GINA Regulations

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Tuesday,

November 9, 2010

Part III

Equal EmploymentOpportunityCommission29 CFR Part 1635

Regulations Under the GeneticInformation Nondiscrimination Act of2008; Final Rule

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68912 Federal Register / Vol. 75, No. 216 / Tuesday, November 9, 2010/ Rules and Regulations

1This regulation does not interpret therequirements of GINA Title I relating to geneticnondiscrimination in health coverage. Thoserequirements are administered by the Departmentsof Health and Human Services, Labor, and theTreasury.

2Prior to November 21, 2009, Executive Order13145 prohibited federal executive branch agenciesfrom discriminating against applicants andemployees on the basis of genetic information andlimited access to and use of genetic information.Since its effective date in November 2009, GINAhas protected federal employees from geneticdiscrimination.

EQUAL EMPLOYMENT OPPORTUNITYCOMMISSION

29 CFR Part 1635

RIN [3046AA84]

Regulations Under the GeneticInformation Nondiscrimination Act of2008

AGENCY: Equal EmploymentOpportunity Commission.

ACTION: Final rule.

SUMMARY: The Equal EmploymentOpportunity Commission (EEOC orCommission) is issuing a final rule toimplement Title II of the GeneticInformation Nondiscrimination Act of2008 (GINA). Congress enacted Title IIof GINA to protect job applicants,current and former employees, laborunion members, and apprentices andtrainees from discrimination based on

their genetic information. Title II ofGINA requires the EEOC to issueimplementing regulations. TheCommission issued a proposed rule inthe Federal Register on March 2, 2009,for a sixty-day notice and commentperiod that ended on May 1, 2009. Afterconsideration 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, AssistantLegal Counsel, or Kerry E. Leibig, SeniorAttorney Advisor, at (202) 6634638

(voice) or (202) 6637026 (TTY). (Theseare not toll free numbers.) This rule alsois available in the following formats:large print, Braille, audio tape, andelectronic file on computer disk.Requests for this rule in an alternativeformat should be made to thePublications Information Center at18006693362 (voice) or18008003302 (TTY).

SUPPLEMENTARY INFORMATION:

Introduction

On May 21, 2008, President GeorgeW. Bush signed the Genetic Information

Nondiscrimination Act of 2008(GINA), Public Law 110233, 122 Stat.881, codified at 42 U.S.C. 2000ffet seq.,into law. Congress enacted GINA inrecognition of, among manyachievements in the field of genetics,the decoding of the human genome andthe creation and increased use ofgenomic medicine. As Congress noted,New knowledge about genetics mayallow for the development of bettertherapies that are more effective againstdisease or have fewer side effects thancurrent treatments. These advances give

rise to the potential misuse of geneticinformation to discriminate in healthinsurance and employment. GINASection 2(1), 42 U.S.C. 2000ff, note.

Experts predict that the twenty-firstcentury will see tremendous strides inthe new field of genomic medicine,

bringing it into mainstream medicalpractice. The National Human Genome

Research Institute (NHGRI), the institutewithin the National Institutes of Healthresponsible for the mapping of thehuman genome, notes that byidentifying the genetic factors associatedwith disease, researchers may be able todesign more effective drugs; to prescribethe best treatment for each patient; toidentify and monitor individuals at highrisk from disease; and to avoid adversedrug reactions. NHGRI, The Future ofGenomic Medicine: Policy Implicationsfor Research and Medicine (Bethesda,Md. Nov. 16, 2005), available athttp://www.genome.gov/17516574(last visited

July 7, 2010).Many genetic tests now exist that caninform individuals whether they may beat risk for developing a specific diseaseor disorder. But just as the number ofgenetic tests increases, so do theconcerns of the general public aboutwhether they may be at risk of losingaccess to health coverage oremployment if insurers or employershave their genetic information. Congressenacted GINA to address theseconcerns, by prohibiting discrimination

based on genetic information andrestricting acquisition and disclosure ofsuch information, so that the general

public would not fear adverseemployment- or health coverage-relatedconsequences for having a genetic testor participating in research studies thatexamine genetic information. Scientificadvances require significant cooperationand participation from members of thegeneral public. In the absence of suchparticipation, geneticists and otherscientists would be hampered in theirresearch, and efforts to develop newmedicines and treatments for geneticdiseases and disorders would be slowedor stymied.

GINA Title Is health coverage

provisions apply to group health planssponsored by private employers, unions,and state and local governmentemployers; issuers in the group andindividual health insurance markets;and issuers of Medicare supplemental(Medigap) insurance.1 These Title Iprovisions generally prohibit

discrimination in group premiumsbased on genetic information and theuse of genetic information as a basis fordetermining eligibility or settingpremiums in the individual andMedigap insurance markets, and placelimitations on genetic testing and thecollection of genetic information ingroup health plan coverage, the

individual insurance market, and theMedigap insurance market. Title I alsorequires the Secretary of Health andHuman Services to revise the privacyregulations promulgated pursuant to theHealth Insurance Portability andAccountability Act of 1996 (HIPAA).HHS has published a notice of proposedrulemaking that proposes to clarify thatgenetic information is healthinformation, and to prohibit grouphealth plans, health insurance issuers(including HMOs), issuers of Medicaresupplemental policies, and all otherhealth plans covered under the HIPAA

privacy regulations from using ordisclosing genetic information forunderwriting purposes.

Title II of GINA prohibits use ofgenetic information in the employmentcontext, restricts employers and otherentities covered by Title II fromrequesting, requiring, or purchasinggenetic information, and strictly limitssuch entities from disclosing geneticinformation. The law incorporates byreference many of the familiardefinitions, remedies, and proceduresfrom Title VII of the Civil Rights Act of1964, as amended, and other statutesprotecting federal, state, andCongressional employees fromdiscrimination.2

Background

The Commission published aproposed rule to implement Title II ofGINA on March 2, 2009, and asked forpublic comment on the proposed rule,the discussion in the preamble, andother Title II issues not addressed ineither document. See 74 FR 9056(March 2, 2009). Several days earlier, onFebruary 25, 2009, the Commission helda public meeting to announce itsapproval of the proposed rule at which

invited panelists spoke about the impactof genetic information discrimination inthe workplace (transcript available athttp://www.eeoc.gov/eeoc/meetings/2-25-09/index.cfm). Although they hadnot had an opportunity to review the

http://www.genome.gov/17516574http://www.genome.gov/17516574http://www.eeoc.gov/eeoc/meetings/2-25-09/index.cfmhttp://www.eeoc.gov/eeoc/meetings/2-25-09/index.cfmhttp://www.eeoc.gov/eeoc/meetings/2-25-09/index.cfmhttp://www.genome.gov/17516574http://www.genome.gov/17516574http://www.eeoc.gov/eeoc/meetings/2-25-09/index.cfmhttp://www.eeoc.gov/eeoc/meetings/2-25-09/index.cfm


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68913Federal Register / Vol. 75, No. 216 / Tuesday, November 9, 2010/ Rules and Regulations

3Unless otherwise noted, use of the term GINAmeans Title II of GINA. When needed for clarity,the preamble will refer to Title I of GINA or TitleII of GINA.

4The National Association of InsuranceCommissioners issued conforming modelregulations relating to section 104 on September 24,2008, published in the Federal Register on April24, 2009 at 74 FR 18808.

proposed rule, commenters at the publicmeeting did express their views onissues they believed should beaddressed in EEOCs regulation toeffectuate Title IIs purposes.

The Commission received 43comments from individuals, fromgroups representing individuals, andfrom organizations representing

employers and professionals in responseto the proposed rule. Most of those whoparticipated in the February 25, 2009public meeting submitted writtencomments after reviewing the proposedrule that were consistent with theirpublic testimony. Further, on March 26,2010, President Obama appointed to theCommission by way of recessappointments the Chair and two newCommissioners. These new members ofthe Commission (and others who werepreviously serving on the Commission)met with a number of stakeholders whohad submitted comments to the record.

Records of these meetings are includedin the rulemaking docket.In developing this regulation, the

Commission closely followed the termsof the statute. The Commissions goal isto implement the various provisions ofTitle II consistent with Congresssintent, to provide some additionalclarification of those provisions, and toexplain more fully those sections whereCongress incorporated by referenceprovisions from other statutes. Forexample, where GINA section201(2)(A)(i) defines employeebyreference to Title VII of the Civil RightsAct of 1964 and other statutes, thisregulation expands on that reference byimporting language from these statutesso that those using the final regulationneed not refer to other sources whendetermining the scope of GINAscoverage.3

The Commission also recognizes thatTitle II of GINA includes terms that areoutside the areas of its expertise. Inparticular, the definition ofgenetictest refers to analysis of human DNA,RNA, chromosomes, proteins, ormetabolites that detects genotypes,mutations, or chromosomal changes.None of these terms is common to

employment discrimination law. Forthis reason, Commission staff soughtand obtained technical assistance fromNHGRI, the institute within the NationalInstitutes of Health responsible fordecoding the human genome and fordeveloping technologies applicable tothe study of the genetic components ofcomplex disorders.

