Tuesday, 

November 9, 2010 

Part III 

Equal Employment 

Opportunity 

Commission 

29 CFR Part 1635 

Regulations Under the Genetic 

Information Nondiscrimination Act of 

2008; Final Rule 


wwoods2 on DSK1DXX6B1PROD with RULES3
68912 Federal Register / Vol. 75, No. 216 / Tuesday, November 9, 2010 / Rules and Regulations 

1This 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. 

2Prior 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. 

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. 

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. 

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

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 


wwoods2 on DSK1DXX6B1PROD with RULES3
Federal Register / Vol. 75, No. 216 / Tuesday, November 9, 2010 / Rules and Regulations 68913 

3Unless 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. 

4The 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. 

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

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. 

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 decisionmaking, 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 


wwoods2 on DSK1DXX6B1PROD with RULES3
68914 Federal Register / Vol. 75, No. 216 / Tuesday, November 9, 2010 / Rules and Regulations 

5The 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. 

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 § 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 labormanagement 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 


wwoods2 on DSK1DXX6B1PROD with RULES3
Federal Register / Vol. 75, No. 216 / Tuesday, November 9, 2010 / Rules and Regulations 68915 

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) 

7This 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. 

8Since 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. 

through marriage, birth, adoption, or 

placement for adoption.6

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), greatgrandparents, 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 halfsiblings 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. 

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 firstdegree, 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

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 


wwoods2 on DSK1DXX6B1PROD with RULES3
68916 Federal Register / Vol. 75, No. 216 / Tuesday, November 9, 2010 / Rules and Regulations 

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 § 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 

§ 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 


wwoods2 on DSK1DXX6B1PROD with RULES3
Federal Register / Vol. 75, No. 216 / Tuesday, November 9, 2010 / Rules and Regulations 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 nonmedical 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 

(§ 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 § 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 


wwoods2 on DSK1DXX6B1PROD with RULES3
68918 Federal Register / Vol. 75, No. 216 / Tuesday, November 9, 2010 / Rules and Regulations 

manifested disease caused by the 

variant. We note that § 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 § 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 § 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 


wwoods2 on DSK1DXX6B1PROD with RULES3
Federal Register / Vol. 75, No. 216 / Tuesday, November 9, 2010 / Rules and Regulations 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 § 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 


wwoods2 on DSK1DXX6B1PROD with RULES3
68920 Federal Register / Vol. 75, No. 216 / Tuesday, November 9, 2010 / Rules and Regulations 

9When asking questions likely to elicit 

information about a disability, covered entities 

must, of course, also abide by the requirements of 

the ADA. 

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 coworkers 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 coworker about the health of an 

employee’s family member). 

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 


wwoods2 on DSK1DXX6B1PROD with RULES3
Federal Register / Vol. 75, No. 216 / Tuesday, November 9, 2010 / Rules and Regulations 68921 

10There 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. 

11One 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. 

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 employmentrelated 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. 

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 


wwoods2 on DSK1DXX6B1PROD with RULES3
68922 Federal Register / Vol. 75, No. 216 / Tuesday, November 9, 2010 / Rules and Regulations 

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/guidanceinquiries.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 


wwoods2 on DSK1DXX6B1PROD with RULES3
Federal Register / Vol. 75, No. 216 / Tuesday, November 9, 2010 / Rules and Regulations 68923 

12The 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. 

13A 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). 

14Whether 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 selfinsured or insured plans. 

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

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 nonparticipation 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. 

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 


wwoods2 on DSK1DXX6B1PROD with RULES3
68924 Federal Register / Vol. 75, No. 216 / Tuesday, November 9, 2010 / Rules and Regulations 

15Although 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. 

16Chamber/SHRM reiterated its comment that a 

covered entity must undertake an intentional act of 

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: 

• 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; 

• 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); 

• 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

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


wwoods2 on DSK1DXX6B1PROD with RULES3
Federal Register / Vol. 75, No. 216 / Tuesday, November 9, 2010 / Rules and Regulations 68925 

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. 

17For example, one commenter provided several 

lists of identifiable individuals with diabetes 

available for sale on the Internet. See Comment of 

World Privacy Forum. 

