9 FAM 601.11
VISAS AND DNA
(CT:VISA3; 11182015) (Office of Origin: CA/VO/L/R)
9 FAM 601.111
DNA TESTING TO VERIFY RELATIONSHIPS
9 FAM 601.111(A)
Introduction to DNA Testing, Accredited Labs
(Previous location: 9 FAM 42.44 N1; CT:VISA2188; 10032014)
a. General Information on DNA Testing:
(1) Deoxyribonucleic Acid (DNA) testing is the most accurate and widely available technology to test a biological relationship. The types of tests used by the DNA scientific community continue to evolve; currently, the Polymerase Chain ReactionShort Tandem Repeat (PCRSTR) and the Restriction Fragment Length Polymorphism (RFLP) methods are the two tests that we believe to be the most advanced, offering the best results. These tests are preferred over older technologies such as human leukocyte antigens (HLA) and human blood alleles (ABO) blood typing because they do not require blood samples and are more accurate when all parties are not available for testing and/or when the other possible father (in a paternity case) or mother (in a maternity case) is thought to be related to the tested party.
(2) DNA testing reliability has advanced to the industryaccepted standard of 99.5 percent. Consular officers may only accept test results reporting a 99.5 percent or greater degree of certainty with respect to paternity/maternity as sufficient to support a biological relationship between a parent and child in visa cases. However, a test that supports paternity/maternity to a degree less than 99.5 percent generally can be followed by retests to determine if the 99.5 percent accuracy can be achieved. If, after several attempts, it is not possible to reach the accepted level, and you remain unconvinced of the bona fides of the relationship in question, return the petition to the Department
of Homeland Security (DHS)/U.S. Citizenship and Immigration Services (USCIS) via the National Visa Center along with a memo explaining the return and a copy of the DNA test(s) results. Keep in mind that in IR2 cases, the definition of a child is not limited to a biological relationship and thus the adjudicating officer must also rule out adoptive and stepchildren relationships before a petition can be returned.
(3) Questions regarding DNA testing can be addressed to CADNATeam@state.gov; this email collective consists of individuals from CA/EX, CA/VO/F, CA/FPP, and CA/OCS/L.
(Previous location: 9 FAM 42.44 N6; CT:VISA2188; 10032014)
b. Selection of AABB Lab for DNA Testing:
(1) Any DNA testing for visa or citizenship purposes must be processed by a lab that is accredited by the American Association of Blood Banks (AABB). Names of AABB accredited labs can be found on the AABB Accredited Relationship Testing Facilities website.
NOTE: The list of laboratories on the site is based on the physical location of the lab's headquarters, and the operations of most labs are not restricted to that location. Therefore, the petitioner should be able to choose from the full list of AABB laboratories that conduct DNA testing.
(2) The petitioner must select an AABBaccredited laboratory, contact the lab directly, make the necessary arrangements for sample collection and testing, and include payment for all tested parties.
(3) Under no circumstances should petitioners use thirdparty vendors to select their lab, arrange appointments, or transport the specimens outside of the lab chainofcustody controls. Thirdparty vendors include, but are not limited to, private companies or clearinghouses that serve as intermediaries to make appointments on behalf of petitioners, applicants or beneficiaries. A petitioner or applicant must independently choose the AABB accredited DNA testing lab, make the sample collection appointment directly with the lab, and, if in the United States, go in person to the lab's designated sample collection site. If the sample collection site is not at the lab's DNA testing facility, the collection site must then send the sample to the main AABB lab testing site directly, through the lab's internal, controlled system. The authority for collecting DNA specimens in the United States resides exclusively with the AABB labs and their directly affiliated collection sites.
(4) Under no circumstances should petitioners or applicants, including those in the United States, directly receive test kits for use in establishing a claimed relationship in connection with a visa petition or citizenship claim. The DNA samples for the petitioner must be collected at a designated AABB testing
site, lab, or clinic, unless the petitioner is located in a country where an AABB lab is not located. If
the petitioner is overseas and there is no AABB lab that country, the DNA sample may be collected at post following the collection procedures outlined in this section. The AABB laboratory selected by the petitioner will send a test kit, including a prepaid, preaddressed return envelope and explicit sampling instructions, directly to the consular section (and petitioner if applicable).
(5) Post must note and report to CA/VO/F and CA/FPP any anomalies, such as petitioners traveling unusual distances to get to a collection site when other collection sites are available closer to them.
