Summary of EEOC Final Regulations on GINA

EEOC Final Regulations on GINA Title II are codified at 29 C.F.R. Part 1635

Key Definitions

The final regulations define employee to include not only current employees but also applicants and former employees. In addition, the regulations define family member to cover persons who are or who become related to an individual through marriage, birth, adoption or placement for adoption. Thus, even if an adopted child is not related genetically to a covered employee, GINA prohibits the acquisition of genetic information regarding the employee’s adopted child.

The final regulations clarify definitions including what constitutes a genetic test under GINA and provide examples of tests for purposes of GINA that are considered and are not considered genetic tests. For instance, tests for infectious and communicable diseases, complete blood counts, cholesterol tests and liverfunction tests are not considered genetic tests. Genetic tests include but are not limited to:

Certain genetic tests that might determine whether individuals are genetically predisposed to breast cancer, colon cancer, or Huntington’s Disease;

Carrier screening to detect the risk of conditions such as cystic fibrosis, sickle cell anemia, spinal muscular atrophy, or fragile X syndrome in future offspring;

  • Amniocentesis;
  • Newborn screening;
  • Preimplantation genetic diagnosis performed on embryos created using in vitro fertilization;
  • Pharmocogenetic tests to predict how an individual might react to a drug or particular dosage of a drug;
  • DNA testing to detect genetic markers associated with information about ancestry; and
  • DNA testing that reveals family relationships such as paternity.

The regulations also clarify the definition of “manifested disease” so that individuals whose diagnosis was principally based on genetic information would remain protected by GINA and that individuals who had manifested a genetically based disease continued to have their genetic information protected.

General Prohibitions

The final regulations take an expansive view of both the prohibitions on discrimination as well as collection of genetic information; providing strong and unambiguous definitions of key terms and clear examples.

For instance, the regulations make clear that an employer may violate GINA without a specific intent to acquire genetic information. Further, the regulations broadly interpret the term “request” to include:

  • the searching of an individual’s personal effects to obtain genetic information or
  • the making of requests for information about an individual’s current health status in a manner likely to result in obtaining genetic information.

GINA prohibits retaliation against individuals who complain about the acquisition, use or disclosure of their genetic information or the genetic information of their family members. The preamble to the final regulations recognizes a potential claim for harassment on the basis of genetic information. However, the regulations specifically note that GINA does not create a cause of action on the basis of disparate impact. GINA provides remedies consistent with Title VII for individuals whose genetic information (or the genetic information of their family members) was acquired, used or disclosed in violation of GINA.

The regulation’s make clear that GINA’s exception for commercially and publically available information does not apply to materials made available to the public, or to some portion of the public, on a restricted basis (i.e., when more than simple registration is required for access). The exception also does not apply to publicly available materials accessed with the intent of obtaining genetic information such as the conducting of Internet searches on an individual in a manner likely to result in the obtaining of genetic information.

Inadvertent Disclosure and Safe-Harbor Language

GINA exempts employers from liability for “inadvertent” receipt of medical history or genetic information of an individual or his or her family members. For example, accidentally overhearing a conversation by an employee or generally inquiring “How are you?” regarding an employee’s health qualifies as an inadvertent disclosure under the regulations. In addition, genetic information that may be received in connection with an employee’s request for FMLA leave would not violate GINA.

The Regulations impose an affirmative duty on employers and other covered entities to prevent acquiring genetic information. Employers are required under GINA to affirmatively inform healthcare providers not to collect genetic information as part of a medical examination intended to determine an individual’s ability or fitness for work. The final regulations include specific safe-harbor provision language to include on forms or questionnaires in which a lawful request for medical information is made. The purpose of the safe-harbor language is to caution healthcare providers not to provide a company with genetic information.

If an employer receives any genetic information in response to a lawful request that contained the required safe-harbor language, the disclosure will be deemed inadvertent—and not a violation of GINA.

Wellness Programs

GINA allows employers to obtain genetic information in connection with employer-sponsored health services or wellness programs, as long as any identifying genetic information is accessible only to the employee and the healthcare provider. Employers offering an employer-sponsored wellness program are required to obtain knowing, voluntary and written authorization that is written in a manner that the individual providing the genetic information is reasonably likely to understand, describes the information being requested, from whom it is being sought and the safeguards to protect against unlawful disclosure.

The final regulations allow for employers to offer financial incentives to encourage employee participation in a wellness program, but employers cannot offer financial incentives to employees to provide genetic information. The EEOC adopts the same standard it has adopted in Enforcement Guidance under the Americans with Disabilities Act (ADA): a wellness program is voluntary if it neither requires employees to participate nor penalizes employees for nonparticipation. Thus, if an employer is offering an incentive for employees to complete a health-risk assessment that includes questions concerning the employee’s medical history (or the medical history of the employee’s family members), the employer must identify such questions and indicate that the employee need not respond to them in order to receive the incentive.

Confidentiality and Posting Requirements

Like the ADA, GINA requires employers to keep records containing genetic information on separate forms and in separate medical files and to treat them as confidential medical records. According to the Final Regulations, genetic information placed in an employee’s personnel file before November 21, 2009 does not need to be removed from the file. However, the prohibitions against disclosing or using genetic information apply to all such information, regardless of when it was obtained.

The Final Regulations also provide that every covered entity “shall post and keep posted in conspicuous places upon its premises where notices to employees, applicants for employment, and members are customarily posted a notice to be prepared or approved by the Commission setting forth excerpts from or, summaries of, the pertinent provisions of this regulation and information pertinent to the filing of a complaint.”