I

103D CONGRESS

1ST SESSION H. R. 33

To amend the Public Health Service Act to establish standards for the

certification of laboratories engaged in urine drug testing, and for other

purposes.

IN THE HOUSE OF REPRESENTATIVES

JANUARY 5, 1993

Mr. DINGELL (for himself and Mr. BLILEY) introduced the following bill;

which was referred to the Committee on Energy and Commerce

A BILL

To amend the Public Health Service Act to establish standards for the certification of laboratories engaged in urine

drug testing, 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.

4 This Act may be cited as the ‘‘Drug Testing Quality

5 Act’’.

6 SEC. 2. STANDARDS FOR CERTIFICATION OF LABORA7 TORIES ENGAGED IN DRUG TESTING.

8 Title V of the Public Health Service Act is amended

9 by adding at the end the following:
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1 ‘‘PART F—DRUG TESTING

2 ‘‘SEC. 571. CERTIFICATION PROGRAM.

3 ‘‘(a) IN GENERAL.—Not later than one year after the

4 date of enactment of this part, the Secretary shall, by reg5 ulation, establish a program (hereinafter referred to in

6 this part as the ‘certification program’) for the certifi7 cation of laboratories for the performance of toxicological

8 urinalysis conducted for drug testing programs. The cer9 tification program shall, except as provided in subsection

10 (b), conform, to the maximum extent practicable, to sub11 part C of the mandatory guidelines for Federal workplace

12 drug testing programs published on April 11, 1988, by

13 the Department of Health and Human Services at 53 Fed.

14 Reg. 11979 and any amendments to such guidelines (here15 inafter referred to in this part as the ‘HHS guidelines’).

16 ‘‘(b) SPECIFIC PROVISION.—The certification pro17 gram established by the Secretary under subsection (a)

18 shall, with respect to laboratory inspection, the monitoring

19 of laboratory performance, and the conduct of quality con20 trol and performance testing programs, be consistent with

21 the consensus of expert scientific and medical opinion on

22 such matters as determined by the Secretary.

23 ‘‘(c) ADDITIONAL REGULATIONS.—

24 ‘‘(1) The certification program established by

25 the Secretary under subsection (a) shall, in addition

26 to the requirements of subsections (a) and (b)—
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1 ‘‘(A) provide that the Secretary shall, in

2 considering applications for certification under

3 the certification program, consider whether the

4 applicant has, directly or indirectly, owned or

5 operated a laboratory which has had its certifi6 cation suspended or revoked under the pro7 gram, and

8 ‘‘(B)(i) include criteria for recognition by

9 the Secretary of—

10 ‘‘(I) State agencies and private non11 profit accrediting bodies to certify labora12 tories in accordance with the requirements

13 of this section if such agencies and bodies

14 meet such criteria, and

15 ‘‘(II) State agencies and private non16 profit accrediting bodies to act on the Sec17 retary’s behalf in certifying laboratories in

18 accordance with the requirements of this

19 section if such agencies and bodies meet

20 such criteria,

21 ‘‘(ii) provide that the Secretary shall over22 see and review the performance of any agency

23 or accrediting body recognized by the Secretary

24 as meeting the criteria described in clause (i) to
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1 ensure its compliance with the requirements of

2 the certification program, and

3 ‘‘(iii) provide that the Secretary shall have

4 the right to obtain from an agency or accredit5 ing body described in clause (ii) and from any

6 laboratory that may be certified by such an

7 agency or accrediting body all records and ma8 terials that are necessary in the Secretary’s

9 judgment for the oversight and review required

10 by clause (ii).

11 ‘‘(2) A laboratory may not be certified to per12 form drug testing under the certification program

13 established under subsection (a) unless the labora14 tory is certified under section 353, except that a lab15 oratory which only performs toxicological urinalyses

16 is not required to be certified under section 353 to

17 be certified under the certification program.

18 ‘‘(3)(A) A laboratory may not be certified to

19 perform drug testing under the certification program

20 established under subsection (a) unless it dem21 onstrates to the Secretary its competence to perform

22 toxicological urinalyses in accordance with the re23 quirements of this section and section 572 for the

24 following drugs and drug classes;
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1 ‘‘(i) the drugs and drug classes for which

2 test methods and cutoff levels are provided

3 under subpart B of the HHS guidelines;

4 ‘‘(ii) barbiturates listed in schedules I and

5 II under the Controlled Substances Act (21

6 U.S.C. 801 et seq.); and

7 ‘‘(iii) oxazepam and alprazolam.