9 FAM 601.111(B)
Genetic (DNA) Testing
(Previous location: 9 FAM 42.44 N3; CT:VISA1324 09252009)
a. When to Recommend Genetic Testing to Verify Relationships:
(1) Genetic testing is a useful tool for verifying an alleged biological relationship when no other form of credible evidence is available in conjunction with a visa application. Commonly tested relationships requiring DNA testing include paternity, maternity, or fullsiblingship. More distant relationships cannot be proven reliably using DNA testing. Testing to establish relationships other than parent/child, such as sibling, may also be recommended but only in addition to a parent/child test (see 9 FAM 601.111(B) paragraph b).
(2) DNA technology is the only nondocumentary method accepted for proof of a biological relationship.
However, due to the expense, complexity, and logistical delays inherent in parentage testing, genetic testing should be used only if no other credible proof (documentation, photos, etc.) of the
relationship exists. The process is timeconsuming for the applicant, the petitioner, and the consular section, and it does not necessarily yield conclusive results. Note that you may recommend DNA testing, but may not require it.
(3) When genetic testing appears warranted, advise the applicant that genetic testing may establish the validity of the relationship; that such testing is entirely voluntary; and that all costs of testing and related expenses must be borne by the petitioner and/or beneficiary and paid to the laboratory in advance. In addition, caution the applicant that submitting to testing does not guarantee the subsequent issuance of a visa.
(Previous location: 9 FAM 42.44 N4; CT:VISA1324 09252009)
b. When Not to Recommend Genetic Testing to Verify Relationships:
(1) You may recommend DNA testing to establish a blood relationship that would qualify an applicant for an immigration benefit. You may not request DNA testing in an attempt to disprove a relationship. For example, do not request DNA testing between marital partners on suspicion that they are blood relatives.
(2) Do not recommend direct sibling testing without parental testing. Direct testing between siblings may show an apparent lack of relationship even when the individuals are full siblings because of the variations in genetic contribution by each parent to individual children. For all sibling cases, each sibling must be tested against the parents (vice direct siblingtosibling testing) of the sibling group and return at least a 99.5 percent probability of maternity/paternity. If the results of the siblingto parent tests meet the 99.5 percent standard, then the sibling relationship is established through DNA.
(3) Recommend a DNA test of stepchildren only to establish paternity or maternity with the biological parent who is the spouse of the qualified petitioner. Do not recommend DNA testing to test for half sibling relationships, cousins, or other such extended relationships, as these tests cannot reach the minimum requirement of 99.5 percent probability.
9 FAM 601.111(C)
DNA Testing Procedures at Post
(Previous location: 9 FAM 42.44 N2; CT:VISA1324 09252009)
a. DNA Testing Collection Method:
(1) The preferred specimen collection technique for DNA testing is by buccal (cheek or mouth cavity) swab. When buccal swabs are taken, cells are collected from the inside cheek using a long cotton swab. Cheek swabs are preferred over blood samples because they are easier to collect, non invasive, painless, and easier to ship. The accuracy of a DNA test conducted with a cheek swab is equivalent to a test conducted using a blood test, and, unlike blood, cheek swabs are not considered to be biohazardous. Inform panel physicians and lab technicians that this is the preferred collection method for immigration cases.
(2) Post must obtain advance approval from the Office of Field Operations (CA/VO/F) if you are unable to use buccal swabs and must use blood draws instead.
(Previous location: 9 FAM 42.44 N7; CT:VISA1628 03012011)
b. Standards for the Collection of the DNA Samples:
(1) Though advanced, DNA results are only accurate if strict standards are followed for every sample collected. The AABB establishes standards for relationship testing, and the Department of State follows these standards for use in the collection of DNA samples to verify relationships for IVs, passports, and other benefits based on biological relationships.
(2) There are four essential elements that must be understood and maintained to protect the integrity of the DNA collection and relationship testing procedures:
(a) As DNA testing is voluntary, the individual being tested must consent to the testing;
(b) The identity of the individual being tested must be verified and confirmed by a cleared American; (c) The integrity of the sample must be maintained through a strict chain of custody; and
(d) The actual collection of the DNA sample must be witnessed by a cleared American.
(3) Effective immediately, all DNA collections must take place at the embassy or consulate and not at the panel physician's office or other lab facility. Department of State medical officers may not collect biological samples for genetic testing purposes. Furthermore, under no circumstances should
consular officers attempt to collect samples themselves. All sample collection must be done by medical personnel employed by the panel physician.