The Commission also coordinatedwith the Departments of Labor (DOL),Health and Human Services (HHS), andthe Treasury, which have responsibilityfor issuing regulations applicable toGINA Title I. In particular, DOL (theEmployee Benefits SecurityAdministration), HHS (the Centers forMedicare & Medicaid Services), and the

Treasury (the Internal Revenue Service)are responsible for issuing regulationsapplicable to GINA sections 101103.4These agencies issued interim finalrules on sections 101 through 103 ofGINA on October 7, 2009. See 74 FR51664. The HHS Office for Civil Rightsis responsible for issuing the regulationsapplicable to GINA section 105 andissued a proposed rule on October 7,2009 at 74 FR 51698. Among the variousTitle II provisions are several thataddress the relationship between Title Iand Title II, and the relationship

between Title II and several statutes that

the Departments enforce, including theEmployee Retirement Income SecurityAct of 1974 (ERISA), the Public HealthService Act, the Internal Revenue Code,and HIPAA.

Section-by-Section Analysis of theRegulation

Section 1635.1 Purpose

In this section, the Commission setsforth the general purposes of GINA. Thelanguage in this section of the final rulehas been modified slightly in responseto several comments that disagreed withthe characterization of Title II as

prohibiting thedeliberate acquisition

of genetic information. See Comments ofthe American Civil Liberties Union(ACLU), Coalition for Genetic Fairness(CGF), Genetic Alliance, and theGenetics and Public Policy Center incollaboration with Jeremy Gruber(GPPC). These organizations noted thatthe term deliberate acquisitionsuggested that a covered entity musthave a specific intent to acquire geneticinformation in order to violate the law.According to these commenters, acovered entity violates GINA byengaging in acts that present aheightened risk of acquiring geneticinformation, even without a specificintention to do so, such as when theyfail to inform an individual from whomthey have requested documentationabout a manifested disease or disordernot to provide genetic information orwhen they access sources of information(e.g., certain types of databases, Web

sites, or social networking sites) that arelikely to contain genetic informationabout individuals.

For reasons more fully set forth in thepreambles discussion of 1635.8(a),(b)(1) and (4), the Commission agreesthat a covered entity may violate GINAwithout a specific intent to acquiregenetic information. For that reason, the

Commission has removed the referenceto deliberate acquisition of geneticinformation in 1635.1. We likewiserecognize that not every acquisition ofgenetic information violates GINA.Accordingly, the section now simplyindicates that Title II of GINA restrictsrequesting, requiring, or purchasinggenetic information. The rest of thelanguage of 1635.1 concerning GINAsprohibition on the use of geneticinformation in employment decision-making, the requirement that geneticinformation be kept confidential (whichincludes maintaining written genetic

information that exists in paper orelectronic form as a confidentialmedical record), and the limitations ondisclosure of genetic information is thesame as the language in the proposedrule.

We have also modified this section toinclude a point made only in thepreamble to the proposed rule. A newsubparagraph, 1635.1(b), clarifies thatthe final rule does not apply to actionsof a covered entity that do not pertainto an individuals status as an employee,member of a labor organization, orparticipant in an apprenticeshipprogram. The final rule offers two

examples to illustrate this point. Title IIof GINA would not apply to a medicalexamination of an individual conductedfor the purpose of diagnosis andtreatment unrelated to employment,which is conducted by a health careprofessional in the hospital or otherhealth care facility where the individualis an employee. Similarly, Title II wouldnot govern the actions of a coveredentity carried out in its capacity as a lawenforcement agency investigatingcriminal conduct, even where thesubject of the investigation is also anemployee of the covered entity.

Section 1635.2 DefinitionsGeneralThe Commission reiterates the

definitions set forth in GINA section201, many of which come from Title VIIof the Civil Rights Act of 1964.However, where the statute merelyincorporates by reference differentcategories of covered employees, theregulation describes more fully theemployees GINA protects. We haveretained without change language fromthe proposed rule which said that theterm employee also includes former



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5The Commissions definition ofdependent issolely for purposes of interpreting Title II of GINA,and is not relevant to interpreting the termdependent under Title I of GINA or under section701(f)(2) of ERISA and the parallel provisions of thePublic Health Service Act and the Internal RevenueCode. The Commission believes its interpretation ofthe term family member, particularly the way inwhich GINAs reference to section 701(f)(2) ofERISA relates to that term, is consistent with theplain language of both section 701(f)(2) and Title IIof GINA, furthers Congresss intent to prohibitgenetic discrimination in the employment context,and provides covered entities with clear standardsgoverning compliance with the law.

employees. We received two commentsraising concerns with this inclusion.The Illinois Credit Union League (ICUL)suggested that there should be atemporal qualifier on the term formeremployee, while a comment jointlysubmitted by the U.S. Chamber ofCommerce, the Society for HumanResource Management and a number of

other employer representatives(Chamber/SHRM) objected that ourcitation to Robinson v. Shell Oil Co., 519U.S. 337, 346 (1997), did not supportthe proposition that the termemployee also includes formeremployees. Chamber/SHRM contendsthat Robinson decided only that theterm employee as used in Title VIIsanti-retaliation provision, 42 U.S.C.2000e3(a), applied to formeremployees, not whether employee asused in section 701(f) of Title VIIapplied to former employees. InRobinson, the Supreme Court observed

that the definition ofemployee

insection 701(f), which is the basis for the

term employee in GINA, lacks anytemporal qualifier and is consistent witheither current or past employment.Robinson, 519 U.S. at 342. TheCommission has read Robinson assupporting its well-established positionthat [f]ormer employees are protected

by the EEO statutes when they aresubjected to discrimination arising fromthe former employment relationship.See EEOCs Compliance Manual Section2 on Threshold Issues at 2III.A.2. &n. 79 (available at http://www.eeoc.gov/

policy/docs/threshold.html#2-III-A-2)

(citing to Robinson). An example underGINA would be a situation in which aformer employer disclosed to aprospective employer an individualsgenetic information. Accordingly, thefinal regulation makes clear that theterm employee includes an applicantand a former employee.

The final regulation provides aconcise explanation of the employerscovered by GINA, rather than followingthe statutes example of providingcitations to definitions ofemployerprovided by other laws. For example,the final regulation explains that Indian

tribes, as well as bona fide private clubs(other than labor organizations) that areexempt from taxation under section501(c) of the Internal Revenue Code of1986, are not employers, rather thanmerely referring to Title VIIs exclusionof these groups from the definition ofemployer. See 42 U.S.C. 2000e(b)(1)and (2).

One commenter asked that the finalregulation state that there is noindividual liability for violations ofGINA. See Comment of TOCManagement Services (TOC). As the

statute makes clear, GINAs definition ofemployer includes employers asdefined by Title VII at 42 U.S.C.2000(e)b. Numerous courts have heldthat this definition was not intended topermit individual liability. See Lane v.Lucent Tech., Inc., 388 F. Supp. 2d 590(M.D.N.C. 2005) (citing cases from everycircuit except the First Circuit rejecting

individual liability); see also, e.g.,Mandellv. County of Suffolk, 316 F.3d368 (2d Cir. 2003); Wathen v. GeneralElec. Co., 115 F.3d 400 (6th Cir. 1997);Cross v. Alabama, 49 F.3d 1490 (11thCir. 1995); Grantv. Lone Star Co., 21F.3d 649 (5th Cir. 1994). Therefore, it isnot necessary to make this point in theregulation.

The final regulation includes adefinition ofcovered entity. It uses theterm to refer to all entities subject toTitle II of GINA: The different categoriesof GINA-covered employers (privatesector, state and local government,

Congressional employers, executivebranch, federal/civil service), as well asemployment agencies, labororganizations, and joint labor-management training andapprenticeship programs. By using theterm covered entity to describe therequirements or prohibited practicesapplicable to all entities subject to TitleII of GINA, the final regulation avoidssome of the repetition found in sections202205 of the statute. This use of theterm covered entity as a simplifyingshorthand to aid in the readability of thefinal regulation is similar to EEOCs useofcovered entity in the regulation

implementing Title I of the Americanswith Disabilities Act, 42 U.S.C. 12111(ADA). One comment urged theCommission not to use the termcovered entitybecause of possibleconfusion with the same term inHIPAA. See Comment of AmericanMedical Association (AMA). We do not

believe that use of the term coveredentity in this regulation will causeconfusion, as most of the entities subjectto Title II are not HIPAA coveredentities and those that are should beable to distinguish between their rolesas HIPAA covered entities and as

covered entities subject to Title II ofGINA. We note that HIPAA coveredentities do not appear to haveexperienced confusion from use of theterm covered entities in Title I of theADA, even though the ADA, likeHIPAA, places limitations on theacquisition and disclosure of medicalinformation.

