[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[S. 1898 Introduced in Senate (IS)]







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.

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

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This act may be cited as the ``Genetic 
Confidentiality and Nondiscrimination Act of 1996''.
    (b) Table of Contents.--The table of contents of this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Findings and purposes.
Sec. 3. Definitions.
       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 COURT-ORDERED 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.

SEC. 2. FINDINGS AND PURPOSES.

    (a) Findings.--Congress finds the following:
            (1) The DNA molecule contains an individual's genetic 
        information, and this information is written in a code that is 
        being rapidly deciphered, sequenced, and understood.
            (2) Genetic information is uniquely private and personal 
        information.
            (3) Genetic information has been misused resulting in harm 
        to individuals.
            (4) The improper use and disclosure of genetic information 
        can lead to significant harm to the individual, including 
        stigmatization and discrimination.
            (5) The potential for misuse with respect to genetics is 
        tremendous since genetics transcends medicine. It has the 
        potential to penetrate many aspects of life including 
        employment, insurance, forensics, finance, education, and even 
        one's self-perception.
            (6) DNA samples and genetic information should not be 
        collected, stored, analyzed, nor disclosed without the 
        individual's authorization.
            (7) A genetic analysis of an individual's DNA provides 
        information not only about an individual, but also about that 
        individual's parents, siblings and children, potentially 
        infringing on individual and family privacy.
            (8) Because of its unique nature, DNA can be linked to a 
        single identifiable individual, regardless of whether 
        identifiers are limited to a DNA sample.
            (9) Existing legal protections for genetic information are 
        inadequate to ensure genetic privacy.
            (10) Uniform rules for the collection, storage and use of 
        DNA samples and genetic information obtained from such samples 
        are needed both to protect individual privacy and to permit 
        legitimate genetic research.
    (b) Purposes.--It is the purpose of this Act to--
            (1) define the circumstances under which genetic 
        information may be created, stored, analyzed, and disclosed;
            (2) define the rights of individuals and persons with 
        respect to genetic information;
            (3) define the responsibilities of persons with respect to 
        genetic information;
            (4) protect individuals from genetic discrimination;
            (5) establish uniform rules that protect individual genetic 
        privacy and allow the advancement of genetic research; and
            (6) establish effective mechanisms to enforce the rights 
        and responsibilities established under this Act.

SEC. 3. DEFINITIONS.

    In this Act:
            (1) Collection.--The term ``collection'' means obtaining a 
        DNA sample or samples.
            (2) Compulsory disclosure.--The term ``compulsory 
        disclosure'' means any disclosure of genetic information 
        mandated or required by Federal or State law in connection with 
        a judicial, legislative, or administrative proceeding, 
        including, disclosure required by subpoena, subpoena duces 
        tecum, request or notice to produce, court order, or any other 
        method of requiring a person maintaining genetic information to 
        produce genetic information under the criminal or civil 
        discovery laws of any State or under Federal law.
            (3) Disclose.--The term ``disclose'', when used with 
        respect to genetic information, means to provide access to the 
        information, but only if such access is provided to a person 
        other than the individual.
            (4) Disclosure.--The term ``disclosure'' means the act or 
        an instance of disclosing.
            (5) DNA.--The term ``DNA'' means deoxyribonucleic acid 
        including mitochondrial DNA, complementary DNA, as well as any 
        DNA derived from ribonucleic acid (RNA).
            (6) DNA matching.--The term ``DNA matching'' means a 
        scientifically reliable method for characterizing and comparing 
        sequences of DNA, and applying a statistical analysis of 
        population frequency to determine that if the DNA sequences 
        match, and the probability that the match occurs by chance.
            (7) DNA sample.--The term ``DNA sample'' means any human 
        biological specimen from which DNA is intended to be extracted, 
        or DNA extracted from such specimen.
            (8) Employer.--The term ``employer'' has the same meaning 
        given such term in section 3(d) of the Fair Labor Standards Act 
        of 1938 (29 U.S.C. 203(d)).
            (9) Family.--The term ``family'' includes an individual's 
        blood relatives and any legal relatives, including a spouse or 
        adopted child.
            (10) Genetic analysis.--The term ``genetic analysis'' means 
        extracting genetic information from DNA.
            (11) Genetic information.--The term ``genetic information'' 
        means the information that may derive from an individual or a 
        family member about genes, gene products, or inherited 
        characteristics. Such term includes DNA sequence information 
        including that which is derived from the alteration, mutation, 
        or polymorphism of DNA or the presence or absence of a specific 
        DNA marker or markers.
            (12) Individual.--The term ``individual'' means the source 
        of the DNA sample, including the body, body parts, or bodily 
        fluids of the individual from whom the DNA sample originated.
            (13) Individual identifier.--The term ``individual 
        identifier'' means a name, address, social security number, 
        health insurance identification number, or similar information 
        by which the identity of an individual can be determined with 
        reasonable accuracy, either directly or by reference to other 
        available information. Such term does not include characters, 
        numbers, or codes assigned to an individual or a DNA sample 
        that cannot singly be used to identify an individual.
            (14) Institutional review board.--The term ``Institutional 
        Review Board'' means a board established in accordance with 
        section 46.102(g) of title 45, Code of Federal Regulations 
(1992), as such regulation may from time to time be amended.
            (15) Insurer.--The term ``insurer'' means any insurance 
        company, health care service contractor, fraternal benefit 
        organization, insurance agent, third party administrator, 
        insurance support organization or other person subject to 
        regulation under State insurance laws. Such term includes any 
        managed care organization as well as self-funded health plans 
        and health plans regulated under the Employee Retirement Income 
        Security Act of 1974 (29 U.S.C. 1001 et seq.).
            (16) Person.--The term ``person'' shall include a family, 
        corporation, partnership, association, joint venture, 
        government, governmental subdivision or agency, and other legal 
        or commercial entity.
            (17) Research.--The term ``research'' means systematic 
        scientific (including social science) investigation that 
        includes development, testing, and evaluation, designed or 
        developed to contribute to original generalizable knowledge.
            (18) Researcher.--The term ``researcher'' means a person 
        who conducts research.
            (19) Secretary.--The term ``Secretary'' means the Secretary 
        of Health and Human Services.
            (20) Storage.--The term ``storage'' means retention of a 
        DNA sample for any length of time.