(4) Consular management must approve each lab technician prior to his or her authorization to collect DNA samples from applicants. Each panel physician's office must recommend several lab technicians who will then be cleared and approved by post. The completion of a CLASS namecheck and review of previous visa application(s) and RSO records is the minimum required clearance to approve a lab
technician for operation inside the consulate. Post should take factors including multiple visa refusals into consideration prior to clearing the technician for conducting DNA testing.
(5) Post must choose a site in the consular section for collection of the buccal swab. The collection must be witnessed by the consular officer or another cleared American, and in certain circumstances, section management as well. Posts may wish to explore privacy options, including (but not limited to) privacy booths, interview windows with a curtain separator for privacy, or a regular interview window. Regardless of the final collection location, both the applicant and medical technician must be in the immediate presence of the cleared American witness at all times.
(6) Any American citizen employee of the consular section, possessing a valid "Secret" or higher national security clearance may serve as the cleared American witness for DNA tests. At post's discretion, locally employed staff (LE staff) may accompany the cleared American to witness the collection. However, a cleared American must be the official witness of DNA testing procedures.
(7) Post must observe the guidelines outlined herein in order to maintain clear chain of custody, including a log to monitor accountability through all steps. See 9 FAM 601.111(E) below for the template for the required accountability log.
(8) DNA procedures should be posted on the post's websites as general information to the public, and updated annually. Any questions about what should be included in this information should be directed to CA/VO/F.
(9) Any additional postspecific internal controls and procedures involving DNA testing, not included in this FAM section, must be approved in advance by CA/VO/F.
(Previous location: 9 FAM 42.44 N8; CT:VISA2188; 10032014)
c. DNA Testing Procedures:
(1) A consular officer recommends DNA testing and simultaneously refers the case to FPU through the Enterprise Case Assessment System (ECAS). All cases whereby DNA has been recommended must be entered into ECAS. On the case referral form, click "DNA Testing". See "Using the Visa Fraud Module" for specific details on how to refer cases to ECAS.
(2) Petitioner/putative parent selects AABB accredited lab (see 9 FAM 601.111(A) paragraph b). (3) The selected AABB lab sends the beneficiary DNA testing kit(s) directly to the consular section.
(4) The Accountable Consular Officer (ACO) checks in all test kits on the DNA accountability log (see 9
FAM 601.111(E) below for sample log) upon receipt in the consular section. This consists of ensuring that the kit has not been opened or damaged and if the kit includes a seal, confirming the kit seal is intact, adding the kit to the accountability log stored in the ACO safe, and storing it in the ACO safe or a bar lock cabinet. The safe where the DNA kits are stored must be accessible only to the ACO or designated backup.
(5) Once the ACO records receipt of the collection kit, the consular section must contact the applicant to schedule an appointment date for DNA collection and tell the applicant that he/she must bring his/her passport and a photograph.
(6) On the DNA collection appointment date, a lab technician from the panel physician's office must
come to the consular section to collect the DNA sample(s).
(7) Immediately prior to the testing, the ACO checks the test kit out of the safe and gives it to the cleared American witness who will witness the collection, recording the cleared American witness's name in the accountability log. The witness verifies that the kit is unopened, and if applicable, the seal is intact. The cleared American witness is responsible for the custody of the testing materials until he or she applies the security seal to the mailing package.
(8) The cleared American witness should review the instructions sent by the AABB lab prior to the DNA collection, so as to be familiar enough with the sample collection technique to recognize if it is not being executed properly by the lab technician.
(9) At the time of testing, the cleared American witness must have the medical technician and applicant/beneficiary come to the interview window or designated location within the consular section, one applicant at a time.
(10) The cleared American witness must personally verify the identity of the donor through: (a) Presentation of passport; and
(b) Verifying that the applicant signs on the back of his or her photograph for attachment to the chain of custody document(s).
(11) Once the identity of the applicant has been confirmed, the cleared American witness must do the following:
(a) Collect the signed applicant photograph and supporting documents from the applicant; (b) Provide the sealed DNA kit to the lab technician or panel physician;
(c) Witness the collection of the buccal swab from the donor/applicant; (d) Legibly record required information on chainofcustody documents.
