Employer's Guide to GINA

GINA defines the term “genetic information” broadly to include an individual's genetic tests; genetic tests of the individual's “family members” (defined as dependents and all relatives to the fourth degree, whether related by blood, marriage or adoption); the manifestation of disease or disorder in family members of the individual (i.e., “family medical history”); an individual's request for, or receipt of, genetic services or participation in clinical research that includes genetic services; and the genetic information of a fetus carried by a pregnant woman or about an embryo held by the individual or family member using assisted reproductive technology.

Congress' intent in enacting GINA was to extend the protections of Title VII of the Civil Rights Act of 1964 to individuals based on their protected genetic information. Not surprisingly, GINA parallels Title VII in its enforcement mechanisms and procedures. Under Title II of GINA, employers are prohibited from: 1) the use of genetic information in employment decisions (i.e., discrimination based upon genetic information); 2) disclosing genetic information in their possession; and 3) requesting, requiring or purchasing genetic information.

Discrimination Based Upon Genetic Information

Under Title II of GINA, it is unlawful for an employer to discriminate against individuals based upon genetic information, regardless of how that information is acquired. Such discrimination includes limiting, segregating or otherwise classifying employees based upon genetic information. Additionally, employers are prohibited from using genetic information in decisions related to employment. Prohibited employment practices include the use of genetic information in deciding whether to hire or fire an individual, or using genetic information to decide whether to provide different compensation, terms, conditions or privileges of employment to an individual. There are no exceptions to the prohibition against discrimination based upon genetic information.

Disclosure of Genetic Information

Title II of GINA strictly limits an employer's ability to disclose any genetic information in its possession. An employer that possesses genetic information must treat it as confidential medical information and store it in separate files and on separate forms, apart from other personnel records. Such genetic information may, however, be kept in the same file as an employee's medical information.

Title II contains six situations in which an employer is permitted to disclose genetic information. An employer may lawfully disclose genetic information in its possession: 1) to the employee or family member about whom the genetic information pertains, upon their written request; 2) to an occupational or health researcher conducting research in compliance with certain federal laws; 3) in response to a court order but only to the extent authorized by the order and after informing the employee; 4) to government officials investigating GINA claims or compliance; 5) to comply with certification under the Family and Medical Leave Act of 1993 (FMLA); and 6) to public health agencies surveying the spread of certain contagious diseases.

Any genetic information in an employer's possession prior to Nov. 21, 2009 need not be removed. However, following that date an employer is not permitted to disclose such information to any third party unless the disclosure falls within one of the previously described exceptions.

Acquisition of Genetic Information

Title II of GINA prohibits employers from acquiring genetic information. Employers cannot request, require or purchase the genetic information of an individual or his or her family members, even if it is never used. The final regulations clarify that requests for genetic information specifically include conducting an Internet search on an individual in a way that is likely to result in obtaining such information. Additionally, actively listening to third-party conversations, searching through an individual's belongings for the purpose of obtaining genetic information, and making requests for information about an individual's current health status in a way that is likely to result in obtaining genetic information are other examples of prohibited employment practices. However, the EEOC's final regulations also make clear that there is no “intent” requirement to establish an employer's violation of GINA. The unintentional acquisition of genetic information is a violation of Title II, unless such acquisition falls under one of Title II's limited exceptions. 75 Fed. Reg. 68,913 (Nov. 9, 2010).

Exceptions Under Title II of GINA

GINA establishes a presumption of unlawfulness when an employer requests, requires or purchases genetic information of an individual or an individual's family members. However, Title II of GINA contains six limited exceptions which the EEOC has stated will be narrowly construed. An employer will not violate Title II of GINA when: 1) it acquires genetic information inadvertently; 2) the genetic information is provided voluntarily by the employee as part of employer-sponsored health or genetic services including wellness programs; 3) it requests and receives genetic information in order to comply with the certification requirements of the FMLA, state leave laws, or certain employer leave policies; 4) the genetic information comes from sources that are commercially and publically available; 5) it requests and receives genetic information as part of genetic monitoring required by law or conducted voluntarily under carefully defined conditions; and 6) it is engaged in conducting DNA tests for law enforcement purposes as a forensic laboratory or for identification of human remains. 26 C.F.R. ” 1635.8(b)(1)-(6) (2010).

