II

104TH CONGRESS

2D SESSION S. 1898

To protect the genetic privacy of individuals, and for other purposes.

IN THE SENATE OF THE UNITED STATES

JUNE 24, 1996

Mr. DOMENICI introduced the following bill; which was read twice and referred

to the Committee on Labor and Human Resources

A BILL

To protect the genetic privacy of individuals, and for other

purposes.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

4 (a) SHORT TITLE.—This act may be cited as the

5 ‘‘Genetic Confidentiality and Nondiscrimination Act of

6 1996’’.

7 (b) TABLE OF CONTENTS.—The table of contents of

8 this Act is as follows:

Sec. 1. Short title; table of contents.

Sec. 2. Findings and purposes.

Sec. 3. Definitions.
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TITLE I—COLLECTION, STORAGE, AND ANALYSIS OF DNA

SAMPLES

Sec. 101. Collection of DNA samples.

Sec. 102. Genetic analysis of DNA samples.

Sec. 103. Authorization for collection and storage of DNA samples for genetic

analysis.

Sec. 104. Ownership and destruction of DNA samples.

Sec. 105. Notice of rights and assurances.

TITLE II—DISCLOSURE OF GENETIC INFORMATION

Sec. 201. Disclosure of genetic information.

Sec. 202. Authorization for disclosure of genetic information.

Sec. 203. Inspection and copying of records containing genetic information.

Sec. 204. Amendment of records.

Sec. 205. Disclosures pursuant to compulsory process.

TITLE III—DISCRIMINATION PROHIBITED

Sec. 301. Discrimination by employers or potential employers.

Sec. 302. Discrimination by insurers.

TITLE IV—EXCEPTIONS FOR IDENTIFICATION AND COURTORDERED GENETIC ANALYSIS

Sec. 401. Identification of dead bodies.

Sec. 402. Identification of remains from active-duty military personnel.

Sec. 403. Identification for law enforcement purposes.

Sec. 404. Collection and analysis of DNA samples pursuant to court ordered

analysis.

TITLE V—RESEARCH ACTIVITIES

Sec. 501. Research involving genetic analysis.

Sec. 502. Disclosure of genetic information for research purposes.

Sec. 503. Exception for DNA samples collected prior to the effective date.

TITLE VI—MINORS

Sec. 601. Authorization for collection and analysis of DNA from minors.

TITLE VII—MISCELLANEOUS PROVISIONS

Sec. 701. Notification of privacy obligations.

Sec. 702. Transfer of ownership, discontinuance of services.

TITLE VIII.—ENFORCEMENT

Sec. 801. Civil remedies.

Sec. 802. Civil penalties and injunctive relief.

TITLE IX—EFFECTIVE DATES; APPLICABILITY; AND

RELATIONSHIP TO OTHER LAWS

Sec. 901. Effective dates.

Sec. 902. Applicability.

Sec. 903. Relationship to other laws.
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1 SEC. 2. FINDINGS AND PURPOSES.

2 (a) FINDINGS.—Congress finds the following:

3 (1) The DNA molecule contains an individual’s

4 genetic information, and this information is written

5 in a code that is being rapidly deciphered,

6 sequenced, and understood.

7 (2) Genetic information is uniquely private and

8 personal information.

9 (3) Genetic information has been misused re10 sulting in harm to individuals.

11 (4) The improper use and disclosure of genetic

12 information can lead to significant harm to the indi13 vidual, including stigmatization and discrimination.

14 (5) The potential for misuse with respect to ge15 netics is tremendous since genetics transcends medi16 cine. It has the potential to penetrate many aspects

17 of life including employment, insurance, forensics, fi18 nance, education, and even one’s self-perception.

19 (6) DNA samples and genetic information

20 should not be collected, stored, analyzed, nor dis21 closed without the individual’s authorization.

22 (7) A genetic analysis of an individual’s DNA

23 provides information not only about an individual,

24 but also about that individual’s parents, siblings and

25 children, potentially infringing on individual and

26 family privacy.
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1 (8) Because of its unique nature, DNA can be

2 linked to a single identifiable individual, regardless

3 of whether identifiers are limited to a DNA sample.

4 (9) Existing legal protections for genetic infor5 mation are inadequate to ensure genetic privacy.

6 (10) Uniform rules for the collection, storage

7 and use of DNA samples and genetic information

8 obtained from such samples are needed both to pro9 tect individual privacy and to permit legitimate ge10 netic research.

11 (b) PURPOSES.—It is the purpose of this Act to—

12 (1) define the circumstances under which ge13 netic information may be created, stored, analyzed,

14 and disclosed;

15 (2) define the rights of individuals and persons

16 with respect to genetic information;

17 (3) define the responsibilities of persons with

18 respect to genetic information;

19 (4) protect individuals from genetic discrimina20 tion;

21 (5) establish uniform rules that protect individ22 ual genetic privacy and allow the advancement of ge23 netic research; and
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1 (6) establish effective mechanisms to enforce

2 the rights and responsibilities established under this

3 Act.

4 SEC. 3. DEFINITIONS.

5 In this Act:

6 (1) COLLECTION.—The term ‘‘collection’’

7 means obtaining a DNA sample or samples.

8 (2) COMPULSORY DISCLOSURE.—The term

9 ‘‘compulsory disclosure’’ means any disclosure of ge10 netic information mandated or required by Federal

11 or State law in connection with a judicial, legislative,

12 or administrative proceeding, including, disclosure

13 required by subpoena, subpoena duces tecum, re14 quest or notice to produce, court order, or any other

15 method of requiring a person maintaining genetic in16 formation to produce genetic information under the

17 criminal or civil discovery laws of any State or under

18 Federal law.

19 (3) DISCLOSE.—The term ‘‘disclose’’, when

20 used with respect to genetic information, means to

21 provide access to the information, but only if such

22 access is provided to a person other than the individ23 ual.

