Tag Archives: genetic test

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