Genetic Testing In California

Blaine Bettinger has got an excellent piece on the California genetic testing controversy over at The Genetic Genealogist. I'm glad he's weighed in on this matter.

Last week, I issued a challenge to the industry and the state to come together in a neutral forum to discuss the issues. Next week, I plan to make a formal, concrete proposal to the parties. In the meantime, I'm doing some legal work to prepare for a potential resolution of the issue through the California administrative rulemaking process. I'll be describing that sometime after next week. As I said last week, I'm not entirely sure that the way the state reads the law actually would exclude testing for only "genealogical purposes," whatever that means. See the post about Dick Eastman's speech at the Southern California Jamboree and the upcoming post about genealogists collecting family medical data.

Dick Eastman is Highlight Speaker at Jamboree

Dick Eastman was the featured speaker at the SCGS Jamboree's Saturday Evening Social and Dinner in Burbank last week. Dick described the difference between a "name-gatherer" and a family historian and urged the crowd to be the latter, not the former.

In a speech entitled, "Putting the Genes in Genealogy," Eastman pointed out the great strides made in genetics and its applications to genealogy--a theme underscored by the number and popularity of the DNA sessions at the conference. But Eastman said that in the not-so-far-off future, the use of DNA for medical predictions and preventive health management will transform genealogists into people who can help save the lives of family members. He sees this as a positive development for the health care system as well as for genealogy.

If you haven't heard Dick Eastman speak, try to catch him if he's anywhere near your area. He travels quite a bit. He's a man of many interests and is a speaker of great talent. It occurred to me during his speech that he is not just an historian, but a futurist as well. I mentioned that to him when I saw him in the hotel lobby on Sunday morning. In his sometimes self-deprecating style, Eastman said, "I sometimes think that's just a fancy word for someone who dreams a lot." He thought for a minute, then said, "Maybe there's no difference."

UPDATE: California's Crackdown on Consumer Genomics

Some Good News (Maybe) and Prof. Manson Issues Challenges to Regulators and Industry

Diane at Genealogy Insider reports:

Lea Brooks of the California Department of Public Health told me that "Genetic testing used for ancestor tracking or forensic purposes is not covered by California clinical laboratory law standards."

That is in fact consistent with my initial reading of the regulations. However, seems to me that we'll have to see if that's the way the state and the state courts eventually interpret the regulations. And if the Department of Public Health takes this position, is the Department prepared to adopt an interpretive regulation to that effect?

On the other hand is the "personal genomics" industry prepared to adopt some "best practices" that may ease some of the regulators' concerns? And would the Department of Public Health and the industry work with the Capital Center for Government Law & Policy and our health law and policy institute students and my administrative law students come August to come to a reasonable agreement about the issues? I'll let you know.

California Crackdown on Genetic Genealogy?

This story has been reported elsewhere in the geneablogosphere, notably by Lee Drew (where I first saw it) and by Dick Eastman. But it is of continuing interest.

Apparently, the California Department of Public health has decided to call a halt to the marketing of genetic tests directly to consumers. Companies such as Navigenics, Family Tree DNA, 23andMe, and deCODEme, and others have received "cease-and-desist" letters from CDPH, asserting that the companies are operating in violation of California law. Navigenics and 23andMe are Silicon Valley-based firms.

Now what's really curious about this is that it's received very little coverage here in California. Aside from one brief article in the San Jose Mercury News, there's been virtually no local reporting on the matter in California. And in fact, the CDPH doesn't even have the issue listed on its website either under "News" or "Hot Topics."

The basis for the cease-and-desist letters is to be found in California's clinical laboratory technology statutes. The law prohibits the offering of a clinical laboratory test directly to a consumer without a physician's order. The law also requires a state issued clinical laboratory license or registration for all persons receiving biological specimens originating in California for the purpose of performing a clinical laboratory test or examination.

One should note that not all these companies do the same things. Some are involved in "personal genomics" much more extensively than others which are constrained around the mainly genealogical aspects.

The other point is that there is not necessarily a violation of state law simply because a mid-level bureaucrat says there is. There are questions about how the statute was intended to be interpreted and even some constitutional questions here. On the other hand, the actions that California has taken in recent days may have a chilling effect on those companies doing business, or intending to do business in the Golden State, which is the nation's largest domestic market.

Given the stakes involved here, GeneaBlogie will stay abreast of this story as it develops and we may have a special GeneaBlogie Legal and Policy analysis on the matter.

Sorenson Foundation and GeneTree With New Offer

Like many other folks, I received the following e-mail on Friday:


Get Your Personal DNA Results

Dear SMGF participant,

Sorenson Molecular Genealogy Foundation (SMGF) is excited to announce that your personalized DNA results are now available from the Sorenson mtDNA database, through a special offer made by GeneTree, a family networking website. Eligible participants may obtain their mtDNA-HVI, II, III results and pedigree information for a special introductory price of just $19.50. Comparable tests cost over $150!