8 ‘‘(B) Notwithstanding subparagraph (A), a lab9 oratory certified under subpart C of the HHS guide10 lines prior to the date the Secretary establishes the

11 certification program under subsection (a) shall be

12 deemed by the Secretary to be competent to perform

13 toxicological urinalyses for the drugs and drug class14 es described in subparagraph (A) and shall be cer15 tified by the Secretary to do so for drug testing pro16 grams as of such date.

17 ‘‘(4) A laboratory certified to perform drug

18 testing under the certification program established

19 under subsection (a), shall, in order to retain such

20 certification, require its scientific, technical, and an21 alytical personnel involved in such drug testing to

22 participate in continuing education programs of a

23 nature and at a frequency (not less than annually)

24 specified by the Secretary in regulations.
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1 ‘‘(d) REVISION.—The Secretary shall, in accordance

2 with section 553 of title 5, United States Code, revise the

3 requirements of the certification program as necessary to

4 reflect improvements in drug testing methods for the pur5 pose of ensuring the full reliability and accuracy of drug

6 testing, the accurate reporting of full results, and the in7 tegrity and efficacy of drug testing programs.

8 ‘‘SEC. 572. PROVISIONS TO ENSURE INTEGRITY OF TOXI9 COLOGICAL URINALYSIS.

10 ‘‘(a) IN GENERAL.—Not later than 1 year after the

11 date of enactment of this part, the Secretary shall issue

12 regulations to ensure the integrity of toxicological urinal13 ysis which shall, except as provided in subsection (b), con14 form to the maximum extent practicable to subpart B of

15 the HHS guidelines.

16 ‘‘(b) SPECIFIC PROVISIONS.—The regulations issued

17 under subsection (a) shall—

18 ‘‘(1) except as otherwise provided in this sub19 section, treat any person conducting a drug testing

20 program in the same manner as subpart B of the

21 HHS guidelines treats the Federal agencies to which

22 it is applicable,

23 ‘‘(2) expand the list of drugs and drug classes

24 for which test methods and cutoff levels are provided

25 under subpart B of the HHS guidelines to include
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1 barbiturates listed in schedules I and II under the

2 Controlled Substances Act, oxazepam and

3 alprazolam, anabolic steroids, and such other drugs

4 or drug classes as the Secretary determines under

5 subsection (c) may be appropriate,

6 ‘‘(3)(A) neither require nor prohibit the estab7 lishment of a drug testing program by any person,

8 and

9 ‘‘(B) neither require any person to test nor pro10 hibit any person from testing for any particular drug

11 or class of drugs described in paragraph (2) or sub12 part B of the HHS guidelines,

13 ‘‘(4) provide no specimen collection procedures

14 other than those necessary to establish and maintain

15 a proper chain of custody and to provide for trans16 portation of specimens to the laboratory,

17 ‘‘(5) consistent with the consensus of expert

18 medical and scientific opinion as determined by the

19 Secretary, establish appropriate cutoff levels for each

20 drug or class of drugs described in paragraph (2) or

21 subpart B of the HHS guidelines for both initial and

22 confirmatory tests,

23 ‘‘(6)(A) establish requirements to ensure the in24 tegrity and validity of blind performance testing of

25 laboratories certified under the certification program
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1 established under section 571, including a number or

2 percentage of specimens (or both) to be submitted to

3 a laboratory by a drug testing program for blind

4 performance testing, set at the lowest level consist5 ent with the consensus of expert medical and sci6 entific opinion as determined by the Secretary and

7 with the need to ensure accuracy, integrity, and pro8 tection of the interests of test subjects, and

9 ‘‘(B) establish procedures for drug testing pro10 grams to notify the Secretary of any false positive

11 results discovered in blind performance testing or by

12 a medical review officer and for the Secretary to

13 take appropriate action on the basis of such notifica14 tion,

15 ‘‘(7) provide no interim certification procedures,

16 and

17 ‘‘(8) allow access by any test subject or any test

18 subject’s authorized representative, upon written re19 quest, to any record relevant to the results of such

