Tag Archives: GINA

EEOC Stays Mum on GINA

In “an informal discussion” that it hopes “is helpful,” the Equal Employment Opportunity Commission (EEOC) has given an apparently negative answer to the following question:

Are DNA sequences that cannot be used and are not acquired by an employer to obtain medically relevant information on an employee “genetic information” as the term is used in the Genetic Information and Nondiscrimination Act of 2008 (GINA)?

The question came from the Scientific Working Group on DNA Analysis Methods (SWGDAM), which requested an “Informal Advisory Opinion … on the GINA exemption for forensic laboratories.” GINA makes it generally illegal for “an employer to request, require, or purchase genetic information with respect to an individual.” � 202. It defines “genetic information” as “information about [an] individual’s genetic tests.” � 206(A)(i). Finally, it defines a “genetic test” as “an analysis of human DNA, RNA, chromosomes, proteins, or metabolites, that detects genotypes, mutations, or chromosomal changes.” � 201(7)(A).

Congress, in its finite wisdom, devoted almost no attention to the problem this law could create for police departments, laboratories that perform DNA testing, and manufacturers of reagents and materials used for DNA testing. Because personnel at these organizations can–and have–contaminated samples or equipment with their own DNA, it would be helpful to have DNA identification profiles from all employees who might possibly be a source of foreign DNA on record. A check of the records could the confirm or exclude any suspicions of such employee contamination. And even without a database, in a specific case, an employer might have good reason to ask a particular employee for a DNA sample to check whether that individual’s DNA seems like it could have affected a DNA test.

What Is a “Genetic Test”?

This situation could be resolved most simply by interpreting “genetic test” in light of the express Congressional goal of preventing employers from using health-related DNA sequence information to disadvantage applicants for jobs or employees. Because the DNA identification profile does not reveal such information and is not being used for such a purpose, this biometric identifier should not be considered a genetic test under Section 201(7). It is, of course, “an analysis of human DNA,” but does it “detect[] genotypes, mutations, or chromosomal changes”? Current STR testing does not detect “genotypes” in the sense of alleles of genes. It does detect “mutations” inasmuch as all genomic variation comes from changes in base-pair sequences, but that cannot be what Congress meant by “mutations.” Such a reading would render the preceding word, “genotypes,” superfluous. Perhaps “mutations” is in the list to cover sequences that do not cause disease but have predictive power as a result of linkage disequilibrium, or perhaps it refers to somatic mutations that can produce diseases without altering intergenerationally inherited genotypes. Finally, “chromosomal changes” probably refers to breaks in chromosomes or changes in their number (aneuploidy), since these produce medical conditions in children.

Rather than focus on what Congress intended to accomplish with the words in the bills it passed, however, the EEOC passed the buck to a scientific body with no known legal expertise. The EEOC letter reads as follows: “we coordinated closely with experts at the National Human Genome Research Institute (NHGRI) … who confirmed that forensic DNA analysis constitutes a genetic test.” The unnamed experts at NHGRI are no doubt whizzes at understanding how genetic and genomic research is conducted, but if the EEOC wanted to know whether scientists call forensic DNA profiling “genetic testing,” all it had to do was glance at NHGRI’s website. A webpage states that “The term ‘genetic testing’ covers an array of techniques including analysis of human DNA, RNA or protein. Genetic tests are used as a health care tool to detect gene variants associated with a specific disease or condition, as well as for non-clinical uses such as paternity testing and forensics.”

But what should we make of the tautology that forensic DNA testing of human DNA tests human DNA? This issue is not how scientists use the words “genetic testing,” but what usage best fits the structure and function of GINA. The fact that scientists define “genetic testing” one way for the purpose of medical research or diagnosis does not mean that the members of Congress used the words the same way for the purpose of combating a perceived problem in the workplace. Cf. Nix v. Hedden, 149 U.S. 304 (1893) (refusing to follow botanical definitions in interpreting an Act of Congress establishing different tariffs on fruits and vegetables).

What Is the CODIS Laboratory Exception and How Did It Get here?

So what reason is there to believe that Congress intended to use “genetic tests” to refer not just to the tests “used as a health care tool,” but also to those used for nonclinical purposes? Beyond invoking the impressive five-letter acronym NHGRI, the “informal discussion” adds that “the fact that Congress included an exception specifically permitting forensic DNA analysis suggests that it constitutes genetic testing that would be prohibited in the absence of the exception.” However, other explanations for this text are possible. As I suggested in an essay entitled GINA’s Genotypes, 108 Mich. L. Rev. First Impressions 51 (2010), “most likely, individual legislators may not have had any view about the distinction between genomic and genetic information, but perceived no reason not to include the quality-control exception of section 202(b)(6) for laboratories conducting law enforcement and human remains testing.” If that is correct, then it would be questionable to read the exception as circumscribing the unresolved definition of genetic testing–especially considering the haphazard manner in which the exception came into existence.

