July 30, 2018
THE GENETIC INFORMATION NONDISCRIMINATION ACT (“GINA”)
A. Introduction
The federal Genetic Information Nondiscrimination Act (“GINA”) took effect on November 21, 2009. The law was extraordinarily popular at the time it was enacted; GINA passed the U.S. Senate by a 95-0 vote and passed the House of Representatives by a vote of 414-1.1
As applied to employers, the law (1) prohibits employers from acquiring employees’ genetic information; (2) prohibits employers from discriminating on the basis of any genetic information they do acquire; and (3) requires that employers keep strictly confidential any employee genetic information that they have. Although much remains to be seen about the law and its enforcement, the regulations and early guidance issued by the Equal Employment Opportunity Commission (“EEOC”) indicate that the EEOC intends to take a hard line in enforcing GINA. And employees seem to be well aware of the law – as of July 2010 about 200 charges alleging employment discrimination in violation of GINA had already been filed with the EEOC. Following is a detailed look at GINA, followed by guidance and tips for employers in complying with the new law and avoiding its pitfalls.
B. Overview of GINA and “Genetic Information”
1. Coverage
GINA adopts the definitions of “employer” and “employee” set forth in Title VII. Thus, GINA applies to all private employers with 15 or more employees, as well as to state and local government employers. The employment-related provisions of GINA are codified at 42 U.S.C. § 2000ff (generally the same section of the United States Code as Title VII).
2. Basic Rules and Requirements
Broadly speaking, GINA imposes these rules on employers:
a. Employers are prohibited from intentionally acquiring genetic information about their employees.
b. Employers are prohibited from using genetic information to discriminate in employment.
c. Employers must keep any genetic information that they have acquired confidential.
Before turning to a detailed explanation of these three provisions in Part C below, it is necessary to address some of the definitions contained in GINA.
3. Definitions
Generally speaking, genetic information is any information about an employee’s genetic tests or about the employee’s family member’s genetic tests or health conditions. Family member is defined extremely broadly, reaching all the way to great-great grandparents and first cousins once removed. Thus, while it may be fairly easy for employers to avoid liability relating to genetic tests, what is likely to be more challenging will be avoiding liability relating to acquiring or using information about an employee’s family members. GINA’s pertinent definitions are set forth in detail below:
a. Genetic Information means, with respect to an individual employee, any information regarding:
i. the individual’s genetic tests;
ii. the genetic tests of the individual’s family members;
iii. the manifestation of a disease or disorder in family members of an individual;
iv. any request for, or receipt of, genetic services, or participation in clinical research which includes genetic services, by the individual or any family member of the individual;
v. genetic information of a fetus carried by a pregnant individual or family member of an individual, as well as genetic information of an embryo legally held by an individual or family member utilizing assisted reproductive technology. 42 U.S.C. § 2000ff-1, -8(b). Genetic information excludes:
i. information about an individual’s or family member’s sex or age;
ii. information about a current disease or disorder affecting the individual (a “manifested condition”) – this would be covered by the ADA, not GINA. Id. Note that GINA also provides that an employer is not “considered to be” in violation of GINA based on the employer’s use, acquisition, or disclosure of medical information that is not genetic information about a manifested disease, disorder, or pathological condition of an employee, including a disease, disorder or condition that may have a genetic basis. 42 U.S.C. § 2000ff-9.
b. Family Member means:
i. a dependent of the employee (through marriage, birth, or adoption or placement for adoption); or
ii. any other individual who is a first-degree, seconddegree, third-degree, or fourth-degree relative of the employee or of the employee
• first-degree relatives include an individual’s parents, siblings, children, and half-siblings
• second-degree relatives include an individual’s grandparents, grandchildren, uncles, aunts, nieces, and nephews
• third-degree relatives include an individual’s greatgrandparents, great grandchildren, great uncles/aunts, and first cousins
• fourth-degree relatives include an individual’s great-great grandparents, great-great grandchildren, and first cousins once removed 29 C.F.R. § 1635.3.
c. Family Medical History means information about the manifestation of disease or disorder in family members of the individual. 29 C.F.R. § 1635.3.
