“No DNA for you!”
You remember that episode of Seinfeld with the Soup Nazi? If you didn’t stay on the good side of the soup stand owner, all you got was a stern “No soup for you!” The phrase went viral back before anybody even knew what going viral meant.
The Legal Genealogist can’t help but think that’s probably pretty close to what’s going through the mind of folks who’ve finally decided to get in on DNA testing now that 23andMe has lowered its price for its autosomal testing to $99 — only to discover that, if they live in New York or Maryland, it’s “No DNA for you!”
Seriously.
At least not the kind of DNA testing you get with 23andMe, which includes health-related traits and not just genealogy.
Both states have decided that they need to protect us from ourselves by making sure that, if we get health-related tests of any kind, we get them from state-approved laboratories.
Never mind that you may have no interest at all in the health part of 23andMe’s tests; you can’t take the test in New York and you can’t even buy it if you live in Maryland.
Here’s the story:
New York
Right now, New York State law requires that all specimens obtained within New York State be tested by a laboratory that holds a New York State clinical laboratory permit, if the test has any health related aspects at all. The law specifically forbids any lab that doesn’t have that permit from “accepting specimens from New York state.”1
And, 23andMe advises its customers, the New York Department of Health considers 23andMe’s Personal Genome Service a test requiring a lab license and direct physician involvement.
Now there’s nothing in the law that says you can’t buy a DNA test kit from 23andMe if you live in New York. And the law doesn’t stop 23andMe from shipping the kit to you in New York. So you can order it and receive it in New York.
But the law does say you can’t provide the specimen in New York and have it tested by 23andMe, since it doesn’t have that New York permit. So to be legal, you have to cross the border into New Jersey or Connecticut and spit into the saliva collection tube there.
And you can’t send it in from New York and have it tested even if you spit into the tube in New Jersey or Connecticut. The policy at 23andMe is that any sample arriving in a package postmarked New York is discarded, so that it won’t run afoul of New York law.
The theory behind all of this is that New York has its own Clinical Laboratory Evaluation Program (CLEP), which
seeks to ensure the accuracy and reliability of results of laboratory tests on specimens obtained within the state through on-site inspections, proficiency testing and evaluation of the qualifications of personnel of state permit-holding clinical laboratories and blood banks. The proper performance of diagnostic laboratory tests is a matter of vital concern, affecting the public health, safety and welfare of all NYS residents. Clinical laboratories and blood banks provide essential public health services in aiding the medical practitioner by furnishing information invaluable in the diagnosis and treatment of disease. Substandard performance of such tests may and has contributed to erroneous diagnoses and/or the selection of inappropriate treatment protocols.2
If 23andMe eventually does get FDA approval for its tests, and it is seeking that approval,3 then New York residents may find testing easier: there’s a new regulatory proposal that would allow some testing at labs that don’t have the New York permits if the lab and its test are FDA-approved.
In the interim, however, it’s a PATH ride across the Hudson or “No DNA for you!” if you want to test with 23andMe. Purely genealogical tests from Family Tree DNA or AncestryDNA aren’t affected by the New York State law. And it doesn’t affect the National Geographic Geno 2.0 testing either.
Maryland
It’s even worse for Maryland residents. For them, it’s always “No DNA for you!” The law there doesn’t let Maryland residents buy direct-to-consumer tests of any kind if they have health aspects. If you want any kind of lab test done in Maryland, you have to get it through a medical practitioner — or a court order.