       TITLE I--COLLECTION, STORAGE, AND ANALYSIS OF DNA SAMPLES

SEC. 101. COLLECTION OF DNA SAMPLES.

    (a) Requirement of Written Authorization.--Except as provided in 
sections 401, 402, 403, and 404, no person may collect or cause to be 
collected a DNA sample for genetic analysis without the written 
authorization of the individual.
    (b) Required Information.--Prior to the collection of a DNA sample 
from an individual for genetic analysis, the person collecting the 
sample or causing the sample to be collected shall verbally inform the 
individual--
            (1) that consent to or refusal of the collection or taking 
        of the DNA sample is voluntary;
            (2) that consent to or refusal of genetic analysis is 
        voluntary;
            (3) of the information that can reasonably be expected to 
        be derived from the genetic analysis;
            (4) of the uses, if any, that the individual will be able 
        to make of the information derived from the genetic analysis;
            (5) of the uses, if any, that the person will make of the 
        information derived from the genetic analysis;
            (6) of the right to inspect records that contain 
        information derived from the genetic analysis;
            (7) of the right to have the DNA sample destroyed;
            (8) of the right to revoke consent to the genetic analysis 
        at any time prior to the commencement of the genetic analysis;
            (9) that the genetic analysis may result in information 
        about the individual's family which may not be known to such 
        relatives but could be important, and if so the individual 
        should consider whether or not to share that information with 
        relatives;
            (10) of the existence and protections afforded by this Act; 
        and
            (11) of the availability of optional genetic and 
        psychological counseling.

SEC. 102. GENETIC ANALYSIS OF DNA SAMPLES.

    (a) Genetic Analysis Prohibited Without Authorization.--Except as 
provided in sections 401, 402, 403, and 404, genetic analysis of a DNA 
sample is prohibited unless specifically authorized in writing by the 
individual.
    (b) Ascertainment of Authorization.--No person may analyze a DNA 
sample without ascertaining that written authorization for the genetic 
analysis has been obtained.

SEC. 103. AUTHORIZATION FOR COLLECTION AND STORAGE OF DNA SAMPLES FOR 
              GENETIC ANALYSIS.

    (a) Written Authorization.--To be valid, the authorization required 
by sections 101 and 102 shall comply with each of the following:
            (1) Writing.--The authorization must be in writing, signed 
        by the individual, and dated on the date of such signature.
            (2) Collector identified.--The authorization must identify 
        the person who collects the DNA sample or causes the DNA sample 
        to be collected.
            (3) Collection described.--The authorization must state the 
        exact bodily source from and the manner in which the DNA sample 
        is to be collected.
            (4) Authorized use.--The authorization must include a 
        description of all authorized uses of the DNA sample.
            (5) Statement regarding storage after completion of 
        analysis.--The authorization must indicate whether or not the 
        individual permits the sample to be maintained or stored after 
the analysis is completed.
            (6) Statement regarding uses of dna samples for research or 
        commercial purposes.--The authorization must include a 
        provision that enables the individual to allow the uses of the 
        DNA sample for purely academic research and a separate 
        provision that gives specific authorization for commercial 
        uses.
    (b) Retention of Authorization.--The authorization for the 
collection, storage and analysis of a DNA sample shall be retained for 
the period during which the DNA sample is retained.
    (c) Copy.--A copy of the authorization shall be provided to the 
individual.

SEC. 104. OWNERSHIP AND DESTRUCTION OF DNA SAMPLES.