Inadvertent Acquisition

An employer does not violate GINA when it receives genetic information inadvertently. The final rule includes several examples of inadvertent acquisition. These include the so-called “water cooler situation,” in which a supervisor overhears an employee discuss genetic information pertaining to him- or herself, or a family member. Inadvertent acquisition could also occur if an employee offers genetic information to the employer in response to a general question about the employee's well-being, not meant to solicit genetic information.

Also covered under this exception is an employer's receipt of genetic information in response to a lawful request for documentation regarding an employee's current medical condition or for certification under the FMLA, state leave or an absence policy. Disclosures under this example will only be considered inadvertent if the employer instructs the individual or health care provider not to provide genetic information. In order to ensure that the inadvertent acquisition exception applies to such requests, the EEOC has suggested that employers provide the following “safe harbor” language:

The Genetic 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 of the individual, 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.

26 C.F.R. ' 1635.8(b)(1)(i)(B) (2010). If such a warning is not given and an employer receives genetic information in response to a lawful request for health-related information, the employer can only avoid liability under GINA if it can demonstrate that the request was made in a manner unlikely to result in the receipt of genetic information as part of the response.

Voluntary Disclosure by the Employee

Title II of GINA exempts employers from liability for receiving genetic information through voluntary disclosure arising from an employee's participation in an employer-sponsored health or wellness program. This exception was enacted in order to encourage employers to provide such services. However, the employee's provision of genetic information in such programs must be voluntary ' meaning that the employer must neither require it nor penalize those who choose not to provide it. In order to satisfy this exception, the employer must show that the employee provided prior knowing, voluntary, written authorization. Additionally, only the employee and a licensed health care professional may receive individually identifiable genetic information, and the employer can only receive genetic information in aggregate form. However, an employer will not violate GINA simply because the small number of participants in such a program makes individual identification possible. 26 C.F.R.
' 1635.8(b)(2) (2010).

The final regulations under Title II state that the common practice of offering financial inducements to encourage employee participation in health or wellness programs is still permitted. However, an employer is prohibited from offering the financial inducement in order to encourage the employee to provide genetic information. 26 C.F.R.
' 1635.8(b)(2)(ii) (2010).

Acquisition Due to Compliance with the FMLA

Under the FMLA, certain state and local leave laws, and an employer's own leave policies, an employer may request medical information from its employees in order to substantiate the need for leave. Title II of GINA recognizes that such requests result in the receipt of family medical history. To that end, Title II includes an exception for an employer receiving such genetic information pursuant to its leave policy, the FMLA, state or local laws. Employers should note that this exception differs from the inadvertent acquisition exception in that under this exception the employer may intentionally request and receive genetic information, as long as it is required for compliance with company policy or leave laws. 26 C.F.R. ' 1635.8(b)(3) (2010).

Genetic Information Derived from Commercially and Publicly Available Sources

Title II allows an exception from liability for an employer that receives genetic information disclosed in publicly or commercially available sources. In enacting this exception, Congress recognized that genetic information about individuals and their family members is sometimes publicly available. Congress wanted to reduce the number of potentially frivolous lawsuits that could result from an employer's acquisition of genetic information from sources such as television, newspapers, or the Internet. However, the exception does not extend to Internet sites that require specific permission to gain access (such as Facebook), or medical databases, court records or research databases available to scientists on a restricted basis. It is important for employers to note that this exception only includes information received through passive means. A search made by an employer with the intent to obtain genetic information will not be protected by this exception, even if the information is found in commercially or publicly available sources. 26 C.F.R. ' 1635.8(b)(4) (2010).

Acquisition Due to Monitoring Effects of Toxic Substances in the Workplace

An employer that performs genetic monitoring to determine whether its employees are being affected by harmful substances in the workplace will not be liable under Title II of GINA. If the monitoring program is not required by law, however, the employer must provide written notice to its employees and obtain their prior voluntary, knowing, written authorization. If an employee refuses to provide genetic information under these circumstances, GINA prohibits the employer from retaliating or otherwise discriminating against the employee. The employer should inform the employee of the potential dangers, but take no adverse action. Under this exception, individualized genetic information may only be provided to the employee or health care professional administering the program. Employers are to receive genetic information in aggregate form only. As in the case of voluntary disclosure, the employer will not be deemed to have violated GINA simply because the small number of participants in such a program makes individual identification possible. 26 C.F.R.
' 1635.8(b)(5) (2010).

