The Genetic Information Nondiscrimination Act (GINA) became law on May 21, 2008. Title I of GINA amends portions of the Employee Retirement Income Security Act (ERISA), the Public Health Service Act, and the Internal Revenue Code to address the use of genetic information in health insurance. Title II prohibits the use of genetic information in employment, restricts employers and other entities covered by Title II from requesting, requiring, or purchasing genetic information, and strictly limits the disclosure of genetic information.
GINA requires the Equal Employment Opportunity Commission (EEOC) to issue regulations implementing Title II of the Act, which it did on November 9, 2010. The following questions and answers are intended to provide practical information about the most important requirements of Title II of GINA and the EEOC’s regulations.
1. Who must comply with Title II of GINA?
Title II applies to private employers and state and local government employers with 15 or more employees, employment agencies, labor unions, and joint labor-management training programs. It also covers Congress, federal executive branch agencies, and the Executive Office of the President. The final rule and this document use the term “covered entity” to refer collectively to all entities subject to Title II of GINA.
2. Are entities subject to Title II of GINA required to comply with the law now?
Yes. Title II of GINA was effective on November 21, 2009.
3. Why is GINA needed?
GINA was enacted, in large part, because of developments in the field of genetics, the decoding of the human genome, and advances in the field of genomic medicine. Genetic tests now exist that can determine whether individuals are at risk for specific diseases or disorders. As the number of genetic tests increases, so do the concerns of individuals fearing the loss of health coverage or employment because of their genetic information.
Congress enacted GINA to address these concerns, by prohibiting discrimination based on genetic information and restricting the acquisition and disclosure of such information, so that individuals would not fear adverse employment- or health coverage-related consequences from genetic testing or participation in genetic research.
4. What practices does GINA Title II prohibit?
Title II of GINA prohibits the use of genetic information in making decisions related to any terms, conditions, or privileges of employment (e.g., hiring, firing, and opportunities for advancement); restricts employers and other entities covered by Title II from requesting, requiring, or purchasing genetic information, with limited exceptions; generally requires covered entities to keep any genetic information they have about applicants or employees confidential; and prohibits retaliation.
The language in the regulation describing these rules is slightly different from that used in the proposed rule. Language in the proposed rule suggested that a covered entity had to have a specific intent to obtain genetic information in order to violate GINA’s provisions prohibiting the acquisition of genetic information. The final rule clarifies that a specific intent to acquire genetic information is not necessary for a covered entity to violate GINA’s provisions that prohibit requesting, requiring or purchasing genetic information.
The final rule also clarifies that a “request” for genetic information includes actions such as 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.
5. What is “genetic information”?
The statute and the final rule say that “genetic information” includes:
6. What are examples of tests that would and would not be considered genetic tests?
The final rule offers numerous examples (at § 1635.3(f)) of tests that are and are not genetic tests, many of which were added in response to public comments. Tests used to determine whether an individual has a certain genetic variant associated with predisposition to a disease are considered genetic tests. For example, a test to determine whether an individual has the genetic variants associated with a predisposition to breast cancer (the BRCA1 or BRCA2 gene) would be considered a genetic test. Other examples of genetic tests include a test for a genetic variant for Huntington’s Disease and carrier screenings of 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.
Examples of tests that are not genetic tests include an HIV test, a cholesterol test, and a test for the presence of drugs or alcohol.
7. Does GINA protect individuals discriminated against on the basis of impairments that have a genetic basis, such as certain forms of breast cancer?
No. GINA is concerned primarily with protecting those individuals who may be discriminated against because an employer thinks they are at increased risk of acquiring a condition in the future. Someone who is discriminated against because she actually has breast cancer or another condition would not be protected by GINA, even if the condition has a genetic basis. The ADA , however, may protect such an individual whose cancer or other condition meets the definition of “disability.” Recent amendments to the ADA make it much easier for individuals with cancer and other kinds of impairments to establish that they have disabilities, and thus are entitled to the law’s protection.1
8. Are there any situations in which a covered entity could use genetic information to make employment decisions?
No. The prohibition on the use of genetic information in employment decision-making is absolute, since the possibility that someone may develop a disease or disorder in the future has nothing to do with his or her current ability to perform a job.
