21, 2009, Executive Order 13145 prohibited 
federal executive branch agencies from discriminating against 
applicants and employees on the basis of genetic information and 
limited access to and use of genetic information. Since its 
effective date in November 2009, GINA has protected federal 
employees from genetic discrimination.
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Background

    The Commission published a proposed rule to implement Title II of 
GINA on March 2, 2009, and asked for public comment on the proposed 
rule, the discussion in the preamble, and other Title II issues not 
addressed in either document. See 74 FR 9056 (March 2, 2009). Several 
days earlier, on February 25, 2009, the Commission held a public 
meeting to announce its approval of the proposed rule at which invited 
panelists spoke about the impact of genetic information discrimination 
in the workplace (transcript available at http://www.eeoc.gov/eeoc/meetings/2-25-09/index.cfm). Although they had not had an opportunity 
to review the

[[Page 68913]]

proposed rule, commenters at the public meeting did express their views 
on issues they believed should be addressed in EEOC's regulation to 
effectuate Title II's purposes.
    The Commission received 43 comments from individuals, from groups 
representing individuals, and from organizations representing employers 
and professionals in response to the proposed rule. Most of those who 
participated in the February 25, 2009 public meeting submitted written 
comments after reviewing the proposed rule that were consistent with 
their public testimony. Further, on March 26, 2010, President Obama 
appointed to the Commission by way of recess appointments the Chair and 
two new Commissioners. These new members of the Commission (and others 
who were previously serving on the Commission) met with a number of 
stakeholders who had submitted comments to the record. Records of these 
meetings are included in the rulemaking docket.
    In developing this 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 regulation expands on that 
reference by importing language from these statutes so that those using 
the final 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 test'' refers to ``analysis of human DNA, RNA, 
chromosomes, proteins, or metabolites that detects genotypes, 
mutations, or chromosomal changes.'' None of these terms is common to 
employment discrimination law. For this reason, Commission staff sought 
and obtained technical assistance from NHGRI, 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 (the Employee Benefits Security Administration), 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.\4\ These agencies issued interim 
final rules on sections 101 through 103 of GINA on October 7, 2009. See 
74 FR 51664. The HHS Office for Civil Rights is responsible for issuing 
the regulations applicable to GINA section 105 and issued a proposed 
rule on October 7, 2009 at 74 FR 51698. 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.
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    \4\ The National Association of Insurance Commissioners issued 
conforming model regulations relating to section 104 on September 
24, 2008, published in the Federal Register on April 24, 2009 at 74 
FR 18808.
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Section-by-Section Analysis of the Regulation

Section 1635.1 Purpose

    In this section, the Commission sets forth the general purposes of 
GINA. The language in this section of the final rule has been modified 
slightly in response to several comments that disagreed with the 
characterization of Title II as prohibiting the ``deliberate 
acquisition'' of genetic information. See Comments of the American 
Civil Liberties Union (ACLU), Coalition for Genetic Fairness (CGF), 
Genetic Alliance, and the Genetics and Public Policy Center in 
collaboration with Jeremy Gruber (GPPC). These organizations noted that 
the term ``deliberate acquisition'' suggested that a covered entity 
must have a specific intent to acquire genetic information in order to 
violate the law. According to these commenters, a covered entity 
violates GINA by engaging in acts that present a heightened risk of 
acquiring genetic information, even without a specific intention to do 
so, such as when they fail to inform an individual from whom they have 
requested documentation about a manifested disease or disorder not to 
provide genetic information or when they access sources of information 
(e.g., certain types of databases, Web sites, or social networking 
sites) that are likely to contain genetic information about 
individuals.
    For reasons more fully set forth in the preamble's discussion of 
1635.8(a), (b)(1) and (4), the Commission agrees that a covered entity 
may violate GINA without a specific intent to acquire genetic 
information. For that reason, the Commission has removed the reference 
to ``deliberate acquisition'' of genetic information in 1635.1. We 
likewise recognize that not every acquisition of genetic information 
violates GINA. Accordingly, the section now simply indicates that Title 
II of GINA restricts requesting, requiring, or purchasing genetic 
information. The rest of the language of 1635.1 concerning GINA's 
prohibition on the use of genetic information in employment decision-
making, the requirement 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 the 
limitations on disclosure of genetic information is the same as the 
language in the proposed rule.
    We have also modified this section to include a point made only in 
the preamble to the proposed rule. A new subparagraph, 1635.1(b), 
clarifies that the final rule does not apply to actions of a covered 
entity that do not pertain to an individual's status as an employee, 
member of a labor organization, or participant in an apprenticeship 
program. The final rule offers two examples to illustrate this point. 
Title II of GINA would not apply to a medical examination of an 
individual conducted for the purpose of diagnosis and treatment 
unrelated to employment, which is conducted by a health care 
professional in the hospital or other health care facility where the 
individual is an employee. Similarly, Title II would not govern the 
actions of a covered entity carried out in its capacity as a law 
enforcement agency investigating criminal conduct, even where the 
subject of the investigation is also an employee of the covered entity.

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 regulation describes more fully 
the employees GINA protects. We have retained without change language 
from the proposed rule which said that the term ``employee'' also 
includes former

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employees. We received two comments raising concerns with this 
inclusion. The Illinois Credit Union League (ICUL) suggested that there 
should be a temporal qualifier on the term ``former employee,'' while a 
comment jointly submitted by the U.S. Chamber of Commerce, the Society 
for Human Resource Management and a number of other employer 
representatives (Chamber/SHRM) objected that our citation to Robinson 
v. Shell Oil Co., 519 U.S. 337, 346 (1997), did not support the 
proposition that the term ``employee'' also includes former employees. 
Chamber/SHRM contends that Robinson decided only that the term 
``employee'' as used in Title VII's anti-retaliation provision, 42 
U.S.C. 2000e-3(a), applied to former employees, not whether 
``employee'' as used in section 701(f) of Title VII applied to former 
employees. In Robinson, the Supreme Court observed that the definition 
of ``employee'' in section 701(f), which is the basis for the term 
``employee'' in GINA, ``lacks any temporal qualifier and is consistent 
with either current or past employment.'' Robinson, 519 U.S. at 342. 
The Commission has read Robinson as supporting its well-established 
position that ``[f]ormer employees are protected by the EEO statutes 
when they are subjected to discrimination arising from the former 
employment relationship.'' See EEOC's Compliance Manual Section 2 on 
Threshold Issues at Sec.  2-III.A.2. & n. 79 (available at http://www.eeoc.gov/policy/docs/threshold.html#2-III-A-2) (citing to 
Robinson). An example under GINA would be a situation in which a former 
employer disclosed to a prospective employer an individual's genetic 
information. Accordingly, the final regulation makes clear that the 
term ``employee'' includes an applicant and a former employee.
    The final 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 final 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).
    One commenter asked that the final regulation state that there is 
no individual liability for violations of GINA. See Comment of TOC 
Management Services (TOC). As the statute makes clear, GINA's 
definition of ``employer'' includes employers as defined by Title VII 
at 42 U.S.C. 2000(e)b. Numerous courts have held that this definition 
was not intended to permit individual liability. See Lane v. Lucent 
Tech., Inc., 388 F. Supp. 2d 590 (M.D.N.C. 2005) (citing cases from 
every circuit except the First Circuit rejecting individual liability); 
see also, e.g., Mandell v. County of Suffolk, 316 F.3d 368 (2d Cir. 
2003); Wathen v. General Elec. Co., 115 F.3d 400 (6th Cir. 1997); Cross 
v. Alabama, 49 F.3d 1490 (11th Cir. 1995); Grant v. Lone Star Co., 21 
F.3d 649 (5th Cir. 1994). Therefore, it is not necessary to make this 
point in the regulation.
    The final regulation includes a definition of ``covered entity.'' 
It 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. By using the term ``covered entity'' to describe the 
requirements or prohibited practices applicable to all entities subject 
to Title II of GINA, the final regulation avoids 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 final 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). One comment urged the 
Commission not to use the term ``covered entity'' because of possible 
confusion with the same term in HIPAA. See Comment of American Medical 
Association (AMA). We do not believe that use of the term ``covered 
entity'' in this regulation will cause confusion, as most of the 
entities subject to Title II are not HIPAA covered entities and those 
that are should be able to distinguish between their roles as HIPAA 
covered entities and as covered entities subject to Title II of GINA. 
We note that HIPAA covered entities do not appear to have experienced 
confusion from use of the term ``covered entities'' in Title I of the 
ADA, even though the ADA, like HIPAA, places limitations on the 
acquisition and disclosure of medical information.
    The final 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 final regulation appropriately puts 
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 final 
regulation provides some additional guidance regarding these terms. One 
comment said that many of the definitions in the NPRM were too 
difficult to understand without scientific knowledge. See Comment of 
Federal Deposit Insurance Corporation (FDIC). As noted above, in 
developing these definitions, EEOC coordinated closely with NHGRI. We 
also were careful to track closely the language of Title II itself 
where possible to avoid any unintended consequences that might result 
from attempting to paraphrase or simplify scientifically technical 
language. However, we have added a number of examples to the regulation 
itself that will further clarify the meanings of some of these terms.

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.\5\ 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

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through marriage, birth, adoption, or placement for adoption.\6\
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    \5\ 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.
    \6\ ``Placement for adoption'' or being placed for adoption 
means the assumption and retention of a legal obligation for total 
or partial support of a child by a person with whom the child has 
been placed in anticipation of the child's adoption. The child's 
placement for adoption with such person ends upon the termination of 
such legal obligation. See 29 CFR 2590.701-2 (the definitions for 
part 7 of ERISA)
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    Groups who represent employers thought that persons who become 
dependents by adoption or placement for adoption should not be 
considered family members, because genetic information about them would 
not indicate whether an individual protected by GINA might acquire a 
disease or disorder. See Comments of Illinois Chamber of Commerce (ICC) 
and Chamber/SHRM. However, GINA's express reference to section 
701(f)(2) of ERISA and section 701(f)(2)'s explicit reference to 
dependents by adoption or placement for adoption makes it absolutely 
clear that Congress intended to include such persons in GINA's 
definition of ``family member.'' Moreover, the acquisition of 
information about the occurrence of a disease or disorder in an 
applicant's or employee's adopted child could certainly result in the 
type of discrimination GINA was intended to prohibit. For example, an 
employer might use information it obtains about the current health 
status of an adopted child to discriminate against an employee because 
of concerns over potential health care costs, including increased 
health insurance rates, associated with the family member's medical 
condition. See S. Rep. No. 110-48 at 28 (indicating that spouses and 
adopted children were included in the definition of family member for 
this exact reason).
    Second, GINA includes as family members persons related from the 
first to the fourth degree of an individual. The degree of relationship 
reflects the average proportion of genes in common between two 
individuals. The GINA provisions thus include the individual's 
children, siblings, and parents (first degree), grandparents, 
grandchildren, uncles, aunts, nephews, nieces, and half-siblings 
(second degree), great-grandparents, great grandchildren, great uncles, 
great aunts, and first cousins (third degree), and great-great 
grandparents and first cousins once removed (the children of a first 
cousin) (fourth degree). The inclusion of half-siblings among second-
degree relatives responds to a comment we received to the proposed rule 
which said that we had incorrectly listed half-siblings among first-
degree relatives.\7\ See Comment of GPPC.
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    \7\ This approach is different from the approach taken in 
regulations implementing Title I of GINA. See GINA Title I 
regulations at 26 CFR 54.9802-3T(a)(2)(ii), 29 CFR 2590.702-
1(a)(2)(ii) and 45 CFR 146.122(a)(2)(ii), which were published in 
the Federal Register on October 7, 2009 at 74 FR 51664.
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    The Commission declines, however, to expand the degree of 
relationship of family members beyond the fourth degree as one comment 
suggested we should do. See Comment of Members of the Personal Genetics 
Education Project (PGEP). Whether or not genetic information about an 
individual's relatives beyond the fourth degree of relationship has 
predictive value with respect to the individual, the language of the 
statute on which the regulation is patterned does not permit such an 
expansion of the definition of ``family member.'' In fact, GINA's 
definition of ``family member'' is already broader than that term is 
understood in the practice of medicine. As discussed in the following 
section, a typical family medical history used for the purposes of 
diagnosis and treatment includes information about an individual's 
first-degree, second-degree, and third-degree relatives.