The final regulation says that the termcovered entity includes an employingoffice. The term employing office,referenced in sections 201 and 207 ofGINA, is used in the Congressional

Accountability Act, which protectsemployees in the legislative branch. See2 U.S.C. 1301(9). Although the EEOChas no enforcement authority under theCongressional Accountability Act, as theonly agency with authority to issueregulations under Title II of GINA, we

believe that referencing that law in thisfinal regulation appropriately puts

employees in the legislative branch andcovered employing offices on notice oftheir rights and responsibilities underGINA.

Section 1635.3 Definitions Specific toGINA

GINA includes six terms not found inany of the other employmentdiscrimination statutes that theCommission enforces. This finalregulation provides some additionalguidance regarding these terms. Onecomment said that many of thedefinitions in the NPRM were toodifficult to understand withoutscientific knowledge. See Comment ofFederal Deposit Insurance Corporation(FDIC). As noted above, in developingthese definitions, EEOC coordinatedclosely with NHGRI. We also werecareful to track closely the language ofTitle II itself where possible to avoidany unintended consequences thatmight result from attempting toparaphrase or simplify scientificallytechnical language. However, we haveadded a number of examples to theregulation itself that will further clarifythe meanings of some of these terms.

Section 1635.3(a) Family Member

The statute defines an individualsfamily memberboth by reference toERISA section 701(f)(2) and asextending to the individuals fourthdegree relatives. First, section 201(3)(a)of GINA states that family member isdefined as a dependent (as that term isused for purposes of section [701(f)(2) ofERISA]) of the individual.5 Forpurposes of Title II, the Commission hasdetermined that the dependents covered

by Title II are limited to persons whoare or become related to an individual

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6 Placement for adoption or being placed foradoption means the assumption and retention of alegal obligation for total or partial support of a childby a person with whom the child has been placedin anticipation of the childs adoption. The childsplacement for adoption with such person endsupon the termination of such legal obligation. See29 CFR 2590.7012 (the definitions for part 7 ofERISA)

7This approach is different from the approachtaken in regulations implementing Title I of GINA.See GINA Title I regulations at 26 CFR 54.98023T(a)(2)(ii), 29 CFR 2590.7021(a)(2)(ii) and 45 CFR146.122(a)(2)(ii), which were published in theFederal Register on October 7, 2009 at 74 FR 51664.

8Since 2004 the U.S. Surgeon Generals FamilyHistory Initiative has actively promoted thecollection and use of family history information inclinical settings, including featuring a bilingualWeb-based tool through which the user creates andorganizes his/her family health history (http://www.hhs.gov/familyhistory/). GINA is not intendedto limit the collection of family medical history byhealth care professionals for diagnostic or treatmentpurposes.

through marriage, birth, adoption, orplacement for adoption.6

Groups who represent employersthought that persons who becomedependents by adoption or placementfor adoption should not be consideredfamily members, because geneticinformation about them would not

indicate whether an individualprotected by GINA might acquire adisease or disorder. See Comments ofIllinois Chamber of Commerce (ICC) andChamber/SHRM. However, GINAsexpress reference to section 701(f)(2) ofERISA and section 701(f)(2)s explicitreference to dependents by adoption orplacement for adoption makes itabsolutely clear that Congress intendedto include such persons in GINAsdefinition offamily member.Moreover, the acquisition of informationabout the occurrence of a disease ordisorder in an applicants or employeesadopted child could certainly result in

the type of discrimination GINA wasintended to prohibit. For example, anemployer might use information itobtains about the current health statusof an adopted child to discriminateagainst an employee because ofconcerns over potential health carecosts, including increased healthinsurance rates, associated with thefamily members medical condition. SeeS. Rep. No. 11048 at 28 (indicating thatspouses and adopted children wereincluded in the definition of familymember for this exact reason).

Second, GINA includes as familymembers persons related from the firstto the fourth degree of an individual.The degree of relationship reflects theaverage proportion of genes in common

between two individuals. The GINAprovisions thus include the individualschildren, siblings, and parents (firstdegree), grandparents, grandchildren,uncles, aunts, nephews, nieces, andhalf-siblings (second degree), great-grandparents, great grandchildren, greatuncles, great aunts, and first cousins(third degree), and great-greatgrandparents and first cousins onceremoved (the children of a first cousin)

(fourth degree). The inclusion of half-siblings among second-degree relativesresponds to a comment we received tothe proposed rule which said that wehad incorrectly listed half-siblings

among first-degree relatives.7 SeeComment of GPPC.

The Commission declines, however,to expand the degree of relationship offamily members beyond the fourthdegree as one comment suggested weshould do. See Comment of Members ofthe Personal Genetics Education Project(PGEP). Whether or not genetic

information about an individualsrelatives beyond the fourth degree ofrelationship has predictive value withrespect to the individual, the languageof the statute on which the regulation ispatterned does not permit such anexpansion of the definition offamilymember. In fact, GINAs definition offamily member is already broader thanthat term is understood in the practiceof medicine. As discussed in thefollowing section, a typical familymedical history used for the purposes ofdiagnosis and treatment includesinformation about an individuals first-

degree, second-degree, and third-degreerelatives.

Section 1635.3(b) Family MedicalHistory

The final regulation includes adefinition offamily medical history

because it is a term used in the statutesdiscussion of prohibited employmentpractices, but it is not specificallydefined by the statute. In the legislativehistory of GINA, Congress stated thatthe term family medical history[should] be understood as it is used bymedical professionals when treating orexamining patients. S. Rep. No. 110

48, at 16. In particular, the SenateReport notes as follows:

[T]he American Medical Association(AMA) has developed an adult family historyform as a tool to aid the physician andpatient to rule out a condition that may havedeveloped later in life, which may or may nothave been inherited. This form requestsinformation about the patients brothers,sisters, and their children, biological mother,the mothers brothers, sisters, and theirchildren, maternal grandfather, maternalgrandmother, biological father, the fathers

brothers, sisters, and their children, paternalgrandfather and paternal grandmother. Thecommittee expects that the use of familyhistory in this bill will evolve with themedical profession and the tools it developsin this area.

Id. The Report further notes that afamily medical history could be used asa surrogate for a genetic trait, id., andthat the definition ofgeneticinformation had to include family

medical history to prevent a coveredentity from making decisions about anindividuals health based on theexistence of an inheritable disease of afamily member. See also id. at 28(reiterating the Title I discussion offamily medical history in the Reportsection addressing Title II).8

Citing this legislative history, some

employer groups urged that we includethe word inheritablebefore the wordsdisease or disorder in the regulationsdefinition offamily medical history,arguing that Congress did not intendthat GINA apply to conditions such asthe common cold or the flu. SeeComments of Chamber/SHRM and ICC.For three reasons, the Commission hasdecided not to make this change in thefinal rule. First, the regulationslanguage is consistent with the plainlanguage of the statute, which also doesnot include the word inheritable.Second, given the rapidly-developing

field of genetics, we believe thatrequiring Title II covered entities orEEOC investigators to determinewhether a disease or disorder in familymembers of an individual isinheritable or has a genetic basiswould present significant complianceand enforcement problems. Finally, theCommission doubts that questions aboutwhether a family member has a cold, theflu, or similar conditions will oftenresult in charges being filed underGINA.

One commenter also suggested thatwe clarify that medical informationobtained from one employee will not be

considered family medical history of afamily member who also works for theemployer. See Comment of Chamber/SHRM. This commenter is apparentlyconcerned that an employer will beliable for a violation of GINA if itrequests information about a manifesteddisease or disorder of an employeewhose family member also works for theemployer. The Commission recognizesthe problem that this commenter istrying to avoid, but does not agree withthe proposed solution. We disagree thatthe first employees medical informationis not family medical history as to the

second employee. An employer wholearns that one employee has amanifested disease or disorder would bein possession of family medical historyabout a second employee who is a

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family member as defined by GINA.Likewise, an employer who learns theresults of one employees genetic test orlearns that the employee has sought orreceived genetic services would possessgenetic information about the employeewho is a family member. (Seediscussion of the definition ofgeneticinformation,below.) We do not think

Congress could have intended that anemployee not be protected from thediscriminatory use or the disclosure ofhis or her genetic information just

because the employer obtained it froma family member who was also anemployee.

However, we do agree with thecomment to the extent it seeks to limitliability under GINA for the acquisitionof information about an employeesmanifested condition. Althoughacquisition of information aboutmanifested conditions is limited underother laws such as the ADA, it is

permissible under GINA, even where anemployees family member works forthe same employer. We have added anew subsection to 1635.8 to clarifythis point, and to make the related pointthat an employer will not violate GINAsprovisions prohibiting the acquisition ofan employees genetic information whenit requests genetic information orinformation about a manifested diseaseor disorder from an employees familymember to whom health or geneticservices are being provided on avoluntary basis. (See discussion of 1635.8(c), below.)