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. 

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 


wwoods2 on DSK1DXX6B1PROD with RULES3
68926 Federal Register / Vol. 75, No. 216 / Tuesday, November 9, 2010 / Rules and Regulations 

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. 


wwoods2 on DSK1DXX6B1PROD with RULES3
Federal Register / Vol. 75, No. 216 / Tuesday, November 9, 2010 / Rules and Regulations 68927 

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. 

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. 

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 coworkers 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 coworkers 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 


wwoods2 on DSK1DXX6B1PROD with RULES3
68928 Federal Register / Vol. 75, No. 216 / Tuesday, November 9, 2010 / Rules and Regulations 

19As 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. 

20As 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. 

21As 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 

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: 

• 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. 

• 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. 

• 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 


wwoods2 on DSK1DXX6B1PROD with RULES3
Federal Register / Vol. 75, No. 216 / Tuesday, November 9, 2010 / Rules and Regulations 68929 

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. 

sections provide for counseling and 

mediation of employment 

discrimination allegations and the 

formal process of complaints before the 

Commission using the same 

administrative process generally 

applicable to employees in the 

Executive Branch of the Federal 

government; that is, the process set forth 

in 29 CFR part 1614. 

Employees covered through the 

Congressional Accountability Act of 

1995 must use the procedures set forth 

in that statute. The Commission has no 

authority with respect to the 

enforcement of GINA as to employees 

covered through this provision. 

The 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 disabilityrelated inquiry or medical examination. 

For example, an employer will no 

longer be able to obtain family medical 

history or conduct genetic tests of postoffer 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 employerprovided 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: 

• Imposing a preexisting condition 

exclusion based solely on genetic 

information, in the absence of a 

diagnosis of a condition; 

• Discriminating against individuals 

in eligibility and continued eligibility 

for benefits based on genetic 

information; and 


wwoods2 on DSK1DXX6B1PROD with RULES3
68930 Federal Register / Vol. 75, No. 216 / Tuesday, November 9, 2010 / Rules and Regulations 

• 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: 

• 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. 

• 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. 

• 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 § 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 


wwoods2 on DSK1DXX6B1PROD with RULES3
Federal Register / Vol. 75, No. 216 / Tuesday, November 9, 2010 / Rules and Regulations 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/preemployment medical examination 

process of some employers, to remove 

from the process questions pertaining to 

family medical history. We do not have 

data on the number and size of 

businesses that obtain family medical 

history as part of a post-offer medical 

examination. However, our experience 

with enforcing the ADA, which required 

all employers with fifteen or more 

employees to remove medical inquiries 

from their application forms, suggests 

that 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 GINAspecific 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. 


wwoods2 on DSK1DXX6B1PROD with RULES3
68932 Federal Register / Vol. 75, No. 216 / Tuesday, November 9, 2010 / Rules and Regulations 

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. 

■ 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. 

§ 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 decisionmaking; 

(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. 

§ 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 policymaking level, or to serve the elected 

official as the immediate advisor on the 

exercise of the elected official’s 

constitutional or legal powers. 

(3) As defined by section 101 of the 

Congressional Accountability Act, 2 

U.S.C. 1301, any employee of the House 

of Representatives, the Senate, the 

Capitol Guide Service, the Capitol 

Police, the Congressional Budget Office, 

the Office of the Architect of the 

Capitol, the Office of the Attending 

Physician, the Office of Compliance, or 

the Office of Technology Assessment; 

(4) As defined by, and subject to the 

limitations in, section 2(a) of the 

Presidential and Executive Office 

Accountability Act, 3 U.S.C. 411(c), any 

employee of the executive branch not 

otherwise covered by section 717 of the 

Civil Rights Act of 1964, 42 U.S.C. 

2000e–16, section 15 of the Age 

Discrimination in Employment Act of 

1967, 29 U.S.C. 633a, or section 501 of 

the Rehabilitation Act of 1973, 29 U.S.C. 