Section 1635.3(b) Family Medical History

    The final 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).\8\
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    \8\ 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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    Citing this legislative history, some employer groups urged that we 
include the word ``inheritable'' before the words ``disease or 
disorder'' in the regulation's definition of ``family medical 
history,'' arguing that Congress did not intend that GINA apply to 
conditions such as the common cold or the flu. See Comments of Chamber/
SHRM and ICC. For three reasons, the Commission has decided not to make 
this change in the final rule. First, the regulation's language is 
consistent with the plain language of the statute, which also does not 
include the word ``inheritable.'' Second, given the rapidly-developing 
field of genetics, we believe that requiring Title II covered entities 
or EEOC investigators to determine whether a disease or disorder in 
family members of an individual is ``inheritable'' or has a genetic 
basis would present significant compliance and enforcement problems. 
Finally, the Commission doubts that questions about whether a family 
member has a cold, the flu, or similar conditions will often result in 
charges being filed under GINA.
    One commenter also suggested that we clarify that medical 
information obtained from one employee will not be considered family 
medical history of a family member who also works for the employer. See 
Comment of Chamber/SHRM. This commenter is apparently concerned that an 
employer will be liable for a violation of GINA if it requests 
information about a manifested disease or disorder of an employee whose 
family member also works for the employer. The Commission recognizes 
the problem that this commenter is trying to avoid, but does not agree 
with the proposed solution. We disagree that the first employee's 
medical information is not family medical history as to the second 
employee. An employer who learns that one employee has a manifested 
disease or disorder would be in possession of family medical history 
about a second employee who is a

[[Page 68916]]

family member as defined by GINA. Likewise, an employer who learns the 
results of one employee's genetic test or learns that the employee has 
sought or received genetic services would possess genetic information 
about the employee who is a family member. (See discussion of the 
definition of ``genetic information,'' below.) We do not think Congress 
could have intended that an employee not be protected from the 
discriminatory use or the disclosure of his or her genetic information 
just because the employer obtained it from a family member who was also 
an employee.
    However, we do agree with the comment to the extent it seeks to 
limit liability under GINA for the acquisition of information about an 
employee's manifested condition. Although acquisition of information 
about manifested conditions is limited under other laws such as the 
ADA, it is permissible under GINA, even where an employee's family 
member works for the same employer. We have added a new subsection to 
Sec.  1635.8 to clarify this point, and to make the related point that 
an employer will not violate GINA's provisions prohibiting the 
acquisition of an employee's genetic information when it requests 
genetic information or information about a manifested disease or 
disorder from an employee's family member to whom health or genetic 
services are being provided on a voluntary basis. (See discussion of 
Sec.  1635.8(c), below.)

Section 1635.3(c) Genetic Information

    GINA section 201(4) and the regulation define genetic information 
to include information from genetic tests, the genetic tests of family 
members, and family medical history. Genetic information also includes 
information about an individual's or family member's request for or 
receipt of genetic services. GINA section 209(b) and the regulation add 
that the term genetic information includes 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. See Comment of FDIC (noting that the 
preamble to the proposed rule cited to the wrong section of GINA when 
discussing the genetic information of a fetus or embryo). The statute 
and regulation exclude from coverage information about an individual's 
or family member's age or gender. In response to a comment, and mindful 
that many employers routinely request such information on a voluntary 
basis to comply with their EEO obligations, the final rule also says 
that information about race and ethnicity that is not derived from a 
genetic test is not genetic information. See Comment of ACLU.

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 final 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.
    A number of comments asked that the final rule offer additional 
examples of genetic services that emphasize the term's breadth, 
including genetic education before and after testing and preventive 
therapies that an individual might undergo in response to a genetic 
test to reduce or eliminate the risk of acquiring a condition in the 
future. See Comments of AMA, CGF, Genetic Alliance, and GPPC. We have 
not made any additions to the definition in the final regulation. The 
definition of genetic services provided in the proposed rule 
encompasses genetic education, whether it is offered before, after, or 
unrelated to genetic testing. Moreover, we have determined that the 
statutory definition of genetic services was not intended to encompass 
the types of clinical services mentioned by these commenters.

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 invited comments on the scope of the term ``genetic 
test.'' In response, we received comments generally agreeing with how 
the Commission characterized certain kinds of tests in the preamble and 
text of the proposed rule. Several comments asked that we place 
examples from the preamble to the proposed rule in the text of the 
regulation itself, and we have done so. See Comments of the Equal 
Employment Advisory Council (EEAC), CGF, Genetic Alliance, GPPC and 
TOC. Thus, the regulation says that tests for infectious and 
communicable diseases that may be transmitted through food handling, 
complete blood counts, cholesterol tests, and liver-function tests are 
not genetic tests. To the proposed rule's examples of genetic tests, we 
have added a number of others suggested by several commenters, 
including carrier screenings of adults to determine the risk of 
conditions such as cystic fibrosis, sickle cell anemia, spinal muscular 
atrophy, and fragile X syndrome in future offspring; amniocentesis and 
other evaluations used to determine the presence of genetic 
abnormalities in a fetus; newborn screening tests for conditions such 
as PKU, which may allow preventive treatment to begin before the 
disease manifests; DNA testing that reveals family relationships (e.g., 
paternity tests); and DNA testing that determines the presence of 
genetic markers associated with ancestry. See Comments of CGF, Genetic 
Alliance, and GPPC.
    Two commenters requested that the preamble and regulation refrain 
from listing specific tests that are excluded from the definition of 
genetic test. One argued that the science of genetics is constantly 
developing and that it is therefore shortsighted to specify tests that 
are not genetic in nature. See Comment of National Counsel of EEOC 
Locals no. 216, American Federation of Government Employees, AFL-CIO

[[Page 68917]]

(AFGE). Although we acknowledge this concern, excluding illustrative 
examples of what does not meet this definition would only serve to 
confuse those attempting to understand the bounds of the law.
    Another comment argued that while the excluded tests are not 
genetic tests, it is still important that the results of tests that are 
not genetic tests be kept confidential and not be used as a basis for 
discrimination. See Comment of Disability Rights Legal Center (DRLC). 
Concerns about the discriminatory use of medical tests that are not 
genetic are addressed by the ADA, which limits the use of medical 
examinations and prohibits the use of medical and non-medical tests 
that screen out or tend to screen out an individual with a disability 
or a class of individuals with disabilities from employment, unless the 
test is shown to be job-related for the position in question and 
consistent with business necessity. See 29 CFR 1630.10. Section 
1635.11(a) of the final rule and the accompanying preamble discussion 
make it clear that Title II of GINA does not limit other laws, 
including the ADA, that protect individuals on the basis of disability.
    The Title II definition of ``genetic test'' differs from the 
definition of this term in Title I. Specifically, the Title II 
definition 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). 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

    The final rule includes a definition of the term ``manifestation or 
manifested'' because sections 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 NHGRI. The proposed rule defined ``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.

    The final rule deletes the words ``or on the results of one or more 
genetic tests,'' which are unnecessary, given that the term ``genetic 
information'' already includes the results of genetic tests. The 
definition 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 S. 
Rep. No. 110-48. at 16, and with the notion, discussed above in 
conjunction with the definition of genetic test (Sec.  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. 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 29 CFR 2590.701-3(b)(6)(ii). However, if an 
individual is diagnosed with a condition, even if the condition relates 
to genetic information--for example, breast cancer stemming from the 
BRCA1 gene variant--the plan may impose a preexisting condition 
exclusion with respect to the condition as of the date the disease was 
diagnosed, subject to other HIPAA portability requirements. See 29 CFR 
2590.701-3(b)(6)(i).
    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.
    Two comments asked the Commission to delete from Sec.  1635.3(g) 
the concept that a disease, disorder, or pathological condition is not 
manifested if it is based ``principally on genetic information or on 
the results of one or more genetic tests.'' See Comments of America's 
Health Insurance Plans (AHIP) and Chamber/SHRM; see also Comments of 
EEAC and SBA (raising similar concern). Although the Commission has 
deleted reference to ``the results of one or more genetic tests'' as 
explained above, the final rule still includes the basic concept that a 
condition is not manifest if it is based principally on genetic 
information. We agree, however, that a clarification is needed to 
address what we believe to be the central concern of these commenters, 
i.e., that the language at issue extends the protections of GINA to 
people with manifested conditions when genetic information played a 
role in diagnosing them. We therefore note that where diagnosis of a 
disease, disorder, or pathological conditions depends on both the 
presence of signs and symptoms and genetic information, the disease, 
disorder, or pathological condition will be considered manifested. The 
fact that an individual has the diagnosed disease, disorder, or 
pathological condition will not be considered genetic information about 
the individual; nor will information about the signs or symptoms the 
individual has. Such information, however, is still subject to other 
laws regulating the acquisition and use of medical information, 
including Title I of the ADA. See 42 U.S.C. 12112(d). Moreover, 
information about any genetic test or family medical history used as 
part of the diagnosis of the disease, disorder, or pathological 
condition is genetic information subject to Title II of GINA and this 
regulation.
    Several commenters requested that the final regulation clarify that 
the genetic information of an individual with a manifested disease is 
still protected under GINA, citing the example of an individual with 
breast cancer who undergoes a genetic test and learns that she tests 
positive for a BRCA mutation, which increases one's risk for developing 
ovarian cancer as well as breast cancer. See Comments of CGF, Genetic 
Alliance, and GPPC. These commenters requested that we make clear that 
discriminating against this individual due to the presence of the 
genetic variant is a violation of GINA despite the fact that she also 
has a

[[Page 68918]]

manifested disease caused by the variant. We note that Sec.  1635.12(b) 
makes it clear that genetic information of an individual with a 
manifested disease is protected genetic information under GINA and that 
discriminating against someone based on this information is prohibited.

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 response to a comment, we further note 
that the broad language Congress adopted in describing the practices 
prohibited by Title II makes clear that claims of harassment on the 
basis of genetic information are cognizable. See Comment of Disability 
Rights Legal Center (DLRC). 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 final 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 final regulation 
creates a cause of action for disparate impact. Section 208 of GINA 
specifically prohibits such actions, and establishes the Genetic 
Nondiscrimination 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 final regulation 
does not address the establishment of this Commission, which is 
scheduled to begin its work on May 21, 2014.
    In response to a comment, we clarify that a covered entity will not 
be deemed to have violated Sec.  1635.5 if it limits or restricts an 
employee's job duties based on genetic information because it was 
required to do so by a law or regulation mandating genetic monitoring 
such as regulations administered by the Occupational and Safety Health 
Administration (OSHA). See Comment of EEAC (requesting clarification of 
this point); see also 1635.8(b)(5) (concerning voluntary genetic 
monitoring and monitoring pursuant to state or federal law) and 
1635.11(a) below (GINA does not limit the statutory or regulatory 
authority of OSHA, the Mine Safety and Health Administration or other 
workplace health and safety laws and regulations.)

Section 1635.6 Causing a Covered Entity To Discriminate

    GINA sections 203(a)(3), 204(a)(3), and 205(a)(3) 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. 
Such conduct would violate sections 203(a)(3) and 204(a)(3), regardless 
of the intent of the employment agency or union in sharing the 
information. See Comment of DLRC (requesting clarification on this 
point).
    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. The final rule modifies the 
language of Sec.  1635.6 of the proposed rule slightly so that it 
leaves no doubt that no GINA covered entity may cause another covered 
entity to discriminate on the basis of genetic information.

Section 1635.7 Retaliation

    The final 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 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

[[Page 68919]]

