After several delays, the US Equal Employment Opportunity Commission (EEOC) has issued final regulations that interpret and implement Title II of the Genetic Information Nondiscrimination Act of 2008 (GINA), which took effect on November 21, 2009. Title II of GINA generally prohibits the use of genetic information in making employment decisions, restricts employers from requesting, requiring or purchasing genetic information, and strictly limits the disclosure of genetic information.

The new regulations were published in the Federal Register on November 9, 2010 and will take effect 60 days thereafter. The regulations, which were unanimously approved, were developed: (i) with technical assistance from the National Human Genome Research Institute, an organization within the National Institutes of Health; (ii) in coordination with the Departments of Labor, Health and Human Services, and the Treasury, which have responsibility for issuing regulations applicable to GINA Title I; and (iii) with input from various “stakeholders” and other interested parties who filed public comments during the rulemaking process.

According to the EEOC, its goal was to “implement the various provisions of Title II consistent with Congress’ intent, to provide some additional clarification of those provisions, and to explain more fully those sections where Congress incorporated by reference provisions from other statutes.” The EEOC sought to achieve this goal by including specific examples of key statutory terms and exceptions not contained in the proposed regulations.

Some of the highlights of the final regulations are discussed below.

Clarification of Key Definitions

  • Scope

The regulations clarify that GINA’s anti-discrimination provision includes harassment and retaliation claims.

  • Employee

Despite opposition from employer organizations, the final regulations define “employee” to include former employees. The EEOC reasoned that this definition was consistent with the US Supreme Court’s analysis under Title VII. The final regulations also include several other Title VII definitions.

  • Family Member

The final regulations clarify GINA’s protection of genetic information pertaining to an employee’s family member. The statute defines an individual’s “family member” as a dependent, but the regulations make clear that a dependent includes only those “who are or become related to an individual through marriage, birth, adoption, or placement for adoption.” Although some commenters objected to the inclusion of adoptees, the EEOC explained that an employer’s use of an adopted child’s genetic information to discriminate against an employee would result in the type of discrimination GINA was intended to prohibit.

Under GINA, a “family member” includes first degree relatives, such as parents and children, through fourth degree relatives, such as great-great grandparents and first cousins once removed. The EEOC described this definition as “broader than the term is understood in the practice of medicine,” and declined to extend it despite requests from commenters.

  • Genetic Tests

GINA prohibits an employer’s use and disclosure of genetic information, which includes genetic testing. The statute thereafter defines a “genetic test” as “an analysis of human DNA, RNA, chromosomes, proteins, or metabolites that detects genotypes, mutations, or chromosomal changes.” The EEOC invited comments on the scope of the term “genetic test” and was asked to include specific examples in the text of the regulation. The final regulations explain that genetic tests include carrier screenings for cystic fibrosis and sickle cell anemia, amniocentesis and DNA testing that reveal information about ancestry or family relationships, but does not include alcohol and drug testing, complete blood counts and cholesterol and liver function tests.

Prohibition Against Requesting, Requiring, or Purchasing Genetic Information

GINA restricts an employer from “requesting, requiring, or purchasing genetic information.” The EEOC deleted language from the proposed rule prohibiting the “deliberate acquisition of genetic information.” In doing so, the EEOC agreed with several organizations that those terms improperly imposed a specific intent requirement.

The regulations, however, recognize that GINA does not prohibit inadvertent acquisitions of genetic information such as information obtained through: (1) “water cooler” conversations; (2) casual conversations regarding a general inquiry about an employee or family member’s health; (3) a social networking profile the employer is given permission to access; (4) lawful requests for medical information under the Americans with Disabilities Act (ADA), Family and Medical Leave Act (FMLA), or other leave laws, provided a “safe-harbor” warning (discussed below) is given; or (5) any other situation in which an employer inadvertently acquires genetic information. Moreover, the regulations also recognize that an employee requesting leave to care for a seriously ill family member under the FMLA or a similar state or local law will be required to provide genetic information such as family medical history. And, while the employer’s receipt of this information is not inadvertent, it would not violate GINA.

Safe-Harbor Provision

The final regulations also include a safe harbor provision insulating employers from liability if they inadvertently receive genetic information in response to a medical inquiry. The EEOC has recommended language that an employer may use in medical inquiry forms, such as pre-and post-offer medical exams and fitness-for-duty exams. This language could also be used for medical information requests under the ADA and FMLA, but is not required to be incorporated into the ADA or FMLA form:

  • 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 employees or their family members. In order 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.

Alternative language may be used as long as the individuals are informed that genetic information should not be provided. While failure to give the warning will not generally preclude the employer from arguing that genetic information was inadvertently acquired, the EEOC noted that the warning is mandatory whenever an employer requests a health care professional to conduct an employer-related medical examination on its behalf because the employer “should know that the acquisition of genetic information (e.g., family medical history) would be likely in the absence of the warning.”

The regulations also allow an employer to convey this warning verbally, if the request for medical information is verbal. If the employer is provided with genetic information, the employer must maintain the information in a separate and confidential file in the same manner as required for medical information under the ADA and FMLA.

Wellness Programs

Based upon several employer comments and suggestions, the EEOC amended its proposed regulations allowing employers to offer financial inducements for participation in wellness programs and health assessments if:

  1. the assessment specifically identifies which questions request genetic information; and
  2. the assessment includes a notice that completing that portion is optional and that the financial reward will be provided whether that portion is completed or not.

Best Practices for Employers

Employers should take the following steps to ensure GINA compliance: (1) review and update, if necessary, employment policies to prohibit discrimination based upon genetic discrimination; (2) post the EEOC’s GINA Notice; (3) maintain lawfully obtained genetic information in a separate and confidential file; (4) revise medical information request forms to incorporate the above-referenced safe harbor language; (5) ensure that financial incentives for wellness programs and health assessments are properly given; and (6) conduct GINA training for managers and supervisors.