Section 1635.3(c) Genetic InformationGINA section 201(4) and the

regulation define genetic information toinclude information from genetic tests,the genetic tests of family members, andfamily medical history. Geneticinformation also includes informationabout an individuals or familymembers request for or receipt ofgenetic services. GINA section 209(b)and the regulation add that the termgenetic information includes geneticinformation of a fetus carried by anindividual or an individuals familymember or an embryo lawfully held by

an individual or family memberreceiving assistive reproductiveservices. See Comment of FDIC (notingthat the preamble to the proposed rulecited to the wrong section of GINAwhen discussing the genetic informationof a fetus or embryo). The statute andregulation exclude from coverageinformation about an individuals orfamily members age or gender. Inresponse to a comment, and mindfulthat many employers routinely requestsuch information on a voluntary basis tocomply with their EEO obligations, the

final rule also says that informationabout race and ethnicity that is notderived from a genetic test is not geneticinformation. See Comment of ACLU.

Section 1635.3(d) Genetic Monitoring

Genetic monitoring is defined inGINA section 201(5) as the periodicexamination of employees to evaluate

acquired modifications to their geneticmaterial * * * caused by the toxicsubstances they use or are exposed to inperforming their jobs. The finalregulation uses language similar to thatfound in the statute in defining theterm. As more fully described in1635.8(b)(5) and its accompanyingpreamble discussion, a covered entitymay acquire genetic information as partof genetic monitoring that is eitherrequired by law or voluntarilyundertaken, provided the entitycomplies strictly with certainconditions.

Section 1635.3(e) Genetic ServicesThe term genetic services is defined

in GINA section 201(6). It includesgenetic tests, genetic counseling, andgenetic education. Making anemployment decision based onknowledge that an individual hasreceived genetic services violates GINA,even if the covered entity is unaware ofthe specific nature of the geneticservices received or the specificinformation exchanged in the course ofproviding them.

A number of comments asked that thefinal rule offer additional examples of

genetic services that emphasize theterms breadth, including geneticeducation before and after testing andpreventive therapies that an individualmight undergo in response to a genetictest to reduce or eliminate the risk ofacquiring a condition in the future. SeeComments of AMA, CGF, GeneticAlliance, and GPPC. We have not madeany additions to the definition in thefinal regulation. The definition ofgenetic services provided in theproposed rule encompasses geneticeducation, whether it is offered before,after, or unrelated to genetic testing.

Moreover, we have determined that thestatutory definition of genetic serviceswas not intended to encompass thetypes of clinical services mentioned bythese commenters.

Section 1635.3(f) Genetic Test

GINA section 201(7) defines genetictest to mean the analysis of humanDNA, RNA, chromosomes, proteins, ormetabolites that detects genotypes,mutations, or chromosomal changes.Genetic tests are used to detect genevariants associated with a specific

disease or condition. For example, teststo determine whether an individualcarries the genetic variant evidencing apredisposition to breast cancerwhether the individual has the BRCA1or BRCA2 variantor to determinewhether an individual has a geneticvariant associated with hereditarynonpolyposis colorectal cancer are

genetic tests. It is important to note,however, that the presence of a geneticvariant relating to a predisposition todisease is not evidence of, and does notequate to, disease. Similarly, a positivetest for a genetic variant as stronglypenetrant as Huntingtons Disease doesnot equate to the presence of thedisease, even though development ofthe disease is almost inevitable.

The Commission invited commentson the scope of the term genetic test.In response, we received commentsgenerally agreeing with how theCommission characterized certain kinds

of tests in the preamble and text of theproposed rule. Several comments askedthat we place examples from thepreamble to the proposed rule in thetext of the regulation itself, and we havedone so. See Comments of the EqualEmployment Advisory Council (EEAC),CGF, Genetic Alliance, GPPC and TOC.Thus, the regulation says that tests forinfectious and communicable diseasesthat may be transmitted through foodhandling, complete blood counts,cholesterol tests, and liver-function testsare not genetic tests. To the proposedrules examples of genetic tests, we haveadded a number of others suggested by

several commenters, including carrierscreenings of adults to determine therisk of conditions such as cystic fibrosis,sickle cell anemia, spinal muscularatrophy, and fragile X syndrome infuture offspring; amniocentesis andother evaluations used to determine thepresence of genetic abnormalities in afetus; newborn screening tests forconditions such as PKU, which mayallow preventive treatment to begin

before the disease manifests; DNAtesting that reveals family relationships(e.g., paternity tests); and DNA testingthat determines the presence of genetic

markers associated with ancestry. SeeComments of CGF, Genetic Alliance,and GPPC.

Two commenters requested that thepreamble and regulation refrain fromlisting specific tests that are excludedfrom the definition of genetic test. Oneargued that the science of genetics isconstantly developing and that it istherefore shortsighted to specify teststhat are not genetic in nature. SeeComment of National Counsel of EEOCLocals no. 216, American Federation ofGovernment Employees, AFLCIO



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(AFGE). Although we acknowledge thisconcern, excluding illustrative examplesof what does not meet this definitionwould only serve to confuse thoseattempting to understand the bounds ofthe law.

Another comment argued that whilethe excluded tests are not genetic tests,it is still important that the results of

tests that are not genetic tests be keptconfidential and not be used as a basisfor discrimination. See Comment ofDisability Rights Legal Center (DRLC).Concerns about the discriminatory useof medical tests that are not genetic areaddressed by the ADA, which limits theuse of medical examinations andprohibits the use of medical and non-medical tests that screen out or tend toscreen out an individual with adisability or a class of individuals withdisabilities from employment, unlessthe test is shown to be job-related for theposition in question and consistent with

business necessity. See 29 CFR 1630.10.Section 1635.11(a) of the final rule andthe accompanying preamble discussionmake it clear that Title II of GINA doesnot limit other laws, including the ADA,that protect individuals on the basis ofdisability.

The Title II definition ofgenetic testdiffers from the definition of this termin Title I. Specifically, the Title IIdefinition does not have the expressexclusion that Title I does for ananalysis of proteins or metabolites thatis directly related to a manifesteddisease, disorder, or pathologicalcondition that could reasonably be

detected by a health care professionalwith appropriate training and expertisein the field of medicine involved. GINA101(d), 29 U.S.C. 1191b(d)(7)(B).However, as explained below, theCommission borrowed from Title Is useof the term manifest in the definitionofgenetic test in formulating adefinition ofmanifested ormanifestation.

Section 1635.3(g) Manifestation orManifested

The final rule includes a definition ofthe term manifestation or manifested

because sections 201(4)(A)(iii) and 210use the terms. Specifically, GINAsection 201(4)(A)(iii), defining geneticinformation, refers to themanifestation of a disease or disorderin family members of an individual,and section 210, entitled Medicalinformation that is not geneticinformation, refers to a manifesteddisease, disorder, or pathologicalcondition.

The definition ofmanifestation ormanifested was developed with theassistance of NHGRI. The proposed rule

defined manifestation or manifested tomean, with respect to a disease,disorder, or pathological condition:

that an individual has been or couldreasonably be diagnosed with the disease,disorder, or pathological condition by ahealth care professional with appropriatetraining and expertise in the field ofmedicine involved. For purposes of this part,

a disease, disorder, or pathological conditionis not manifested if the diagnosis is basedprincipally on genetic information or on theresults of one or more genetic tests.

The final rule deletes the words or onthe results of one or more genetic tests,which are unnecessary, given that theterm genetic information alreadyincludes the results of genetic tests. Thedefinition of the term manifested isconsistent both with the definition ofgenetic test found in Title I, whichpermits use of certain diagnostic tests inorder to determine whether anindividual has a currentor manifestdisease, disorder, or condition, see S.

Rep. No. 11048. at 16, and with thenotion, discussed above in conjunctionwith the definition of genetic test( 1635.3(f)), that the mere presence of agenetic variant does not mean that anindividual has an associated condition,disease, or disorder. The presence of agenetic variant alone does not constitutea diagnosis; other signs or symptomsmust be present. This interpretation isconsistent with current ERISAregulations which prohibit a grouphealth plan, and a health insuranceissuer offering group health insurancecoverage, from imposing a preexisting

condition exclusion relating to acondition based solely on geneticinformation. Thus, for example, awoman who has group health plancoverage and has the BRCA1 genevariant may not be subject to apreexisting condition exclusion merely

because she has the variant. Id. Exampleat 29 CFR 2590.7013(b)(6)(ii).However, if an individual is diagnosedwith a condition, even if the conditionrelates to genetic informationforexample, breast cancer stemming fromthe BRCA1 gene variantthe plan mayimpose a preexisting condition

exclusion with respect to the conditionas of the date the disease was diagnosed,subject to other HIPAA portabilityrequirements. See 29 CFR 2590.7013(b)(6)(i).

