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EEOC Holds Meeting on GINA Title II; Issues Notice of Proposed Rule for Public Comment


In line with the statutes of the Genetic Information Nondiscrimination Act, the Equal Employment Opportunity Commission last week issued a notice of proposed rulemaking to gather public comments on how best to implement the law and protect people from employment discrimination based on genetic information.

GINA, which was finally signed into law by President George W. Bush last year after being held up in Congress for more than a decade, prohibits genetic discrimination from insurers (Title I) and from employers (Title II) [see PGx Reporter 07-11-2008].

Under Title II of the law, the EEOC must issue regulations by May. As a result, the commission last week issued an NPRM implementing Title II and held a public hearing at its new headquarters in Washington, DC, to discuss the topic of genetic discrimination in the workplace. The public has 60 days from Feb. 25 to comment on the document.

At the public meeting, speakers from groups representing employers and employees pointed out the need for the EEOC to clarify "inadvertent acquisition" of genetic information under which employers would not be held in violation of the law and to provide specific examples of the types of "manifested diseases" for which the law does not shield a person's genetic data from employment discrimination.

The public hearing was followed by a closed session, which was listed in an EEOC-issued agenda as considering an "amicus curiae recommendation." However, the EEOC did not reveal further details to Pharmacogenomics Reporter, describing the topics discussed during the closed session as "internal matters."

Inadvertent Acquisition

Title II of GINA makes it unlawful for an employer to make hiring, firing, or compensation decisions based on the genetic information of an employee or their family members. Furthermore, the law generally prohibits employers from requesting, requiring, or purchasing their employees' genetic information.

However, employers would not be violating the law if they "inadvertently" gain access to the family medical history of employees through an employer-sponsored wellness program; via authorization by the employee; through publicly available, commercial information; or as part of a program to monitor biological effects of toxic substances in the workplace.

"With respect to the 'inadvertent requests' exception, the regulations should clarify that this exception applies not only to casual, 'water cooler' office discussions, but also any time an employee volunteers genetic information without prompting by the employer," Rae Vann, general counsel to the Equal Employment Advisory Counsel, said during the public hearing.

Furthermore, the EEOC should provide "practical illustrations" of how an employer might gain knowledge of an employee's genetic risk data through publicly available information, Vann suggested.

"One example" Vann offered, "might [involve] a manager who buys and reads a weekly news magazine that includes a story on genetic markers, in which an employee is quoted as having tested positive for such a marker."

In his comments, Vann asserted that the EEOC's rules highlight that employees must produce evidence of their employers' violations of GINA.

Additionally, certain definitions in the law, such as "family members" need more clarification. GINA defines "family members" as an employee's first, second, third, and fourth degree relatives. "The EEOC’s implementing regulations should provide guidance as to what these degrees of relationship mean," Vann noted.

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Overall GINA should not be a burden to employers as implemented by EEOC, Vann pointed out.

"As a general observation, to the extent that employment discrimination on the basis of genetic discrimination has not been a pervasive problem, the EEOC should point out in its implementing regulations that the aim of the law is to prevent a discrimination problem from developing, and its regulations should be 'user-friendly,' designed to provide clear and practical examples of both prohibited conduct and employer best practices," Vann said.

Also at the meeting, Karen Elliott of the small business-focused law firm Gregory Kaplan and a member of the professional group Society for Human Resource Management, pointed out that employers should have protections that keep them safe in several circumstances regarding possession of genetic information that are not clearly protected under the law. The employer should be covered when it did not seek the information, and when it was disclosed by the employee, Elliott stated.

Michael Eastman, a member of the Genetic Information Non-Discrimination in Employment Coalition, a group that had expressed opposition to several provisions within Title II while GINA was still in congress, told Pharmacogenomics Reporter this week that the GINEC has not yet reviewed EEOC proposed rule.

However, he noted that GINEC will be specifically looking to clarify language in the law that would keep employers from "tripping themselves up in the confidentiality provisions" of Title II.

“We hope the regulatory process limits well-intentioned employers from inadvertently violating statute," said Eastman, who is also executive director of labor law policy at the US Chamber of Commerce.

Manifested Diseases

One exception within GINA does not protect genetic information that is linked to a manifest condition.

In comments to the EEOC, Susannah Baruch, law and policy director at the Johns Hopkins University's Genetics and Public Policy Center, urged the agency to provide clear examples of when genetic information would not be protected under GINA.

According to the GPPC, EEOC's regulations should make clear that a “manifestation of a disease” refers to signs and symptoms of a pre-existing condition in an individual, and does not refer to a genetic test result.

In line with this recommendation, the EEOC states in the NPRM that under the law, a "disease, disorder, or pathological condition is not manifested if the diagnosis is based principally on genetic information or on the results of one or more genetic tests."

In the NPRM, the EEOC cites BRCA testing for hereditary breast cancer and genetic testing for Huntington's disease as examples of when genetic information would not fall under the "manifest disease" exemption.

For instance, "a woman who has group health plan coverage and has the BRCA1 gene variant may not be subject to a preexisting condition exclusion merely because she has the variant," the EEOC states in the NPRM.

"Similarly, Huntington's disease is an example of a genetic disease that is not diagnosed solely through use of a genetic test; other signs and symptoms must be present. The presence of the genetic variant virtually guarantees the later development of disease, but the disease does not usually manifest until adulthood.

"Therefore, even when a genetic variant is 100 percent predictive for development of disease, the presence of the variant does not by itself equal diagnosis of the disease," the EEOC notes.

Baruch agreed with industry advocates that the laws should not burden employers and should be presented in a manner that limits confusion about "inadvertent acquisition" of genetic information.

At the meeting, Baruch also urged EEOC to handle "carefully" implementation of the law with regard to employee-offered wellness programs.

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According to Baruch, although some wellness programs are governed by existing law under the Health Insurance Portability and Accountability Act and are supposed to be voluntary, HIPAA's rules allow for significant increases or reductions in health care premiums, as well as other incentives and disincentives for participation in the programs.

"We believe the HIPAA nondiscrimination rules currently permit a great deal of discrimination based on health status and should be revisited, and we would welcome EEOC’s discussion of whether wellness programs currently authorized under HIPAA qualify as “voluntary” wellness programs under federal employment law," Baruch said during the meeting.


GINA includes provisions separating the potential liabilities insurers and employers could face, exempts employers from liabilities if the employer “inadvertently” garners genetic information through a company-sponsored wellness program, and requires employers to request such information in order to monitor biological effects of toxic substances in the workplace.

The inclusion of this "firewall" was a key point for industry groups during congressional negotiations of the bill.

Baruch pointed out that in many small companies, the same office manager in charge of hiring and firing decisions also handles administration of health care benefits, which could potentially cause confusion with regard to the "firewall" between Title I and Title II.

"The protection should be seamless to the individual: neither the employer nor the employer-sponsored health plan can request or require the information or use it to discriminate," she noted. "The regulations should clarify what the firewall means and does not mean."