24 (4) DISCLOSURE.—The term ‘‘disclosure’’

25 means the act or an instance of disclosing.
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1 (5) DNA.—The term ‘‘DNA’’ means

2 deoxyribonucleic acid including mitochondrial DNA,

3 complementary DNA, as well as any DNA derived

4 from ribonucleic acid (RNA).

5 (6) DNA MATCHING.—The term ‘‘DNA match6 ing’’ means a scientifically reliable method for char7 acterizing and comparing sequences of DNA, and

8 applying a statistical analysis of population fre9 quency to determine that if the DNA sequences

10 match, and the probability that the match occurs by

11 chance.

12 (7) DNA SAMPLE.—The term ‘‘DNA sample’’

13 means any human biological specimen from which

14 DNA is intended to be extracted, or DNA extracted

15 from such specimen.

16 (8) EMPLOYER.—The term ‘‘employer’’ has the

17 same meaning given such term in section 3(d) of the

18 Fair Labor Standards Act of 1938 (29 U.S.C.

19 203(d)).

20 (9) FAMILY.—The term ‘‘family’’ includes an

21 individual’s blood relatives and any legal relatives,

22 including a spouse or adopted child.

23 (10) GENETIC ANALYSIS.—The term ‘‘genetic

24 analysis’’ means extracting genetic information from

25 DNA.
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1 (11) GENETIC INFORMATION.—The term ‘‘ge2 netic information’’ means the information that may

3 derive from an individual or a family member about

4 genes, gene products, or inherited characteristics.

5 Such term includes DNA sequence information in6 cluding that which is derived from the alteration,

7 mutation, or polymorphism of DNA or the presence

8 or absence of a specific DNA marker or markers.

9 (12) INDIVIDUAL.—The term ‘‘individual’’

10 means the source of the DNA sample, including the

11 body, body parts, or bodily fluids of the individual

12 from whom the DNA sample originated.

13 (13) INDIVIDUAL IDENTIFIER.—The term ‘‘in14 dividual identifier’’ means a name, address, social

15 security number, health insurance identification

16 number, or similar information by which the identity

17 of an individual can be determined with reasonable

18 accuracy, either directly or by reference to other

19 available information. Such term does not include

20 characters, numbers, or codes assigned to an individ21 ual or a DNA sample that cannot singly be used to

22 identify an individual.

23 (14) INSTITUTIONAL REVIEW BOARD.—The

24 term ‘‘Institutional Review Board’’ means a board

25 established in accordance with section 46.102(g) of
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1 title 45, Code of Federal Regulations (1992), as

2 such regulation may from time to time be amended.

3 (15) INSURER.—The term ‘‘insurer’’ means any

4 insurance company, health care service contractor,

5 fraternal benefit organization, insurance agent, third

6 party administrator, insurance support organization

7 or other person subject to regulation under State in8 surance laws. Such term includes any managed care

9 organization as well as self-funded health plans and

10 health plans regulated under the Employee Retire11 ment Income Security Act of 1974 (29 U.S.C. 1001

12 et seq.).

13 (16) PERSON.—The term ‘‘person’’ shall in14 clude a family, corporation, partnership, association,

15 joint venture, government, governmental subdivision

16 or agency, and other legal or commercial entity.

17 (17) RESEARCH.—The term ‘‘research’’ means

18 systematic scientific (including social science) inves19 tigation that includes development, testing, and eval20 uation, designed or developed to contribute to origi21 nal generalizable knowledge.

22 (18) RESEARCHER.—The term ‘‘researcher’’

23 means a person who conducts research.

24 (19) SECRETARY.—The term ‘‘Secretary’’

25 means the Secretary of Health and Human Services.
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1 (20) STORAGE.—The term ‘‘storage’’ means re2 tention of a DNA sample for any length of time.

3 TITLE I—COLLECTION, STOR4 AGE, AND ANALYSIS OF DNA

5 SAMPLES

6 SEC. 101. COLLECTION OF DNA SAMPLES.

7 (a) REQUIREMENT OF WRITTEN AUTHORIZATION.—

8 Except as provided in sections 401, 402, 403, and 404,

9 no person may collect or cause to be collected a DNA sam10 ple for genetic analysis without the written authorization

11 of the individual.

12 (b) REQUIRED INFORMATION.—Prior to the collec13 tion of a DNA sample from an individual for genetic anal14 ysis, the person collecting the sample or causing the sam15 ple to be collected shall verbally inform the individual—

16 (1) that consent to or refusal of the collection

17 or taking of the DNA sample is voluntary;

18 (2) that consent to or refusal of genetic analysis

19 is voluntary;

20 (3) of the information that can reasonably be

21 expected to be derived from the genetic analysis;

22 (4) of the uses, if any, that the individual will

23 be able to make of the information derived from the

24 genetic analysis;
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1 (5) of the uses, if any, that the person will

2 make of the information derived from the genetic

3 analysis;

4 (6) of the right to inspect records that contain

5 information derived from the genetic analysis;

6 (7) of the right to have the DNA sample de7 stroyed;

8 (8) of the right to revoke consent to the genetic

9 analysis at any time prior to the commencement of

10 the genetic analysis;

11 (9) that the genetic analysis may result in in12 formation about the individual’s family which may

13 not be known to such relatives but could be impor14 tant, and if so the individual should consider wheth15 er or not to share that information with relatives;

16 (10) of the existence and protections afforded

17 by this Act; and

18 (11) of the availability of optional genetic and

19 psychological counseling.

20 SEC. 102. GENETIC ANALYSIS OF DNA SAMPLES.

21 (a) GENETIC ANALYSIS PROHIBITED WITHOUT AU22 THORIZATION.—Except as provided in sections 401, 402,

23 403, and 404, genetic analysis of a DNA sample is prohib24 ited unless specifically authorized in writing by the individ25 ual.
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1 (b) ASCERTAINMENT OF AUTHORIZATION.—No per2 son may analyze a DNA sample without ascertaining that

3 written authorization for the genetic analysis has been ob4 tained.