9. Are there any exceptions to the general rule against requesting, requiring, or purchasing genetic information?
Yes, there are six narrowly-defined situations in which a covered entity may acquire genetic information.
10. In what types of situations would the acquisition of genetic information be considered inadvertent?
GINA’s legislative history says that the exception for inadvertent acquisition of genetic information was intended to address the “water cooler problem” – a situation in which a manager or supervisor learns genetic information by overhearing a discussion between co-workers. For example, it would not violate GINA for a supervisor to overhear one employee tell another that her mother has breast cancer, or that the employee herself has had a test to determine whether she has the gene associated with increased risk for breast cancer.
The regulations explain that this exception can apply in other situations as well, such as when a supervisor receives genetic information in response to a question about an employee’s general well-being (“How are you?” or “Did they catch it early?” asked of an employee who was just diagnosed with cancer), or a question about the general health of a family member (“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?”). Another example of inadvertent acquisition is when a supervisor receives an unsolicited communication about an employee’s family member (e.g., an email indicating that an employee’s mother has cancer). The rule also notes that the inadvertent acquisition exception applies 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 (e.g., where a supervisor and employee are connected on a social networking site and the employee provides family medical history on his page). Employers that lawfully request documentation about an employee’s current medical condition may also inadvertently receive genetic information, particularly family medical history (see Questions 11 and 12).
11. What must an employer do to comply with GINA when lawfully requesting health-related information from an employee?
Although the proposed rule said that genetic information acquired as the result of an inquiry about an individual’s current health status would be considered inadvertent if the request was lawful, the final rule says that when a covered entity makes a request for health-related information (e.g., to support an employee’s request for reasonable accommodation under the ADA or a request for sick leave), it should warn the employee and/or health care provider from whom it requested the information not to provide genetic information. The warning may be in writing or oral (if the covered entity typically does not make such requests in writing).
The regulations suggest language such as the following:
“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.”
12. What if a covered entity does not provide a warning like the one the EEOC suggests when it requests health-related information?
If the covered entity can show that its request for health-related information was not made in a way that was likely to result in the covered entity’s obtaining genetic information , any genetic information the entity acquires will be considered inadvertent (see Question 10). For example, an employer who asks an employee to provide a doctor’s note explaining a five-day absence will not violate GINA if the doctor includes the family medical history taken as part of the employee’s medical examination, even if the employer has not warned the employee or the doctor against providing genetic information.
13. May an employer ask for family medical history or other genetic information as part of a medical examination related to employment (i.e., a post-offer or fitness-for-duty examination)?
No. Although employers may conduct post-offer medical examinations/inquiries or fitness-for-duty examinations consistent with ADA requirements, it is a violation of GINA to request or require an individual to provide genetic information, including family medical history, during a medical examination related to employment.
A covered entity must tell its health care providers not to collect genetic information as part of an employment-related medical exam. If a covered entity tells its health care provider not to collect genetic information and the health care provider does so anyway, the employer will not be liable for that particular collection of genetic information, but the covered entity must take additional reasonable measures within its control to prevent this behavior in the future. This could include no longer using the services of that health care provider.
Unlike the warning described in Question 11, which may be unnecessary if a covered entity’s lawful request for medical documentation was not made in a way that was likely to result in receipt of genetic information, a warning is required when an employer sends an applicant or employee for a medical examination.
14. What do GINA and the regulations say about the acquisition of genetic information when a covered entity offers health or genetic services?
GINA and the regulations say that a covered entity may acquire genetic information about an employee or his or her family members when it offers health or genetic services, including wellness programs, on a voluntary basis. The individual receiving the services must give prior voluntary, knowing, and written authorization. While individualized genetic information may be provided to the individual receiving the services and to his or her health or genetic service providers, genetic information may only be provided to the employer or other covered entity in aggregate form.