First, Maryland law prohibits anyone from offering or advertising for lab business except to medical professionals. The law expressly states:
A person may not directly or indirectly advertise for or solicit business in this State for any medical laboratory, regardless of location, from anyone except a physician, hospital, medical laboratory, clinic, clinical installation, or other medical care facility.4
So 23andMe can’t even ask for your business if you live in Maryland. But say you find out about the test anyway. You’re not allowed to buy 23andMe’s test because, again, its Personal Genome Service is considered the kind of test that requires direct physician involvement. Its administrative code provides:
A laboratory may not perform a laboratory test, except a cholesterol or HDL-C, without obtaining written or electronic authorization from:
(1) A court of law;
(2) A doctor of medicine, osteopathy, podiatric medicine, or dentistry; or
(3) Another person authorized to order laboratory tests under the Annotated Code of Maryland.5
And the Maryland Department of Health stepped up enforcement of that statute and regulation in 2012, explaining its in year-end report:
This enforcement mandated that over fifty websites, offering direct to consumer laboratory testing, add a disclaimer prohibiting ordering for Maryland residents. Direct to Consumer testing is dangerous because it occurs without physical examination or medical assistance. It can also lead to inaccurate diagnoses and a higher cost for the consumer for irrelevant testing.6
Once again, these laws do not affect strictly genealogical DNA tests such as those offered by Family Tree DNA and AncestryDNA, or National Geographic’s Geno 2.0 testing.
But the rule does mean that, if you live in Maryland, you can’t even try to connect to your genetic cousins who’ve tested with 23andMe by doing your own test at 23andMe for genealogical purposes. The mere fact that 23andMe gives you health-related information means you’re out of luck.
“No DNA for you!”
SOURCES
- N.Y. Pub. Health Law § 574, Article 5, Title V. ↩
- “Clinical Laboratory Evaluation Program,” New York State Department of Health (http://www.wadsworth.org : accessed 22 Dec 2012). ↩
- Dick Eastman, “23andMe seeks FDA Approval for Personal DNA Test,” Eastman’s Online Genealogy Newsletter, posted 30 Jul 2012 (http://blog.eogn.com : accessed 22 Dec 2012). ↩
- Maryland Code, Health Law § 17-215. ↩
- Code of Maryland Regulations, 10.10.06.02 (Authorization to Request Laboratory Tests). ↩
- Maryland Department of Health, Fiscal Year 2012 Annual Report & Staffing Analysis, PDF report at 12 (http://dhmh.maryland.gov : accessed 22 Dec 2012). ↩
Thank you Judy for this comparison. I had always wondered what the differences were
between NY and MD law. The Maryland Department of Health and Mental Hygiene in
particular seems to be moving backwards while the scientific world is moving forward.
As a genetic genealogist and a physician, I was particularly struck by the state-
ment, “Direct to Consumer testing is dangerous because it occurs without physical
examination or medical assistance. It can also lead to inaccurate diagnosis and a
higher cost for consumer for irrelevant testing.” I wondered if the person who
wrote this statement (was it Joshua Sharfstein, M.D.?) also feels the same way
about pregnancy testing.
If DTC testing is detrimental, then show us the scientific evidence. There is no
good scientific study to date that proves that 23andMe tests are dangerous – quite
the opposite. 23andMe never has claimed that it will diagnose your current illness.
It merely shows possible or potential correlations based on your own genetic code
that each one of us possesses. Who owns this information anyway? We know that there
is much work to be done, especially in the diagnosis of complex diseases. We also
see that consumers understand these limitations based on recent investigations
reported by researchers at the November meeting of the American Society of Human
Genetics in San Francisco.
I would also like to see a study that proves that this test results in “higher costs
and irrelevant testing.” Currently a 23andMe test is only $99. The tests are
conducted in a CLIA certified laboratory so the actual data is not being questioned.
Genealogists around the world are ordering DTC tests in record numbers and if they
had experienced any significant medical harm, then I think we would have heard
about it. The Center for Disease Control has not issued any medical alerts as far as I know
I know even though this 23andMe test has been under surveillance for several years.
What makes the state of Maryland so adamant that legislation is necessary at this
point in time? It would seem that education rather than support of outdated laws is
what is needed.
I would encourage people in MD and NY to write to their governor and state
legislature. These laws are particularly paternalistic and are not based on any
sound scientific studies.
I couldn’t agree with you more… on all counts!
This goes a bit deeper than these tests being dangerous. The MDHMH and state legislature are 100% against adoptees finding their information out. This kind of testing over time makes closed adoption records obsolete and Maryland for whatever reason thinks that all people born before the year of 2000 are not able to handle their own information.