(i) This function may not be performed by locally employed staff (LE staff) or an outside party;
(ii) Minimal chain of custody requirements include, but are not limited to:
Date and time of the sample collection
Name and signature of lab technician conducting the swabs. Name is verified with the technician's ID badge or card
Name and signature of the cleared American witness
Other specific information required by the AABB laboratory as indicated in the kit instructions
(e) Witness the lab technician placing the completed DNA sample into the protective sleeve or pouch provided by the lab, accept the specimen from the lab technician or panel physician, and personally seal and sign the sample in accordance with the kit instructions;
(f) Seal the specimen in the prepaid shipping envelope provided by the lab. The sample must be in the direct possession of the same cleared American who witnessed the sample collection until the return mailing envelope is sealed in accordance with the instructions from the lab or shipping company. See paragraph d below for further details on storing and shipping DNA samples;
(g) Record in the applicant's ECAS case notes:
(i) His/her name as witness to the collection; (ii) Date and time of sample collection;
(iii) The name of the lab technician (from ID badge or card);
(iv) The name of the lab or panel physician where the technician is employed; and
(v) A clear description of the relationship(s) being tested (e.g., probability that the tested mother or father is the mother/father of the child tested).
(h) Scan all chainofcustody documents into the applicant's ECAS record and associate them with the applicant's case. Be sure that the information provided to the AABB lab clearly defines the relationship(s) to be tested. The request should be specific, not "are the parties related?", but rather "is the petitioner the mother/father of the tested applicant?"
(Previous location: 9 FAM 42.44 N9; CT:VISA1324 09252009)
d. Storing and Shipping of DNA Samples:
(1) Once the test is completed, the DNA samples must be placed into the prepaid shipping envelope, sealed, and shipped as soon as possible, preferably the same day. The shipping envelope may not be shipped through the local mail services and must be shipped by a company similar to FedEx or DHL. The cleared American must ensure that all documentation, including supporting forms, photos of the donors, chainofcustody documents, etc., requested in the test kit, accompany the specimen.
Once the kit is sealed, the cleared American is responsible for delivering or ensuring pickup of the test kit(s) by the mail service. He/she is responsible for the kits until they are turned over for shipment.
(2) All DNA samples must be shipped within 2448 hours after collection is complete. If kits cannot be shipped on the same day the sample is collected, then the sample must be returned to the ACO for storage until it is released for shipment. The DNA sample kit and all chain of custody materials are controlled items and must be stored securely, at minimum in a barlock safe, until the kit is shipped back to the U.S.based lab.
(3) When the test kit is shipped, a receipt for all kits must be collected from the shipper, the shipment date and tracking number must be entered into the case notes, and the airbill must be scanned into the appropriate case records.
(4) Under no circumstances may posts use the diplomatic pouch or local mail services to return samples to the testing laboratory.
(5) Any variations from these DNA procedures must be approved by CA/VO/F in advance and will be considered on a casebycase basis.
(Previous location: 9 FAM 42.44 N10(a) and (b); CT:VISA1932 10102012)
e. Communicating With Labs About the Results of the DNA Test:
(1) In all phases of testing, communication of the results of the test must be directly between consular officers or cleared Americans and the laboratory. Posts have the option to receive DNA test results electronically from AABB labs. AABB laboratories may send all test results directly to consular sections via email or post may retrieve the results via secure portal, if the lab has this capability. Consular sections must establish a dedicated email address to receive DNA results if they do not have one already. A consular officer or cleared American must open the email from the lab containing the results or log onto the secure portal to retrieve the results. Consular managers will ensure that access to this email account and/or the secure portal is safeguarded. LE staff are not authorized to access the email account or secure portal.
(2) The procedures for receiving DNA test results via courier have not changed. If receiving results via courier, AABB laboratories will send the test results to consular sections in sealed envelopes with the same type of security tape used when samples are taken. Only a consular officer or cleared American may open the sealed envelopes and record the information (see paragraph f below on handling DNA test results.)
(Previous location: 9 FAM 42.44 N10; CT:VISA1932 10102012)
f. Recording DNA Test Results:
(1) A cleared American receives and opens the sealed DNA results letter/email and enters the results of the test into the Enterprise Case Assessment Service (ECAS) case notes, recording the probability of relationship determined by the testing. Results must be recorded using the following standard phrase: "DNA results indicate xx.xx% likelihood of paternity (or maternity) with PA."