The regulations point out that, if information provided in the aggregate makes identification of specific individuals’ genetic information possible because of the small number of participants in a wellness program, the employer will not violate GINA.
The proposed rule sought comments on the extent to which a covered entity could offer financial inducements to encourage participation in health or genetic services, particularly wellness programs. The final rule says 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. Therefore, 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 to receive the inducement.
Title II does not prohibit covered entities from offering 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).2
To avoid a violation of Title II of GINA, however, covered entities that 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.3
15. Why does GINA include an exception that allows a covered entity to acquire family medical history as part of the FMLA’s certification process?
The exception is necessary when someone is asking for leave to care for a family member with a serious health condition because under the FMLA, family medical history (i.e., information about the manifestation of a disease or disorder in family members of the individual) must be provided as part of the certification process. The regulations also permit the acquisition of genetic information pursuant to similar requirements of state or local leave laws. The final rule notes that this exception also applies to similar policies that an employer might have irrespective of FMLA or state or local law requirements.
16. In what types of situations might a covered entity lawfully acquire genetic information from sources that are commercially and publicly available?
An employer is not liable under GINA for acquiring genetic information from sources that are commercially and publicly available, such as newspapers, books, magazines, periodicals, television shows, movies, or the Internet. For example, an employer would not be liable if it accidentally came across a newspaper article saying that an employee’s father died of a sudden heart attack. The regulations note, however, that this exception does not apply to medical databases, court records, or research databases available to scientists on a restricted basis.
The final rule further provides that this exception does not apply to:
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. Similarly, an employer who required all applicants to grant the employer access to Facebook pages that were otherwise protected (i.e., required the creator’s permission to access) would not be able to take advantage of this exception if it acquired genetic information, though it might still be able to show that it obtained the information inadvertently (as discussed in Question 10 above). However, this exception would apply to an employer who learned genetic information about an applicant as the result of a general internet search for information about the applicant.
17. In what circumstances may an employer acquire genetic information through genetic monitoring of its workforce?
GINA and the regulations say that a covered entity may engage in genetic monitoring of the biological effects of toxic substances in the workplace as long as certain requirements are met. The covered entity must provide written notice of the monitoring program and, if the monitoring is not specifically required by federal or state law or regulation, must obtain an individual’s prior knowing, written, and voluntary authorization. Furthermore, while individualized genetic information may be disclosed to the employee and the doctors and certified genetic counselors involved in the monitoring, the employer may only be given genetic information in aggregate form. As in the case of health or genetic services offered by a covered entity on a voluntary basis, if information provided in the aggregate makes identification of specific individuals’ genetic information possible because of the small number of participants in a monitoring program, the employer will not violate GINA.
The final rule clarifies 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 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 may not take any adverse action against the individual for refusing to participate. However, a covered entity does not violate Title II of GINA if it limits or restricts an employee’s job duties based on genetic information because it was required to do so by law or regulation, such as regulations administered by the Occupational and Safety Health Administration (OSHA).
18. What do GINA and the final rule say about whether an employer may acquire genetic information for law enforcement purposes or for human remains identification?
GINA Title II and the regulations permit covered entities that engage in DNA testing for law enforcement purposes as a forensic laboratory or for purposes of human remains identification to collect their employees’ genetic information in certain limited circumstances. Specifically, these entities may request or require genetic information only to the extent that the information is used for analysis of DNA identification markers for quality control to detect sample contamination.
Covered entities in possession of genetic information about applicants or employees must keep the information confidential and, if the information is in writing, must keep it apart from other personnel information in separate medical files. A covered entity may keep genetic information in the same file as medical information subject to the ADA.
There are limited exceptions to GINA’s prohibition on disclosure of genetic information that allow covered entities to disclose genetic information:
The final rule clarifies that genetic information placed in personnel files prior to GINA’s effective date of November 21, 2009, need not be removed and an employer will not be liable under GINA for the mere existence of that genetic information in a personnel file. The final regulation further notes, however, that disclosing that genetic information to a third party is prohibited.
