Statement of Christopher J. Kuczynski, J.D., LL.M. Assistant Legal Counsel ADA Policy Division

Meeting of February 25, 2009 - on Notice of Proposed Rulemaking Implementation of Title II of the Genetic Information Non-Discrimination Act of 2008


I am very pleased to speak to you briefly about the Notice of Proposed Rulemaking (NPRM) to implement Title II of the Genetic Information Non-Discrimination Act of 2008 (GINA) that the Commission has recently approved. I will summarize the twelve sections of the proposed rule, which will ultimately be published as a final rule at 29 C.F.R. Part 1635, in very general terms, noting a few issues on which we are particularly interested in public comment.


GINA was enacted in response to developments in the field of genetics, the decoding of the human genome, and advances in genomic medicine. Congress believed that individuals were not taking advantage of genetic tests that could inform them whether they are at risk of acquiring certain conditions, because of concerns about discrimination by insurers or employers with access to their genetic information. Moreover, without this legislation, Congress believed individuals might be reluctant to participate in beneficial genetic research.

Consequently, Title I of GINA amends portions of the Employee Retirement Income Security Act, the Public Health Service Act, and the Internal Revenue Code to prohibit certain insurance practices based on genetic information. And, Title II of GINA prohibits employers, employment agencies, labor organizations, joint labor-management committees, and apprenticeship programs (all of which we refer to collectively in the NPRM as covered entities) from using genetic information to make employment decisions, prohibits deliberate acquisition of genetic information from employees and applicants for employment, and strictly limits the circumstances under which covered entities may disclose genetic information about applicants and employees.


Section 1635.1 does nothing more than to state that the proposed rule's purpose is to implement Title II of GINA. Proposed Section 1635.2 is a list of definitions common to employment discrimination laws, such as Title VII of the Civil Rights Act of 1964 and the Americans with Disabilities Act. As this section makes clear, GINA applies to private employers with fifteen or more employees, state and local government employers of the same size, federal executive branch agencies (including the Executive Office of the President), and the United States Congress.

Proposed section 1635.3 includes definitions of terms unique to GINA: family member, family medical history, genetic information, genetic test, genetic monitoring, genetic services, and "manifested or manifestation" as that term applies to a disease or disorder in an individual or a family member of the individual. EEOC staff developed these definitions through close collaboration– both informally, before the Commission voted on the September 26, 2008 version of the NPRM, and subsequently during the formal coordination process through the Office of Management and Budget – with agencies having the necessary expertise, such as the National Institutes of Health.

The Preamble accompanying the proposed rule specifically invites public comment on these definitions. For example, consistent with the plain language of the statute, the proposed regulation defines "genetic test" as "an analysis of human DNA, RNA, chromosomes, proteins, or metabolites that detects genotypes, mutations, or chromosomal changes." The regulation adds, however, that a test to detect the presence of a virus that is not composed of DNA, RNA, chromosomes, proteins, or metabolites is not a genetic test; nor is a test to determine whether someone is using drugs or alcohol. These points were included to provide some additional clarity and some assurance to the regulated community that certain types of tests they may legitimately conduct are still permitted, subject of course to whatever limitations the ADA or other laws may impose. The Preamble asks for comment on whether additional examples of what do or do not constitute genetic tests should be included in the final regulation or Preamble.

Sections 1635.4 through 1635.7 prohibit the same forms of discrimination as Title VII and other employment discrimination laws. Section 1635.4 prohibits discrimination with respect to hiring, promotion and demotion, seniority, discipline, termination, compensation, and other terms, conditions, and privileges of employment. Section 1635.5 prohibits policies and practices that limit, segregate, or classify employees because of genetic information. Section 1635.6 prohibits an employment agency, labor organization, or joint labor-management committee from causing an employer to discriminate against an individual because of genetic information, such as where an employment agency refuses to refer an applicant for employment because of genetic information. Section 1635.7 prohibits retaliation against an individual who opposes any act made unlawful by GINA, files a charge of discrimination or assists another in doing so, or gives testimony in connection with a charge. Unlike Title VII, GINA does not provide a cause of action for disparate impact. Instead, it requires that a special commission study the issue beginning in 2014 and make recommendations on whether the law ought to be changed to provide for such a cause of action.

Section 1635.8 includes the general rule that a covered entity may not request, require, or purchase genetic information about an applicant or employee, and then describes six narrow exceptions to this rule. The first exception is where the acquisition of genetic information is inadvertent, which may include information that a supervisor or manager overhears in a conversation between co-workers (sometimes referred to as the "water cooler" exception), as well as inadvertent disclosures that occur in other circumstances, such as when an employee inadvertently provides genetic information as part of documentation to support a request for a reasonable accommodation under the ADA. Genetic information may also be provided as part of a voluntary wellness program, in support of a request for FMLA leave, through documents that are publicly and commercially available (such as newspapers, magazines, or books), as part of genetic monitoring of toxic substances in the workplace (so long as an employee provides prior knowing, written, and voluntary consent), and where an employer engages in DNA collection for law enforcement purposes as a forensic lab or for human remains identification.