20 subject’s drug test and to any record relating to the

21 result of any relevant certification, review, suspen22 sion, or revocation of certification proceeding, and

23 require a copy of such record to be provided to such

24 test subject or representative upon written request.
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1 Paragraphs (3) and (4) shall not be construed to affect

2 the applicability of the requirements of subpart B of the

3 HHS guidelines to drug testing programs conducted by

4 Federal agencies under Executive Order 12564.

5 ‘‘(c) ADDITIONAL DRUGS.—

6 ‘‘(1)(A) Any person may file with the Secretary

7 a petition proposing the issuance of a regulation

8 under subsection (b)(2) prescribing test methods and

9 cutoff levels for any drug or class of drugs for which

10 such test methods and cutoff levels have not been

11 previously prescribed. Notice of the regulation pro12 posed by a petitioner shall be published in the Fed13 eral Register within 30 days after filing.

14 ‘‘(B) Twelve months following the issuance of

15 regulations under subsection (a), and every 24

16 months thereafter, the Secretary shall publish in the

17 Federal Register a request for public comment on

18 the advisability of and need for including test meth19 ods and cutoff levels in such regulations for drugs

20 or classes of drugs for which such test methods and

21 cutoff levels have not been previously prescribed.

22 ‘‘(C) A petitioner or commenter under this

23 paragraph shall be required to demonstrate in such

24 person’s petition or comment, as applicable, that—
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1 ‘‘(i) widespread or otherwise significant

2 abuse of such drug or class in the United

3 States or any region of the United States poses

4 a serious threat to public health or safety,

5 ‘‘(ii) there exists a well-documented and re6 liable method for toxicological urinalysis of such

7 drug or class and for establishing cutoff levels

8 applicable to such drug or class,

9 ‘‘(iii) such test methods and cutoff levels

10 provide specificity and protection of the inter11 ests of test subjects equal to or greater than

12 that provided with respect to the drugs or class13 es for which test methods and cutoff levels have

14 been previously prescribed by the Secretary,

15 and

16 ‘‘(iv) at least one laboratory certified under

17 section 571 has an interest in providing toxi18 cological urinalysis for the drug or class de19 scribed in the petition or comment and is com20 petent to do so.

21 A petitioner or commenter shall also furnish to the

22 Secretary such additional explanatory and support23 ing data as the Secretary may require.

24 ‘‘(2)(A) Commencing 90 days following publica25 tion in the Federal Register of the request for public
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1 comment described in paragraph (1)(B), and every

2 24 months thereafter, the Secretary shall review all

3 petitions received and pending under paragraph

4 (1)(A) and all comments received and pending under

5 paragraph (1)(B), together with additional explana6 tory and supporting data submitted by petitioners

7 and commenters and shall, with respect to each drug

8 or class of drugs which is the subject of a petition

9 or comment, determine whether the petitioner or

10 commenter has made the demonstration required by

11 paragraph (1)(C) and whether other facts, cir12 cumstances, or considerations outweigh the need to

13 prescribe test methods and cutoff levels for such

14 drug or class.

15 ‘‘(B)(i) If the Secretary determines under sub16 paragraph (A) that a petitioner or commenter has

17 made the demonstration required by paragraph

18 (1)(C) and that no other facts, circumstances, or

19 considerations outweigh the need to prescribe test

20 methods and cutoff levels for such drug or class, the

21 Secretary shall by order issue a regulation prescrib22 ing test methods and cutoff levels for such drug or

23 class.

24 ‘‘(ii) If the Secretary determines that a peti25 tioner has failed to make the demonstration required
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1 by paragraph (1)(C) and that other facts, cir2 cumstances, or considerations outweigh the need to

3 prescribe test methods and cutoff levels as requested

4 in the petition, the Secretary shall by order deny the

5 petition and within 30 days thereafter notify the pe6 titioner of such order and of the reasons for such ac7 tion.

8 ‘‘(C) The order required by subparagraph (B)

9 shall be issued within 90 days after review by the

10 Secretary commences under paragraph (2)(A), ex11 cept that the Secretary may (prior to such 90th

12 day), by written notice to a petitioner in the case of

13 a petition or publication in the Federal Register in

14 the case of a comment, extend such 90-day period

15 to such time (not more than 180 days after com16 mencement of such review) as the Secretary deems

17 necessary to permit appropriate study and investiga18 tion.

