Thanks to the decoding of the human genome, many genetic tests now exist that can help determine whether individuals may be at risk of developing specific diseases or disorders. These scientific advances raise concerns that certain individuals might lose access to health insurance coverage or employment if insurers or employers learn that an individual’s genetic information suggests an increased risk of acquiring a disease or disorder in the future.

The Genetic Information Nondiscrimination Act of 2008 (“GINA”) is intended to prevent discrimination by health insurers and employers based on individuals’ genetic information. Title I of GINA applies to health insurers. Title II applies to private employers with 15 or more employees, employment agencies, labor unions, joint labor-management training programs, and certain other entities.

Title II of GINA is administered by the Equal Employment Opportunity Commission (“EEOC”). On November 9, 2010, the EEOC published its final regulations implementing Title II of GINA. The final regulations take effect on January 10, 2011. This bulletin discusses GINA and the EEOC’s implementing regulations, and provides practical guidance for covered employers.

The Genetic Information Nondiscrimination Act of 2008 (“GINA”)

Congress enacted Title II of GINA to protect job applicants, current and former employees, labor union members, and apprentices and trainees from discrimination based on their genetic information. Title II of GINA restricts employers and others from deliberately acquiring genetic information, prohibits the use of even properly acquired genetic information in any employment decision, requires that properly acquired genetic information be kept confidential, and provides remedies for individuals whose genetic information is acquired, used, or disclosed in violation of GINA’s protections.

GINA does not preempt any other state or local law that provides equal or greater protection from discrimination on the basis of genetic information, equal or greater protection from improper access to or disclosure of genetic information, or greater privacy protection of genetic information.

GINA does not affect individuals’ rights under the Americans with Disabilities Act (“ADA”), the Rehabilitation Act, or other laws prohibiting discrimination based on disability. GINA prohibits discrimination (including harassment and retaliation) based on genetic information and not on the basis of a manifested condition. In contrast, the ADA prohibits discrimination based on manifested conditions that meet the definition of disability. However, GINA does limit an employer’s ability to obtain genetic information as a part of a disability-related inquiry or medical examination permitted under the ADA.

EEOC Final Regulations Implementing Title II of GINA

The EEOC’s final regulations implementing Title II of GINA provide guidance to covered employers regarding GINA’s restrictions on the deliberate acquisition of genetic information, prohibition on the use of genetic information in employment decisions, confidentiality provisions and enforcement and remedies.

Restrictions on Deliberate Acquisition of Genetic Information

Covered employers are prohibited from: requesting genetic information from applicants, employees, or other persons; requiring applicants or employees to provide genetic information; and purchasing genetic information about an applicant or employee. “Requesting” genetic information includes conducting internet searches, intentionally listening to third-party conversations, searching an individual’s personal effects and making requests for information about an individual’s current health status in a way that is likely to result in a covered employer obtaining genetic information. Thus, under certain circumstances, a covered employer may violate GINA even if the employer did not specifically intend to acquire genetic information.

However, not every acquisition of genetic information violates GINA. The regulations identify six exceptions:

  1. Where an employer inadvertently requests genetic information from a person or the person’s family member. Note that an employer seeking to take advantage of this exception should warn anyone from whom it requests health-related information not to provide genetic information. The final regulations include specific “safe harbor” warning language (as described below) for this purpose.
  2. Where an employer offers health or genetic services, including such services offered as part of a voluntary wellness program.
  3. Where an employer requests family medical history to comply with the certification provisions of the Family and Medical Leave Act (“FMLA”).
  4. Where an employer inadvertently acquires genetic information included in documents that are commercially and publicly available for review or purchase.
  5. Where an employer acquires genetic information for use in voluntary programs monitoring the biological effects of toxic substances in the workplace.
  6. Where an employer conducts DNA analysis for law enforcement purposes as a forensic laboratory or for purposes of human remains identification, to the extent genetic information is used for quality control to detect sample contamination.

Prohibition on the Use of Genetic Information in Employment Decisions

GINA prohibits discrimination with respect to a wide range of employment practices, including hiring, promotion and demotion, seniority, discipline, termination, compensation and other terms and conditions of employment. GINA also prohibits retaliation against individuals for asserting their rights under the statute. The regulations reiterate GINA’s statutory language barring actions by employers that may limit, segregate or classify employees based on their genetic information. For example, an employer could not reassign someone whom it learned had a family medical history of heart disease from a job it believed would be too stressful and might eventually lead to heart-related problems for the employee. This means that employers cannot rely on genetic information to justify deciding that reassigning the employee would avoid an undue hardship under the ADA.