apprenticeship programs, include a sixth exception. The proposed 
regulation addressed each of the exceptions, as does the final 
regulation. Covered entities are cautioned, however, that the use of 
genetic information to discriminate, no matter how that information may 
have been acquired, is prohibited.
    Concerning the general prohibition on acquiring genetic 
information, two commenters noted that the regulatory language of 
1635.8(a) did not track the statutory language in that it failed to 
indicate that the prohibition applies to the genetic information of 
family members of individuals, as well as to that of the individuals 
themselves. See Comment of the American Psychological Association (APA) 
and FDIC. Although we believe the substance of the regulatory language 
is correct, in that the genetic information of an individual includes 
the genetic information of that individual's family members, we agree 
that it would be best to follow the statutory language of this 
prohibition and have altered 1635.8(a) accordingly.
    Another comment argued that a covered entity violates GINA's 
provisions prohibiting the acquisition of genetic information only when 
it undertakes the purposeful act of requesting, requiring, or 
purchasing genetic information. See Comment of Chamber/SHRM. It was 
improper, this comment reasoned, for the Commission to have included 
examples of ``passive acquisition'' in 1635.8(b)(1) (governing 
inadvertent acquisition of genetic information) and 1635.8(b)(4) 
(concerning acquisition of genetic information through sources that are 
commercially and publicly available).
    However, other commenters read the prohibition on acquisition more 
broadly, noting their view that GINA restricts ``deliberate acts that 
result in the acquisition of genetic information,'' not just 
purposefully requesting, requiring, or purchasing genetic information. 
See Comments of ACLU, CGF, Genetic Alliance, and GPPC. A similar 
construction of the acquisition prohibition underlay suggestions for 
changes to the portion of the rule concerning inadvertent acquisition 
of genetic information. Several commenters said that covered entities 
that make inquiries or engage in actions reasonably likely to result in 
the acquisition of genetic information should not be able to avail 
themselves of the exceptions in 1635.8(b)(1) or 1635.8(b)(4). Thus, for 
example, as discussed below, commenters asked that the Commission 
require that covered entities requesting information about an 
individual's current health status (e.g., for the purpose of making a 
reasonable accommodation) affirmatively warn the person providing the 
information not to include genetic information, since acquisition of 
genetic information in the form of family medical history would be 
likely in the absence of a warning. See Comments of ACLU, the American 
Medical Association (AMA), CGF, Genetic Alliance, GPPC, and the 
Leadership Conference on Civil Rights (LCCR). Similarly, most of these 
commenters said that the exception for acquisition of genetic 
information from sources that are commercially and publicly available 
should not apply to sources that are likely to, or present a 
``heightened risk'' of, containing genetic information, and one 
commenter specifically asked that the final rule prohibit Internet 
searches that include an individual's name and a particular genetic 
marker. See Comments of LCCR.
    The Commission acknowledges all these concerns and, for purposes of 
GINA Title II, has added language to 1635.8(a) as follows: `` `Request' 
includes conducting an Internet search on an individual in a way that 
is likely to result in a covered entity obtaining genetic information; 
actively listening to third-party conversations or searching an 
individual's personal effects for the purpose of obtaining genetic 
information; and making requests for information about an individual's 
current health status in a way that is likely to result in a covered 
entity obtaining genetic information.''
    We think it is equally clear that Congress intended certain 
``passive acquisitions'' of genetic information to be exceptions to the 
rule prohibiting acquisition, rather than being wholly outside the 
prohibition. The examples, particularly those in Sec.  1635.8(b)(1) and 
(4), are similar to the so-called ``water cooler'' example that 
Congress thought should be an exception to the general prohibition 
against requesting, requiring, or purchasing genetic information. See 
S. Rep. No. 110-48, at 29 (``[t]he committee recognizes that 
conversations among coworkers about the health of a family member are 
common and intends to prevent such normal interaction from becoming the 
basis of litigation''). We therefore retain the examples offered in the 
preamble to the proposed rule, as we believe that they provide useful 
guidance. See Comment of TOC (encouraging EEOC to retain examples).
    We now turn to a discussion of the specific exceptions described in 
1635.8(b). We received a number of comments concerning these 
exceptions, particularly in response to 1635.8(b)(1), (2) and (4).
    Inadvertently Requesting or Requiring Genetic Information: First, 
as noted in the proposed rule, 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 
therefore noted 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).
    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 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. Although we 
received numerous comments in regard to 1635.8(b)(1), no commenter 
expressed disagreement with the decision to extend the exception to all 
genetic information that a covered entity inadvertently acquires. See, 
e.g., Comment of GPPC (discussing the need for a restrictive view of 
this

[[Page 68920]]

exception, but expressing agreement that it was intended to extend to 
all genetic information and not just family medical history).
    The Commission also understands this exception to apply in any 
situation in which an employer might inadvertently acquire genetic 
information, not just to situations involving conversations between co-
workers that are overheard. The proposed regulation provided an 
illustrative list of examples, reiterated here, where we believe 
Congress intended the exception to apply. 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 inquiry about the individual's health 
(e.g., ``How are you?'' or ``Did they catch it early?'' asked of an 
employee who was just diagnosed with cancer) or a question as to 
whether the individual has a manifested condition.\9\ Similarly, a 
casual question between colleagues, or between a supervisor and 
subordinate, concerning the general well-being of a family member would 
not violate GINA (e.g., ``How's your son feeling today?'', ``Did they 
catch it early?'' asked of an employee whose family member was just 
diagnosed with cancer, or ``Will your daughter be OK?''), nor would the 
receipt of genetic information that was not solicited or sought by the 
employer (e.g., where a manager or supervisor receives an unsolicited 
email from a co-worker about the health of an employee's family 
member).
---------------------------------------------------------------------------

    \9\ When asking questions likely to elicit information about a 
disability, covered entities must, of course, also abide by the 
requirements of the ADA.
---------------------------------------------------------------------------

    A number of commenters raised concerns about the exact parameters 
of this exception. Civil rights groups and organizations promoting 
genetic research asked that the EEOC clarify that pointed questions or 
other attempts to gather genetic information by, for example, 
intentionally eavesdropping on private conversations or asking highly 
specific follow-up questions when an employee mentions that a family 
member is ill, do not fall within the bounds of this exception. See 
Comments of ACLU, CGF, the Genetic Alliance, GPPC, and LCCR. The 
Illinois Chamber of Commerce (ICC) requested that the regulation 
specifically state that there is no violation of the prohibition 
against acquisition unless the employer purposefully acquires genetic 
information and both ICC and Chamber/SHRM requested that it be made 
clear that the examples provided are not exhaustive. See Comments of 
ICC and Chamber/SHRM. The FDIC made a similar point when it requested 
that the rule state that this exception applies to questions by an 
employer ``not likely to elicit genetic information'' but does not 
apply to questions ``likely to elicit genetic information.'' See 
Comment of FDIC.
    These comments make apparent the need for greater clarity 
concerning this exception. We include in the final regulation itself 
the examples from the preamble to the proposed rule that illustrate how 
this exception applies and provide an additional example both here and 
in the final regulation at 1635.8(b)(1)(ii)(B). The additional example 
is as follows: A covered entity that inadvertently acquires genetic 
information about someone's family member in response to a general 
question about the family member's health may not then ask follow-up 
questions that are probing in nature, such as whether other family 
members also have the condition, or whether the individual has been 
tested for the condition.
    We also include an additional example here and in the final 
regulation at 1635.8(b)(1)(ii)(D) to clarify that the inadvertent 
acquisition exception applies not only to interactions within the 
workplace during which a covered entity unwittingly receives genetic 
information, but also to interactions that take place in the 
``virtual'' world, i.e., through a social media platform from which a 
covered entity unwittingly receives genetic information. In other 
words, this exception applies where a manager, supervisor, union 
representative, or employment agency representative inadvertently 
learns genetic information from a social media platform which he or she 
was given permission to access by the creator of the profile at issue 
(e.g., where a supervisor and employee are connected on a social 
networking site and the employee provides family medical history on his 
page).
    We further note that the examples provided in this preamble and the 
regulation are non-exhaustive and that other situations in which a 
covered entity inadvertently acquires genetic information are covered 
by this exception as long as the requirements provided in the 
regulation are met.
    We received a significant number of comments expressing concern 
about GINA's application to a covered entity's request for medical 
information that results in the receipt of genetic information that was 
not requested. Civil rights groups, groups promoting genetic research, 
and others argued that covered entities will obtain a great deal of 
genetic information through general requests for medical information if 
they are not required to affirmatively indicate that genetic 
information should not be provided. See Comments of the ACLU, AMA, CGF, 
Genetic Alliance, GPPC, and LCCR. See also Comments of Burton Blatt 
Institute (noting that the exception's application to acquisition 
through legitimate medical information requests should be limited 
because doctors will not know to exclude genetic information) and World 
Privacy Forum (requesting further limitations on this exception). 
Employer groups raised the related point that human resource offices do 
not have control over what is received from health care providers in 
response to requests for medical information and that covered entities 
should not be subjected to liability if health care providers provide 
genetic information that was not requested. See Comments of Chamber/
SHRM, EEAC and the International Public Management Association for 
Human Resources, the League of Minnesota Cities and the International 
Municipal Lawyers Association (IPMA/IMLA).
    In response to these comments and to facilitate compliance with the 
law, we have added language to the final rule indicating that when a 
covered entity warns anyone from whom it requests health-related 
information not to provide genetic information, the covered entity may 
take advantage of the exception in 1635.8(b)(1) if it nevertheless 
receives genetic information. This ``safe harbor'' in 
1635.8(b)(1)(i)(B) provides that any receipt of genetic information in 
response to a lawful request for medical information will be deemed 
inadvertent and not in violation of GINA if the request contained such 
a warning.
    The final rule includes the following language that a covered 
entity may use to provide such notice: ``The Genetic Information 
Nondiscrimination Act of 2008 (GINA) prohibits employers and other 
entities covered by GINA Title II from requesting or requiring genetic 
information of employees or their family members. In order to comply 
with this law, we are asking that you not provide any genetic 
information when responding to this request for medical information. 
`Genetic information,' as defined by GINA, includes an individual's 
family medical history, the results of an individual's or family 
member's genetic tests, the fact that an individual or an individual's 
family member sought or received genetic services, and genetic 
information of a fetus carried by an individual or an individual's 
family member or an

[[Page 68921]]

embryo lawfully held by an individual or family member receiving 
assistive reproductive services.'' Alternative language may also be 
used, as long as individuals and health care providers are informed 
that genetic information should not be provided.
    Although one commenter expressed concern that giving notice would 
impose an unnecessary burden on small businesses, we note that the 
warning may be conveyed verbally if the request for medical information 
itself is also verbal. See Comment of the National Federation of 
Independent Business (NFIB). We are aware that many businesses, 
especially small businesses, do not use forms when requesting medical 
information, and we do not intend this regulation to change the 
practice of making such requests verbally.
    If a covered entity does not give such a written or verbal notice, 
it may nonetheless establish that a particular receipt of genetic 
information in response to a request for medical information was an 
inadvertent acquisition because the covered entity's request was not 
made in a way that was ``likely to result in the covered entity's 
obtaining genetic information'' (for example where an overly broad 
response is received in response to a tailored request for medical 
information). We note, however, that a warning is mandatory in all 
cases where a covered entity requests a health care professional to 
conduct an employment-related medical examination on the covered 
entity's behalf, since in that situation, the covered entity should 
know that the acquisition of genetic information (e.g., family medical 
history) would be likely in the absence of the warning. (See discussion 
of 1635.8(d), below.)
    The proposed regulation noted that when a covered entity seeks 
information from an individual who requests a reasonable accommodation 
under the ADA or state or local law, the acquisition of genetic 
information as part of the documentation that the individual provides 
in support of the request is considered inadvertent, as long as the 
request for documentation was lawful. We received numerous comments 
asking us to describe in the regulation itself what it means for a 
request for documentation supporting a request for reasonable 
accommodation to be considered lawful. See Comments of APA, Disability 
Rights Legal Center (DRLC), the Epilepsy Foundation, and ICC. In 
response, we explain in the final rule that in order to be considered a 
lawful request for documentation made in response to an individual 
seeking a reasonable accommodation under the ADA or state or local law, 
the request for medical documentation can be made only when the 
disability and/or the need for accommodation is not obvious. In this 
situation, the employer may ask the individual for reasonable 
documentation about his/her disability and/or need for accommodation. 
Reasonable documentation means that the employer may require only the 
documentation that is needed to establish that a person has a 
disability within the meaning of the ADA and that the disability 
necessitates a reasonable accommodation. For example, an employer 
cannot request a person's complete medical records because they are 
likely to contain information unrelated to the disability at issue and 
the need for accommodation. If an individual has more than one 
disability, an employer can request information pertaining only to the 
disability that requires a 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. Like any request for medical documentation, the 
request for documentation as part of the reasonable accommodation 
process should generally inform the individual or entity from whom the 
documentation is sought, using language like that noted above, that 
genetic information should not be provided.
    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. 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. For example, a covered entity 
might receive genetic information in connection with an employee's 
request for FMLA leave to attend to the employee's own serious health 
condition or in connection with the FMLA's employee return to work 
certification requirements, even though an employee is not required to 
provide genetic information in either of these situations.\10\ 
Acquisition of genetic information in these circumstances will be 
considered inadvertent if the covered entity affirmatively warns 
individuals and health care providers from whom they are seeking 
medical documentation not to provide genetic information, or, in the 
absence of such a warning, where the request for medical information 
was not likely to result in the acquisition of genetic information.\11\ 
In response to two comments concerning the need for additional clarity 
with regard to how the exceptions to the prohibition against acquiring 
genetic information apply to information received pursuant to the FMLA, 
we have added the above examples to 1635.8(b)(1)(ii)(D)(2)(which was 
1635.8(b)(1)(iv) in the proposed rule), as well as additional detail to 
the preamble's discussion of the FMLA exception (1635.8(b)(3)), 
discussed below. See Comments of APA and Anil Chaudhry.
---------------------------------------------------------------------------

    \10\ There is a separate exception for the acquisition of family 
medical history received from individuals requesting leave under the 
FMLA or similar state or local laws to care for a family member. 
This exception is discussed in detail below.
    \11\ One commenter expressed concern that adding any language to 
the FMLA certification form would result in a statutory violation of 
the FMLA. See Comment of Illinois Credit Union League. The EEOC does 
not enforce the Family and Medical Leave Act and therefore has no 
authority to interpret it. We know of no reason, however, that 
informing a health care provider that genetic information should not 
be provided when certifying an employee's own serious health 
condition would lead to a violation of the FMLA. Moreover, the 
notice informing applicants/employees and health care providers that 
they must not provide genetic information, including family medical 
history, to covered entities need not be made on the FMLA 
certification form itself, as long as it is provided in writing 
along with the form.
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    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. Acquisition of genetic information in these circumstances, like 
the acquisition of genetic information where leave is requested 
pursuant to the FMLA or a state or local leave law, will be considered 
inadvertent if the covered entity affirmatively warns individuals and 
health care providers from whom they are seeking medical documentation 
not to provide genetic information, using language like that noted 
above, or, in the absence of such a warning, where the request for 
medical information was not made in a way that was likely to result in 
the covered entity's obtaining genetic information. Covered entities 
should also be aware that overbroad requests for documentation to 
support