19 ‘‘(d) AMATEUR ATHLETICS.—In issuing regulations

20 under subsection (a), the Secretary shall take into consid21 eration any special factors or circumstances applicable to

22 the testing of participants in—

23 ‘‘(1) organized interscholastic or intercollegiate

24 athletic competition, or
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1 ‘‘(2) organized athletic competition conducted

2 under the auspices of or sanctioned by the United

3 States Olympic Committee or any member thereof,

4 that warrant separate or different treatment of such test5 ing under the regulations.

6 ‘‘(e) REVISION.—The Secretary shall, in accordance

7 with section 553 of title 5, United States Code, revise the

8 regulations issued under subsection (a) as necessary to re9 flect improvements in drug testing methods for the pur10 pose of ensuring the full reliability and accuracy of drug

11 testing, the accurate reporting of results, and the integrity

12 and efficacy of drug testing programs.

13 ‘‘SEC. 573. SPECIMEN COLLECTION PROCEDURES.

14 ‘‘(a) IN GENERAL.—Not later than 1 year after the

15 date of enactment of this part, the Secretary shall issue

16 model specimen collection procedures for the guidance of

17 drug testing programs other than those conducted by Fed18 eral agencies under Executive Order 12564. Such model

19 procedures shall include provisions for designation of a

20 collection site, security, personnel access, and privacy in

21 the collection process, and precautions to ensure the integ22 rity and identity of specimens. In issuing such model pro23 cedures, the Secretary may recommend alternatives to ad24 dress appropriate particularized needs or circumstances,

25 including those applicable to athletic competition, and may
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1 provide technical assistance to drug testing programs

2 adopting or considering adoption of such model proce3 dures.

4 ‘‘(b) SAVINGS PROVISION.—Subsection (a) shall not

5 be construed to affect the applicability of the specimen col6 lection procedures in subpart B of the HHS guidelines to

7 drug testing programs conducted by Federal agencies

8 under Executive Order 12564.

9 ‘‘SEC. 574. PROHIBITIONS.

10 ‘‘(a) CERTIFICATION REQUIREMENT.—(1) No person

11 may perform any toxicological urinalysis in connection

12 with any drug testing program unless that person is a lab13 oratory which is certified under the certification program

14 established under section 571.

15 ‘‘(2) It shall be unlawful for any laboratory certified

16 to perform toxicological urinalysis under the certification

17 program established under section 571 to perform toxi18 cological urinalyses in connection with any drug testing

19 program for any drug or drug class other than those listed

20 in section 571(c)(3)(A) unless—

21 ‘‘(A) in a case where such other drug or drug

22 class is one for which the Secretary has prescribed

23 test methods and cutoff levels under section

24 572(b)(2) or 572(c), such laboratory is certified by
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1 the Secretary to perform toxicological urinalyses for

2 such other drug or drug class, or

3 ‘‘(B) in the case of any other drug or drug

4 class, such drug testing program provides the lab5 oratory with a statement signed by the test subject

6 acknowledging that disclosure of a test for such

7 other drug or drug class has been made and con8 senting to the performance of such test.

9 ‘‘(b) OTHER VIOLATIONS.—It shall be unlawful for

10 any person—

11 ‘‘(1) who is a test subject to knowingly disclose

12 the results of a toxicological urinalysis in connection

13 with any drug testing program which was not per14 formed on such person,

15 ‘‘(2) who is not a test subject and who has been

16 directly or indirectly involved in a drug testing pro17 gram or a toxicological urinalysis under such a pro18 gram, to knowingly disclose the results of any toxi19 cological urinalysis in connection with any drug test20 ing program, except—

21 ‘‘(A) as provided in the regulations issued

22 under section 572,

23 ‘‘(B) that if the person is authorized to

24 represent—
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1 ‘‘(i) an educational institution in

2 which a participant described in section

3 572(d) is enrolled,

4 ‘‘(ii) an organized interscholastic or

5 intercollegiate athletic team, league, or as6 sociation, or

7 ‘‘(iii) an organization that conducts

8 organized athletic competition under the

9 auspices of or sanctioned by the United

10 States Olympic Committee or any member

11 thereof,

12 such person may disclose the results of a toxi13 cological urinalysis performed on a participant