d. Manifestation means, with respect to a disease, disorder, or pathological condition, that an individual has been or could reasonably be diagnosed with the disease, disorder, or pathological condition by a health care professional with appropriate training and expertise in the field of medicine involved. The disease, disorder, or condition is not “manifested” within the meaning of GINA if the diagnosis is based principally on genetic information or on the results of one or more genetic tests. 29 C.F.R. § 1635.3.
e. Genetic Test means an analysis of human DNA, RNA, chromosomes, proteins, or metabolites, that detects genotypes, mutations, or chromosomal changes. It excludes any such analysis that does not detect genotypes, mutations, or chromosomal changes. 42 U.S.C. § 2000ff-1. Further, testing for the presence of a virus that is not composed of human DNA, RNA, chromosomes, proteins, or metabolites is not a genetic test. Testing for the presence of drugs or alcohol is not genetic testing, but testing to determine whether a person has a genetic predisposition for alcoholism or drug testing is a genetic test. 29 C.F.R. § 1635.3.
f. Genetic Services means a genetic test; genetic counseling; or genetic education.
g. Genetic monitoring means the periodic examination of employees to evaluate acquired modifications to their genetic material, such as chromosomal damage or evidence of increased occurrence of mutations, that may have developed in the course of employment due to exposure to toxic substances in the workplace, in order to identify, evaluate, and respond to the effects of or control adverse environmental exposures in the workplace. 42 U.S.C. § 2000ff-1.
C. Employer Requirements and Prohibited Practices in Detail
GINA’s three main requirements are discussed in detail below. Note also that GINA, like the other laws enforced by the EEOC, comes with a posting requirement. The EEOC has issued a new poster, which includes GINA. Be sure to update the postings at your workplace with the new poster, or with a posting that includes EEOC’s information on GINA.
1. Acquisition of genetic information prohibited
In short, GINA prohibits employers from acquiring (via request, purchase, or requirement) genetic information with respect to an employee or a family member of the employee. This means employers are not only prohibited from collecting information as to an employee’s genetic tests, but employers are also prohibited from collecting information as to an employee’s family medical history.
There are six exceptions to the blanket prohibition on acquisition of genetic information, but it is likely that they will be construed narrowly. See 29 C.F.R. § 1635.8(b). The six exceptions to the prohibition on an employer’s acquisition of genetic information are:
a. Where an employer inadvertently requests or requires genetic information of the individual or family member of the individual (the so-called “watercooler exception”). The EEOC’s final regulations list the following hypothetical situations where the employer’s acquisition of genetic information might be considered inadvertent and not in violation of GINA:
• A manager, supervisor, union representative, or employment agency personnel learns genetic information about an individual by overhearing a conversation between the individual and others; or
• A manager, supervisor, union representative, or employment agency personnel learns genetic information about an individual by receiving it from the individual or third parties without having solicited or sought the information, including inadvertently learning the information through a social media platform to which he or she has been granted access.
• An individual provides genetic information as part of documentation to support a request for reasonable accommodation under Federal, State, or local law, as long as the covered entity's request for such documentation is lawful;
• An employer requests medical information (other than genetic information) as permitted by Federal, State, or local law from an individual, who responds by providing, among other information, genetic information;
• An individual provides genetic information to support a request for leave that is not governed by Federal, State, or local laws requiring leave, as long as the documentation required to support the request otherwise complies with the requirements of the Americans with Disabilities Act and other laws limiting a covered entity's access to medical information; or
• A covered entity learns genetic information about an individual in response to an inquiry about the individual's general health, an inquiry about whether the individual has any current disease, disorder, or pathological condition, or an inquiry about the general health of an individual’s family member.
Note that in order to be shielded by the “inadvertent acquisition” exception when making a lawful request for medical records, the employer must have included in have included in the request for medical information a statement explicitly directing the respondent not to provide genetic information. The EEOC’s final regulations include sample “safe harbor” language to include in such requests. See 29 C.F.R. 1635.8(b)(1)(i)(B) (included as an Appendix to this article).
