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Final GINA Rules to Take Effect Soon

By Matt Jones

NEW YORK (GenomeWeb News) – The final pieces of the Genetic Information Nondiscrimination Act (GINA) that deal with employee rights and employer practices have been finalized by the Equal Employment Opportunity Commission and will be put in place in January 2010, according to the EEOC.

This week, the EEOC issued its final rules on GINA's Title II regulations, which were created to protect job applicants, employees, union members, and others from being discriminated against based on their genetics, and to inform employers about how to deal with their workers' genetic information.

"I am pleased that the new Commission was able to complete the GINA regulations and make some common-sense changes based on the public record," EEOC Commissioner Victoria Lipnic said in a statement yesterday.

"While fulfilling the law's purpose to protect individuals from genetic discrimination, I believe these final regulations properly balance and reflect the needs and realities of the workplace and preserve the appropriate means for employers to offer health and wellness plans," Lipnic said.

Passed into law in 2008, GINA's Title II forbids discrimination based on genetic information regarding hiring, firing, pay, promotions, layoffs, training, lawsuits, and other aspects of employment, by stating that employers may not use genetic information in making employment decisions and by limiting employers' ability to access, possess, and use genetic information about their employees.

Patient advocates praised the EEOC's detailed rules and related policy explanations.

"Americans can finally take advantage of the tremendous potential of genetic research without the fear that their own genetic information will be used against them," Council of Responsible Genetics President Jeremy Gruber said in a statement.

Long-time GINA supporter and Genetic Alliance President and CEO Sharon Terry told GenomeWeb Daily News in an e-mail that the EEOC's ruling plan "looks great."

"We got what was needed and are excited to see this come to fruition," she added.

Critics, such as the National Association of Manufacturers, who had concerns about some of the rules in the law, expressed worries during the rule-making process that if it is interpreted too broadly GINA's Title II could lead to lawsuits for employers who inadvertently come to possess an employee's genetic information. They also suggested that it could undercut the effectiveness of health-risk assessments (HRAs).

NAM said that employers could use genetic and family history information in HRAs to help make evidence-based decisions about how to provide wellness, prevention, and disease management services and incentives to their employees, particularly those with chronic conditions, and that GINA makes such services less feasible.

"The GINA interim final rule leaves two key problematic options for employers: employers must remove questions about family medical history from their HRAs, which will significantly diminish their effectiveness, or must end the use of incentives altogether, which will significantly impair employee participation rates in wellness and prevention programs," NAM said in comments submitted to EEOC in 2009.

NAM declined to comment on the final rules that the EEOC issued Tuesday.

Kerry Leibig, senior attorney-advisor for the EEOC, told GWDN on Wednesday that making the regulations clearer and more easily understandable were important parts of the EEOC's final development process and that she thinks EEOC tried to address NAM's concerns.

Leibig said that EEOC "tried to explain in layman's terms what genetic information is" and what the other parts of the law entail. She noted that EEOC, whose five commissioners voted unanimously for the final regulations, went back and forth in discussions with various stakeholders, as well as the Office of Management and Budget, and other departments in finishing its work on GINA.

"The final rules don't strike me as being any great departure from the proposed regulations," explained Lauren Dame, associate director for the Center for Genome Ethics, Law, and Policy at Duke University's Institute for Genome Sciences and Policy, in an interview on Wednesday.

Dame described the final regulations as offering more information and useful examples for employers to turn to as they implement their policies concerning their workers' medical and genetic information. The EEOC "expand their definitions and give examples in a way that I think people will find very helpful when they are trying to apply this to what they actually do in a company," she said.

Another point of focus was in agreeing on the six exceptions for employers who come into possession of genetic information for various reasons but who did not intend to break the law, Leibig said. "GINA says you may not request, require, or purchase genetic information unless one of these exceptions is met," she said.

The commission also made judgments about how much financial burden the law would place on employers and decided that the costs would be marginal.

Leibig and Peggy Mastroianni, who is associate legal counsel in EEOC's Office of Legal Counsel, explained that GINA would function in some ways with other civil rights legislation, such as the Americans with Disabilities Act, and that cases filed under GINA would probably look similar to ADA cases.

But there are differences between the two.

"Before GINA that area of the law was ruled by the [ADA], which enabled asking any kind of information — as long as you treated everyone the same," Leibig said. "The world has changed after GINA."