14 described in section 572(d) in connection with

15 a drug testing program, and

16 ‘‘(C) that if the person is authorized to

17 represent a team, league, or association which

18 conducts a drug testing program in which par19 ticipants in athletic competitions who are paid

20 for their performance are test subjects, such

21 person may disclose the results of a toxi22 cological urinalysis performed on such partici23 pant in connection with a drug testing program,

24 ‘‘(3) to knowingly—
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1 ‘‘(A) alter or falsely report the results of a

2 toxicological urinalysis, or

3 ‘‘(B) adulterate any urine specimen (other

4 than a specimen spiked for use in performance

5 testing),

6 in connection with any drug testing program or per7 formance testing,

8 ‘‘(4) except in connection with epidemiological,

9 biomedical, or other medical research in which the

10 identity of the person providing the urine specimen

11 is unknown, to knowingly perform or cause to be

12 performed on a urine specimen a test for any medi13 cal condition or any substance, other than alcohol or

14 a drug or drug class for which the Secretary has

15 prescribed test methods and cutoff levels under sec16 tion 572(a) or 562(b)(2), without the consent of the

17 person providing the urine specimen following disclo18 sure to such person of the medical condition or sub19 stance for which testing will be performed,

20 ‘‘(5) if the consent of a person providing a

21 urine specimen is required under paragraph (4) be22 fore the specimen may be tested, to take any adverse

23 action against such person for refusing to give such

24 consent, unless such person is a participant de25 scribed in section 572(d) or is a participant in ath-
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1 letic competition who is paid for the participant’s

2 performance,

3 ‘‘(6) in the case of a toxicological urinalysis, to

4 take any adverse action against any test subject

5 based, in whole or in part, upon a positive result

6 that has not been confirmed by a test—

7 ‘‘(A) which uses gas chromatography/mass

8 spectrometry (or, in the case of alprazolam,

9 which uses high-performance liquid chroma10 tography), or

11 ‘‘(B) which, after the establishment of the

12 certification program under section 571, is per13 formed in accordance with the requirements of

14 such program,

15 ‘‘(7) in the case of a toxicological urinalysis,

16 where a confirmed positive result has not been veri17 fied by a medical review officer because there exists

18 a legitimate medical explanation for the result con19 sistent with legal drug use, including use of a drug

20 pursuant to and in accordance with a valid prescrip21 tion, or because the result is scientifically insuffi22 cient for further action, to take any adverse action

23 against any test subject based in whole or in part

24 upon such result, except that, in the case of a drug

25 testing program conducted in connection with ath-
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1 letic competition, a medical review officer may verify

2 a confirmed positive result for any drug described in

3 subsection (a)(2)(B) notwithstanding the existence

4 of a legitimate medical explanation for the result,

5 and adverse action may be taken against any partici6 pant in athletic competition based upon such result,

7 or

8 ‘‘(8) to knowingly fail to administer or conduct

9 any toxicological urinalysis or drug testing program

10 in accordance with the requirements of the certifi11 cation program established under section 571 or the

12 regulations issued under section 572.

13 As used in paragraph (4), the term ‘any medical condition

14 or any substance’ does not include creatinine, pH, or spe15 cific gravity.

16 ‘‘SEC. 575. SANCTIONS AND REMEDIES.

17 ‘‘(a) CRIMINAL PENALTY.—A person who violates

18 section 574(a) shall be subject to imprisonment for not

19 more than 3 years, or a fine under title 18, United States

20 Code, or both.

21 ‘‘(b) ADMINISTRATIVE REMEDIES.—

22 ‘‘(1) A laboratory performing any toxicological

23 urinalysis in connection with any drug testing pro24 gram that violates any regulation issued under sec25 tion 572 shall be subject to assessment by the Sec-
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1 retary of a civil penalty of not less than $1,000 or

2 more than $10,000, taking into account the previous

3 record of the laboratory under sections 571 and 572

4 and the gravity of the violation.

5 ‘‘(2) If the Secretary discovers a violation of

6 any regulation issued under section 572 by any per7 son other than a laboratory, the Secretary shall refer

8 the matter to the Attorney General for further inves9 tigation and appropriate action.