Acquisition for Law Enforcement Purposes or to Identify Human Remains

Employers that engage in DNA testing as a forensic laboratory or for identification of human remains are permitted under Title II to collect their employees' genetic information for certain quality control purposes and in order to detect sample contamination. 26 C.F.R. ' 1635.8(b)(6) (2010).

Conclusion

In light of the implementation of the regulations enforcing Title II of GINA, employers should review their policies and procedures, including those related to any sponsored health or wellness programs. Employers should amend their policies to include specific reference to nondiscrimination on the basis of genetic information and should review their recordkeeping procedures to ensure that they comply with GINA. Additionally, employers should include GINA safe harbor language in any forms that are used for processing medical or leave requests. The employer may also wish to include a statement that the employer is permitted to receive family medical history when the employee is requesting leave to care for a sick family member under the employer's leave policy, the FMLA or other state leave laws. Policies should also include a prohibition on the use of company systems in a manner likely to cause the employer to obtain genetic information. Employers would also be well-advised to update EEO postings to include references to GINA.

Last, it should be noted that GINA does not preempt any state or local law that provides equal or greater protection to employees. For that reason, employers should consult local laws and their regular employment counsel to ensure that they are in full legal compliance.

John D. Shyer, a member of this newsletter's Board of Editors, is a labor and employment law partner in the New York office of Latham & Watkins LLP and co-chair of the firm's Employment Law practice group. Kevin Kay is an associate in the firm's New York office.

On May 21, 2008, President George W. Bush signed the Genetic Information Nondiscrimination Act of 2008 (GINA) into law. GINA was enacted out of concern that discrimination based upon a person's genetic information could result in the loss of health coverage or employment. GINA addresses this concern through two main components: Title I generally prohibits group health plans and insurance providers from discriminating based upon genetic information (expanding upon the Health Insurance Portability and Accounting Act of 1996 (HIPAA)). Title II of GINA is focused on federal, state and local employers, private employers with 15 or more employees, as well as employment agencies, labor unions and joint labor-management training programs (collectively employer(s)). On Jan. 10, 2011, the EEOC's final regulations implementing Title II became effective. 26 C.F.R. Part 1635 (2010). This article reviews the new regulations and summarizes Title II's limited exceptions.

Overview of Title II

Title II of GINA is based upon the premise that genetic tests disclose only the possibility that someone may develop a disease or disorder in the future and, therefore, are not indicative of an employee's current ability to perform his or her job. Accordingly, Title II protects individuals from discrimination because of a belief that a person has an increased risk of developing a condition in the future. Discrimination by an employer based upon the fact that an individual currently has a condition or disease may be addressed under the Americans with Disabilities Act of 1990 (ADA) or state law, but not GINA.

GINA defines the term “genetic information” broadly to include an individual's genetic tests; genetic tests of the individual's “family members” (defined as dependents and all relatives to the fourth degree, whether related by blood, marriage or adoption); the manifestation of disease or disorder in family members of the individual (i.e., “family medical history”); an individual's request for, or receipt of, genetic services or participation in clinical research that includes genetic services; and the genetic information of a fetus carried by a pregnant woman or about an embryo held by the individual or family member using assisted reproductive technology.

Congress' intent in enacting GINA was to extend the protections of Title VII of the Civil Rights Act of 1964 to individuals based on their protected genetic information. Not surprisingly, GINA parallels Title VII in its enforcement mechanisms and procedures. Under Title II of GINA, employers are prohibited from: 1) the use of genetic information in employment decisions (i.e., discrimination based upon genetic information); 2) disclosing genetic information in their possession; and 3) requesting, requiring or purchasing genetic information.

Discrimination Based Upon Genetic Information

Under Title II of GINA, it is unlawful for an employer to discriminate against individuals based upon genetic information, regardless of how that information is acquired. Such discrimination includes limiting, segregating or otherwise classifying employees based upon genetic information. Additionally, employers are prohibited from using genetic information in decisions related to employment. Prohibited employment practices include the use of genetic information in deciding whether to hire or fire an individual, or using genetic information to decide whether to provide different compensation, terms, conditions or privileges of employment to an individual. There are no exceptions to the prohibition against discrimination based upon genetic information.

