State of California Sends Cease-and-Desist Letters to DNA Testing Companies

The state of California's Health Department sent cease-and-desist letters to several personal genomic testing companies last week. I haven't been able to find out if any genealogy DNA companies received such letters. The companies do not need to be registered in California but such a letter would seemingly prohibit companies in other states from doing business with California residents.

The Health Department's actions were more of an opening salvo than a final knockdown in what could be a protracted fight over how consumers can access the information contained in their own DNA. Several DNA testing companies have publicly stated that they will ignore the letters because they believe that they are already in compliance with California laws.

You can read more on Wired's web site at http://blog.wired.com/wiredscience/2008/06/regulators-gene.html.

Comments

[Ann Turner]

Thank goodness, I have already tested myself and some family members at both 23andMe and deCODEme. The anonymous complaints may not have anything to do with those companies, which I find to be very conscientious about explaining the scope and limits of the technology, but it is certainly frustrating not to know the nature of the complaints or the names of the companies. I suspect at least some of the complaints may be directed at companies that sell expensive dietary supplements based on "nutrigenomic" testing.

I rather doubt that the current cease-and-desist letters apply to genealogically oriented companies, but there are some people with a regulatory mindset who have actually proposed such regulations. Here's a post I made on the GENEALOGY-DNA mailing list a couple of months ago:

===

The March 19 issue of the Journal of the American Medical Association (JAMA,
available at many public libraries), is a theme issue devoted to genetics.
Along with several original research articles, there are some tutorials and
commentaries.

There's a common tendency for pundits and professionals to call for more
government regulation and oversight of DTC (Direct to Consumer) genetic testing.
I'm of a more libertarian bent myself, and this quote from Kenneth Offit's
article "Genomic Profiles for Disease Risk: Predictive or Premature?" particularly
raised my hackles. In the category of ancestry testing (mtDNA and Y), he
writes:

"Because ancestry and risk for specific diseases are often intertwined, the
policies and professional attention focused on direct-to-consumer genetic
testing for disease should also be applied to testing for ancestry."

[Dorothy Coltrin]

If I understand the DNA testing for mtDNA and Y markers correctly, only the "nonsense" portion of DNA is being measured, not the DNA of genes. And I am under the impression that gene DNA is where the risk for disease lies. A company such as Family Tree DNA does not make the information public. And for surname grouping, I have not seen any individual persons listed, only their geographical background. I would be very unhappy to lose this tool when facing a "dead end" when tracing ancestry.

[Michael Pollock]

It is my experience that most people calling for "regulation" for the benefit of the "consumer" tend to be people who presume themselves to be not just more "intelligent" than the avereage person, but obliged to use that "intelligence" for the "benefit" of others, whether the others like it or not, and they also tend to label themselves "liberals". A smaller percentage are people who REACT to a perceived problem and so attempt to address the consequences rather than observe with a cool head to determine the cause and reach a solution that will prevent recurrences. A perfect example is identity theft. It has resulted in demands for databases containing an woman's maiden name be shut down or at least access restricted because banks used "mother's maiden name" as a part of their account security protocol, and when that did not solve the problem, the demands extended to restricting access to birth and death records and social security numbers. Restricting access to mother's maiden name would require, if carried to its logical extreme, require books in public libraries, such as Marquis' Who's Who, containing such information be kept in locked cabinets if not destroyed. Would it not make eminently more sense to have required banks to change their security protocol? It would simply have required that banks offer customers more options on what could be used as a password and the means that could be used to remember it. I am reminded of the security protocol used by Georgetown University, which suggests, among other options, "favorite professor at Georgetown" as a possible password and also requires that the password include at least 1 number and 1 symbol. My password is the name of a professor at Georgetown from whom I NEVER took a class AT Georgetown, so is virtually impossible break without someone going to substantially greater lengths than a "hacker" is apt to be willing.

[Don Ridgway]

Good old California!! Seems to me the United States Constitution restricts the regulation of interstate commerce to the Congress of the United States and the taxation of interstate goods and services as well. This is beyond a ruling by the 9th Circuit Court, too.

[Judy Bretzger]

In response to the post by Michael Pollock, I want to say that I am quite surprised to see politics injected into this discussion. I, for one, dislike seeing anyone defining someone else or another group of people. I don't believe a genealogy site should contain someone's defining what "Liberals" or "Conservatives" think about anything.
I hope I don't see any future posts of this nature. It has no place in genealogy discussion.

[Roger]

Personally, I thought that Michael Pollock made some excellent points, which were very pertinent to the topic under discussion.

[Joy Rich]

Michael Pollock, keep your political bent to yourself, please.

[Susan James]

Michael Pollock was absolutely right on. Kind of makes me wonder why the strong reactions -- if you feel his comments apply to you, do you really feel you have the right to place restrictions on everyone else? But you can't take any kind of restrictions or corrections yourself?

[Betty]

Thank you Judy Bretzger!

[Margaret]

Lest this degenerate into a shouting match, let's keep some cool heads here. Even if Michael did mention the political inclinations of those who would regulate everything justin case anyone anywhere had any kind of a problem, let's focus on the issue of constantly restrictive legislation that makes it hard to do genealogical research or much of anything else. Let's try to put pressure on those legislators who get in the way of our research without very good cause and without adequate public input before voting to restrict.

[Carlos]

Of course this regulation has nothing to do with liberal or conservative doctrine, it'a all about vested interests and money.

The AMA is behind this.

[Sharryn]

Why certainly it's about money and control. Medical community does not want part of their business model interrupted!

[Neal]

When the Liberal bureaucrats and politicians begin interfering with genealogy, then that is an absolutely appropriate topic for discussion. Those people are arrogant elitists who think that they know what is best for all the rest of us and think they have an inherent right to regulate whatever they please. Further, there is a very clear line of distinction involving the scope of regulatory authority. Doctors "treat" patients. They directly affect a person's physical body by acting on it through prescribing medicine or performing surgery. That requires appropriate credentials. The DNA companies merely provide information about our own bodies.

[Helen]

According to the California Department of Public Health http://ww2.cdph.ca.gov/HealthInfo/news/Pages/LabTestLandingPg.aspx

This does not apply to either paternity or genealogy testing.

The list of companies is on the Department website above.

Also see June 26th article of NY Times:

http://www.nytimes.com/2008/06/26/business/26gene.html?_r=1&hp&oref=slogin