10 ‘‘(c) INJUNCTION.—The Secretary or the Attorney

11 General, as appropriate, or any aggrieved person, may

12 bring an action to restrain violations of section 574(a) or

13 any regulation issued under section 572. In any action

14 brought under this subsection, the district courts of the

15 United States shall have jurisdiction for cause shown, to

16 issue declaratory relief, temporary restraining orders, and

17 preliminary and permanent injunctions to require compli18 ance with such provisions.

19 ‘‘(d) CIVIL ACTION.—Any test subject who is tested,

20 or whose test results are handled, in violation of, or is

21 deprived of rights because of a violation under, subsection

22 (a) or paragraphs (1) through (7) of subsection (b) of sec23 tion 574, or who is adversely affected by a material breach

24 in an applicable chain of custody under section 572, may

25 institute a civil action in any district court of the United
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1 States of competent jurisdiction for appropriate legal and

2 equitable relief, including employment, reinstatement, pro3 motion, the payment of lost wages and benefits, and dam4 ages. The costs of suit, including a reasonable attorney’s

5 fee, shall be allowed to a prevailing party. Such an attor6 ney’s fee shall be allowed in the manner in which attor7 ney’s fees are allowed under the last sentence of section

8 722 of the Revised Statutes (42 U.S.C. 1988). It shall

9 not be a defense to such an action that the plaintiff has

10 waived the rights or protections provided for in this sec11 tion or has otherwise consented to a violation, deprivation,

12 or breach. No action may be instituted under this sub13 section after the expiration of 2 years from the date the

14 person discovers the violation, deprivation, or breach.

15 ‘‘(e) INDEMNIFICATION AND CONTRIBUTION.—Any

16 person conducting a drug testing program who takes any

17 adverse action against any test subject based, in whole or

18 in part, upon a report by a laboratory of a positive test

19 result which is thereafter found to have been a false posi20 tive result and who consequently is held liable under sub21 section (d) for damages or other sums may institute a civil

22 action against such laboratory for indemnification or con23 tribution, as appropriate, in any district court of the Unit24 ed States of competent jurisdiction. No action may be in25 stituted under this subsection after the expiration of one
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1 year from the date on which a judgment under subsection

2 (d) becomes final.

3 ‘‘SEC. 576. CONSTRUCTIONS.

4 ‘‘(a) IN GENERAL.—Nothing in this part limits the

5 authority—

6 ‘‘(1) of the Secretary under section

7 571(c)(1)(B)(i) to permit an agency or accrediting

8 body described in section 571(c)(1)(B)(ii) to main9 tain, or

10 ‘‘(2) of any test subject or duly authorized rep11 resentative of a test subject to contract for,

12 standards, procedures, or requirements more protective of

13 test subjects than those provided by the certification pro14 gram established under section 571 or the regulations is15 sued under section 572.

16 ‘‘(b) LIMITATION.—Notwithstanding subsection

17 (a)(1), the Secretary shall not permit an agency or accred18 iting body described in section 571(c)(1)(B)(ii) to deny

19 certification under section 571 to any laboratory comply20 ing with the standards, procedures, and requirements es21 tablished by the Secretary under section 571.

22 ‘‘(c) CERTIFICATION.—To the extent that this part

23 imposes a more protective standard, procedure, or require24 ment on—

25 ‘‘(1) the Secretary,
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1 ‘‘(2) laboratories performing toxicological uri2 nalysis, or

3 ‘‘(3) a person conducting a drug testing pro4 gram, such standard, procedure, or requirement

5 shall supersede and replace that provided by the

6 HHS guidelines and by any statute, rule, regulation,

7 Executive order, or other law in effect on the date

8 on which such standard, procedure, or requirement

9 becomes effective.

10 ‘‘SEC. 577. PREEMPTION.

11 ‘‘(a) IN GENERAL.—No State or local government

12 may adopt or enforce any law, rule, regulation, ordinance,

13 standard, or order relating to—

14 ‘‘(1) the certification of laboratories which per15 form drug testing, or

16 ‘‘(2) requirements for the conduct of drug test17 ing under the certification program established

18 under this part,

19 which is different from such certification program.

20 ‘‘(b) PROHIBITION.—No State or local government

21 may adopt or enforce any law, rule, regulation, ordinance,

22 standard, or order that permits or requires any act prohib23 ited by section 574.
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1 ‘‘SEC. 578. FEES.