5 SEC. 103. AUTHORIZATION FOR COLLECTION AND STOR6 AGE OF DNA SAMPLES FOR GENETIC ANALY7 SIS.

8 (a) WRITTEN AUTHORIZATION.—To be valid, the au9 thorization required by sections 101 and 102 shall comply

10 with each of the following:

11 (1) WRITING.—The authorization must be in

12 writing, signed by the individual, and dated on the

13 date of such signature.

14 (2) COLLECTOR IDENTIFIED.—The authoriza15 tion must identify the person who collects the DNA

16 sample or causes the DNA sample to be collected.

17 (3) COLLECTION DESCRIBED.—The authoriza18 tion must state the exact bodily source from and the

19 manner in which the DNA sample is to be collected.

20 (4) AUTHORIZED USE.—The authorization must

21 include a description of all authorized uses of the

22 DNA sample.

23 (5) STATEMENT REGARDING STORAGE AFTER

24 COMPLETION OF ANALYSIS.—The authorization

25 must indicate whether or not the individual permits
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1 the sample to be maintained or stored after the

2 analysis is completed.

3 (6) STATEMENT REGARDING USES OF DNA SAM4 PLES FOR RESEARCH OR COMMERCIAL PURPOSES.—

5 The authorization must include a provision that en6 ables the individual to allow the uses of the DNA

7 sample for purely academic research and a separate

8 provision that gives specific authorization for com9 mercial uses.

10 (b) RETENTION OF AUTHORIZATION.—The author11 ization for the collection, storage and analysis of a DNA

12 sample shall be retained for the period during which the

13 DNA sample is retained.

14 (c) COPY.—A copy of the authorization shall be pro15 vided to the individual.

16 SEC. 104. OWNERSHIP AND DESTRUCTION OF DNA SAM17 PLES.

18 (a) OWNERSHIP OF THE DNA SAMPLE.—A DNA

19 sample is the property of the individual.

20 (b) RIGHT TO ORDER DESTRUCTION OF THE DNA

21 SAMPLE.—Except when a DNA sample has been collected

22 pursuant to section 402, 403, or 404, the individual shall

23 have the right to order the destruction of the DNA sam24 ple.
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1 (c) ROUTINE DESTRUCTION OF SAMPLES.—A DNA

2 sample shall be destroyed on completion of genetic analy3 sis unless the individual has directed otherwise in writing.

4 SEC. 105. NOTICE OF RIGHTS AND ASSURANCES.

5 A person who collects or stores DNA samples for ge6 netic analysis shall provide the individual prior to the col7 lection, storage, or analysis of the DNA sample, and any

8 other person upon request, with a notice of rights and as9 surances that contains the following information and as10 surances:

11 (1) That a DNA sample will only be used as

12 authorized in the written authorization.

13 (2) That a DNA sample is the property of the

14 individual.

15 (3) That the individual has the right to order

16 the destruction of the DNA sample at any time.

17 (4) That the DNA sample will be destroyed

18 upon the completion of the analysis unless the indi19 vidual has previously directed otherwise in writing.

20 (5) That the individual can designate another

21 person as the one authorized to make decisions re22 garding the DNA sample after the death of the indi23 vidual, and if any person is so designated, that the

24 individual should notify the facility in which the

25 DNA sample is stored.
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1 (6) That the individual has the right to examine

2 records containing genetic information, to obtain

3 copies of such records, and to request correction or

4 amendment of such records.

5 (7) That researchers may be granted access to

6 a DNA sample solely for research purposes and only

7 if specifically authorized by the individual.

8 (8) That the collection, storage and analysis of

9 the DNA sample and the genetic information derived

10 from the analysis is protected by this Act, and that

11 anyone whose rights under this Act have been vio12 lated can seek civil remedies, including damages and

13 attorney’s fees as provided for in this Act.

14 (9) That optional genetic and psychological

15 counseling are available.

16 TITLE II—DISCLOSURE OF

17 GENETIC INFORMATION

18 SEC. 201. DISCLOSURE OF GENETIC INFORMATION.

19 (a) REQUIREMENT OF WRITTEN AUTHORIZATION.—

20 Except as provided in sections 205 and 502, no person

21 who, in the ordinary course of business, practice of a pro22 fession, or rendering of a service, creates, stores, receives

23 or furnishes genetic information may disclose by any

24 means of communication genetic information except in ac-
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1 cordance with a written authorization as provided for in

2 section 202.

3 (b) REDISCLOSURE PROHIBITED.—Redisclosure of

4 genetic information which has been disclosed to any per5 son pursuant to a valid written authorization is prohibited.

6 SEC. 202. AUTHORIZATION FOR DISCLOSURE OF GENETIC

7 INFORMATION.

8 (a) WRITTEN AUTHORIZATIONS.—To be valid, an au9 thorization for disclosure of genetic information shall com10 ply with of the following:

11 (1) WRITING.—The authorization must be in

12 writing, signed by the individual and dated on the

13 date of such signature.

14 (2) PERSON MAKING DISCLOSURE IDENTI15 FIED.—The authorization must identify the person

16 permitted to make the disclosure.

17 (3) INFORMATION DESCRIBED.—The authoriza18 tion must describe the specific genetic information to

19 be disclosed.

20 (4) RECIPIENT IDENTIFIED.—The authoriza21 tion must identify the person to whom the informa22 tion is to be disclosed.

23 (5) PURPOSE DESCRIBED.—The authorization

24 must describe the purpose for which the disclosure

25 is being made.
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1 (6) EXPIRATION DATE.—The authorization

2 must state the date upon which the authorization

3 will expire, which in no event shall be longer than

4 30 days after the date of the authorization.

5 (7) REVOCATION STATEMENT.—The authoriza6 tion must include a statement that the authorization

7 is subject to revocation at any time before the disclo8 sure is actually made or the individual is made

9 aware of the details of the genetic information.