Confidentiality

Under GINA, employers must treat genetic information in their possession the same way they treat employees’ medical information generally. Employers’ must keep such information confidential. If the genetic information is in writing, it must be kept in confidential files, separate from other personnel information. An employee’s genetic information may be kept in the same file as his or her medical information that is protected under the ADA.

GINA permits disclosure of genetic information in the following limited circumstances: (1) where an individual requests disclosure of his or her own genetic information in writing; (2) to an occupational or other health researcher conducting research in compliance with regulations of research involving human subjects; (3) in compliance with a court order, where the employer informs the employee of the court order and the information that was disclosed; (4) to government officials investigating compliance with GINA; (5) in complying with the requirements of the FMLA or similar state or local leave laws; and (6) to governmental public health officials in connection with a contagious disease that presents an imminent hazard of death or life-threatening illness.

Employers subject to HIPAA must continue to apply the requirements of HIPAA, and not the requirements of GINA, to protecting the confidentiality of genetic information that is also protected health information. However, all employers covered by GINA, regardless of whether they are also covered by HIPAA, must follow the non-disclosure requirements of GINA.

Enforcement and Remedies

The procedures for enforcement of GINA are the same as those for other federal anti-discrimination laws administered by the EEOC. Also, similar to other federal anti-discrimination laws, GINA provides for recovery of pecuniary and non-pecuniary damages, including compensatory and punitive damages, reasonable attorney’s fees, and injunctive relief.

Practical Recommendations for Employers

The following five steps are available to employers to comply with GINA and the EEOC’s implementing regulations.

  1. Display EEO Poster Supplement

Employers must obtain and conspicuously post supplemental Equal Employment Opportunity notices informing employees of their rights under GINA. A copy of the EEOC’s Poster Supplement may be downloaded from www.eeoc.gov/employers/upload/eeoc_gina_supplement.pdf.

  1. Include EEOC’s “Safe Harbor” Notice in All Requests for Medical Information

Employers who request medical information from employees should make such requests in writing and include the EEOC’s “safe harbor” notice. This notice informs employees that they are not being asked to provide genetic information. The EEOC’s notice [provided at 29 CFR § 1635.8(b)(1)(i)(B)] reads as follows:

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 an individual or family member, except as specifically allowed by this law. 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.

In the absence of the above “safe harbor” notice, the EEOC may deem any genetic information obtained by an employer as having been deliberately acquired, potentially in violation of GINA. Accordingly, employers should include the EEOC’s “safe harbor” language in all forms used each time medical information is requested from employees or applicants—including forms used in connection with wellness programs.

  1. Review Medical Exam Policies and Procedures

GINA may require some employers to modify their policies and procedures regarding medical examinations. Although the ADA permits employers under certain circumstances to conduct a medical examination after making a job offer or during employment, the examination may not include the collection of a family medical history. Further, GINA’s final regulations provide that the employer must notify health care professionals administering the examination not to collect genetic information. Employers also must take further reasonable measures within their control if they learn that genetic information is being requested or required by health care providers to whom they send an employee or applicant.

  1. Review Wellness Programs

Employers also should review their wellness programs in light of GINA. As discussed above, GINA permits employers to acquire genetic information where health or genetic services are offered by the employer, including such services offered as part of a wellness program. However, in order to qualify for this exception, an employer must meet specific requirements. The employer must use an authorization form that: (1) is written in language reasonably likely to be understood by the individual from whom the information is sought; (2) describes the information being requested; and (3) describes the safeguards in place to protect against unlawful disclosure. Additionally, wellness programs must be voluntary, meaning that the employer neither requires participation, nor penalizes employees for non-participation. As noted above, forms requesting medical information from employees in connection with wellness programs should include the EEOC’s “safe harbor” notice. Any financial incentive offered to employees for completing such forms or participating in a wellness program must: (i) specifically identify any questions requesting genetic information; and (ii) state that employees will receive the financial incentive regardless of whether they answer the identified questions.

  1. Review Biological Monitoring Programs

Finally, employers who monitor the biological effects of toxic substances in the workplace must meet certain requirements in order to fall under GINA’s monitoring exception. Employers must (1) provide written notice of the monitoring and obtain an individual’s prior knowing, written, and voluntary authorization; (2) provide a certain type of authorization form that is written in a way that is reasonably likely to be understood by the person from whom the information is being sought, describes any type of genetic information that will be obtained and the general purposes for which it will be used, and describes the limitations on disclosure of the genetic information; and (3) comply with all applicable provisions of the Occupational Safety and Health Act of 1970, the Federal Mine Safety and Health Act of 1977, and the Atomic Energy Act of 1954. An individual who refuses to participate in a voluntary genetic monitoring program should be informed of the potential dangers, but the employer is prohibited from taking any adverse action against the individual.