Mastroianni estimated that around 200 charges have been filed with EEOC under GINA so far, and that many of these involve cases where there is "an actual health issue" at stake that may have led to the suit. She contrasted those cases with the possibility that an employee might file charges because employers had misused genetic information about healthy people who had no underlying health issues involved.

"Employment discrimination cases [are difficult because] the person who is claiming that they were fired for discriminatory reason has the burden of proving that, and that can be hard to prove," said Dame. "The majority of employment discrimination cases the plaintiff does not win."

The final rules cement and explain several important definitions for words and phrases that are unique to GINA in the civil rights law field, such as "family member," "family medical history," "genetic monitoring," "genetic history," "genetic test," and "manifestation."

The regulations also bar actions to limit, segregate, or classify employees because of genetic information. As an example, EEOC explained that 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 that employee.

Exempting Inadvertent Access

Responding to industry's concerns, the rules also reaffirm GINA's exemption of the inadvertent requesting or requiring of genetic information as violations. The aim of these exemptions was to solve the situations such as the so-called 'water cooler problem,' in which employers unwittingly receive prohibited family history through casual conversations or through other incidental methods.

EEOC said it has extended that inadvertent status to cover "any genetic information" and not just family history, as long as it is received inadvertently, because it fits within the spirit of the law. "The regulations show when the acquisition of genetic information might be considered inadvertent, and when it's not going to be considered inadvertent," Dame added.

"The Commission does not believe, for example, that Congress intended that an employer would be liable for the acquisition of genetic information because it overhears a conversation in which one employee tells another that her mother had a genetic test to determine whether she was at increased risk of getting breast cancer," EEOC said in its final rules.

That exemption also is extended to include inadvertent inquiries about the individual directly — for example, if an employer's question about how someone is feeling brings results in the surrender of genetic information.

The exemption also will cover instances in which genetic information is acquired inadvertently through social media, such as in a case when an employee posts family medical history information on a social networking site to which the employer has been granted access. If someone were to post on their Facebook account that several family members have had certain cancers or other family history information, for example, then that could fall under the inadvertent rule of public availability.

"The way they distinguish whether it is publicly available or not is not whether it is a blog versus social media, but whether it is open to all comers, or whether it's protected … unless they're deliberately going there to hunt for genetic information about me," Dame said.

However, she noted, if an employer is searching for information about an employee and starts clicking on links about some genetic disorders which includes the employee's name, then that employer may be violating GINA.

Another section of the regulations that had drawn comments and which EEOC has explained is the employer's options for employee wellness programs, an issue that Dame called "an area of hot debate" since the law was passed. Employers use health and family history information in wellness plans to develop incentives and programs for boosting employee health.

"People who were pushing employee wellness programs were very unhappy about the idea that they couldn't get family medical histories," Dame added.

"On the one hand you have GINA saying that you can't collect family history, and on the other hand you have this phenomenon of employer wellness programs. People who think wellness programs are a very important thing think, 'Well, you've just taken one of the tools in my toolkit,'" Dame explained.

EEOC decided that employers providing voluntary wellness programs may offer financial inducements for participation in health or genetic services and HRAs, but that they may not offer such inducements for individuals to provide their genetic information and that any questions about genetic information in HRAs are clearly voluntary.

EEOC "clearly paid attention to this issue and concluded that there's a lot of support for the idea of wellness programs, and they shouldn't make it so that employers can't have them," said Dame. "So what they conclude is that employers can have wellness programs, they can offer financial inducements to people to participate in wellness programs, but they can't offer financial inducements to provide genetic information."

The rules also explain that employers are supposed to direct doctors not to ask for genetic information.

"What the regulation does is it provides safe harbor language," Dame explained. "There's a specific paragraph that is language that an employer can stick in a request form that they give to a medical provider. It essentially says that under GINA you're not supposed to give me genetic information and this is what genetic information is.

The way rules should work in practice is that a health risk assessment might have questions that ask for family medical history, which are effectively genetic information, but the employees do not have to answer those questions if they choose not to.

"There's always going to be a tension when there is information about a person which can be used for good reasons, and can be used for bad reasons," said Dame. "Do you design the law so that it absolutely can never be collected or used in order to protect against all the bad reasons, at the cost of being used for any of the good reasons?" she asked.

"I think they have struck a balance," she said of EEOC.

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