Similarly, Huntingtons Disease (HD)is an example of a genetic disease thatis not diagnosed solely through use ofa genetic test; other signs and symptomsmust be present. The presence of thegenetic variant virtually guarantees thelater development of disease, but thedisease does not usually manifest untiladulthood. Therefore, even when a

genetic variant is 100 percent predictivefor development of disease, the presenceof the variant does not by itself equaldiagnosis of the disease.

Two comments asked the Commissionto delete from 1635.3(g) the conceptthat a disease, disorder, or pathologicalcondition is not manifested if it is basedprincipally on genetic information or

on the results of one or more genetictests. See Comments of AmericasHealth Insurance Plans (AHIP) andChamber/SHRM; see also Comments ofEEAC and SBA (raising similarconcern). Although the Commission hasdeleted reference to the results of oneor more genetic tests as explainedabove, the final rule still includes the

basic concept that a condition is notmanifest if it is based principally ongenetic information. We agree, however,that a clarification is needed to addresswhat we believe to be the centralconcern of these commenters, i.e., that

the language at issue extends theprotections of GINA to people withmanifested conditions when geneticinformation played a role in diagnosingthem. We therefore note that wherediagnosis of a disease, disorder, orpathological conditions depends on

both the presence of signs andsymptoms and genetic information, thedisease, disorder, or pathologicalcondition will be consideredmanifested. The fact that an individualhas the diagnosed disease, disorder, orpathological condition will not beconsidered genetic information aboutthe individual; nor will information

about the signs or symptoms theindividual has. Such information,however, is still subject to other lawsregulating the acquisition and use ofmedical information, including Title I ofthe ADA. See 42 U.S.C. 12112(d).Moreover, information about anygenetic test or family medical historyused as part of the diagnosis of thedisease, disorder, or pathologicalcondition is genetic information subjectto Title II of GINA and this regulation.

Several commenters requested thatthe final regulation clarify that thegenetic information of an individual

with a manifested disease is stillprotected under GINA, citing theexample of an individual with breastcancer who undergoes a genetic test andlearns that she tests positive for a BRCAmutation, which increases ones risk fordeveloping ovarian cancer as well as

breast cancer. See Comments of CGF,Genetic Alliance, and GPPC. Thesecommenters requested that we makeclear that discriminating against thisindividual due to the presence of thegenetic variant is a violation of GINAdespite the fact that she also has a



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manifested disease caused by thevariant. We note that 1635.12(b) makesit clear that genetic information of anindividual with a manifested disease isprotected genetic information underGINA and that discriminating againstsomeone based on this information isprohibited.

Section 1635.4 Prohibited PracticesIn General

In describing the prohibited practicesunder GINA Title II, Congress adoptedlanguage similar to that used in Title VIIand other equal employment statutes,evincing its intent to prohibitdiscrimination with respect to a widerange of covered entity practices,including hiring, promotion anddemotion, seniority, discipline,termination, compensation, and theterms, conditions, and privileges ofemployment. In response to a comment,we further note that the broad languageCongress adopted in describing thepractices prohibited by Title II makesclear that claims of harassment on the

basis of genetic information arecognizable. See Comment of DisabilityRights Legal Center (DLRC). In separateGINA sections 203205, the statutenotes additional covered actions ofemployment agencies (failing orrefusing to refer for employment), laborunions (excluding or expelling frommembership), and training, retraining,and apprenticeship programs (denyingadmission to or employment in suchprograms).

Section 1635.5 Limiting, Segregating,and Classifying

The final regulation reiterates thestatutory language barring actions bycovered entities that may limit,segregate, or classify employees becauseof genetic information. For example, anemployer could not reassign someonewhom it learned had a family medicalhistory of heart disease from a job it

believed would be too stressful andmight eventually lead to heart-relatedproblems for the employee. This sectionalso makes clear that although thelanguage of the statute specifically

prohibits actions that have the

purposeor effect of limiting, segregating, orclassifying individuals on the basis ofgenetic information, neither the statutenor the final regulation creates a causeof action for disparate impact. Section208 of GINA specifically prohibits suchactions, and establishes the GeneticNondiscrimination Study Commission,to examine the developing science ofgenetics and recommend to Congresswhether to provide a disparate impactcause of action under this Act. Thefinal regulation does not address the

establishment of this Commission,which is scheduled to begin its work onMay 21, 2014.

In response to a comment, we clarifythat a covered entity will not be deemedto have violated 1635.5 if it limits orrestricts an employees job duties basedon genetic information because it wasrequired to do so by a law or regulation

mandating genetic monitoring such asregulations administered by theOccupational and Safety HealthAdministration (OSHA). See Commentof EEAC (requesting clarification of thispoint); see also 1635.8(b)(5) (concerningvoluntary genetic monitoring andmonitoring pursuant to state or federallaw) and 1635.11(a) below (GINA doesnot limit the statutory or regulatoryauthority of OSHA, the Mine Safety andHealth Administration or otherworkplace health and safety laws andregulations.)

Section 1635.6 Causing a Covered

Entity To DiscriminateGINA sections 203(a)(3), 204(a)(3),

and 205(a)(3) expressly bar employmentagencies, labor organizations, andapprenticeship or other trainingprograms from causing an employer todiscriminate on the basis of geneticinformation. These sections recognizethat employers engage in most of theemployment-related activities that theAct reaches. Other covered entities,however, might engage in conduct thatcould cause an employer todiscriminate. For example, anemployment agency or union might

share or attempt to share geneticinformation it obtained (whether legallyor not) about a client or member withan employer. Such conduct wouldviolate sections 203(a)(3) and 204(a)(3),regardless of the intent of theemployment agency or union in sharingthe information. See Comment of DLRC(requesting clarification on this point).

Although section 202 does notinclude a similar provision explicitlyprohibiting an employer from causinganother covered entity to discriminate,it is well settled under Title VII that thedefinition of employer includes

employers agents under common lawagency principles. See Vinson v. MeritorSavings Bank, 477 U.S. 57, 72 (1986).Because GINA incorporates Title VIIsdefinition of employer, including theapplication of common law agencyprinciples, GINA would bar anemployer from engaging in actions thatwould cause another covered entityacting as its agent to discriminate. Forexample, an employer that directed anemployment agency to ask applicantsfor genetic information or told theemployment agency not to send it

candidates with a family medicalhistory for certain conditions wouldviolate GINA. An employment agencythat acted pursuant to the employersdirection would be liable for violatingGINA either directly, because the lawapplies to employment agencies, or asan agent of the employer. Similarly, anemployer would violate GINA if it used

a labor organizations hiring hall toobtain genetic information in makingjob referrals, and the labor union would

be liable under GINA either directly oras the employers agent. The final rulemodifies the language of 1635.6 of theproposed rule slightly so that it leavesno doubt that no GINA covered entitymay cause another covered entity todiscriminate on the basis of geneticinformation.

Section 1635.7 Retaliation

The final regulation reiterates thestatutory prohibition against retaliationwhere an individual opposes any actmade unlawful by GINA, files a chargeof discrimination or assists another indoing so, or gives testimony inconnection with a charge. BecauseCongress adopted in GINA the languageof the anti-retaliation provision in TitleVII of the Civil Rights Act of 1964, theCommission believes that Congressintended the standard for determiningwhat constitutes retaliatory conductunder GINA to be the same as thestandard under Title VII, as announced

by the Supreme Court in BurlingtonNorthern & Santa Fe Ry. v. White, 548U.S. 53 (2006). In that case, the Court

held that Title VIIs anti-retaliationprovision protects an individual fromconduct, whether related toemployment or not, that a reasonableperson would have found materiallyadverse, meaning that the action wellmight have dissuaded a reasonableworker from making or supporting acharge of discrimination. Id. at 5758(citations omitted).

Section 1635.8 Acquisition of GeneticInformation

Each of the discrete GINA sectionsaddressing the conduct of employers,

employment agencies, labororganizations, and apprenticeship orother training programs includes asection prohibiting covered entitiesfrom requesting genetic informationfrom applicants, employees, or otherindividuals; from requiring thatapplicants or employees provide geneticinformation; or from purchasing geneticinformation about an applicant oremployee. Each section also includesthe same five exceptions. Sections 202,covering employers, and 205, coveringjoint labor-management training and



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apprenticeship programs, include asixth exception. The proposedregulation addressed each of theexceptions, as does the final regulation.Covered entities are cautioned,however, that the use of geneticinformation to discriminate, no matterhow that information may have beenacquired, is prohibited.