10 (b) COPY.—A copy of the authorization shall be pro11 vided to the individual.

12 (c) REVOCATION OR AMENDMENT OF AUTHORIZA13 TION.—An individual may revoke or amend the authoriza14 tion, in whole or in part, at any time.

15 (d) IDENTIFICATION OF INFORMATION AS PRO16 TECTED BY LAW.—Each disclosure made with the written

17 authorization described in subsection (a) shall be accom18 panied by the following written statement:

19 ‘‘This information has been disclosed to you from

20 confidential records protected under the Genetic Confiden21 tiality and Nondiscrimination Act of 1996 and any further

22 disclosure of the information without specific authoriza23 tion is prohibited.’’.

24 (e) EFFECT OF GENERAL AUTHORIZATION FOR RE25 LEASE OF MEDICAL RECORDS.—A general authorization
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1 for the release of medical records or medical information

2 shall not be construed as an authorization for disclosure

3 of genetic information. With respect to medical records

4 that contain genetic information, the requirements for dis5 closure of genetic information under this section must be

6 complied with.

7 SEC. 203. INSPECTION AND COPYING OF RECORDS CON8 TAINING GENETIC INFORMATION.

9 (a) INSPECTION OF RECORDS.—Except as provided

10 in section 501(c)(2) and 501(f), a person who maintains

11 genetic information shall, upon written request, permit the

12 individual to inspect records containing genetic informa13 tion and shall provide a copy of any such records upon

14 request of the individual.

15 (b) RESPONSE TO REQUEST EXAMINATION AND

16 COPYING OF INFORMATION.—Upon receipt of a written

17 request from an individual to inspect or copy all or part

18 of records containing genetic information, a person as

19 promptly as required under the circumstances, but in no

20 event later than 90 business days after receiving the re21 quest, shall make the information available to the individ22 ual for inspection during regular business hours or provide

23 a copy, if requested, to the individual.

24 (c) EXPLANATION OF TERMS AND CODES.—A person

25 shall provide an explanation of terms and any code or ab-
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1 breviations used in records containing the genetic informa2 tion upon the request of the individual.

3 (d) FEE.—A person may charge a reasonable fee, not

4 to exceed the person’s actual duplication cost, for copies

5 of records which are provided under this section.

6 SEC. 204. AMENDMENT OF RECORDS.

7 (a) IN GENERAL.—Not later than 90 days after the

8 receipt of a written request by an individual to amend in

9 whole or in part any record containing genetic informa10 tion, a person who maintains records containing such ge11 netic information shall—

12 (1) make the amendment requested;

13 (2) inform the individual that the amendment

14 has been made;

15 (3) make reasonable efforts to inform any per16 son to whom the unamended portion of the informa17 tion was previously disclosed of the amendment that

18 has been made; and

19 (4) at the request of the individual, make rea20 sonable efforts to inform any known source of the

21 unamended portion of the information about the

22 amendment that has been made.

23 (b) REASONS FOR REFUSAL AND REVIEW PROCE24 DURES.—If an amendment is refused under subsection
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1 (a), the person maintaining the records shall inform the

2 individual of—

3 (1) the reasons for the refusal of the person to

4 make the amendment;

5 (2) the procedures for further review of such re6 fusal; and

7 (3) the individual’s right to file with the person

8 a concise statement setting forth the requested

9 amendment and the individual’s reasons for dis10 agreeing with the refusal of the person to make the

11 amendment.

12 With respect to a concise statement filed under paragraph

13 (3), such statement shall be made part of the record.

14 (c) STANDARDS FOR AMENDMENT.—A person main15 taining records containing genetic information shall

16 amend such information in accordance with a request

17 made under subsection (a) if such information is not accu18 rate or complete for the purposes for which such informa19 tion may be used or disclosed by the person.

20 (d) STATEMENT OF DISAGREEMENT.—After an indi21 vidual has filed a statement of disagreement under sub22 section (b)(3), the person, in any subsequent disclosure

23 of the disputed portion of the information, shall include

24 a copy of the individual’s statement and may include a
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1 statement of the reasons for not making the requested

2 amendment.

3 SEC. 205. DISCLOSURES PURSUANT TO COMPULSORY

4 PROCESS.

5 (a) PROCEEDINGS IN WHICH AVAILABLE.—No per6 son who maintains genetic information may be compelled

7 to disclose such information pursuant to a request for

8 compulsory disclosure in any judicial, legislative, or ad9 ministrative proceeding, unless—

10 (1) the request for compulsory disclosure is in

11 accordance with section 404;

12 (2) the individual whose genetic information is

13 requested is a party to the proceeding and the ge14 netic information is at issue; or

15 (3) the genetic information is for use in a law

16 enforcement proceeding or investigation in which the

17 person maintaining the information is the subject or

18 party.

19 (b) NOTICE.—If genetic information is sought under

20 subparagraph (2) of subsection (a), or in a proceeding or

21 investigation pursuant to subparagraph (3) of subsection

22 (a), the person requesting compulsory disclosure shall

23 serve upon the person maintaining the genetic informa24 tion, and upon the individual, or on the individual’s attor25 ney, the original or a copy of the compulsory disclosure
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1 request at least 30 days prior to the date on which the

2 compulsory disclosure is requested, and a statement of the

3 right of the individual, and of the person maintaining the

4 genetic information, to have any objections to such com5 pulsory disclosure heard by such court or governmental

6 agency prior to the issuance of an order for such compul7 sory disclosure, and the procedure to be followed to have

8 any such objections heard. Such service shall be made by

9 certified mail, return receipt requested, or by hand deliv10 ery, in addition to any form of service required by applica11 ble State or Federal law.