20. Are disparate impact claims permitted under Title II of GINA?
No. However, the Act directs that a commission be formed six years after enactment to report on the possibility of allowing disparate impact claims.
21. Does Title II of GINA prohibit harassment?
The Commission interprets Title II of GINA to prohibit harassment based on genetic information. In describing the prohibited practices under Title II, Congress adopted language similar to that used in Title VII of the Civil Rights Act of 1964 and other equal employment opportunity statutes, which is understood to prohibit discrimination with respect to a wide range of practices, including harassment.
22. Does Title II of GINA apply to employment decisions concerning health benefits?
Yes. Employers and other GINA Title II covered entities are 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.
However, Title II of GINA includes a “firewall” provision intended to eliminate “double liability” by preventing claims under GINA Title II from being asserted regarding matters subject to enforcement under Title I of GINA or the other genetics provisions for group coverage in ERISA, the Public Health Service Act, and the Internal Revenue Code.4
The firewall ensures 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. Therefore, 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.
The final rule (at § 1635.11(b)(2)) provides three examples not found in the proposed rule, that show how the firewall works. The examples make clear that whether Title I or Title II of GINA applies in a particular situation depends on which entity – the health plan or the employer – is engaging in the prohibited act.
23. What effect does Title II of GINA have on other laws addressing genetic discrimination in employment?
Title II of GINA does not preempt any state or local law that provides equal or greater protections from employment discrimination on the basis of genetic information or improper access to 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, and does not affect an individual’s rights under the ADA, the Rehabilitation Act, or state or local laws that prohibit discrimination on the basis of disability.
24. What are the remedies for a violation of GINA Title II?
The same remedies available under Title VII of the Civil Rights Act of 1964 are available under Title II of GINA. An aggrieved individual may seek reinstatement, hiring, promotion, back pay, injunctive relief, pecuniary and non-pecuniary damages (including compensatory and punitive damages), and attorneys’ fees and costs. Title VII’s cap on combined compensatory and punitive damages also applies to actions under Title II of GINA.5
Punitive damages are not available against federal, state, or local government employers.
25. What happens when an employee files a charge under GINA?
Charges Against Private Sector Employers/State and Local Governments
An individual who believes that his or her employment rights have been violated on the basis of genetic information may file a “charge of discrimination” with the EEOC within 180 days from the date of the alleged violation, or within 300 days if a state or local agency enforces a law that prohibits employment discrimination on the basis of use or acquisition of genetic information or genetic testing.6
If a charge is filed, the EEOC will notify the employer and provide the name and contact information of an investigator. The parties may choose to resolve the dispute through settlement, or in some cases mediation. If the dispute is not resolved voluntarily, the investigator will ask both parties for information. The employer may be asked to:
Once the investigation is complete, the EEOC will determine whether there is “reasonable cause” to believe discrimination occurred. If there is insufficient evidence to find reasonable cause, the EEOC will issue a Dismissal and Notice of Rights stating that the charging party has a right to file a lawsuit in federal court within 90 days of receipt of the notice.
If reasonable cause is found, the EEOC will issue a Letter of Determination and try to conciliate the charge. Where the charge cannot be resolved through conciliation, the EEOC will either file a court action, or issue a Notice of Right to Sue, stating that the charging party has a right to file a lawsuit in federal court within 90 days of receipt of the notice. A charging party also can request a Notice of Right to Sue from the EEOC 180 days after the charge was first filed with the EEOC.
For a detailed description of the process, please refer to the EEOC website at http://www.eeoc.gov/employers/process.cfm.
Complaints Against Federal Executive Branch Agencies
A federal government applicant or employee who believes that his or her employment rights have been violated on the basis of genetic information and wants to make a claim against a federal agency must file a complaint with that agency and follow the procedures set forth at 29 C.F.R. part 1614. The first step is to contact an EEO Counselor at the agency within 45 days of the alleged discriminatory action. The individual may choose to participate in either counseling or in Alternative Dispute Resolution (ADR) if the agency offers this alternative. Ordinarily, counseling must be completed within 30 days and ADR within 90 days.