Three instances in which we specifically ask for public comments in connection with proposed section 1635.8 are noteworthy. First, we ask for input on how the term "voluntary" should be defined with respect to a wellness program. In ADA enforcement guidance, the Commission has said only that a wellness program is voluntary if it neither requires employees to participate, nor penalizes employees for non-participation. Second, we invite comment on whether the exception for genetic information acquired through sources that are publicly and commercially available should include sources other than those mentioned in the statute – newspapers, magazines, or books. The proposed regulation also includes electronic media, such as the Internet, television, and movies. We ask whether these sources should remain a part of the regulation, and whether others (such as personal websites and social networking sites) ought to be included. Finally, we ask for comments on how the exception applicable to DNA collection for forensic labs and human remains identification will affect law enforcement.

Section 1635.9 includes GINA's confidentiality requirement and six narrow exceptions to confidentiality. Consistent with GINA's plain language, a covered entity must keep genetic information separate from personnel files, but it may keep it in the same file as medical information subject to the ADA. Also, the NPRM states that covered entities are not required to keep genetic information confidential that they obtained through sources that are publicly and commercially available, but they still may not use such information to discriminate.

The NPRM allows disclosure of genetic information in six situations, all found in the statute: to the individual to whom the information relates, if the individual requests disclosure in writing; to an occupational health researcher "if the research is being conducted in compliance with certain federal regulations;" to comply with a court order, as long as the disclosure is carefully tailored to the terms of the order and the covered entity informs the individual about the order and what information it disclosed; to government officials investigating compliance with GINA; to comply with the requirements of the FMLA or similar state or local leave laws; and to federal, state, or local public health officials in connection with a family member's contagious disease that presents an imminent hazard of death or life-threatening illness, as long as the employee is informed of the disclosure.

Section 1635.10 sets forth the remedies, rights, and procedures available for violations of GINA. Essentially, they are the same remedies, rights, and procedures that are available for violations of Title VII, including the requirement to file charges with EEOC against private or state or local government employers and the requirement to exhaust administrative remedies and meet all applicable time frames for filing complaints against federal sector employers. Statutory caps on damages apply, and punitive damages are unavailable against federal, state, or local government employers.

Proposed section 1635.11 describes the relationship of GINA to other federal, state, or local laws. GINA does not limit the protections available under any federal, state, or local laws (including privacy laws) that provide equal or greater protection than GINA provides, and does not limit an individual's rights under any federal state or local laws that prohibit discrimination on the basis of disability. This section also includes GINA's "firewall" provision that seeks to ensure that health plan or issuer requirements or prohibitions are addressed and remedied through ERISA, the Public Health Service Act, or the Internal Revenue Code (as those laws are amended by Title I of the GINA) and not through Title II and other employment discrimination procedures. To try and put it simply, if Title I provides a remedy for a particular insurance-related practice, then that practice may not be challenged and a remedy may not be sought under Title II.

Other provisions in this section clarify that GINA does not limit or expand rights or obligations under workers' compensation laws; limit or expand the rights of federal agencies to conduct or support occupational or other health research conducted in accordance with certain federal regulations; or limit the statutory or regulatory authority of the Occupational Safety and Health Administration or the Mine Safety and Health Administration to promulgate workplace health and safety laws and regulations. Another provision addresses the exemption from GINA of the Armed Forces Repository of Specimen Samples for the Identification of Remains.

Finally, proposed section 1635.11 states that the provisions of the HIPAA Privacy Rule, not those of GINA, govern the obligations of HIPAA covered entities with respect to genetic information that is protected health information. For example, if an employee received treatment at the hospital where she was employed, HIPAA would govern the collection and maintenance of medical records obtained by the hospital in its role as a health care provider. However, Title II of GINA would govern genetic information about the same employee obtained by the hospital in the course of employment, such as family medical history provided to support a request for FMLA leave.

Finally, proposed section 1635.12 says that GINA does not apply to the acquisition, use, or disclosure of information about a manifested disease or disorder, other than genetic information, even if the disease or disorder has a genetic basis. However, provisions of the ADA governing the acquisition, use, and disclosure of medical information continue to apply to information about a manifested disease or disorder.


The NPRM has been sent to the Federal Register and we expect it to be published for a sixty-day comment period this week. I would be happy to take any questions.