That pesky NY law

Testing with 23andMe in the Empire State

So yesterday The Legal Genealogist had the chance to share information about autosomal DNA testing with several dozen thoroughly enthusiastic New Yorkers at the Patchogue-Medford Public Library.

It’s a great group, and one of the highpoints of my year when I get to speak to them. I’m so grateful for the invitation to join them.

But they sure didn’t like one thing I had to say, and, frankly, neither do I.

I had to tell them about a New York law that affects their right to get a DNA test from one of the major DNA testing companies, 23andMe.

Now I’ve written about this law before (see NY and MD limits on 23andMe). But from the questions yesterday it’s clear people still don’t understand it. So let’s review the situation.

First off, the test we’re talking about here is the autosomal DNA test. That’s the kind of test that works across genders and helps you find cousins in recent generations.1 Unlike YDNA, you don’t have to locate sons of sons of sons to test and only get results in the male line,2 and unlike mitochondrial DNA, you don’t have to locate daughters of daughters of daughters and only get results in the female line.3 With autosomal DNA, you can test the son of a daughter of a son against the daughter of a son of a daughter and get good results even across genders.4

Second, there are three big DNA testing companies: Family Tree DNA; AncestryDNA; and 23andMe. But only one of the three — 23andMe — has a health component to its testing. The other two — Family Tree DNA and AncestryDNA — provide genealogy information only. So this doesn’t apply to their tests, only to 23andMe.

And that’s because New York doesn’t care what we find out about our ancestry. It just wants to protect us from ourselves and the mistakes we might make if we got information about our health issues.

It does that through Title 5 of the New York Public Health Law, entitled Clinical Laboratory and Blood Banking Services.

The purpose of the New York law is admirable:

It is the purpose of this title to promote the public health, safety and welfare by requiring the licensure of clinical laboratories and blood banks, by establishing minimum qualifications for directors, and by requiring that the performance of all procedures employed by clinical laboratories and blood banks meet minimum standards accepted and approved by the department.5

And so, New York declares:

The improper performance of a laboratory procedure may induce an erroneous diagnosis or contribute to the selection of an inappropriate method of treatment, resulting in prolonged or unnecessary hospitalization, injury or even death. The protection of the people of this state requires affirmative action to insure that the performance of clinical laboratory and blood banking services meet high standards of public health care.6

The law defines a clinical laboratory as “a facility for the … examination of materials derived from the human body, for the purpose of obtaining information for the diagnosis, prevention, or treatment of disease or the assessment of a health condition…”7 and while 23andMe does say its product isn’t intended to diagnose, prevent or treat disease, it sure does assess health conditions. So it falls within the law.

Now let’s answer the key questions about the law.

“Is it legal for me as a New York resident to buy a test from 23andMe?”

Yes. The law doesn’t touch on what individual New Yorkers can and can’t buy; it only relates to what the laboratories can and can’t do.8

“Can I be prosecuted as a New York resident if I get a DNA test from 23andMe?”

Absolutely not. Again, the law regulates laboratories. It says that the labs themselves have to have permits. Its enforcement provisions deal only with what happens if a lab violates the law. There are no provisions in the law at all that can serve as the basis for any kind of action against an individual resident who gets tested.9

“Can 23andMe ship a test kit to me at my home in New York?”

Yes. And the 23andMe website says as much: “23andMe is authorized to ship sample collection kits to the state of New York.”10

“What do I have to do to make sure 23andMe can legally process my test?”

Take your test kit across state lines to New Jersey or Connecticut (or anywhere else except Maryland, which has even stricter laws11). Spit into the test tubes (remember, 23andMe is a spit test, not a swab test), put the test tubes into the kit mailer, and mail it back from the other state.

Seriously, that’s all you have to do. According to 23andMe, “You or the recipient of the saliva kit must collect your sample and mail it from outside the state of New York. Upon receipt of your saliva kit, you or the recipient will be required to affirm under penalty of law that the sample for the saliva kit has not been collected in or mailed from the state of New York.”12

“Does that make any sense at all?”