Disclosure of Genetic Information

Title II of GINA strictly limits an employer's ability to disclose any genetic information in its possession. An employer that possesses genetic information must treat it as confidential medical information and store it in separate files and on separate forms, apart from other personnel records. Such genetic information may, however, be kept in the same file as an employee's medical information.

Title II contains six situations in which an employer is permitted to disclose genetic information. An employer may lawfully disclose genetic information in its possession: 1) to the employee or family member about whom the genetic information pertains, upon their written request; 2) to an occupational or health researcher conducting research in compliance with certain federal laws; 3) in response to a court order but only to the extent authorized by the order and after informing the employee; 4) to government officials investigating GINA claims or compliance; 5) to comply with certification under the Family and Medical Leave Act of 1993 (FMLA); and 6) to public health agencies surveying the spread of certain contagious diseases.

Any genetic information in an employer's possession prior to Nov. 21, 2009 need not be removed. However, following that date an employer is not permitted to disclose such information to any third party unless the disclosure falls within one of the previously described exceptions.

Acquisition of Genetic Information

Title II of GINA prohibits employers from acquiring genetic information. Employers cannot request, require or purchase the genetic information of an individual or his or her family members, even if it is never used. The final regulations clarify that requests for genetic information specifically include conducting an Internet search on an individual in a way that is likely to result in obtaining such information. Additionally, actively listening to third-party conversations, searching through an individual's belongings for the purpose of obtaining genetic information, and making requests for information about an individual's current health status in a way that is likely to result in obtaining genetic information are other examples of prohibited employment practices. However, the EEOC's final regulations also make clear that there is no “intent” requirement to establish an employer's violation of GINA. The unintentional acquisition of genetic information is a violation of Title II, unless such acquisition falls under one of Title II's limited exceptions. 75 Fed. Reg. 68,913 (Nov. 9, 2010).

Exceptions Under Title II of GINA

GINA establishes a presumption of unlawfulness when an employer requests, requires or purchases genetic information of an individual or an individual's family members. However, Title II of GINA contains six limited exceptions which the EEOC has stated will be narrowly construed. An employer will not violate Title II of GINA when: 1) it acquires genetic information inadvertently; 2) the genetic information is provided voluntarily by the employee as part of employer-sponsored health or genetic services including wellness programs; 3) it requests and receives genetic information in order to comply with the certification requirements of the FMLA, state leave laws, or certain employer leave policies; 4) the genetic information comes from sources that are commercially and publically available; 5) it requests and receives genetic information as part of genetic monitoring required by law or conducted voluntarily under carefully defined conditions; and 6) it is engaged in conducting DNA tests for law enforcement purposes as a forensic laboratory or for identification of human remains. 26 C.F.R. ” 1635.8(b)(1)-(6) (2010).

Inadvertent Acquisition

An employer does not violate GINA when it receives genetic information inadvertently. The final rule includes several examples of inadvertent acquisition. These include the so-called “water cooler situation,” in which a supervisor overhears an employee discuss genetic information pertaining to him- or herself, or a family member. Inadvertent acquisition could also occur if an employee offers genetic information to the employer in response to a general question about the employee's well-being, not meant to solicit genetic information.

Also covered under this exception is an employer's receipt of genetic information in response to a lawful request for documentation regarding an employee's current medical condition or for certification under the FMLA, state leave or an absence policy. Disclosures under this example will only be considered inadvertent if the employer instructs the individual or health care provider not to provide genetic information. In order to ensure that the inadvertent acquisition exception applies to such requests, the EEOC has suggested that employers provide the following “safe harbor” language:

The Genetic 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 of the individual, 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.

26 C.F.R. ' 1635.8(b)(1)(i)(B) (2010). If such a warning is not given and an employer receives genetic information in response to a lawful request for health-related information, the employer can only avoid liability under GINA if it can demonstrate that the request was made in a manner unlikely to result in the receipt of genetic information as part of the response.

Voluntary Disclosure by the Employee

Title II of GINA exempts employers from liability for receiving genetic information through voluntary disclosure arising from an employee's participation in an employer-sponsored health or wellness program. This exception was enacted in order to encourage employers to provide such services. However, the employee's provision of genetic information in such programs must be voluntary ' meaning that the employer must neither require it nor penalize those who choose not to provide it. In order to satisfy this exception, the employer must show that the employee provided prior knowing, voluntary, written authorization. Additionally, only the employee and a licensed health care professional may receive individually identifiable genetic information, and the employer can only receive genetic information in aggregate form. However, an employer will not violate GINA simply because the small number of participants in such a program makes individual identification possible. 26 C.F.R.
' 1635.8(b)(2) (2010).