(2) After a cleared American enters the results into the ECAS case notes, the results must be scanned into the case record. A locally employed staff (LE staff) member may do the scanning provided that the results have already been entered into the case notes.
(3) The applicant or petitioner bears full financial responsibility for DNA testing and there is no legal basis for preventing him/her from also receiving a copy of the results directly from the laboratory. Post should not give copies of DNA test results directly to petitioners, applicants, or other parties without express consent from the Department.
(Previous location: 9 FAM 42.44 N1; CT:VISA1932 10102012)
g. Reporting Possible Compromise of DNA Sample or Results:
(1) Under no circumstances may any other party, including those being tested, be permitted to carry or transport biological samples or test results. If a cleared American or any other member of the consular team observes or has any reason to suspect that the test specimen or results have been tampered with, or may have even momentarily or inadvertently been subject to a compromised chain of custody, immediately notify post management, CA/VO/F, and CA/FPP. In the event of an actual or suspected breach of custody, post must suspend processing of the IV case until it has consulted with, and obtained clearance from, CA/VO/F and CA/FPP.
(2) Any procedural questions about this guidance should be directed to CA/VO/F or to CA/FPP.
(Previous location: 9 FAM 42.44 N12; CT:VISA1932 10102012)
h. Retention and Destruction of Unused DNA Kits:
(1) Dispose of unused DNA kits after one year. DNA kits have a shelflife of several years, so disposing of unused kits after one year will prevent usage of an expired kit. To determine the oneyear time frame, use the date when the petitioner, beneficiary, or applicant was first contacted to appear for sample collection in the consular section. If this date is unknown, use the date of the DNA kit’s
arrival in the consular section, which should be recorded in the DNA Accountability log.
(2) When DNA kits reach the oneyear mark, dispose of them, shred the enclosed documentation, and record the destruction in the DNA Accountability log.
(3) Discard the unused kits rather than use them for another case. Do not use the unused kits for another case because a petitioner has already paid to have the kit shipped to the consular section and the kit is associated with that particular case. Given that each kit bears the markings of a particular AABB lab, reuse of the kit could also give the erroneous impression that post is endorsing a particular AABB lab. For these reasons, post must discard any unused DNA kits.
9 FAM 601.111(D)
Genetic Testing for USCIS and Adjudication of Form
I130, Petition for Alien Relative
(Previous location: 9 FAM 42.44 N5; CT:VISA1324 09252009)
When USCIS does not find enough documentary evidence to approve a Form I130 the officer may request further proof of the relationship. Much like our own standards, USCIS officers may suggest DNA testing, but they may not require it. At posts without a USCIS officer who can conduct the testing, the consular section conducts the DNA testing.
(1) If the petitioner decides to pursue DNA testing, it is up to the petitioner to contact an approved AABB lab and arrange for her/her own testing and for the lab to send a kit to the appropriate embassy or consulate.
(2) All procedures for handling the test kits, conducting the tests, and the storing and/or shipping of samples are the same as for our own cases.
(3) If a case has been approved by USCIS, but DNA testing performed at the suggestion of post has disproven the biological relationship, return the petition to USCIS. In IR2 cases, keep in mind that the definition of a child is not limited to a biological relationship and thus the adjudicating officer must also rule out adoptive and stepchildren relationships in addition to the biological relationship not being valid.
(4) If post has been approved to adjudicate an I130, Petition for Alien Relative, under exceptional circumstances per 9 FAM 504.24, but it lacks documentary evidence and relies upon genetic testing as sole proof of the qualifying relationship, do not approve the I130. Such cases are not clearly approvable and therefore the petitions must be forwarded to USCIS for adjudication. Explain in the accompanying return memorandum why other evidence of the alleged relationship is unavailable or not credible, that the case is not clearly approvable, and suggest USCIS inform petitioner of DNA testing option. USCIS can approve a petition based solely on genetic testing.
c. Reporting Possible Compromise of Test Results:
See 9 FAM 601.111(C) paragraph (f), for information on dealing with potential compromise or chainofcustody issues involving DNA test results.
9 FAM 601.111(E)
Sample DNA Accountability Log
(Previous location: 9 FAM 42.44 Exhibit I; CT:VISA1773 11162011)
Please see the sample DNA accountability log below.
Kit # and Lab Name
Signature of ACO
Date kit removed for DNA sampling (dd/mm/yyyy)
Name and Initials of Cleared American witness who received DNA kit
Signature of ACO
Date kit delivered to shipping company