With your mtDNA results in hand you can explore new and exciting genetic-genealogy territory by taking advantage of GeneTree's:

* Tools for making connections with mtDNA cousins
* Resources for interpreting mtDNA results
* Innovative tools for discovering migration patterns of ancient and recent ancestors
* Media sharing and storage capacity for pictures, video and other media

To be eligible for this offer you must have requested an SMGF participation kit prior to October 23, 2007 and returned your kit prior to Dec 31, 2007. To view promotion details and get your mtDNA results please click here.

We encourage you to take advantage of this special GeneTree introductory offer!

Sincerely,
The SMGF Team

Unlock and view your personal mtDNA results now at GeneTree.com

SMGF takes great care in protecting your confidential information. SMGF does not transfer or share data with third parties without explicit donor consent.


I was intrigued. I had submitted a sample to the Sorenson Foundation's project last year. At the time, the project was merely a database to which folks could add their DNA (along with a four-generation genealogy. In the meantime, as reported by Blaine Bettinger, the Sorenson enterprises rolled out "GeneTree," a site that combines social networking, family history, and genetic genealogy.

I gave the matter some thought. reviewed the FAQ and Privacy Policy and then signed up. I gave them a six generation genealogy of my direct ancestors. GeneTree replied fairly promptly, telling me that, "The team of researchers at SMGF are now searching the information you gave to verify your participation in the project. The privacy of our users is important. This process can take up to two weeks to verify identity and notify you that your results are ready."

I've read both of Blaine's e-books, so I think I know what to expect and what not to expect. I'll keep you updated.

Can DNA Solve "The Lumbee Problem"?

How does a group of people who have American Indian ancestry but no records of treaties, reservations, Native language, or peculiarly "Indian" customs come to be accepted--socially and legally--as Indians?

That question is asked on the jacket of the 2001 printing of The Lumbee Problem--The Making of an American Indian People by anthropologist Karen I. Blu (University of Nebraska Press, 2001; copyright 1980, Karen I. Blu). And that's just the surface of "the Lumbee problem."

Suppose Scots-Irish settlers in North Carolina in the early eighteenth century came upon a group of people who in some ways seemed to be indigenous, but spoke seventeenth century English and had English names. History or an episode of the Twilight Zone?

Indeed, this seems to be the history of the Lumbee Indians of North Carolina. But who are they really? Are they Indians? What is their origin?

A prominent theory is that the Lumbees are descendants of Native Americans and survivors of the Lost Colony of North Carolina.

In 1587, a group of colonists under Sir Walter Raleigh's charter landed in the Outer Banks of what is now North Carolina. This was the second or third group of colonists in the area. One group had returned to England with Sir Francis Drake. The latter group was headed by Governor John White. White returned to England to re-supply the colony; his voyage back to America was delayed by the complications of the English war with Spain and the winter weather. When White did return in 1590, the colonist were gone, but strange "clues" were found. The word "Croatan" was found carved in the wall of a structure that had been built by the colonists. The colonists were never found.

In the early 1700's, Scots-Irish settlers came upon English-speaking people in the interior of southeastern North Carolina. These people appeared to be of mixed race. It is said that in the early censuses, these people were enumerated as "mulattoes" or "free Negroes." The people themselves claimed to be Indians. They waged a legal and political struggle in t he nineteenth century for recognition as Indians.

The federal government never has recognized the Lumbee as tribal Indians. In the late 1800's, the state of North Carolina recognized them as the "Croatan Indians." This name was not fully satisfactory to the people so designated and in the 1950's, the name was changed to Lumbee.

The truth of the origins and identity of the Lumbee has been complicated by a number of political and sociological problems. Among these problems would be the fact that there were black people in the area where the Lumbees were found and it may be difficult to tease out which of the "mulattoes" or "free Negroes" were Indian and which were of African descent.

There are several distinct surnames that occur among the Lumbee. These include Oxendine, Chavis, Locklear, Dial, Lowry, and Brayboy, among others. Some of these surnames occur with high frequency among Africian-Americans. Brayboy, for instance, is one of the surnames in my family tree.

My Brayboy ancestors lived in Louisiana and South Carolina. They had been taken to Louisiana in bondage from South Carolina. The question, however, is whether they are related to the Lumbees. Perhaps DNA can solve my Lumbee problem.

I understand that DNA generally cannot pinpoint a specific Native American tribe. But the Lumbee are an especially insular people, thought to number about 40,000, mostly in Robeson County, North Carolina. Under these circumstances, perhaps DNA can tell us about links to the Lumbee.