At the end of counseling, or if ADR is unsuccessful, the individual may file a complaint with the agency. The agency must conduct an investigation unless the complaint is dismissed. If a complaint contains one or more issues that must be appealed to the Merit Systems Protection Board (MSPB), the complaint is processed under the MSPB’s procedures. For all other EEO complaints, once the agency finishes its investigation, the complainant may request a hearing before an EEOC administrative judge or an immediate final decision from the agency.
In cases where a hearing is requested, the administrative judge issues a decision and sends the decision to both parties. If the agency does not issue a final order within 40 days after receiving the administrative judge’s decision, the decision becomes the final action of the agency.
A complainant may appeal an agency’s final action to EEOC within 30 days of receipt. The agency may appeal a decision by an EEOC administrative judge within 40 days of receiving the administrative judge's decision.
For more information concerning enforcement procedures for federal applicants and employees, visit the EEOC website at http://www.eeoc.gov/federal/fed_employees/index.cfm
Congress and the Executive Office of the President
The EEOC does not enforce Title II of GINA as it applies to Congress or the Executive Office of the President. Employees in the legislative branch who believe they have been discriminated against in violation of Title II of GINA should contact the Office of Compliance at 202-724-9250. Employees of the Executive Office of the President should contact the White House Office of Equal Employment Opportunity at 202-395-7704 for guidance.
1 On September 23, 2009, EEOC published a Notice of Proposed Rulemaking (NPRM) to implement the ADA Amendments Act. See 74 FR 48431. More information about the NPRM is available at http://www.eeoc.gov/laws/statutes/adaaa_notice.cfm
2 A wellness program that provides (directly, through reimbursement, or otherwise) medical care (including genetic counseling) may constitute a group health plan required to comply with section 9802 of the Internal Revenue Code of 1986, 26 U.S.C. 9802, section 702 of the Employee Retirement Income Security Act of 1974 (ERISA), 29 U.S.C. 1182, or section 2705 of the Public Health Service Act (i.e., Title I of GINA). Regulations issued under these statutes impose special requirements on wellness programs that collect genetic information. Moreover, wellness programs that condition rewards on an individual satisfying a standard related to a health factor must meet additional requirements See 26 CFR 54.9802-1(f), 29 CFR 2590.702(f), and 45 CFR 146.121(f).
3 Providing financial incentives in compliance with 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, that HIPAA requires “reasonable alternatives” for individuals with medical conditions that make it unreasonably difficult or medically inadvisable to satisfy wellness program standards, and that wellness programs that constitute group health plans may have to comply with Title I of GINA, among other laws).
4 According to the Department of Labor (DOL), questions about Title I of GINA should be referred to DOL’s Employee Benefits Security Administration (EBSA) at 1-866-444-EBSA(3272). The EBSA website also has educational material on Title I of GINA. Information pertaining to Section 105 of Title I of GINA’s protections for genetic information in the HIPAA Privacy Rule is available at the HHS Office for Civil Rights website on privacy and genetic information at: http://www.hhs.gov/ocr/privacy/hipaa/understanding/special/genetic/index.html.
5 The cap on combined compensatory and punitive damages (excluding past monetary losses) ranges from $50,000 for employers with 15-100 employees to $300,000 for employers with more than 500 employees.
6 Many states and localities have agencies that enforce laws prohibiting employment discrimination on the basis of genetic information. EEOC refers to these agencies as “Fair Employment Practices Agencies” (FEPAs). EEOC and many FEPAs have worksharing agreements in place to prevent the duplication of effort in charge processing. This process, which is defined as dual filing, also helps to protect charging parties’ rights under both federal and state law. When an individual initially files with a FEPA, and the allegation is covered by Title II of GINA, the FEPA will “dual file” the charge with EEOC, but will usually retain the charge for processing. If the charge is initially filed with EEOC and the charge is also covered by state or local law, EEOC “dual files” the charge with the state or local FEPA, but ordinarily retains the charge for processing.