12 (c) CERTIFICATION.—Service of compulsory process

13 or discovery requests upon a person maintaining genetic

14 information shall be accompanied by a written certifi15 cation—

16 (1) signed by the person seeking to obtain the

17 genetic information or his or her authorized rep18 resentative;

19 (2) identifying at least one paragraph of sub20 section (a) under which compulsory process or dis21 covery is being sought; and

22 (3) that states, in the case of information

23 sought under paragraph (2) or (3) of subsection (a),

24 that the requirements under subsection (b) for no25 tice have been met.
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1 The signature of a person on the certification shall be

2 valid only if the person, at the time of signing, reasonably

3 believed that the paragraph of subsection (a) that is iden4 tified in the certification provides an appropriate basis for

5 the use of discovery or compulsory process. A copy of the

6 written certification shall be maintained as a permanent

7 part of the records of genetic information.

8 (d) STANDARD FOR ISSUANCE OF ORDER.—An order

9 under this section may only be entered by a court of com10 petent jurisdiction after a hearing and determination that

11 good cause exists. To make such determination the court

12 must find that—

13 (1) other ways of obtaining the genetic informa14 tion are not available or would not be effective; and

15 (2) there is a compelling need for the genetic

16 information which outweighs the potential harm to

17 the privacy interest of the subject of the informa18 tion.

19 (e) CONTENT OF ORDER.—An order under this sec20 tion which authorizes disclosure of genetic information

21 shall—

22 (1) limit disclosure to those parts of records

23 containing such information which are essential to

24 fulfill the objective of the order;
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1 (2) limit disclosure to those persons whose need

2 for the information is the basis of the order;

3 (3) require the deletion of individual identifiers

4 from any documents made available to the public;

5 and

6 (4) include such other measures as are nec7 essary to limit disclosure for the protection of the

8 subject of the information including sealing from

9 public scrutiny the record or any portion of the

10 record of any proceeding for which disclosure of the

11 information has been ordered.

12 TITLE III—DISCRIMINATION

13 PROHIBITED

14 SEC. 301. DISCRIMINATION BY EMPLOYERS OR POTENTIAL

15 EMPLOYERS.

16 (a) IN GENERAL.—An employer may not seek to ob17 tain, obtain or use the genetic information of an employee

18 or a prospective employee, or require the collection of a

19 DNA sample of an employee or prospective employee for

20 analysis to distinguish between, discriminate against, or

21 restrict any right or benefit otherwise due or available to

22 the employee or prospective employee.

23 (b) ENFORCEMENT.—The powers, remedies, and pro24 cedures set forth in sections 705 through 709 of the Civil

25 Rights Act of 1964 shall be the powers, remedies, and pro-
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1 cedures applicable under this section to any person alleg2 ing a violation of this section.

3 SEC. 302. DISCRIMINATION BY INSURERS.

4 (a) IN GENERAL.—An insurer offering a policy or

5 plan may not—

6 (1) terminate, restrict, limit, or otherwise apply

7 conditions to the coverage of an individual or family

8 member under the policy or plan, or restrict the sale

9 of the policy or plan to an individual or family mem10 ber;

11 (2) cancel or refuse to renew the coverage of an

12 individual or family member under the policy or

13 plan;

14 (3) deny coverage or exclude an individual or

15 family member from coverage under the policy or

16 plan;

17 (4) impose a rider that excludes coverage for

18 certain benefits or services under the policy or plan;

19 (5) establish differentials in premium rates or

20 cost sharing for coverage under the policy or plan;

21 or

22 (6) otherwise discriminate against an individual

23 or family member in the provision of insurance;

24 on the basis of any genetic information concerning an indi25 vidual or family member or on the basis of an individual’s
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1 or family member’s request for or receipt of genetic serv2 ices.

3 (b) PROHIBITION ON TESTING OR QUESTIONING.—

4 An insurer may not require an applicant for coverage

5 under the policy or plan, or an individual or family mem6 ber who is presently covered under a policy or plan, to

7 be the subject of a genetic test or to be subjected to ques8 tions relating to genetic information.

9 (c) DISCLOSURE.—An insurer shall, in the applica10 tion or enrollment information provided by the insurer

11 concerning a policy or plan, provide an applicant or en12 rollee with a written statement disclosing the rights of the

13 applicant or enrollee under this Act. Such statement shall

14 be in a form and manner that is noticeable to and under15 standable by an average applicant or enrollee.

16 (d) ENFORCEMENT.—

17 (1) PLANS OTHERS THAN EMPLOYEE WELFARE

18 BENEFIT PLANS.—The requirements established

19 under subsections (a), (b), and (c) shall be enforced

20 by the State insurance commissioner for the State

21 involved or the official or officials designated by the

22 State, except that in no case shall a State enforce

23 such requirements as they relate to employee welfare

24 benefit plans (as defined in section 3 of the Em25 ployee Retirement Income Security Act of 1974).
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1 (2) EMPLOYEE WELFARE BENEFIT PLANS.—

2 With respect to employee welfare benefit plans, the

3 Secretary shall enforce the requirements established

4 under subsections (a), (b), and (c) in the same man5 ner as provided for under sections 502, 504, 506,

6 and 510 of the Employee Retirement Income Secu7 rity Act of 1974 (29 U.S.C. 1132, 1134, 1136, and

8 1140).

9 TITLE IV—EXCEPTIONS FOR

10 IDENTIFICATION AND COURT11 ORDERED GENETIC ANALYSIS

12 SEC. 401. IDENTIFICATION OF DEAD BODIES.

13 Notwithstanding any other provision of this Act, a

14 person may provide access to a DNA sample, or to data

15 derived from DNA matching, to assist in the identification

16 of a dead body if the analysis of any DNA sample or data

17 is limited only to that which is necessary to determine the

18 identity of the dead body.