[[Page 68922]]

an employee's use of leave may violate the ADA. 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, (Enforcement Guidance) Questions 15-17 (July 27, 2000) 
available at http://www.eeoc.gov/policy/docs/guidance-inquiries.html.
    One commenter raised a concern about proposed 1635.8(b)(1)(vi), 
which extended the inadvertent acquisition exception to a covered 
entity that 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. See Comment of APA. APA asked that this 
exception be limited to requests ``permitted by Federal, State or local 
law.'' Rather than add any limiting language, we have decided to 
eliminate this subsection altogether, as it merely reiterates the 
examples spelled out in 1635.8(b)(1)(ii)(B) (formerly 1635.8(b)(1)(ii) 
in the proposed rule).
    Finally, one commenter asked that the inadvertent acquisition 
exception be extended to acquisition of genetic information by a self-
insured employer making health insurance billing determinations in its 
capacity as an insurer. See Comment of Navigenics. It is not necessary 
to extend the exception to cover these circumstances because, when a 
self-insured employer is acting in its capacity as an insurer, its 
actions are regulated by Title I of GINA, not Title II. Title I of GINA 
has specific rules about acquiring genetic information for insurance 
payment purposes. See 42 U.S.C. 1182(c)(3); 42 U.S.C. 300gg-1(c)(3); 26 
U.S.C. 9802(c)(3).
    Health or Genetic Services: GINA permits covered entities to 
acquire genetic information where health or genetic services are 
offered by the employer, including such services offered as part of a 
wellness program, if the covered entity meets specific requirements. 
The proposed regulation listed the specific requirements in the statute 
as prerequisites to the acquisition of genetic information when 
offering health or genetic services: the individual provides prior 
knowing, voluntary, and written authorization, meaning that the covered 
entity uses an authorization form that is written in language 
reasonably likely to be understood by the individual from whom the 
information is sought; describes the information being requested; and 
describes the safeguards in place to protect against unlawful 
disclosure. Additionally, the proposed rule said that a wellness 
program or other health or genetic services that a covered entity 
offers must be voluntary. The preamble to the proposed rule noted that, 
under the ADA, a wellness program that requires employees to answer 
disability-related inquiries and/or to submit to a medical examination 
is voluntary if the program neither requires participation, nor 
penalizes employees for non-participation.
    We received two comments asking whether the written request and 
authorization to participate in a wellness program could be provided 
electronically. See Comments of AHIP and Kelly Hart & Hallman (KHH). We 
think this is permissible and have revised the final rule accordingly. 
We do not think it is necessary to provide in the final rule specific 
standards for an electronic consent and authorization. The particular 
format chosen, however, must be functionally equivalent to what would 
be required in a written authorization, in terms of content and form. 
For example, because written authorization is a prerequisite to the 
acquisition of genetic information as part of health or genetic 
services offered by a covered entity, such as a voluntary wellness 
program, a covered entity could not utilize an on-line form that first 
requires an individual to input family medical history and then asks 
the individual to indicate his or her acceptance of the terms of an 
authorization. Instead, a potential participant in the health or 
genetic services being offered must first be presented with an 
electronic authorization that describes the request in terms reasonably 
likely to be understood by the individual, the purposes for which it 
will be used, and the safeguards in place for assuring its 
confidentiality, before any genetic information (such as family medical 
history) can be provided.
    The proposed regulation stated 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. Some comments objected to a statement in the 
preamble to the proposed rule that 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, noting that this 
would impose burdens particularly on small businesses. See Comments 
Chamber/SHRM and IPMA/IMLA.
    In the final rule, we have retained the language in the NPRM, which 
tracked the statutory language. GINA says that a covered entity may 
only receive genetic information related to a wellness program ``in 
aggregate terms that do not disclose the identity of specific 
[individuals],'' see 42 U.S.C. 2000ff-1(b)(2)(D); 2000ff-2(b)(2)(D); 
2000ff-3(b)(2)(D); and 2000ff-4(b)(2)(D). However, we have reconsidered 
the position taken in the preamble to the NPRM that a covered entity 
offering health or genetic services will not comply with 1635.8(b)(2) 
if aggregate information disclosed to the covered entity makes the 
genetic information of individuals readily identifiable. A provider of 
health or genetic services will likely be unaware of facts known to a 
covered entity that would make identification of specific individuals 
readily identifiable from aggregate information. Likewise, a covered 
entity may not know that the identity of specific individuals from 
aggregate information will be readily identifiable until after it 
receives the information. We do not believe that Congress intended to 
impose liability on covered entities who receive aggregate information 
about health or genetic services under such circumstances. Therefore, 
the Commission here clarifies that GINA is not violated if the provider 
of health or genetic services gives information to a covered entity in 
aggregate terms that, for reasons outside the control of the provider 
or the covered entity (such as the small number of participants), makes 
the genetic information of a particular individual readily identifiable 
with no effort on the covered entity's part. On the other hand, efforts 
undertaken by a covered entity to link genetic information provided in 
the aggregate to a particular employee will violate GINA.
    We received numerous comments in response to a question we asked in 
the preamble to the proposed rule concerning when a wellness program 
that includes a request for genetic information should be considered 
voluntary. Specifically, we wanted to know the level of inducement, if 
any, that a covered entity could offer to promote participation in a 
wellness program. See 74 FR 9056, 9062 (March 2, 2009). From the many 
comments we received emphasizing the potential cost savings and 
benefits for employee

[[Page 68923]]

health that could be brought about through wellness programs, four 
approaches to voluntariness emerged. One approach suggested that we use 
regulations promulgated pursuant to HIPAA, which define maximum levels 
of inducements employers may offer to employees who participate in, or 
achieve certain health outcomes as a result of participating in, 
wellness programs. See Comments of American Benefits Council (ABC), 
Chamber/SHRM, DMAA: The Care Continuum Alliance (DMAA), Dorsey and 
Whitney, LLP, Healthways, National Business Group on Health (NBGH), and 
United Healthcare. Under the HIPAA regulations, employers may offer 
financial inducements of any size to encourage participation in 
wellness programs, and may offer inducements of up to a specified 
percentage of the cost of group health insurance coverage for an 
individual or an individual and family to participants who achieve 
specific health outcomes. See 26 CFR 54.9802-1(f)(1), 29 CFR 
2590.702(f)(1), and 45 CFR 146.121(f)(1) (explaining that a wellness 
program does not violate HIPAA's nondiscrimination requirements if none 
of the conditions for obtaining a reward are based on an individual 
satisfying a certain health standard, as long as participation in the 
program is offered to all similarly situated individuals). See also 26 
CFR 54.9802-1(f)(2), 29 CFR 2590.702 (f)(2), and 45 CFR 146.121(f)(2) 
(providing limits on financial inducements when rewards are conditioned 
on achieving certain health outcomes).\12\
---------------------------------------------------------------------------

    \12\ The 20 percent threshold described in the HIPAA 
nondiscrimination rules will increase to 30 percent beginning in 
2014 under statutory changes made under the Patient Protection and 
Affordable Care Act, Public Law 111-148.
---------------------------------------------------------------------------

    Other comments appeared to suggest a combination of the approach 
taken in the HIPAA regulations and the rule under the ADA as 
articulated by EEOC in its Enforcement Guidance on Disability-Related 
Inquiries and Medical Examinations of Employees Under the Americans 
with Disabilities Act (July 27, 2000) (``Enforcement Guidance''). As we 
understand this suggestion, the standard for determining whether a 
wellness program is voluntary under the ADA--that a covered entity 
neither requires participation nor penalizes individuals for non-
participation--should apply to GINA as well. See Enforcement Guidance 
at Question 22. Any inducement that complied with the HIPAA ``twenty 
percent rule'' should be deemed neither a penalty for non-participation 
nor a requirement to participate. Inducements greater than those 
allowed under the ``twenty percent rule'' would violate the standard 
for voluntariness under the ADA and GINA. See Comments of AHIP, IPMA/
IMLA, KHH, NFIB, and Staywell Health Management.
    A third approach merely asked that we allow employers to offer 
inducements to promote employee participation in wellness programs, but 
did not indicate whether inducements should be limited in any way. See 
Comments of EEAC and Navigenics. Finally, several comments urged that 
covered entities not be allowed to offer any monetary inducements to 
promote participation in wellness programs that include the collection 
of genetic information, including family medical history. See Comments 
of ACLU, AMA, GPPC and World Privacy Forum.
    Balancing the potential benefits of health and genetic services 
offered to employees on a voluntary basis, including wellness programs, 
with the need to construe exceptions to the prohibition of acquisition 
of genetic information in a manner appropriately tailored to their 
specific purposes, we have concluded that covered entities may offer 
certain kinds of financial inducements to encourage participation in 
health or genetic services under certain circumstances, but they may 
not offer an inducement for individuals to provide genetic information. 
As a result, the Commission concludes that it would not violate Title 
II of GINA for a covered entity to offer individuals an inducement for 
completing a health risk assessment that includes questions about 
family medical history or other genetic information, as long as the 
covered entity specifically identifies those questions and makes clear, 
in language reasonably likely to be understood by those completing the 
health risk assessment, that the individual need not answer the 
questions that request genetic information in order to receive the 
inducement. The regulation provides two examples to illustrate this 
approach to health risk assessments.
    We also believe that Title II allows covered entities to offer 
financial inducements for participation in disease management programs 
or other programs that encourage healthy lifestyles, such as programs 
that provide coaching to employees attempting to meet particular health 
goals (e.g., achieving a certain weight, cholesterol level, or blood 
pressure).\13\ To avoid a violation of Title II of GINA, however, 
covered entities who offer such programs and inducements to individuals 
based on their voluntarily provided genetic information must also offer 
the programs and inducements to individuals with current health 
conditions and/or to individuals whose lifestyle choices put them at 
risk of acquiring a condition.
---------------------------------------------------------------------------

    \13\ A wellness program that provides (directly, through 
reimbursement, or otherwise) medical care (including genetic 
counseling) may constitute a group health plan required to comply 
with section 9802 of the Internal Revenue Code of 1986, 26 U.S.C. 
9802, section 702 of the Employee Retirement Income Security Act of 
1974 (ERISA), 29 U.S.C. 1182, or section 2705 of the Public Health 
Service Act (i.e., Title I of GINA). Regulations issued under these 
statutes impose special requirements on wellness programs that 
collect genetic information. Moreover, wellness programs that 
condition rewards on an individual satisfying a standard related to 
a health factor must meet additional requirements. See 26 CFR 
54.9802-1(f), 29 CFR 2590.702(f), and 45 CFR 146.121(f).
---------------------------------------------------------------------------

    Recognizing that employers that sponsor group health plans 
(including self-insured group health plans) are required to comply with 
Title II of GINA when operating as employers, and that their plans are 
required to comply with Title I of GINA, the Commission wishes to 
provide examples of how Titles I and II allow employers and plans to 
use financial incentives to promote employee wellness and healthy 
lifestyles.\14\ The Commission notes that providing financial 
incentives in compliance with these GINA Title II regulations does not 
relieve covered entities of their responsibility to comply with other 
GINA requirements under Title I, with other civil rights laws, such as 
the ADA, and with other applicable laws and regulations. See 
1635.8(b)(2)(iv) (indicating that the ADA requires ``reasonable 
accommodations'' to enable individuals with disabilities to participate 
fully in wellness programs, and that the HIPAA nondiscrimination rules 
require plans and issuers to provide an individual with a ``reasonable 
alternative'' (or waiver of the otherwise applicable standard), when it 
is unreasonably difficult due to a medical condition to satisfy or 
medically inadvisable to attempt to satisfy the otherwise applicable 
standard, 26 CFR 54.9802-1(f)(2), 29 CFR 2590.702(f)(2), and 45 CFR 
146.121(f)(2)) and 1635.8(b)(2)(v) (noting that wellness programs that 
constitute group health plans may have to comply with Title I of GINA, 
among

[[Page 68924]]

other laws). While the GINA Title II regulations and the interim rules 
issued on October 7, 2009 to implement Title I (29 CFR 2590.702-1; 45 
CFR 146.122, 26 CFR 54.9802-3T) each prohibit the use of financial 
inducements to collect genetic information, they both permit covered 
entities or group health plans (including self-insured plans) to:
---------------------------------------------------------------------------

    \14\ Whether an employer or other covered entity that sponsors a 
group health plan chooses to provide benefits through self-insurance 
or through a policy, certificate, or contract of insurance does not 
affect the applicability of GINA Titles I and II. See 29 CFR 
1635.11(b)(2) (discussing the relationship of GINA Titles I and II). 
The above examples of actions permissible under both titles are 
therefore helpful to all employers who offer health coverage to 
employees, whether through self-insured or insured plans.
---------------------------------------------------------------------------