Section 202(b)(6) of GINA, 42 U.S.C. 2000ff-1(b)(6), allows an employer to acquire genetic information

where the employer conducts DNA analysis for law enforcement purposes as a forensic laboratory or for purposes of human remains identification, and requests or requires genetic information of such employer’s employees, but only to the extent that such genetic information is used for analysis of DNA identification markers for quality control to detect sample contamination.

On April 25, however, the House suspended its rules and passed a bill that differed from the one reported out of committee. The modified bill added (among other things) an exception for any kind of genetic analysis

(6) where the employer conducts DNA analysis for law enforcement purposes as a forensic laboratory, includes such analysis in the Combined DNA Index System pursuant to section 210304 of the Violent Crime Control and Law Enforcement Act of 1994 (42 U.S.C. 14132), and requests or requires genetic information of such employer’s employees, but only to the extent that such genetic information is used for analysis of DNA identification markers for quality control to detect sample contamination.

The belatedly modified bill, approved by the House without committee consideration or floor debate on the amendment, went to the Senate. The Senate adopted the bill (with a few more amendments). This Senate version made no change to subsection 6.

The House then took up the Senate version of the original House bill. No committee of either house of Congress had ever discussed subsection 6, and there was not a word from any member about it. But somebody noticed one problem with it, for an eleventh hour change was made. House Concurrent Resolution 340 introduced the “technical amendment” of expanding the exception beyond laboratories that submit profiles for inclusion in CODIS databases. Representative George Miller explained:

[W]ith respect to the Department of Defense Labs, in our current bill, section 202(b)(6) and section 205(b)(6) of H.R. 493 provides an exclusion for an employer to conduct DNA analysis for law enforcement purposes as a forensic laboratory, which submits analyses to the Combined DNA Index System, known as CODIS, if the employer only uses that analysis of DNA identification markers for quality control to detect sample contamination.

However, we recently learned that the Armed Forces DNA Identification Laboratory, AFDIL, of the Armed Forces Medical Examiner System, which identifies soldiers’ remains, would not be included in this exclusion because it does not submit DNA to the CODIS system.

It was not our intent to prevent the Armed Forces, AFDIL, from using DNA analysis for human remains identification. This technical change would allow them to continue their mission.

Cong. Rec., May 1, 2008, at H2982, 110th Congress.

On May 1, 2008, the House adopted the amended bill. The remarks about allowing AFDIL to continue analyzing DNA to identify the remains of soldiers, do support the EEOC’s view that Congress thought it needed to have Section 202(b)(6) because the definition of “genetic test” in Section 201(7) was so broad as to reach forensic testing of medically uninformative loci. But if the only purpose of the “technical” change to Section 202(b)(6) was to allow AFDIL to stay in business, then the 202(b)(6) exception applies only to AFDIL and the previously defined group of forensic laboratories that submit samples to the CODIS system. Other forensic laboratories have no safe harbor.

Years ago, I wrote the staff of Representative Slaughter, who fought for 14 years for GINA’s passage, for information on the process that led to the belated insertion of an exception into the bill after the House already had approved of it. I also wrote Representative Miller’s office (twice) but received no reply. Representative Slaughter’s staff provided no real answer either but referred me to Kathy Hudson, then the director of Johns Hopkins University’s Center for Genetics and Public Policy (and now NIH’s Deputy Director for Science, Outreach, and Policy). Dr. Hudson indicated that the provision was added because the Hopkins Center learned that forensic laboratories routinely collect employee DNA for “quality assurance.” She did not explain why this rationale does not also apply to employers such as police departments, whose officers come into contact with biological traces at crime scenes, and manufacturers of supplies used in forensic DNA profiling, whose employees’ DNA might lead to unwitting contamination in the laboratory.

In short, despite 14 years of introducing federal bills to stop employers from using “genetic information” to the detriment of employees and an explosion of state law on “genetic discrimination,” it appears that no one inside (or contributing to) the federal legislative process had a clear idea of the scope of the law-enforcement issues that GINA might create.

Where Does the EEOC Stand?

Rather than attempt to fill this gap with meaningful, if informal guidance, the EEOC threw up its hands, writing that

Interpreting GINA to allow manufacturers of supplies used in DNA forensic analysis to acquire genetic information under the DNA testing exception might well constitute a reasonable interpretation of the statutory exception, but the issue you have identified was not raised during the public comment period on the regulation implementing Title II of GINA. Nor is there any legislative history to indicate that it was contemplated during the drafting of the statute. The Commission has not taken a position on this issue.