    (a) Ownership of the DNA Sample.--A DNA sample is the property of 
the individual.
    (b) Right To Order Destruction of the DNA Sample.--Except when a 
DNA sample has been collected pursuant to section 402, 403, or 404, the 
individual shall have the right to order the destruction of the DNA 
sample.
    (c) Routine Destruction of Samples.--A DNA sample shall be 
destroyed on completion of genetic analysis unless the individual has 
directed otherwise in writing.

SEC. 105. NOTICE OF RIGHTS AND ASSURANCES.

    A person who collects or stores DNA samples for genetic analysis 
shall provide the individual prior to the collection, storage, or 
analysis of the DNA sample, and any other person upon request, with a 
notice of rights and assurances that contains the following information 
and assurances:
            (1) That a DNA sample will only be used as authorized in 
        the written authorization.
            (2) That a DNA sample is the property of the individual.
            (3) That the individual has the right to order the 
        destruction of the DNA sample at any time.
            (4) That the DNA sample will be destroyed upon the 
        completion of the analysis unless the individual has previously 
        directed otherwise in writing.
            (5) That the individual can designate another person as the 
        one authorized to make decisions regarding the DNA sample after 
        the death of the individual, and if any person is so 
        designated, that the individual should notify the facility in 
        which the DNA sample is stored.
            (6) That the individual has the right to examine records 
        containing genetic information, to obtain copies of such 
        records, and to request correction or amendment of such 
        records.
            (7) That researchers may be granted access to a DNA sample 
        solely for research purposes and only if specifically 
        authorized by the individual.
            (8) That the collection, storage and analysis of the DNA 
        sample and the genetic information derived from the analysis is 
        protected by this Act, and that anyone whose rights under this 
        Act have been violated can seek civil remedies, including 
        damages and attorney's fees as provided for in this Act.
            (9) That optional genetic and psychological counseling are 
        available.

              TITLE II--DISCLOSURE OF GENETIC INFORMATION

SEC. 201. DISCLOSURE OF GENETIC INFORMATION.

    (a) Requirement of Written Authorization.--Except as provided in 
sections 205 and 502, no person who, in the ordinary course of 
business, practice of a profession, or rendering of a service, creates, 
stores, receives or furnishes genetic information may disclose by any 
means of communication genetic information except in accordance with a 
written authorization as provided for in section 202.
    (b) Redisclosure Prohibited.--Redisclosure of genetic information 
which has been disclosed to any person pursuant to a valid written 
authorization is prohibited.

SEC. 202. AUTHORIZATION FOR DISCLOSURE OF GENETIC INFORMATION.

    (a) Written Authorizations.--To be valid, an authorization for 
disclosure of genetic information shall comply with of the following:
            (1) Writing.--The authorization must be in writing, signed 
        by the individual and dated on the date of such signature.
            (2) Person making disclosure identified.--The authorization 
        must identify the person permitted to make the disclosure.
            (3) Information described.--The authorization must describe 
        the specific genetic information to be disclosed.
            (4) Recipient identified.--The authorization must identify 
        the person to whom the information is to be disclosed.
            (5) Purpose described.--The authorization must describe the 
        purpose for which the disclosure is being made.
            (6) Expiration date.--The authorization must state the date 
        upon which the authorization will expire, which in no event 
        shall be longer than 30 days after the date of the 
        authorization.
            (7) Revocation statement.--The authorization must include a 
        statement that the authorization is subject to revocation at 
        any time before the disclosure is actually made or the 
        individual is made aware of the details of the genetic 
        information.
    (b) Copy.--A copy of the authorization shall be provided to the 
individual.
    (c) Revocation or Amendment of Authorization.--An individual may 
revoke or amend the authorization, in whole or in part, at any time.
    (d) Identification of Information as Protected by Law.--Each 
disclosure made with the written authorization described in subsection 
(a) shall be accompanied by the following written statement:
    ``This information has been disclosed to you from confidential 
records protected under the Genetic Confidentiality and 
Nondiscrimination Act of 1996 and any further disclosure of the 
information without specific authorization is prohibited.''.
    (e) Effect of General Authorization for Release of Medical 
Records.--A general authorization for the release of medical records or 
medical information shall not be construed as an authorization for 
disclosure of genetic information. With respect to medical records that 
contain genetic information, the requirements for disclosure of genetic 
information under this section must be complied with.

SEC. 203. INSPECTION AND COPYING OF RECORDS CONTAINING GENETIC 
              INFORMATION.

    (a) Inspection of Records.--Except as provided in section 501(c)(2) 
and 501(f), a person who maintains genetic information shall, upon 
written request, permit the individual to inspect records containing 
genetic information and shall provide a copy of any such records upon 
request of the individual.
    (b) Response To Request Examination and Copying of Information.--
Upon receipt of a written request from an individual to inspect or copy 
all or part of records containing genetic information, a person as 
promptly as required under the circumstances, but in no event later 
than 90 business days after receiving the request, shall make the 
information available to the individual for inspection during regular 
business hours or provide a copy, if requested, to the individual.
    (c) Explanation of Terms and Codes.--A person shall provide an 
explanation of terms and any code or abbreviations used in records 
containing the genetic information upon the request of the individual.
    (d) Fee.--A person may charge a reasonable fee, not to exceed the 
person's actual duplication cost, for copies of records which are 
provided under this section.