    <bullet> Provide bifurcated health risk assessments (HRAs), under 
which financial incentives permitted under the applicable title may be 
used to encourage individuals to complete the HRA, if the section of 
the questionnaire seeking genetic information (e.g. family medical 
history) includes a notice that completing that portion is optional and 
that the reward will be provided whether that portion is completed or 
not;
    <bullet> Use information collected through such bifurcated HRAs, 
including voluntarily provided genetic information indicating that an 
individual may be at risk for a disease, to target advertising 
materials or otherwise solicit voluntary participation in a disease 
management or prevention program, provided that such a program is also 
available to individuals who do not provide genetic information as part 
of the HRA (that is, the program is not limited only to individuals who 
complete the portion of the HRA that requests genetic information);
    <bullet> Provide financial incentives permitted under the 
appropriate title to individuals to participate in certain disease 
management or prevention programs. The incentives to participate in 
such programs must also be available to individuals who qualify for the 
program but have not volunteered genetic information through an HRA.
    Under the Title II regulation, covered entities may contract with a 
third party to operate a wellness program or to provide other health or 
genetic services, or may provide such programs and services through an 
in-house health services office, as long as individually identifiable 
genetic information is accessible only to the individual and the health 
care provider involved in providing such services. Covered entities 
must ensure that individually identifiable genetic information is not 
accessible to managers, supervisors, or others who make employment 
decisions, or to anyone else in the workplace.
    Family and Medical Leave Act: Third, GINA recognizes that 
individuals requesting leave to care for a seriously ill family member 
under the Family and Medical Leave Act (FMLA) or similar state or local 
law will be required to provide family medical history (for example, 
when completing the certification form required by section 103 of the 
FMLA). A covered entity that receives family medical history under 
these circumstances would not violate GINA. This exception is needed 
because, unlike the situations discussed under the inadvertent 
acquisition exception, the receipt of genetic information in these 
circumstances is not inadvertent. By asking the employee to provide the 
information required by the FMLA certification form or similar state or 
local laws when seeking leave to care for a seriously ill family 
member, a covered entity is requesting family medical history from the 
employee.
    One commenter expressed concern that businesses that are not 
covered by the FMLA or similar state or local laws, but who have 
company policies allowing the use of leave to care for seriously ill 
family members, would not be covered by this exception. See Comment of 
the Small Business Administration (SBA). We agree that it was unclear 
in the proposed rule whether acquisition of genetic information in such 
circumstances would be covered by the exception and therefore provide 
this clarification: This exception applies to an employer that is not 
covered by the FMLA or similar state or local laws but that has a 
policy allowing for the use of leave to care for ill family members, as 
long as that policy is applied evenhandedly by requiring all employees 
seeking leave to provide documentation about the health condition of 
the relevant family member.\15\
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    \15\ Although we also received a comment requesting that the 
exception be limited to the acquisition of genetic information 
directly relevant to the leave request--e.g., if the request is to 
care for the employee's daughter, only information received about 
the daughter's condition would be covered by the exception--we find 
that such a requirement is beyond the scope of our enforcement 
authority as it would be an attempt to limit the actions of the 
employee's health care provider who completes the certification 
form. See Comment of World Privacy Foundation.
---------------------------------------------------------------------------

    Of course, family medical history received from individuals 
requesting leave pursuant to the FMLA, similar state or local laws, or 
company policies, is still subject to GINA's confidentiality 
requirements and must be placed in a separate medical file and 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 added to that list information obtained through electronic 
media, such as the Internet, television, and movies. The exception does 
not include genetic information 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.''
    We received numerous comments in response to our queries as to 
whether the additional sources noted in the proposed regulation should 
remain part of the final regulation and whether there are sources 
similar in kind to those identified in the statute that may contain 
genetic information 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. In general, civil rights groups 
and groups promoting genetic research, as well as others, indicated 
that excepted sources should be limited to widely available media with 
no heightened risk for containing genetic information, providing a 
variety of arguments in support of this position. See Comments of ACLU, 
APA, CGF, FDIC, GPPC, Genetic Alliance, LCCR, Members of PGEP, and 
World Privacy Forum. Several of these groups also noted that employers 
who access commercially and publicly available materials with a 
specific intent of searching for genetic information should not be 
permitted to take advantage of the exception. See Comments of CGF, 
FDIC, GPPC, Genetic Alliance, LCCR and World Privacy Forum. Employers 
and employer groups, on the other hand, maintained that media formats 
such as personal web pages, social networking sites, and blogs should 
be part of the exception arguing, among other things, that such sources 
are publicly available and that employers have legitimate reasons to 
access them. See Comments of Chamber/SHRM, EEAC, Navigenics, NFIB, SBA 
and TOC.\16\
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    \16\ Chamber/SHRM reiterated its comment that a covered entity 
must undertake an intentional act of requesting, requiring or 
purchasing genetic information to violate the prohibition on 
acquisition and argued that accessing a social networking site that 
does not require payment is therefore outside the scope of Title II. 
As explained above, we reject this interpretation of the statute.

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[[Page 68925]]

    We conclude that a more detailed explanation of this exception is 
necessary. First, we agree that media sources with limited access 
should not be considered commercially and publicly available. Thus, if 
a media source requires permission for access from a specific 
individual, as opposed to a media source that simply requires users to 
obtain a username and/or password, or if access is conditioned on 
membership in a particular group (e.g., a professional organization), 
the acquisition of genetic information through that source will not be 
protected by this exception. For example, many Facebook, Linked In, My 
Space profiles, and other social networking platforms require 
permission from the creator of the profile to gain access to anything 
beyond basic information such as name and profession and therefore 
would not be considered commercially and publicly available, although 
the exception at 1635.8(b)(1) would still apply to any genetic 
information inadvertently obtained from such sources. On the other 
hand, most personal Web sites and blogs are not so limited, but may 
simply require users to obtain a username and/or password, and 
therefore would be considered commercially and publicly available. Of 
course, there are profiles or portions thereof on social networking 
sites that do not require permission to access, and there may be 
situations in which access to a social networking site is granted 
routinely, so that access cannot be said to be limited. There are also 
Web sites and blogs that do limit access. The determining factor, then, 
in deciding whether a media source is commercially and publicly 
available is whether access requires permission of an individual or is 
limited to individuals in a particular group, not whether the source is 
categorized as a social networking site, personal Web site, or blog.
    Second, we agree that the exception does not apply to genetic 
information acquired by covered entities that access commercially and 
publicly available sources with the intent of obtaining genetic 
information. This exception was intended to protect from liability a 
covered entity that inadvertently obtains genetic information and not a 
covered entity that is actively searching for genetic information. See 
S. Rep. 110-48 at 30 (``The fourth exception, like the first, relates 
to the inadvertent acquisition of family medical history.''). For 
example, an employer who acquires genetic information by conducting an 
Internet search for the name of an employee and a particular genetic 
marker will not be protected by this exception, even if the information 
the employer ultimately obtained was from a source that is commercially 
and publicly available. Conversely, an employer who inadvertently 
acquires genetic information while conducting an Internet search of an 
employee without reference to a genetic marker will be protected by 
this exception.
    Third, we have concluded that the exception does not apply to the 
acquisition of genetic information through a media source, whether or 
not it is commercially and publicly available, if the covered entity is 
likely to acquire genetic information by accessing that source. Thus, a 
covered entity that acquires genetic information after accessing a Web 
site that focuses on issues such as genetic testing of individuals or a 
commercial database containing individually identifiable health 
information \17\ will not be able to take advantage of this exception. 
Finally, in response to comments from some employer groups that human 
resource professionals and other employers may access various media 
sources for personal reasons and not in their capacity as covered 
entities, we clarify that the requirements and prohibitions of GINA do 
not apply to acquisitions of genetic information outside the employment 
context. See Comments of NFIB and Navigenics.
---------------------------------------------------------------------------

    \17\ For example, one commenter provided several lists of 
identifiable individuals with diabetes available for sale on the 
Internet. See Comment of World Privacy Forum.
---------------------------------------------------------------------------

    In response to one comment we received, we further clarify that 
genetic information about an individual acquired through any media 
source, including one that is commercially and publicly available or a 
source accessed outside the employment context, may not be used to 
discriminate in employment decision-making and may not be disclosed in 
violation of Title II's confidentiality provisions. See Comment of 
National Counsel of EEOC Locals no. 216, American Federation of 
Government Employees, AFL-CIO (AFGE).
    Genetic Monitoring: The statute also permits a covered entity to 
engage in the genetic monitoring of the biological effects of toxic 
substances in the workplace, as long as that monitoring meets 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 or regulation, must obtain an individual's 
prior knowing, written, and voluntary authorization. Second, the 
regulation describes the type of authorization form the employer must 
provide in order to ensure that an individual's authorization is 
knowing and voluntary. The authorization form 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 is the case with health or genetic services offered by 
a covered entity on a voluntary basis, we have concluded that there is 
no violation of GINA if a covered entity receives information only in 
aggregate terms, but is able to identify the genetic information of 
specific individuals for reasons outside the covered entity's control 
and with no effort on its part (e.g., because of the small number of 
employees involved in the monitoring). We have revised the language in 
the final regulation to mirror the statutory language.
    Several commenters mentioned the need for a provision in the final 
regulation that protects workers who refuse to participate in genetic 
monitoring that is not required by law. See Comments of ACLU, CGF, 
Genetic Alliance, GPPC and LCCR. These commenters also requested that 
the final regulation describe what actions a covered entity may 
legitimately take in response to such a refusal. Id. We agree with 
these groups that GINA prohibits a covered entity from retaliating or 
otherwise discriminating against an employee who refuses to participate 
in genetic monitoring that is not specifically required by law. An 
individual who refuses to participate in a voluntary genetic monitoring 
program

[[Page 68926]]

should be informed of the potential dangers (e.g., the consequences 
that might result if the effects of certain toxins in the workplace are 
not identified), but the covered entity is prohibited from taking any 
adverse action, as that term is understood under Title VII of the Civil 
Rights Act of 1964 and other civil rights laws, against the individual.
    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.'' 42 U.S.C. 2000ff-1(b)(6) and 2000ff-
4(b)(6). The genetic information may be maintained and disclosed in a 
manner consistent with this limited use. This is a very limited 
exception and, if the analysis is properly conducted, an employer or 
training program would not obtain health-related genetic information. 
Several comments, while expressing general agreement with EEOC's 
position, requested that the final regulation make clear that genetic 
information covered by this exception must be destroyed after a 
designated time period and that the samples and results be used solely 
for quality control and not be entered into any law enforcement 
database. See Comments of CGF, Genetic Alliance, and GPPC. We find that 
it is unnecessary to add any further limitations to those set forth in 
the statute and the proposed regulation. Both make clear that this is a 
very limited exception, allowing only for the use of genetic 
information for analysis of DNA identification markers for quality 
control and to detect sample contamination, and not for any other law 
enforcement purpose. Rather than specifying in the regulation how such 
information should be used, we believe it is sufficient to state, as 
the final rule does, that the information may be used in accordance 
with the purpose for which it was acquired.
Section 1635.8(c)
    We have added a new provision to 1635.8. Subsection (c)(1) responds 
to a comment that said that information about an employee's manifested 
disease, disorder, or pathological condition should not be considered 
genetic information (i.e. family medical history) about a family member 
working for the same employer. See Comment of Chamber/SHRM. We decline 
to take this position in the final rule, because we believe that the 
information would be family medical history that an employer could not 
use to discriminate against, or disclose with respect to, the second 
employee. We agree, however, that a request for information about 
whether an individual has a manifested disease, disorder, or 
pathological condition does not violate GINA simply because a family 
member of the individual to whom the request was made works for the 
same employer, is a member of the same labor organization, or is 
participating in the same apprenticeship program as the person from 
whom the information was requested. We have modified the final rule to 
reflect this more limited point.
    Section 1635.8(c)(2) addresses a related issue that may arise when 
an individual's family member who, although not an employee of the same 
employer, a member of the same labor organization, or a participant in 
the same apprenticeship program as the individual, nevertheless 
receives health or genetic services offered by a covered entity as 
permitted under 1635.8(b)(2). The collection of information about the 
manifested disease or disorder of a family member in the course of 
providing health or genetic services to the family member is not an 
unlawful acquisition of genetic information about the individual.
Section 1635.8(d)
    We received several comments concerning the extent to which health 
care professionals may request genetic information (particularly family 
medical history) as part of a lawful medical examination (e.g., a post-
offer exam or fitness for duty exam) to determine whether an individual 
has a manifested disease, disorder, or pathological condition. A number 
of comments suggested that the final rule should not necessarily limit 
the scope of the inquiries a health care professional may make, but 
should ensure that any genetic information collected as part of the 
examination is not shared with the employer. See Comments of AMA, 
Chamber/SHRM, EEAC and IPMA; see also Comments of United States Customs 
and Immigration Service (requesting clarification on this point). We do 
not think it is sufficient for an employer or other covered entity 
merely to indicate to the health care professional conducting a medical 
examination on its behalf that the covered entity does not want to 
receive genetic information acquired as part of the examination. The 
final rule says that the covered entity must tell the health care 
professional not to collect genetic information as part of a medical 
examination intended to determine the ability to perform a job, and 
must take additional reasonable measures within its control if it 
learns that genetic information is being requested or required. This 
could include no longer using the services of a health care 
professional who continues to request or require genetic information 
during medical examinations after being informed not to do so. Unlike 
the warning described in 1635.8(b)(1), which may not be necessary if a 
covered entity can show that it could not have known it would receive 
genetic information in response to a lawful request for medical 
documentation, the warning provided for in 1635.8(d) is required, 
because any time an employer sends an applicant or employee for a 
medical examination, the employer knows or should know that genetic 
information is likely to be requested. We note, however, that family 
medical history and other genetic information may be obtained as part 
of health or genetic services provided by the employer (see 29 CFR 
1635.8(b)(2)), and that Title II of GINA does not apply at all to 
medical examinations conducted for the purpose of diagnosis and 
treatment that are unrelated to employment (e.g., where an employee 
seeks health services from the same hospital where he or she works). 
See 1635.1(b)(1).
    The preamble to the proposed rule suggested that there would never 
be situations in which genetic information (including family medical 
history) would be needed as part of a medical examination conducted to 
assess an individual's ability to perform a job. One federal agency 
asked whether the final rule would include an exception allowing an 
employer or other covered entity to collect family medical history 
(e.g., questions about the prevalence of a psychiatric disability in 
family members of an individual) as part of the process of determining 
whether to grant or deny a security clearance. See Comments of United 
States Customs and Immigration Services. Neither the plain language of 
Title II, which enumerates very specific exceptions to the rule 
prohibiting acquisition of genetic information, nor GINA's legislative 
history references such an exception; therefore, the Commission 
declines to include one in the final rule.