No. We’re grown-ups, for crying out loud. We understand the limits of this test and the information it can provide. We’re not about to run out and do anything stupid because of the results we get about our health and, in fact, study after study has shown that people who do get these direct-to-consumer tests act very responsibly after getting their results and consult with medical professionals when they’re concerned about what the results show.13

And remember: this law only affects tests actually taken and processed in New York. As long as the sample isn’t collected in New York or mailed from New York, New York law doesn’t reach it. So New Yorkers can go right ahead and get their tests. Just don’t spit in New York — in test tubes or on the sidewalk…


 
SOURCES

  1. See generally Judy G. Russell, “Autosomal DNA testing,” National Genealogical Society Magazine, October-December 2011, 38-43.
  2. See ISOGG Wiki (http://www.isogg.org/wiki), “Y chromosome DNA test,” rev. 30 May 2013.
  3. See ISOGG Wiki (http://www.isogg.org/wiki), “Mitochondrial DNA test,” rev. 21 Jun 2013
  4. See generally Russell, “Autosomal DNA testing.”
  5. § 570, N.Y. Pub. Health Law, Article 5, Title V.
  6. Ibid.
  7. Ibid., § 571.
  8. See Ibid., §§ 577-578.
  9. See Ibid.
  10. Is the 23andMe service available in the state of New York?,” 23andMe Customer Care (https://customercare.23andme.com : accessed 22 Jun 2013).
  11. See Judy G. Russell, “NY and MD limits on 23andMe,” The Legal Genealogist, posted 23 Dec 2013 (http://www.legalgenealogist.com/blog : accessed 22 Jun 2013).
  12. Is the 23andMe service available in the state of New York?,” 23andMe Customer Care (https://customercare.23andme.com : accessed 22 Jun 2013).
  13. See generally Ricki Lewis, “Direct-to-Consumer Genetic Testing: A New View,” DNA Science Blog, posted 8 Nov 2012 (http://blogs.plos.org/dnascience : accessed 22 Jun 2013).
Print Friendly
This entry was posted in DNA. Bookmark the permalink.

4 Responses to That pesky NY law

  1. Darwin FONTENOT says:

    Ok, i get it. I don’t live in New York and I understand the the idea that adults aren’t stupid, but then again some adults ARE stupid. So how can stupid people get in trouble with 23andMe in New York?

    • Judy G. Russell says:

      About the only stupid thing an adult could do would be to send the kit back with a New York postmark on it, because 23andMe won’t — can’t legally — process the sample.

  2. Joe Hay says:

    Hi Judy, Just want to say I enjoy reading all your articles and I appreciate how you make technical and legal terms clear to the average person.
    Why is 23andMe even looking at a persons genes for health issues? I think that should be left to the health professionals.
    Most of the DNA testing labs, assure us that they do not look for any abnormalities that would indicate a medical condition, and I say good! As a society we’re already too worried about all the things in our world that can make us sick our even kill us (real or imagined).
    When my cousin decided to be tested and found she had the indicator gene for the a high risk of hereditary cancer, she had a full hysterectomy and a double mastectomy performed. Even with this done there is still a risk of getting cancer. I do believe some people are better off not trying to predict their future.
    I have a beautiful 20 year old daughter, that doctors wanted to abort because DNA testing indicated an 85% chance she could be born with defects. We refused to end her life and prepared ourselves for whatever the outcome would be, trusting God for the best.
    I think DNA results can be dangerous in the wrong hands.
    Here is a link that describes some pros & cons about predictive medicine for cancer in women. http://annonc.oxfordjournals.org/content/15/suppl_1/i65.full.pdf

    …and yes you can get a ticket for spitting on the sidewalk in NYC. :) JPH

    • Judy G. Russell says:

      Thanks for the comments, Joe, and I certainly understand your views — and honor you for the choices you’ve made — and will fight for your right to make them.

      But because I believe in choice, I respectfully disagree about whether companies “should” be in the health testing business. If you don’t want that information for you or your family except through a health professional, that’s your choice. But there’s no reason to interfere with my choice except the paternalistic attitude that somebody else is in a better position to make decisions for me than I am to make them for myself.

Leave a Reply

Your email address will not be published. Required fields are marked *

You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <strike> <strong>