Additionally, the regulations provide that a request for documentation supporting a request for reasonable accommodation is lawful “only when the disability and/or the need for accommodation is not obvious; the documentation is no more than is sufficient to establish that an individual has a disability and needs a reasonable accommodation; and the documentation relates only to the impairment that the individual claims to be a disability that requires reasonable accommodation.” Id. at 1635.8(b)(1)(i)(D).
b. Where an employer offers health or genetic services, including such services offered as part of a voluntary wellness program. This exception applies only where –
• The individual provides prior knowing, voluntary, and written authorization that: (A) Is written so that the individual from whom the genetic information is being obtained is reasonably likely to understand the form; (B) Describes the type of genetic information that will be obtained and the general purposes for which it will be used; and (C) Describes the restrictions on disclosure of genetic information; and
• individually identifiable genetic information is provided only to the individual (or family member if the family member is receiving genetic services) and the licensed health care professional or board certified genetic counselor involved in providing such services (i.e., not to the employer); and
• any individually identifiable genetic information provided is only available for purposes of such services and is not disclosed to the covered entity except in aggregate terms that do not disclose the identity of specific individuals.
c. Where the employer requests family medical history to comply with the certification provisions of the Family and Medical Leave Act (FMLA) or State or local family and medical leave laws.
d. Where the employer acquires genetic information from documents that are commercially and publicly available for review or purchase, including newspapers, magazines, periodicals, or books, or through electronic media, such as information
communicated through television, movies, or the Internet, except that a covered entity may not research medical databases or court records, even where such databases may be publicly and commercially available, for the purpose of obtaining genetic information about an individual.
e. Where the employer acquires genetic information for use in genetic monitoring of the biological effects of toxic substances in the workplace, which is required by federal or state law or is pursuant to voluntary, knowing, written authorization from the individual. In order for this exception to apply, the employer must provide written notice of the monitoring to the individual.
f. Where the employer conducts DNA analysis for law enforcement purposes as a forensic laboratory or for purposes of human remains identification and requires genetic testing of employees as a way to check for sample contamination. 29 C.F.R. § 1635.8(b). Note that if the employer does inadvertently obtain genetic information where the acquisition is excused pursuant to one of the above exceptions, the employer may not use the information for discriminatory purposes and must keep the information confidential as described below.
2. Discrimination, harassment, and retaliation prohibited
GINA prohibits employers from discriminating, harassing, or retaliating against any employee “because of genetic information with respect to the employee[.]” 42 U.S.C. § 2000ff-1(a).
Essentially, GINA prohibits discrimination to the same extent that Title VII prohibits discrimination as to a person in a protected category. There is one notable exception, however. GINA specifically provides that it does not create a cause of action for disparate impact based upon genetic information. 42 U.S.C. § 2000ff-7(a). (Disparate impact occurs when an employer adopts a seemingly-neutral policy or practice that has the effect of discriminating against members of a protected group.) Although Congress decided against recognizing a cause of action for disparate impact based on genetic information, the decision may be only temporary; GINA provides for a study commission to be convened six years after GINA’s enactment (i.e., May 21, 2014) “to review the developing science of genetics and to make recommendations to Congress regarding whether to provide a disparate impact cause of action under this Act.” Id. § 2000ff-7(b).
3. Genetic information must be kept strictly confidential
Again, there are circumstances where an employer will acquire protected genetic information – indeed, many employers currently have such information in their files. The information does not necessarily need to be purged; the final GINA regulations note 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 this part for the mere existence of the information in the file.” 29 C.F.R. § 1635.9. This suggests that an employer should be on the alert for information that it may have placed in its files after that date, and remove it. In any event, all such information must be kept strictly confidential. GINA and the EEOC’s regulations require that genetic information be treated as part of the employee’s confidential medical records, and be kept separate from the employee’s personnel records, in a secure location. 42 U.S.C. § 2000ff-5.
Note that the regulations provide that if an employer obtains genetic information orally, it need not reduce the information to writing, but it must keep the information confidential and may not use it to discriminate. See 29 C.F.R. § 1635.9(a)(3). Similarly, genetic information that is acquired through publicly-available sources is not considered confidential, but it may not be used to discriminate against the employee. See id. 1635.9(a)(4).