SEC. 204. AMENDMENT OF RECORDS.

    (a) In General.--Not later than 90 days after the receipt of a 
written request by an individual to amend in whole or in part any 
record containing genetic information, a person who maintains records 
containing such genetic information shall--
            (1) make the amendment requested;
            (2) inform the individual that the amendment has been made;
            (3) make reasonable efforts to inform any person to whom 
        the unamended portion of the information was previously 
        disclosed of the amendment that has been made; and
            (4) at the request of the individual, make reasonable 
        efforts to inform any known source of the unamended portion of 
        the information about the amendment that has been made.
    (b) Reasons for Refusal and Review Procedures.--If an amendment is 
refused under subsection (a), the person maintaining the records shall 
inform the individual of--
            (1) the reasons for the refusal of the person to make the 
        amendment;
            (2) the procedures for further review of such refusal; and
            (3) the individual's right to file with the person a 
        concise statement setting forth the requested amendment and the 
        individual's reasons for disagreeing with the refusal of the 
        person to make the amendment.
With respect to a concise statement filed under paragraph (3), such 
statement shall be made part of the record.
    (c) Standards for Amendment.--A person maintaining records 
containing genetic information shall amend such information in 
accordance with a request made under subsection (a) if such information 
is not accurate or complete for the purposes for which such information 
may be used or disclosed by the person.
    (d) Statement of Disagreement.--After an individual has filed a 
statement of disagreement under subsection (b)(3), the person, in any 
subsequent disclosure of the disputed portion of the information, shall 
include a copy of the individual's statement and may include 
a statement of the reasons for not making the requested amendment.

SEC. 205. DISCLOSURES PURSUANT TO COMPULSORY PROCESS.

    (a) Proceedings in Which Available.--No person who maintains 
genetic information may be compelled to disclose such information 
pursuant to a request for compulsory disclosure in any judicial, 
legislative, or administrative proceeding, unless--
            (1) the request for compulsory disclosure is in accordance 
        with section 404;
            (2) the individual whose genetic information is requested 
        is a party to the proceeding and the genetic information is at 
        issue; or
            (3) the genetic information is for use in a law enforcement 
        proceeding or investigation in which the person maintaining the 
        information is the subject or party.
    (b) Notice.--If genetic information is sought under subparagraph 
(2) of subsection (a), or in a proceeding or investigation pursuant to 
subparagraph (3) of subsection (a), the person requesting compulsory 
disclosure shall serve upon the person maintaining the genetic 
information, and upon the individual, or on the individual's attorney, 
the original or a copy of the compulsory disclosure request at least 30 
days prior to the date on which the compulsory disclosure is requested, 
and a statement of the right of the individual, and of the person 
maintaining the genetic information, to have any objections to such 
compulsory disclosure heard by such court or governmental agency prior 
to the issuance of an order for such compulsory disclosure, and the 
procedure to be followed to have any such objections heard. Such 
service shall be made by certified mail, return receipt requested, or 
by hand delivery, in addition to any form of service required by 
applicable State or Federal law.
    (c) Certification.--Service of compulsory process or discovery 
requests upon a person maintaining genetic information shall be 
accompanied by a written certification--
            (1) signed by the person seeking to obtain the genetic 
        information or his or her authorized representative;
            (2) identifying at least one paragraph of subsection (a) 
        under which compulsory process or discovery is being sought; 
        and
            (3) that states, in the case of information sought under 
        paragraph (2) or (3) of subsection (a), that the requirements 
        under subsection (b) for notice have been met.
The signature of a person on the certification shall be valid only if 
the person, at the time of signing, reasonably believed that the 
paragraph of subsection (a) that is identified in the certification 
provides an appropriate basis for the use of discovery or compulsory 
process. A copy of the written certification shall be maintained as a 
permanent part of the records of genetic information.
    (d) Standard for Issuance of Order.--An order under this section 
may only be entered by a court of competent jurisdiction after a 
hearing and determination that good cause exists. To make such 
determination the court must find that--
            (1) other ways of obtaining the genetic information are not 
        available or would not be effective; and
            (2) there is a compelling need for the genetic information 
        which outweighs the potential harm to the privacy interest of 
        the subject of the information.
    (e) Content of Order.--An order under this section which authorizes 
disclosure of genetic information shall--
            (1) limit disclosure to those parts of records containing 
        such information which are essential to fulfill the objective 
        of the order;
            (2) limit disclosure to those persons whose need for the 
        information is the basis of the order;
            (3) require the deletion of individual identifiers from any 
        documents made available to the public; and
            (4) include such other measures as are necessary to limit 
        disclosure for the protection of the subject of the information 
        including sealing from public scrutiny the record or any 
        portion of the record of any proceeding for which disclosure of 
        the information has been ordered.