Concerning the general prohibition onacquiring genetic information, twocommenters noted that the regulatorylanguage of 1635.8(a) did not track thestatutory language in that it failed toindicate that the prohibition applies tothe genetic information of familymembers of individuals, as well as tothat of the individuals themselves. SeeComment of the AmericanPsychological Association (APA) andFDIC. Although we believe thesubstance of the regulatory language iscorrect, in that the genetic informationof an individual includes the genetic

information of that individuals familymembers, we agree that it would be bestto follow the statutory language of thisprohibition and have altered 1635.8(a)accordingly.

Another comment argued that acovered entity violates GINAsprovisions prohibiting the acquisition ofgenetic information only when itundertakes the purposeful act ofrequesting, requiring, or purchasinggenetic information. See Comment ofChamber/SHRM. It was improper, thiscomment reasoned, for the Commissionto have included examples ofpassiveacquisition in 1635.8(b)(1) (governing

inadvertent acquisition of geneticinformation) and 1635.8(b)(4)(concerning acquisition of geneticinformation through sources that arecommercially and publicly available).

However, other commenters read theprohibition on acquisition more

broadly, noting their view that GINArestricts deliberate acts that result inthe acquisition of genetic information,not just purposefully requesting,requiring, or purchasing geneticinformation. See Comments of ACLU,CGF, Genetic Alliance, and GPPC. Asimilar construction of the acquisition

prohibition underlay suggestions forchanges to the portion of the ruleconcerning inadvertent acquisition ofgenetic information. Severalcommenters said that covered entitiesthat make inquiries or engage in actionsreasonably likely to result in theacquisition of genetic informationshould not be able to avail themselvesof the exceptions in 1635.8(b)(1) or1635.8(b)(4). Thus, for example, asdiscussed below, commenters asked thatthe Commission require that coveredentities requesting information about an

individuals current health status (e.g.,for the purpose of making a reasonableaccommodation) affirmatively warn theperson providing the information not toinclude genetic information, sinceacquisition of genetic information in theform of family medical history would belikely in the absence of a warning. SeeComments of ACLU, the American

Medical Association (AMA), CGF,Genetic Alliance, GPPC, and theLeadership Conference on Civil Rights(LCCR). Similarly, most of thesecommenters said that the exception foracquisition of genetic information fromsources that are commercially andpublicly available should not apply tosources that are likely to, or present aheightened risk of, containing geneticinformation, and one commenterspecifically asked that the final ruleprohibit Internet searches that includean individuals name and a particulargenetic marker. See Comments of LCCR.

The Commission acknowledges allthese concerns and, for purposes ofGINA Title II, has added language to1635.8(a) as follows: Request includesconducting an Internet search on anindividual in a way that is likely toresult in a covered entity obtaininggenetic information; actively listening tothird-party conversations or searchingan individuals personal effects for thepurpose of obtaining geneticinformation; and making requests forinformation about an individualscurrent health status in a way that islikely to result in a covered entity

obtaining genetic information.

We think it is equally clear thatCongress intended certain passiveacquisitions of genetic information to

be exceptions to the rule prohibitingacquisition, rather than being whollyoutside the prohibition. The examples,particularly those in 1635.8(b)(1) and(4), are similar to the so-called watercooler example that Congress thoughtshould be an exception to the generalprohibition against requesting,requiring, or purchasing geneticinformation. See S. Rep. No. 11048, at29 ([t]he committee recognizes thatconversations among coworkers aboutthe health of a family member arecommon and intends to prevent suchnormal interaction from becoming the

basis of litigation). We therefore retainthe examples offered in the preamble tothe proposed rule, as we believe thatthey provide useful guidance. SeeComment of TOC (encouraging EEOC toretain examples).

We now turn to a discussion of thespecific exceptions described in1635.8(b). We received a number ofcomments concerning these exceptions,

particularly in response to 1635.8(b)(1),(2) and (4).

Inadvertently Requesting or RequiringGenetic Information: First, as noted inthe proposed rule, a covered entity thatinadvertently requests or requiresfamily medical history from anindividual does not violate GINA.Congress intended this exception to

address what it called the water coolerproblem in which an employerunwittingly receives otherwiseprohibited genetic information in theform of family medical history throughcasual conversations with an employeeor by overhearing conversations amongco-workers. S. Rep. No. 11048, at 29;see also H.R. Comm. on Education andLabor, Genetic InformationNondiscrimination Act of 2007, H.R.Rep. No. 11028 part I, 3738 (2008)(H.R. Rep. No. 11028, part I). Congressdid not want casual conversation amongco-workers regarding health to trigger

federal litigation whenever someonementioned something that mightconstitute protected family medicalhistory. The Commissions proposedregulation therefore noted that a coveredentity inadvertently acquires familymedical history where a manager orsupervisor overhears a conversationamong co-workers that includesinformation about family medicalhistory (e.g., a conversation in whichone employee tells another that herfather has Alzheimers disease).

Although the language of thisexception in GINA specifically refers tofamily medical history, the Commission

believes that it is consistent withCongresss intent to extend theexception to any genetic informationthat an employer inadvertently acquires.The Commission does not believe, forexample, that Congress intended that anemployer would be liable for theacquisition of genetic information

because it overhears a conversation inwhich one employee tells another thather mother had a genetic test todetermine whether she was at increasedrisk of getting breast cancer. If theexception were read to cover onlyfamily medical history, this would

violate GINA, even though it occurredinadvertently, because information thata family member has had a genetic test,while genetic information, is notinformation about the occurrence of adisease or disorder in a family member.Although we received numerouscomments in regard to 1635.8(b)(1), nocommenter expressed disagreementwith the decision to extend theexception to all genetic information thata covered entity inadvertently acquires.See, e.g., Comment of GPPC (discussingthe need for a restrictive view of this



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9When asking questions likely to elicitinformation about a disability, covered entitiesmust, of course, also abide by the requirements ofthe ADA.

exception, but expressing agreementthat it was intended to extend to allgenetic information and not just familymedical history).

The Commission also understandsthis exception to apply in any situationin which an employer mightinadvertently acquire geneticinformation, not just to situations

involving conversations between co-workers that are overheard. Theproposed regulation provided anillustrative list of examples, reiteratedhere, where we believe Congressintended the exception to apply. Thus,for example, the exception applies whenthe covered entity, acting through asupervisor or other official, receivesfamily medical history directly from anindividual following a general inquiryabout the individuals health (e.g., Howare you? or Did they catch it early?asked of an employee who was justdiagnosed with cancer) or a question as

to whether the individual has amanifested condition.9 Similarly, acasual question between colleagues, or

between a supervisor and subordinate,concerning the general well-being of afamily member would not violate GINA(e.g., Hows your son feeling today?,Did they catch it early? asked of anemployee whose family member wasjust diagnosed with cancer, or Willyour daughter be OK?), nor would thereceipt of genetic information that wasnot solicited or sought by the employer(e.g., where a manager or supervisorreceives an unsolicited email from a co-

worker about the health of anemployees family member).A number of commenters raised

concerns about the exact parameters ofthis exception. Civil rights groups andorganizations promoting geneticresearch asked that the EEOC clarifythat pointed questions or other attemptsto gather genetic information by, forexample, intentionally eavesdroppingon private conversations or askinghighly specific follow-up questionswhen an employee mentions that afamily member is ill, do not fall withinthe bounds of this exception. SeeComments of ACLU, CGF, the Genetic

Alliance, GPPC, and LCCR. The IllinoisChamber of Commerce (ICC) requestedthat the regulation specifically state thatthere is no violation of the prohibitionagainst acquisition unless the employerpurposefully acquires geneticinformation and both ICC and Chamber/SHRM requested that it be made clearthat the examples provided are not

exhaustive. See Comments of ICC andChamber/SHRM. The FDIC made asimilar point when it requested that therule state that this exception applies toquestions by an employer not likely toelicit genetic informationbut does notapply to questions likely to elicitgenetic information. See Comment ofFDIC.

These comments make apparent theneed for greater clarity concerning thisexception. We include in the finalregulation itself the examples from thepreamble to the proposed rule thatillustrate how this exception appliesand provide an additional example bothhere and in the final regulation at1635.8(b)(1)(ii)(B). The additionalexample is as follows: A covered entitythat inadvertently acquires geneticinformation about someones familymember in response to a generalquestion about the family membershealth may not then ask follow-up

questions that are probing in nature,such as whether other family membersalso have the condition, or whether theindividual has been tested for thecondition.

We also include an additionalexample here and in the final regulationat 1635.8(b)(1)(ii)(D) to clarify that theinadvertent acquisition exceptionapplies not only to interactions withinthe workplace during which a coveredentity unwittingly receives geneticinformation, but also to interactions thattake place in the virtual world, i.e.,through a social media platform fromwhich a covered entity unwittingly

receives genetic information. In otherwords, this exception applies where amanager, supervisor, unionrepresentative, or employment agencyrepresentative inadvertently learnsgenetic information from a social mediaplatform which he or she was givenpermission to access by the creator ofthe profile at issue (e.g., where asupervisor and employee are connectedon a social networking site and theemployee provides family medicalhistory on his page).