The genetic information may not be disclosed except in the following circumstances:
• to the employee (or family member if the family member is receiving the genetic services) at the written request of the employee;
• to an occupational or other health researcher if the research is conducted in compliance with the applicable federal regulations and protections;
• in response to an order of a court, except that –
• the employer may disclose only the genetic information expressly authorized by such order; and
• if the court order was secured without the knowledge of the employee, the employer shall inform the employee of the court order and any genetic information that was disclosed pursuant to such order;
• to government officials who are investigating compliance with GINA if the information is relevant to the investigation;
• to the extent that such disclosure is made in connection with the employee’s compliance with the certification provisions of the FMLA or such requirements under State family and medical leave laws; or
• to a Federal, State, or local public health agency, but only with regard to information about the manifestation of a disease or disorder that concerns a contagious disease that presents an imminent hazard of death or lifethreatening illness, and only if the employee whose family member(s) is the subject of a disclosure under this provision is notified of the disclosure. 42 U.S.C. § 2000ff-5. In sum, GINA is in one sense very straightforward: do not obtain genetic information, but if you have genetic information, do not use it to discriminate and do not disclose it to anyone. The devil will be in the numerous detailed exceptions, and in how they are construed as the law plays out over the next few years.
D. Causes of Action/ Enforcement
It is clear that an employee has a right of action for personal discrimination experienced in violation of GINA. Presumably, the employee also has a right of action for an employer’s illegal acquisition of or disclosure of the employee’s protected genetic information, as these are apparently a “per se” violation of GINA, even in the absence of discrimination or retaliation as to the employee.
All Title VII’s procedures and remedies, including compensatory and punitive damages, injunctive relief, and attorney’s fees, apply to actions brought under GINA. 42 U.S.C. § 2000ff-6.
GINA is enforced by the EEOC, through the same charge-filing system as Title VII and the ADA. Like Title VII, GINA requires an employee to file a charge within:
• 180 days of the alleged violation, if there is not a state or local law that prohibits genetic discrimination in employment; or
• 300 days of the alleged violation, if there is a state or local law that prohibits genetic discrimination in employment.
Although 35 states had some type of law in place banning genetic discrimination in employment at the time GINA was enacted, Tennessee does not have such a law.
Thus, in Tennessee the 180-day charge-filing period applies. As mentioned above, by the end of the federal government’s fiscal year in July 2010, just a few months after GINA’s effective date, the EEOC had received 201 GINA charges. Of those, the EEOC made a “no reasonable cause” finding as to 38 charges, a “cause” finding as to two charges, and reached resolutions on the merits of seven other charges. The following well-publicized charge illustrates the GINA charge process. Pamela Fink was employed by a Connecticut-based company, Mxenergy, as the director of public relations and marketing. For the first three and a half years on the job, she received glowing performance reviews. Then, in late 2009, she decided to have a double-mastectomy to reduce her risk of breast cancer. She had tested positive for BRCA2 (a gene that can increase the risk of breast cancer) in 2004, and both of her sisters were breast cancer survivors. When she decided to have the mastectomy in 2009, she told her employer that it was because she had tested positive for the gene and because of her sisters’ health history – both of which, of course, qualified as pieces of genetic information under GINA.
When Ms. Fink returned from her medical leave following the mastectomy, she found that her job responsibilities were gradually being shifted away from her, and she began receiving negative performance evaluations. Just a few months later, she was fired.
Ms. Fink filed a charge with the EEOC in April 2010, alleging discrimination in violation of GINA. Although her employer’s acquisition of Ms. Fink’s genetic information was inadvertent, since Ms. Fink volunteered it (and was therefore not a violation of GINA), if the employer did in fact terminate her because of her genetic predisposition for breast cancer, the action was in violation of GINA. (Note that Ms. Fink would not be protected by the ADA, because she does not actually have breast cancer.)
Ms. Fink’s story shows that GINA has created a new protected class of employees, and – as with any protected class – employers must exercise caution if they take an adverse action against those employees.
E. Comparison and Interaction with other laws
1. GINA and ADA
Although the protections of GINA and the ADA are closely related, they are distinct. As explained by the EEOC, GINA prohibits discrimination based on genetic information, not on the basis of a manifested condition.
The ADA, on the other hand, prohibits discrimination on the basis of a manifested condition that meets the definition of a disability. In other words, for example, GINA prohibits a woman like Ms. Fink, discussed above, who has been diagnosed with the “breast cancer gene” or whose mother or sister suffered from breast cancer. The employee in that case is protected from being discriminated against due to her carrying the gene, i.e. her increased likelihood of developing breast cancer. The ADA, on the other hand, protects a woman who is actually diagnosed with breast cancer, which is a disability.