                  TITLE III--DISCRIMINATION PROHIBITED

SEC. 301. DISCRIMINATION BY EMPLOYERS OR POTENTIAL EMPLOYERS.

    (a) In General.--An employer may not seek to obtain, obtain or use 
the genetic information of an employee or a prospective employee, or 
require the collection of a DNA sample of an employee or prospective 
employee for analysis to distinguish between, discriminate against, or 
restrict any right or benefit otherwise due or available to the 
employee or prospective employee.
    (b) Enforcement.--The powers, remedies, and procedures set forth in 
sections 705 through 709 of the Civil Rights Act of 1964 shall be the 
powers, remedies, and procedures applicable under this section to any 
person alleging a violation of this section.

SEC. 302. DISCRIMINATION BY INSURERS.

    (a) In General.--An insurer offering a policy or plan may not--
            (1) terminate, restrict, limit, or otherwise apply 
        conditions to the coverage of an individual or family member 
        under the policy or plan, or restrict the sale of the policy or 
        plan to an individual or family member;
            (2) cancel or refuse to renew the coverage of an individual 
        or family member under the policy or plan;
            (3) deny coverage or exclude an individual or family member 
        from coverage under the policy or plan;
            (4) impose a rider that excludes coverage for certain 
        benefits or services under the policy or plan;
            (5) establish differentials in premium rates or cost 
        sharing for coverage under the policy or plan; or
            (6) otherwise discriminate against an individual or family 
        member in the provision of insurance;
on the basis of any genetic information concerning an individual or 
family member or on the basis of an individual's or family member's 
request for or receipt of genetic services.
    (b) Prohibition on Testing or Questioning.--An insurer may not 
require an applicant for coverage under the policy or plan, or an 
individual or family member who is presently covered under a policy or 
plan, to be the subject of a genetic test or to be subjected to 
questions relating to genetic information.
    (c) Disclosure.--An insurer shall, in the application or enrollment 
information provided by the insurer concerning a policy or plan, 
provide an applicant or enrollee with a written statement disclosing 
the rights of the applicant or enrollee under this Act. Such statement 
shall be in a form and manner that is noticeable to and understandable 
by an average applicant or enrollee.
    (d) Enforcement.--
            (1) Plans others than employee welfare benefit plans.--The 
        requirements established under subsections (a), (b), and (c) 
        shall be enforced by the State insurance commissioner for the 
        State involved or the official or officials designated by the 
        State, except that in no case shall a State enforce such 
        requirements as they relate to employee welfare benefit plans 
        (as defined in section 3 of the Employee Retirement Income 
        Security Act of 1974).
            (2) Employee welfare benefit plans.--With respect to 
        employee welfare benefit plans, the Secretary shall enforce the 
        requirements established under subsections (a), (b), and (c) in 
        the same manner as provided for under sections 502, 504, 506, 
        and 510 of the Employee Retirement Income Security Act of 1974 
        (29 U.S.C. 1132, 1134, 1136, and 1140).

   TITLE IV--EXCEPTIONS FOR IDENTIFICATION AND COURT-ORDERED GENETIC 
                                ANALYSIS

SEC. 401. IDENTIFICATION OF DEAD BODIES.

    Notwithstanding any other provision of this Act, a person may 
provide access to a DNA sample, or to data derived from DNA matching, 
to assist in the identification of a dead body if the analysis of any 
DNA sample or data is limited only to that which is necessary to 
determine the identity of the dead body.

SEC. 402. IDENTIFICATION OF REMAINS FROM ACTIVE-DUTY MILITARY 
              PERSONNEL.

    (a) In General.--Notwithstanding any other provision of this Act, 
the United States Armed Forces may--
            (1) collect, store, or analyze a DNA sample from an active-
        duty member only for the purposes of the identification of 
        remains; and
            (2) disclose DNA matching information from active-duty 
        members only for the purposes of the identification of remains.
    (b) Destruction.--A DNA sample shall be destroyed upon the request 
of the individual at time of his or her discharge.

SEC. 403. IDENTIFICATION FOR LAW ENFORCEMENT PURPOSES.

    Nothing in this Act shall be construed to prohibit Federal, State 
or local law enforcement authorities from collecting, storing or 
marking DNA samples, if--
            (1) the collection, storage and marking is authorized under 
        Federal or State law;
            (2) the collection, storage and marking is limited to the 
        purpose of DNA matching in criminal investigations;
            (3) access to such DNA samples is limited to authorized law 
        enforcement agencies, prosecutors, defense counsel, defendants, 
        accused individuals, suspects, and their authorized agents; and
            (4) such authorities have probable cause to collect, store, 
        or mark a sample.