791, whether appointed by the President 

or any other appointing authority in the 

executive branch, including an 

employee of the Executive Office of the 

President; 

(5) As defined by, and subject to the 

limitations in, section 717 of the Civil 

Rights Act of 1964, 42 U.S.C. 2000e–16, 

and regulations of the Equal 

Employment Opportunity Commission 

at 29 CFR 1614.103, an employee of a 

federal executive agency, the United 

States Postal Service and the Postal Rate 

Commission, the Tennessee Valley 

Authority, the National Oceanic and 

Atmospheric Administration 

Commissioned Corps, the Government 

Printing Office, and the Smithsonian 

Institution; an employee of the federal 

judicial branch having a position in the 

competitive service; and an employee of 

the Library of Congress. 

(d) Employer means any person that 

employs an employee defined in 

§ 1635.2(c) of this part, and any agent of 

such person, except that, as limited by 

section 701(b)(1) and (2) of the Civil 

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 


wwoods2 on DSK1DXX6B1PROD with RULES3
Federal Register / Vol. 75, No. 216 / Tuesday, November 9, 2010 / Rules and Regulations 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-thejob training programs. 

(h) Labor organization is defined at 42 

U.S.C. 2000e(d) to mean an organization 

with fifteen or more members engaged 

in an industry affecting commerce, and 

any agent of such an organization in 

which employees participate and which 

exists for the purpose, in whole or in 

part, of dealing with employers 

concerning grievances, labor disputes, 

wages, rates of pay, hours, or other 

terms or conditions of employment. 

(i) Member includes, with respect to 

a labor organization, an applicant for 

membership. 

(j) Person is defined at 42 U.S.C. 

2000e(a) to mean one or more 

individuals, governments, governmental 

agencies, political subdivisions, labor 

unions, partnerships, associations, 

corporations, legal representatives, 

mutual companies, joint-stock 

companies, trusts, unincorporated 

organizations, trustees, trustees in cases 

under title 11, or receivers. 

(k) State is defined at 42 U.S.C. 

2000e(i) and includes a State of the 

United States, the District of Columbia, 

Puerto Rico, the Virgin Islands, 

American Samoa, Guam, Wake Island, 

the Canal Zone, and Outer Continental 

Shelf lands defined in the Outer 

Continental Shelf Lands Act (43 U.S.C. 

1331 et seq.). 

§ 1635.3 Definitions specific to GINA. 

(a) Family member means with 

respect to any individual: 

(1) A person who is a dependent of 

that individual as the result of marriage, 

birth, adoption, or placement for 

adoption; or 

(2) A first-degree, second-degree, 

third-degree, or fourth-degree relative of 

the individual, or of a dependent of the 

individual as defined in § 1635.3(a)(1). 

(i) First-degree relatives include an 

individual’s parents, siblings, 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 


wwoods2 on DSK1DXX6B1PROD with RULES3
68934 Federal Register / Vol. 75, No. 216 / Tuesday, November 9, 2010 / Rules and Regulations 

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. 

§ 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. 

§ 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. 

§ 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. 

§ 1635.7 Retaliation. 

A covered entity may not discriminate 

against any individual because such 

individual has opposed any act or 

practice made unlawful by this title or 

because such individual made a charge, 

testified, assisted, or participated in any 

manner in an investigation, proceeding, 

or hearing under this title. 

§ 1635.8 Acquisition of genetic 

information. 

(a) General prohibition. A covered 

entity may not request, require, or 

purchase genetic information of an 

individual 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, 


wwoods2 on DSK1DXX6B1PROD with RULES3
Federal Register / Vol. 75, No. 216 / Tuesday, November 9, 2010 / Rules and Regulations 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 thirdparties 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 coworker); 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 


wwoods2 on DSK1DXX6B1PROD with RULES3
68936 Federal Register / Vol. 75, No. 216 / Tuesday, November 9, 2010 / Rules and Regulations 

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 

§ 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 postoffer 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 


wwoods2 on DSK1DXX6B1PROD with RULES3
Federal Register / Vol. 75, No. 216 / Tuesday, November 9, 2010 / Rules and Regulations 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 

§§ 1635.4, 1635.5, or 1635.6, and must 

keep such information confidential as 

required by § 1635.9. 

§ 1635.9 Confidentiality. 

(a) Treatment of genetic information. 