Note also that GINA provides that it is not to be construed to diminish in any way any protections under the ADA or the Rehabilitation Act. 42 U.S.C. § 2000ff-8(a).
3. GINA and HIPAA
GINA specifically provides that regulations promulgated under the Health Insurance Portability and Accountability Act (“HIPAA”) trump GINA for purposes of use or disclosure of health information by a covered entity (as defined by HIPAA). Thus, if there is a conflict between HIPAA and GINA as to whether a covered entity may use or disclose health information, HIPAA prevails. 42 U.S.C. § 2000ff-5(c).
3. GINA and State Law
Like other federal anti-discrimination laws, GINA provides that it does not preempt a state law or other federal law that provides greater protection than GINA. 42 U.S.C. § 2000ff-8(a).
4. GINA and Worker’s Compensation
GINA provides that nothing in the statute shall be construed to limit or expand the protections, rights, or obligations of employees or employers under applicable workers' compensation laws. 42 U.S.C. § 2000ff-8(a)(4). Aside from that statement, GINA and its regulations are silent as to how GINA applies to employers and their attorneys or other agents when requesting and reviewing medical information in the context of a workers’ compensation claim. The EEOC is currently reviewing the issue and is expected to promulgate additional guidance in the future. In the meantime, the safe harbor language requesting exclusion of family medical history should be used in all workers’ compensation-related medical records requests. Likewise, be sure to keep workers’ compensation information, which may contain genetic information, separate from employee personnel files.
5. GINA and Health and Safety Laws
GINA provides that nothing in the statute shall be construed to limit the authority of a Federal department or agency to conduct or sponsor occupational or other health research that is conducted in compliance with applicable regulations or to limit the statutory or regulatory authority of the Occupational Safety and Health Administration or the Mine Safety and Health Administration to promulgate or enforce workplace safety and health laws and regulations. 42 U.S.C. § 2000ff-8(a)(5)-(6).
6. GINA and Health Insurance
Finally, GINA provides that nothing in the statute shall be construed to require any specific benefit for an employee or member or a family member of an employee or member under any group health plan or health insurance issuer offering group health insurance coverage in connection with a group health plan. 42 U.S.C. § 2000ff-8(a)(7).
F. Tips for Employers
Employers who use genetic testing in making employment decisions generally will be subject to liability if they continue that practice. According to published reports, a 2001 study by the American Management Association showed that nearly two-thirds of major U.S. companies require medical examinations of new hires, with some 14% conducting tests for susceptibility to workplace hazards, and 20% collecting information about family medical history. To avoid running afoul of GINA, these types of tests and inquiries must not delve into family medical history or an employee or applicant’s genetic information.
Thus, if the company has its own physician or other in-house medical provider, that person should not collect any information about family medical history. If a physician or other provider who is not a company employee collects information on family medical history as part of medical treatment or a medical evaluation connected with the employment, be sure to notify the physician or provider not to forward that information to you.
In sum, employers should:
1. Be aware that genetic discrimination may lead to liability under federal law and some state laws.
2. Not take any adverse action (including failing to hire) against any employee because of genetic information, including family medical history, with respect to the employee.
3. Never request, require, or purchase genetic information with respect to an employee or a family member of the employee unless the employer is certain that one of GINA’s narrow exceptions applies.
4. Continue to keep medical records confidential, secure and separate from other personnel records, and keep any genetic information with those medical records.
5. Implement a practice of purging genetic information from employee files to the extent practicable, particularly where the information was placed in the files after GINA’s effective date of November 21, 2009.
5. Adopt and promulgate genetic non-discrimination policies in the workplace, including posting EEOC’s required information about GINA. 6. Include the EEOC’s suggested language in lawful requests for medical information instructing the medical provider not to provide genetic information, pursuant to 29 C.F.R. 1635.8(b)(1)(B) (see Appendix).
G. Conclusion
Only time will tell how significant GINA will be on workplaces and the employment discrimination landscape. In the meantime, employers should exercise their best efforts to comply with the new law.