SEC. 404. COLLECTION AND ANALYSIS OF DNA SAMPLES PURSUANT TO COURT 
              ORDERED ANALYSIS.

    Nothing in this Act shall be construed to prohibit court ordered 
paternity testing in civil actions to determine paternity.

                      TITLE V--RESEARCH ACTIVITIES

SEC. 501. RESEARCH INVOLVING GENETIC ANALYSIS.

    (a) Conditions for a Genetic Analysis.--Except as provided in 
section 503, no DNA sample shall be analyzed as part of a research 
project unless an Institutional Review Board has determined that--
            (1) use of DNA samples is essential to the research 
        project;
            (2) the potential benefit of the research project outweighs 
        the potential risks to the subjects including psychosocial 
        risks and intrusion into the privacy of the subjects that would 
        result from genetic analysis of DNA samples; and
            (3) the research protocol--
                    (A) contains adequate safeguards to protect against 
                disclosure of genetic information that is generated by 
                the research;
                    (B) requires that research subjects will be given 
                the applicable information required under section 101 
                in addition to meeting the informed consent 
                requirements contained in section 46.116 of title 45, 
                Code of Federal Regulations (1992) as such regulation 
                may from time to time be amended;
                    (C) requires the written authorization of research 
                subjects that complies with the applicable requirements 
                of section 103, and that describes the protocol and the 
                intended uses;
                    (D) prohibits inclusion of research records in 
                medical records unless the individual authorizes such 
                inclusion in writing; and
                    (E) with respect to protocols involving the use of 
                DNA samples from individuals deceased prior to the 
                effective date of this Act, provides a method for 
                disclosing the risk associated with genetic 
                information, which in reasonable medical judgment can 
                be effectively ameliorated, prevented, or treated, to 
                an individual's family members, such method to take 
                into account that family members have the right to 
                refuse learning of any genetic information.
Additionally, the researcher or the researcher's institution is 
responsible for any fees or costs associated with the disclosure, 
including for optional genetic or psychological counselling.
    (b) Safeguards Against Disclosures of Genetic Information.--For 
purposes of paragraph (3)(A) of subsection (a), adequate safeguards 
against disclosure of genetic information, at a minimum, include--
            (1) obtaining a certificate of confidentiality from the 
        Secretary as provided for in section 301(d) of the Public 
        Health Service Act (42 U.S.C. 241(d));
            (2) ensuring that research subjects will not be 
        identifiable in any report or publication which results from 
        the research; and
            (3) having procedures to remove or destroy at the earliest 
        opportunity consistent with the purposes of the project, any 
        individual identifiers.
    (c) Further Limitations on Research Involving Individuals Under 
18.--With respect to an individual who is under 18 years of age, no 
research shall be conducted on DNA samples unless--
            (1) a parent or guardian is given the applicable 
        information required under section 101;
            (2) a parent or guardian executes an authorization that 
        meets the applicable requirements of section 103 and which 
        specifically states that the parent or guardian understands and 
        agrees that unless the analysis reveals a genetic condition 
        which in reasonable medical judgment can only be effectively 
        ameliorated, prevented, or treated while the individual is 
        under 18 years of age, the results of the analysis will not be 
        disclosed to the parent or guardian of the individual; and
            (3) any provisions for soliciting the assent of minors as 
        contained in section 46.408 of title 45, Code of Federal 
        Regulations, which the Institutional Review Board determines to 
        be applicable are met.
    (d) Destruction of DNA Samples or Identifiers.--In the absence of a 
specific authorization to maintain a DNA sample, DNA samples collected, 
stored or analyzed in connection with a research project shall be 
destroyed upon completion of the project or withdrawal of the 
individual from the project, whichever occurs first.
    (e) Pedigree Analysis and Family Linkage Studies.--When a research 
project includes genetic analysis of family members for pedigree 
analysis or linkage analysis--
            (1) the Institutional Review Board, in addition to making 
        the determinations required in subsection (a), shall also 
        require that to the maximum extent practicable, separate 
        records are maintained on each subject; and
            (2) subjects, prior to their participation, and in addition 
        to the disclosures required by section 101, shall be--
                    (A) informed that one risk of their participation 
                is that other family members may learn genetic 
                information about themselves;
                    (B) informed of what will be done with records and 
                data generated during the project; and
                    (C) informed that the project may determine that 
                some members of their family are not genetic relatives.
    (f) Subjects Right To Obtain Information.--When complying with the 
provisions of section 203, no person shall provide an individual in the 
pedigree with genetic information about any individual in the pedigree 
without that individual's authorization.

SEC. 502. DISCLOSURE OF GENETIC INFORMATION FOR RESEARCH PURPOSES.