Overall, the letter seems to state that the Commission has adopted the broad and mechanical definition of “genetic test” by reason of its consultation with the scientists or administrators at NHGRI but that it remains willing to contemplate the possibility that the exception for some forensic laboratories and AFDIL is broader than its words suggest.

The letter concludes that “this … discussion … does not constitute an official opinion of the EEOC.” What. then, is it? An unofficial opinion? An official nonopinion? A nonofficial nonopinion? It hardly matters. The EEOC’s analysis of the question posed is of little use to anyone who thinks seriously about GINA. If and when an employee–or the EEOC–sues a police department or a manufacturer for a practice that Congress clearly had no interest in preventing, one can only hope that the courts will supply a more thoughtful and complete analysis.

Cross-posted to Forensic, Science, Statistics and the Law

Striking Out with GINA

An article in the New York Times refers to the problems the major leagues have encountered in verifying the ages of young baseball players from the Dominican Republican. It reports that there is talk of taking fingerprints from aspiring players at around age 10. It adds that

The disclosure that Major League Baseball is considering fingerprinting young prospects comes six months after The New York Times reported that investigators for the commissioner’s office were conducting genetic testing on some Dominican prospects and their parents to ensure that the players were not lying about their identities and ages.

The practice was widely criticized by experts in genetics and bioethics who said they believed it was a violation of personal privacy and that it was illegal under an act passed by Congress that took effect in November 2009.

According to several people in baseball, the commissioner’s office has not conducted DNA testing since the practice was disclosed.

But was the earlier “genetic testing” was “a violation of personal privacy” and illegal under the Genetic Information Nondiscrimination Act”? It depends, I would submit, on the tests done. GINA was meant to prohibit tests for medically relevant conditions in employment and insurance. Its application — if any — to identity testing is discussed in the essay, GINA’s Genotypes. There, I argue that GINA should not prohibit an employer from testing potential or actual employees at the usual forensic identification loci. Of course, the privacy issue is more acute if the leagues were doing parentage testing, but even that is outside the strike zone of GINA.

References

David H. Kaye, Commentary, GINA’s Genotypes, 108 Mich. L. Rev. First Impressions 51 (2010), http://www.michiganlawreview.org/assets/fi/108/kaye2.pdf

Michael S. Schmidt, Baseball Considers Plan to Curtail Age Fraud, N.Y. Times, Feb. 10, 2010, at B11

Previous entries in this blog tagged with “GINA”

Confusion over CODIS: Akron Faculty Senate Adopts an Anti-DNA Profiling Resolution

The faculty Senate weighed in on the University of Akron’s new DNA-profiling policy described in the October 31 posting, “Foolishness in Akron Raises a Serious Question about GINA.” Its resolution of November 5th characterizes the DNA sampling requirement as “of doubtful legality,” overbroad, and counterproductive. Not much to argue with here (although an adequate legal analysis of the policy’s legality under GINA is not trivial).

One of the Senate’s arguments, however, seems hyperbolic. The resolution states that the Board of Trustees’ new regulation “poses a serious threat to the personal privacy of University employees, not least because of the likelihood that DNA records submitted to the Federal Bureau of Investigation will remain in its database.” But this outcome is likely only if the FBI has the statutory authority to include in CODIS DNA identification profiles of not only those individuals who have been arrested or convicted of certain crimes, but of everyone applying for a job with the university.

As originally enacted, the DNA Identification of 1994 authorized the FBI to “establish an index of–(1) DNA identification records of persons convicted of crimes; (2) analyses of DNA samples recovered from crime scenes; and (3) analyses of DNA samples recovered from unidentified human remains.” 42 U.S.C. � 14132(a). In 1999, the Act was amended to include “(4) analyses of DNA samples voluntarily contributed from relatives of missing persons.” Plainly, these provisions do not authorize the inclusion of job applicants in the Convicted Offender DNA Index System.  

In 2004, � 14132(a)(1) was broadened to encompass “DNA identification records of–(A) persons convicted of crimes; (B) persons who have been charged in an indictment or information with a crime; and (C) other persons whose DNA samples are collected under applicable legal authorities, provided that DNA profiles from arrestees who have not been charged in an indictment or information with a crime, and DNA samples that are voluntarily submitted solely for elimination purposes shall not be included in the National DNA Index System.” Finally, in 2006, the categories became “(A) persons convicted of crimes; (B) persons who have been charged in an indictment or information with a crime; and (C) other persons whose DNA samples are collected under applicable legal authorities, provided that DNA samples that are voluntarily submitted solely for elimination purposes shall not be included in the National DNA Index System.”