We further note that the examplesprovided in this preamble and the

regulation are non-exhaustive and thatother situations in which a coveredentity inadvertently acquires geneticinformation are covered by thisexception as long as the requirementsprovided in the regulation are met.

We received a significant number ofcomments expressing concern aboutGINAs application to a covered entitysrequest for medical information thatresults in the receipt of geneticinformation that was not requested.Civil rights groups, groups promotinggenetic research, and others argued that

covered entities will obtain a great dealof genetic information through generalrequests for medical information if theyare not required to affirmatively indicatethat genetic information should not beprovided. See Comments of the ACLU,AMA, CGF, Genetic Alliance, GPPC,and LCCR. See also Comments ofBurton Blatt Institute (noting that the

exceptions application to acquisitionthrough legitimate medical informationrequests should be limited becausedoctors will not know to excludegenetic information) and World PrivacyForum (requesting further limitations onthis exception). Employer groups raisedthe related point that human resourceoffices do not have control over what isreceived from health care providers inresponse to requests for medicalinformation and that covered entitiesshould not be subjected to liability ifhealth care providers provide geneticinformation that was not requested. See

Comments of Chamber/SHRM, EEACand the International PublicManagement Association for HumanResources, the League of MinnesotaCities and the International MunicipalLawyers Association (IPMA/IMLA).

In response to these comments and tofacilitate compliance with the law, wehave added language to the final ruleindicating that when a covered entitywarns anyone from whom it requestshealth-related information not toprovide genetic information, thecovered entity may take advantage ofthe exception in 1635.8(b)(1) if itnevertheless receives genetic

information. This safe harbor in1635.8(b)(1)(i)(B) provides that anyreceipt of genetic information inresponse to a lawful request for medicalinformation will be deemed inadvertentand not in violation of GINA if therequest contained such a warning.

The final rule includes the followinglanguage that a covered entity may useto provide such notice: The GeneticInformation Nondiscrimination Act of2008 (GINA) prohibits employers andother entities covered by GINA Title IIfrom requesting or requiring geneticinformation of employees or their family

members. In order to comply with thislaw, we are asking that you not provideany genetic information whenresponding to this request for medicalinformation. Genetic information, asdefined by GINA, includes anindividuals family medical history, theresults of an individuals or familymembers genetic tests, the fact that anindividual or an individuals familymember sought or received geneticservices, and genetic information of afetus carried by an individual or anindividuals family member or an



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10There is a separate exception for the acquisitionof family medical history received from individualsrequesting leave under the FMLA or similar stateor local laws to care for a family member. Thisexception is discussed in detail below.

11

One commenter expressed concern that addingany language to the FMLA certification form wouldresult in a statutory violation of the FMLA. SeeComment of Illinois Credit Union League. TheEEOC does not enforce the Family and MedicalLeave Act and therefore has no authority tointerpret it. We know of no reason, however, thatinforming a health care provider that geneticinformation should not be provided when certifyingan employees own serious health condition wouldlead to a violation of the FMLA. Moreover, thenotice informing applicants/employees and healthcare providers that they must not provide geneticinformation, including family medical history, tocovered entities need not be made on the FMLAcertification form itself, as long as it is provided inwriting along with the form.

embryo lawfully held by an individualor family member receiving assistivereproductive services. Alternativelanguage may also be used, as long asindividuals and health care providersare informed that genetic informationshould not be provided.

Although one commenter expressedconcern that giving notice would

impose an unnecessary burden on smallbusinesses, we note that the warningmay be conveyed verbally if the requestfor medical information itself is alsoverbal. See Comment of the NationalFederation of Independent Business(NFIB). We are aware that many

businesses, especially small businesses,do not use forms when requestingmedical information, and we do notintend this regulation to change thepractice of making such requestsverbally.

If a covered entity does not give sucha written or verbal notice, it maynonetheless establish that a particularreceipt of genetic information inresponse to a request for medicalinformation was an inadvertentacquisition because the covered entitysrequest was not made in a way that waslikely to result in the covered entitysobtaining genetic information (forexample where an overly broadresponse is received in response to atailored request for medicalinformation). We note, however, that awarning is mandatory in all cases wherea covered entity requests a health careprofessional to conduct an employment-related medical examination on the

covered entitys behalf, since in thatsituation, the covered entity shouldknow that the acquisition of geneticinformation (e.g., family medicalhistory) would be likely in the absenceof the warning. (See discussion of1635.8(d), below.)

The proposed regulation noted thatwhen a covered entity seeks informationfrom an individual who requests areasonable accommodation under theADA or state or local law, theacquisition of genetic information aspart of the documentation that theindividual provides in support of the

request is considered inadvertent, aslong as the request for documentationwas lawful. We received numerouscomments asking us to describe in theregulation itself what it means for arequest for documentation supporting arequest for reasonable accommodationto be considered lawful. See Commentsof APA, Disability Rights Legal Center(DRLC), the Epilepsy Foundation, andICC. In response, we explain in the finalrule that in order to be considered alawful request for documentation madein response to an individual seeking a

reasonable accommodation under theADA or state or local law, the requestfor medical documentation can be madeonly when the disability and/or theneed for accommodation is not obvious.In this situation, the employer may askthe individual for reasonabledocumentation about his/her disabilityand/or need for accommodation.

Reasonable documentation means thatthe employer may require only thedocumentation that is needed toestablish that a person has a disabilitywithin the meaning of the ADA and thatthe disability necessitates a reasonableaccommodation. For example, anemployer cannot request a personscomplete medical records because theyare likely to contain informationunrelated to the disability at issue andthe need for accommodation. If anindividual has more than one disability,an employer can request informationpertaining only to the disability that

requires a reasonable accommodation.See EEOCs Enforcement Guidance onReasonable Accommodation and UndueHardship Under the Americans WithDisabilities Act, EEOC Notice No.915.002 (Oct. 17, 2002), available athttp://www.eeoc.gov/policy/docs/accommodation.html.Like any requestfor medical documentation, the requestfor documentation as part of thereasonable accommodation processshould generally inform the individualor entity from whom the documentationis sought, using language like that notedabove, that genetic information shouldnot be provided.

We note that GINAs prohibition onrequesting, requiring, or purchasinggenetic information would controlduring the interactive process used todetermine an appropriate reasonableaccommodation. The Commissionknows of no reason why a coveredentity would need to request geneticinformation to determine anindividuals current physical or mentallimitations and whether thoselimitations can be accommodated.

The Commission further recognizesthat other federal, state, or local lawsmay allow covered entities to obtain

medical information about employees.A covered entity that inadvertentlyreceives genetic information in responseto a lawful request for medicalinformation under such a law would notviolate GINA. For example, a coveredentity might receive genetic informationin connection with an employeesrequest for FMLA leave to attend to theemployees own serious healthcondition or in connection with theFMLAs employee return to workcertification requirements, even thoughan employee is not required to provide

genetic information in either of thesesituations.10 Acquisition of geneticinformation in these circumstances will

be considered inadvertent if the coveredentity affirmatively warns individualsand health care providers from whomthey are seeking medical documentationnot to provide genetic information, or,in the absence of such a warning, where

the request for medical information wasnot likely to result in the acquisition ofgenetic information.11 In response totwo comments concerning the need foradditional clarity with regard to how theexceptions to the prohibition againstacquiring genetic information apply toinformation received pursuant to theFMLA, we have added the aboveexamples to 1635.8(b)(1)(ii)(D)(2)(whichwas 1635.8(b)(1)(iv) in the proposedrule), as well as additional detail to thepreambles discussion of the FMLAexception (1635.8(b)(3)), discussed

below. See Comments of APA and Anil

Chaudhry.The Commission believes that the firstexception to the general prohibition ofrequesting, requiring, or purchasinggenetic information should also applywhen an individual requests leavepursuant to a leave policy independentof a federal, state, or local leave ordisability law. Acquisition of geneticinformation in these circumstances, likethe acquisition of genetic informationwhere leave is requested pursuant to theFMLA or a state or local leave law, will

be considered inadvertent if the coveredentity affirmatively warns individualsand health care providers from whom

they are seeking medical documentationnot to provide genetic information,using language like that noted above, or,in the absence of such a warning, wherethe request for medical information wasnot made in a way that was likely toresult in the covered entitys obtaininggenetic information. Covered entitiesshould also be aware that overbroadrequests for documentation to support

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an employees use of leave may violatethe ADA. For information on theappropriate scope of inquiries inresponse to requests for leave (otherthan as a reasonable accommodation),see EEOCs Enforcement Guidance onDisability-Related Inquiries and MedicalExaminations of Employees Under theAmericans With Disabilities Act, 8 Fair

Empl. Prac. Man. (BNA) 405:7701,(Enforcement Guidance) Questions 1517 (July 27, 2000) available athttp://www.eeoc.gov/policy/docs/guidance-inquiries.html.

