Proposed GINA Regulations are Published

The Equal Employment Opportunity Commission (EEOC) has published in the Federal Register its proposed regulations for Title II of the Genetic Information Non-Discrimination Act (GINA). GINA – which, among other things, prohibits employment discrimination based on genetic information, bars the intentional acquisition of genetic information about applicants and employees, and imposes strict confidentiality requirements – mandates that the EEOC issue implementing regulations by May 21 of this year. Title II of GINA, which governs the employment provisions of the Act, takes effect on November 21, 2009.  Comments on the proposed regulations are due by May 1, 2009.

GINA was enacted on May 21, 2008 as Pub. L. 110-233, and codified at 42 U.S.C. 2000ff et. seq. Title I of GINA applies to group health plans sponsored by private employers, unions, and state and local government employers, among other entities. Title II prohibits genetic discrimination in the employment context, prohibiting the deliberate acquisition and disclosure of genetic information by employers. Title II also prevents employers from making adverse employment decisions based on an employee’s or applicant’s genetic information. In drafting implementing regulations for GINA, the EEOC borrowed many terms and concepts it has used for other employment anti-discrimination laws, such as the Americans with Disabilities Act (ADA) and Title VII of the Civil Rights Act.

The GINA proposed regulations are divided into 12 sections that will ultimately be codified at 29 C.F.R. § 1635. Although all areas are eligible for comment, the EEOC is seeking input in a few specific areas; particularly those the EEOC acknowledges certain terms and concepts that are unique to GINA which are outside the EEOC’s scope. In addition to consulting with the National Human Genome Research Institute, the EEOC is inviting comments regarding certain definitions particular to GINA. Of note, the definition of “genetic test” – an “analysis of human DNA, RNA, chromosomes, proteins, or metabolites that detects genotypes, mutations, or chromosomal changes” – contains terms that are not common in employment discrimination law. Other terms and phrases specific to GINA over which the EEOC welcomes comment include “family member,” “family medical history,” “genetic monitoring,” “genetic services,” and “manifestation” of a genetic condition or disease.

The regulations also clarify that a test to detect the presence of a virus that is not composed of DNA, RNA, chromosomes, proteins, or metabolites does not render it a “genetic test” under the Act, nor are drug and alcohol tests. The EEOC is seeking comment on whether other types of tests should be included/excluded from the “genetic test” umbrella.

Under GINA, an employer may not “request, require, or purchase genetic information” about an applicant or employee. One of the six exceptions to this rule under the Act includes any voluntary disclosure. The EEOC therefore seeks comment about how this voluntary exception would apply to a voluntary employer-provided wellness program.

GINA also makes an exception for the purchase of commercially and publicly available material that may include a family medical history. The regulations explain, for example, that an employer would not violate GINA if it discovered an employee had the breast cancer gene by reading an article profiling individuals who knew they had that gene. The statute provides a list of media sources that may make an individual’s genetic information publicly available, such as newspapers, magazines, periodicals, and books. The regulations add to that list information obtained through electronic media, such as the Internet, television, and movies. The EEOC seeks input as to whether other types of sources should be added to this list.

The statute also includes a narrow exception for employers that engage in DNA testing for law enforcement purposes as a forensics lab or for purposes of human remains identification. Under GINA, these employers may request or require “genetic information of such employer’s employees, apprentices, or trainees, but only to the extent that such genetic information is used for analysis of DNA identification markers for quality control to detect sample contamination and maintained in a manner consistent with such use.” The EEOC thus seeks public comment on how this exception would impact law enforcement.

With respect to the protections offered under Title I of GINA, the regulations explain that if Title I offers a remedy for a special insurance-related practice or act, then that practice or act cannot be challenged and no remedy may be sought under Title II.

The regulations also emphasize that some of the employer inquiries that are deemed permissible under the ADA are now unlawful under GINA. For example, the ADA had permitted employers under certain circumstances to obtain medical information – including genetic information – from post-offer applicants. GINA, however, proscribes the solicitation of any genetic information, including family medical history, from such applicants or employees, except under very limited circumstances.

Finally, the regulations explain the interplay between GINA and other employment laws, including the ADA and the Family and Medical Leave Act (FMLA)

Comments on these proposed regulations may be sent by mail to Stephen Llewellyn, Executive Officer, Executive Secretariat, Equal Employment Opportunity Commission, 131 M Street, NE., Suite 6NE03F, Washington, DC  20507, or by facsimile (six or fewer pages only) to (202) 663-4114. Alternatively, comments may be submitted online at All comment submissions must include the agency name (EEOC) and docket number or the Regulatory Information Number (RIN): 3046-AA84.

According to the EEOC, the typical human resources professional will need to dedicate, at most, three hours to gain a satisfactory understanding of the new requirements imposed under GINA. For more information on GINA, see Littler’s ASAP: Genetic Antidiscrimination Law Creates New Compliance Challenges for Employers by: Philip L. Gordon and Jennifer L. Mora.

Information contained in this publication is intended for informational purposes only and does not constitute legal advice or opinion, nor is it a substitute for the professional judgment of an attorney.