[[Page 68927]]

    In response to comments from some employers that genetic 
information may be needed to make a diagnosis of a manifested disease, 
disorder, or pathological condition, we considered adding a very narrow 
exception to the prohibition on acquiring genetic information to allow 
a covered entity or health care professional acting on the covered 
entity's behalf to request genetic information as part of a medical 
examination where doing so is necessary to determine whether an 
individual has a particular manifested disease, disorder, or 
pathological condition and where information about the particular 
disease, disorder, or pathological condition, as opposed to its signs 
and symptoms, is necessary to evaluate an individual's ability to 
perform a particular job. See Comments of AHIP, Chamber/SRHM, EEAC and 
SBA. We decided against creating this extra-statutory exception, 
however, because neither the commenters that raised this concern nor 
the experts with whom we consulted were able to provide an example that 
fits within it. Although there may be cases where a manifested disease, 
disorder, or pathological condition can only be positively diagnosed 
through use of genetic information, there does not appear to be a case 
in which the diagnosis, as opposed to the signs and symptoms, is 
necessary to evaluate an individual's ability to perform a particular 
job. For example, although experts at the National Institutes of Health 
noted that a genetic test may be used to confirm a diagnosis of cystic 
fibrosis based principally on the clinical analysis of the patient, the 
signs or symptoms of cystic fibrosis (including, for example, frequent 
lung infections, sinusitis, bronchitis and pneumonia, and nasal polyps, 
among others) would be sufficient, regardless of the specific disease, 
disorder, or pathological condition that may be causing them, to assess 
an individual's ability to do a job. Moreover, in the case of cystic 
fibrosis, it is extremely unlikely that an individual seeking 
employment would be unaware of his or her diagnosis. Because we have no 
information supporting the need for this type of exception, we decided 
not to add to the exceptions specifically described in the statute.

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 in their possession the same way they treat medical 
information generally. They must keep the information confidential and, 
if the information is in writing, must keep it apart from other 
personnel information in separate medical files.\18\ Congress made 
express the requirement that covered entities keep genetic information 
confidential by using the confidentiality regime required by the ADA 
generally for medical records. H.R. Rep. 110-28, part I, at 39. GINA 
does not require that covered entities maintain a separate medical file 
for genetic information. Genetic information may be kept in the same 
file as medical information subject to the ADA.
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    \18\ 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 in the 
regulation at 1635.9(a)(3), a covered entity need not reduce to 
writing genetic information that it receives orally. Although one 
commenter requested that this language be altered to indicate that 
covered entities should not reduce genetic information that it 
receives orally to writing, we have decided to maintain the existing 
language. See Comment of DLRC. This language was inserted in the 
proposed rule to respond to concerns that GINA required employers to 
reduce to writing any genetic information received.
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    In response to questions raised by commenters, we note that 
although genetic information placed in personnel files prior to the 
effective date of GINA Title II need not be removed and an employer 
will not be liable under GINA for the mere existence of the information 
in the file, disclosing such information to a third party is 
prohibited. See Comments of EEAC and SBA. GINA's prohibitions on use 
and disclosure of genetic information apply to all genetic information 
that meets the statutory definition, including genetic information 
acquired prior to the effective date of GINA. See Comments of CGF, 
Genetic Alliance, and GPPC (requesting clarification of this point). We 
would not anticipate that removing genetic information in a personnel 
file acquired before GINA's effective date in response to a request to 
disclose the file would impose a significant burden on covered 
entities. Most genetic information is medical information that has been 
subject to the ADA's confidentiality requirements since 1992 (with 
respect to employers with 25 or more employees) or 1994 (with respect 
to employers with 15 to 24 employees). Consequently, although all 
covered entities must remove genetic information from personnel files 
prior to disclosing those files, we would anticipate that covered 
entities who have been complying with the ADA will have very few 
personnel files that contain genetic information.
    We received one comment questioning what an employer should do if 
it is aware that employees are discussing genetic information of co-
workers with other employees. See Comment of Navigenics. We do not 
think this has been a significant problem under the ADA, which has a 
similar confidentiality rule pertaining to employee medical information 
in general, and therefore do not think that many charges will be filed 
alleging that a covered entity violated GINA by allowing co-workers to 
share genetic information about another individual. However, we note 
that the analysis of an employer's responsibility to prevent harassment 
by co-workers is instructive--an employer is liable for harassment of 
an employee by co-workers if it knew or should have known of the 
misconduct, unless it can show that it took immediate and appropriate 
corrective action. See 29 CFR 1604.11(d). We believe a similar standard 
would work well in the case of an employer's responsibility to prevent 
individuals from discussing the genetic information of co-workers.
    Chamber/SHRM requested that the final regulation clarify that 
certain communications are exempt from GINA's confidentiality 
provisions, such as communications to a contractor performing relevant 
business functions (e.g., storing medical information on behalf of an 
employer) or to attorneys for purposes of litigation or legal 
assessment. This clarification is not necessary. First, it is apparent 
that a covered entity's attorney or a business with whom it has 
contracted to store medical information on its behalf is an agent of 
the covered entity and would therefore be permitted access to relevant 
genetic information. Second, as noted above, GINA uses the 
confidentiality regime required by the ADA generally for medical 
records. This regime does not include specific exceptions for 
communications to attorneys for the purposes of litigation or to 
contractors performing relevant business functions; yet we have not 
seen any charges challenging these types of communications.
    As noted above, a covered entity does not violate GINA when it 
acquires genetic information through sources that are publicly and 
commercially available, as long as it does not research those sources 
with the intent of acquiring genetic information or access sources that 
are likely to include genetic

[[Page 68928]]

information. 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 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 sources 
that are publicly and commercially available, 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 genetic 
information obtained through sources that are commercially and publicly 
available 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) Exceptions to 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 requests 
disclosure in writing. Second, the section states that genetic 
information may be provided to an occupational or other health 
researcher ``if the research is being conducted in compliance with the 
regulations under'' 45 CFR part 46 (regulating research involving human 
subjects). One commenter requested that this type of disclosure only be 
permitted if participation in the research is voluntary and the 
information obtained is not used for secondary research purposes. See 
Comment of ACLU. The requirements of 45 CFR part 46 itself, however, 
include obtaining the informed consent of research participants, which 
involves fully informing participants of the purposes and risks of the 
research, as well as the extent to which confidentiality of identifying 
records will be maintained. See 45 CFR 46.116. We need not adopt 
further safeguards in these circumstances.
    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. Moreover, the language of 
the regulation, taken from the statute, notes that if the court order 
was secured without the knowledge of the employee or member to whom the 
information refers, the covered entity must inform the employee or 
member of the court order and the information that was disclosed. 
Because the covered entity may not know whether the employee or member 
is aware of the court order, it should inform the employee or member of 
the court order and the disclosed information unless it knows that the 
employee or member already has this information. This exception does 
not allow disclosures in other circumstances during litigation, such as 
in response to discovery requests or subpoenas that are not governed by 
an order specifying that genetic information must be disclosed. Thus, a 
covered entity's refusal to provide genetic information in response to 
a discovery order, subpoena, or court order that does not specify that 
genetic information must be disclosed is consistent with the 
requirements of GINA.
    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 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 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 final regulation provide the following:
    <bullet> The enforcement mechanism applicable and remedies 
available to employees and others covered by Title VII of the Civil 
Rights Act of 1964 apply to GINA as well.\19\ 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.
---------------------------------------------------------------------------

    \19\ As defined by section 701 of the Civil Rights Act of 1964, 
42 U.S.C. 2000e, an employee is 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.
---------------------------------------------------------------------------

    <bullet> 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.\20\ EEOC regulations applicable to GERA are found at 29 CFR part 
1603.
---------------------------------------------------------------------------

    \20\ As defined by section 304(a) of GERA, 42 U.S.C. 2000e-
16c(a), an employee is 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.
---------------------------------------------------------------------------

    <bullet> 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.\21\ These

[[Page 68929]]

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.

    \21\ 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), these employees include 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.
---------------------------------------------------------------------------

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 final 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, at 1635.10(c) the regulation notes that covered entities 
are required to post notices in conspicuous places describing GINA's 
applicable provisions. The Commission issued a revised EEO poster that 
may be used for this purpose prior to GINA's effective date (November 
21, 2009). It is available to order or print on EEOC's Web site at 
http://www1.eeoc.gov/employers/poster.cfm.

Section 1635.11 Construction

    GINA section 209 and this section of the 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 30 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. The EEOC will provide information on our public Web site 
about state and local laws that prohibit employment discrimination on 
the basis of genetic information. See Comment of SBA (requesting more 
information about state and local laws addressing 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.
    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, 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. We reiterate, 
however, that family medical history and other genetic information may 
be acquired in connection with employer-provided health or genetic 
services, including wellness programs, that are provided on a voluntary 
basis (see 1635.8(b)(2)), and that Title II of GINA does not apply to 
genetic information acquired as part of a medical examination conducted 
for the purpose of diagnosis and treatment that is wholly unrelated to 
employment (e.g., where an employee seeks health services from the 
hospital where he or she works).
    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 under 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 under 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:
    <bullet> Imposing a preexisting condition exclusion based solely on 
genetic information, in the absence of a diagnosis of a condition;
    <bullet> Discriminating against individuals in eligibility and 
continued eligibility for benefits based on genetic information; and

[[Page 68930]]