The final regulations under Title II state that the common practice of offering financial inducements to encourage employee participation in health or wellness programs is still permitted. However, an employer is prohibited from offering the financial inducement in order to encourage the employee to provide genetic information. 26 C.F.R.
' 1635.8(b)(2)(ii) (2010).

Acquisition Due to Compliance with the FMLA

Under the FMLA, certain state and local leave laws, and an employer's own leave policies, an employer may request medical information from its employees in order to substantiate the need for leave. Title II of GINA recognizes that such requests result in the receipt of family medical history. To that end, Title II includes an exception for an employer receiving such genetic information pursuant to its leave policy, the FMLA, state or local laws. Employers should note that this exception differs from the inadvertent acquisition exception in that under this exception the employer may intentionally request and receive genetic information, as long as it is required for compliance with company policy or leave laws. 26 C.F.R. ' 1635.8(b)(3) (2010).

Genetic Information Derived from Commercially and Publicly Available Sources

Title II allows an exception from liability for an employer that receives genetic information disclosed in publicly or commercially available sources. In enacting this exception, Congress recognized that genetic information about individuals and their family members is sometimes publicly available. Congress wanted to reduce the number of potentially frivolous lawsuits that could result from an employer's acquisition of genetic information from sources such as television, newspapers, or the Internet. However, the exception does not extend to Internet sites that require specific permission to gain access (such as Facebook), or medical databases, court records or research databases available to scientists on a restricted basis. It is important for employers to note that this exception only includes information received through passive means. A search made by an employer with the intent to obtain genetic information will not be protected by this exception, even if the information is found in commercially or publicly available sources. 26 C.F.R. ' 1635.8(b)(4) (2010).

Acquisition Due to Monitoring Effects of Toxic Substances in the Workplace

An employer that performs genetic monitoring to determine whether its employees are being affected by harmful substances in the workplace will not be liable under Title II of GINA. If the monitoring program is not required by law, however, the employer must provide written notice to its employees and obtain their prior voluntary, knowing, written authorization. If an employee refuses to provide genetic information under these circumstances, GINA prohibits the employer from retaliating or otherwise discriminating against the employee. The employer should inform the employee of the potential dangers, but take no adverse action. Under this exception, individualized genetic information may only be provided to the employee or health care professional administering the program. Employers are to receive genetic information in aggregate form only. As in the case of voluntary disclosure, the employer will not be deemed to have violated GINA simply because the small number of participants in such a program makes individual identification possible. 26 C.F.R.
' 1635.8(b)(5) (2010).

Acquisition for Law Enforcement Purposes or to Identify Human Remains

Employers that engage in DNA testing as a forensic laboratory or for identification of human remains are permitted under Title II to collect their employees' genetic information for certain quality control purposes and in order to detect sample contamination. 26 C.F.R. ' 1635.8(b)(6) (2010).

Conclusion

In light of the implementation of the regulations enforcing Title II of GINA, employers should review their policies and procedures, including those related to any sponsored health or wellness programs. Employers should amend their policies to include specific reference to nondiscrimination on the basis of genetic information and should review their recordkeeping procedures to ensure that they comply with GINA. Additionally, employers should include GINA safe harbor language in any forms that are used for processing medical or leave requests. The employer may also wish to include a statement that the employer is permitted to receive family medical history when the employee is requesting leave to care for a sick family member under the employer's leave policy, the FMLA or other state leave laws. Policies should also include a prohibition on the use of company systems in a manner likely to cause the employer to obtain genetic information. Employers would also be well-advised to update EEO postings to include references to GINA.

Last, it should be noted that GINA does not preempt any state or local law that provides equal or greater protection to employees. For that reason, employers should consult local laws and their regular employment counsel to ensure that they are in full legal compliance.

John D. Shyer, a member of this newsletter's Board of Editors, is a labor and employment law partner in the New York office of Latham & Watkins LLP and co-chair of the firm's Employment Law practice group. Kevin Kay is an associate in the firm's New York office.