This progression reflects a desire to share the fruits of state laws that require mere arrestees to provide DNA samples. Federal law currently permits the FBI to include in the set of records for CODIS searches the profiles of individuals arrested for violations of various state and federal criminal statutes. The interesting legal question is whether the recent expansion of � 14132(a)(1)(C) goes beyond arrestees. If a state such as Ohio were to change its DNA database statute to permit the profiles of applicants for government jobs to be added to its state database, would the FBI be allowed to include this group in its CODIS searches for other states? If the hypothetical Ohio law were an “applicable legal authority,” then this result would seem to follow from the text of the amended Act. Yet, I doubt that the broadening of the 1994 DNA Identification Act was meant to go beyond the incorporation of arrestee profiles in CODIS searches. Perhaps the legislative history of the 2004 and 2006 amendments would shed some light on this question. Comments are welcome.

References

Declan McCullagh, University Backs Away From New-Hire DNA Testing, CBS News Blogs: Taking Liberties, Nov. 6, 2009, http://www.cbsnews.com/blogs/2009/11/06/taking_liberties/entry5545118.shtml, last accessed Nov. 9, 2009

Foolishness in Akron Raises a Serious Question about GINA

The University of Akron recently reserved the right to demand DNA samples from applicants for certain jobs (Jaschik 2009, McCullagh 2009). The relevant portion of its policy reads as follows:

Certain positions at the university of Akron, if required by law or contract, will be subject to both state of Ohio and federal criminal background checks regardless of how long the preferred candidate has resided in Ohio. Further, at discretion of the university of Akron, any applicant may be asked to submit fingerprints or DNA sample for purpose of a federal criminal background check (University of Akron 2009).

Initial reaction has been predictably negative. One adjunct faculty member — who was not asked for any DNA — quit teaching his class in the middle of the semester to show his students “that there are principles worth fighting for.” He is “considering filing for a temporary restraining order to keep the university from implementing this.” (McCullagh 2009).

The thought that a court would grant an extraordinary remedy, based on a finding of imminent, irreparable injury, for an action that has not occurred, is not planned, and probably never will come to pass, is absurd. At the same time, the university’s new policy statement is ludicrous. A spokeswoman for the university tried to justify it on the ground that “there have been national discussions that indicate that in the future, reliance on fingerprinting will diminish and DNA for criminal identification will be the more prominent technology. By including it in the policy we have the flexibility to match the technology if the Ohio State Highway Patrol makes changes to its system.” (Id.)

It is extremely improbable that law enforcement agencies will abandon fingerprinting as the routine form of identification. Fingerprint examination is superior to DNA typing for distinguishing among individuals. DNA profiling for identification does not distinguish between monozygotic twins (a situation that occurs in about 4 out of every 1000 births), and digital scanning and comparison of fingerprints is only getting better. Moreover, if and when DNA typing were to replace fingerprinting, the university could revise its requirements. There is no plausible reason to adopt the policy in advance of the hypothetical change, especially when the university does not do criminal background checks on existing employees. (Id.)

Although the University of Akron’s ostensible reason to collect DNA from its present or prospective employees is nonsense, some enterprises have more a serious interest in some of their employees’ DNA. A laboratory that does forensic DNA typing, for instance, might wish to build a database of its employees’ profiles so that it, the police, prosecutors, and judges and juries can be assured that the DNA profiles reported out by laboratory are free of any effects of contamination from the employees’ DNA. An extreme example of this kind of problem comes from “the Phantom of Heilbronn.” (Himmelreich 2009). Police in Germany linked DNA evidence from 40 crimes — including the homicide of a policewoman in the southern German town of Heilbronn — to the same woman. It turned out that the mysteriously prevalent DNA profile was that of a worker at a factory in Austria that produced the cotton swabs that the police used to obtain DNA samples at crime scenes. (Id.)

Other employers besides laboratories and their suppliers may have plausible reasons to acquire DNA identification profiles from selected employees. New York City already requires police officers who handle crime-scene materials to provide DNA samples. Beyond identification for elimination purposes, forensic DNA analysis of employees could be useful when internal investigations of theft or sexual conduct on company property produce traces of DNA samples at the locations in question.