19 SEC. 402. IDENTIFICATION OF REMAINS FROM ACTIVE20 DUTY MILITARY PERSONNEL.

21 (a) IN GENERAL.—Notwithstanding any other provi22 sion of this Act, the United States Armed Forces may—

23 (1) collect, store, or analyze a DNA sample

24 from an active-duty member only for the purposes of

25 the identification of remains; and
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1 (2) disclose DNA matching information from

2 active-duty members only for the purposes of the

3 identification of remains.

4 (b) DESTRUCTION.—A DNA sample shall be de5 stroyed upon the request of the individual at time of his

6 or her discharge.

7 SEC. 403. IDENTIFICATION FOR LAW ENFORCEMENT PUR8 POSES.

9 Nothing in this Act shall be construed to prohibit

10 Federal, State or local law enforcement authorities from

11 collecting, storing or marking DNA samples, if—

12 (1) the collection, storage and marking is au13 thorized under Federal or State law;

14 (2) the collection, storage and marking is lim15 ited to the purpose of DNA matching in criminal in16 vestigations;

17 (3) access to such DNA samples is limited to

18 authorized law enforcement agencies, prosecutors,

19 defense counsel, defendants, accused individuals,

20 suspects, and their authorized agents; and

21 (4) such authorities have probable cause to col22 lect, store, or mark a sample.
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1 SEC. 404. COLLECTION AND ANALYSIS OF DNA SAMPLES

2 PURSUANT TO COURT ORDERED ANALYSIS.

3 Nothing in this Act shall be construed to prohibit

4 court ordered paternity testing in civil actions to deter5 mine paternity.

6 TITLE V—RESEARCH ACTIVITIES

7 SEC. 501. RESEARCH INVOLVING GENETIC ANALYSIS.

8 (a) CONDITIONS FOR A GENETIC ANALYSIS.—Except

9 as provided in section 503, no DNA sample shall be ana10 lyzed as part of a research project unless an Institutional

11 Review Board has determined that—

12 (1) use of DNA samples is essential to the re13 search project;

14 (2) the potential benefit of the research project

15 outweighs the potential risks to the subjects includ16 ing psychosocial risks and intrusion into the privacy

17 of the subjects that would result from genetic analy18 sis of DNA samples; and

19 (3) the research protocol—

20 (A) contains adequate safeguards to pro21 tect against disclosure of genetic information

22 that is generated by the research;

23 (B) requires that research subjects will be

24 given the applicable information required under

25 section 101 in addition to meeting the informed

26 consent requirements contained in section
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•S 1898 IS

1 46.116 of title 45, Code of Federal Regulations

2 (1992) as such regulation may from time to

3 time be amended;

4 (C) requires the written authorization of

5 research subjects that complies with the appli6 cable requirements of section 103, and that de7 scribes the protocol and the intended uses;

8 (D) prohibits inclusion of research records

9 in medical records unless the individual author10 izes such inclusion in writing; and

11 (E) with respect to protocols involving the

12 use of DNA samples from individuals deceased

13 prior to the effective date of this Act, provides

14 a method for disclosing the risk associated with

15 genetic information, which in reasonable medi16 cal judgment can be effectively ameliorated,

17 prevented, or treated, to an individual’s family

18 members, such method to take into account

19 that family members have the right to refuse

20 learning of any genetic information.

21 Additionally, the researcher or the researcher’s institution

22 is responsible for any fees or costs associated with the dis23 closure, including for optional genetic or psychological

24 counselling.
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1 (b) SAFEGUARDS AGAINST DISCLOSURES OF GE2 NETIC INFORMATION.—For purposes of paragraph (3)(A)

3 of subsection (a), adequate safeguards against disclosure

4 of genetic information, at a minimum, include—

5 (1) obtaining a certificate of confidentiality

6 from the Secretary as provided for in section 301(d)

7 of the Public Health Service Act (42 U.S.C. 241(d));

8 (2) ensuring that research subjects will not be

9 identifiable in any report or publication which re10 sults from the research; and

11 (3) having procedures to remove or destroy at

12 the earliest opportunity consistent with the purposes

13 of the project, any individual identifiers.

14 (c) FURTHER LIMITATIONS ON RESEARCH INVOLV15 ING INDIVIDUALS UNDER 18.—With respect to an individ16 ual who is under 18 years of age, no research shall be

17 conducted on DNA samples unless—

18 (1) a parent or guardian is given the applicable

19 information required under section 101;

20 (2) a parent or guardian executes an authoriza21 tion that meets the applicable requirements of sec22 tion 103 and which specifically states that the par23 ent or guardian understands and agrees that unless

24 the analysis reveals a genetic condition which in rea25 sonable medical judgment can only be effectively
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1 ameliorated, prevented, or treated while the individ2 ual is under 18 years of age, the results of the anal3 ysis will not be disclosed to the parent or guardian

4 of the individual; and

5 (3) any provisions for soliciting the assent of

6 minors as contained in section 46.408 of title 45,

7 Code of Federal Regulations, which the Institutional

8 Review Board determines to be applicable are met.

9 (d) DESTRUCTION OF DNA SAMPLES OR IDENTIFI10 ERS.—In the absence of a specific authorization to main11 tain a DNA sample, DNA samples collected, stored or

12 analyzed in connection with a research project shall be de13 stroyed upon completion of the project or withdrawal of

14 the individual from the project, whichever occurs first.

15 (e) PEDIGREE ANALYSIS AND FAMILY LINKAGE

16 STUDIES.—When a research project includes genetic anal17 ysis of family members for pedigree analysis or linkage

18 analysis—

19 (1) the Institutional Review Board, in addition

20 to making the determinations required in subsection

21 (a), shall also require that to the maximum extent

22 practicable, separate records are maintained on each

23 subject; and
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1 (2) subjects, prior to their participation, and in

2 addition to the disclosures required by section 101,

3 shall be—

4 (A) informed that one risk of their partici5 pation is that other family members may learn

6 genetic information about themselves;

7 (B) informed of what will be done with

8 records and data generated during the project;

9 and

10 (C) informed that the project may deter11 mine that some members of their family are not

12 genetic relatives.