    (a) In General.--Any person who, in the ordinary course of 
business, practice of a profession, or rendering of a service, stores 
or maintains genetic information is prohibited from allowing access to 
such information to researchers unless--
            (1) an Institutional Review Board has approved the conduct 
        of the research program or study; and
            (2) the individual has specifically consented to the access 
        or disclosure of such information in an authorization that 
        meets the requirements of section 202.
Such information should be provided in a coded form with all individual 
identifiers removed.
    (b) Limited Access for Statistical Use.--Notwithstanding the 
provisions of subsection (a), a person who stores or maintains genetic 
information may grant access to such information solely for the purpose 
of inspection or review of records containing the information if--
            (1) the inspection or review is for the purpose of 
        compiling data for statistical or epidemiological studies and 
        genetic information is not to be copied, removed from the 
        records, or redisclosed in any way; and
            (2) the person conducting the inspection or review 
        certifies in writing--
                    (A) that the limitations in paragraph (1) will be 
                complied with;
                    (B) to knowledge of their liability for violations 
                of this Act; and
                    (C) that the person has complied with sections 101 
                and 103.

SEC. 503. EXCEPTION FOR DNA SAMPLES COLLECTED PRIOR TO THE EFFECTIVE 
              DATE.

    Notwithstanding the provisions of section 501, a DNA sample that 
was collected from an individual prior to the effective date of this 
Act may be analyzed as part of a research project under a protocol 
approved by an Institutional Review Board, if such project--
            (1) withdraws or destroys the DNA sample if the individual 
        makes a written request within 3 years of the effective date of 
        this Act; and
            (2) except as provided under section 502, discloses genetic 
        information only with the authorization of--
                    (A) the individual; or
                    (B) a member of the family of the individual if the 
                individual is deceased.

                            TITLE VI--MINORS

SEC. 601. AUTHORIZATION FOR COLLECTION AND ANALYSIS OF DNA FROM MINORS.

    (a) In General.--Except as provided in section 501(c), the DNA 
sample of an individual who is under 18 years of age shall not be 
collected, stored, or analyzed to determine the existence of a risk 
from genetic information that does not in reasonable medical judgment 
produce signs or symptoms of disease before the age of 18, unless--
            (1) there is an effective intervention that will prevent or 
        delay the onset or ameliorate the severity of the disease; and
            (2) the intervention is initiated before the individual 
        reaches the age of 18; and
            (3) the individual's parent or guardian has received the 
        disclosures required by section 101 and has executed a written 
        authorization which meets the requirements of section 103 and 
        which also limits the uses of such analysis to those permitted 
        by this section.
    (b) Destruction of DNA Samples of Individuals Under 18.--An 
individual's parent or guardian may, on behalf of an individual who is 
under 18 years of age, order the destruction of a DNA sample collected 
pursuant to subsection (a).
    (c) Prohibition on Use of Newborn Screening.--In no event shall any 
DNA collected, stored, or analyzed as part of a newborn screening 
program be used except for the strict purposes of newborn screening as 
authorized under State law or regulation.

                  TITLE VII--MISCELLANEOUS PROVISIONS

SEC. 701. NOTIFICATION OF PRIVACY OBLIGATIONS.

    Not less than annually, every person who maintains individual DNA 
samples or genetic information shall notify their employees of their 
responsibilities under this Act and the penalties for violating the 
provisions of this Act.

SEC. 702. TRANSFER OF OWNERSHIP, DISCONTINUANCE OF SERVICES.

    (a) Activities Involving DNA Samples.--Any person in possession of 
DNA samples who intends to discontinue a program, business, enterprise, 
or service in which such DNA samples were collected, stored, or 
analyzed or who intends to transfer control of such program, business, 
enterprise, or service to a person who intends to use such DNA samples 
for a substantially different purpose than was authorized at the time 
of collection, storage, or analysis of such DNA samples shall inform 
the individual that the individual has the right to order that the 
records regarding such samples be returned to the individual.
    (b) No Response.--If a person to which subsection (a) applies 
receives no response from an individual to which information is 
provided under such subsection, the person in possession of the records 
involved--
            (1) in the case of discontinuance, shall destroy the 
        records, or
            (2) in the case of an intended transfer, may proceed with 
        transfer of control of the records.

                        TITLE VIII--ENFORCEMENT

SEC. 801. CIVIL REMEDIES.