There certainly is a major league impact on adoptees of this kind of policy, Patrice. Fortunately, it’s relatively easy to get around it by crossing the border into another state to do the testing. That doesn’t help the closed records, but does open some options.
Way to go NY! Now I’m going to have to work harder to connect to my New York State distant cousins. Perhaps 23andMe will change their way of doing business and offer a genealogy-only DNA test. Thanks, Judy, for bringing this issue to light.
Glad to help, Doug.
From the wording of the law, it sounds like the test would be okay with a prescription from an MD. I’m in Calif, so it’s all hypothetical for me, but I know my doctor would write that script in a heartbeat, because of the potential of the test helping me figure out some tricky medical issues I have (I’ve already taken the test and, yep, it’s been extraordinarily helpful). After all, how many people pay more than $100 for single genetic tests ordered by a doctor? Wouldn’t it be more cost effective to do 23andme and get a bunch of them all at once? Insurance doesn’t always cover those tests either.
Since the law only exempts cholesterol tests, it obviously allows scripts for a wide variety of tests. Why not order 23andme with a script? What am I missing?
Why should I need to spend money for a doctor’s appointment I don’t need in order to take a test I want?
Just a couple of quick thoughts. There are a couple of “old” sayings that come to mind. “Water finds it own level” and “there isn’t a contract that can’t be broken.” Someone asked earlier on why the State of Maryland would require this type of law now. Answer, control. All these types of restrictions will do is to slow down the rate in which people will buy these tests. It will not stop them.
I’m not even sure it’ll slow it down, Jeff — nor do I have any idea why it should. Not on these grounds.
WNYers also have PA as an option. Beautiful road trips as the fall leaves change
You’re quite right — and Pennsylvania can be gorgeous at many times of the year.
The good news for Maryland residents? It’s geographically a small state. No one is very far from a bordering state where friends live.
Too true, Jane — but that doesn’t answer the question of why Marylanders should need to resort to that.
I would like to add here as well that if 23andme does find out that you are in MD, they will invalidate your test results. I had mine invalidated about 5 days before getting my results. I fully intend to see if we have a case against the state of MD and additionally will be contacting lawmakers to change this archaic law!
Ouch. That hurts. Good luck in getting the law changed.
I should clarify that the legislation is not new, but the stepping up of enforcement based on unsubstantial claims is what makes no sense to me. A public outcry can make a difference.
We can hope it makes a difference!
You said in regard to NY testing, “So to be legal, you have to cross the border into New Jersey or Connecticut and spit into the saliva collection tube there.” This is a pretty NYC-centric way of looking at it, speaking as an upstate NY-er. What would happen if you went into Pennsylvania, Massachusetts, Vermont or Canada? They all share borders with NY state as well. Canada, I concede, might well be a problem, as I have no idea if international orders are accepted. I also concede that I am nit-picking, but I couldn’t resist making the point.
Kathy, you’re absolutely right — and I am a NJ resident just outside the borders of NYC. So guilty as charged!
Of course, this also begs another question. This is interstate commerce, so how do these states have any right to regulate it in the first place? They can regulate the advertising, I’ll agree, but to my un(legal)educated mind the Constitution of the United States means what it says: interstate commerce is the province of the Congress and only the Congress.
You’re being too literal, Dave. Unless Congress steps in and says it wants to occupy an area as being interstate commerce, then there is room for state regulation alongside any federal rules. Here, the area of health has always been a traditional sphere of state interest and state regulation is allowed except where Congress says it doesn’t want the states involved.
So let me get this straight after reading this article twice: THE moment I buy the kit from 23andme at approx. $110 (After shipping/taxes), have it get delivered to my house in upstate NY is just a one-way trip only?
New York will certainly allow you to take it with you to a neighboring state (or country!), and provide the sample and mail it back from there. Otherwise, yep, NY says you can’t do that test in NY.