    <bullet> 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 so that health plan or issuer provisions 
or actions are addressed and remedied through GINA Title I, ERISA, the 
Public Health Service Act, or the Internal Revenue Code and not through 
Title II and other employment discrimination procedures.
    We received a variety of comments requesting further clarification 
of the firewall provision. Employer groups argued that the final 
regulation should make very clear that the firewall is broad. See 
Comments of ABC, Blue Cross and Blue Shield Association (BCBSA), 
Chamber/SHRM and NFIB. Some of these same groups requested that more 
specific language about the lack of double liability be inserted into 
the regulation itself and provided model language for this purpose. See 
Comments of ABC, Blue Cross and Blue Shield Association, (BSBCA), and 
Chamber/SHRM. Civil rights groups, groups promoting genetic research, 
and others argued that the final rule should clarify that the firewall 
was not intended to immunize from liability decisions and actions that 
violate Title II, simply because those decisions involve health 
benefits governed by Title I. See Comments of CGF, Congressional 
Committee on Education and Labor (CCEL) (offering specific model 
language), Genetic Alliance, and GPPC. CCEL argued that the proposed 
regulation failed to make clear that liability under GINA is based on 
the actor who discriminates (i.e., employers or health plans/insurers) 
and not the act of discrimination. See Comment of CCEL. Commenters also 
requested that the final regulation include additional examples 
illustrating how the firewall will work, with one commenter providing 
specific examples for this purpose. See Comments of CCEL (providing 
specific examples and model language), Navigenics and SBA. We agree 
that further clarification of the firewall is required and, after 
careful review of the comments received, have made the necessary 
changes to the preamble and the final regulation.
    Section 209(a)(1)(B) eliminates ``double liability'' for health 
plans and insurers 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 provisions or actions are 
addressed and remedied through ERISA, the Public Health Service Act, or 
the Internal Revenue Code, while actions taken by employers and other 
GINA Title II entities are remedied through GINA Title II. The 
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.
    Employers and other GINA Title II covered entities, however, would 
remain liable for any of their actions that violate Title II, even 
where those actions involve access to 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, health plan or issuer provisions or actions related to the 
imposition of a preexisting condition exclusion; a health plan's or 
issuer's discrimination in health plan eligibility, benefits, or 
premiums based on genetic information; a health plan's or issuer's 
request that an individual undergo a genetic test; and/or a health 
plan's or issuer's collection of genetic information remain subject to 
enforcement under Title I exclusively. Below are a few examples of how 
the firewall is intended to operate:
    <bullet> If an employer contracts with a health insurance issuer to 
request genetic information, the employer has committed a Title II 
violation. In addition, the plan and issuer may have violated Title I 
of GINA.
    <bullet> If an employer directs its employees to undergo mandatory 
genetic testing in order to be eligible for health benefits, the 
employer has committed a Title II violation.
    <bullet> If an employer or union amends a health plan to require an 
individual to undergo a genetic test, then the employer or union is 
liable for a violation of Title II. In addition, the health plan's 
implementation of the requirement may violate Title I.
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 the GINA 
Title I provisions identified in GINA section 209(a)(2)(B)(i)-(iv), 
including any implementing regulations thereunder. The section and the 
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
    Final Sec.  1635.11(d) implements section 206(c) of GINA Title II 
by providing, as a general rule of construction, that this regulation 
does not apply to protected 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. 
Similarly, a health care provider may share genetic information, 
consistent with the HIPAA Privacy Rule, in the course of providing 
genetic services as part of a voluntary wellness program.
    Several commenters requested that the final regulation make clear 
that genetic information obtained by a health care provider covered by 
the HIPAA Privacy Rule may not be used in making employment decisions 
and must be kept separate from employment files. See Comments of CGF, 
Genetic Alliance and GPPC. Another commenter was concerned that the 
language in the proposed preamble suggested that an entity covered by 
both the HIPAA Privacy Rule and GINA can use genetic information to 
discriminate against applicants and employees because the requirements 
of GINA do not apply to it. See Comment of World Privacy Forum. In 
response to these comments, we clarify that all entities covered by 
Title II of GINA, whether or not they are also covered by the HIPAA 
Privacy Rule, must follow the requirements of GINA when they are acting 
as employers.

Section 1635.12 Medical Information That Is Not Genetic Information

    The final regulation states that a covered entity does not violate 
GINA by

[[Page 68931]]

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 ADA, 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. In response to 
a comment, we clarify that GINA prohibits discrimination based on 
genetic information and not on the basis of a manifested condition, 
while the ADA prohibits discrimination on the basis of manifested 
conditions that meet the definition of disability. See Comment of ICC. 
Although another commenter expressed concern that neither GINA nor the 
ADA protects individuals with a manifested genetic disease that is not 
yet substantially limiting, we note that we have no authority under 
these regulations to expand the coverage of GINA. See Comment of Burton 
Blatt Institute. Moreover, given the broader definition of disability 
that now exists under the Americans with Disabilities Act Amendments 
Act (ADAAA), it is less likely that a significant number of individuals 
will fall within this gap. Perhaps most notably, the revised definition 
of the ``regarded as'' definition of ``disability'' would apply to 
anyone against whom an employer or other covered entity takes a 
prohibited action (e.g., failure to hire or termination) based on an 
actual or perceived physical or mental impairment that is not 
transitory (lasting or expected to last for six months or less) and 
minor. See 42 U.S.C. 12102(3)(A).

Regulatory Procedures

Executive Order 12866

    Pursuant to Executive Order 12866, EEOC has coordinated this final 
rule with the Office of Management and Budget. Under section 3(f)(1) of 
Executive Order 12866, EEOC has determined that the 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-benefit assessment of the regulation is not 
required.

Paperwork Reduction Act

    This rule 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 final 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 revising post-offer medical 
questionnaires to eliminate questions about family medical history 
would not impose significant costs. We recognize that some employers 
who currently request medical information from employees verbally may 
decide to make such requests in writing and may create a form for this 
purpose, in response to the safe harbor described in 1635.8(b)(1)(i). 
We have no data that would enable us to determine how many businesses 
will change their practices, but do not believe the cost of creating a 
form for those businesses who choose to do so would be significant.
    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 District offices 
conducted 530 no-fee outreach events directed toward small businesses, 
including many events in partnership with employer associations, such 
as the Society for Human Resource Management, and the Industry Liaison 
Groups and other federal agencies, such as the National Labor Relations 
Board and the Office of Federal Contract Compliance Programs. Events 
included oral presentations, training and stakeholder input meetings 
involving 28,525 small business representatives. We expect to include 
information about GINA in our outreach programs in general and to offer 
numerous GINA-specific outreach programs once the regulation 
implementing Title II of GINA becomes 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 typical human resources professionals 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 $46.40. See Bureau of Labor Statistics, Occupational 
Employment and Wages, May 2009 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 
getting appropriate training will be between approximately $139.00 and 
$696.00, at the high end. EEOC does not believe that this cost will be 
significant for the impacted small entities.

[[Page 68932]]

    Although several commenters requested that EEOC provide training 
and technical assistance specifically geared towards small businesses, 
we received no comments disputing our estimates of the number of small 
entities impacted or the cost to those entities. See Comments of NFIB, 
NSBA and SBA. As noted above, EEOC will offer training on Title II of 
GINA in various formats, as well as issuing the necessary technical 
assistance guidance.

Unfunded Mandates Reform Act of 1995

    This final 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: October 29, 2010.

    For the Commission.
Jacqueline A. Berrien,
Chair.

List of Subjects in 29 CFR Part 1635

    Administrative practice and procedure, Equal employment 
opportunity.

0
For the reasons set forth in the preamble, the EEOC amends 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 a covered entity 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.

    (a) The purpose of this part is to implement Title II of the 
Genetic Information Nondiscrimination Act of 2008, 42 U.S.C. 2000ff, et 
seq. Title II of GINA:
    (1) Prohibits use of genetic information in employment decision-
making;
    (2) Restricts employers and other entities subject to Title II of 
GINA from requesting, requiring, or purchasing genetic information;
    (3) Requires that genetic information be maintained as a 
confidential medical record, and places strict limits on disclosure of 
genetic information; and
    (4) Provides remedies for individuals whose genetic information is 
acquired, used, or disclosed in violation of its protections.
    (b) This part does not apply to actions of covered entities that do 
not pertain to an individual's status as an employee, member of a labor 
organization, or participant in an apprenticeship program. For example, 
this part would not apply to:
    (1) A medical examination of an individual for the purpose of 
diagnosis and treatment unrelated to employment, which is conducted by 
a health care professional at the hospital or other health care 
facility where the individual is an employee; or
    (2) Activities of a covered entity carried on in its capacity as a 
law enforcement agency investigating criminal conduct, even where the 
subject of the investigation is an employee of the covered entity.


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:
    (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

[[Page 68933]]

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, and children.
    (ii) Second-degree relatives include an individual's grandparents, 
grandchildren, uncles, aunts, nephews, nieces, and half-siblings.
    (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, the sex or age of family members, or 
information about the race or ethnicity of the individual or family 
members that is not derived from a genetic test.
    (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 to in performing 
their jobs, in order to identify, evaluate, and respond to the effects 
of, or to control adverse environmental exposures in the workplace.
    (e) Genetic services. 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.
    (2) Genetic tests include, but are not limited to:
    (i) A test to determine whether someone has the BRCA1 or BRCA2 
variant evidencing a predisposition to breast cancer, a test to 
determine whether someone has a genetic variant associated with 
hereditary nonpolyposis colon cancer, and a test for a genetic variant 
for Huntington's Disease;
    (ii) Carrier screening for adults using genetic analysis to 
determine the risk of conditions such as cystic fibrosis, sickle cell 
anemia, spinal muscular atrophy, or fragile X syndrome in future 
offspring;
    (iii) Amniocentesis and other evaluations used to determine the 
presence of genetic abnormalities in a fetus during pregnancy;
    (iv) Newborn screening analysis that uses DNA, RNA, protein, or 
metabolite analysis to detect or indicate genotypes, mutations, or 
chromosomal changes, such as a test for PKU performed so that treatment 
can begin before a disease manifests;
    (v) Preimplantation genetic diagnosis performed on embryos created 
using invitro fertilization;
    (vi) Pharmacogenetic tests that detect genotypes, mutations, or 
chromosomal changes that indicate how an individual will react to a 
drug or a particular dosage of a drug;
    (vii) DNA testing to detect genetic markers that are associated 
with information about ancestry; and
    (viii) DNA testing that reveals family relationships, such as 
paternity.
    (3) The following are examples of tests or procedures that are not 
genetic tests:
    (i) An analysis of proteins or metabolites that does not detect 
genotypes, mutations, or chromosomal changes;
    (ii) A medical examination that tests for the presence of a virus 
that is not composed of human DNA, RNA, chromosomes, proteins, or 
metabolites;
    (iii) A test for infectious and communicable diseases that may be 
transmitted through food handling;
    (iv) Complete blood counts, cholesterol tests, and liver-function 
tests.
    (4) Alcohol and Drug Testing--
    (i) A test for the presence of alcohol or illegal 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

[[Page 68934]]

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.


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. A covered entity will not be deemed to have violated 
this section if it limits or restricts an employee's job duties based 
on genetic information because it was required to do so by a law or 
regulation mandating genetic monitoring, such as regulations 
administered by the Occupational and Safety Health Administration 
(OSHA). See 1635.8(b)(5) and 1635.11(a).
    (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 a covered entity to discriminate.

    A covered entity may not cause or attempt to cause another covered 
entity, 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 or family member of 
the individual, except as specifically provided in paragraph (b) of 
this section. ``Request'' includes conducting an Internet search on an 
individual in a way that is likely to result in a covered entity 
obtaining genetic information; actively listening to third-party 
conversations or searching an individual's personal effects for the 
purpose of obtaining genetic information; and making requests for 
information about an individual's current health status in a way that 
is likely to result in a covered entity obtaining genetic information.
    (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.
    (i) Requests for Medical Information:
    (A) If a covered entity acquires genetic information in response to 
a lawful request for medical information, the acquisition of genetic 
information will not generally be considered inadvertent unless the 
covered entity directs the individual and/or health care provider from 
whom it requested medical information (in writing, or verbally, where 
the covered entity does not typically make requests for medical 
information in writing) not to provide genetic information.
    (B) If a covered entity uses language such as the following, any 
receipt of genetic information in response to the request for medical 
information will be deemed inadvertent: ``The Genetic Information 
Nondiscrimination Act of 2008 (GINA) prohibits employers and other 
entities covered by GINA Title II from requesting or requiring genetic 
information of an individual or family member of the individual, except 
as specifically allowed by this law. To comply with this law, we are 
asking that you not provide any genetic information when responding to 
this request for medical information. `Genetic information' as defined 
by GINA, includes an individual's family medical history, the results 
of an individual's or family member's genetic tests, the fact that an 
individual or an individual's family member sought or received genetic 
services, 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.''
    (C) A covered entity's failure to give such a notice or to use this 
or similar language will not prevent it from establishing that a 
particular receipt of genetic information was inadvertent if its 
request for medical information was not ``likely to result in a covered 
entity obtaining genetic information'' (for example, where an overly 
broad response is received in response to a tailored request for 
medical information).
    (D) Situations to which the requirements of subsection (b)(1)(i) 
apply include, but are not limited to the following:
    (1) Where a covered entity requests 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. A request for documentation supporting a request for reasonable 
accommodation is lawful only when the disability and/or the need for 
accommodation is not obvious; the documentation is no more than is 
sufficient to establish that an individual has a disability and needs a 
reasonable accommodation; and the documentation relates only to the 
impairment that the individual claims to be a disability that requires 
reasonable accommodation;
    (2) Where an employer requests medical information from an 
individual as required, authorized, or permitted by Federal, State, or 
local law, such as where an employee requests leave under the Family 
and Medical Leave Act (FMLA) to attend to the employee's own serious 
health condition or where an employee complies with the FMLA's employee 
return to work certification requirements; or
    (3) Where a covered entity requests documentation to support a 
request for leave that is not governed by Federal,

[[Page 68935]]