13 (f) SUBJECTS RIGHT TO OBTAIN INFORMATION.—

14 When complying with the provisions of section 203, no

15 person shall provide an individual in the pedigree with ge16 netic information about any individual in the pedigree

17 without that individual’s authorization.

18 SEC. 502. DISCLOSURE OF GENETIC INFORMATION FOR RE19 SEARCH PURPOSES.

20 (a) IN GENERAL.—Any person who, in the ordinary

21 course of business, practice of a profession, or rendering

22 of a service, stores or maintains genetic information is

23 prohibited from allowing access to such information to re24 searchers unless—
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1 (1) an Institutional Review Board has approved

2 the conduct of the research program or study; and

3 (2) the individual has specifically consented to

4 the access or disclosure of such information in an

5 authorization that meets the requirements of section

6 202.

7 Such information should be provided in a coded form with

8 all individual identifiers removed.

9 (b) LIMITED ACCESS FOR STATISTICAL USE.—Not10 withstanding the provisions of subsection (a), a person

11 who stores or maintains genetic information may grant ac12 cess to such information solely for the purpose of inspec13 tion or review of records containing the information if—

14 (1) the inspection or review is for the purpose

15 of compiling data for statistical or epidemiological

16 studies and genetic information is not to be copied,

17 removed from the records, or redisclosed in any way;

18 and

19 (2) the person conducting the inspection or re20 view certifies in writing—

21 (A) that the limitations in paragraph (1)

22 will be complied with;

23 (B) to knowledge of their liability for viola24 tions of this Act; and
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•S 1898 IS

1 (C) that the person has complied with sec2 tions 101 and 103.

3 SEC. 503. EXCEPTION FOR DNA SAMPLES COLLECTED

4 PRIOR TO THE EFFECTIVE DATE.

5 Notwithstanding the provisions of section 501, a

6 DNA sample that was collected from an individual prior

7 to the effective date of this Act may be analyzed as part

8 of a research project under a protocol approved by an In9 stitutional Review Board, if such project—

10 (1) withdraws or destroys the DNA sample if

11 the individual makes a written request within 3

12 years of the effective date of this Act; and

13 (2) except as provided under section 502, dis14 closes genetic information only with the authoriza15 tion of—

16 (A) the individual; or

17 (B) a member of the family of the individ18 ual if the individual is deceased.

19 TITLE VI—MINORS

20 SEC. 601. AUTHORIZATION FOR COLLECTION AND ANALY21 SIS OF DNA FROM MINORS.

22 (a) IN GENERAL.—Except as provided in section

23 501(c), the DNA sample of an individual who is under

24 18 years of age shall not be collected, stored, or analyzed

25 to determine the existence of a risk from genetic informa-
35

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1 tion that does not in reasonable medical judgment produce

2 signs or symptoms of disease before the age of 18, un3 less—

4 (1) there is an effective intervention that will

5 prevent or delay the onset or ameliorate the severity

6 of the disease; and

7 (2) the intervention is initiated before the indi8 vidual reaches the age of 18; and

9 (3) the individual’s parent or guardian has re10 ceived the disclosures required by section 101 and

11 has executed a written authorization which meets

12 the requirements of section 103 and which also lim13 its the uses of such analysis to those permitted by

14 this section.

15 (b) DESTRUCTION OF DNA SAMPLES OF INDIVID16 UALS UNDER 18.—An individual’s parent or guardian

17 may, on behalf of an individual who is under 18 years of

18 age, order the destruction of a DNA sample collected pur19 suant to subsection (a).

20 (c) PROHIBITION ON USE OF NEWBORN SCREEN21 ING.—In no event shall any DNA collected, stored, or ana22 lyzed as part of a newborn screening program be used ex23 cept for the strict purposes of newborn screening as au24 thorized under State law or regulation.
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1 TITLE VII—MISCELLANEOUS

2 PROVISIONS

3 SEC. 701. NOTIFICATION OF PRIVACY OBLIGATIONS.

4 Not less than annually, every person who maintains

5 individual DNA samples or genetic information shall no6 tify their employees of their responsibilities under this Act

7 and the penalties for violating the provisions of this Act.

8 SEC. 702. TRANSFER OF OWNERSHIP, DISCONTINUANCE OF

9 SERVICES.

10 (a) ACTIVITIES INVOLVING DNA SAMPLES.—Any

11 person in possession of DNA samples who intends to dis12 continue a program, business, enterprise, or service in

13 which such DNA samples were collected, stored, or ana14 lyzed or who intends to transfer control of such program,

15 business, enterprise, or service to a person who intends

16 to use such DNA samples for a substantially different pur17 pose than was authorized at the time of collection, storage,

18 or analysis of such DNA samples shall inform the individ19 ual that the individual has the right to order that the

20 records regarding such samples be returned to the individ21 ual.

22 (b) NO RESPONSE.—If a person to which subsection

23 (a) applies receives no response from an individual to

24 which information is provided under such subsection, the

25 person in possession of the records involved—
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•S 1898 IS

1 (1) in the case of discontinuance, shall destroy

2 the records, or

3 (2) in the case of an intended transfer, may

4 proceed with transfer of control of the records.

5 TITLE VIII—ENFORCEMENT

6 SEC. 801. CIVIL REMEDIES.

7 (a) PRIVATE RIGHT OF ACTION.—Any person whose

8 rights under this Act have been violated may maintain a

9 civil action for damages or equitable relief as provided for

10 in this section.

11 (b) JURISDICTION.—An action may be brought under

12 this section in the district courts of the United States or

13 a State court of competent jurisdiction.

14 (c) RELIEF.—In any action brought under this sec15 tion, a court may order a person to comply with the provi16 sions of this Act and may order any other appropriate eq17 uitable relief.