2 ‘‘The Secretary shall require the payment of fees by

3 a laboratory for certification and recertification in such

4 amounts as the Secretary may, from time to time, deter5 mine are necessary to recover the cost of granting or deny6 ing such certification or recertification under the certifi7 cation program established under section 571. The Sec8 retary shall also require the payment thereafter of annual

9 fees by certified laboratories in such amounts as the Sec10 retary may, from time to time, determine are necessary

11 to recover the cost of ongoing testing, inspection, inves12 tigation, enforcement, and other supervisory activities with

13 respect to certified laboratories under this part and such

14 certification program. Subject to appropriation Acts, the

15 Secretary may use fees collected under this section to ad16 minister the certification program under section 571 and

17 to carry out the activities described in the preceding sen18 tence.

19 ‘‘SEC. 579. DEFINITIONS.

20 ‘‘As used in this part—

21 ‘‘(1) the term ‘blank specimen’ means a urine

22 specimen containing no drug,

23 ‘‘(2) the term ‘controlled substance’ has the

24 meaning given to it in section 102(b) of the Con25 trolled Substances Act (21 U.S.C. 802(6)),
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1 ‘‘(3) the term ‘drug’ means any controlled sub2 stance and any metabolite of a controlled substance,

3 ‘‘(4) the term ‘drug testing program’ means

4 any program or policy under which 2 or more indi5 viduals are, or can reasonably be expected to be, re6 quired or requested to submit urine specimens for

7 toxicological urinalysis, but such term does not in8 clude—

9 ‘‘(A) any program for toxicological urinal10 ysis—

11 ‘‘(i) administered by the armed forces

12 (as defined in section 2101(2) of title 5,

13 United States Code) or the intelligence

14 community (as defined in Executive Order

15 12333 of December 4, 1981), or

16 ‘‘(ii) involving the testing of arrestees,

17 detainees, probationers, incarcerated per18 sons, or parolees in the criminal justice

19 system, and

20 ‘‘(B) the submission to a laboratory of any

21 urine specimen by an individual’s physician if

22 the testing by the laboratory of the specimen is

23 to be conducted as part of the regular course of

24 diagnosis or treatment prescribed by the physi25 cian,
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1 ‘‘(5) the term ‘false positive result’ means a re2 port in connection with any toxicological urinalysis

3 of the presence of a drug in a urine specimen in

4 which that drug is not in fact present at or above

5 the cutoff level for that drug established by the

6 Secretary,

7 ‘‘(6) the term ‘medical review officer’ has the

8 meaning given such term in subpart A of the HHS

9 guidelines,

10 ‘‘(7) the term ‘person’ includes the Federal

11 Government, a State or local government, or any

12 agency of such a government,

13 ‘‘(8) the term ‘performance testing’ means test14 ing of a laboratory’s ability—

15 ‘‘(A) to identify correctly whether a urine

16 specimen contains a quantity of a drug, and

17 ‘‘(B) in the case of a spiked specimen, to

18 identify correctly the amount of any drug in

19 that specimen within qualitative threshold levels

20 and quantitative ranges established by the regu21 lations issued under section 572,

22 ‘‘(9) the term ‘spiked specimen’ means a urine

23 specimen into which a quantity of a drug or drugs

24 has intentionally been placed for use in performance

25 testing,
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•HR 33 IH

1 ‘‘(10) the term ‘test subject’ means an individ2 ual who has been required or requested to submit a

3 urine specimen for toxicological urinalysis in connec4 tion with a drug testing program, and

5 ‘‘(11) the term ‘toxicological urinalysis’ means

6 the performance of any analytical procedure or set

7 of procedures on a urine specimen to identify the

8 presence in that specimen of any drug and the

9 amount thereof.’’.

10 SEC. 3. EFFECTIVE DATE.

11 Part F of title V of the Public Health Service Act,

12 added by section 2, shall take effect on the date of the

13 enactment of this Act, except that subsections (a), (b)(2),

14 and (b)(8) of section 574 of such part shall take effect

15 one year after the date the Secretary of Health and

16 Human Services establishes the laboratory certification

17 program under section 571 of such part.

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HR 33 IH——2