(1) A covered entity that possesses 

genetic information in writing about an 

employee or member must maintain 

such information on forms and in 

medical files (including where the 

information exists in electronic forms 

and files) that are separate from 

personnel files and treat such 

information as a confidential medical 

record. 

(2) A covered entity may maintain 

genetic information about an employee 

or member in the same file in which it 

maintains confidential medical 

information subject to section 

102(d)(3)(B) of the Americans with 

Disabilities Act, 42 U.S.C. 

12112(d)(3)(B). 

(3) Genetic information that a covered 

entity receives orally need not be 

reduced to writing, but may not be 

disclosed, except as permitted by this 

part. 

(4) Genetic information that a covered 

entity acquires through 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 §§ 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 lifethreatening illness, provided that the 

individual whose family member is the 

subject of the disclosure is notified of 

such disclosure. 

(c) Relationship to HIPAA Privacy 

Regulations. Pursuant to § 1635.11(d) of 

this part, nothing in this section shall be 

construed as applying to the use or 

disclosure of genetic information that is 

protected health information subject to 

the regulations issued pursuant to 

section 264(c) of the Health Insurance 

Portability and Accountability Act of 

1996. 

§ 1635.10 Enforcement and remedies. 

(a) Powers and procedures: The 

following powers and procedures shall 

apply to allegations that Title II of GINA 

has been violated: 

(1) The powers and procedures 

provided to the Commission, the 

Attorney General, or any person by 

sections 705 through 707 and 709 

through 711 of the Civil Rights Act of 

1964, 42 U.S.C. 2000e–4 through 2000e– 

6 and 2000e–8 through 2000e–10, where 

the alleged discrimination is against an 

employee defined in 1635.2(c)(1) of this 

part or against a member of a labor 

organization; 

(2) The powers and procedures 

provided to the Commission and any 

person by sections 302 and 304 of the 

Government Employees Rights Act, 42 

U.S.C. 2000e–16b and 2000e–16c, and 

in regulations at 29 CFR part 1603, 

where the alleged discrimination is 

against an employee as defined in 

§ 1635.2(c)(2) of this part; 

(3) The powers and procedures 

provided to the Board of Directors of the 

Office of Compliance and to any person 

under the Congressional Accountability 

Act, 2 U.S.C. 1301 et seq. (including the 

provisions of Title 3 of that act, 2 U.S.C. 

1381 et seq.), where the alleged 

discrimination is against an employee 

defined in § 1635.2(c)(3) of this part; 

(4) The powers and procedures 

provided in 3 U.S.C. 451 et seq., to the 

President, the Commission, or any 

person in connection with an alleged 

violation of section 3 U.S.C. 411(a)(1), 

where the alleged discrimination is 

against an employee defined in 

§ 1635.2(c)(4) of this part; 

(5) The powers and procedures 

provided to the Commission, the 

Librarian of Congress, and any person 

by section 717 of the Civil Rights Act, 

42 U.S.C. 2000e–16, where the alleged 

discrimination is against an employee 

defined in § 1635.2(c)(5) of this part. 

(b) Remedies. The following remedies 

are available for violations of GINA 

sections 202, 203, 204, 205, 206, and 

207(f): 


wwoods2 on DSK1DXX6B1PROD with RULES3
68938 Federal Register / Vol. 75, No. 216 / Tuesday, November 9, 2010 / Rules and Regulations 

(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. 

§ 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 statusrelated 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 § 1635.11(b) of 

this part, including any implementing 

regulations noted in § 1635.11(b). 

(d) Relationship to HIPAA Privacy 

Regulations. This part does not apply to 

genetic information that is protected 

health information subject to the 

regulations issued by the Secretary of 

Health and Human Services pursuant to 

section 264(c) of the Health Insurance 

Portability and Accountability Act of 

1996. 


wwoods2 on DSK1DXX6B1PROD with RULES3
Federal Register / Vol. 75, No. 216 / Tuesday, November 9, 2010 / Rules and Regulations 68939 

§ 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 

§§ 1635.4 through 1635.9 of this part. 

[FR Doc. 2010–28011 Filed 11–8–10; 8:45 am] 

BILLING CODE 6570–01–P 


wwoods2 on DSK1DXX6B1PROD with RULES3