Although the University of Akron’s policy seems silly, it provoked discussion of the somewhat ill-defined scope of a statute that the late Senator Edward Kennedy hailed as “the first major new civil rights bill of the new century of life sciences.” (Aldhous 2008).  According to CBS News, “the policy . . . appears to violate a federal law . . . called the Genetic Information Nondiscrimination Act, better known as GINA.” (McCullagh 2009). Susannah Baruch, an attorney and consultant for Johns Hopkins University’s Genetics and Public Policy Center, opined that:

GINA clearly prohibits the collection of a DNA sample from employees or prospective employees by the University of Akron. One of the primary targets for GINA was employers collecting genetic information from employers and using it to make decisions about hiring and firing and promotions. It’s that kind of discrimination that GINA was designed to prohibit. (Id.)

But is an employer’s use of the DNA loci whose variations are recorded in criminal-offender databases — loci that have no significant predictive or diagnostic medical applications (Kaye 2007) — really the “kind of discrimination that GINA was designed to prohibit.”  Was GINA designed to foreclose all the possible uses of DNA samples strictly for identification?  The Act is concerned with medical, not biometric, information. Section 2 explains that Congress was worried about “[n]ew knowledge about the genetic basis of illness [allowing] for earlier detection of illnesses, often before symptoms have begun, [thus giving] rise to the potential misuse of genetic information to discriminate in health insurance and employment.” The examples of discrimination in the Congressional findings offered to justify the statute are “sterilization laws by the States based on early genetic science,” actions taken against individuals with an allele for sickle cell anemia, and more recent cases in which employers allegedly performed genetic tests on employees relating to specific medical conditions. Thus, the stated objective of GINA is to establish “a national and uniform basic standard . . . to fully protect the public from discrimination and allay their concerns about the potential for discrimination, thereby allowing individuals to take advantage of genetic testing, technologies, research, and new therapies.” � 2(5).

At first blush, it might be hard to imagine how the Akron policy would discourage individuals from seeking appropriate medical care or volunteering for genetic research. It is possible, however, that potential employees might worry that if the university has samples of their DNA, it might use them — not for criminal background checks — but for excluding them on the basis of genetic tests that indicate increased risk for certain diseases. Although this is not what the University of Akron is doing or contemplating, and even though it makes little sense to distinguish between using genetic and nongenetic information in employment decisions, as GINA attempts to (Rothstein 2008), at least it is the kind of “discrimination” that “GINA was designed to prohibit.”

As a result, the question becomes whether Congress chose to ban, as a prophylactic measure, the collection of tissue samples from job applicants because of the risk that an employer might engage in the forbidden “discrimination.” This issue is, I think, rather more subtle than the news reports so far have implied.  Arguably, the DNA profiles commonly used for identification purposes do not involves the tests of “mutations, genotypes, and chromosomal changes” that the Act defines as “genetic information.” Furthermore, even if one concludes that GINA does apply to all identification profiles (as it probably does), then the exceptions it creates to its ban of an employer’s acquisition of genetic information are insufficient to meet the legitimate needs of employers.  I hope to develop these initial ideas more fully later.

Acknowledgments

Thanks to Marie T. Reilly for calling the University of Akron policy to my attention.

References

Peter Aldhous, US Outlaws Genetic Discrimination , New Scientist, Apr. 28, 2008, http://www.newscientist.com/article/dn13785-us-outlaws-genetic-discrimination.html

Genetic Information Nondiscrimination Act of 2008,  Pub. L. 110-233, 42 U.S.C. 2000ff et. seq. http://thomas.loc.gov/cgi-bin/bdquery/z?d110:HR00493:@@@L&summ2=m&

Claudia Himmelreich, Germany’s Phantom Serial Killer: A DNA Blunder, Time Mag., Mar. 27, 2009, http://www.time.com/time/world/article/0,8599,1888126,00.html]

Scott Jaschik, DNA Swab for Your Job, Inside Higher Education, Oct. 29, 2009, http://www.insidehighered.com/news/2009/10/29/akron

Declan McCullagh, Want A Job In Akron? Hand Over Your DNA, Oct. 28, 2009, http://www.cbsnews.com/blogs/2009/10/28/taking_liberties/entry5438012.shtml

David H. Kaye, Please, Let’s Bury the Junk: The CODIS Loci and the Revelation of Private Information, 102 Nw. U. L. Rev. Colloquy 70 (2007), http://www.law.northwestern.edu/lawreview/colloquy/2007/25/

David H. Kaye, Mopping Up After Coming Clean About “Junk DNA”, Nov. 23, 2007, http://ssrn.com/abstract=1032094

Mark A. Rothstein, GINA, the ADA, and Genetic Discrimination in Employment,
36 J. L., Med. & Ethics, No. 4 (2008)

University of Akron, http://www.uakron.edu/ogc/docs/11-22_8-5-09.pdf, visited Oct. 29, 2009