One commenter raised a concernabout proposed 1635.8(b)(1)(vi), whichextended the inadvertent acquisitionexception to a covered entity that learnsgenetic information about an individualin response to an inquiry about theindividuals general health, an inquiryabout whether the individual has anycurrent disease, disorder, orpathological condition, or an inquiry

about the general health of anindividuals family member. SeeComment of APA. APA asked that thisexception be limited to requestspermitted by Federal, State or locallaw. Rather than add any limitinglanguage, we have decided to eliminatethis subsection altogether, as it merelyreiterates the examples spelled out in1635.8(b)(1)(ii)(B) (formerly1635.8(b)(1)(ii) in the proposed rule).

Finally, one commenter asked that theinadvertent acquisition exception beextended to acquisition of geneticinformation by a self-insured employermaking health insurance billing

determinations in its capacity as aninsurer. See Comment of Navigenics. Itis not necessary to extend the exceptionto cover these circumstances because,when a self-insured employer is actingin its capacity as an insurer, its actionsare regulated by Title I of GINA, notTitle II. Title I of GINA has specificrules about acquiring geneticinformation for insurance paymentpurposes. See 42 U.S.C. 1182(c)(3); 42U.S.C. 300gg1(c)(3); 26 U.S.C.9802(c)(3).

Health or Genetic Services: GINApermits covered entities to acquire

genetic information where health orgenetic services are offered by theemployer, including such servicesoffered as part of a wellness program, ifthe covered entity meets specificrequirements. The proposed regulationlisted the specific requirements in thestatute as prerequisites to theacquisition of genetic information whenoffering health or genetic services: theindividual provides prior knowing,voluntary, and written authorization,meaning that the covered entity uses anauthorization form that is written in

language reasonably likely to beunderstood by the individual fromwhom the information is sought;describes the information beingrequested; and describes the safeguardsin place to protect against unlawfuldisclosure. Additionally, the proposedrule said that a wellness program orother health or genetic services that a

covered entity offers must be voluntary.The preamble to the proposed rulenoted that, under the ADA, a wellnessprogram that requires employees toanswer disability-related inquiries and/or to submit to a medical examinationis voluntary if the program neitherrequires participation, nor penalizesemployees for non-participation.

We received two comments askingwhether the written request andauthorization to participate in awellness program could be providedelectronically. See Comments of AHIPand Kelly Hart & Hallman (KHH). We

think this is permissible and haverevised the final rule accordingly. Wedo not think it is necessary to providein the final rule specific standards for anelectronic consent and authorization.The particular format chosen, however,must be functionally equivalent to whatwould be required in a writtenauthorization, in terms of content andform. For example, because writtenauthorization is a prerequisite to theacquisition of genetic information aspart of health or genetic services offered

by a covered entity, such as a voluntarywellness program, a covered entitycould not utilize an on-line form that

first requires an individual to inputfamily medical history and then asks theindividual to indicate his or heracceptance of the terms of anauthorization. Instead, a potentialparticipant in the health or geneticservices being offered must first bepresented with an electronicauthorization that describes the requestin terms reasonably likely to beunderstood by the individual, thepurposes for which it will be used, andthe safeguards in place for assuring itsconfidentiality, before any geneticinformation (such as family medical

history) can be provided.The proposed regulation stated thatindividually identifiable informationmay be provided only to the individualfrom whom it was obtained and thatcovered entities are entitled only toreceive information in aggregate termsthat do not disclose the identity ofspecific individuals. Some commentsobjected to a statement in the preambleto the proposed rule that a coveredentity that receives aggregateinformation may still violate GINAwhere the small number of participants,

alone or in conjunction with otherfactors, makes an individuals geneticinformation readily identifiable, notingthat this would impose burdensparticularly on small businesses. SeeComments Chamber/SHRM and IPMA/IMLA.

In the final rule, we have retained thelanguage in the NPRM, which tracked

the statutory language. GINA says that acovered entity may only receive geneticinformation related to a wellnessprogram in aggregate terms that do notdisclose the identity of specific[individuals], see 42 U.S.C. 2000ff1(b)(2)(D); 2000ff2(b)(2)(D); 2000ff3(b)(2)(D); and 2000ff4(b)(2)(D).However, we have reconsidered theposition taken in the preamble to theNPRM that a covered entity offeringhealth or genetic services will notcomply with 1635.8(b)(2) if aggregateinformation disclosed to the coveredentity makes the genetic information of

individuals readily identifiable. Aprovider of health or genetic serviceswill likely be unaware of facts known toa covered entity that would makeidentification of specific individualsreadily identifiable from aggregateinformation. Likewise, a covered entitymay not know that the identity ofspecific individuals from aggregateinformation will be readily identifiableuntil after it receives the information.We do not believe that Congressintended to impose liability on coveredentities who receive aggregateinformation about health or geneticservices under such circumstances.

Therefore, the Commission here clarifiesthat GINA is not violated if the providerof health or genetic services givesinformation to a covered entity inaggregate terms that, for reasons outsidethe control of the provider or thecovered entity (such as the smallnumber of participants), makes thegenetic information of a particularindividual readily identifiable with noeffort on the covered entitys part. Onthe other hand, efforts undertaken by acovered entity to link geneticinformation provided in the aggregate toa particular employee will violate GINA.

We received numerous comments inresponse to a question we asked in thepreamble to the proposed ruleconcerning when a wellness programthat includes a request for geneticinformation should be consideredvoluntary. Specifically, we wanted toknow the level of inducement, if any,that a covered entity could offer topromote participation in a wellnessprogram. See 74 FR 9056, 9062 (March2, 2009). From the many comments wereceived emphasizing the potential costsavings and benefits for employee

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12The 20 percent threshold described in theHIPAA nondiscrimination rules will increase to 30percent beginning in 2014 under statutory changesmade under the Patient Protection and AffordableCare Act, Public Law 111148.

13A wellness program that provides (directly,through reimbursement, or otherwise) medical care(including genetic counseling) may constitute agroup health plan required to comply with section

9802 of the Internal Revenue Code of 1986, 26U.S.C. 9802, section 702 of the EmployeeRetirement Income Security Act of 1974 (ERISA), 29U.S.C. 1182, or section 2705 of the Public HealthService Act (i.e., Title I of GINA). Regulationsissued under these statutes impose special

requirements on wellness programs that collectgenetic information. Moreover, wellness programsthat condition rewards on an individual satisfyinga standard related to a health factor must meetadditional requirements. See 26 CFR 54.98021(f),29 CFR 2590.702(f), and 45 CFR 146.121(f).

14Whether an employer or other covered entitythat sponsors a group health plan chooses toprovide benefits through self-insurance or througha policy, certificate, or contract of insurance doesnot affect the applicability of GINA Titles I and II.See 29 CFR 1635.11(b)(2) (discussing therelationship of GINA Titles I and II). The aboveexamples of actions permissible under both titlesare therefore helpful to all employers who offerhealth coverage to employees, whether through self-insured or insured plans.

health that could be brought aboutthrough wellness programs, fourapproaches to voluntariness emerged.One approach suggested that we useregulations promulgated pursuant toHIPAA, which define maximum levelsof inducements employers may offer toemployees who participate in, orachieve certain health outcomes as a

result of participating in, wellnessprograms. See Comments of AmericanBenefits Council (ABC), Chamber/SHRM, DMAA: The Care ContinuumAlliance (DMAA), Dorsey and Whitney,LLP, Healthways, National BusinessGroup on Health (NBGH), and UnitedHealthcare. Under the HIPAAregulations, employers may offerfinancial inducements of any size toencourage participation in wellnessprograms, and may offer inducements ofup to a specified percentage of the costof group health insurance coverage foran individual or an individual and

family to participants who achievespecific health outcomes. See 26 CFR54.98021(f)(1), 29 CFR 2590.702(f)(1),and 45 CFR 146.121(f)(1) (explainingthat a wellness program does not violateHIPAAs nondiscriminationrequirements if none of the conditionsfor obtaining a reward are based on anindividual satisfying a certain healthstandard, as long as participation in theprogram is offered to all similarlysituated individuals). See also 26 CFR54.98021(f)(2), 29 CFR 2590.702 (f)(2),and 45 CFR 146.121(f)(2) (providinglimits on financial inducements when

rewards are conditioned on achievingcertain health outcomes).12Other comments appeared to suggest

a combination of the approach taken inthe HIPAA

GINA Regulations

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Transcript of GINA Regulations