18 (d) LIABILITY FOR NEGLIGENT VIOLATIONS.—Any

19 person who through negligence collects, stores, or analyzes

20 a DNA sample in violation of this Act, or discloses genetic

21 information in violation of this Act, shall be liable to the

22 individual for each such violation in an amount equal to—

23 (1) any actual damages sustained as a result of

24 the collection, storage, analysis, or disclosure, or

25 $50,000, whichever is greater;
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•S 1898 IS

1 (2) in any case where such violation has re2 sulted in profit or monetary gain, treble damages;

3 and

4 (3) in the case of a successful action to enforce

5 any liability under this section, the costs of the ac6 tion together with reasonable attorneys’ fees as de7 termined by the court.

8 (e) LIABILITY FOR WILLFUL VIOLATIONS.—Any per9 son who—

10 (1) through a request, the use of persuasion,

11 under threat, or with a promise of reward, willfully

12 induces another to collect, store, or analyze a DNA

13 sample in violation of this Act, or disclose genetic in14 formation in violation of this Act, or

15 (2) willfully collects, stores, or analyzes a DNA

16 sample in violation of this Act, or willfully discloses

17 genetic information in violation of this Act, shall be

18 liable to the individual for each such violation in an

19 amount equal to—

20 (A) any actual damages sustained as a re21 sult of the collection, analysis, or disclosure, or

22 $100,000, whichever is greater;

23 (B) punitive damages as the court may

24 allow; and
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•S 1898 IS

1 (C) in the case of a successful action under

2 this section, the costs of the action together

3 with reasonable attorneys’ fees as determined

4 by the court.

5 (f) STATUTE OF LIMITATIONS.—Except with respect

6 to subsection (g), any action under this section must be

7 brought within 6 years of the date that the alleged viola8 tion was or should have been discovered.

9 (g) TOLLING OF LIMITATIONS.—If the person enti10 tled to maintain an action under this section is a minor,

11 or is incapacitated by reason of mental illness when the

12 right to bring an action first occurs, the action may be

13 commenced up to 10 years after the disability is removed.

14 SEC. 802. CIVIL PENALTIES AND INJUNCTIVE RELIEF.

15 (a) IN GENERAL.—Whenever the Attorney General

16 has reason to believe that any person is using or is about

17 to use any method, act or practice in violation of the provi18 sions of this Act, and that proceedings would be in the

19 public interest, the Attorney General may bring an action

20 against such person to restrain by temporary restraining

21 order or preliminary or permanent injunction the use of

22 such method, act or practice.

23 (b) JURISDICTION.—The action may be brought in

24 the district court of the jurisdiction in which the person

25 resides or has a principal place of business.
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1 (c) RELIEF.—The court may issue temporary re2 straining orders or preliminary or permanent injunctions

3 and make such other orders or judgments as may be nec4 essary to prevent harm or to remedy harm suffered by

5 any person as a result of the use or employment of such

6 method, act or practice in violation of this Act.

7 (d) CIVIL PENALTY.—If the court finds that a person

8 has employed any method, act or practice which the per9 son knew or should have known to be in violation of this

10 Act, the court may require such person to pay a civil pen11 alty of not more than $50,000 for each such violation and

12 may also require such person to pay reasonable costs of

13 investigation and litigation of such violation, including

14 reasonable attorneys fees.

15 TITLE IX—EFFECTIVE DATES;

16 APPLICABILITY; AND RELA17 TIONSHIP TO OTHER LAWS

18 SEC. 901. EFFECTIVE DATES.

19 This Act shall take effect on January 1, 1998.

20 SEC. 902. APPLICABILITY.

21 (a) AUTHORIZATION FOR ANALYSIS OF DNA SAM22 PLES COLLECTED PRIOR TO EFFECTIVE DATE.—In order

23 to comply with the provisions of this Act, any person who,

24 prior to the effective date of this Act, is in possession of

25 a DNA sample shall, prior to performing any genetic anal-
41

•S 1898 IS

1 ysis on the DNA samples make the disclosures required

2 by section 101(c), and obtain a written authorization that

3 meets the requirements of section 202.

4 (b) RESEARCH ON DNA SAMPLES COLLECTED

5 PRIOR TO EFFECTIVE DATE.—Any person who is con6 ducting research under a protocol approved by an Institu7 tional Review Board may use DNA samples collected prior

8 to the effective date of this Act for the 3-year period begin9 ning on the date of enactment of this Act.

10 (c) AUTHORIZATIONS FOR DISCLOSURES.—An au11 thorization for the disclosure of genetic information that

12 is executed before January 1, 1998, and which does not

13 meet the requirements of section 103, but which is valid

14 under State law on January 1, 1997, shall remain valid

15 until the expiration of 30 days after the effective date of

16 this Act, or the expiration date specified in the authoriza17 tion, whichever occurs earlier.

18 SEC. 903. RELATIONSHIP TO OTHER LAWS.

19 (a) IN GENERAL.—No State may establish or enforce

20 any law or regulation concerning the collection, storage,

21 of analysis of DNA samples except to the extent that such

22 law or regulation—

23 (1) prohibits or further restricts the collection,

24 storage, or analysis of DNA samples; or
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1 (2) provides additional protections to the pri2 vacy interests of the individual who is a DNA sam3 ple source.

4 (b) DISCLOSURE.—No State may establish or enforce

5 any law or regulation concerning the disclosure of genetic

6 information except to the extent that such law or regula7 tion, with respect to the limitations contained in this

8 Act—

9 (1) prohibits or further restricts the disclosure

10 of such information;

11 (2) prohibits or further restricts the use of such

12 information; or

13 (3) provides additional protection to the privacy

14 interests of the individual who is a DNA sample

15 source or the subject of the genetic information.

16 (c) CONSTRUCTION.—Nothing in this Act shall be

17 construed as limiting or prohibiting the pursuit of any

18 other remedies available under common or statutory law

19 in regard to the collection, storage, analysis of DNA sam20 ples, and the disclosure of genetic information.

Æ