Regulations Under the Genetic Information Nondiscrimination Act of 2008, 68912-68939 [2010-28011]

Agencies

• Equal Employment Opportunity Commission

[Federal Register Volume 75, Number 216 (Tuesday, November 9, 2010)]
[Rules and Regulations]
[Pages 68912-68939]
From the Federal Register Online via the Government Printing 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

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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 https://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 https://www.eeoc.gov/eeoc/meetings/2-25-09/index.cfm). Although they had not had an opportunity 
to review the

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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 https://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 (https://www.hhs.gov/familyhistory/). GINA is not intended to limit the collection of 
family medical history by health care professionals for diagnostic 
or treatment purposes.
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    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).
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    \9\ When asking questions likely to elicit information about a 
disability, covered entities must, of course, also abide by the 
requirements of the ADA.
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    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