    (a) Private Right of Action.--Any person whose rights under this 
Act have been violated may maintain a civil action for damages or 
equitable relief as provided for in this section.
    (b) Jurisdiction.--An action may be brought under this section in 
the district courts of the United States or a State court of competent 
jurisdiction.
    (c) Relief.--In any action brought under this section, a court may 
order a person to comply with the provisions of this Act and may order 
any other appropriate equitable relief.
    (d) Liability for Negligent Violations.--Any person who through 
negligence collects, stores, or analyzes a DNA sample in violation of 
this Act, or discloses genetic information in violation of this Act, 
shall be liable to the individual for each such violation in an amount 
equal to--
            (1) any actual damages sustained as a result of the 
        collection, storage, analysis, or disclosure, or $50,000, 
        whichever is greater;
            (2) in any case where such violation has resulted in profit 
        or monetary gain, treble damages; and
            (3) in the case of a successful action to enforce any 
        liability under this section, the costs of the action together 
        with reasonable attorneys' fees as determined by the court.
    (e) Liability for Willful Violations.--Any person who--
            (1) through a request, the use of persuasion, under threat, 
        or with a promise of reward, willfully induces another to 
        collect, store, or analyze a DNA sample in violation of this 
        Act, or disclose genetic information in violation of this Act, 
        or
            (2) willfully collects, stores, or analyzes a DNA sample in 
        violation of this Act, or willfully discloses genetic 
        information in violation of this Act, shall be liable to the 
        individual for each such violation in an amount equal to--
                    (A) any actual damages sustained as a result of the 
                collection, analysis, or disclosure, or $100,000, 
                whichever is greater;
                    (B) punitive damages as the court may allow; and
                    (C) in the case of a successful action under this 
                section, the costs of the action together with 
                reasonable attorneys' fees as determined by the court.
    (f) Statute of Limitations.--Except with respect to subsection (g), 
any action under this section must be brought within 6 years of the 
date that the alleged violation was or should have been discovered.
    (g) Tolling of Limitations.--If the person entitled to maintain an 
action under this section is a minor, or is incapacitated by reason of 
mental illness when the right to bring an action first occurs, the 
action may be commenced up to 10 years after the disability is removed.

SEC. 802. CIVIL PENALTIES AND INJUNCTIVE RELIEF.

    (a) In General.--Whenever the Attorney General has reason to 
believe that any person is using or is about to use any method, act or 
practice in violation of the provisions of this Act, and that 
proceedings would be in the public interest, the Attorney General may 
bring an action against such person to restrain by temporary 
restraining order or preliminary or permanent injunction the use of 
such method, act or practice.
    (b) Jurisdiction.--The action may be brought in the district court 
of the jurisdiction in which the person resides or has a principal 
place of business.
    (c) Relief.--The court may issue temporary restraining orders or 
preliminary or permanent injunctions and make such other orders or 
judgments as may be necessary to prevent harm or to remedy harm 
suffered by any person as a result of the use or employment of such 
method, act or practice in violation of this Act.
    (d) Civil Penalty.--If the court finds that a person has employed 
any method, act or practice which the person knew or should have known 
to be in violation of this Act, the court may require such person to 
pay a civil penalty of not more than $50,000 for each such violation 
and may also require such person to pay reasonable costs of 
investigation and litigation of such violation, including reasonable 
attorneys fees.

  TITLE IX--EFFECTIVE DATES; APPLICABILITY; AND RELATIONSHIP TO OTHER 
                                  LAWS

SEC. 901. EFFECTIVE DATES.

    This Act shall take effect on January 1, 1998.

SEC. 902. APPLICABILITY.

    (a) Authorization for Analysis of DNA Samples Collected Prior to 
Effective Date.--In order to comply with the provisions of this Act, 
any person who, prior to the effective date of this Act, is in 
possession of a DNA sample shall, prior to performing any genetic 
analysis on the DNA samples make the disclosures required by section 
101(c), and obtain a written authorization that meets the requirements 
of section 202.
    (b) Research on DNA Samples Collected Prior to Effective Date.--Any 
person who is conducting research under a protocol approved by an 
Institutional Review Board may use DNA samples collected prior to the 
effective date of this Act for the 3-year period beginning on the date 
of enactment of this Act.
    (c) Authorizations for Disclosures.--An authorization for the 
disclosure of genetic information that is executed before January 1, 
1998, and which does not meet the requirements of section 103, but 
which is valid under State law on January 1, 1997, shall remain valid 
until the expiration of 30 days after the effective date of this Act, 
or the expiration date specified in the authorization, whichever occurs 
earlier.

SEC. 903. RELATIONSHIP TO OTHER LAWS.

    (a) In General.--No State may establish or enforce any law or 
regulation concerning the collection, storage, of analysis of DNA 
samples except to the extent that such law or regulation--
            (1) prohibits or further restricts the collection, storage, 
        or analysis of DNA samples; or
            (2) provides additional protections to the privacy 
        interests of the individual who is a DNA sample source.
    (b) Disclosure.--No State may establish or enforce any law or 
regulation concerning the disclosure of genetic information except to 
the extent that such law or regulation, with respect to the limitations 
contained in this Act--
            (1) prohibits or further restricts the disclosure of such 
        information;
            (2) prohibits or further restricts the use of such 
        information; or
            (3) provides additional protection to the privacy interests 
        of the individual who is a DNA sample source or the subject of 
        the genetic information.
    (c) Construction.--Nothing in this Act shall be construed as 
limiting or prohibiting the pursuit of any other remedies available 
under common or statutory law in regard to the collection, storage, 
analysis of DNA samples, and the disclosure of genetic information.
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