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.
    (ii) The exception for inadvertent acquisition of genetic 
information also applies in, but is not necessarily limited to, 
situations where--
    (A) A manager, supervisor, union representative, or employment 
agency representative learns genetic information about an individual by 
overhearing a conversation between the individual and others;
    (B) A manager, supervisor, union representative, or employment 
agency representative learns genetic information about an individual by 
receiving it from the individual or third-parties during a casual 
conversation, including in response to an ordinary expression of 
concern that is the subject of the conversation. 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 ``Did they catch it early?'' asked of an employee who was just 
diagnosed with cancer) or a question as to whether the individual has a 
manifested condition. Similarly, a casual question between colleagues, 
or between a supervisor and subordinate, concerning the general well-
being of a parent or child would not violate GINA (e.g., ``How's your 
son feeling today?'', ``Did they catch it early?'' asked of an employee 
whose family member was just diagnosed with cancer, or ``Will your 
daughter be OK?''). However, this exception does not apply where an 
employer follows up a question concerning a family member's general 
health with questions that are probing in nature, such as whether other 
family members have the condition, or whether the individual has been 
tested for the condition, because the covered entity should know that 
these questions are likely to result in the acquisition of genetic 
information;
    (C) A manager, supervisor, union representative, or employment 
agency representative learns genetic information from the individual or 
a third-party without having solicited or sought the information (e.g., 
where a manager or supervisor receives an unsolicited email about the 
health of an employee's family member from a co-worker); or
    (D) A manager, supervisor, union representative, or employment 
agency representative inadvertently learns genetic information from a 
social media platform which he or she was given permission to access by 
the creator of the profile at issue (e.g., a supervisor and employee 
are connected on a social networking site and the employee provides 
family medical history on his page).
    (2) Where a covered entity offers health or genetic services, 
including such services offered as part of a voluntary wellness 
program.
    (i) This exception applies only where--
    (A) The provision of genetic information by the individual is 
voluntary, meaning the covered entity neither requires the individual 
to provide genetic information nor penalizes those who choose not to 
provide it;
    (B) The individual provides prior knowing, voluntary, and written 
authorization, which may include authorization in electronic format. 
This requirement is only met if the covered entity uses an 
authorization form that:
    (1) Is written so that the individual from whom the genetic 
information is being obtained is reasonably likely to understand it;
    (2) Describes the type of genetic information that will be obtained 
and the general purposes for which it will be used; and
    (3) Describes the restrictions on disclosure of genetic 
information;
    (C) Individually identifiable genetic information is provided only 
to the individual (or family member if the family member is receiving 
genetic services) and the licensed health care professionals or board 
certified genetic counselors involved in providing such services, and 
is not accessible to managers, supervisors, or others who make 
employment decisions, or to anyone else in the workplace; and
    (D) 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 (a covered entity will not violate the requirement that it 
receive information only in aggregate terms if it receives information 
that, for reasons outside the control of the provider or the covered 
entity (such as the small number of participants), makes the genetic 
information of a particular individual readily identifiable with no 
effort on the covered entity's part).
    (ii) Consistent with the requirements of paragraph (b)(2)(i) of 
this section, a covered entity may not offer a financial inducement for 
individuals to provide genetic information, but may offer financial 
inducements for completion of health risk assessments that include 
questions about family medical history or other genetic information, 
provided the covered entity makes clear, in language reasonably likely 
to be understood by those completing the health risk assessment, that 
the inducement will be made available whether or not the participant 
answers questions regarding genetic information. For example:
    (A) A covered entity offers $150 to employees who complete a health 
risk assessment with 100 questions, the last 20 of them concerning 
family medical history and other genetic information. The instructions 
for completing the health risk assessment make clear that the 
inducement will be provided to all employees who respond to the first 
80 questions, whether or not the remaining 20 questions concerning 
family medical history and other genetic information are answered. This 
health risk assessment does not violate Title II of GINA.
    (B) Same facts as the previous example, except that the 
instructions do not indicate which questions request genetic 
information; nor does the assessment otherwise make clear which 
questions must be answered in order to obtain the inducement. This 
health risk assessment violates Title II of GINA.
    (iii) A covered entity may offer financial inducements to encourage 
individuals who have voluntarily provided genetic information (e.g., 
family medical history) that indicates that they are at increased risk 
of acquiring a health condition in the future to participate in disease 
management programs or other programs that promote healthy lifestyles, 
and/or to meet particular health goals as part of a health or genetic 
service. However, to comply with Title II of GINA, these programs must 
also be offered to individuals with current health conditions and/or to 
individuals whose lifestyle choices put them at increased risk of 
developing a condition. For example:
    (A) Employees who voluntarily disclose a family medical history of 
diabetes, heart disease, or high blood pressure on a health risk 
assessment that meets the requirements of (b)(2)(ii) of this section 
and employees who have a current diagnosis of one or more of these 
conditions are offered $150 to participate in a wellness program 
designed to encourage weight loss and a healthy lifestyle. This does 
not violate Title II of GINA.
    (B) The program in the previous example offers an additional

[[Page 68936]]

inducement to individuals who achieve certain health outcomes. 
Participants may earn points toward ``prizes'' totaling $150 in a 
single year for lowering their blood pressure, glucose, and cholesterol 
levels, or for losing weight. This inducement would not violate Title 
II of GINA.
    (iv) Nothing contained in Sec.  1635.8(b)(2)(iii) limits the rights 
or protections of an individual under the Americans with Disabilities 
Act (ADA), as amended, or other applicable civil rights laws, or under 
the Health Insurance Portability and Accountability Act (HIPAA), as 
amended by GINA. For example, if an employer offers a financial 
inducement for participation in disease management programs or other 
programs that promote healthy lifestyles and/or require individuals to 
meet particular health goals, the employer must make reasonable 
accommodations to the extent required by the ADA, that is, the employer 
must make ``modifications or adjustments that enable a covered entity's 
employee with a disability to enjoy equal benefits and privileges of 
employment as are enjoyed by its other similarly situated employees 
without disabilities'' unless ``such covered entity can demonstrate 
that the accommodation would impose an undue hardship on the operation 
of its business.'' 29 CFR 1630.2(o)(1)(iii); 29 CFR 1630.9(a). In 
addition, if the employer's wellness program provides (directly, 
through reimbursement, or otherwise) medical care (including genetic 
counseling), the program may constitute a group health plan and must 
comply with the special requirements for wellness programs that 
condition rewards on an individual satisfying a standard related to a 
health factor, including the requirement to provide an individual with 
a ``reasonable alternative (or waiver of the otherwise applicable 
standard)'' under HIPAA, when ``it is unreasonably difficult due to a 
medical condition to satisfy'' or ``medically inadvisable to attempt to 
satisfy'' the otherwise applicable standard. See section 9802 of the 
Internal Revenue Code (26 U.S.C. 9802, 26 CFR 54.9802-1 and 54.9802-
3T), section 702 of the Employee Retirement Income Security Act of 1974 
(ERISA) (29 U.S.C. 1182, 29 CFR 2590.702 and 2590.702-1), and section 
2705 of the Public Health Service Act (45 CFR 146.121 and 146.122).
    (3) Where the covered entity 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, or pursuant to a policy (even in the absence of 
requirements of Federal, State, or local leave laws) that permits the 
use of leave to care for a sick family member and that requires all 
employees to provide information about the health condition of the 
family member to substantiate the need for leave.
    (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 this exception does 
not apply--
    (i) To medical databases, court records, or research databases 
available to scientists on a restricted basis;
    (ii) To genetic information acquired through sources with limited 
access, such as social networking sites and other media sources which 
require permission to access from a specific individual or where access 
is conditioned on membership in a particular group, unless the covered 
entity can show that access is routinely granted to all who request it;
    (iii) To genetic information obtained through commercially and 
publicly available sources if the covered entity sought access to those 
sources with the intent of obtaining genetic information; or
    (iv) To genetic information obtained through media sources, whether 
or not commercially and publicly available, if the covered entity is 
likely to acquire genetic information by accessing those sources, such 
as Web sites and on-line discussion groups that focus on issues such as 
genetic testing of individuals and genetic discrimination.
    (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 
and the individual must be informed of the individual monitoring 
results. The covered entity may not retaliate or otherwise discriminate 
against an individual due to his or her refusal to participate in 
genetic monitoring that is not required by federal or state law. This 
exception further provides that such monitoring:
    (i) Is either required by federal or state law or regulation, or is 
conducted only where the individual gives prior knowing, voluntary and 
written authorization. The requirement for individual authorization is 
only met if the covered entity uses an authorization form 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; and
    (C) Describes the restrictions on disclosure of genetic 
information;
    (ii) 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
    (iii) 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 conducts DNA analysis for law enforcement 
purposes as a forensic laboratory or for purposes of human remains 
identification and 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 is maintained 
and disclosed in a manner consistent with such use.
    (c) Inquiries Made of Family Members Concerning a Manifested 
Disease, Disorder, or Pathological Condition. (1) A covered entity does 
not violate this section when it requests, requires, or purchases 
information about a manifested disease, disorder, or pathological 
condition of an employee, member, or apprenticeship program participant 
whose family member is an employee for the same employer, a member of 
the same labor organization, or a participant in the same 
apprenticeship program. For example, an employer will not violate this 
section by asking someone whose sister also works for the employer to 
take a post-offer medical examination that does not include requests 
for genetic information.
    (2) A covered entity does not violate this section when it 
requests, requires, or purchases genetic information or

[[Page 68937]]

information about the manifestation of a disease, disorder, or 
pathological condition of an individual's family member who is 
receiving health or genetic services on a voluntary basis. For example, 
an employer does not unlawfully acquire genetic information about an 
employee when it asks the employee's family member who is receiving 
health services from the employer if her diabetes is under control.
    (d) Medical examinations related to employment. The prohibition on 
acquisition of genetic information, including family medical history, 
applies to medical examinations related to employment. A covered entity 
must tell health care providers not to collect genetic information, 
including family medical history, as part of a medical examination 
intended to determine the ability to perform a job, and must take 
additional reasonable measures within its control if it learns that 
genetic information is being requested or required. Such reasonable 
measures may depend on the facts and circumstances under which a 
request for genetic information was made, and may include no longer 
using the services of a health care professional who continues to 
request or require genetic information during medical examinations 
after being informed not to do so.
    (e) A covered entity may not use genetic information obtained 
pursuant to subparagraphs (b) or (c) of this section 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 
sources that are commercially and publicly available, as provided by, 
and subject to the limitations in, 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.
    (5) Genetic information placed in personnel files prior to November 
21, 2009 need not be removed and a covered entity will not be liable 
under this part for the mere existence of the information in the file. 
However, the prohibitions on use and disclosure of genetic information 
apply to all genetic information that meets the statutory definition, 
including genetic information requested, required, or purchased prior 
to November 21, 2009.
    (b) Exceptions to 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 commercially and 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 employee or member to whom the information refers, the covered 
entity shall inform the employee or member 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 
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):

[[Page 68938]]

    (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).
    (c) Posting of Notices. (1) Every covered entity shall post and 
keep posted in conspicuous places upon its premises where notices to 
employees, applicants for employment, and members are customarily 
posted a notice to be prepared or approved by the Commission setting 
forth excerpts from or, summaries of, the pertinent provisions of this 
regulation and information pertinent to the filing of a complaint.
    (2) A willful violation of this requirement shall be punishable by 
a fine of not more than $100 for each separate offense.


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. (1) 
General: 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 under:
    (i) Amendments made by Title I of GINA.
    (ii) Section 701(a) of the Employee Retirement Income Security Act 
(29 U.S.C. 1181) (ERISA), section 2704(a) of the Public Health Service 
Act, 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 section 701(b)(1)(B) of ERISA, section 2704(b)(1)(B) of the 
Public Health Service Act, and section 9801(b)(1)(B) of the Internal 
Revenue Code, 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;
    (iii) Section 702(a)(1)(F) of ERISA (29 U.S.C. 1182(a)(1)(F)), 
section 2705(a)(6) of the Public Health Service Act, 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
    (iv) Section 702(b)(1) of ERISA (29 U.S.C. 1182(b)(1)), section 
2705(b)(1) of the Public Health Service Act, 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.
    (2) Application. The application of paragraph (b)(1) of this 
section is intended to prevent 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 provisions or actions are 
addressed and remedied through ERISA, the Public Health Service Act, or 
the Internal Revenue Code, while actions taken by employers and other 
GINA Title II covered entities are remedied through GINA Title II. 
Employers and other GINA Title II covered entities would remain liable 
for any of their actions that violate Title II, even where those 
actions involve access to 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, health plan or 
issuer provisions or actions related to the imposition of a preexisting 
condition exclusion; a health plan's or issuer's discrimination in 
health plan eligibility, benefits, or premiums based on genetic 
information; a health plan's or issuer's request that an individual 
undergo a genetic test; and/or a health plan's or issuer's collection 
of genetic information remain subject to enforcement under Title I 
exclusively. For example:
    (i) If an employer contracts with a health insurance issuer to 
request genetic information, the employer has committed a Title II 
violation. In addition, the issuer may have violated Title I of GINA.
    (ii) If an employer directs his employees to undergo mandatory 
genetic testing in order to be eligible for health benefits, the 
employer has committed a Title II violation.
    (iii) If an employer or union amends a health plan to require an 
individual to undergo a genetic test, then the employer or union is 
liable for a violation of Title II. In addition, the health plan's 
implementation of the requirement may subject the health plan to 
liability under Title I.
    (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.

[[Page 68939]]

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 
pathological condition is subject to the requirements and prohibitions 
in sections 202 through 206 of GINA and Sec. Sec.  1635.4 through 
1635.9 of this part.

[FR Doc. 2010-28011 Filed 11-8-10; 8:45 am]
BILLING CODE 6570-01-P