Belated thanks for the excellent post with references. As a Maryland resident, I was quite miffed to learn about this just this past weekend and have taken action via social media: Twitter, Facebook and LinkedIn; FB and Twitter include local and state level politicians. When a friend informed me that I would not be allowed to order directly, but would have to take the side route and have the kit sent to a friend in VA or DC (the same inconvenient route used to get around Maryland’s outdated beer and wine laws), I found your blog post to answer my howling ‘But why?!’ Considering Maryland’s waning ability to attract new businesses, esp in biotech, this can certainly be used as leverage.
I’m glad you found the information useful. Good luck with the bureaucrats.
As far as I can tell (haven`t gone back to check yet) the only reference to address is “shipping address”. Entering a Maryland address results in the annoying popup, after having spent quite some time examining the website and finally deciding to order the kit. Frustrating in the extreme.
Am I missing something or could one just use a friend/relative in PA, VA, DE or DC as a shipping address?
I don’t know if 23andMe asks you to represent that you don’t actually live in Maryland before selling you a test kit. Your credit card information might give it away, though.
Judy, here’s part of the TOS I had to agree to when activating the 23andme kit:
3. Prerequisites
Whether you submit your own saliva sample, a saliva sample for anyone for whom you have legal authority to agree, or otherwise provide your own Genetic Information, you may not use the Services and may not accept the TOS if (1) you are not of legal age to form a binding contract with 23andMe, or (2) you are a person barred from receiving the Services under the laws of the jurisdiction in which you are resident or from which you use the Services.
I received the kit yesterday and activated it last night. I don’t live in MD or NY so not an issue for me.
It’s good that that information is in the terms of service… but it’s still annoying that NY and MD are taking these positions.
I’m a Maryland resident and my wife and I had to do the side route by sending the kits to relatives in VA though we used credit card with a Maryland billing address. It’s was no problem mailing our samples from MD and we can now see our results. Somehow we averted serious danger (!) despite doing the end-around Maryland’s poorly written laws.
With all the income tax, property tax and sales tax I pay you’d think my State wouldn’t treat me like an infant.
Other antiquated laws on the books in MD don’t allow for car sales in some counties on Sundays and mandate that at-home businesses can’t keep inventory except for yard sales. So in MD don’t try having a retail website or selling on eBay without first opening a storefront in some strip mall to store your items). Some laws were just made to be broken.
Sigh… makes you wonder, doesn’t it, Kevin?
Hey Kevin I am an MD resident too and want to do 23 and me. I know some people in VA and DC and am considering doing what you did, but can you get in trouble for that?
The law doesn’t affect individuals and there are no penalties if you find a way around it. The law affects the lab companies, and they can get in trouble if they get caught.
Judy,
For clarification, that means if an individual mailed a test out for me from another state they would not be committing a crime? That was how I read it but want to be sure!
Maryland cannot legislate about conduct anywhere except in Maryland. So it cannot make it a crime for someone outside Maryland to do something.
Do I get it clear – I can order the kit delivered to NYC, then take
the PATH to New Jersey & mail it to 23&Me from a NJ post. Is there
any problem with my New York return address being on “that package.”
Then, 23&Me is able to send my results straight to the New York address.
I’m 80 years old, and I need to find out who I am. I do not want to
end up in one of Cuomo’s gulags – how can you ever get behind these people
when they do things like this?
Yes, you can do just what you’re saying, including having the results sent to your NY address (actually they’re sent to a web location where you simply log in from any location anywhere). You simply need to make sure the kit is mailed from NJ to 23andMe,
I like the idea that Maryland protects its citizens from hokey scammy websites. Is it not best that we get our health directives from people that went to medical school?
(a) Genetic genealogy tests are neither hokey nor scammy.
(b) Genetic genealogy tests don’t give you the kind of health information you should ONLY get from a doctor, and if there’s anything about what you do get that you don’t understand, you can certainly consult with one if you want to. But requiring everybody to go to a doctor for a test that tells you about your ancestors is just plain silly.
The only thing that Maryland is trying to protect is the closed adoption records that they hold so tightly!
There is nothing about the information obtained that would allow anyone to side step the Medical Community, if anything it may encourage people to seek out medical advise.
The studies done in this are do suggest that people who get information from consumer genetic testing do seek medical advice if it’s warranted.